The growth of suburban poverty over the past two decades raises questions about the ability of nonprofit organizations to adapt to this relatively new geography of metropolitan poverty. These organizations play multiple roles, including providing basic safety net services, connecting residents to new opportunities, and serving as advocates (and sometimes as organizers) for low-income communities.

Although federal, state, and local governments are often the primary funders of nonprofits, governments do not often take the lead in creating new organizational capacities or in coordinating capacity across political jurisdictions. In many regions, the local philanthropic community has become aware of these gaps in services for the poor and has sought to assist the nonprofit community in building capacity and expanding activities. Local foundations are experimenting with various strategies to address the growing dispersion of poverty.

This analysis combines an original data set of foundation grants for social services with in-depth interviews to assess the role of foundations in supporting the suburban social safety net in the Atlanta, Chicago, Denver, and Detroit regions. It finds that:

Suburban community foundations in the four regions studied are newer and smaller than those in core cities, despite faster growth of suburban poor populations. In the regions studied, most suburban community foundations began operating in the 1990s, and have not accumulated significant asset bases. Some larger city-based foundations have taken a regional approach, but face restrictions on the extent to which they can address growing need in poor suburban communities.

The share of foundation dollars targeted to organizations serving low-income residents varies widely across regions, but relatively few of those dollars are devoted to building organizational capacity in the suburbs. Chicago saw the largest share of foundation grant dollars go to organizations serving low-income people (60 percent), while Atlanta posted the lowest share (19 percent). Detroit was the only region where total grants to suburban-based human service providers were relatively comparable to their city-based counterparts.

Suburbs with high rates of poverty have substantially fewer grantees and grant dollars per poor person than either central cities or lower-poverty suburbs. Though metropolitan Atlanta has the highest rate of suburban poverty among the regions studied, it has the lowest rate of suburban grant-making per poor person. Denver’s results are a mirror image of Atlanta’s, with the lowest poverty rate and highest suburban grant-making per poor person.

Four types of strategies to build and strengthen the capacity of the suburban safety net are showing promise in these regions. Each region is engaging in four types of capacity building strategies: supporting existing regional organizations, creating new regional organizations, supporting regional networks, and establishing new suburban community foundations.

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In last summer’s congressional debate over the Iran nuclear deal—the Joint Comprehensive Plan of Action (JCPOA)—one of the more hotly debated issues was whether the deal would decrease or increase the likelihood that countries in the Middle East would pursue nuclear weapons.

Supporters of the JCPOA argued that, by removing the risk of a nuclear-armed Iran, it will reduce incentives for countries of the region to acquire nuclear arms. Opponents of the deal—not just in the United States but also abroad, especially Israel—claimed that the JCPOA would increase those incentives because it would legitimize enrichment in Iran, allow Iran to ramp up its nuclear capacity when key restrictions expire after 10 and 15 years, and boost the Iranian economy and the resources Iran could devote to a weapons program.

I strongly believe the JCPOA will significantly reduce prospects for proliferation in the Middle East (and as my colleague Richard Nephew explains in another post out today, there are things the United States and other powers can do to help reduce that prospect further). But uncertainties about the future of the JCPOA and the region will persist for quite some time—and these uncertainties could motivate regional countries to keep their nuclear options open. They may ask themselves a variety of questions in the years ahead: Will the JCPOA be sustainable over time? Will it unravel over concerns about compliance? Will it withstand challenges by opponents in Tehran and Washington? Will it survive leadership transitions in the United States and Iran? Will Iran ramp up its fissile material production capacities when key restrictions expire? Will it then break out of the JCPOA and seek to build nuclear weapons? Will Iran continue to threaten the security of its neighbors in the years ahead? And will the United States maintain a strong regional military presence and be seen by its partners as a reliable guarantor of their security?

I strongly believe the JCPOA will significantly reduce prospects for proliferation in the Middle East.

Richard and I studied how these and other questions might affect nuclear decision-making in the Middle East. In particular, we evaluated the likelihood that key states will pursue nuclear weapons, or at least enrichment or reprocessing programs that could give them a latent nuclear weapons capability. We focused on four states often regarded as potential candidates to join the nuclear club: Saudi Arabia, the United Arab Emirates, Egypt, and Turkey.

Saudi Arabia

Of the four, Saudi Arabia is the most highly motivated to pursue nuclear weapons. It sees Iran as an implacable foe that is intent on destabilizing its neighbors, achieving regional hegemony, and upending the Kingdom’s internal order. At the same time, the Saudis have lost much confidence in the U.S. commitment to the security of its regional partners. In part as a result, the new Saudi leadership has taken a more assertive, independent role in regional conflicts, especially in Yemen. But despite their reservations about the United States, the Saudis know they have no choice but to rely heavily on Washington for their security—and they know they would place that vital relationship in jeopardy if they pursued nuclear weapons.

The Saudis clearly have sufficient financial resources to make a run at nuclear weapons. But acquiring the necessary human and physical infrastructure to pursue an indigenous nuclear program would take many years.

Given the Kingdom’s difficulty in developing an indigenous nuclear weapons capability, speculation has turned to the possibility that it would receive support from a foreign power, usually Pakistan, which received generous financial support from Saudi Arabia in acquiring its own nuclear arsenal. But while rumors abound about a Pakistani commitment to help Saudi Arabia acquire nuclear weapons, the truth is hard to pin down. If such a Saudi-Pakistani agreement was ever reached, it was probably a vague, unwritten assurance long ago between a Pakistani leader and Saudi king, without operational details or the circumstances in which it would be activated. In any event, the Saudis would find it hard to rely on such an assurance today, when Pakistanis are trying to put the legacy of A.Q. Khan behind them and join the international nonproliferation mainstream. 

United Arab Emirates (UAE)

Like Saudi Arabia, the UAE believes Iran poses a severe threat to regional security and has become more aggressive since the completion of the JCPOA. And like the Saudis, the Emiratis have lost considerable confidence in the reliability of the United States as a security guarantor. But also like the Saudis, the Emiratis are reluctant to put their vital security ties to the United States in jeopardy.

[L]ike the Saudis, the Emiratis have lost considerable confidence in the reliability of the United States as a security guarantor.

Moreover, the Emiratis are heavily invested in their ambitious nuclear energy program—with efforts currently underway, with the help of a South Korean-led consortium, to construct four nuclear power reactors—and they know this project would be dead in the water if they opted for nuclear weapons.

The Emiratis have also been a leading regional supporter of nonproliferation. In their bilateral agreement for civil nuclear cooperation with the United States, they formally renounced the acquisition of enrichment or reprocessing capabilities (the so-called “gold standard”), effectively precluding the pursuit of nuclear weapons. After the JCPOA permitted Iran to retain its enrichment program, the UAE, faced with criticism domestically and from some Arab governments for having given up its nuclear “rights,” said it may reconsider its formal renunciation of enrichment. But subsequently, Emirati officials have made clear that their nuclear energy plans have not changed and that they have no intention to pursue enrichment or reprocessing.

