The potential for confrontation between the United States and Iran, stemming from ongoing tensions over Iran’s nuclear program and western covert actions intended to delay or degrade it, remains a pressing concern for U.S. policymakers. The Saban Center for Middle East Policy hosted a one-day crisis simulation in September that explored different scenarios should a confrontation occur.

The Saban Center's new Middle East Memo, A Series of Unfortunate Events: A Crisis Simulation of a U.S.-Iranian Confrontation, authored by senior fellow Kenneth M. Pollack, presents lessons and observations from the exercise.

Key findings include:

• Growing tensions are significantly reducing the “margin of error” between the two sides, increasing the potential for miscalculations to escalate to a conflict between the two countries.

• Should Iran make significant progress in enriching fissile material, both sides would have a powerful incentive to think short-term rather than long-term, in turn reinforcing the propensity for rapid escalation.

• U.S. policymakers must recognize the possibility that Iranian rhetoric about how the Islamic Republic would react in various situations may prove consistent with actual Iranian actions.

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In advance of President Obama’s trip to Panama later this week, Brookings experts Richard Feinberg, Ted Piccone, and Harold Trinkunas discuss expectations for the Seventh Summit of the Americas. Obama will arrive holding a strong hand given recent policy changes that have addressed historic obstacles, such as relations with Cuba. However, a slowing regional economy and U.S.-Venezuela tensions may yet cast a shadow over the proceedings.

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Improved United States-Latin America relations

“The United States is going into this next Summit of the Americas in a somewhat improved position compared to the summits in both Cartagena in 2012 and in Trinidad in 2009, where there was a considerable amount of friction among the countries on issues related to Cuba, to counter narcotics policy, to immigration policy. Broadly speaking, I think the Obama administration has done something incredible on each of these fronts, which the countries will recognize and which will help clear the air.”  —Harold Trinkunas

Friction with Venezuela?

“There are 35 countries. At any given time, there's going to be some friction. At the last summit, the Argentines raised the Malvinas issue.  At previous summits, the Bolivians raised the outlets of the sea issue. So there's always a little bit of this. But whether or not [Venezuela] dominates the summit is an issue largely for the Latin Americans to decide. And my guess is the Latin Americans in general will not want to follow Maduro over the cliff. I don't even think that the Cubans will want Maduro to take the summit over the cliff. So therefore, I think we have this sort of tremendous irony in which the country that adds -- that dampens the dissident voices of ALBA will actually be Cuba, because Cuba wanted to demonstrate that it can be a constructive voice in regional diplomacy, that they're not just the force of disruption and therefore, the U.S. all these years was right to keep them out because they would just be disruptive if you let them in. They've already demonstrated they're a mature country that can engage constructively.”  —Richard Feinberg

Dialogue with Cuba

“It's in our interest, U.S. national interest, to have this dialogue process with our close neighbor, Cuba. And to, frankly, bring them back towards the inter-American community, where they've been missing for all these years. [The U.S. rapprochement with Cuba] is also going to raise the question of shifting attention to the role of the rest of the region vis-à-vis Cuba; that it's not just the United States. It's actually the other countries in the hemisphere that could help Cuba come along, as I said, modernize, update its economy, and hopefully at some point, engage more formally in the inter-American system.”  —Ted Piccone

Sub-regional groupings

“This is a much more diverse hemisphere than we saw 20 years ago... In fact, we may see that there's sort of a broad agreement on general themes and then much more sub-regional groupings that work on issues like the Northern Triangle, for example, or Caribbean Energy Security, which was an initiative of the vice president last year.”  —Harold Trinkunas

Summit side events with the private sector and civil society

“You have the leaders representing the executive branches of their governments, but you also have the CEO Summit. Seven hundred corporate executives will be there. There will be interaction between the leaders and the corporate executives...It's indicative of the rise of the private sector and the corporate sector in Latin America as part of a dynamic growing region economically.

Throughout the hemisphere, the acceptance of Civil Society as a concept, as an actor, adds depth to democracy. Democracy is not just elections or that's important, but an active, vibrant Civil Society. And that's what you'll see at the Civil Society meeting. And President Obama personally we're told will interact with Civil Society leaders, as will other leaders present there.”  —Richard Feinberg

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On Friday, April 3, the Brookings Latin America Initiative hosted Assistant Secretary of State for Western Hemisphere Affairs Roberta Jacobson to discuss the state of inter-American relations and expectations for the Seventh Summit of the Americas to be held on April 10 to 11 in Panama City, Panama. With Cuba in attendance for the first time, this summit will be a chance for the entire region to have a robust conversation on hemispheric challenges and opportunities.

