When the Volkswagen emissions control scandal broke into the headlines in September, I wrote here how I felt like my lifelong love affair with VW had been violated. As an environmentalist, owning a Jetta that zipped along for 42 miles on a gallon of diesel was the best of both worlds. And it was a lie. My wife, Holly Flood, said she felt like she’d been “duped,” and since then she’s vowed never to buy another VW.

I’m not so sure. But I was pleased this week to see the agreed terms for the nearly half million of us who own the smaller diesel engine cars in the U.S. This was the largest car settlement in U.S. history.

What I like is the combination of individual and collective compensation for this crime.

On the individual side, if this deal is approved by the judge in early October, my family will get our 2009 Jetta TDI sedan fixed for free (if the Environmental Protection Agency approves the fix), and we’ll get a check for $5,100. Holly says that’s perfect timing for a down payment on a new car (which will not be a VW).

I’m pushing for a plug-in electric hybrid, which we can charge with renewable energy we get off the grid from our local provider, People’s Power & Light. In our case, for every electron we use, they pay to have one electron put in from wind power somewhere right here in New England. Hopefully we’ll have variable pricing of electricity by then, allowing us to charge the car when the juice is cheapest, like when the wind blows at night but few people are using much electricity.

The unknown for us is whether the VW fix will noticeably harm the performance of the car. I’m guessing it will, perhaps in its remarkable torque, in its gas mileage, or both. But at this point the car has tons of my wife’s commuting miles on it, so we’re hanging on to it as the in-town backup car. Under the settlement we could get an extra $7k and give up the car entirely. That may be tempting, as it’s at that point where it’s getting substantially more expensive to maintain, and the Kelley Blue Book value is around $6k. They apparently aren’t lowballing us.

The collective part of this agreement is actually more interesting.

VW agreed to pay $4.7 billion  into environmental programs, which in my estimation will eliminate more harm than they created. One estimate guessed that scores of premature deaths occurred in the U.S. from VW’s “defeat devices” that shut off emissions controls when they were not being tested. Most of the deaths were probably in California, where there were many more sales of diesels than elsewhere in the country. (Of course in Europe the concentration of diesels is much greater and the Guardian put the number of deaths at thousands in the U.K. alone.) 

One part of this fund will go to replace diesel buses with electric ones. This will measurably improve air quality in inner cities, the precise places where extra sooty VWs were causing ill health and premature deaths with their NOx emissions. Another part will go to install electric vehicle charging stations in California. This helps overcome the “chicken and egg” problem of people not being willing to switch to electric vehicles for fear of running out of juice. The settlement says that “Volkswagen must spend $2 billion to promote non-polluting cars (“zero emissions vehicles” or “ZEV”), over and above any amount Volkswagen previously planned to spend on such technology.” That counterfactual will probably be impossible to prove, but the idea here is fairness.

Sociologically, this is a fascinating case, because it reveals how our society resolves scandals that killed people through knowing contamination of the environment. As Deputy U.S. Attorney General Sally Yates harshly put it, "By duping regulators, Volkswagen turned nearly half a million American drivers into unwitting accomplices in an unprecedented assault on our environment." There are individuals inside this company who deserve criminal prosecution, but apparently most of the thousands of other employees did not know what was going on.

The corporate response has been interesting, and seems to vary sharply from how most U.S. auto firms have dealt with similar lawsuits and scandals in the past. VW did not drag out the battle, but set aside $16 billion immediately as a loss, and then settled rather generously with us. (This spring they had already given us a $500 gift card and $500 in repairs in what was essentially hush money.)

VW’s response to this crisis was creative, forward-looking, and ultimately pro-social. Just a week or so ago they announced that their new business model was to be in electrics: They announced they’d be rolling out 31 electric vehicles in the coming years. This is a remarkable turn for a company that pushed diesels for decades as the solution to climate change. This is what it looks like when a massive corporation whose reputation was built on trust and belief in the integrity of a brand seeks to battle its way back into a changing market.

Spending billions on charging stations and replacing diesel buses may make immediate sense—can we say if this is helping avoid premature deaths or it is merely crass self-interest? Does it matter? 

Of course it does. But my first impression of what VW did this week was of a fair deal that was not just lining my pocket. It was helping us get off fossil fuels as a society and benefiting human health and the environment in a substantial way. And by rebuilding a major employer in Germany, the U.S., and around the world into one that might be a part of the solution to climate change, this is a significant and fairly brilliant business move to position the company for the next half century.

Or am I merely a sucker for my old flame?

Today, Egyptian President Abdel-Fattah el-Sissi is witnessing the most vocal and angry objection to his rule since he took power via a military coup in 2013. Across Cairo and beyond, Egyptians are gathering and chanting some of the same slogans from the January 2011 revolution—such as “the people want the fall of the regime” and “down with military rule.” These protests are not a spontaneous uprising. They were planned and announced on April 15, when thousands of Egyptians took to the streets, protesting the latest in a series of bold and controversial decisions that are slowly and steadily chipping away at Sissi’s once solid support structure abroad and at home.

During Saudi King Salman’s recent visit to Cairo, the Egyptian government announced that it had agreed to transfer sovereignty of two Red Sea islands—Tiran and Sanafir—to Saudi Arabia. This decision, which coincided with a $22 billion oil and aid deal, has a clear short term pay-off: a substantial Band-Aid on Egypt’s gaping economic wounds. But Sissi and his government are once again dramatically underestimating just how self-destructive their behavior can be. As my colleague Tamara Wittes eloquently noted, Egypt “continues to throw obstacles in the road of U.S.-Egyptian cooperation.” But even worse than the self-sabotage in Egypt’s foreign relations is the damage Sissi is doing to his reputation at home. 

The decision to transfer the islands to Saudi Arabia may turn out to be the final nail in Sissi’s coffin.

To the streets, again

Following the announcement of this decision, Egyptians took to Twitter, with the hashtag “leave” and “I didn’t elect Sissi” trending in Egypt. Lawyers filed lawsuits in Egyptian courts opposing the agreement. And plans were made for a much larger protest today, Sinai Liberation Day. 

But today’s protests are different than in the past. First, while the anti-Sissi protesters had time to plan and coordinate their actions, so did the regime. Today, pro-Sissi supporters organized their own protests, proudly waving the Saudi flag in Cairo’s symbolic Tahrir Square. The Egyptian Air Force painted the Egyptian flag in the sky. And the security forces came out in droves early today across greater Cairo, closing off access to most of the usual protests sites (such as the Journalists’ Syndicate and the Doctors’ Syndicate) and making a massive show of force to deter people from coming out. 