Egypt

Egypt is on everyone’s short list of potential nuclear aspirants—in part because of its former role as leader of the Arab world and its flirtation with nuclear weapons in the Gamal Abdel Nasser years. But while Egypt and Iran have often been regional rivals, Egypt does not view Iran as a direct military threat. Instead, Egypt’s main concerns include extremist activities in the Sinai, the fragmentation of Iraq and Syria, disarray in Libya—and the adverse impact of these developments on Egypt’s internal security. The Egyptians recognize that none of these threats can be addressed by the possession of nuclear weapons.

Although Russia is committed to work with Egypt on its first nuclear power reactor, Cairo’s nuclear energy plans have experienced many false starts before, and there is little reason to believe the outcome will be different this time around, especially given the severe economic challenges the Egyptian government currently faces. Moreover, although Egypt trained a substantial number of nuclear scientists in the 1950s and 1960s, its human nuclear infrastructure atrophied when ambitious nuclear energy plans never materialized.

Turkey

Because of its emergence in the last decade as a rising power, its large and growing scientific and industrial basis, and its ambition to be an influential regional player, Turkey is also on everyone’s short list of potential nuclear-armed states. But Turkey has maintained reasonably good relations with Tehran, even during the height of the sanctions campaign against Iran. Although the two countries have taken opposing sides in the Syria civil war, Turkey, like Egypt, does not regard Iran as a direct military threat. Indeed, Ankara sees instability and terrorism emanating from the Syrian conflict as its main security concerns—and nuclear weapons are not viewed as relevant to dealing with those concerns.

Current tensions with Russia over Turkey’s November 2015 shoot-down of a Russian fighter jet are another source of concern in Ankara. But the best means of addressing that concern is to rely on the security guarantee Turkey enjoys as a member of NATO. While Turkish confidence in NATO has waxed and waned in recent decades, most Turks, especially in the military, believe they can count on NATO in a crisis, and they would be reluctant to put their relationship with NATO at risk by pursuing nuclear weapons.

Former nuclear aspirants

For the sake of completeness, our study also looked at regional countries that once actively pursued nuclear weapons but were forced to abandon their programs: Iraq, Libya, and Syria. But we concluded that, given the civil strife tearing those countries apart, none of them was in a position to pursue a sustained, disciplined nuclear weapons effort.

Bottom line

Our study found that the Iran nuclear deal has significantly reduced incentives for countries of the Middle East to reconsider their nuclear options. At least for the foreseeable future, none of them is likely to pursue nuclear weapons or even latent nuclear weapons capabilities—or to succeed if they do. 

Editors’ Note: Bob Einhorn and Richard Nephew spoke about their new report at a recent Brookings event. You can see the video from the event here.

Was the Iran nuclear deal, signed last summer, a prelude to proliferation across the Middle East? This is a question that Brookings Senior Fellow Robert Einhorn and Non-resident Senior Fellow Richard Nephew explore in a new report. At an event to discuss their findings—moderated by Brookings Deputy Director of Foreign Policy and Senior Fellow Suzanne Maloney and with panelists Derek Chollet and H.E. Yousef Al Otaiba—Einhorn and Nephew argued that none of the Middle East’s “likely suspects” appears both inclined and able to acquire indigenous nuclear weapons capability in the foreseeable future. They also outlined policy options for the United States and other members of the P5+1.

Einhorn described the incentives and capabilities of Egypt, Saudi Arabia, Turkey, and the United Arab Emirates for acquiring nuclear weapons. He argued that, while both Saudi Arabia and the UAE a) consider Iran a direct military threat, b) have concerns about the U.S. commitment to the security of the region, and c) have sufficient financial resources, they recognize that they have no choice but to rely on the United States for their security and are unwilling to jeopardize that relationship by seeking nuclear weapons. Einhorn also said that both Egypt and Turkey do not view Iran as a direct military threat and are more preoccupied with instability on their borders and internal security, concerns that cannot be addressed by possession of a nuclear weapons capability.

Nephew outlined policy recommendations, including measures to ensure strict implementation of the JCPOA, greater intelligence sharing and security cooperation with Middle East allies, and means of fostering IAEA-supervised regional arrangements that would encourage peaceful nuclear energy development and limit potentially destabilizing nuclear activities. Nephew also asserted that some elements of the JCPOA, such as online monitoring of nuclear facilities, could be applied to other nuclear energy programs in the region to enhance transparency. 

Derek Chollet of the German Marshall Fund argued the United States must deter Iran and reassure U.S. allies by maintaining a robust military presence in the region, planning a range of U.S. responses to destabilizing Iranian activities, and ensuring that U.S. forces have the weapons systems and personnel required for scenarios involving Iran. He suggested that the United States and its Middle East allies continue regular summit meetings on security and broader partnership issues, and possibly formalize security cooperation by establishing a dedicated regional security framework. 

Emirati Ambassador to the United States Yousef Al Otaiba emphasized that, to many of the countries in the region, Iran poses a threat wider than just its nuclear activities. He suggested that the JCPOA will be judged on the degree to which the United States and its allies address Iran’s destabilizing behavior outside of the nuclear file, such as Tehran’s support for Hezbollah and the Houthis, as well as its ballistic missile activities. Al Otaiba said that, though he has seen some efforts by the Obama administration to push Iran on its regional behavior, it has sent a mixed message overall, with senior U.S. officials also encouraging European banks to invest in Iran. The ambassador asserted that rigorous enforcement of the JCPOA will be critical to convincing Iran not to eventually proceed to build nuclear weapons.

On Saudi Arabia, Einhorn noted that although the Obama administration supported the Saudi military campaign in Yemen, there was a risk that the Kingdom would overreact to its regional security challenges. He suggested that the United States pursue a dual-track approach: counter provocative Iranian behavior and defend the security interests of its regional partners, while at the same time seeking a resolution of regional disputes and encouraging Saudi Arabia and Iran to find ways of reducing tensions between them.

On the possibility that Iran would rapidly scale up its enrichment program, Einhorn acknowledged that while Tehran can legally do so under the JCPOA in 10 to 15 years, it will not have a strong civil nuclear rationale since it will be able to acquire nuclear fuel from Russia and other suppliers. Furthermore, Iran’s progress in centrifuge research and development may not be as rapid as Iran currently anticipates. Moreover, even if Iran elects to ramp up its enrichment program down the line, the JCPOA and Nuclear Non-Proliferation Treaty (NPT) will bar it from pursuing nuclear weapons, and monitoring arrangements still in place will provide warning and enable the United States to intervene and prevent Iran from building nuclear weapons.

