Egypt needs a new inclusive and equitable economic growth model. Unemployment has spiked since the 2011 revolution, clearing over 12 percent, a figure which is not expected to decrease for several years at least and the situation is even more dire for the country’s youth. While the likely IMF program will offer the macroeconomy a measure of relief, it cannot reverse decades of mismanagement. Egypt’s private sector may therefore not experience a recovery in the near future. The government’s situation looks similarly stressed as its gross debt is projected to rise from 73 percent of GDP in 2010 to 79 percent this year. Combined with the confusion surrounding the government’s structure and organization, it is unlikely that the public sector can fill the jobs gap or provide the needed high quality and affordable goods and services. However, the legal limbo surrounding inclusive business models (IBs) as well as intermediary support organizations (ISOs), which are supposed to provide the needed support to IBs, has unnecessarily shrunk this sector of the economy and disabled it from playing its necessary role.

In his inaugural speech, Egyptian President Mohamed Morsi portrayed himself as a president for all Egyptians, including the menial and underprivileged rickshaw drivers. The Muslim Brotherhood’s Al-Nahda Program emphasizes social justice and a consensus vision across all groups in society. The new leadership is committed to social innovation with “a national strategy to develop mechanisms to support innovation dealing with community issues.”

Although the constitution has not yet been drafted and there is currently no parliament, this moment in time contains a golden opportunity for the government of Egypt to capture the energy, civic engagement and entrepreneurial spirit in the country. Under Mubarak, Egypt’s economic growth and business policy reforms helped foster the private sector, but 85 percent of the population continued to live under $5/day and this ratio did not change during the decade of growth prior to 2008. Safeguards against abuse and incentives for inclusiveness were missing, and the economy became dominated by crony capitalism with wealth concentrated in the hands of a few. People’s perception of inequity and dissatisfaction with public services increased. The governance indicators of “Voice & Accountability” and “Control of Corruption” deteriorated from 2000 to 2010, even though there was a steady improvement in “Regulatory Quality.”

Egypt needs an enabling legal framework to promote a more equitable growth model. Such a framework should encourage forms of inclusive businesses (such as cooperatives) and ISOs that could help micro and small enterprises. These firms (with less than 50 employees) represent nearly 99 percent of all non-public sector, non-agricultural firms and provide about 80 percent of employment in Egypt. But their expansion has been restricted because of the weakness of the ecosystem of incubators, angel investor networks, microfinance institutions (MFIs) and impact investors necessary to allow young entrepreneurs to start up and grow. This policy paper argues that legal and regulatory reforms that encourage ISOs and allow new forms of inclusive business to register and operate are a necessary first step towards a new inclusive growth model.

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• Download the full paper

      

Before the City Club in Cleveland, Bruce Katz emphasized the importance of Ohio's older industrial cities for the state's overall prosperity and outlined, despite seemingly grim statistics, why now is the time for a rebirth of those places and how it can be achieved.

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• Download Remarks by Lt. Gov. Fisher

       

Editor's Note: At a “Restoring Prosperity” gathering at Cleveland State University, Bruce Katz called upon Ohio’s leaders to take bold measures to stabilize the state’s economy by focusing on core communities—home to the assets that are key to recovery.

I want to thank Ned Hill of Cleveland State, Lavea Brachman of Greater Ohio, and Randell McShepard of Policy Bridge for hosting this important forum today.

Last Thursday I attended a keynote speech by Ban Ki Moon, the Secretary General of the United Nations.

The Secretary General provided a sober analysis of the stark challenges facing the global community:

• The worst economic and financial crisis since the Great Depression;
• the acquisition and testing of nuclear weapons by rogue states like North Korea and Iran;
• the existential threat of climate change; and
• the continued instability in the Middle East and other regions of the world.

The Secretary General ended his talk with a clarion call for new international frameworks and structures to govern our troubled world.

“This is not a time for tinkering,” he said, “but a time for transformation.”

Ban Ki Moon’s call for transformative thinking and action frames my talk today.

A housing crisis—fueled by reckless lending and regulatory abdication—has evolved into a full blown economic collapse, here and abroad.

In the last year, the US unemployment rate rose almost 4 percentage points, and now stands at 9.4 percent. In March, 13.2 million people were unemployed—the highest number since records started being kept in 1948.

On a whole series of indicators, in fact, we are at the worst levels since the government started tallying this information 40, 50, 60 years ago:

• continued unemployment claims
• consumer confidence index
• housing starts
• new home sales
• new home completions

Ohio doesn’t look any better, and on many indicators it is faring worse than the nation as a whole. The state’s unemployment rate is currently over 10 percent. Ohio is one of the four states whose metros were hit hardest in terms of employment figures over the last year (with Michigan, California, and Florida).

Downloads

• Full Speech

       

       

       

      

      

As expected, on August 10, Prime Minister Recep Tayyip Erdoğan from the Justice and Development Party (AKP) decisively won Turkey’s first directly-elected presidential election. He received just about 52 percent of the votes, falling somewhat short of the 55 percent that the polls were predicting.

At a time when Turkey’s neighborhood is in a state of chaos and the country is deeply polarized, what will his next steps as president be? Will he transform Turkey’s political system from a parliamentary to a presidential one? Will he be able to simultaneously run his party, control the prime minister and be the president of Turkey? Will he be able to overcome the authoritarian and abrasive politics of the last two years and replace it with politics reminiscent of the mid-2000s characterized by consensus building and liberal reforms? Or will it be a case of more of the same?

Traditionally, presidents were elected by members of the Turkish Parliament, and had limited powers. However, Erdoğan has been aspiring for a strong presidency since AKP won close to half of the votes at the national elections in June 2011. While serving as prime minister, Erdoğan attempted to write a new constitution, but resistance from opposition parties together with the May 2013 Gezi Park protests and the December 2013 corruption scandal prevented him from achieving his goal. Consequently, his fallback plan has been to emerge triumphant from the 2014 presidential elections,use the presidential powers in the current constitution to its full extent and aim to get AKP to emerge from the parliamentary elections scheduled for June 2015 with enough seats, enabling him to see to the adoption of a new constitution. This new constitution would transform Turkey’s parliamentary system into a presidential one and give Erdoğan the possibility to run the country until 2023, the Republic’s centenary.

Erdoğan’s Opponents: İhsanoğlu and Demirtaş

Ekmeleddin İhsanoğlu and Selahattin Demirtaş were Erdoğan’s main opponents. Although neither constituted major challenges for Erdoğan, each represent something significant for Turkey. The left-leaning secularist Republican People’s Party (CHP) and right-wing Nationalist Movement Party (MHP) joined forces to support İhsanoğlu’s candidacy. İhsanoğlu, born and raised in Cairo, a prominent religious scholar, and a secretary-general of the Organization of Islamic Cooperation from 2004 to 2010, was seen as the best candidate to attract former AKP members, and votes from the wider conservative electorate. Though he lacked political experience and visibility in Turkey, he managed to receive more than 38 percent of the votes. This performance falls short of the 44 percent that CHP and MHP garnered at the local elections in March this year, but would still be considered as a respectable performance.

Demirtaş, a prominent figure amongst Turkey’s Kurdish minority population and a keen partner in government efforts to find a political solution to the Kurdish problem in Turkey, ran for presidency on a secular and somewhat leftist agenda, sensitive to the interests of especially minorities and women. He received almost 10 percent of the votes, one point short of most poll predictions, but almost twice the amount that his party, Peace and Democracy Party (BDP), received in March local elections. This suggests that Demirtaş received support not just from Kurdish, but also Turkish voters, a very significant development in terms of politics in Turkey.

How Has the Turkish Political System Worked in the Past?

With Erdoğan’s victory, Turkey is now at an important crossroad. Since World War II, Turkey has been a parliamentary system. The prime minister was the head of the executive branch of government and the president, elected by the parliament, held a ceremonial role. This changed after General Kenan Evren led the 1980 military coup d’état. In 1982, Evren introduced a new constitution that empowered the president with some executive powers intended to exert some control over civilian politicians. However, with the exception of Evren and his successor, Turgut Özal, subsequent presidents, Süleyman Demirel and Ahmet Necdet Sezer, refrained from using these constitutional powers in any conspicuous manner. So where did the notion of a directly-elected president come from?

The idea of a president elected directly by the electorate, rather than by the parliament, is an outcome of the military’s interference in politics in 2007. As the end of the staunchly secular and politically shy Sezer’s term approached, the military in a rather undemocratic manner, tried to prevent the then-Minister of Foreign Affairs, Abdullah Gül, from becoming president. The military and the judicial establishment deeply distrusted Gül’s, as well as the AKP’s, commitment to secularism. The government overcame the challenge by calling for an early snap election that AKP won handsomely, opening the way for Gül’s election as the new president. Furthermore, the electoral victory encouraged Erdoğan to hit back at the military by calling for a referendum on whether future presidents should be directly elected by the people or by the parliament. Erdoğan’s initiative received support from 58 percent of the electorate, thereby quite decisively demonstrating to his opponents the very extent of his popularity while allowing him to emphasize the “will of the people” as the basis of his understanding of democracy.

The Campaigns: Two Approaches to Turkey’s Future

The 2014 presidential campaign unfolded as a competition between two political approaches to the future of governance in Turkey. The first approach, represented by Erdoğan, calls for a narrow and majoritarian understanding of democracy based on the notion of the “will of the people” (milli irade) at the expense of constitutional checks and balances and separation of powers. In return for such an authoritarian form of governance, Erdoğan promises a prosperous Turkey that will grow to be the 10th largest economy by 2023 and become a major regional, if not global power. It is with this in mind that Erdoğan aspires for a powerful presidential system dominated by him alone. The second approach, especially pushed for by İhsanoğlu, advocates the maintenance of the existing parliamentary system and warns that a hybrid system where both the prime minister and the president is elected directly by the people, risks creating instability, tension and polarization within the country. He advocated for a president who would be above party politics and who would focus on protecting freedoms and the rule of law.

Does Erdoğan Have a Mandate?

What will Erdoğan do now? He is confident that he enjoys wide-spread popularity among the masses. However, it is difficult to conclude if the electorate went to the polls on Sunday with a referendum to change the political system in mind. If they did, then they did so with a rather slim margin. Nevertheless, it is likely that Erdoğan will interpret the results of the elections as an explicit approval of his political agenda, and will thus proceed to transform Turkey towards a presidential system. However, a number of challenges will be awaiting his project. The first and immediate challenge will emerge with respect to the next prime minister. As a prominent Turkish columnist put it, Erdoğan will want a prime minister who will always be “one step behind”. But will politics allow for this to occur? Can Erdoğan find a loyal and unquestioning prime minister? The current constitution requires the president to resign his/her political party affiliations. Once he takes up his position as president at the end of August, will he be able to continue to enjoy control over AKP from a distance? This is not a challenge to be taken lightly considering that there will be parliamentary elections in 2015 and the ranks of AKP will be quite restless both in terms of the selection of candidates, as well as the prospects of ensuring a victory at the polls. Lastly, with ISIS’s growing power, political instability in many neighboring countries, a troubled relationship with the European Union and the United States and continued bloodbath in Syria, keeping the Turkish economy on course may turn out to be Erdogan’s greatest challenge. The coming months are going to be critical in terms of whether Erdoğan will overcome these challenges and succeed in transforming Turkey’s political system. The outcome will illustrate if Erdoğan is actually bigger than Turkey or vice versa. However, whatever happens in the next few months, it will largely determine if in 2023, Turkey will celebrate its centenary as a liberal or illiberal democracy. In the meantime, the fact that Erdoğan plans to use a constitution that was drawn up under military tutelage to achieve his presidential ambitions is both ironic, but also not very promising in terms of Turkey’s democracy turning liberal.

Editor's Note: Ranu Nath, the Turkey Project intern in the Foreign Policy Program at Brookings, contributed to this piece.

       

Editor's Note: During an appearance on the Platts Energy Week program, Mark Muro discussed jobs in the green sector, using findings from the "Sizing the Clean Economy" report.

Host BILL LOVELESS: Green jobs – what are they? And can they make much of a contribution to the economy? It’s an ongoing debate in Washington, and the rest of the U.S. for that matter, and it’s a knotty one because defining the term “green jobs” is difficult.

But now the Brookings Institution has taken a crack at it with a new report, “Sizing the Clean Economy.” One of the authors, Mark Muro, with the Brookings Metropolitan Policy Program, joins me now. Mark, do you think you’ve defined, once and for all, what the clean economy is?

MARK MURO: The answer to that is “no.” This has been an ongoing discussion for decades, really. On the other hand, I do think that we have done is tried to embrace good precedents, good sensible precedents from Europe. The European Statistical Agency comes at it similar to the way we did. But we’ve also anticipated where the Bureau of Labor Statistics, here in the U.S., will be next year when it offers our first U.S. official definition.

LOVELESS: A summer preview, maybe. I know the Bureau of Labor Statistics is working on that. Should this report ... tell me a little bit about this report — where the jobs are and should this in any way change the way we look at green jobs.

MURO: I think one thing that comes from this is that it’s a broad swath of, sometimes not very glamorous, industries that are very familiar. Wastewater, mass transit – those are properly viewed as green jobs because they take pressure off the environment. They keep our environment clean.

Watch Mark Muro's full interview with Platts Energy Week »

       

     

Event Information

From August 3 to 6, 2005, fifty preeminent international leaders from the public, private, and nonprofit sectors came together at the Aspen Institute for a roundtable, "The Private Sector in the Fight against Global Poverty."

The roundtable was hosted by Richard C. Blum of Blum Capital Partners and Strobe Talbott and Lael Brainard of the Brookings Institution, with the active support of honorary cochairs Walter Isaacson of the Aspen Institute and Mary Robinson of Realizing Rights: The Ethical Globalization Initiative. By highlighting the power of the market to help achieve social and economic progress in the world's poorest nations, the roundtable's organizers hoped to galvanize the private, public, and nonprofit sectors to move beyond argument and analysis to action. Put simply, as Brookings president Strobe Talbott explained, the roundtable's work was "brainstorming with a purpose."

With experts hailing from around the world and representing diverse sectors and approaches, the dialogue was as multilayered as the challenge of poverty itself. Rather than summarize the conference proceedings, this essay weaves together the thoughtful observations, fresh insights, and innovative ideas that characterized the discussion. A companion volume, Transforming the Development Landscape: The Role of the Private Sector, contains papers by conference participants, providing in-depth analysis of each conference topic.

View the 2005 report » (PDF)
View the conference agenda »
View the list participants »

      

Event Information

Lifting an estimated 1.2 billion people from extreme poverty over the next generation will require robust and broadly-shared economic growth throughout the developing world that is sufficient to generate decent jobs for an ever-expanding global labor force. Innovative but affordable solutions must also be found to meet people’s demand for basic needs like food, housing, a quality education and access to energy resources. And major investments will still be required to effectively address global development challenges, such as climate change and child and maternal health.  On all these fronts, the private sector, from small- and medium-sized enterprises to major global corporations, must play a significant and expanded role.

On August 4-6, 2013, Brookings Global Economy and Development is hosting the tenth annual Brookings Blum Roundtable on Global Poverty in Aspen, Colorado. This year’s roundtable theme, “The Private Sector in the New Global Development Agenda,” brings together global leaders, entrepreneurs, practitioners and public intellectuals to discuss how the contribution of the private sector be enhanced in the push to end poverty over the next generation and how government work more effectively with the private sector to leverage its investments in developing countries. 