The government clearly learned a few lessons since Mubarak’s fall. A law passed in 2013 requires pre-approval from the Interior Ministry for any protest activity. That gave Sissi’s henchmen a green light to round up actual and suspected protesters as they have been doing since Thursday, arresting hundreds of suspected agitators and human rights activists on charges related to organizing today’s protests. (Notably, the pro-Sissi demonstrators have not been touched.) As each new anti-regime protest pops up today, security forces are there, arresting protesters and journalists and dispersing them with tear gas and rubber bullets. Regardless of the final outcome of today’s events, Sissi should pay attention to the growing dissatisfaction among the Egyptian people. 

The symbolism of holding today’s protests on Sinai Liberation Day is potent. Threats to Egypt’s nationalism and national sovereignty have long been key drivers of Egyptian rage, allowing the protest organizers to tap in to the anger and frustration shared by Egyptians across the political spectrum. The outrage citizens have expressed in the streets, online, and in the media should be a red flag to Sissi, who is hemorrhaging support. 

Notably, he’s now struck a nerve not just with Islamists or others in the anti-Sissi crowd, but with one of the few remaining bastions of Sissi supporters—the everyday Egyptians who are not normally politically engaged. This is a group of people who, following five years of political turmoil, see Sissi as Egypt’s best chance at stability in an increasingly unstable neighborhood. And they’re generally willing to forgive Sissi for his transgressions. They don’t believe the theory that the Egyptian security services are responsible for Italian PhD student Giulio Regeni’s death. They agree that foreign funding of NGOs is a form of Western meddling in Egyptian affairs. They justify the brutal crackdown on free expression in the name of security. But secretly concocting a deal to give away Egyptian land—that is one pill even they can’t swallow. 

Final straws?

Making matters worse are reports that Egypt consulted with Israel and the United States prior to the transfer. While the Israeli-Egyptian peace treaty remains active, Egypt and Israel’s peace is cold, at best. The notion that Sissi would consult with Israel over something that he kept secret from his own people is the ultimate insult and betrayal to many Egyptians. The facts behind the transfer matter very little. What matters is the perception of the Egyptian public that President Sissi has duped them. 

The decision to transfer the islands to Saudi Arabia may turn out to be the final nail in Sissi’s coffin. Over the past several months, he has lost other pillars of support—including secular revolutionaries, who saw former President Morsi and the Muslim Brotherhood as subverting the revolution and supported the military’s return to power. The far-reaching and brutal crackdown on Egyptian journalists and NGOs turned many of them off from Sissi. And wealthy Egyptians, who believed Sissi’s promises to grow the economy and protect their assets, have increasingly questioned their leader as Egypt’s economy continues to plummet. 

Sissi is not only running out of supporters, he is also running out of excuses.

Sissi is not only running out of supporters, he is also running out of excuses. Rather than admit his mistakes, Sissi has defended his actions, shifting the blame and feeding conspiracy theories. While protests were growing across Egypt on April 15, Sissi spoke to a group of Egyptian youth, referencing a “hellish scheme” to destabilize Egypt from within. 

Unfortunately for Sissi, there is no such “scheme.” In 2011 it was not a Western plot, as some Egyptian conspiracy theories have suggested, that ousted Mubarak—it was the Egyptian people, fed up with actions Mubarak carried out as president. In 2013, the coup that ousted Morsi succeeded because the people were fed up with decisions he made in office to consolidate power and reject democratic reforms. Had either Mubarak or Morsi spent as much time responding to the wants and needs of their citizenry as they had quashing dissent, one of them might still be in office. Much like his predecessors, what Sissi fails to understand is that the thing most likely to destabilize his government is neither an external conspiracy not an internal scheme—it’s him. 

There are now more than 335 Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) in 47 states, DC, and Puerto Rico. Early results show that most Medicare ACOs are succeeding at meeting their quality benchmarks, but only about a quarter of MSSP participants have been able to reduce their spending enough below projected financial targets to qualify for shared savings. While these results are encouraging, especially given the financial and practice transformation necessary to succeed as an ACO, they also suggest that more work is needed from both CMS and the providers to ensure continued sustainability of the MSSP ACOs.

Given that the first three year cycle of MSSP ends in 2015 and more providers will likely be entering the MSSP in the coming years , the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) that will establish the rule for participation in the Medicare ACO program. In anticipation of these coming changes, the Engelberg Center for Health Care Reform released an issue brief that identifies the "Top Eight ACO Challenges" to encourage further discussion and considerations for ensuring the continued success of ACOs. These potential policy alternatives build on discussions with ACO Learning Network members and other related stakeholders implementing accountable care across the country and include the following issues.

These issues, and many others, will be a focus of the discussions at the upcoming Fifth National ACO Summit later this week.

Top Eight Medicare ACO Challenges

1. Make Technical Adjustments to Benchmarks and Payments
In order for ACOs to qualify for shared savings, they must be able to hold spending below a financial benchmark set using historical spending patterns and meet a certain threshold of person and population-level quality metrics. A number of issues should be considered that affect the ACO’s chances of being able to attain shared savings and have more predictability about their performance: benchmark calculation methodology, how to adjust for regional variation in performance, and risk adjustment.

2. Transition to More Person-Based Payments
The ultimate goal of an ACO is to improve quality at the patient and population level and control the growth of health care costs. In order to successfully achieve this mission, ACOs must over time make a transition to payments that involve the assumption of more risk by the provider organization with a reward for better health outcomes for groups of patients. ACOs must have a clear transition path for increasing accountability and assumption of more risk for patient health outcomes.

3. Increase Beneficiary Engagement
Patients can play a critical role in helping to achieve the goals of an ACO. Health outcomes are determined by whether patients follow prescribed therapies. Increasing beneficiary engagement holds the potential to make patients more activated members of the ACO who can contribute to its success. A number of issues should be considered to improve beneficiary engagement, including adjusting attribution methods, creating more incentives for patients to seek care within the ACO, and finding opportunities to activate patients as part of the care team.