On reaching a regional accommodation that includes Iran, Al Otaiba indicated that the UAE would have much to gain, especially economically, from a better relationship with Tehran. He said the UAE and others in the region would like to try to engage with Iran to reduce tensions—but Iran, for its part, seems unwilling.

On prospects for a U.S.-Saudi civil nuclear cooperation agreement, Einhorn said that progress on such an agreement has stalled due to Saudi reluctance to formally renounce enrichment, something the United States has so far insisted on. He suggested that Washington should be prepared to relax the so-called “gold standard” (i.e., a formal renunciation of on enrichment and reprocessing) and instead accept an approach that would still discourage Saudi fuel cycle programs, such as giving Riyadh the right to pursue enrichment but allowing the United States to cease its nuclear cooperation if the Kingdom exercised that right. On the UAE’s civil nuclear program, Al Otaiba affirmed that the Emiratis continue to value the “gold standard” barring enrichment which is enshrined in the U.S.-UAE civil nuclear agreement, and have no plans to change their position on enrichment.

One unintended but very important consequence of the Iran nuclear deal has been to aggravate and intensify Saudi Arabia's concerns about Iran's regional goals and intentions. This fueling of Saudi fears has in turn fanned sectarian tensions in the region to unprecedented levels.

Of course stoking Saudi angst and perhaps even paranoia was not the intention of the deal’s negotiators. They sought to reduce tensions and prevent a nuclear arms race. A combination of circumstances outside their control exacerbated the problem of Saudi-Iranian rivalry that dates back before the Iranian revolution. But the results are likely to haunt the region for years to come.

An array of worries

Riyadh's concerns about Iran have never been primarily focused on the nuclear danger. The Saudis have long calculated the risk of Iranian use of nuclear weapons as low. They also believe the American nuclear umbrella protects them. The key Saudi concern is their belief that Iran seeks regional hegemony and uses terrorism and subversion to achieve it.

The deal deliberately does not deal with this issue. In Saudi eyes it actually makes the situation worse, because lifting sanctions removed Iran's isolation as a rogue state and gives it more income. Iran's ambition to be the region's hegemon is fueled not reduced by the deal.

The debate over the deal that ended a year ago coincided with two key developments in the Kingdom in early 2015. First was the succession of King Salman Abd al Aziz. His predecessor and half-brother Abdullah was a hardliner on Iran, but he was also risk-averse and cautious by nature. He had experimented with detente with Iran in the 1980s, even sending a Saudi Shiite as ambassador to Tehran. He wanted American soldiers to deal with Iran, not Saudis, a posture that greatly irritated Americans like former Secretary of Defense Bob Gates who likened it to using his soldiers as mercenaries. King Abdullah sought to avoid confrontation not embrace it.

The second coincidence was the takeover of the Yemeni capital Sanaa by the alliance of Zaydi Shiite Houthi rebels and former President Ali Abdullah Saleh early last year. The rebels opened direct air links to Tehran and proposed other concessions to Iran. They marched on the southern port of Aden, Sunni territory. Iran hailed their victories. The Saudis and other Gulf states saw an Iranian foothold emerging in the Achilles heel of the Arabian Peninsula.

The new king and his young Defense Minister Prince Muhammad bin Salman reacted angrily and firmly. An Arab coalition was created rapidly to intervene and fight the rebels. The result, Operation Decisive Storm, was distinctly unlike anything in recent Saudi history. Bold and aggressive in design, it stopped the rebels’ advance and prevented any Iranian intrusion into Yemen—but it also created a humanitarian disaster and a bloody stalemate. The United States and United Kingdom, eager to quiet Saudi objections to the nuclear deal, provided crucial support to the Saudi war. Pakistan, a longtime ally with a large Shiite minority, voted unanimously in parliament to stay out because it was worried about intensified sectarianism. 

A year ago Saudi intelligence renditioned Ahmed Mughassil after he debarked from a flight from Tehran to Beirut. The Saudi Shiite Mughassil was the mastermind of the Khobar attack twenty years ago in Saudi Arabia that killed nineteen American airmen. He was also involved in the assassination of several Saudi diplomats in the 1980s. He is the epitome of Iranian support and direction of terror. No doubt his interrogation has underscored Saudi concern about Iran's clandestine actions in the Gulf.

In January this year, the Saudis executed a prominent Shite dissident for allegedly supporting terrorism. An Iranian mob attacked the Saudi embassy—probably encouraged by regime hardliners—and then the Saudis broke diplomatic relations. Since then, Riyadh has encouraged its allies to follow suit. Iranian pilgrims will not attend this year's Hajj.

Saudi concern about Iranian conspiracies is reaching new heights. At least one prominent Saudi commentator has argued the terrorist attack on the Prophet’s Mosque in Medina on July 4th was a false flag operation controlled by Iranian intelligence to discredit the king's standing as the Custodian of the Two Holy Mosques. His column is getting wide attention.

Former intelligence chief and Ambassador to the United States Prince Turki al Faysal last weekend attended a large demonstration in France sponsored by the Mujahideen e Khalq group and called for the regime to be overthrown. Turki's backing for the MeK and his open call for regime change escalates the rivalry even further.

Entrenched position?

The combination of a new leadership in Riyadh that is more prepared to take firm action and the crisis in Yemen have added to Saudi disagreement over the Iran deal. As the Pakistanis feared, it has polarized an already deeply divided Muslim world. The Islamic State and al-Qaida benefit from the Muslim Cold War and the escalating sectarian violence.

Washington has tried hard to reassure the Saudis that they are not alone in their legitimate concerns about Iran's terrorist activities and destabilizing subversion. President Obama has wisely sought to build confidence with the king and his young son. The Iran deal is a good one, and I've supported it from its inception.

But it has had consequences that are dangerous and alarming. In the end, Riyadh and Tehran are the only players who can deescalate the situation. The Saudis show no sign of interest in that road. 

With the economy still reeling from the effects of the recession, metropolitan areas have become increasingly willing to explore new approaches to economic development. Moving away from traditional one-size-fits-all approaches that emphasized Starbucks, stadium-building, and stealing businesses, metro leaders are instead crafting metropolitan business plans that grow jobs from within, building on their distinct market advantages.

By partnering with private industry, nonprofit intermediaries, universities, civic leaders, research institutions, and other interested parties, regional public sector leaders are working to strengthen their economies by focusing on those industries with the greatest potential for future growth.

For some regions, these efforts have involved helping existing firms make the transition to emerging industries. Northeast Ohio’s long struggle with post-deindustrialization was made worse by the Great Recession and the collapse of the auto sector and the foreclosure crisis.

In response, regional leaders came together to launch PRISM, the Partnership for Regional Innovation Services to Manufacturers initiative. The goal of PRISM is to help small and medium-sized manufacturers in old commodities industries, like steel and automotive, reinvent their products and business models to take advantage of growth opportunities in emerging markets like bio-science, health care and clean energy.