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Roundtable Agenda

Sunday, August 4, 2013

Welcome: 8:40AM - 9:00AM MST
Brookings Welcome
• Strobe Talbott, Brookings

Opening Remarks
• Richard C. Blum, Blum Capital Partners, LP and Founder of 
the Blum Center for Developing Economies at UC Berkeley
• Julie Sunderland, Bill and Melinda Gates Foundation
• Kemal Derviş, Global Economy and Development, Brookings

Session I: 9:00AM - 10:30AM MST
Framing Session: Reimagining the Role of the Private Sector
In this opening discussion, participants will explore the overarching questions for the roundtable: How can the contribution of the private sector be enhanced in the push to end poverty over the next generation? What are the most effective mechanisms for strengthening private sector accountability? How can business practices and norms be encouraged that support sustainable development and job creation? How can business build trust in its contributions to sustainable development?

Moderator
• Nancy Birdsall, Center for Global Development

Introductory Remarks
• Homi Kharas, Brookings Institution
• Viswanathan Shankar, Standard Chartered Bank
• Shannon May, Bridge International Academies


Session II: 10:50AM - 12:20PM MST
Private Equity
Participants will explore the following questions for the roundtable: What are the constraints to higher levels of private equity in the developing world, including in non-traditional sectors? How can early-stage investments be promoted to improve deal flow? How can transaction costs and technical assistance costs be lowered?

Moderator
• Laura Tyson, University of California, Berkeley

Introductory Remarks
• Robert van Zwieten, Emerging Markets Private Equity Association
• Runa Alam, Development Partners International
• Vineet Rai, Aavishkaar

Dinner Program: 6:45PM - 9:15PM MST
Aspen Institute Madeleine K. Albright Global Development Lecture

Featuring
• Dr. Paul Farmer, Chief Strategist and Co-Founder, Partners in Health

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Monday, August 5, 2013

Session III: 9:00AM - 10:30AM MST
Goods, Services and Jobs for the Poor
Participants will explore the following questions for the roundtable: In what areas are the most promising emerging business models that serve the poor arising? What are the major obstacles in creating and selling profitable, quality, and beneficial products to the poor and how can they be overcome? What common features distinguish successful and replicable solutions?

Moderator
• Mary Robinson, Mary Robinson Foundation

Introductory Remarks
• Ashish Karamchandani, Monitor Deloitte
• Chris Locke, GSMA
• Ajaita Shah, Frontier Markets
• Hubertus van der Vaart, SEAF

Session IV: 10:50AM - 12:20PM MST
Blended Finance
Participants will explore the following questions for the roundtable: Can standard models of blended finance deliver projects at a large enough scale? How can leverage be measured and incorporated into aid effectiveness measures? Should governments have explicit leverage targets to force change more rapidly and systematically?

Moderator
• Henrietta Fore, Holsman International

Introductory Remarks
• Elizabeth Littlefield, OPIC
• Ewen McDonald, AusAID
• Laurie Spengler, ShoreBank International 

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Tuesday, August 6, 2013 

Session V: 9:00AM - 10:30AM MST
Unlocking Female Entrepreneurship
Participants will explore the following questions for the roundtable: How is the global landscape for female entrepreneurship changing? What types of interventions have the greatest ability to overturn barriers to female entrepreneurship in the developing world? Who, or what institutions, should lead efforts to advance this agenda? Can progress be made without a broader effort to end economic discrimination against women?

Moderator
• Smita Singh, Independent

Introductory Remarks
• Dina Powell, Goldman Sachs
• Carmen Niethammer, IFC
• Randall Kempner, ANDE

Session VI: 10:50AM - 12:20PM MST
U.S. Leadership and Resources to Engage The Private Sector
Participants will explore the following questions for the roundtable: How can U.S. foreign assistance be strengthened to more effectively promote the role of the private sector? How can U.S. diplomacy support private sector development in the emerging economies and multinational enterprises investing in the developing world? What can the US do to promote open innovation platforms?

Moderator
• George Ingram, Brookings

Introductory Remarks
• Sam Worthington, InterAction
• John Podesta, Center for American Progress
• Rajiv Shah, USAID

Closing Remarks
• Richard C. Blum, Blum Capital Partners, LP and Founder of the Blum Center for Developing Economies at Berkeley
• Kemal Derviş, Global Economy and Development, Brookings

Public Event: 4:30PM - 6:00PM MST
Brookings and the Aspen Institute Present: "America's Fiscal Health and its Implications for International Engagement"
Global Economy and Development at Brookings and the Aspen Institute will host the 66th U.S. Secretary of State Condoleezza Rice and Administrator of the U.S. Agency for International Development Rajiv Shah for a discussion on the current state of the U.S.'s fiscal health and its impact on American diplomatic and development priorities. Moderated by Ambassador Nicholas Burns, Director, Aspen Strategy Group.

Moderator
• Nicholas Burns, Director, Aspen Strategy Group

Panelists
• Condoleezza Rice, 66th United States Secretary of State
• Rajiv Shah, Administrator of the United States Agency for International Development

 

Event Materials

• BBR Participant List 2013_FINAL

       

       

       

       

      

As the income inequality discussion continues to simmer across the country, municipal minimum wage ordinances have become hot topics of conversation in many cities. In January 2016, Seattle will implement its second step-up in the local minimum wage in 9 months, reaching $13 for many employers in the city and edging closer to a $15 an hour minimum that will apply to most firms by 2019. San Francisco will reach a $15 an hour minimum by July 2018. Yet cities as diverse as Birmingham, Chicago, Los Angeles, and Louisville have enacted or proposed similar minimum wage laws. It is too early to discern true impact of these local wage ordinances, but speculation abounds regarding whether or how the higher wage will affect firms and the earnings of low-wage workers.

Less prominent in debate and discussion about the minimum wage is the potential impact that higher minimum wage rates may have for nonprofit organizations. Nonprofits perform many critical functions in our communities—often serving the most at-risk and disadvantaged. Yet, fiscal constraints often place a low ceiling on what many nonprofits can pay frontline staff. As a result, many different types of nonprofit organizations—child care centers, home health care organizations, senior care providers—pay staff at rates near or below the targets set by the recent crop of local minimum wage laws. Our popular image of a minimum wage worker is the teen-age cashier at a drive-through window or the sales clerk at a retail store in the local strip mall, but many workers in these “helping professions” are being paid low wages.

Increases in the minimum wage are occurring at the same time that many nonprofit service organizations are confronted with fixed or declining revenue streams. Facing fiscal pressure, nonprofit service organizations may pursue one or more coping strategies. In addition to reductions in staffing or hours, commonly expected responses, nonprofits may cut back services offered, scale back service areas, or favor clients that can afford higher fees.

Such responses could reduce the amount and quality of the services provided to vulnerable populations. For example, elderly populations on fixed incomes may have fewer options for home care. Working poor parents may find higher child care costs prohibitively expensive. Employment service organizations may find it harder to place hard-to-serve jobseekers in jobs due to more competitive applicant pools.

At the same time, higher minimum wages could have positive consequences for nonprofit staffing and capacity. Higher wages could reduce employee turnover and increase staff morale and productivity. Organizations may not have to grapple with the contradiction of serving low-income persons, but paying modest wages.

The most recent set of wage ordinances take cities to unknown territory. Anticipating potential negative effects, Chicago has exempted individuals in subsidized employment programs from its recent minimum wage ordinance. The city of Seattle has set aside funds to help nonprofits meet the higher local minimum wage, but many nonprofit funding streams are beyond the city’s control and are not seeing similar adjustments.

In the coming years, more research on how local nonprofits are affected by local minimum wage laws needs to occur. We should expect there to be a mix of positive and negative effects within a particular nonprofit organization and across different types of organizations. Nonprofit organizations should be engaged as stakeholders in debates around higher local minimum wages. And, nonprofits should actively engage in research efforts to document the impact of higher wages. In particular, nonprofits should work to compile data that can compare staffing, service delivery, and program outcomes before and after wage laws phase-in. Such data could provide important insight into the impact of local wage ordinances.

We also should be careful not to confuse other challenges confronting the nonprofit sector with the impact of higher minimum wages. For example, private philanthropy to human service nonprofits has failed to keep up with rising need and declining public sector revenue streams in most communities—realities that may pose more serious challenges than minimum wage laws, but ones without an obvious scapegoat.

In the end, ongoing debate around local minimum wage ordinances should provide us with the opportunity to re-examine how we support community-based nonprofits as a society and assess whether that support fits with all that we expect the nonprofit sector to accomplish for children and families in our communities. 

      

       

Policy Brief #175

As the nation strives to recover from the “Great Recession,” job creation remains one of the biggest challenges to renewed prosperity. Small businesses have been among the most powerful generators of new jobs historically, suggesting the value of a stronger focus on supporting small businesses—especially high-growth firms—and encouraging entrepreneurship. Choosing the right policies will require public and private decision-makers to establish clear goals, such as increasing employment, raising the overall return on investment, and generating innovations with broader benefits for society. Good mechanisms will also be needed for gauging their progress and ultimate success. This brief examines policy recommendations to strengthen the small business sector and provide a platform for effective programs. These recommendations draw heavily from ideas discussed at a conference held at the Brookings Institution with academic experts, successful private-sector entrepreneurs, and government policymakers, including leaders from the Small Business Administration. The gathering was intended to spur the development of creative solutions in the private and public sectors to foster lasting economic growth.

	RECOMMENDATIONS
	What incentives and assistance could be made available to “gazelles” and to small business more generally? What policies are likely to work most effectively? In the near term, government policies aimed at bolstering the recovery and further strengthening the financial system will help small businesses that have been hard hit by the economic downturn. Spurred by the interchange of ideas at a Brookings forum on small businesses, we have identified the following more targeted ideas for fostering the health and growth of small businesses (and, in many cases, larger businesses) over the longer run: Improve access to public and private capital. Reexamine corporate tax policy with an eye toward whether provisions of our tax code are discouraging small business development. Promote education to help businesses struggling with shortages of workers with particular skills, and promote research to spur innovation. Rethink immigration policy, as current policy may be contributing to shortages of key workers and deterring entrepreneurs who wish to start promising businesses in our country. Explore ways to foster “innovation-friendly” environments, such as regional cluster initiatives. Strengthen government counseling programs.

The term “small business” applies to many different types of firms. To begin, the small business community encompasses an enormous range of “Main Street” stores and services we use every day, such as restaurants, dry cleaners, card shops and lawn care providers. When such a business fails, it is often replaced by a similar firm. The small business community also includes somewhat bigger firms—in industries such as manufacturing, consulting, advertising and auto sales—that may have more staying power than Main Street businesses, but still tend to stay relatively small, with under 250 employees. While these two kinds of small businesses contribute relatively little to overall employment growth, they are a steady source of mainstream employment. If economic conditions do not support the formation of new businesses to replace the ones that fail, there would be a significant net destruction of jobs and harm to local communities.

Yet another type of small business has an explicit ambition for rapid growth. These high-growth companies are sometimes known as “gazelles.” According to the Small Business Administration, small businesses account for two-thirds of new jobs, and the gazelles account for much of this job creation. The most striking examples—such as Google and eBay—have tended to be in high-tech industries and were gazelles for a significant time before they graduated to be very large businesses. However, gazelles exist in all industry types and in all regions of the country, and the large majority are not grazing in the nation’s technology-dominated Silicon Valleys. According to one expert, the three largest industry categories for high-growth companies are restaurant chains, administrative services and health care companies. One non-high-tech example is Potbelly Sandwiches, a restaurant chain that began in Chicago. Another is the San Francisco-based Gymboree Corporation, a provider of child development programs and children’s clothing.

 

Fostering the Development of High-Growth Companies

High-growth small businesses represent only about 5 percent of total startups, making it important to determine how to spot and foster them. A key common characteristic is that growth is critically dependent on the entrepreneurs who start these companies; they are people on a mission, charismatic leaders who can inspire creativity and commitment from their staffs.

The age of these firms is highly correlated with when their growth is highest. Generally, the most dramatic growth occurs after at least four years of existence—and coincidentally lasts about four years—before it slows again to a more typical pace for small businesses. Of course, some firms such as Google defy this pattern and continue to experience high growth for many years.

Although dynamic small businesses can be found nearly everywhere and in many industries, some regions spawn more of them than others. These regions may have especially supportive features, such as a critical mass of potential workers with relevant skills, a social climate and network that encourage idea generation, locally available venture capital, or some combination of these factors.

Unfortunately, attempts to anticipate which companies or even industries are likely to produce gazelles are prone to error. Thus, excessive emphasis on national industrial policies that favor specific industries are likely misplaced. Without knowing how to target assistance precisely, broad strategies, such as assistance with funding, knowledge, contacts and other essential resources, may be the best approach to fostering high-growth businesses. Such support has the added value of also aiding Main Street businesses.

Many of the most promising policies focus on removing obstacles that hinder entrepreneurs with solid business plans from launching and expanding their businesses.

Funding

As a result of the burst of the dot.com bubble in early 2000 and the recent financial crisis, small businesses have found the availability of venture capital funds drastically diminished. The crisis has also made it more difficult to obtain funding from banks and other conventional means. These trends particularly affect the “missing middle” of small businesses—roughly, those with between 10 and 100 employees.

The venture capital market. Historically, venture capital has financed only a relatively small portion of small businesses, but those financed have tended to be the ones with the greatest growth potential. In recent years, firms that eventually grew to where they could issue initial public stock offerings generally relied more heavily on venture capital financing than the average small business.

The dollar value of venture capital deals funded today is only about one-fifth the size it reached at its peak. While the peak amount may have been too large, today’s value is probably too small. With their capital heavily invested in a small range of industries and locales, it seems likely that venture capital firms have missed a high proportion of potential investment opportunities. Further, “once burned, twice shy” funders have increasingly focused on larger, later-stage ventures. Consequently, mezzanine financing, which new companies need to survive and thrive in the critical early stages, is scarce.

The funding problems partly stem from venture capital firms today having less money to invest. Some investors who formerly contributed to such firms have become more risk-averse, and worse performance figures have discouraged new investors. Lack of venture capital affects some industries more than others, and even some green energy companies—viewed by some as one of the nation’s more promising industry sectors—have moved to China, where financial support is more readily available.

Bank lending. In contrast to large businesses, which can turn to capital markets for funding, many small businesses are dependent on banks for financing. Although the worst of the 2008–09 credit crunch is behind us, many small businesses still find it difficult to obtain bank loans. Community banks, a key source of small business financing, have been hard hit by losses in commercial real estate, which have limited their lending capacity. Further, many small business owners who historically would have used real estate assets as collateral for expansion loans can no longer do so because of declines in real estate prices. In addition, small businesses that have, in the past, used credit cards to purchase equipment and supplies have been hindered by reductions in credit limits.

Overall economic conditions

The high degree of uncertainty currently surrounding the economic and financing climate may have prompted many entrepreneurs and would-be entrepreneurs to hold off on growth plans. Despite their reputation as high-flying risk-takers, good entrepreneurs take only calculated risks, where the benefits outweigh the dangers. Uncertainties about the future trajectory of the economy merely increase risk without raising potential rewards.

Government policies

Government policies affect the climate for small businesses in many ways. For example, small businesses face substantial hurdles when entering the complicated world of federal grants and contracts. At the state level, severe budget shortfalls mean that even well-designed initiatives to boost small businesses may founder.