4. Enhance and Improve Alignment of Performance Measures
A central tenet of Medicare ACOs is delivering high quality health care as determined by performance on 33 measures established by CMS. ACOs must meet performance benchmarks in order to be eligible for shared savings, ensuring that these organizations are delivering high value, rather than simply cheaper, care. A number of barriers exist to achieving better performance measurement, including administrative burdens, lack of measure alignment among payers, lack of rewards for quality improvement, and concerns about measure selection.

5. Enable Better and More Consistent Supporting Data
In order to succeed as an ACO, organizations must be able to effectively collect, interpret, and use clinical and claims data to transform care of their patients. ACOs need to adopt new health IT systems and other technologies in order to collect and use the growing amount of data. ACOs currently struggle with reconciling data between different sources, dealing with patients who opt out of data sharing, lack of timeliness for receiving data, difficulty of tracking patients through the health system, and delays in performance feedback.

6. Link to Additional Value-Based Payment Reforms
ACOs are just one of many payment reforms that health care organizations across the country are implementing to improve quality and reduce costs. Aligning the vision and components of these other initiatives with ACO reforms has the potential to reinforce the shared goals and fundamentally change the health system. However, there are barriers to achieving this alignment such as lacks of linkages to bundled payments and other new payment models, multi-payer ACOs with different payment systems, and inability for organizations to participate in multiple CMS payment innovations.

7. Develop Bonus Payments and Other Incentives to Participate
In order to effectively transform clinical practice, ACOs must create or procure significant financial and human capital, as well as transform their information technology and delivery infrastructure. A recent survey estimates the average start-up cost for creating an ACO to be $2 million, with some ACOs investing significantly more in their first few years. Many ACOs, especially smaller ones, struggle to find sufficient start-up capital, are uncertain if they can assume the level of risk required for an ACO, and need significant staff and clinical change to effectively transform care.

8. Support Clinical Transformation
Becoming and succeeding as an ACO is a vast undertaking that requires immediately beginning to transform practice, finance, and operations. However, many providers, particularly those that are less experienced at systemic practice transformation, need more support in undertaking clinical transformation.

Downloads

• Issue Brief: Improving the Medicare ACO Program

Contributors: Alice M. Rivlin and Christine Dang-Vu

Recent data suggest that Accountable Care Organizations (ACOs) are improving important aspects of care and some are achieving early cost savings, but there is a long way to go. Not all ACOs will be successful at meeting the quality and cost aims of accountable care. The private sector has to date allowed more flexibility in terms of varying risk arrangements—there are now over 250 accountable care arrangements with private payers in all parts of the country—with notable success in some cases, particularly in ACOs that have been able to move farther away from fee-for-service payments. Future growth of the Medicare ACO program will depend on providers having the incentives to become an ACO and the flexibility to assume different levels of risk, ranging from exclusively upside arrangements to partial or fully capitated payment models.

Given that the first three year cycle of Medicare ACOs ends in 2015 and more providers will be entering accountable care in the coming years, the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) affecting the Medicare ACO program.

In anticipation of these coming changes, the Engelberg Center for Health Care Reform has identified the "Top Eight ACO Challenges" that warrant further discussion and considerations for ensuring the continued success of ACOs across the country. To support that discussion, we also present some potential alternatives to current Medicare policies that address these concerns. These findings build on the experiences of the Engelberg Center’s ACO Learning Network members and other stakeholders implementing accountable care across the country.  In some cases, the alternatives might have short-term costs, but could also improve the predictability and feasibility of Medicare ACOs, potentially leading to bigger impacts on improving care and reducing costs over time.  In other cases, the alternatives could lead to more savings even in the short term. In every case, thoughtful discussion and debate about these issues will help lead to a more effective Medicare ACO program.

Top Eight ACO Challenges

1. Make technical adjustments to benchmarks and payments
2. Transition to more person-based payments
3. Increase beneficiary engagement
4. Enhance and improve alignment of performance measures
5. Enable better and more consistent supporting data
6. Link to additional value-based payment reforms
7. Develop bonus payments and other incentives to participate
8. Support clinical transformation

Downloads

• Issue Brief: Improving the Medicare ACO Program

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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Introduction

Many American workers do not have access to employer-sponsored payroll deduction plans for retirement saving. Groups with low rates of access include younger workers, members of minority groups, and those with low-to-moderate incomes. 1 Small business employees are especially at risk. Only about 14 percent of businesses with 100 or fewer employees offer their employees a retirement plan, leaving between 51 and 71 percent of the roughly 42 million people who work for a small business without access to an employer-administered plan (Government Accountability Office 2013).

Lack of access makes it difficult to build retirement wealth. A study by the Employee Benefit Research Institute (2014) shows that 62 percent of employees with access to an employer-sponsored plan held more than $25,000 in saving balances and 22 percent had $100,000 or more. In contrast, among those without access to a plan, 94 percent held less than $25,000 and only three percent hold $100,000 or more. Although workers without an employer-based plan can contribute to Individual Retirement Accounts (IRAs), very few do.2 But employees at all income levels tend to participate at high rates in plans that are structured to provide guidance about the decisions they should make (Wu and Rutledge 2014).

With these considerations in mind, many experts and policy makers have advocated for increased retirement plan coverage. While a national approach would be desirable, there has been little legislative progress to date. States, however, are acting. Three states have already created state-sponsored retirement saving plans for small business employees, and 25 are in some stage of considering such a move (Pension Rights Center 2015). John and Koenig (2014) estimate that 55 million U.S. wage and salary workers between the ages of 18 and 64 lack the ability to save for retirement through an employer-sponsored payroll deduction plan. Among such workers with wages between $30,000 and $50,000 only about one out of 20 contributes regularly to an IRA (Employee Benefit Research Institute 2006).

This paper highlights a variety of issues that policymakers will need to address in creating and implementing an effective state-sponsored retirement saving plan. Section II discusses policy design choices. Section III discusses management issues faced by states administering such a plan, employers and employees. Section IV is a short conclusion.

Note: this paper was presented at a October 7, 2015 Brookings Institution event focused on state retirement policies.

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Many American workers do not have access to employer-sponsored payroll deduction plans for retirement saving. Groups with low rates of access include younger workers, members of minority groups, and those with low-to-moderate incomes. Small business employees are especially at risk. Only about 14 percent of businesses with 100 or fewer employees offer their employees a retirement plan, leaving between 51 and 71 percent of the roughly 42 million people who work for a small business without access to an employer-administered plan (Government Accountability Office 2013).