The event began with a keynote address by Assistant Secretary Jacobson, and was followed with a discussion moderated by Richard Feinberg—dubbed the “godfather” of the Summit process for his role in the first Miami Summit of the Americas in 1994—and Harold Trinkunas. This event also launched a new Brookings policy brief by Richard Feinberg, Emily Miller, and Harold Trinkunas, entitled "Better Than You Think: Reframing Inter-American Relations." 

Assistant Secretary Jacobson began her remarks by highlighting the areas where her own thinking coincides with the arguments in this new policy brief. Principally, she argued that developments in the hemisphere over the past few decades have largely been positive for U.S. interests. Although this does not mean Latin America and the United States will agree on everything, she noted that there are many areas of mutual interests on which the United States can work together with Latin America countries as equal partners.

Jacobson explained that this desire to forge equal partnerships based on common values and interests was precisely the notion expressed by President Obama at the 2009 Summit in Trinidad. The upcoming Summit is a chance to showcase this updated architecture for cooperation and partnership, which includes the CEO Summit of the Americas (initiated in 2012) and the Civil Society and Social Actors Forum (new this year).

Key issues for the U.S. at the Summit of the Americas

Assistant Secretary Jacobson outlined the four priorities for the United States going into the Summit:

• Democracy and human rights: Jacobson stated that the United States “applauds governments around the hemisphere that have supported a more robust civil society role.” The civil society side event provides a critical feedback loop that is one way for leaders to be held accountable by their citizens. Jacobson noted, however, that there remain very real challenges to democracy in Venezuela. While this is something that should concern the entire hemisphere, it is ultimately up to the Venezuelans to resolve.

• Global competitiveness: The focus of the United States will be on small businesses, which are important job creators but do not always receive the support they need in terms of access to credit or support in job training. The Small Business Network of the Americas has fostered over 4,000 small business development centers, and in Colombia alone has created nearly 6,000 jobs.

• Social development: Latin America remains the most unequal region of the world. There have been important reductions in poverty and growth of the middle class, but sustained improvements will require economic diversification and targeted efforts to reach vulnerable populations. To address the education deficit in the region, Jacobson highlighted the 100,000 Strong in the Americas program which connects institutions to institutions and seeks to provide students with actionable and employable skills. 

• Energy and climate change: The high cost of energy prevents some countries from realizing their full potential and feeds migration, poverty, and violence. Sharing in the enormous energy wealth of other nations must be done responsibly and sustainably, noted Jacobson. The Energy and Climate Partnership of the Americas and Connecting the Americas 2022 aim to “promote renewable energy efficiency, cleaner fossil fuels, resilient infrastructure, and interconnection.”

U.S. rationale behind targeted sanctions on Venezuela

When asked about flashpoints or problems areas for the United States in the upcoming summit, Jacobson pointed to the sanctions on seven Venezuelan officials and the concern they have generated. However, she was careful to clarify that the executive order used standard language and was in no way a prelude to invasion or a forced regime change. Moreover, she noted that the legislation had been pending in Congress for two years, during which a dialogue between the opposition and government facilitated by the Union of South American Nations (UNASUR) was attempted but stalled. Jacobson explained that it is important to remember that these sanctions are very targeted and do not intend to harm the Venezuelan people or even the Venezuelan government as a whole.

Engagement with Cuba and Brazil

In Jacobson’s view, there are no large systemic issues that stand to block progress at the Summit. She explained that the Obama administration’s greater flexibility on counter-narcotics policies, reestablishment of diplomatic ties with Cuba, and focus on the Trans-Pacific Partnership have removed many historic obstacles.

There remains work to be done, however. Jacobson stated that while interaction at the Summit between President Obama and Raúl Castro will serve to further the relationship and continue momentum for the normalization process, the engagement with Cuba will not deter the United States from speaking out on human rights violations. The administration’s view is that the human rights situation in Cuba is inadequate. Jacobson reiterated the need to respect international norms of human rights and that the United States will continue to support those who peacefully fight for that space to be open.

Finally, she recognized the importance of U.S. engagement with Brazil. According to Jacobson, the United States sees Brazil as a leader on social inclusion, and even on economic competitiveness as it openly debates how to restart economic growth. Though the United States and Brazil do not see eye-to-eye on issues of climate change, she recognized that working with Brazil will be crucial in this area as well.

A desire for cooperation

With a desire to focus on pragmatic approaches rather than ideology, Jacobson expressed an openness to cooperation: “We’re willing to engage with every country in the hemisphere, every country in the hemisphere, any country that wants to partner with us. Because they’re in all of our interests. And that’s the way partnerships should be based, on mutual interests…that’s what makes them durable.”

For more information, check out Latin America Initiative Director and Senior Fellow Harold Trinkunas's blog on the lessons in global governance the hemisphere has to offer.