The Small Business Administration (SBA) assists the full continuum of small businesses through a variety of means. These include: an $80 billion loan guarantee portfolio; specialized counseling and training centers; specialized business development programs targeting the socially and economically disadvantaged; oversight to ensure that at least 23 percent of federal government contracts go to small businesses (with certain preferences for minority and women-owned businesses); and the Small Business Innovation Research and Small Business Investment Companies programs.

The Obama administration is attempting to broaden support for small businesses by bringing the SBA into multi-agency initiatives that tackle common problems. For example, the Departments of Energy, Commerce, Housing and Urban Development, Education, and Labor, along with the National Science Foundation and the SBA, are supporting a five-year, nearly $130 million Energy Regional Innovation Cluster.

Strength of “social capital”

Through the 1990s, the United States was a worldwide leader in fostering innovation and entrepreneurship and reaped the reward of employment growth. Current international comparisons suggest that we are now closer to tenth place among some 70 nations in our ability to support innovation. Much of what has kept our nation from remaining in the top spot appears to relate to insufficient cultural support for entrepreneurship.

Strong social networks in specific geographic regions appear to substantially bolster the growth of innovative businesses. These networks are built around entrepreneurial dealmakers who serve as the nodes of the network, forming connections among researchers, entrepreneurs and investors. Unfortunately, many regions and industries lack strong networks.

Access to decision-making information. Entrepreneurs need an array of information and advice about how to tackle the problems that arise at different stages in business development. The SBA reports that companies that have taken advantage of their long-term counseling programs, for example, have higher growth than companies that have not.

Opportunity for all. Social networks are self-selecting, and some people have to work extra hard to gain entry to a region’s network of entrepreneurs. While various organizations exist to help women and people of color access entrepreneurial skills and information, these efforts may not suffice. Under-representation of any group presumably would filter out a number of potential high-growth companies.

Workforce issues

A long-time strength of the American workforce, worker mobility has declined. This trend has been attributed in part to an aging population and in part to the current difficulty people have in selling their homes. Businesses report difficulty finding employees with the right training, especially at the technician level, where straightforward vocational training could help.

Global competition

Increasing global competition for good projects, entrepreneurs and capital is a positive trend from an international perspective, but runs counter to the national goal of promoting rapid growth in U.S. industry and employment. Today, many entrepreneurs can choose among starting a business here, in their home country, or even in a third, more hospitable nation. At the same time, current U.S. immigration policy hinders entrepreneurs from coming here to launch their companies. A recent report from The Brookings- Duke Immigration Policy Roundtable concluded that “educated workers with the knowledge and skills to innovate are critical” to the United States and recommended increasing the annual number of skilled visas.

 

Policy Goals for Small Business

Measuring Results

More work is needed to identify key policy goals and priorities related to small business success. Critically, what would constitute “improvement” in public policy regarding small business employment, and how would we measure it? Clearly, increasing the total number of jobs created each year (by both small and large businesses, net of job destruction) would be a positive outcome, all else being equal. Another potential goal would be improving the “quality” of the jobs created, as measured by average compensation or by job creation in new industries or geographic areas where unemployment is high. Creating “good jobs” that bring generous compensation would seem to be always desirable, but this outcome could conflict with other social goals, for example, if the jobs created required skills out of the reach of groups that are traditionally difficult to employ.

Slowing job destruction could be as important as increasing the creation of new jobs, but discouraging layoffs without increasing performance would do more harm than good. The trick is to raise the quality of marginal firms so that their improved performance allows them to retain employees they would otherwise have to let go.

A final key factor in setting policy goals that would support small businesses is measuring the cost to taxpayers of the initiatives that flow from the goals. This includes the subsidy cost contained in the federal budget, as well as costs and tradeoffs in society at large.

Changing Key Policies

Small businesses face both short-run and long-run challenges. With regard to the former, many small businesses have been hard hit by the recession and appear to be lagging behind larger businesses in their recovery. The cyclical struggles of this sector in part reflect the dependence of many small firms on the still-strained banking system for their financing; they also reflect the high toll that our extremely soft labor markets have taken on demand for Main Street goods and services. Thus, government policies aimed at broadly bolstering the recovery and further strengthening the financial system will yield important benefits to small businesses.

The government, in conjunction with the private sector, can also take steps that will foster an economic environment that is supportive of entrepreneurship and economic growth over the long run. Specific policy steps that might help small businesses (and, in many cases, large businesses) include:

Improve access to public and private capital. Implementing serious financial reform will reduce the likelihood that we will see a repeat of the recent credit cycle that has been so problematic for the small business sector. When credit market disruptions do occur, policymakers should be attentive to whether temporary expansions of the SBA loan guarantee program are needed to sustain lending to creditworthy borrowers. The SBA should also consider expanding the points of access to its loan programs through an expansion of its lending partners. Finally, the SBA (or a similar entity) might encourage venture capital funds to broaden their investments beyond familiar areas by systematically bringing these investors together with entrepreneurs from neglected geographic regions and business sectors.

Reexamine corporate tax policy. More thinking is needed about whether provisions in our tax code discourage small business development in a way that is harmful to the broader economy and that places the United States at a relative disadvantage internationally. For example, Congress might consider whether it would be beneficial, on net, to lower employment taxes as a way of spurring hiring at businesses with high-growth potential. In addition, some analysts believe there would be gains from increasing tax credits for research and development and further lowering taxes on capital equipment. A design priority in all cases should be simplicity, as complicated rules can limit take-up among smaller firms that do not have extensive accounting or legal expertise.

Promote education and research. Entrepreneurs report difficulty in finding workers with the skills they need for manufacturing, technology and other jobs that do not require four-year college degrees. Access to such educational opportunities, including tailored vocational training, should be affordable and ubiquitous.

At the university level, improvements are needed in the way academic research is brought to the commercial market. Continued public and private support for basic research might be wise, particularly if we are in a trough between waves of innovation, as some analysts believe. The large investments by the National Science Foundation, National Institutes of Health, Defense Advanced Research Projects Agency, and other ambitious public and private programs laid the groundwork for many of the high-growth businesses of today. It may be worth exploring whether support for research in “softer” areas than the sciences might do an equal or better job of inspiring innovations.

Rethink immigration policy. A reconsideration of limits on H1-B visas might help entrepreneurs struggling with shortages of workers with particular skills. In addition, current immigration policy discourages immigrants who want to establish entrepreneurial businesses in America. Any efforts to expand immigration are frequently perceived as “taking jobs away from Americans,” but studies have shown that new businesses create jobs for Americans.

Explore ways to foster “innovation-friendly” environments. Some regions of the United States clearly do a better job of encouraging innovation. Silicon Valley is the classic example, but there may be as many as 40 such clusters scattered around the country. While clusters often arise organically, typically near major universities, some states have made an explicit commitment to innovation and entrepreneurship. Examples include the Massachusetts Technology Collaborative and California’s Biological Technologies Initiative, involving community colleges statewide. Federal, state and local policymakers should keep a keen eye on ways of adapting best practices from these initiatives as information becomes available about which elements are most effective.

Strengthen government counseling programs. The SBA might do more to expand and tailor its already successful growth counseling programs to better meet the needs of both Main Street and potential high-growth businesses, as well as firms at different developmental stages. Any effort to expand small businesses’ opportunities for federal grants and contracts should be accompanied by significant streamlining of the application process.

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Policy Brief #179

During an "exit interview" with the Wall Street Journal, departing National Economic Council Director Lawrence Summers argued that history would judge the United States based on how well we adjust to China’s emergence as a great power, economically and politically. In the face of China’s progress, America’s manufacturing sector faces major challenges in becoming and remaining competitive and our choice of national economic policies will affect how well we meet those challenges. It is essential that the U.S. trade deficit not balloon as the economy recovers. There is scope to expand our exports in services and agriculture, but improving the competitiveness of U.S. manufacturing is vital.

The U.S. Trade Deficit: Background

Components of the Trade Deficit. The U.S. trade deficit in goods and services was just under $700 billion in 2008—4.9 percent of Gross Domestic Product (GDP). However, the deficit in goods trade was nearly $835 billion, which was partially offset by a $136 billion surplus in services trade. The latter surplus has grown consistently over a range of service types and has important potential to expand. Going forward, we can assume this surplus will remain around one percent of GDP. But services trade surpluses alone cannot solve the U.S. trade deficit problem, because of persistent large deficits in goods trade.

Very important are deficits in the energy sector. In 2008, petroleum products accounted for $386 billion of the total trade deficit (2.7 percent of GDP). reducing energy imports (and consumption) is a significant challenge for the U.S. economy, and with global energy demand continuing to rise and supply constrained, oil prices are more likely to rise than fall. The U.S. bill for imported oil is unlikely to fall below 2.7 percent of GDP for years to come.

In future, for overall U.S. trade in goods and services to be balanced, non-energy products (that is, manufactured and agricultural products) would have to achieve a surplus of around 1.7 percent of GDP. Added to the one percent services surplus, the two would balance out the almost unavoidable petroleum deficit.

Obviously, elements in this rough calculation could shift, for better or worse, but if the U.S. economy is to achieve a more balanced growth path, the competitive position of U.S. manufacturing must improve sharply.

Growth of the U.S. Trade Deficit. In 1999, the U.S. economy was experiencing strong growth and low inflation, but the trade deficit in manufactured and agricultural products was high—$262.5 billion—and concentrated in four broad industry categories. The largest deficit was in plastic, wood and paper products ($62 billion). Transportation equipment—from autos to aerospace—was close behind ($61 billion), followed by textiles and apparel ($52 billion) and computers and electronics ($44 billion). Only two categories had trade surpluses: chemicals at more than $9 billion and agriculture at $4 billion.

By 2008, the trade deficit had risen to $400 billion, an increase of $138 billion or nearly 52 percent in nominal terms. The deficit in computers and electronics accounted for nearly half of the overall increase in the trade deficit (48 percent, a $66 billion increase). Two other industries had large deficit increases: plastic, wood and paper products; and textiles and apparel. By contrast, agricultural products contributed an additional $27 billion to a small 1999 surplus. And transportation equipment reduced its trade deficit by nearly $12 billion. Chart 1 illustrates how the increase in the U.S. goods trade deficit (excluding oil) was distributed by segment between 1999 and 2008.

Rising Imports from China

Simply put, the United States runs chronic trade deficits and China runs trade surpluses because we spend more than we produce, and they do the opposite. The U.S. trade deficit with China in manufactured and agricultural products was already large in 1999—$68.6 billion or 26 percent of the nation’s total trade deficit. By 2008, it had increased to nearly $268 billion. The story of the increasing U.S. trade deficit from 1999-2008—apart from oil—is the explosion in the deficit with China.

Computers and electronic products account for much of the increase in U.S. imports from China. In 2008, China exported $108 billion in these products to the United States, up from less than $19 billion in 1999. Beyond this sector, Chinese exports to the United States have grown strongly pretty much across the board. Although the United States exports agricultural products to China, there is a large return flow of processed and labor-intensive food products. And, while Chinese textile and apparel imports have risen, U.S. demand for Chinese goods in this category has grown only modestly as other emerging economies have become major clothing exporters.

The Nature of Chinese Exports. On a visit to China early in 2010, I heard a memorable speech declaring that the United States is exploiting China. The Chinese perception is based on where profits land. For example, a 2009 survey by Greg Linden, Kenneth Kraemer and Jason Dedrick of the University of California suggests that Apple, Inc. sells iPhones or iPods for several hundred dollars, most of them “made in China,” but the Chinese producer and Chinese workers receive just under four dollars apiece. The retail price of the 2005 video iPod was $299, the wholesale price $224 and the factory price $144.56. The largest part of the factory price ($101.40) came from Japanese components, with U.S. companies other than Apple supplying $14.14 in components and many different suppliers providing other small components. The final assembly and checking is done in China for $3.86, while Apple’s estimated gross margin is $80 per unit sold at wholesale, plus a portion of the retail margin through its Apple online and retail stores.

These same researchers deconstructed the value of a 2005 Hewlett-Packard Notebook PC, which sold at retail for $1,399 and had a factory cost of $856.33. Intel and Microsoft received a total of $305.43 for each computer sold, while the assembly and checking done in China netted $23.76— only 1.7 percent of the retail price. China’s massive export boom in computers and electronics derives from the fact that it is a very good place to assemble electronic products that clearly benefit U.S. companies’ profits. However, China’s policymakers want change; they are determined to attempt to obtain more of the value added of the goods their citizens assemble.

The place of China as a supplier to the United States is further illuminated in the forthcoming book Rising Tide: Is Growth in Emerging Economies Good for the United States? by Lawrence Edwards and Robert Lawrence, who have taken a detailed look at the “unit values” of traded products, particularly U.S. exports and imports. Detailed trade data identify specific classes of products and provide total dollar value and number of physical items sold in each class. For example, the data report the value of electric motors exported by China to the United States, along with the number of motors, which allows a calculation of the price per motor. If a country is selling motors for electric shavers or toys, the unit value will be small; if the motors are for large capital goods, the unit value will be high.

Edwards and Lawrence find a striking result for China, one that also applies to other emerging economies. It turns out that unit values in the same product categories are hugely different. China sells low unit value products to the United States, and the United States sells high unit value products around the world. These price differentials are so great, in fact, they suggest the United States and China are not really competing. They are making completely different things. Perhaps even more surprising, over the past several years, there appears to be no tendency for the unit values to converge. This contradicts the hypothesis that China is successfully moving up the technology or “value ladder.” Instead, U.S. competitors are Europe and Japan.

Although the volume of Chinese exports to the United States has soared, in high-tech, as we saw, it is assembling components originating elsewhere and, in other industries, it is making primarily low value products, such as toys and children’s clothing— market niches where the U.S. would not be expected to be competitive.

China and Multinational Companies

When China emerged from the Cultural Revolution and started on a path to become a productive and market-oriented economy, it faced massive educational, technological and business hurdles. Competent scientists, engineers and managers had been exiled and “re-educated.” Heroic efforts were needed to catch up to developed nations’ economies. Asian precursors such as Japan and Korea had faced their own catch-up challenges, taking advantage of the global market in capital goods to help them, and China followed their lead. Unlike the others, China encouraged direct foreign investments and required partnerships with domestic businesses. These relationships provided not only financing, but also the business and technology skills of global corporations and sped development of Chinese companies.

Germany provides a fascinating case study of the benefits and perils of a strong relationship with China. Spiegel Online notes that the most important driving force behind the current German economic upswing is its exports of sophisticated capital goods to China. German companies find, however, that the Chinese demand access to their industrial know-how. German businesses are reluctant to offend their Chinese customers, but deeply concerned about the loss of intellectual property. Beijing does not want merely to catch up to German companies—its goal is to surpass them. It has already done so in the manufacture of solar panels, by subsidizing research into solar technology. China exports perhaps 70 percent of its output of solar panels, about half of which goes to Germany, where demand is heavily subsidized by the German government. In electricity generation, Beijing invited Western companies to build power plants jointly with domestic Chinese partners. Now the Chinese are upgrading the plants with their own technology, based on what they learned through the German company Siemens and the French company Alstom.