Lack of access makes it difficult to build retirement wealth. A study by the Employee Benefit Research Institute (2014) shows that 62 percent of employees with access to an employer-sponsored plan held more than $25,000 in saving balances and 22 percent had $100,000 or more. In contrast, among those without access to a plan, 94 percent held less than $25,000 and only 3 percent hold $100,000 or more. Although workers without an employer-based plan can contribute to Individual Retirement Accounts (IRAs), very few do. But employees at all income levels tend to participate at high rates in plans that are structured to provide guidance about the decisions they should make (Wu and Rutledge 2014).

With these considerations in mind, many experts and policy makers have advocated for increased retirement plan coverage. While a national approach would be desirable, there has been little legislative progress to date. States, however, are acting. Three states have already created state-sponsored retirement saving plans for small business employees, and 25 are in some stage of considering such a move (Pension Rights Center 2015).

This policy brief, based on John and Gale (2015), highlights a variety of issues that policymakers will need to address in creating and implementing an effective state-sponsored retirement saving plan.

Download "Policy Design and Management Issues for State Retirement Saving Plans" »

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As every good teacher knows, education is not just about academics. It is about broadening horizons and discovering passions. (The root of education is the Latin e ducere, meaning “to draw out.”) From this perspective, extra-curricular activities count for a great deal. But as Robert Putnam highlights in his book Our Kids, there are growing class gaps in the availability of music, sports, and other non-classroom activities.

Fewer field trips?

Schools under pressure may also cut back on field trips outside the school walls to parks, zoos, theaters, or museums. In the 2008-09 school year, 9 percent of school administrators reported eliminating field trips, according to the annual surveys by the American Association of School Administrators (AASA). That figure rose through the recession:

Just 12 percent of the administrators surveyed about 2015-16 said they had brought back their field trips to pre-recession levels. Museums around the country report hosting fewer students, from Los Angeles and Sarasota, to Minneapolis, and Columbia, Missouri. None of this is definitive proof of a decline in field trips, since we are relying on a single survey question. But it suggests a downward trend in recent years.

Museums help with science tests

If some children are missing out on field trips, does it matter? They may be nice treats, but do they have any real impact, especially when they take time away from traditional learning? There is some evidence that they do.

Middle school children with the chance to go on a field trip score higher on science tests, according to a 2015 study by Emilyn Ruble Whitesell.

She studied New York City middle schools with teachers in Urban Advantage, a program that gives science teachers additional training and resources—as well as vouchers for visiting museums. In some schools, the Urban Advantage teachers used the field trip vouchers more than others. Whitesell exploits this difference in her study, and finds that attending a school with at least 0.25 trips per student increased 8^th grade scores by 0.026 standard deviations (SD). The odds of a student passing the exam improved by 1.2 percentage points. There were bigger effects for poor students, who saw a 0.043 SD improvement in test scores, and 1.9 percentage point increase in exam pass rates.

Art broadens young minds

Students visiting an art museum show statistically significant increases in critical thinking ability and more open-minded attitudes, according to a randomized evaluation of student visits to the Crystal Bridges Museum in northwest Arkansas. One example: those who visited the museum more often agreed with statements like: “I appreciate hearing views different from my own” and “I think people can have different opinions about the same thing.” The effects are modest. But the intervention (a single day at the museum) is, too. Again, there were larger effects for poor students:

All this needs to be put in perspective. In comparison with the challenge of closing academic gaps and quality teaching, field trips are small beer. But schools create citizens as well as undergraduates and employees. It matters, then, if we have allowed field trips to become a casualty of the great recession.

Americans are enjoying longer lifespans than ever before. Living longer affords individuals the opportunity to make more contributions to the world, to spend more time with their loved ones, and to devote more years to their favorite activities – but a longer life, and particularly a longer retirement, is also expensive. The retirement security landscape is evolving as workers, employers, retirees, and financial services companies find their needs shifting. Once, many workers planned to stay with a single employer for most or all of their careers, building up a sizeable pension and looking forward to a comfortable retirement. Today, workers more and more workers will be employed by many different employers.  Additionally, generous defined benefit (DB) retirement plans are less popular than they once were – though they were never truly commonplace – and defined contribution (DC) plans are becoming ever more prevalent.  

Figure 1, below, shows the change from DB to DC that has occurred over the past three decades.

In the past many retirees struggled financially towards the end of their lives, just as they do now, but even so, the changes to the retirement security landscape have been real and marked, and have had a serious impact on workers and retirees alike. DB plans are dwindling, DC plans are on the rise, and as a result individuals must now take a more active role in managing their retirement savings. DC plans incorporate contributions from employees and employers alike, and workers much choose how to invest their nest egg.  When a worker leaves a job for retirement or for a different job he or she will often roll over the money from a 401(k) plan into an Individual Retirement Account (IRA). While having more control over one’s retirement funds might seem on its face to be a net improvement, the reality is that the average American lacks the financial literacy to make sound decisions (SEC 2012).

The Council of Economic Advisers (CEA) expressed concern earlier this year that savers with IRA accounts may receive poor investment advice, particularly in cases where their financial advisors are compensated through fees and commissions. “[The] best recommendation for the saver may not be the best recommendation for the adviser’s bottom line” (CEA 2015). President Obama echoed these concerns in a speech at AARP in February, asking the Department of Labor (DoL) to update its rules for financial advisors to follow when handling IRA accounts (White House 2015). The DoL receives its authority to craft such rules and requirements from the 1974 Employee Retirement Income Security Act (ERISA) (DoL 2015a).

The DoL recently proposed a regulation designed to increase consumer protection by treating some investment advisors as fiduciaries under ERISA and the 1986 Internal Revenue Code (DoL 2015b). The proposed rule has generated heated debate, and some financial advisors have responded with great concern, arguing that it will be difficult or impossible to comply with the rule without raising costs to consumers and/or abandoning smaller accounts that generate little or no profit. Advisors who have traditionally offered only the proprietary products of a single company worry that the business model they have used for many years will no longer be considered to be serving the best interests of clients.

Rather than offering detailed comments on the DoL proposals, this paper will look more broadly at the problem of saving for retirement and the role for professional advice. This is, of course, a well-travelled road with a large literature by academics, institutions and policy-makers, however, it is worthwhile to think about market failures, lack of information and individual incentives and what they imply for the investment advice market.