Led by the Manufacturing Advocacy and Growth Network (MAGNET), a regional intermediary organization, PRISM brings together higher education institutions, regional economic development organizations, and Ohio’s Edison Technology Centers to provide market research and business consulting services, increase firms’ access to capital and talent, and foster stronger relationships within growing industry clusters. [Full disclosure: The Brookings-Rockefeller Project on State and Metropolitan Innovation provided initial advisory support to PRISM.]

“Through PRISM, we hope to demonstrate that a growing manufacturing sector is not only possible, but desirable for the region,” says MAGNET president and CEO Daniel Berry. “Reclaiming the legacy of manufacturing innovation in Northeast Ohio will enable the region’s companies to create more well-paying jobs.”

In other parts of the country, partnerships are linking up existing industry strengths to create new growth opportunities. To ensure the Seattle region continues to be a global hub of innovation, public and private sector leaders have formed the Building Energy-Efficiency Testing and Integration (BETI) Center and Demonstration Network to develop new products, services and technologies around energy efficiency for customers around the world. BETI capitalizes and integrates this region’s distinct, competitive advantages – unparalleled software and information technology, strong sustainability ethos, an emerging building energy efficiency sector, and strong post-secondary institutions and talent that can support future demand. This is not a cookie cutter idea but one that can best work with the market formula found in the Puget Sound region.

With financial support from a federal i6 Green Challenge grant and a state match, BETI will help local businesses commercialize innovations in building energy-efficient technologies, platforms, and materials by providing product validation and integration services. In addition, BETI will foster greater collaboration among industry stakeholders, including businesses, entrepreneurs, trade associations, local and state government agencies, state universities, research networks, venture capitalists, and regional utilities.  

Both Northeast Ohio and the Puget Sound region arrived at these collaborative partnerships during the course of their efforts to develop metropolitan business plans. Like private sector business plans, these regional economic development plans are rooted in market dynamics and competitive assets. The metropolitan business planning process offers a framework for regional business, civic, and government leaders to assess their metro’s distinctive market position, identify pragmatic economic development strategies that capitalize on regional assets and set forth detailed implementation-ready plans for economic growth. Once established, these metropolitan business plans will act as roadmaps for metro economies as they drive the nation toward greater prosperity, increased job creation, and a leading position in the next economy.

Brookings John Austin provided Great Lakes regional economic context for a forum of Ohio and Pennsylvania business and civic leaders convened by Congressmen Jason Altmire (PA), and Tim Ryan (OH) to develop strategies for growing the bi-state regional economy.

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An analysis of the growth and characteristics of the foreign-born in the Philadelphia metropolitan area between 1970 and 2006 finds:

• Among its peers, metropolitan Philadelphia has the largest and fastest growing immigrant population, which now stands at over 500,000, comprising 9 percent of the population. Between 2000 and 2006, greater Philadelphia’s immigrant population grew by 113,000, nearly as many as had arrived in the decade of the 1990s.
• Metropolitan Philadelphia has a diverse mix of immigrants and refugees from Asia (39 percent), Latin America and the Caribbean (28 percent), Europe (23 percent) and Africa (8 percent). The 10 largest source countries are India, Mexico, China, Vietnam, Korea, Italy, Ukraine, Philippines, Jamaica, and Germany.
• Immigrant growth in suburban Philadelphia has outpaced the city’s growth, but numerically, the city has the largest population of all local jurisdictions. Outside the city, Montgomery County had the earliest post- World War II suburban settlement of the foreign born and has the largest number of immigrants among jurisdictions, while Chester County saw the fastest growth during the 1970-2006 time period.
• Nearly 60 percent of the foreign-born living in metropolitan Philadelphia arrived in the United States after 1990. Although their naturalization rates and educational levels reflect their recentness of arrival, on the whole, greater Philadelphia’s immigrants are doing well on these measures as compared with some other U.S. metropolitan immigrant populations.
• Nearly 75 percent of greater Philadelphia’s labor force growth since 2000 is attributable to immigrants. Immigrants’ contributions to the labor force are considerably higher in this period than in the 1990s, when just 36 percent of the growth was due to immigrants.

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Bringing together the five counties of Southeastern Pennsylvania, the nonprofit Metropolitan Caucus, a new regional consortium there, is promoting a joint regional application for ARRA’s competitive Energy Efficiency and Conservation Block Grant dollars. Its four-part proposal, which will add and refine partners and programs over time, draws on the collaboration of multiple regional institutions to establish and operate a loan fund for green building and retrofits; support clean energy technology deployment; assist local governments with energy efficiency plans; and measure the energy performance of public facilities.

The newly created Metropolitan Caucus of southeastern Pennsylvania is leading the bold new regional energy efficiency strategy targeting for the competitive Energy Efficiency and Conservation Block Grants (EECBG) in the American Recovery and Reinvestment Act (ARRA). Unprecedented for the region, the Metropolitan Caucus has brought together five area counties—Bucks, Chester, Delaware, Montgomery, and Philadelphia—to make the most of the stimulus opportunity by coordinating their plans, goals, and assets to achieve maximum regional benefit. Their proposed joint EECBG competitive application for roughly $35 million calls for financing construction and retrofits, supporting clean energy companies, measuring building energy performance, and assisting local governments in implementing various sustainability solutions. To carry out each of these activities, the caucus intends to engage in broad cross-sector collaboration to leverage the strengths and unique assets of regional educational institutions, key nonprofits, and planning agencies.

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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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To access a curated stream of tweets from the #CleanEcon event, please visit this Storify page. Below you will find this event's full webcast archive--or, you may view one of four segments taken from that webcast.

No swath of the U.S. economy has been more widely celebrated as a source of economic renewal than the “clean” or “green” economy. However, surprisingly little is really known about these industries’ nature, size and growth—especially at the regional level. As a result, debates on transitioning to a green or clean economy are frequently short on facts and long on speculation as the nation searches for new sources of economic growth.

On July 13, the Metropolitan Policy Program at Brookings brought together business, economic development and political leaders to review the progress of clean industries, identify policy issues and opportunities, and consider how faster and broader growth of the clean economy could be encouraged at the national, state and regional level. A report and first-of-its-kind database, produced in collaboration with Battelle’s Technology Partnership Practice, was released at the event, providing new measures of the clean economy at the national and metropolitan levels. Also featured was an interactive web tool that allows users to track jobs, growth, segments, and other variables nationally, by state and by region.

Brookings Managing Director William Antholis welcomed participants and Bruce Katz, vice president and director of the Metropolitan Policy Program, presented the findings of this major new report on the status of the U.S. clean economy. Panel discussions followed, presenting the corporate and regional perspective.