A 2010 study by James McGregor of APCO sharply criticizing Chinese industrial and technology policies provides additional examples of China’s determination to leverage Western technology. Notably, China is expected to spend $730 billion on its rail network by 2020, with about half being used to expand high-speed passenger lines. This level of capital spending is irresistible for European producers. The China National Railway Corporation (CNR) invited Siemens to bid on a $919 million contract to build 60 passenger trains for service between Beijing and Tianjin. Siemens built the first three, but the remaining 57 were built in China by CNR, using 1,000 Chinese technicians Siemens had trained. In March 2009, Siemens announced an agreement for it to build 100 additional high-speed trains to serve Beijing-Shanghai, but China denied such an agreement ever existed. Siemens ultimately received a contract for $1 billion in components, but $5.7 billion went to CNR, which built the trains.

In the long run, China favors its own producers. It brings in foreign companies at the launching of an industry, then uses government procurement to advance the market share of Chinese companies and, eventually, to shut out competition. This strategy has allowed it to build on foreign companies’ expertise, develop domestic champions and raise the technological level of its economy and exports. Because of its large and rapidly growing market, China can pressure foreign companies to partner with Chinese companies, allowing their employees to learn managerial and technical skills. Over time, China has somewhat loosened formal requirements for foreign companies to accept partners, but the strategy of technology and skills transfer remains very much in force.

Developing countries naturally learn from best practices world-wide; indeed the 19th century economic history of the United States includes considerable technology transfer from Britain and the rest of Europe. Nevertheless, companies that have invested heavily to develop new technologies and efficient processes cannot afford to simply allow China to free-ride on their efforts. Yet many Chinese leaders make it clear they are on a mission to acquire the best technology, using their size and growth as a way to obtain it.

A December 23, 2010 New York Times editorial noted this strategy, saying, “[I]ntellectual property misappropriation cannot be a government policy goal, especially in a country the size of China, which can flood world markets with ill-begotten high tech products.” The editorial acknowledged some U.S. progress at the World Trade Organization, but urged our government to be “more vigilant and aggressive” against intellectual property losses.

Helping U.S. Manufacturers Adjust to China

U.S. exports of manufactured goods reached $952 billion in 2009 and grew strongly in 2010. The goal of increasing exports substantially is feasible, given favorable economic conditions and policies. It may even be possible to bring some off-shored production back to the United States, a possibility some manufacturers have been exploring, in order to remediate cost, quality and delivery problems. But first, policymakers must recognize that:

1. Today’s trade deficit is not a technology problem. The U.S. economy simply must become a more attractive place to develop and manufacture new products. The best ways to do this are to balance the budget and lower the marginal tax rate on corporations. Our trade problem is that U.S. companies develop innovative products but choose not to manufacture much of their value here. One chronic reason is that the value of a dollar has been too high, making U.S. production too expensive. If the U.S. saved more and balanced the federal budget, that problem would take care of itself. This would require global exchange rate adjustments including an increase in the real exchange rate of the renminbi, although economic forces will force this to happen without the need for U.S. political action. In addition, the U.S. corporate tax rate is higher than that of other countries, encouraging overseas investments. Both of the recently announced deficit reduction plans provide blueprints for balancing the budget and lowering corporate tax rates.
    
2. Technology may become a problem in the future. The United States should work with the European Union, Japan and multinational companies to develop a uniform code of conduct to protect technology and patents when emerging market companies work with multinationals. Government sanctions that would draw the United States into direct conflict with China are inadvisable, and the World Trade Organization (WTO) has limited effectiveness. Thus, multinational corporations should take the lead and refuse to work with foreign entities that demand access to and misuse proprietary technology. They should be fully informed of past unacceptable practices and the policies and behavior they should expect before entering new markets. If companies nevertheless reveal their technology as the price of market access, that is their choice.
    
3. Policymakers must work with the private sector to identify and reduce barriers to U.S. exports. The expansion of U.S. exports will be in industries such as advanced manufacturing, electronics, aerospace and medical devices. These industries will require new technologies, capital, R&D and skilled labor. There is a strong case for support of technology development through direct funding, improved tax treatment of R&D, increased access to capital and a reduced marginal corporate tax rate. Skill shortages appear to be another important barrier to expansion. Improving the U.S. education and training system in science, math, engineering and technology is a long-term national priority. Furthermore, as recommended by Brookings vice president Darrell West, easing restrictions on H-1B visas to prioritize high-value immigrants with technology expertise is an obvious policy fix with immediate benefits.
    
4. The policy debate must focus on the right issue, and not be drawn down blind alleys. Indicators that the U.S. economy is falling behind must be evaluated carefully. For example, A 2007 National Academy of Sciences study, Rising Above the Gathering Storm, reviewed a range of such indicators. It noted that China is building 50 chemical plants, whereas the United States is building one; and computer chip fabrication plants are being built in China (and elsewhere in Asia), but not in the United States. However, the lack of U.S. investment in these sectors may not be a reason for concern. It can be difficult to operate either bulk petrochemical or chip fabrication plants profitably over the long run, and they create few jobs.
    
5. Companies should focus on innovation and cost reduction and avoid dragging policymakers and themselves along time-wasting tangents. Endless discussions took place during the Clinton administration about how Fuji was competing unfairly with Kodak, whereas the real challenge to Kodak was not Fuji but digital technology. Currently, the World Trade Organization is assessing appeals from the European Union (EU) and the United States regarding its decision that the EU unfairly subsidized Airbus to the detriment of Boeing. Whatever the merits of the arguments in the parties’ six years of legal wrangling over this issue, Boeing’s future success may depend more on how well it solves problems with the new 787, now several years behind schedule, and whether it can make its factories leaner and more productive.

Conclusion

Expanding manufactured exports is a key to our nation’s global competitiveness and reduced trade deficits. Recovery in manufacturing will help employment and the revival of local economies. Competition from emerging economies, especially China, means that innovation in products and processes will be essential to maintaining U.S. leadership. While emerging economies are important markets for U.S. manufacturers, these exchanges should not become opportunities to misappropriate U.S. companies’ intellectual property. U.S. policymakers must create a climate that fosters growth in manufacturing while protecting U.S. innovation and technology.

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Event Information

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

Event Materials

• Continuous Manufacturing Agenda
• CM Panelist Bio Sheet
• Participant list
• Continuous manufacturing discussion guide
• allslides_Continuousmanufacturingworkshop_101915
• meetingsummary_101915_continuousmanufacturing

       

Ghana attained middle-income status after rebasing its National Accounts, pushing per capita gross domestic product (GDP) of the country above $1,000 in 2007. After recovering from economic recession in 1984 on account of the Bretton Woods sponsored economic reform introduced at that time, Ghana’s growth has been remarkably strong, with its lowest economic growth of 3.3 percent recorded in 1994. The country’s growth rate reached its peak of 15 percent in 2011 on the back of the commencement of commercial production of oil, making it one of the fastest growing economies globally during that year. This has translated into increased per capita income, which reached a high of about $1,900 in 2013.

The concern, however, has been the ability of the country to sustain this growth momentum given the level and quality of education and skills, and, more importantly, the failure of this strong growth performance to be translated into the creation of productive and decent jobs, improved incomes and livelihoods. The structure of the economy remains highly informal, with a shift in the country’s national output composition from agriculture to low-value service activities in the informal sector. The commencement of commercial production of oil raised the share of the industrial sector in national output. However, the continuous decline in manufacturing value added undermines Ghana’s economic transformation effort to promote high and secure incomes and improve the livelihoods of the people.

Structural change towards higher value added sectors, and upgrading of technologies in existing sectors, is expected to allow for better conditions of work, better jobs, and higher wages. But the low level and quality of human resources not only diverts the economy from its structural transformation path of development but also makes it difficult for the benefits of growth to be spread through the creation of gainful and productive employment. Thus, productive structural economic transformation hinges on the level and quality of education and labor skills. A highly skilled, innovative and knowledgeable workforce constitutes a key ingredient in the process of structural economic transformation, and as productive sectors apply more complex production technologies and research and development activities increase the demand for education and skills. However, the observed weak human capital base does not provide a strong foundation for structural economic transformation of Ghana.

Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47, suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment.

There is also widespread concern about the quality of the country’s growth in terms of employment and inequality, as well as general improvement in the livelihood of the people (see Alagidede et al. 2013; Aryeetey et al. 2014; Baah-Boateng 2013). A key indicator for measuring the extent to which macroeconomic growth results in gains in the welfare of the citizenry is the quality of jobs that the economy generates. Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47 (see Baah-Boateng 2013), suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment. Besides the slow rate of job creation is the dominance of vulnerable employment and the working poverty rate in the labor market. In 2010, 7 out of 10 jobs were estimated to be vulnerable while only 1 out of 5 jobs could be considered as productive jobs that meet the standard of decent work (Baah-Boateng and Ewusi 2013). Workers in vulnerable employment tend to lack formal work arrangements as well as elements associated with decent employment such as adequate social security and recourse to effective social dialogue mechanisms (Sparreboom and Baah-Boateng 2011). The working poverty rate remains a challenge with one out of every five persons employed belonging to poor households.

The article seeks to provide an analytical assessment of Ghana’s economic growth as one of Africa’s growth giants over a period of more than two decades and the implication for labour market and livelihood outcomes. Growth of labor productivity at the national and sectoral level is examined, as well as the sectoral contribution to aggregate productivity growth. The article also analyses the effect of growth on employment and the employment-poverty linkage in terms of elasticity within the growth-employment-poverty nexus in Ghana. It also delves into a discussion of the constraints on growth and productive employment from both demand and supply perspectives, and identifies skills gaps and the opportunities offered in the country, which has experienced strong growth performance. The article has five sections, with an overview of Ghana’s economic growth performance in Section 2, after this introductory section. This is followed by an overview of the developments in the labor market, specifically in the area of employment, unemployment, poverty, and inequality in Ghana in Section 3. The growth-employment-poverty linkage analysis is carried out in Section 4 followed by a discussion of constraints to growth and employment generation in Section 5. Section 6 provides a summary and conclusion, with some policy suggestions for the future.

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As I anticipated in my post on Tuesday, the Hong Kong government on Wednesday announced the details for the 2017 election of the Chief Executive (CE). Based on press commentary from China, it is clear that the PRC government, which has sovereignty over Hong Kong, approves the package. But to understand the implications for democracy in Hong Kong, it is important to look at the details of the proposal.

Since Hong Kong became a special administrative region of China in 1997, the CE has been chosen by an election committee of between 800 and 1,200 individuals. Beijing had promised that starting in 2017 the CE would be elected by the voters of Hong Kong through universal suffrage. Yesterday’s proposal is the latest step in a transition process toward that system. (For all of the recommendations, see the speech of Chief Secretary Carrie Lam to the Legislative Council.) As I outlined in Tuesday’s post, the principal point of controversy for more than a year has been Beijing’s insistence that a nominating committee choose who gets to stand for election. Hong Kong’s democratic camp believes that the nominating committee will give China an opportunity to “screen out” individuals it does not like.

The most prominent element of the Hong Kong government’s proposal yesterday is a recommendation on the procedural mechanism by which the Nominating Committee (NC) would review candidates. This was important for two reasons. One, under the plan the NC will have the authority to pick two or three final candidates to actually run in the election. Two, Mrs. Lam made clear that that the NC’s membership would be similar to the 1,200-person election committee that has picked the CE up until now and is weighted in favor of people who are biased toward Beijing.

Thus, who the NC considers before making its final nominations becomes critical. That will determine whether the election will provide a choice between the majority who have long favored a quick transition to democracy, and those who have preferred to move slower; and also between those who believe that the current economic system benefits only the rich and should be reformed, and those who are happy with current policies.

The proposed procedural mechanism mandates that any individual who can get recommendations from one-tenth to one-twentieth of the NC will be a “potential candidate” and have the opportunity to articulate his/her policy views to the NC and the public in a transparent way. In effect, this means that the NC will likely consider between five to ten individuals for final nomination. And because pan-democrats will have be at least a minority of the NC membership, as they do in the election committee, they will be able to recommend at least one democrat as a potential candidate. That in turn creates the possibility that a democrat could become a final nominee and compete to become CE. In that case, voters who have supported democracy and believe current economic policies are flawed would have a candidate who shares their general outlook. This mechanism would seem to be consistent with what the spokesman of the U.S. Consulate-General said earlier today: “The legitimacy of the chief executive will be greatly enhanced if the chief executive is selected through universal suffrage and Hong Kong’s residents have a meaningful choice of candidates.”

Let me be clear: the pan-democrats do not like this proposal. They do not like a mechanism that amounts to screening by China, and this one certainly opens a backdoor for Beijing to veto candidates it doesn’t like. In addition, the pan-democrats would like to have a promise from Beijing that this is not the end of the reform process when it comes to electing the CE, but Mrs. Lam gave no hope on that score, even though she said future circumstances might require more change.

The pan-democrats were likely unhappy about the government’s refusal to propose changes on two specific issues. Both concern the sub-sectors that will make up the NC, which will be copied from the current election committee. These subsectors represent different parts of the Hong Kong community, but the balance of voting power favors subsectors that 1) represent various business interests, 2) support Beijing on most issues, and 3) are afraid of populist movements. Back in December, the government floated the idea of shifting the balance of power among the existing subsectors so that under-represented groups got more votes, but on one condition, that the existing subsectors agreed. In the end, no change was made here, perhaps due to the stated reasons that there was no social consensus to make this change and that doing so would only create more political controversy. The more likely reason is that the subsectors that stood to lose their relative power were not willing to have their oxen gored.

The second issue had to do with “corporate voting” within subsectors. In some subsectors the constituent members decide their choices based on the preference of the leader of the member organizations. For example, in a subsector made up of commercial firms, the CEO of each member firm decides how to cast the firm’s vote. The alternative would be to have a larger number of people associated with the firm contribute to the decision, up to all the employees. As a matter of principle, the pan-democratic camp has long called for an end to corporate voting, and while there was an opportunity to do so on this occasion, the government didn’t take it.

So, the pan-democratic bloc in the Legislative Council walked out during Mrs. Lam’s presentation to the Legislative Council and has vowed to vote against this proposal. And if all of them did vote against, that would kill the proposal, because it must pass the Legislative Council by a two-thirds margin and the establishment caucus does not have enough votes on its own. On the other hand, Beijing and the Hong Kong government do not need to win over the whole of the disparate democratic camp. They just have to peel off four opposition legislators to secure the necessary majority. Presumably these would be more moderate politicians who might conclude that the reform package is “good enough” compared to the alternative. That is, Beijing and the Hong Kong government say that if the package is vetoed, election of the CE would revert to the 1,200-member election committee, delaying a one-person, one-vote election for some time. The danger for these moderates in voting for the proposal is that they will be excoriated by their colleagues for defecting and betraying principles, to the point of facing a challenge from within their camp in the next legislative election.

Hong Kong public opinion and legislators in particular have to face a couple of critical questions. The first is whether a system that produces a contest between at least one establishment candidate and one democratic candidate is indeed “good enough.” The recommended system could be improved upon in several ways, of that there is no doubt. On the other hand, if this system works as optimists think it could, then Hong Kong voters will have a real choice in picking their leader, for the first time in history.

Second, would this mechanism indeed produce an election contest between at least one establishment candidate and one democratic candidate? Is there a way in which members of the establishment could nominally consider a democratic potential candidate and then deny him or her the nomination? In fact there is. The government’s proposal specifies that after all the potential candidates have been heard from, the NC members then select two or three nominees. Each NC members get two votes, and nomination requires 50 percent. So establishment members of the NC, after going through the motions of considering a pan-democrat, could simply not give that person the majority needed for nomination. The procedure and their numerical majority give them the power to do so.