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With keynote addresses by Federal Reserve Governor Jerome Powell and Counselor to the Treasury Secretary Antonio Weiss

Bond markets are the principal source of credit for businesses and governments in the United States, with almost $40 trillion of outstanding debt. They are also the main mode of investment for pension funds, mutual funds, and many other investors, which is why the safety and efficiency of these markets is, therefore, crucial.

On August 3, the Economic Studies program at Brookings hosted a number of experts to discuss the structure of bond markets in the U.S. and how changes over the last few years are affecting market liquidity, volatility, and overall safety and efficiency. Keynote addresses by Governor Jerome Powell and Counselor Antonio Weiss focused on the Treasury bond market with a panel of experts examining corporate bond markets.

After each session, the speakers and panelists took audience questions.

Antonio Weiss with Jerome Powell and Douglas Elliott (l-r)

Martin Baily with Kashif Riaz, Annette Nazareth, Steve Zamsky and Dennis Kelleher (r-l)

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• Keynote Addresses on the U.S. Treasury Markets
• Panel on the Corporate Bond Markets

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• Are there structural issues in U.S. bond markets?

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• Uncorrected Transcript (.pdf)

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• 20150803_bond_markets_transcript
• 20150803_liquidity_kelleher_presentation

Twenty-five years ago, in March 1991, shaken by the fall of the Berlin Wall and the rise of nationalist-separatist movements in the Soviet Baltic and Caucasus republics, Mikhail Gorbachev held a historic referendum. He proposed the creation of a new union treaty to save the USSR. The gambit failed. Although a majority of the Soviet population voted yes, some key republics refused to participate. And so began the dissolution of the USSR, the event that current Russian President Vladimir Putin has called the “greatest geopolitical catastrophe” of the 20th century.

Today, in the wake of the referendum on leaving the European Union, British Prime Minister David Cameron seems to have put the United Kingdom on a similar, potentially catastrophic, path. Like the fall of the wall and the collapse of the Soviet Union, the fallout from Brexit could have momentous consequences. The U.K. is of course not the USSR, but there are historic links between Britain and Russia and structural parallels that are worth bearing in mind as the U.K. and the EU work out their divorce, and British leaders figure out what to do next, domestically and internationally.

A quick Russian history recap

The British and Russian empires formed at around the same time and frequently interacted. Queen Elizabeth I was pen pals with Ivan the Terrible. The union of the Scottish and English parliaments in 1707 that set the United Kingdom on its imperial trajectory coincided with the 1709 battle of Poltava, in which Peter the Great ousted the Swedes from the lands of modern Ukraine and began the consolidation of the Russian empire. The Russian imperial and British royal families intermarried, even as they jockeyed for influence in Central Asia and Afghanistan in the 19th century. The last Czar and his wife were respectively a distant cousin and granddaughter of British Queen Victoria. The Irish Easter Uprising and the Russian Revolution were both sparked by problems at home, imperial overstretch, and the shock of the World War I. 

Like the fall of the wall and the collapse of the Soviet Union, the fallout from Brexit could have momentous consequences.

Since the end of the Cold War, the U.K. and Russia have both had difficulty figuring out their post-imperial identities and roles. The U.K. in 2016 looks structurally a lot like the USSR in 1991, and England’s current identity crisis is reminiscent of Russia’s in the 1990s. After Gorbachev’s referendum failed to shore up the union, the Soviet Union was undermined by an attempted coup (in August 1991) and then dismantled by its national elites. In early December 1991, Boris Yeltsin, the flamboyant head of the Russian Federation, holed up in a hut deep in the Belarusian woods with the leaders of Ukraine and Belarus and conspired to replace the USSR with a new Commonwealth of Independent States (CIS). With Gorbachev and the Soviet Union gone by the end of December, the hangover set in. Boris Yeltsin was the first to rue the consequences of his actions. The CIS never gained traction as the basis for a new union led by Russia. 

The Ukrainians, Belarussians, and everyone else gained new states and new identities and used the CIS as a mechanism for divorce. Russians lost an empire, their geopolitical anchor, and their identity as the first among equals in the USSR. The Russian Federation was a rump state. And although ethnic Russians were 80 percent of the population, the forces of disintegration continued. Tatars, Chechens, and other indigenous peoples of the Russian Federation, with their own histories, seized or agitated for independence. Ethnic Russians were “left behind” in other republics. Historic territories were lost. Instead of presiding over a period of Russian independence, Boris Yeltsin muddled through a decade of economic collapse and political humiliation.

Separating the U.K. from Europe...could be as wrenching as pulling apart the USSR.

Is Britain laying the same trap?

Another Boris, the U.K.’s Boris Johnson, the former mayor of London and main political opponent of David Cameron, risks doing the same if he becomes U.K. prime minister in the next few months. Separating the U.K. from Europe institutionally, politically, and economically could be as wrenching as pulling apart the USSR. People will be left behind—EU citizens in the U.K., U.K. citizens in the EU––and will have to make hard choices about who they are, and where they want to live and work. The British pound has already plummeted. The prognoses for short- to medium-term economic dislocation have ranged from gloomy to dire. The U.K is a multi-ethnic state, with degrees of devolved power to its constituent parts, and deep political divides at the elite and popular levels. Scotland and Northern Ireland, along with Gibraltar (a contested territory with Spain), clearly voted to stay in the European Union. The prospect of a new Scottish referendum on independence, questions about the fate of the Irish peace process, and the format for continuing Gibraltar’s relationship with Spain, will all complicate the EU-U.K. divorce proceedings. 

Like Russia and the Russians, England and the English are in the throes of an identity crisis.

Like Russia and the Russians, England and the English are in the throes of an identity crisis. England is not ethnically homogeneous. In addition to hundreds of thousands of Irish citizens living in England, there are many more English people with Irish as well as Scottish ancestry––David Cameron’s name gives away his Scottish antecedents––as well as those with origins in the colonies of the old British empire. And there are the EU citizens who have drawn so much ire in the Brexit debate. 

As in the case of the USSR and Russia where all roads led (and still lead) to Moscow, London dominates the U.K.’s population, politics, and economics. London is a global city that is as much a magnet for international migration as a center of finance and business. London voted to remain in Europe. The rest of England, London’s far flung, neglected, and resentful hinterland, voted to leave the EU—and perhaps also to leave London. At the end of the divorce process, without careful attention from politicians in London, England could find itself the rump successor state to the United Kingdom. If so, another great imperial state will have consigned itself to the “dust heap of history” by tying its future to a referendum. 