After each panel, the speakers took audience questions.

Go to the report »

Go to the interactive web tool »

Video

• Introducing the Metropolitan Clean Economy
• Panel One: The Clean Economy, Firm by Firm
• Panel Two: The Clean Economy, Region by Region
• Clean Economy Closing Dialogue
• Growing the Clean Economy in Philadelphia

Audio

• Sizing the Clean Economy: A National and Regional Green Jobs Assessment
• Sizing the Clean Economy: A National and Regional Green Jobs Assessment
• Sizing the Clean Economy: A National and Regional Green Jobs Assessment
• Sizing the Clean Economy: A National and Regional Green Jobs Assessment

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The last time policymakers substantially reviewed federal communications policy, it was the early 1990s. At that time, the Internet was only beginning to reveal itself to be the dynamic technology seen today. Mobile devices and services, such as 100 megabit broadband, smartphones, applications, social networks, tablets, and digital streaming, were barely imagined, let alone factored into policy discussions. As the recent debate around net neutrality highlights, policymakers today can be hamstrung in efforts to fit today's communications technologies and services into last century's communications law. Given that most major communications laws are out of step with today’s advanced mobile capabilities, what shape would smart, updated legislation and regulatory changes take? What are the major changes to U.S. communications law that most need to be addressed and implemented?

On March 24, the Center for Technology Innovation at Brookings hosted a conversation with Craig Silliman, general counsel and executive vice president for public policy at Verizon, to examine what 21st century communications polices might look like.

Video

• Updating communications law and regulations for the mobile era

Audio

• Updating communications law and regulations for the mobile era

Transcript

• Uncorrected Transcript (.pdf)

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• 20150324_communications_law_transcript

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Russia’s annexation of Crimea in March and the continuing crisis in Ukraine have triggered the most heated confrontation between Russia and the West since the Cold War. The standoff over Ukraine has raised critical questions about Russia’s ambitions in the post-Soviet space and the future political perspectives of the countries caught between Russia and the European Union. Despite political and economic pressure and ongoing occupation by Russia, Georgia is pursuing democratic transformation and a path toward the West.

On May 5, the Center on the United States and Europe (CUSE) at Brookings hosted Georgian Defense Minister Irakli Alasania for an address on Georgia’s vision for Euro-Atlantic integration during a period of increased insecurity in the region. In his remarks, Minister Alasania shared his insights on the upcoming NATO summit and Georgia’s approach to enhancing its relations with the West while attempting to normalize relations with Russia to lower tensions still simmering from the war six years ago.

Irakli Alasania previously served as Georgia's permanent representative to the United Nations from 2006 to 2009 and before that as special representative of the president in Georgian-Abkhazian negotiations. He is the founder and chairman of the Our Georgia-Free Democrats Party and one of the founders of Georgian Dream Coalition.

CUSE Director Fiona Hill provided introductory remarks and moderated the discussion.

Audio

• Georgia's Euro-Atlantic Aspirations and Regional Security

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• Transcript (.pdf)

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The use of economic resources to support election campaigns is an essential ingredient of democratic competition. Often viewed as a malady of democracy, campaign finance is actually part of the normal workings of democratic life. However, it is indisputable that money is capable of inflicting significant distortions on politics and policymaking. When there is a failure to regulate money in the political process or existing regulation is ineffectual, the legitimacy of democratic processes can be jeopardized.

These concerns are particularly relevant to Latin America, a region plagued by a highly unequal income distribution, and where organized crime has a major presence, transacts billions of dollars each year in illicit business, and has the potential to corrupt democratic institutions. In this policy brief, Kevin Casas-Zamora and Daniel Zovatto offer practical guidance for making campaign finance regulation feasible and increasing its likelihood of success. In undertaking reform, countries should prioritize the most urgently needed changes with the broadest political consensus. Proposals for reform include:

• Establish greater control over private funding of parties and election campaigns;

• Create a public subsidy system to ensure fair access for parties and candidates to adequate funding to finance both regular day-to-day operations and election campaigns;

• Adopt mechanisms to keep campaign spending from skyrocketing;

• Craft party and candidate reporting systems to increase accountability, transparency, and disclosure; and

• Establish a graduated and credible system of sanctions for the chief financial officers of political parties in the event of violations of the rules in force.

Downloads

• The cost of democracy: Campaign finance in Latin America

 Bruce Katz's keynote presentation to the Mid-America Region Council discussed what metropolitan areas need to succeed in a competitive world, with specific information about how Greater Kansas City compares to other regions and areas for improvement.

The urban center hosts and participates in a variety of public forums. To view a complete list of these events, please visit the urban center's Speeches and Events page which provides copies of major speeches, powerpoint presentations, event transcripts, and event summaries.

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Though possessing much economic strength, the Kansas City region faces stark barriers to its long term competitiveness, including a limited capacity for innovation, unfocused growth, and wide racial disparities. This paper—in conjunction with two companion papers delving into the region's economic assets and its life sciences economy—examines how Kansas City can overcome these challenges.

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• Download assessment by Robert Weissbourd and Alen Amirkhanian

Editors’ Note: It is time to establish a regional reconstruction strategy for the Middle East, argues Sultan Barakat, that involves collective vision, broad participation, smart security, equality, and other key elements.This post originally appeared in Huffington Post.

The World Bank is hosting its annual Fragility Forum this week with the aim of making progress on the post-2015 Sustainable Development Goals. This week has also seen a fragile ceasefire in Syria, potentially landmark elections in Iran, and a violent clash between Jordanian security and so-called Islamic State members. Together these developments have prompted me to reassess what needs to be done to resolve the issues of conflict and fragility in the Middle East.

For the Middle East, the starting point should be to move away from any process that reinforces the image of the West devising solutions and proposing "new" visions to the region. Such approaches are reminiscent of the Sykes-Picot agreement or the neoconservatives' "grand strategy" of the early 2000s and do not appreciate that the Middle East has changed fundamentally since 2011. The region, at all levels, now expects to be treated with dignity and to be the driving force behind its own development.

It is high time to pull together to establish a "Regional Reconstruction Strategy" that can address all sorts of violence, not just Islamist-related conflict. The region needs an ever-evolving strategy that maintains a holistic, problem-solving outlook while drawing on various forms of intervention (e.g. community driven development, inter-regional development projects, targeted counterinsurgency operations, stabilization, statebuilding, etc.) without being straightjacketed by any one toolkit or template. Novel approaches rooted in genuine regional leadership, broad participation, youth engagement, and the utilization of technology will increasingly need to be applied. The pillars of such a strategy should be a collective regional vision, effective local participation, smart security, reconciliation and justice, equity, reconstruction and development, and capacity.