But is such a bait-and-switch tactic wise politically? If this mechanism is sold both to the public and moderate democrats as a “good enough” way to produce a competitive election but the result is a contest between two individuals associated with the establishment and the status quo, how much legitimacy will the process itself and the person ultimately selected have? Will the polarization, obstructionism, and protests that have come to mark Hong Kong politics subside or grow? Will Beijing face more stability in Hong Kong or less?

In short, does this mechanism not put the establishment in a position that it almost has to nominate a moderate democrat if it is to enjoy broad community respect? And if the establishment is being challenged to do the right thing, so are the democrats. As imperfect as they see the current package, if it creates a good enough chance of electing one of their own, would the democrats not lose community respect if they reject it and deny voters a choice (they already know that Beijing and others will blame them for reverting to the old system)?

This dual challenge creates the possibility of a compromise. The missing ingredient, of course, is the mistrust that each camp has about the intentions of the other, mistrust born of the decades-long struggle over whether Hong Kong should have a genuinely democratic system. Providing that ingredient will be a challenge itself. 

      

Next Sunday’s first round of the Tunisian presidential election is unlikely to produce an outright winner but the country can already lay claim to the most democratic success story in the uncertain post-Arab Spring period.

Earlier this year, the Islamist-led National Constituent Assembly in Tunis produced a pluralist constitution that set the stage for a parliamentary contest on October 26 in which the incumbents lost. That simple fact of political alternation is a historic milestone: Ennahda is not the only Islamist party to lose the confidence of its initial protest-vote electorate, but it is the first to live to tell the tale.

Islamist participation in the democratic process

The birthplace of the Arab Spring offers a tantalizing third way toward Islamist participation in the democratic process: a Goldilocks outcome between Turkish majoritarianism and Egyptian militarism. Tunisia is different: it is smaller, lacks a hegemonic army, and Ennahda doesn’t have anywhere near a majority of votes.

The alluring tableau, however, conceals a fragmented elite and a scattered electorate. Twenty-seven parties declared candidates for president, although a handful have dropped out. Last month, more than 15,000 candidates running on over 1,300 party lists vied for 217 parliamentary seats. Only two-fifths of eligible adults registered to vote and less than two-thirds of them actually voted.

The main pattern to emerge from parliamentary elections is the same that has defined the country for decades: an existential battle between Islamists and anti-Islamists with a majority for neither. The Islamists lost six percentage points (32 percent) but the secularists were not exactly embraced. Taking into account non-registration and abstention, the victorious party Nidaa Tounes’s share of the legislative vote (38 percent) corresponds to roughly one out of five eligible voters.

These results accurately reflect a highly polarized society. Nidaa Tounes is led by presidential frontrunner Beji Caïd Essebsi, an 87-year-old who served under every regime since 1956 independence and who stoked voters’ fear of Ennahda’s “seventh century project” during the campaign. Ennahda’s leadership framed the election as a contest “between supporters of the revolution and supporters of the counter-revolution.” It is the only Muslim-majority country where nearly half of the population claims to never step foot in a mosque.

Do Tunisians favor “authoritarian government”?

For the first time since the 2011 revolution, polling this summer showed a majority of Tunisians favoring “authoritarian government” over an “unstable” democratic government. Also for the first time, Ennahda declined to field a presidential candidate to contain apprehensions about them. While Essebsi mostly enjoys an untainted reputation his party, Nidaa Tounes is a loose coalition including many holdovers from the previous regime.

The last time electoral democracies experienced a comparable juncture was not in 2013 Cairo or Gezi Park, but rather Rome during the tense 1970s. In 1976, the Italian Communist Party received one-third of the votes, making it the largest Communist electoral bloc west of the Iron Curtain. Frequent small-scale terrorist attacks took place against the backdrop of global tensions between NATO and Warsaw Pact members.

It is hard to remember a time when the term “socialism” provoked as much angst as “Sharia” does today, but Tunisia stands at a crossroads analogous to the old Cold War alternatives of Washington and Moscow, with Qatar and other Gulf states filling the shoes of the old “evil empire.”

Recognizing that Italy was too divided to govern alone, party leader Enrico Berlinguer proposed a historic compromise (compromesso storico) with the archenemy Christian Democrats to bridge a seemingly impassible cultural-political gap.

Ennahda party faces doubts

Today’s Ennahda party faces the same doubts as Communist leaders in postwar Europe: are they truly pluralist democrats? Do they accept power sharing? The executive director of Nidaa Tounes, Mondher Belhadj Ali, said in an interview in Tunis earlier this year that Ennahda must undergo the equivalent process of the various leftist parties in Europe during the Cold War. The party needs to renounce its “jihadist logic,” Belhadj said, in the same way that the German left distanced itself from international Marxist-Leninist creed at Bad Godesberg in 1959.^[1]

To be considered trustworthy despite its association with a revolutionary ideology, the Italian Communist Party (Partito Comunista Italiano, or PCI) underwent key shifts. Its leadership broke with the international Comintern by supporting Italy’s NATO membership. They also refused Moscow’s order of “intransigence” through silent partnership with a Christian Democrat-led government, giving way to the “via Italiana” – an Italian path – to socialism.

Why did the PCI pursue this path at a moment of rising strength, when their share of the vote was peaking at 32 percent? Italian Communists had no doubt noticed that NATO countries were willing to forego democratic outcomes in Chile three years earlier in the name of political stability and anti-communism.

“Alternative to the Islamic State”

It is also apparent that Ennahda’s leadership has correctly interpreted the West’s silence after the arrest of Egypt’s first democratically elected president last year. The party’s agreement to omit the word “Sharia” from the constitution, its decision to ban the extremist group Ansar Echaria and its voluntary departure from political posts in 2013 have been taken as early signs of a willingness to compromise. There is no exact Islamist equivalent to Moscow and the Comintern, but Ennahda has offered itself up as “the alternative to the Islamic State.” Ennahda has also adopted an official party line not to govern alone but only in alliance with other parties. Party leader Rached Ghannouchi said he hopes to avoid “the repetition of the Egyptian bilateral polarizing model.”

Political pressure already forced Ennahda and its partners to wage not merely ideological but also actual military war on violent Islamist extremism. The martyrs of the Tunisian Revolution now include not only the two secular politicians who were assassinated in the first half of 2013 but also the 39 Tunisian soldiers who have been killed since then – including five in an attack earlier this month.

The interim government has not hesitated to combat religious enemies of the state. President Moncef Marzouki, a human rights activist, looked ashen in an interview in his office this summer: “I deeply regret it: it means killing and arresting people but I have to defend this state” – at times leading to the deaths of a dozen combatants per month, including six on election weekend.^[2]

In the years since the revolution, through a mixture of coercion and conviction, the religious affairs ministry whittled down the number of prayer spaces under the control of Salafi extremists from over 1000 in 2011 to under 100 today. This summer, the government fired an imam who refused to say prayers for a soldier who died in a raid on an Islamist cell.”^[3]

Like Berlinguer before him, Ghannouchi has made timely visits to meet with American officials and offer democratic reassurances – but to far greater effect than the Italian Communists ever managed. Washington’s reception of the PCI is captured by the chiaroscuro headshot of Berlinguer on a June 1976 cover of Time declaiming “The Red Threat.” In 2012, the magazine named Ghannouchi one of the “World’s Most Influential People,” someone who offers “a vision of a moderate, modern and inclusive political movement.”

Critics will point out that shortly after the compromesso storico, the Communist Party’s electoral base bottomed out. Left-wing terrorism did taper off but not before the Red Brigades kidnapped and executed the Communists’ main Christian Democratic interlocutor, former Prime Minister Aldo Moro, in 1978.

Compromise may lead to national unity

With counterterrorism support to resist such extremist violence on the fringes and more enthusiastic backing from Western capitals, however, a Tunisian historic compromise may yet deliver the national unity that the country needs to advance to self-confident partisan rule – and mutual faith in political alternation. The recent announcement of joint U.S.-Tunisian counter-terrorism exercises and a gift of $14 million worth of equipment and supplies are small in scale but their timing conveys a broader reassurance.

The lack of a clear political mandate may turn out to be the hidden advantage of this inaugural election season in Tunisia. The country’s political parties can now use the first full presidency and parliamentary session of a democratic Tunisia to blaze a third way between military rule and majoritarian Islamist democracy.

Just as Italian communism was a different animal than the Soviet Communist Party, Tunisian exceptionalism is a real thing. The accelerated modernization period under Independence leader Habib Bourguiba after decolonization left behind the lowest illiteracy rate and lowest birthrate in the neighborhood. Its relatively peaceful democratic revolution has now passed several institutional milestones. As President Moncef Marzouki put it, “if the experiment in Islamic democracy doesn’t work here then it’s unlikely to work anywhere.”^[4]

The Italian Communist Party voted to dissolve itself almost 24 years ago, not long after the Berlin Wall fell and sealed its obsolescence. An equivalent geopolitical shift in Sunni Islam – away from the hegemony of ideologically rigid Gulf States – is as unimaginable now as was the thaw of November 1989. But a great compromise between the region’s modern nemeses – secularist and Islamist – could well dislodge the first brick.

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[1] Jonathan Laurence interview with Mondher Belhadj Ali, May 2014, Tunis, Tunisia.
[2] Jonathan Laurence interview with Tunisian President Moncef Marzouki, May 2014, Carthage, Tunisia.
[3] Jonathan Laurence Interview with Tunisian Minister of Religious Affairs Mounir Tlili, May 2014, Tunis, Tunisia.
[4] Ibid.

       

Editor’s Note: This post is part of a series on the 2015 Financial and Digital Inclusion Project (FDIP) Report and Scorecard, which were launched at a Brookings public event in August. Previous posts have highlighted five key findings from the 2015 FDIP Report, explored financial inclusion developments in India, and examined the rankings for selected FDIP countries in Southeast and Central Asia, the Middle East, and Africa.

The 2015 Financial and Digital Inclusion Project (FDIP) Report and Scorecard were launched in August of this year and generally reflect data current through May 2015. Since the end of the data collection period for the report, countries have continued to push forward to greater financial inclusion, and international organizations have continued to assert the importance of financial inclusion as a mechanism for promoting individual well-being and macroeconomic development. Financial inclusion is a key component of the United Nations’ Sustainable Development Goals, signaling international commitment to advancing access to and use of quality financial products among the underserved.

We discussed one recent groundbreaking financial inclusion development in a previous post. To learn more about the approval of payments banks in India, read “Inclusion in India: Unpacking the 2015 FDIP Report and Scorecard.”

Below are four other key developments among our 21-country sample since the end of the data collection period for the 2015 FDIP Report and Scorecard. The list is in no way intended to be exhaustive, but rather to provide a snapshot illustrating how rapidly the financial inclusion landscape is evolving globally.   

1) The Philippines launched a national financial inclusion strategy.

In July 2015, the Philippines launched a national financial inclusion strategy (NFIS) and committed to drafting an Action Plan on Financial Inclusion. The Philippines’ NFIS identifies four areas central to promoting financial inclusion: “policy and regulation, financial education and consumer protection, advocacy programs, and data and measurement.”

 As discussed in the 2015 FDIP Report, national financial inclusion strategies often serve as a platform for identifying key priorities, clarifying the roles of key stakeholders, and setting measurable targets. These strategies can foster accountability and incentivize implementation of stated initiatives. While correlation does not necessarily equal causation, it is nonetheless interesting to note that, according to the World Bank, “[o]n average, there is a 10% increase in the percentage of adults with an account at a formal financial institution for countries  that launched an NFIS after 2007, whereas the increase is only 5% for those countries that have not launched an NFIS.”

2) Peru adopted a national financial inclusion strategy.

With support from the World Bank, Peru’s Multisectoral Financial Inclusion Commission established an NFIS that was adopted in July 2015 through a Supreme Decree issued by President Ollanta Humala Tasso. The strategy contains a goal to increase financial inclusion to 50 percent of adults by 2018. This is quite an ambitious target: As of 2014, the World Bank Global Financial Inclusion (Global Findex) database found that only 29 percent of adults in Peru had an account with a formal financial services provider. The NFIS also commits the country to facilitating access to a transaction account among at least 75 percent of adults by 2021.

Peru’s NFIS emphasizes the promotion of electronic payment systems, including electronic money, as well as improvements pertaining to consumer protection and education. Advancing access to both digital and traditional financial services should boost Peru’s adoption levels over time. As noted in the 2015 FDIP Report, while Peru’s national-level commitment to financial inclusion and regulatory environment for financial services are strong, adoption levels remain low (Peru ranked 15^th on the adoption dimension of the 2015 Scorecard, the lowest ranking among the Latin American countries in our sample).

3) Colombia updated its quantifiable targets and released a financial inclusion survey.

The 2015 Maya Declaration Progress Report, published in late August 2015, highlights a number of quantifiable financial inclusion targets set by the Ministerio de Hacienda y Crédito Público de Colombia (Colombia’s primary Maya Declaration signatory) relating to the percentage of adults with financial products and savings accounts. For example, the target for the percentage of adults with a financial product is now 76 percent by 2016, up from a target of 73.7 percent by 2015. The goal for the percentage of adults with an active savings account in 2016 is now 56.6 percent, up from a target of 54.2 percent by 2015. To learn more about concrete financial inclusion targets among other FDIP countries, read the 2015 Maya Declaration Progress Report.

In July, Banca de las Oportunidades, a key financial inclusion stakeholder in Colombia, presented the results of the country’s first demand-side survey specifically related to financial inclusion. As noted by the Economist Intelligence Unit, previous national-level surveys conducted by entities such as the Superintendencia Financiera and Asobancaria have identified supply- and demand-side indicators pertaining to various financial services. As discussed in the 2015 FDIP Report, national-level surveys that focus on access to and usage of financial services can help identify areas of greatest need and enable countries to better leverage their resources to promote adoption of quality financial services among marginalized populations.

4) Nigeria’s “super agent” network enables greater access to digital financial services.

In September 2015, telecommunications company Globacom launched a “super agent” network, Glo Xchange, which can access the mobile money services of any partner mobile money operator. The network has been launched in partnership with four banks. Globacom was given approval in 2014 to develop this network; since then, the company has been recruiting and training its agents. About 1,000 agents will initially be part of this system, with a goal to recruit 10,000 agents by September 2016. Expanding access points to financial services by building agent networks is hoped to boost adoption of digital financial services.

Despite having multiple mobile money operators (19 as of October 2015, according to the GSMA’s Mobile Money Deployment Tracker), Nigeria’s mobile money adoption levels have not reached the degree of success of some other countries in Africa: The Global Findex noted that less than 3 percent of adults in Nigeria had mobile money accounts in 2014, compared with over 30 percent in Tanzania and about 60 percent in Kenya. Nigeria’s primarily bank-led approach to financial services, which excludes mobile network operators from being licensed as mobile money operators, is one factor that may have constrained adoption of mobile money services to date. You can read more about Nigeria’s regulatory environment and financial services landscape in the 2015 FDIP Report.

We welcome your feedback regarding recent financial inclusion developments. Please send any links, questions, or comments to FDIPComments@brookings.edu.

       

Editor’s Note: This post is part of a series on the 2015 Brookings Financial and Digital Inclusion Project (FDIP) Report and Scorecard, which were launched at a Brookings public event in August. Previous posts have highlighted regional findings from Southeast and Central Asia, the Middle East, and Africa, as well as selected financial inclusion milestones from FDIP countries. This post focuses on key financial inclusion achievements and challenges regarding the five Latin American FDIP countries: Brazil, Chile, Colombia, Mexico, and Peru.