So we’ve almost reached the end of the year 2015, which could go down in the history of global sustainable development efforts as one of the more significant years, with the trifecta of the approval of the Sustainable Development Goals (SDGs), the agreement on the Addis Agenda on Financing for Development (FfD) and the (shortly to be completed) Paris COP21 Climate Summit. Yet, all will depend on how the agreements with their ambitious targets are implemented on the ground.

Effective implementation will require a theory of change—a way to think about how we are to get from “here” in 2015 to “there” in 2030. The key problem is what has very appropriately been called by some “the missing middle,” i.e., the gap between the top-down global targets on the one hand and the bottom-up development initiatives, projects, and programs that are supported by governments, aid agencies, foundations, and social entrepreneurs.

One way to begin to close this gap is to aim for scaled-up global efforts in specific areas, as is pledged in the Addis Agenda, including efforts to fight global hunger and malnutrition, international tax cooperation and international cooperation to strengthen capacities of municipalities and other local authorities, investments and international coopera­tion to allow all children to complete free, equitable, inclusive and quality early childhood, primary and secondary education, and concessional and non-concessional financing.

Another way is to develop country-specific national targets and plans consistent with the SDG, Addis, and COP21 targets, as is currently being done with the assistance of the United Nations Development Program’s MAPS program. This can provide broad guidance on policy priorities and resource mobilization strategies to be pursued at the national level and can help national and international actors to prioritize their interventions in areas where a country’s needs are greatest.

However, calling for expanded global efforts in particular priority areas and defining national targets and plans is not enough. Individual development actors have to link their specific projects and programs with the national SDG, Addis, and COP21 targets. They systematically have to pursue a scaling-up strategy in their areas of engagement, i.e., to develop and pursue pathways from individual time-bound interventions to impact at a scale in a way that will help achieve the global and national targets. A recent paper I co-authored with Larry Cooley summarizes two complementary approaches of how one might design and implement such scaling-up pathways. The main point, however, is that only the pursuit of such scaling-up pathways constitutes a meaningful theory of change that offers hope for effective implementation of the new global sustainable development targets.

Fortunately, over the last decade, development analysts and agencies have increasingly focused on the question of how to scale up impact of successful development interventions. Leading the charge, the World Bank in 2004, under its president Jim Wolfensohn, organized a high-level international conference in Shanghai in cooperation with the Chinese authorities on the topic of scaling up development impact and published the associated analytical work. However, with changes in the leadership at the World Bank, the initiative passed to others in the mid-2000s, including the Brookings Institution, ExpandNet (a group of academics working with the World Health Organization), Management Systems International (MSI), and Stanford University. They developed analytical frameworks for systematically assessing scalability of development initiatives and innovations, analyzed the experience with more or less successful scaling-up initiatives, including in fragile and conflict-affected states, and established networks that bring together development experts and practitioners to share knowledge.

By now, many international development agencies (including GIZ, JICA, USAID, African Development Bank, IFAD and UNDP), foundations (including the Bill & Melinda Gates Foundation and Rockefeller Foundation) and leading development NGOs (including Heifer International, Save the Children and the World Resources Institute), among others, have focused on how best to scale up development impact, while the OECD recently introduced a prize for the most successful scaling-up development initiatives. The International Fund for Agricultural Development (IFAD) is perhaps the most advanced among the agencies, having developed a systematic operational approach to the innovation-learning-scaling-up cycle. In a collaborative effort with the Brookings Institution, IFAD reviewed its operational practices and experience and then prepared operational design and evaluation guidelines, which can serve as a good example for other development agencies. The World Bank, while yet to develop a systematic institution-wide approach to the scaling-up agenda, is exploring in specific areas how best to pursue scaled-up impact, such as in the areas of mother and child health, social enterprise innovation, and the “science of delivery.”

Now that the international community has agreed on the SDGs and the Addis Agenda, and is closing in on an agreement in Paris on how to respond to climate change, it is the right time to bridge the “missing middle” by linking the sustainable development and climate targets with effective scaling-up methodologies and practices among the development actors. In practical terms, this requires the following steps:

• Developing shared definitions, analytical frameworks, and operational approaches to scaling up among development experts;
• Developing sectoral and sub-sectoral strategies at country level that link short- and medium-term programs and interventions through scaling-up pathways with the longer-term SDG and climate targets;
• Introducing effective operational policies and practices in the development agencies in country strategies, project design, and monitoring and evaluation;
• Developing multi-stakeholder partnerships around key development interventions with the shared goal of pursuing well-identified scaling-up pathways focused on the achievement of the SDGs and climate targets;
• Developing incentive schemes based on the growing experience with “challenge funds” that focus not only on innovation, but also on scaling up, such as the recently established Global Innovation Fund; and
• Further building up expert and institutional networks to share experience and approaches, such as the Community of Practice on Scaling Up, recently set up by MSI and the Results for Development Institute.

The U.S. is the only advanced country without a paid leave policy, enabling workers to take time off to care for a new baby or other family member. At least two Presidential candidates, Hillary Clinton and Marco Rubio, have been talking about it, making it likely that it will get attention in 2016.

The idea has broad appeal now that most two-parent families and almost all one-parent families struggle with balancing work and family. Polls show that it is favored by 81 percent of the public—94 percent of Democrats, 80 percent of Independents and 65 percent of Republicans. Three states, California, New Jersey, and Rhode Island, have each enacted policies that could become models for other states or for the nation.

Paid leave promotes inclusive growth

Overall, paid leave is good for workers, good for children, and possibly even good for employers because of its role in helping to retain workers. It is also a policy that encourages inclusive growth. Studies of European systems suggest that paid leave increases female labor force participation and that the lack of it in the U.S. may be one reason for the decline in female labor force participation since 2000 and the growing female participation gap between the U.S. and other countries, adversely affecting our absolute and relative growth. The policy would make growth more inclusive because it would disproportionately benefit lower-wage workers.

The devil is in the design

The major issues in designing a paid leave policy are:

1. Eligibility, and especially the extent of work experience required to qualify (often a year);
2. the amount of leave allowed (Clinton suggests three months; Rubio four weeks);
3. the wage replacement rate (often two-thirds of regular wages up to a cap), and
4. financing.