Collective Vision: With the aspirations of the Arab Spring unrealized and many countries descending into sectarianism, what is needed now is a collective vision that goes beyond national borders. This would include pooling the region's resources, specifically all the ingredients for large-scale development, such as human resources, an educated population, capital, mobility, and nature. We could then look to the day when region-wide development is synergistic and not predatory or a zero-sum game. What Morocco has achieved with solar energy is a shining example—a visionary investment has addressed regional developmental and environmental challenges, stimulated employment, and raised confidence that hi-tech and innovative sectors can thrive in the Middle East. Such a broad vision is crucial if the region is to leapfrog into the twenty-first century and not remain in a vicious cycle of conflict and failed development.

Key to an inclusive and non-adversarial vision will be both accepting and embracing Islam as a majority religion while building on human security as an area of common ground. For this to happen some real changes are required in places such as Iran and Saudi Arabia—which would enable both to exercise their regional leadership in coalescing a constructive collective vision rather than perpetuating sectarian hostility.

Broad Participation: It is important that the regional vision recognizes that development requires an active civil society, a free media, and rooting action and ideas at the local level and with popular participation. The process of engaging in a region-wide consultation where contributions are coming from schools, villages, city halls, political parties, unions, and many other civic forums can help the region start dreaming about what it wants to look like in the 50 years to come.

Smart Security: Instead of a collective vision for development we have one for defense, formed with the excuse of the Islamic State group. All appreciate that a minimum level of security is important for implementing reconstruction, but a lack of security cannot be a pretext to do nothing. Experience has shown that delaying reconstruction efforts pushes people down the slope of conflict and violence and leads to dependence on humanitarian assistance. The region needs to find ways of better understanding the granular texture of security at local and regional levels so that strategies can be developed in which localized insecurity does not hold back development in other areas. This could support "spot reconstruction" efforts that create exemplars of what a degree of stability combined with reconstruction intervention can achieve in the midst of larger instability.

Reconciliation and Justice: No long-term investment in reconstruction can be protected without genuine reconciliation across the region. Twenty years ago the main fault line was Israel-Palestine. Today, there are many additional fault lines that need to be addressed, including Muslim-Christian tensions, tensions between displaced and host communities, and tensions between Sunni and Shiite communities. The most fundamental way to initiate reconciliation is to make sure that the rule of law applies to all and that everyone has access to justice regardless of the mechanism. On this a lot can be built on local and traditional systems for achieving justice and reconciliation.

Equity: A common mistake with reconstruction is that it proceeds without sufficient regulation and monitoring to ensure that benefits are equitably distributed. This region has repeatedly seen how easily reconstruction "lords" (most of whom were previously warlords) can emerge to line their pockets at the expense of the general public, thus perpetuating that country's crisis. World Bank arguments for the private sector to take the lead in reconstruction in Afghanistan and elsewhere have done nothing but strengthen this model. Assad's efforts to liberalize Syria's economy prior to 2011 led to the further enrichment of a corrupt elite, contributing to what we see today. Going forward, reconstruction efforts must take into consideration the poorest and least capable—so that nobody is left out.

Reconstruction and Development: There is an urgent need to find new ways of inducing development through international engagement with the region. The current instability has shifted spending toward security and away from the basics of development. As a result, some of the most important development indicators—freedom of expression, women's participation, poverty, quality of education—have taken a step back. All this is happening when the region is facing financial challenges due to severely reduced oil prices. This may prove to be an opportunity as some countries needed a good wake-up call to the pernicious effects of a model of capital development in which billions of dollars are invested in the West, generating jobs and stabilizing economies thousands of miles away at the expense of the region. If the West wants to help the region it should seek to focus minds within the Arab world on the value of investment in addressing regional problems in a mutually beneficial way. Ultimately a more stable region will lead to more prosperous neighbors both in the East and the West.

Building Capacity: To do this we must invest enormous amounts in fostering sustainable capacity at regional, national, and local levels. It is essential to invest in education at all levels, in particular going beyond primary education to support the young men and women that will become leaders with the conviction and capabilities to rebuild the region. In a rush to capture development, we have focused on the hard sciences, engineering, business studies, and computer science while ignoring our own culture, languages, and history. We must correct this imbalance, and it is time we develop our ideas in our own language and not rely on translation.

For all this to happen, fragility must be addressed within a coherent regional vision, not individual national plans. It would be constructive if the international community and donors would try to view the region as a whole—as one canvas in which to facilitate cross-border mobility of population, capital, ideas, and labor—and encourage regional responsibility with different countries leading in their areas of competency. International partners can support this with new and innovative forms of funding that utilize collateral guarantees from the region, not just individual countries. If we can embrace a truly regional approach, there may be a day when we elevate human dignity and human development above petty politics and sectarianism.

Event Information

As Africa's oldest independent country, Ethiopia has a history that is unique in the continent. The country has faced its share of conflict, including a protracted civil war from 1974 through 1991. A land-locked location in Eastern Africa, the country has also been witness to climate catastrophes, — including the drought that killed a half a million people in the 1980s and the threat of a new drought today. Despite being one of Africa's poorest countries, Ethiopia has experienced significant economic growth since the end of the civil war, and a majority of its population is literate. In addition, Ethiopia is a crucial U.S. security partner, particularly when it comes to counterterrorism, in a region plagued by threats.

On April 25, the Africa Security Initiative at Brookings hosted a discussion examining the security situation in Ethiopia, in broader political, economic, and regional context. Panelists included Abye Assefa of St. Lawrence University and Terrence Lyons of George Mason University. Michael O’Hanlon, co-director of the Center for 21st Century Security and Intelligence, moderated.

Video

• The security situation in Ethiopia and how it relates to the broader region

Audio

• The security situation in Ethiopia and how it relates to the broader region

In a recent analysis, I highlighted how employment and disconnection among young people vary by age, race, and place. In this podcast, I dig deeper into the data on the Washington, D.C. region. Although the area generally performs well on employment measures, not all young people are faring equally well.

Listen to the full podcast segment here: 

The use of economic resources to support election campaigns is an essential ingredient of democratic competition. Often viewed as a malady of democracy, campaign finance is actually part of the normal workings of democratic life. However, it is indisputable that money is capable of inflicting significant distortions on politics and policymaking. When there is a failure to regulate money in the political process or existing regulation is ineffectual, the legitimacy of democratic processes can be jeopardized.

These concerns are particularly relevant to Latin America, a region plagued by a highly unequal income distribution, and where organized crime has a major presence, transacts billions of dollars each year in illicit business, and has the potential to corrupt democratic institutions. In this policy brief, Kevin Casas-Zamora and Daniel Zovatto offer practical guidance for making campaign finance regulation feasible and increasing its likelihood of success. In undertaking reform, countries should prioritize the most urgently needed changes with the broadest political consensus. Proposals for reform include:

• Establish greater control over private funding of parties and election campaigns;

• Create a public subsidy system to ensure fair access for parties and candidates to adequate funding to finance both regular day-to-day operations and election campaigns;

• Adopt mechanisms to keep campaign spending from skyrocketing;

• Craft party and candidate reporting systems to increase accountability, transparency, and disclosure; and

• Establish a graduated and credible system of sanctions for the chief financial officers of political parties in the event of violations of the rules in force.