Financial inclusion growth and opportunities in Latin America

With its well-developed banking infrastructure and growing mobile ecosystem, Latin America presents a unique set of opportunities and obstacles with respect to promoting greater financial inclusion. From 2011 to 2014, there was a 12 percentage point increase in the number of adults in Latin America and the Caribbean with formal financial accounts, according to the World Bank’s Global Financial Inclusion (Global Findex) database. As noted in the 2015 GSMA report “Mobile financial services in Latin America & the Caribbean,” in 2014 Latin America and the Caribbean saw the fastest growth of any region in terms of new registered mobile money accounts.

Moreover, these accounts are often used for more advanced transactions that go beyond simple transfers: As stated in a 2015 post published by the GSMA, “ecosystem transactions (transactions that involve third parties, e.g. bill payment, merchant payment or bulk payment) already make up 27% of transaction volumes in Latin America & the Caribbean.” In contrast, only 6 percent of transaction volumes over the same period were considered ecosystem transactions in East Africa, where mobile money has been most widely adopted and used.

Moving forward, facilitating greater adoption of a suite of digital financial services (e.g., savings) will be a vital component of promoting sustainable financial inclusion in the region. Recent regulatory changes in several Latin American countries designed to promote a greater diversity of service providers should propel financial inclusion growth, although a need for regulatory clarity persists in some places. Financial inclusion strengths and challenges germane to our five Latin American FDIP countries are explored below.

Brazil: Branchless banking leadership combined with dynamic mobile market

Brazil achieved the highest ranking of any Latin American country on the Brookings 2015 FDIP Scorecard, ranking 3^rd overall with a score of 78 percent. Brazil’s economy is the largest in Latin America, with a GDP (in current US dollars) of about $2.3 trillion as of 2014; for comparison, Mexico, the Latin American country with the second largest economy, had a GDP of about $1.3 trillion within that same period.

Brazil received strong country commitment and mobile capacity scores (89 and 83 percent, respectively) in the 2015 FDIP Scorecard and earned the highest regulatory environment score among the Latin American FDIP countries, which also included Chile, Colombia, Mexico, and Peru. As noted in the 2015 FDIP Report, Brazil launched a National Partnership for Financial Inclusion in November 2011, which has supported the development of a number of enabling financial inclusion initiatives. In 2013, Law 12865 and associated regulations permitted non-banks to issue e-money as payments institutions. Brazil boasted the largest mobile market in Latin America as of 2014, with a unique subscribership rate of about 57 percent in 2015 (a lower unique subscribership rate than Chile’s by about 7 percentage points, but otherwise higher than that of any of the other Latin American FDIP countries).

Brazil received 4^th place on the 2015 FDIP Scorecard for adoption of selected traditional and digital financial services. As with many other countries in Latin America, branchless banking (i.e., access to formal financial services beyond a traditional brick-and-mortar bank) through “agents” is popular in Brazil — as of 2014, Brazilian banks’ agent networks had a presence in all of the country’s approximately 6,000 municipalities, contributing to formal account growth. Chile was the only Latin American country that received a higher ranking for the adoption dimension, placing 2^nd. In terms of account usage, government-to-person payments comprise a significant source of activity for formal accounts: The 2014 Global Findex report noted that among recipients of government payments in Brazil, 88 percent received their transfers directly into an account.

Yet according to the Global Findex, about 32 percent of Brazilian adults age 15 and older still do not have accounts with a formal financial institution or mobile money provider. As with the other Latin American countries in the FDIP sample, mobile money adoption in Brazil has remained low: Brazil received the lowest score (one out of three possible points) for all six mobile money indicators included in the 2015 FDIP Scorecard. However, given that as of 2014 Brazil had the fifth-largest global smartphone market in the world in terms of subscribers, a combination of growing smartphone penetration and an increasingly enabling regulatory environment should drive greater adoption of digital financial services in the future.

Chile: Opportunities for enhanced e-money regulatory clarity

Chile tied with Colombia and Turkey for 6^th place on the overall 2015 FDIP Scorecard. Chile’s financial inclusion environment is characterized by a firm national commitment to financial inclusion (earning a country commitment score of 89 percent) but a less developed mobile money environment than the other Latin American FDIP countries. While Chile’s unique mobile subscribership rate and 3G network coverage rate by population are higher than and on par with other countries in the region, respectively, Chile’s mobile money offerings are limited. The lack of a robust mobile money market contributed to Chile’s mobile capacity score of 72 percent, the lowest score among the FDIP Latin American countries.

Chile’s regulatory environment score (67 percent) was also the lowest of the Latin American FDIP countries, primarily due to a lack of regulatory clarity surrounding digital financial services. Developing or clarifying regulations pertaining to electronic money in particular could potentially drive more engagement with the sector and advance the diversity of mobile money providers and offerings. Further, supporting the interoperability of digital and traditional financial services could enhance the utility of these products for customers.

Given that 37 percent of adults in Chile did not have an account with a formal financial provider as of 2014, there is also room for growth in terms of expanding financial inclusion. However, it should be noted that Chile earned the highest adoption ranking of any Latin American country featured in the 2015 FDIP Scorecard. While Chile’s adoption levels with respect to mobile money services were limited, adoption rates of other formal financial services were among the highest of the FDIP countries. Chile received three out of three possible points for all but one indicator (savings at a formal financial institution) related to traditional financial services. Chile’s performance on the adoption dimension of the scorecard contributed to its 6^th place ranking overall.

While Chile’s mobile money adoption rates are low, use of other digital financial services is increasingly popular. For example, as noted in the “2015 Maya Declaration Progress Report,” since 2012 the number of CuentaRUT accounts (accounts that feature debit cards associated with a savings account provided by Chile’s BancoEstado) has increased by about 47 percent. As of 2014, there were over 7 million active CuentaRUT cards in Chile.

Colombia: Regulatory advancements coupled with sustained country commitment

As noted above, Colombia tied with Chile for 6^th place on the overall 2015 FDIP Scorecard. Colombia has demonstrated strong commitment to financial inclusion, including through involvement in multinational organizations such as the Alliance for Financial Inclusion (AFI). An example of Colombia’s national-level financial inclusion commitment is the 2006 establishment of Banca de las Oportunidades, an entity charged with fostering regulatory reforms conducive to financial inclusion. Another key player in the financial inclusion space is the Intersectoral Economic and Financial Education Committee, created in February 2014 under Decree 457.

In terms of the country’s regulatory environment, Law 1735 of 2014 permitted new institutions, called Sociedades Especializadas en Depósitos y Pagos Electrónicos, to offer mobile financial services. As part of the law, proportionate “know-your-customer” (KYC) requirements were also instituted for under-resourced customers in order to facilitate greater access to financial services among low-risk populations. In July 2015, Decree 1491 implemented Colombia’s financial inclusion law and highlighted the regulatory regime for the mobile money market. Colombia’s regulatory environment earned a score of 89 percent, ranking it 2^nd among the Latin American FDIP countries in this dimension.

On the supply side, banking correspondents (also known as agents) have been utilized to extend financial access to underserved populations.  As of 2015, all of Colombia’s 1,102 municipalities had at least one financial access point, defined as bank branches, banking correspondents, and ATMs. Another innovative approach to branchless banking in Colombia is bank Davivienda’s initiative to use DaviPlata mobile wallet accounts to distribute government transfers to more than 900,000 recipients of welfare program “Familias en Accion.”

With respect to demand side figures, Colombia tied with Mexico for 7^th place on the adoption dimension. As of 2014, about 38 percent of adults in Colombia had an account with a formal financial institution, and about 2 percent of adults were mobile money account holders. In terms of advancing future mobile money use, Colombia received the highest score of the Latin American countries on the mobile capacity dimension; thus, Colombia is well-positioned to advance access to and use of mobile money services in the future. Promoting usage of appropriate, quality financial services is critical, as dormancy rates have been identified as an obstacle to financial inclusion; about half of accounts in Colombia (including savings accounts, simplified accounts, and electronic deposits) were identified as dormant in 2014.

Mexico: Recent reforms may enhance competition and drive digital takeup

Mexico ranked 9^th on the overall 2015 FDIP Scorecard, with adoption of traditional and digital financial services as its highest-ranked dimension. Among the Latin American FDIP countries, Mexico features the greatest parity in terms of formal financial account ownership rates among men and women, at about 39 percent each.  In terms of national-level commitment to financial inclusion, Mexico tied with Peru for the highest ranking among the Latin American countries. AFI’s Maya Declaration was signed at the 2011 Global Policy Forum held in Riviera Maya, Mexico, signaling Mexico’s public commitment to financial inclusion.

With respect to mobile capacity, as of the first quarter of 2015 Mexico’s unique subscribership rates were the lowest of the Latin American countries. Mexico tied with Chile and Brazil for 3G network coverage by population. In terms of mobile money, Mexico’s market is still developing; several providers were available as of May 2015, but the extent of offerings was somewhat limited. As noted in the GSMA’s “Mobile Economy: Latin America 2014” report, new telecommunications reforms recently passed in Mexico are expected to affect the mobile market and potentially increase competition among the telecommunications sector. This increased competition could in turn drive the development of a greater array of innovative, affordable mobile money products.

Regarding Mexico’s regulatory environment, the country has been lauded for its risk-based KYC requirements that enable underserved individuals to access low-value accounts without fulfilling the full array of traditional identification processes, which can sometimes be burdensome for under-resourced groups. Under Mexico’s four-tiered KYC system (introduced in 2011), “level one” (very low-risk) accounts feature monthly deposit limits and a maximum balance limit of about 400 dollars; accounts can be opened at a bank branch, banking agent, over the internet, or by telephone. Higher-tier accounts have more stringent KYC requirements. A 2015 AFI article noted that Mexico's banking and securities regulator, the Comisión Nacional Bancaria y de Valores, indicated about 7.5 million new accounts were opened between August 2011 and September 2012, including over 4 million “level one” accounts.

Mexico tied with Colombia for 7^th place on the adoption dimension of the 2015 FDIP Scorecard. About 39 percent of adults in Mexico held accounts with a formal financial institution as of 2014, while about 3 percent of adults held mobile money accounts. As with other countries in Latin America, debit card and credit card use were much higher than mobile money use as of 2014, although usage of both kinds of cards was lower in Mexico than in several other Latin American FDIP countries such as Brazil and Chile. Initiatives such as the Saldazo debit card, which enables customers to use a debit card associated with a savings account and does not require a minimum balance, have helped drive adoption of digital financial services in Mexico.

Peru: Enabling regulatory environment, but constrained adoption of financial services

Peru presents perhaps one of the most interesting paradoxes among the FDIP countries. While Peru’s regulatory environment has been consistently recognized as among the best in the world for enabling financial inclusion, adoption of formal financial services remains quite low. Peru received 17^th place overall on the 2015 FDIP Scorecard, which can primarily be attributed to its low adoption score: Peru received a 15^th place ranking on the adoption dimension, the lowest score among the Latin American FDIP countries. However, we anticipate that recent regulatory changes in Peru, coupled with increasing smartphone penetration rates (Peru’s 2014 adoption rates were about 12 percentage points below the Latin American average), will facilitate adoption of digital financial services and drive greater financial inclusion in the future.

With respect to the supply side aspect of financial inclusion, as of 2014 about 92 percent of Peru’s population lived in a district with access to financial services, according to the Superintendencia de Banca, Seguros y AFP (SBS) del Peru. Nonetheless, demand side figures lag behind: The Global Findex found that only about 29 percent of adults had an account with a formal financial provider as of 2014. Peru received a “1” for two-thirds of the non-mobile money indicators on the adoption dimension of the 2015 FDIP Scorecard, and mobile money adoption was negligible. Moreover, as of 2014 there was a 14 percentage point disparity in financial account ownership between men and women, the highest financial inclusion “gender gap” among the Latin American FDIP countries.

However, given Peru’s strong national commitment to financial inclusion (reflected in Peru’s country commitment score of 94 percent) and legislative initiatives designed to promote an enabling regulatory environment, we fully anticipate that financial inclusion growth will accelerate in the future. For example, Peru recently finalized its national financial inclusion strategy, as discussed in our earlier post. Moreover, Peru has adopted laws and regulations that permit a greater diversity of players to enter the financial services market. Law 2998 of January 2013 allowed both banks and non-banks to issue e-money, and October 2013 regulations issued by the SBS enabled e-money issuers to follow a simplified account opening process. These initiatives should facilitate greater access to and usage of formal financial accounts in the future.

In terms of electronic payments specifically, diversifying the mobile money market and increasing unique subscribership could help facilitate greater adoption of mobile money services. Demand side factors, such as ensuring that services are a good fit for customers, are also critical — as evidenced by the fact that Mexico, which had comparable smartphone adoption rates to Peru and lower unique subscribership rates as of 2014, features significantly higher rates of mobile money adoption across all demographics than Peru. Peru is making a concerted effort to develop innovative electronic platforms — for example, the Peruvian Association of Banks (ASBANC) is working on the creation of an electronic money platform accessible by both financial institutions and telecommunications companies. Implementation of this interoperable platform is expected to promote further adoption of digital financial services.

       

       

      

As noted in our recent Brookings Institution report, unmanned aerial vehicles (UAVs), commonly referred to as drones, are an emerging technology that requires the attention of local governments. Unfortunately, regulations governing their usage are significantly lagging the pace of innovation. Individual citizens who do not want these devices flying over (or even near) their property due to privacy or safety concerns have limited options. You can stay in your home and turn the music up until it goes away. Or you can go about your business and ignore the possibility that the drone has a camera to see inside your home. Others might prefer a more active response. In fact, there have been several recent instances where residents have taken it upon themselves to remove these drones from the skies…by force.

Misuses of drones

The usage of UAVs and the lack of a functional regulatory environment have not been without incident. Fire personnel in southern San Bernardino County were fighting the first major fire of the season and had to abort their tanker flights due to someone flying a drone at approximately 12,000 feet and interfering with the safety of the pilots. Just two weeks later, firefighters in Southern California were using several manned aircraft to help put out 20 car fires on an interstate highway that were caused when a wildfire jumped the highway unexpectedly.  Pilots had to ground the planes when it was reported that five drones were flying around the area to get a good look at the fires (two of which were witnessed actually chasing the tanker planes!).

In addition to the general lack of common sense by a few users interfering with life-saving aircraft around the U.S., Britain, Poland, and elsewhere, there have been an increasing number of incidents involving drones accused of serving as remote “peeping toms.” UAVs have also crashed into cars and homes; they have even been used to smuggle drugs across the U.S.-Mexico border in addition to smuggling marijuana into prisons in South Carolina and in Ohio.

Uneven regulations

When it comes to regulations around drones, we are living in the proverbial wild-west. A few states, like Nevada and Wisconsin, have passed legislation to prevent the weaponization of drones. But in July, a YouTube video went viral of a teenager in Connecticut who modified his drone to fire a semi-automatic handgun successfully. When confronted by law enforcement officials, they determined that no laws had actually been broken. Virginia was the first state legislature to put in place a two-year moratorium on drone usage by state or law enforcement agencies. That moratorium expired July 1^st. By the end of 2014, 36 states had introduced legislation aimed at protecting individual privacy in some manner. Only four of those passed last year. Currently, there are 17 states with some form of drone regulation on their books, and several other states still have legislation pending. Most of the laws that have passed, such as those in Idaho and Florida, focus on limiting police usage of drones by requiring probable cause warrants.