Legislation proposed by Rep. Rosa DeLauro (D-CT) and Sen. Kirsten Gillibrand (D-NY) calls for a 0.2 percent payroll tax on employers and employees. Most states have made paid leave a part of their temporary disability systems. Senator Rubio proposes to finance it through a new tax credit for employers. 

Getting it right on eligibility, length of leave, and size of benefit

My own view is that a significant period of work experience should be required for eligibility to encourage stable employment before the birth of a child. This would not only encourage work but also insure that the subsidy was an earned benefit and not welfare by another name (but see below on financing).   

Leave periods need to be long enough to enable parents to bond with a child during the child’s first year of life but not so long that they lead to skill depreciation and to parents dropping out of the labor force. Three months seems like a good first step although it is far less generous than what many European countries provide (an average of 14 months across the OECD). That said, the Europeans may have gone too far. While there is little evidence that a leave as long as 6 months would have adverse effects on employment, when Canada extended their leave from six months to a year, the proportion of women returning to work declined.

A replacement rate of two-thirds up to a cap also seems reasonable although a higher replacement rate is one way to encourage more parents to take the leave. Among other things, more generous policies would have positive effects on the health and well-being of children. They might also encourage more fathers to take leave.  

How to pay for it

On financing, social insurance is the appropriate way to share the putative burden between employers and employees and avoid the stigma and unpopularity of social welfare. It would, in essence, change the default for employees (who are otherwise unlikely to save for purposes of taking leave). Some may worry that imposing any new costs on employers will lead to fewer employment opportunities. However, many economists believe that the employer portion of the tax is largely borne by workers in the form of lower wages. Moreover, in a study of 253 employers in California, over 90 percent reported either positive or no negative effects on profitability, turnover, and employee morale. Reductions in turnover, in particular, are noteworthy since turnover is a major expense for most employers. 

Will paid leave cause discrimination against women?

Another worry is discrimination against women. Here there is some cause for concern unless efforts are made to insure that leave is equally available to, and also used by, both men and women. This concern has led some countries to establish a use-it-or-lose-it set aside for fathers. In the province of Quebec, the proportion of fathers taking leave after implementation of such a policy increased from 21 to 75 percent and even after the leave period was over, men continued to share more equally in the care of their children.

Will Congress enact a national paid leave policy in the next few years? That’s doubtful in our current political environment but states may continue to take the lead. In the meantime, it can’t hurt if the major candidates are talking about the issue on the campaign trail.       

The African Union (AU) will hold its 27th Heads of State Assembly in Kigali from July 17-18, 2016, as part of its ongoing annual meetings, during which time it will elect individuals to lead the AU Commission for the next four years. Given the fierce battle for the chairperson position in 2012; and  as the AU has increasingly been called upon to assume more responsibility for various issues that affect the continent—from the Ebola pandemic that ravaged West Africa in 2013-14 to civil wars in several countries, including Libya, Central African Republic, and South Sudan, both the AU Commission and its leadership have become very important and extremely prestigious actors. The upcoming elections are not symbolic: They are about choosing trusted and competent leaders to guide the continent in good times and bad.

The African Union (AU) [1] came into being on July 9, 2002 and was established to replace the Organization of African Unity (OAU). The AU’s highest decisionmaking body is the Assembly of the African Union, which consists of all the heads of state and government of the member states of the AU. The chairperson of the assembly is the ceremonial head of the AU and is elected by the Assembly of Heads of State to serve a one-year term. This assembly is currently chaired by President Idriss Déby of Chad.

The AU’s secretariat is called the African Union Commission [2] and is based in Addis Ababa. The chairperson of the AU Commission is the chief executive officer, the AU’s legal representative, and the accounting officer of the commission. The chairperson is directly responsible to the AU’s Executive Council. The current chairperson of the AU Commission is Dr. Nkosazana Dlamini Zuma of South Africa and is assisted by a deputy chairperson, who currently is Erastus Mwencha of Kenya.

Dr. Zuma has decided not to seek a second term in office and, hence, this position is open for contest. The position of deputy chairperson will also become vacant, since Mwencha is not eligible to serve in the new commission.

Notably, the position of chairperson of the AU Commission does not only bring prestige and continental recognition to the person that is elected to serve but also to the country and region from which that person hails. Already, the Southern African Development Community (SADC), Dr. Zuma’s region, is arguing that it is entitled to another term since she has decided not to stand for a second. Other regions, such as eastern and central Africa, have already identified their nominees. It is also rumored that some regions have already initiated diplomatic efforts to gather votes for their preferred candidates.

In April 2016, SADC chose Botswana’s minister of foreign affairs, Dr. Pelonomi Venson-Moitoi, as its preferred candidate. Nevertheless, experts believe that even if South Africa flexes its muscles to support Venson-Moitoi’s candidacy (which it is most likely to do), it is not likely to succeed this time because Botswana has not always supported the AU on critical issues, such as the International Criminal Court, and hence, does not have the goodwill necessary to garner the support for its candidate among the various heads of state.

Venson-Moitoi is expected to face two other candidates—Dr. Specioza Naigaga Wandira Kazibwe of Uganda (representing east Africa) and Agapito Mba Mokuy of Equatorial Guinea (representing central Africa). Although Mokuy is relatively unknown, his candidacy could be buoyed by the argument that a Spanish-speaking national has never held the chairperson position, as well as the fact that, despite its relatively small size, Equatorial Guinea—and its president, Teodoro Obiang Nguema—has given significant assistance to the AU over the years. Obiang Nguema’s many financial and in-kind contributions to the AU could endear his country and its candidate to the other members of the AU.

In fact, during his long tenure as president of Equatorial Guinea, Obiang Nguema has shown significant interest in the AU, has attended all assemblies, and has made major contributions to the organization. In addition to the fact that Equatorial Guinea hosted AU summits in 2011 and 2014, Obiang Nguema served as AU chairperson in 2011. Thus, a Mokuy candidacy for the chairperson of the AU Commission could find favor among those who believe it would give voice to small and often marginalized countries, as well as members of the continent’s Spanish-speaking community. Finally, the opinion held by South Africa, one of the continent’s most important and influential countries, on several issues (from the political situation in Burundi to the International Criminal Court and its relations with Africa) appears closer to that of Equatorial Guinea’s than Botswana’s.