Downloads

• The cost of democracy: Campaign finance in Latin America

Over the course of my career, I have watched Egypt’s transformation from an authoritarian state to a revolutionary one and back again. But last month’s murder of Italian graduate student Giulio Regeni (with some pointing fingers at Egyptian security forces) illuminates that today’s Egypt is even less safe, less free, and less tolerant than it was under Hosni Mubarak—an impressive feat. The disintegration in Egypt’s security environment could haunt the country and its leaders, as it will only push international travelers and researchers further from its shores.

Fear and loathing in Cairo

In 2010, shortly before the 2011 revolution, I lived in Cairo interviewing civil society activists and government officials on the ability of NGOs to challenge the Mubarak regime. I returned a few months after the uprising to a very different Egypt. 

In some ways, the environment had become more hospitable for discussing democracy and seeking honest assessments of the regime. Egyptians were still brimming with hope that the revolution would bring them the Egypt they had fought for and expressed overwhelming pride in their accomplishments in Tahrir Square. They were forthcoming with critiques of the former regime and inspired to begin by participating in politics, overturning the draconian NGO law, and founding innovative organizations to help usher in an era of democracy in Egypt. 

But in other ways, the conditions in Egypt had become dangerous. The security situation was precarious, as a post-revolutionary crime wave and general lawlessness keeping Egyptians at home and tourists away. For the first time, I hired a driver to ensure my safety. I was afraid to walk alone at night, ride the metro, or hang out in the same cafes I had frequented during my trips to Mubarak’s Egypt. 

Ironically, I was also far more cognizant of the security services in this new “freer” Egypt than I had been in past visits. The vestiges of Mubarak’s security apparatus remained, but they were operating under different and far more arbitrary and kinetic rules, making it challenging to identify—and avoid—redlines. I heard stories of NGO raids that were no different from the Mubarak era and possibly more punitive, with pro-regime security forces hoping to exact revenge on the activists who unseated their leader. Frustration and anger towards foreigners—governments, donor organizations, and even researchers—had emerged among civil society actors, who believed that Washington, in particular, was meddling in a process that was home-grown. Civil society activists whose NGOs had been fully reliant on international funding vowed to no longer take USAID money, for example. And although I was a full-time doctoral student with no ties to the U.S. government, some of those whom I interviewed distrusted my motives and saw me and other foreign scholars as inextricably linked to our governments. 

I heard stories of NGO raids that were no different from the Mubarak era and possibly more punitive, with pro-regime security forces hoping to exact revenge on the activists who unseated their leader.

Pining for yesterday

But the atmosphere in the immediate aftermath of the revolution was nothing like that of today’s Egypt. The murder of Italian national and Cambridge University student Giulio Regeni, who was last seen alive in Cairo on January 25 (the five-year anniversary of the Egyptian revolution), has sparked outrage around the world. The Italian ambassador to Egypt has said that Regeni’s autopsy revealed “clear, unequivocal marks of violence, beating and torture.” Egyptian security officials have admitted taking Regeni into custody. And while the Ministry of Interior subsequently denied such reports, Egyptian State Prosecutor Ahmed Nagi would not rule out police involvement in his murder. 

Despite the similarity of Regeni’s case to “widespread” reports of torture and forced disappearances by the Egyptian security services, we do not know for sure who is responsible for Regeni’s murder. Scholars across the globe have called on the Egyptian government to conduct a thorough and honest investigation. But regardless of the outcome, the very perception that students are no longer safe in Cairo has caused great harm to Egypt. The very fact that scholars, some of whom have studied Egyptian politics for decades, believe that the Egyptian Security Services could have committed this crime speaks volumes about the state of repression there. 

The very fact that scholars, some of whom have studied Egyptian politics for decades, believe that the Egyptian Security Services could have committed this crime speaks volumes about the state of repression there.

Not all press is good press

Regeni’s violent and tragic death and the Egyptian government’s response have far-reaching implications for Egypt. First, the sheer volume of attention on the Regeni case has caused harm to Egypt’s already decaying reputation. Abdel-Fattah el-Sissi’s regime is engaged in a crackdown on freedom of expression surpassing that of Mubarak. As the leadership of the Middle East Studies Association (MESA)—the most prominent academic organization on the Middle East—rightly note in an open letter to the Egyptian regime, Regeni’s case is not an exception, but rather the latest example of an increasingly vicious attack on freedom of expression in Egypt. As the MESA letter states, “human rights reports suggest that academics, journalists and legal professionals are in greater danger of falling victim to arbitrary state repression today than at any time since the establishment of the republic in 1953.” This was particularly true in the weeks leading to the anniversary of the Egyptian revolution, as the state sought to quiet any public discontent before it started. 

But unlike the hundreds of cases of forced disappearances and systematic torture of Egyptians in custody, the sheer brutality of Regeni’s murder and his status as a young, Western scholar, have made it difficult for Western states to ignore and have shed much needed light on the escalating attack on the rights and freedoms of both foreigners and Egyptians. Most clearly, Egypt’s relationship with an important political and economic partner, Italy, is tarnished. And the suspected state involvement in torture is now an issue that Western interlocutors must raise with their Egyptian counterparts, obliging the Egyptian government to address, or at least find a way to dance around, the issue.

the suspected state involvement in torture is now an issue that Western interlocutors must raise with their Egyptian counterparts, obliging the Egyptian government to address, or at least find a way to dance around, the issue.

Egypt’s foreign minister Sameh Shoukry happened to be in Washington when the circumstances of Regeni’s death was made public. His tone-deaf public responses were telling. He not only flatly denied that Egypt is engaged in a widespread crackdown on freedom of expression, he even compared Egypt’s critics, including internationally respected human rights organizations, to Nazi propaganda minister Joseph Goebbels. Shoukry’s response, so undiplomatic and divorced from reality, is unlikely to quiet Egypt’s critics. Rather, it will keep Regeni’s death (and the issue of security service abuses) in the international press even longer. 

This sort of public attention is something that the Mubarak regime would have taken seriously. Mubarak regularly acknowledged and attempted to diffuse, albeit often ineffectively, accusations of human rights abuses under his watch, often justifying repression in the name of security. But the Sissi regime’s response has been far less strategic, and this has potentially dangerous consequences. By ignoring the festering wound the regime has created for itself by torturing, jailing, disappearing, and killing those who speak out against it, the infection will spread, not disappear. 

Fading from view?