Nevada has been one of the more active states in the drone legislation arena. In addition to their legislation prohibiting the weaponization of civilian drones, the state also has passed legislation to provide homeowners rights to sue drone owners who fly their drones over personal property in certain circumstances. Furthermore, Nevada now requires law enforcement agencies to get warrants when using drones near any home “where there is an expectation of privacy.”

Potential benefits and rulemaking challenges

We do acknowledge and are excited about the positive benefits that drone technology is poised to provide. Amazon has been testing their commercial “Prime Air” package delivery system under an experimental testing agreement with the FAA since early 2015, which will likely impact the nature of their almost two year old partnership with the U.S. Postal Service. Drone startup company Flirtey successfully demonstrated their ability to deliver medicine to a rural medical facility in Virginia as part of their proof of concept efforts this July. Drones may even represent the future of pizza delivery.

The challenge this rapidly developing technology is creating is well ahead of local government efforts to rein in excessive activities. State and local governments need to engage on this policy issue more proactively. To do so, however, requires a delicate balancing act of the multiple competing interests of legitimate commercial uses, policing, public safety, privacy, and private property concerns. And this balancing has to take place in an environment where federal law remains unsettled too.

One thing we would definitely caution against is ‘regulation by default.’ To date, the efforts to regulate drone policy has focused on the drones themselves. As is commonly the case with new technology, governments typically engaged with a heavy hand that sometimes misses the opportunities afforded by the new technologies to improve city services and quality of life. Examples of this possible overreaction is Iowa City, Iowa and Charlottesville, Virginia, both of which were early adopters of complete bans on all surveillance drones within city limits back in 2013.

Local governments need to accept that drone technology is here for the near future. They must recognize that technology is not the problem, but how it is used can be a potential problem. Given the potential drawbacks and benefits, there is justification for reasoned regulation of drone technology.

       

       

       

       

       

       

       

       

       

Editor's Note: The World Bank’s Independent Evaluation Group (IEG) recently published a self-evaluation of its activities. Besides representing current thinking among evaluation experts at the World Bank, it also more broadly reflects some of the strengths and gaps in the approaches that evaluators use to assess and learn from the performance of the international institutions with which they work. The old question “Quis custodet ipsos custodes?” – loosely translated as “Who evaluates the evaluators?” – remains as relevant as ever. Johannes Linn served as an external peer reviewer of the self-evaluation and provides a bird’s-eye view on the lessons learned.

An Overview of the World Bank’s IEG Self-Evaluation Report

In 2011 the World Bank’s Independent Evaluation Group (IEG) carried out and published a self-evaluation of its activities. The self-evaluation team was led by an internal manager, but involved a respected external evaluation expert as the principal author and also an external peer reviewer.

The IEG self-evaluation follows best professional practices as codified by the Evaluation Cooperation Group (ECG). This group brings together the evaluation offices of seven major multilateral financial institutions in joint efforts designed to enhance evaluation performance and cooperation among their evaluators. One can therefore infer that the approach and focus of the IEG self-evaluation is representative of a broader set of practices that are currently used by the evaluation community of international financial organizations.

At the outset the IEG report states that “IEG is the largest evaluation department among Evaluation Capacity Group (ECG) members and is held in high regard by the international evaluation community. Independent assessments of IEG’s role as an independent evaluation function for the Bank and IFC rated it above the evaluation functions in most other ECG members, international nongovernmental organizations, and transnational corporations and found that IEG follows good practice evaluation principles.”

The self-evaluation report generally confirms this positive assessment. For four out of six areas of its mandate IEG gives itself the second highest rating (“good”) out of six possible rating categories. This includes (a) the professional quality of its evaluations, (b) its reports on how the World Bank’s management follows up on IEG recommendations, (c) cooperation with other evaluation offices, and (d) assistance to borrowing countries in improving their own evaluation capacity. In the area of appraising the World Bank’s self-evaluation and risk management practices, the report offers the third highest rating (“satisfactory”), while it gives the third lowest rating (“modest”) for IEG’s impact on the Bank’s policies, strategies and operations. In addition the self-evaluation concludes that overall the performance of IEG has been “good” and that it operates independently, effectively and efficiently.

The report makes a number of recommendations for improvement, which are likely to be helpful, but have limited impact on its activities. They cover measures to further enhance the independence of IEG and the consistency of evaluation practices as applied across the World Bank Group’s branches – the World Bank, the International Finance Corporation (IFC), and the Multilateral Investment Guarantee Agency (MIGA) –; to improve the design of evaluations and the engagement with Bank management upstream for greater impact; and monitoring the impact of recent organizational changes in IEG in terms of results achieved. The report also recommends that more be done to evaluate the Bank’s analytical work and that evaluations draw on comparative evidence.

Assessment

In terms of the parameters of self-evaluation set by the prevailing practice among the evaluators on international financial agencies, the IEG self-evaluation is accurate and helpful. From my own experience as an operational manager in the Bank whose activities were evaluated by IEG in years past, and as a user of IEG evaluations (and of evaluations of other international aid organizations) for my research on aid effectiveness, I concur that IEG is independent and effective in meeting its mandate as defined. Moreover, the self-evaluation produces useful quantitative evidence (including survey results, budget analysis, etc.) to corroborate qualitative judgments.

However, the self-evaluation suffers from a number of limitations in approach and gaps in focus, which are broadly representative of the practices prevalent among many of the evaluation offices of international aid agencies.

Approach of the IEG self-evaluation

The core of the self-evaluation report is about the evaluation process followed by IEG, with very little said about the substance of IEG’s evaluations. The following questions could have usefully been raised, but were not: do evaluations cover the right issues with the right intensity, such as growth and poverty; environmental, governance, and gender impacts; regional dimensions versus exclusive country or project focus; effectiveness in addressing the problems of fragile and conflict states; effectiveness in dealing with global public goods; sustainability and scaling up; etc. Therefore the report does not deal with the question of whether IEG effectively responds in its evaluations to the many important strategic debates and issues with which the development community is grappling.

Related to this limitation is the fact that the report assessed the quality of IEG’s mostly in terms of (a) whether its approach and processes meet certain standards established by the Evaluation Cooperation Group; and (b) how it is judged by stakeholders in response to a survey commissioned for this evaluation. Both these approaches are useful, but they do not have any basis in professional assessments of the quality of individual products. This is equivalent to IEG evaluating the World Bank’s projects on the quality of its processes (e.g., appraisal and supervision processes) and on the basis of stakeholder surveys, without evaluating individual products and their impacts.

Gaps in the Self-Evaluation and in Evaluation Practice

Careful reading of the report reveals six important gaps in the IEG self-evaluation, in the prevailing evaluation practice in the World Bank, and more generally in the way international financial organizations evaluate their own performance. The first three gaps relate to aspects of the evaluation approach used and the second three gaps relate to lack of focus in the self-evaluation on key internal organizational issues:

1. Impact Evaluations: The report notes that IEG carries out two to three impact evaluations per year, but it sidesteps the debate in the current evaluation literature and practice as to what extent the “gold standard” of randomized impact evaluation should occupy a much more central role. Given the importance of this debate and divergence of views, it would have been appropriate for the self-evaluation to assess IEG’s current practice of very limited use of randomized evaluations.

2. Evaluation of Scaling Up: The report does not address the question of to what extent current IEG practice not only assesses the performance of individual projects in terms of their outcomes and sustainability, but also in terms of whether the Bank has systematically built on its experience in specific projects to help scale up their impact through support for expansion or replication in follow-up operations or through effective hand-off to the government or other partners. In fact, currently IEG does not explicitly and systematically consider scaling up in its project and program evaluations. For example, in a recent IEG evaluation of World Bank funded municipal development projects (MDPs) , IEG found that the Bank has supported multiple MDPs in many countries over the years, but the evaluation did not address the obvious question whether the Bank systematically planned for the project sequence or built on its experience from prior projects in subsequent operations. While most other evaluation offices like IEG do not consider scaling up, some (in particular those of the International Fund for Agricultural Development and the United Nations Development Program) have started doing so in recent years.

3. Drawing on the Experience of and Benchmarking Against Other Institutions: The self-evaluation report does a good job in benchmarking IEG performance in a number of respects against that of other multilateral institutions. In the main text of the report it states that “IEG plans to develop guidelines for approach papers to ensure greater quality, in particular in drawing on comparative information from other sources and benchmarking against other institutions.” This is a welcome intention, but it is inadequately motivated in the rest of the report and not reflected in the Executive Summary. The reality is that IEG, like most multilateral evaluation offices, so far has not systematically drawn on the evaluations and relevant experience of other aid agencies in its evaluations of World Bank performance. This has severely limited the learning impact of the evaluations.

4. Bank Internal Policies, Management Processes and Incentives: IEG evaluations traditionally do not focus on how the Bank’s internal policies, management and incentives affect the quality of Bank engagement in countries. Therefore evaluations cannot offer any insights into whether and how Bank-internal operating modalities contribute to results. Two recent exceptions are notable exceptions. First, the IEG evaluation of the Bank’s approach to harmonization with other donors and alignment with country priorities assesses the incentives for staff to support harmonization and alignment. The evaluation concludes that there are insufficient incentives, a finding disputed by management. Second, is the evaluation of the Bank’s internal matrix management arrangements, which is currently under way. The self-evaluation notes that Bank management tried to quash the matrix evaluation on the grounds that it did not fall under the mandate of IEG. This is an unfortunate argument, since an assessment of the institutional reasons for the Bank’s performance is an essential component of any meaningful evaluation of Bank-supported programs. While making a good case for the specific instance of the matrix evaluation, the self-evaluation report shies away from a more general statement in support of engaging IEG on issues of Bank-internal policies, management processes and incentives. It is notable that IFAD’s Independent Office of Evaluation appears to be more aggressive in this regard: It currently is carrying out a full evaluation of IFAD’s internal efficiency and previous evaluations (e.g., an evaluation of innovation and scaling up) did not shy away from assessing internal institutional dimensions.

5. World Bank Governance: The IEG self-evaluation is even more restrictive in how it interprets its mandate regarding the evaluation of the World Bank’s governance structures and processes (including its approach to members’ voice and vote, the functioning of its board of directors, the selection of its senior management, etc.). It considers these topics beyond IEG’s mandate. This is unfortunate, since the way the Bank’s governance evolves will substantially affect its long-term legitimacy, effectiveness and viability as an international financial institution. Since IEG reports to the Bank’s board of directors, and many of the governance issues involve questions of the board’s composition, role and functioning, there is a valid question of how effectively IEG could carry out such an evaluation. However, it is notable that the IMF’s Independent Evaluation Office, which similarly reports to the IMF board of directors, published a full evaluation of the IMF’s governance in 2008, which effectively addressed many of the right questions.

6. Synergies between World Bank, IFC and MIGA: The self-evaluation report points out that the recent internal reorganization of IEG aimed to assure more effective and consistent evaluations across the three member branches of the World Bank Group. This is welcome, but the report does not assess how past evaluations addressed the question of whether the World Bank, IFC and MIGA effectively capitalized on the potential synergies among the three organizations. The recent evaluation of the World Bank Group’s response to the global economic crisis of 2008/9 provided parallel assessments of each agency’s performance, but did not address whether they work together effectively in maximizing their synergies. The reality is that the three organizations have deeply engrained institutional cultures and generally go their own ways rather than closely coordinating their activities on the ground. Future evaluations should explicitly consider whether the three effectively cooperate or not. While the World Bank is unique in the way it has organizationally separated its private sector and guarantee operations, other aid organizations also have problems of a lack of cooperation, coordination and synergy among different units within the agency. Therefore, the same comment also applies to their evaluation approaches.

Conclusions

Self-evaluations are valuable tools for performance assessment and IEG is to be congratulated for carrying out and publishing such an evaluation of its own activities. As for all self-evaluations, it should be seen as an input to an independent external evaluation, a decision that, for now, has apparently been postponed by the Bank’s board of directors.

IEG’s self-evaluation has many strengths and provides an overall positive assessment of IEG’s work. However, it does reflect some important limitations of analysis and of certain gaps in approach and coverage, which an independent external review should consider explicitly, and which IEG’s management should address. Since many of these issues also likely apply to most of the other evaluation approaches by other evaluation offices, the lessons have relevance beyond IEG and the World Bank.

Key lessons include:

• An evaluation of evaluations should focus not only on process, but also on the substantive issues that the institution is grappling with.
• An evaluation of the effectiveness of evaluations should include a professional assessment of the quality of evaluation products.
• An evaluation of evaluations should assess:
  o How effectively impact evaluations are used;
  o How scaling up of successful interventions is treated;
  o How the experience of other comparable institutions is utilized;
  o Whether and how the internal policies, management practices and incentives of the institution are effectively assessed;
  o Whether and how the governance of the institution is evaluated; and
  o Whether and how internal coordination, cooperation and synergy among units within the organizations are assessed.

Evaluations play an essential role in the accountability and learning of international aid organizations. Hence it is critical that evaluations address the right issues and use appropriate techniques. If the lessons above were reflected in the evaluation practices of the aid institutions, this would represent a significant step forward in the quality, relevance and likely impact of evaluations.

       

       

The only interlocutor for the United States in Turkey will be President Recep Tayyip Erdoğan from now on, Professor Kemal Kirişci has said, adding that Washington has come to recognize the reality that whoever becomes the prime minister “knows he is not going to do anything that is unauthorized.”

The U.S. has lost its hopes regarding Turkish democracy, according to Kirişci, who is at the Washington-based Brookings Institute.

Prior to President Erdoğan’s visit, there were a record number of articles saying he would not receive a warm welcome in Washington, let alone a meeting with U.S. President Barack Obama. Yet Erdoğan ended up in the White House for a long meeting.

I was able to observe both of his visits in May 2013, and the one that took place last March. The difference is day and night. In 2013 the U.S. administration was bending over backwards to welcome Erdoğan, and he was hosted very lavishly.

The last visit was also preceded by the article of Jeff Goldberg, where there was a reference to how disappointed Obama was with his relationship with Erdoğan. I think that the appointment was given because Turkey and the president of Turkey is very central and critical to the fight against the Islamic State of Iraq and the Levant (ISIL). This is the only reason why this appointment was given; this is my reading.

The meeting took place despite Obama’s disillusionment with Erdoğan. Does that mean that Turkey is indispensable, regardless of rules Turkey? Or is Erdoğan not expendable?

Both. The term that is being used in Washington for the U.S. relationship with Turkey is “transactional,” meaning wherever we have common interests and common concerns, we are going to try to cooperate. The idea of a model partnership based on shared liberal values is no longer an issue; the cooperation is out of necessity.

Was there ever a Davutoğlu effect in bilateral relations, since he was one of the figures shaping foreign policy?

Starting in September 2015, Davutoğlu projected the image of a pragmatic person wanting to address a problem. The way in which he handled the European migration crisis was assessed as something positive compared to the rhetoric the president uses where he is constantly criticizing and using contemptuous – almost denigrating – language toward Europe but also the U.S. I suspect that Davutoğlu was offered an audience with Obama [shortly after his meeting with Erdoğan] because of this.

How do you think Washington will see his departure?

At the micro level, they thought that there was room for a pragmatic, solution-oriented relationship with Davutoğlu. But in the course of the last year or two, they had also come to realize that Davutoğlu’s foreign policy based around his book “Strategic Depth” was producing conflict between Turkey and the U.S. – the conflict areas being Syria, ISIL, Egypt, Israel and Iraq. 