Of course, both Venson-Moitoi and Kazibwe are seasoned civil servants with international and administrative experience and have the potential to function as an effective chairperson. However, the need to give voice within the AU to the continent’s historically marginalized regions could push Mokuy’s candidacy to the top.

Nevertheless, supporters of a Mokuy candidacy may be worried that accusations of corruption and repression labeled on Equatorial Guinea by the international community could negatively affect how their candidate is perceived by voters.

Also important to voters is their relationship with former colonial powers. In fact, during the last election, one argument that helped defeat then-Chairperson Jean Ping was that both he and his (Gabonese) government were too pro-France. This issue may not be a factor in the 2016 elections, though: Equatorial Guinea, Uganda, and Botswana are not considered to be extremely close to their former colonizers.

Finally, gender and regional representation should be important considerations for the voters who will be called upon to choose a chairperson for the AU Commission. Both Venson-Moitoi and Kazibwe are women, and the election of either of them would continue to support diversity within African leadership. Then again, Mr. Mokuy’s election would enhance regional and small-state representation.

Also open for contest are the portfolios of Peace and Security, Political Affairs, Infrastructure and Energy, Rural Economy and Agriculture, Human Resources, and Science and Technology. Many countries are vying for these positions on the commission in an effort to ensure that their status within the AU is not marginalized. For example, Nigeria and Algeria, both of which are major regional leaders, are competing to capture the position of commissioner of Peace and Security. Algeria is keen to keep this position: It has held this post over the last decade, and, if it loses this position, it would not have any representation on the next commission—significantly diminishing the country’s influence in the AU.

Nigeria’s decision to contest the position of commissioner of Peace and Security is based on the decision by the administration of President Muhammadu Buhari to give up the leadership of Political Affairs. Historically, Nigeria has been unwilling to compete openly against regional powers for leadership positions in the continent’s peace and security area. Buhari’s decision to contest the portfolio of Peace and Security is very risky, since a loss to Algeria and the other contesting countries will leave Nigeria without a position on the commission and would be quite humiliating to the president and his administration.

Since the AU came into being in 2002, there has been an unwritten rule that regional powers (e.g., Algeria, Kenya, Nigeria, South Africa) should not lead or occupy key positions in the AU’s major institutions. Thus, when Dr. Zuma was elected in 2012, South Africa was severely criticized, especially by some smaller African countries, for breaking that rule. The hope, especially of the non-regional leaders, is that the 2016 election will represent a return to the status quo ante since most of the candidates for the chairperson position hail from small- and medium-sized countries.

While professional skills and international experience are critical for an individual to serve on the commission, the AU is quite concerned about the geographical distribution of leadership positions, as well as the representation of women on the commission, as noted above. In fact, the commission’s statutes mandate that each region present two candidates (one female and the other male) for every portfolio. Article 6(3) of the commission’s statutes states that “[a]t least one Commissioner from each region shall be a woman.” Unfortunately, women currently make up only a very small proportion of those contesting positions in the next commission. Thus, participants must keep in mind the need to create a commission that reflects the continent’s diversity, especially in terms of gender and geography.

Individuals that have served in government and/or worked for an international organization dominate leadership positions in the commission. Unfortunately, individuals representing civil society organizations are poorly represented on the nominee lists; unsurprisingly, given the fact that the selection process is controlled by civil servants from states and regional organizations. Although this approach to the staffing of the commission guarantees the selection of skilled and experienced administrators, it could burden the commission with the types of bureaucratic problems that are common throughout the civil services of the African countries, notably, rigidity, tunnel vision, and the inability, or unwillingness to undertake bold and progressive initiatives.

The AU currently faces many challenges, some of which require urgent and immediate action and others, which can only be resolved through long-term planning. For example, the fight against terrorism and violent extremism, and securing the peace in South Sudan, Burundi, Libya, and other states and regions consumed by violent ethno-cultural conflict require urgent and immediate action from the AU. Issues requiring long-term planning by the AU include helping African countries improve their governance systems, strengthening the African Court of Justice and Human Rights, facilitating economic integration, effectively addressing issues of extreme poverty and inequality in the distribution of income and wealth, responding effectively and fully to pandemics, and working towards the equitable allocation of water, especially in urban areas.

Finally, there is the AU’s dependence on foreign aid for its financing. When Dr. Dlamini Zuma took over as chairperson of the AU Commission in 2012, she was quite surprised by the extent to which the AU depends on budget subventions from international donors and feared that such dependence could interfere with the organization’s operations. The AU budget for 2016 is $416,867,326, of which $169,833,340 (40 percent) is assessed on Member States and $247,033,986 (59 percent) is to be secured from international partners.  The main foreign donors are the United States, Canada, China, and the European Union.

Within Africa, South Africa, Angola, Nigeria, and Algeria are the best paying rich countries. Other relatively rich countries, Egypt, Libya, Sudan, and Cameroon, are struggling to pay. Libya’s civil war and its inability to form a permanent government is interfering with its ability to meet its financial obligations, even to its citizens. Nevertheless, it is hoped that South Africa, Nigeria, Angola, Egypt, and Libya, the continent’s richest countries, are expected to eventually meet as much as 60% of the AU’s budget and help reduce the organization’s continued dependence on international donors. While these major continental and international donors are not expected to have significant influence on the elections for leadership positions on the AU Commission, they are likely to remain a determining factor on the types of programs that the AU can undertake.

Dealing fully and effectively with the multifarious issues that plague the continent requires AU Commission leadership that is not only well-educated and skilled, but that has the foresight to help the continent develop into an effective competitor in the global market and a full participant in international affairs. In addition to helping the continent secure the peace and provide the enabling environment for economic growth and the creation of wealth, this crop of leaders should provide the continent with the leadership necessary to help states develop and adopt institutional arrangements and governing systems that guarantee the rule of law, promote the protection of human rights, and advance inclusive economic growth and development.

[1] The AU consists of all the countries on the continent and in the United Nations, except the Kingdom of Morocco, which left the AU after the latter recognized the Sahrawi Arab Democratic Republic (Western Sahara). Morocco claims that the Western Sahara is part of its territory.

[2] The AU Commission is made up of a number of commissioners who deal with various policy areas, including peace and security, political affairs, infrastructure and energy, social affairs, trade and industry, rural economy and agriculture, human resources, science and technology, and economic affairs. According to Article 3 of its Statutes, the Commission is empowered to “represent the Union and defend its interests under the guidance of and as mandated by the Assembly and Executive Council.”