Another outcome of Regeni’s murder is that universities will steer their students away from studying in Cairo, traditionally one of the most popular destinations for American students of Arabic, and may discourage faculty from visiting as well. For the American University in Cairo (AUC), an institution known for high standards and academic freedom, the loss of foreign students and researchers could pose serious financial problems. 

That may not concern the regime, but it is not only AUC that will suffer from a deterioration of foreign contacts. Even prior to Regeni’s murder, some Western scholars believed it was too difficult and risky to conduct serious research in Egypt, and this trend will increase. Other scholars may still study Egypt, but will do so from a distance, rather than risking their lives on the ground there. 

This sort of public attention is something that the Mubarak regime would have taken seriously.

A dramatic decline in international academic contacts should worry the Egyptian government. This will greatly harm the world’s understanding of what is happening in a country that has proven time and again its importance to the region’s economy and political trajectory. Egyptian students and scholars will suffer as well, missing out on the important information and cultural education that comes from cross-border academic exchange. 

Not to mention that Egypt is in the midst of an economic crisis. Regeni’s death will likely keep Western tourists away, harming the tourism industry, which makes up over 10 percent of Egypt’s GDP, and which has failed to recover from dramatic declines during the revolution. 

A continued crackdown on freedom of expression and an increasingly dangerous environment for American and European visitors also has implications for Egypt’s diplomatic relationships. While Egypt’s history, size, and political role in the region will keep it on Washington’s radar, it risks joining the ranks of Somalia or Yemen or Libya—states with a limited (if any) diplomatic presence, and even more limited economic assistance package. The robust U.S.-Egyptian relationship—including several high-profile visits each year and a $1.5 billion aid package--is based, in part, on Egypt’s portrayal of itself as the “leader” of the Arab world and a country on the path toward democracy. If the Sissi regime continues to jail, torture, and murder its critics, including Western scholars, it will make it very challenging for the United States to continue this level of support. 

As Secretary of State John Kerry said last month following his meeting with Shoukry, Egypt is “going through a political transition. We very much respect the important role that Egypt plays traditionally within the region--a leader of the Arab world in no uncertain terms. And so the success of the transformation that is currently being worked on is critical for the United States and obviously for the region and for Egypt.”

The Egyptian government is underestimating the negative repercussions of Regeni’s death. Scholars like Regeni and me study Egypt and visit Egypt are driven by Egypt’s incredible history and because of its important cultural, economic, and political role in the modern Middle East. On my very first day in Cairo back in 2002, a kind Egyptian man took my hand and helped me cross the street amidst the infamously crazy Cairo traffic. When we safely made it across and the look of trepidation fell from my face, he told me to repeat after him, “Ana b’hib Masr” (I love Egypt). It was the first colloquial Egyptian phrase I learned and one I have repeated many times. But sadly, it is not one that I or other international researchers will likely be able to repeat in Egypt any time soon.

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.

Good afternoon Chair Ayotte, Ranking Member Cantwell, and Members of the Subcommittee. Thank you very much for the opportunity to testify today on the important topic of domestic unmanned aircraft systems (UAS).

I am a nonresident senior fellow in Governance Studies and the Center for Technology Innovation at the Brookings Institution. I am also a National Fellow at the Hoover Institution at Stanford, and a professor at UCLA, where I hold appointments in the Electrical Engineering Department and the Department of Public Policy. The views I am expressing here are my own, and do not necessarily represent those of the Brookings Institution, Stanford University or the University of California.

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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.

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).

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.)

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.

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.)

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.

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.

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.

References

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• The Four A's of Expanded Patient Access

Americans who use defined contribution retirement savings plans (for example, 401(k) or 403(b) plans) or Individual Retirement Accounts will see their retirement security enhanced by two recently announced regulatory initiatives. The first is a series of Treasury Department/IRS proposed regulations that such individuals to use annuity-like guaranteed lifetime income products. The second is a final Department of Labor rule requiring complete fee disclosure to employers sponsoring retirement saving plans. Together, the two initiatives will give current retirement savers and future retirees more flexibility in structuring their retirement incomes, while making it possible to avoid excessive or hidden fees.

Four Treasury/IRS proposals, which were developed under the leadership of our former RSP colleague Mark Iwry, deal with several of the most pressing issues faced by employers and savers that currently reduce the use of annuities. The first proposal would reduce barriers to giving retiring savers the option of annuitizing part of their account balances. Currently, people need to annuitize either the entire balance or none at all. People are naturally wary of annuitizing the entire amount because it leaves them with little in the way of a cash cushion for emergencies. By choosing to annuitize part of the balance, people can retain a lump sum for emergency or other purposes.

A second proposal would remove a technical impediment to using longevity annuities, an annuity that is typically purchased close to retirement but does not begin to pay benefit until the retiree reaches age 85 or a similar age. Longevity annuities enable retirees to manage their money for a set period of time, secure in the knowledge that the longevity annuity will provide income after that, should they live longer than expected.

The third proposal would allow an individual to begin to partially annuitize their savings well before retirement. Starting to annuitize early by buying small pieces of an annuity over twenty or so years allows the saver to avoid having to make a “once and for all” decision and allows the savers to spread out the interest rate risk over time. This option had been subject to a requirement that the saver get a notarized statement from his or her spouse (if any) concerning whether the annuity covers just the saver or both the saver and his or her spouse. The proposal allows this to be handled by the issuing insurer when payments would begin rather than when purchases begin.

The fourth proposal would apply to relatively rare case where the employer has both a retirement savings plan and a traditional defined benefit pension, and would allow an employee to buy a low-cost annuity through the employer’s DB pension.

These four regulatory changes are positive developments. The changes announced today eliminate unintentional barriers to the use of lifetime income products without dictating how individuals should use them. Some may choose to partially annuitize at retirement, some to use longevity annuities to protect them in later years, and some to begin to buy annuities well before retirement. Whatever the choice, the proposals open up new options to future retirees, and should encourage even more market innovations.

At about the same time, the Department of Labor released final regulations requiring providers to disclose all direct and indirect fees to the employer sponsoring a 401(k) plan. The regulations will add needed transparency on fees that will enable increased competition to produce better results for employers and employees.

Despite removing a required template of charges, the new regulations nevertheless give employers a complete and accurate picture of all charges they have to pay, including indirect fees paid by the provider to others. Currently, many indirect fees are not disclosed even though they may reduce the earnings of participants. Endorsed by industry and consumer groups, the disclosures will enable employers who use this information properly to meet their fiduciary responsibility to choose a responsible fee level. What is even more important, the full disclosure will enable employers to structure their 401(k) plan so that individual savers can get the best returns possible, and not be subject to unreasonable fees.

While much more remains to be done to improve retirement savings plan, the steps taken by the proposed Treasury/IRS regulations and the Department of Labor’s final regulations will help savers to improve retirement security.