Do you think there will be any changes in relations with Davutoğlu’s departure?

I think there is a recognition in Turkey, Europe, the U.S. and the rest of the world that from today onward, Turkey’s foreign policy will be run by the president. The notion that Turkey is a parliamentary system and the president is supposed to be equidistant from political parties does not reflect reality. The U.S., with this experience behind them, has come to recognize this reality. Whoever becomes the PM, they know he is not going to do anything that is unauthorized. The consequence is that Turkey-U.S. relations will not be where they were when Erdoğan first came to power; that’s how I can answer the question because it is comparative. At that time, in addition to Syria, trade, the economy and Turkey’s relations with the EU were also on the agenda.

These issues will no longer be on the agenda; there will be only one issue: the Syrian issue. [But another will be how will] NATO manage the challenges that Russia is bringing to European security? I think there is some room for interaction there.

Has the U.S. given up on Turkey as a reliable ally sharing the same values? 

It is sad but that is the reality. Turkey’s agenda today in the neighborhood is not an agenda that overlaps with the Western transatlantic community’s agenda. There is a lot of aggravation that emerges from that reality. For the U.S., the issue of ISIL is regarded as the major challenge emanating from the Middle East to U.S. and European security. I think they have reached a conclusion that cooperating with Turkey is an uphill battle. They also recognized Turkey and the U.S. have conflicting interests with respect to the PYD [Democratic Union Party]. Turkey considers it a threat to national security whereas the U.S. sees the PYD as an actor with which they are able to cooperate against ISIL in a decisive, reliable and credible manner. In the case of Turkey, there is cooperation but there are question marks over the reliability and credibility and commitment of Turkey.

Why are you using the word sad?

It is sad from a personal point of view because when you look at the world right now, it looks like there are two governance system competing with each other. One governance system is the system to which I thought Turkey was always committed. We became a member of NATO, Council of Europe and the OECD. We aspire to become part of the EU because I suppose we believed the values of members of this community provides more prosperity, stability and security to its citizens. Then there is an alternative form of governance represented by Russia, Iran and China [based on] the idea that the state should have a greater say on the economy, the state interest should prevail over the interests and the rights of individuals and that freedom of expression and media can be curtailed to serve state interests. Turkey is increasingly moving in the direction of this second form of governance.

Why, then, did Brookings invite Erdoğan, producing embarrassing moments when the president’s security detailed interfered with demonstrators?

Brookings has a long-established program called the Global Leaders Forum and invites presidents and prime ministers to give speeches. It is an independent think tank and does not confer legitimacy or illegitimacy on a speaker. The Washington audience got an opportunity to see how Turkey is being governed.

It looks like the U.S. remains indifferent to democratic backpedalling in Turkey.

There was a time at meetings on Turkey in which questions were raised along the lines of, “Why isn’t the U.S. doing more against this backsliding?” Interestingly, in the course of about six months or so, this question is being raised less and less. The U.S. has lost hopes about Turkish democracy. The primary reason for this is that they have this impression that Turkish society, especially after what happened after the June [2015] elections, gives priority to this kind of governance. Also, the Obama administration, especially compared to the Bush and Clinton administrations, is less comfortable with the idea of promoting democracy and supporting democratization.

The interview was originally published in Hürriyet Daily News.

      

Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version.

Abstract

Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs.

Call to Action: The Importance of Expanded Access Programs

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.)

In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii]

The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants.

Laying the Groundwork with Shared Experiences

The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless.

At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi]

Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly.

Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home.

One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive.

Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years.

To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy.

Development of Structural Principles: The Four A's 

Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1).

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First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website.

In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.)

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Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs.

The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening).

If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access.

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Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.)

Companies can track expanded access requests in order to guarantee that the patient has received follow-up and that the communication loop has been closed. One large pharmaceutical company conducted an internal audit of its expanded access procedures and found that the largest problem was that employees did not know where to find information. Another representative noted that it is important to maintain consistency across patients and the process of requesting a drug.

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The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company.

There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes.

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Regulatory Considerations

The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis.

However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval.

An Expanded Role for the FDA

While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity.

The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway.

Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes.

To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability.

Next Steps

The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]).

One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards.

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Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers.

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With over 16 million people and nearly 8.6 million jobs, America's older industrial cities remain a vital-if undervalued-part of the economy, particularly in states where they are heavily concentrated, such as Ohio and Pennsylvania. They also have a range of other physical, economic, and cultural assets that, if fully leveraged, can serve as a platform for their renewal.

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Across the country, cities today are becoming more attractive to certain segments of society. Meanwhile, economic trends-globalization, the demand for educated workers, the increasing role of universities-are providing cities with an unprecedented chance to capitalize upon their economic advantages and regain their competitive edge.

Many cities have exploited these assets to their advantage; the moment is ripe for older industrial cities to follow suit. But to do so, these cities need thoughtful and broad-based approaches to foster prosperity.

"Restoring Prosperity" aims to mobilize governors and legislative leaders, as well as local constituencies, behind an asset-oriented agenda for reinvigorating the market in the nation's older industrial cities. The report begins with identifications and descriptions of these cities-and the economic, demographic, and policy "drivers" behind their current condition-then makes a case for why the moment is ripe for advancing urban reform, and offers a five-part agenda and organizing plan to achieve it.

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Connecticut State Profile
Connecticut State Presentation 

Michigan State Profile
Michigan State Presentation 

New Jersey State Profile
New Jersey State Presentation 

New York State Profile
New York State Presentation 

Ohio State Profile
Ohio State Presentation
Ohio Revitalization Speech

Pennsylvania State Profile 

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Louisville/Jefferson County is the principal city of America’s 42nd largest metropolitan area, a 13-county, bi-state region with a 2006 population estimated at 1.2 million. It is the largest city by far in Kentucky, but it is neither Kentucky’s capital nor its center of political power.

The consolidated city, authorized by voter referendum in 2000 and implemented in 2003, is home to 701,500 residents within its 399 square miles, with a population density of 4,124.8 per square mile.² It is either the nation’s 16th or its 26th largest incorporated place, depending on whether the residents of smaller municipalities within its borders, who are eligible to vote in its elections, are counted (as local officials desire and U.S. Census Bureau officials resist). The remainder of the metropolitan statistical area (MSA) population is split between four Indiana counties (241,193) and eight Kentucky counties (279,523). Although several of those counties are growing rapidly, the new Louisville metro area remains the MSA's central hub, with 57 percent of the population and almost 70 percent of the job base.

Centrally located on the southern banks of the Ohio River, amid an agriculturally productive, mineral rich, and energy producing region, Louisville is commonly described as the northernmost city of the American South. Closer to Toronto than to New Orleans, and even slightly closer to Chicago than to Atlanta, it remains within a day’s drive of two-thirds of the American population living east of the Rocky Mountains.

This location has been the dominant influence on Louisville’s history as a regional center of trade, commerce and manufacture. The city, now the all-points international hub of United Parcel Service (UPS), consistently ranks among the nation’s top logistics centers. Its manufacturing sector, though much diminished, still ranks among the strongest in the Southeast. The many cultural assets developed during the city’s reign as a regional economic center rank it highly in various measures of quality of life and “best places.”

Despite these strengths, Louisville’s competitiveness and regional prominence declined during much of the last half of the 20th Century, and precipitously so during the economic upheavals of the 1970s and ‘80s. Not only did it lose tens of thousands of manufacturing jobs and many of its historic businesses to deindustrialization and corporate consolidation, it also confronted significant barriers to entry into the growing knowledge-based economy because of its poorly-educated workforce, lack of R&D capacity, and risk-averse business culture.

In response, Louisville began a turbulent, two-decade process of civic and economic renewal, during which it succeeded both in restoring growth in its traditional areas of strength, most notably from the large impact of the UPS hub, and in laying groundwork for 21st century competitiveness, most notably by substantially ramping up university-based research and entrepreneurship supports. Doing so required it to overhaul nearly every aspect of its outmoded economic development strategies, civic relationships, and habits of mind, creating a new culture of collaboration.

Each of the three major partners in economic development radically transformed themselves and their relationships with one another. The often-paralyzing city-suburban divide of local governance yielded to consolidation. The business community reconstituted itself as a credible champion of broad-based regional progress, and it joined with the public sector to create a new chamber of commerce that is the region’s full-service, public-private economic development agency recognized as among the best in the nation. The Commonwealth of Kentucky embraced sweeping education reforms, including major support for expanded research at the University of Louisville, and a “New Economy” agenda emphasizing the commercialization of research-generated knowledge. Creative public-private partnerships have become the norm, propelling, for instance, the dramatic resurgence of downtown.

The initial successes of all these efforts have been encouraging, but not yet sufficient for the transformation to innovation-based prosperity that is the goal. This report details those successes, and the leadership, partnerships, and strategies that helped create them. It begins by describing Louisville’s history and development and the factors that made its economy grow and thrive. It then explains why the city faltered during the latter part of the 20th century and how it has begun to reverse course. In doing so, the study offers important lessons for other cities that are striving to compete in a very new economic era. 

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Chattanooga a few years ago faced what many smaller cities are struggling with today—a sudden decline after years of prosperity in the "old" economy. This case study offers a roadmap for these cities by chronicling Chattanooga's demise and rebirth.

Chattanooga is located in the southern end of the Tennessee Valley where the Tennessee River cuts through the Smoky Mountains and the Cumberland Plateau. The city’s location, particularly its proximity to the Tennessee River, has been one of its greatest assets. Today, several major interstates (I-24, I-59, and I-75) run through Chattanooga, making it a hub of transportation business. The city borders North Georgia and is less than an hour away from both Alabama and North Carolina. Atlanta, Nashville, and Birmingham are all within two hours travel time by car.

Chattanooga is Tennessee’s fourth largest city, with a population in 2000 of 155,554, and it covers an area of 143.2 square miles. Among the 200 most populous cities in the United States, Chattanooga—with 1,086.5 persons per square mile—ranks 190th in population density.2 It is the most populous of 10 municipalities in Hamilton County, which has a population of 307,896, covers an area of 575.7 square miles, and has a population density of 534.8 persons per square mile.

With its extensive railroads and river access, Chattanooga was at one time the “Dynamo of Dixie”—a bustling, midsized, industrial city in the heart of the South. By 1940, Chattanooga’s population was centered around a vibrant downtown and it was one of the largest cities in the United States. Just 50 years later, however, it was in deep decline. Manufacturing jobs continued to leave. The city’s white population had fled to the suburbs and downtown was a place to be avoided, rather than the economic center of the region. The city lost almost 10 percent of its population during the 1960s, and another 10 percent between 1980 and 1990. It would have lost more residents had it not been for annexation of outlying suburban areas.

The tide began to turn in the 1990s, with strategic investments by developing public-private partnerships—dubbed the “Chattanooga way.” These investments spurred a dramatic turnaround. The city’s population has since stabilized and begun to grow, downtown has been transformed, and it is once again poised to prosper in the new economy as it had in the old.

This report describes how Chattanooga has turned its economy around. It begins with a summary of how the city grew and developed during its first 150 years before describing the factors driving its decline. The report concludes by examining the partnerships and planning that helped spur Chattanooga’s current revitalization and providing valuable lessons to other older industrial cities trying to ignite their own economic recovery. 

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Part of the larger Northeast Ohio regional economy, the Akron metropolitan area is composed of two counties (Summit and Portage) with a population of just over 700,000, and is surrounded by three other metropolitan areas. Akron is located approximately 40 miles south of Cleveland, 50 miles west of Youngstown, and 23 miles north of Canton. The Cleveland metro area is a five-county region with a population of 2.1 million. The Youngstown metro area includes three counties, extending into Pennsylvania, and has a population of 587,000. Canton is part of a two-county metropolitan area with a population of 410,000.

The adjacency of the Akron and Cleveland Metropolitan Statistical Areas (MSAs) is an important factor in the economic performance of the Akron region. The interdependence of economies of the two MSAs is evidenced by the strong economic growth of the northern part of Summit County adjacent to the core county of the Cleveland metropolitan area. This part of Summit County beyond the city of Akron provides available land, access to the labor pools of the two metropolitan areas, and proximity to the region’s extensive transportation network.

Although affected by economic activity in the larger region, the fate and future of Akron and its wider region are not solely determined by events in these adjacent areas. While sharing broad economic trends with its neighbors, the Akron metro area has been impacted by a different set of events and has shown different patterns of growth from other areas in Northeast Ohio.

This study provides an in-depth look at Akron’s economy over the past century. It begins by tracing the industrial history of the Akron region, describing the growth of the rubber industry from the late 1800s through much of following century, to its precipitous decline beginning in the 1970s. It then discusses how the “bottoming out” of this dominant industry gave rise to the industrial restructuring of the area. The paper explores the nature of this restructuring, and the steps and activities the city’s business, civic, and government leaders have undertaken to help spur its recovery and redevelopment. In doing so, it provides a series of lessons to other older industrial regions working to find their own economic niche in a changing global economy. 

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In our latest 21st Century Capitalism initiative paper, "What must corporate directors do? Maximizing shareholder value versus creating value through team production," author Margaret M. Blair explores how the share value maximization norm (or the “short-termism” malady) came to dominate, why it is wrong, and why the “team production” approach provides a better basis for governing corporations over the long term.

Blair reviews the legal and economic theories behind the share-value maximization norm, and then lays out a theory of corporate law building on the economics of team production. Blair demonstrates how the team production theory recognizes that creating wealth for society as a whole requires recognizing the importance of all of the participants in a corporate enterprise, and making sure that all share in the expanding pie so that they continue to collaborate to create wealth.

Arguing that the corporate form itself helps solve the team production problem, Blair details five features which distinguish corporations from other organizational forms:

1. Legal personality
2. Limited liability
3. Transferable shares
4. Management under a Board of Directors
5. Indefinite existence

Blair concludes that these five characteristics are all problematic from a principal-agent point of view where shareholders are principals. However, the team production theory makes sense out of these arrangements. This theory provides a rationale for the role of corporate directors consistent with the role that boards of directors historically understood themselves to play: balancing competing interests so the whole organization stays productive.

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The need to confront and drive back the forces of the Islamic State (IS) has pushed long-term reform efforts in Iraq far down the list of priorities. Yet pressing economic reforms – such as restructuring and rebuilding the country’s energy sector – increasingly seem a strategic necessity, as oil prices have fallen far below government projections. How can politicians be persuaded to invest in Iraq’s long-term future at a time of imminent security threats? How can the efforts to reform the Iraqi electricity network be harnessed to reestablish government authority in newly retaken areas?

Luay Al-Khatteeb and Harry Istepanian address these questions through analysis of past attempts at electricity sector reform. They argue that even before IS advances plunged Iraq into a deep political and security crisis, divisions within the Iraqi parliament and various government agencies had stymied efforts at reform. Still, they note that improving the provision of electricity is a clear opportunity to improve basic services to its citizens, boosting government legitimacy and acceptance in areas under its control, especially as it seeks to retake territory from IS.

Khatteeb and Istepanian hold that a comprehensive strategy is needed, one that incorporates an expanded role for the private sector, rationalized electricity tariffs, and a host of technical fixes to improve efficiency. Ultimately, they contend, much will depend on whether the government of Prime Minister Haidar al-Abadi views the IS threat as an excuse for inaction or an impetus for change.

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