In the face of seemingly weekly terrorist attacks and reports that Islamic State affiliates are growing in number, political leaders are under pressure to take tougher action against ISIS and other violent extremist threats. Removing terrorists from the battlefield and from streets remains critical—President Obama announced last week that the United States will send 250 more special operations forces to Syria, for one, and other military, intelligence, and law enforcement efforts will be important. According to one assessment, the United States has spent $6.4 billion on counter-ISIS military operations since August 2014, with an average daily cost of $11.5 million. As a result of these and related efforts, the territory the Islamic State controls has been diminished and its leadership and resources degraded.

The more challenging task, however, may be preventing individuals from joining the Islamic State or future groups in the first place and developing, harnessing, and resourcing a set of tools to achieve this objective. Violent extremism is most likely to take root when communities do not challenge those who seek to radicalize others and can’t offer positive alternatives. Prevention is thus most effectively addressed by the communities themselves—mayors, teachers, social workers, youth, women, religious leaders, and mental health professionals—not national security professionals, let alone national governments. But it’s easier said than done for national governments to empower, train, and resource those communities. 

Political leaders around the globe are increasingly highlighting community engagement and the role of communities more broadly in a comprehensive counterterrorism strategy. States, however, continue to struggle with how to operationalize and sustain these elements of the strategy. 

Show us the money

First, there is the funding shortfall. Too many national governments continue not to provide local governments and communities with the resources needed to develop tailored community engagement programs to identify early signs of and prevent radicalization to violence. To take just one example of the disparity, the $11.5 million per day the United States spends on its military presence in Iraq is more than the $10 million the Department of Homeland Security was given this year to support grassroots countering violent extremism (CVE) efforts in the United States, and nearly twice as much as the State Department’s Bureau of Counterterrorism received this year to support civil society-led CVE initiatives across the entire globe. Although a growing number of countries are developing national CVE action plans that include roles for local leaders and communities, funding for implementation continues to fall short. Norway and Finland are two notable examples, and the situation in Belgium was well-documented following the March attacks in Brussels.

Prevention is thus most effectively addressed by the communities themselves...not national security professionals, let alone national governments.

At the international level, the Global Community Engagement and Resilience Fund (GCERF)—established in 2014 and modeled on the Global AIDS Fund to enable governments and private entities to support grassroots work to build resilience against violent extremism—has struggled to find adequate funding. GCERF offers a reliable and transparent mechanism to give grants and mentoring to small NGOs without the taint of government funding. Yet, despite the fact that “CVE” has risen to near the top of the global agenda, GCERF has only been able raise some $25 million from 12 donors—none from the private sector—since its September 2014 launch. This includes only $300,000 for a “rapid response fund” to support grassroots projects linked to stemming the flow of fighters to Iraq and Syria—presumably a high priority for the more than 90 countries that have seen their citizens travel to the conflict zone. The GCERF Board just approved more than half of the $25 million to support local projects in communities in the first three pilot countries—Bangladesh, Mali, and Nigeria. GCERF’s global ambitions, let alone its ability to provide funds to help sustain the projects in the three pilots or to support work in the next tranche of countries (Burma, Kenya, and Kosovo) are in jeopardy unless donors pony up more resources to support the kind approach—involving governments, civil society, and the private sector—that is likely needed to make progress on prevention over the long-term.

Go grassroots

Second, national governments struggle with how best to involve cities and local communities. Governments still have a traditional view of national security emanating from the capital. Although a growing number of governments are encouraging, and in some cases providing, some resources to support city- or community-led CVE programs, they have generally been reluctant to really bring sub-national actors into conversations about how to address security challenges. Some capitals, primarily in Western Europe, have created national-level CVE task forces with a wide range of voices. Others, like the United States, have stuck with a model that is limited to national government—and primarily law enforcement—agencies, thus complicating efforts to involve and build durable partnerships with the local actors, whether mayors, community leaders, social workers, or mental health officials, that are so critical to prevention efforts. 

Some members of the target communities remain skeptical of government-led CVE initiatives, sometimes believing them to be a ruse for intelligence gathering or having the effect of stigmatizing and stereotyping certain communities. As debates around the FBI’s Shared Responsibilities Committees show, there are high levels of mistrust between the government—particularly law enforcement—and local communities. This can complicate efforts to roll out even well-intentioned government-led programs aimed at involving community actors in efforts to prevent young people from joining the Islamic State. The trouble is, communities are largely dependent on government support for training and programming in this area (with a few exceptions). 

To their credit, governments increasingly recognize that they—particularly at the national level—are not the most credible CVE actors, whether on- or off-line, within the often marginalized communities they are trying to reach. They’re placing greater emphasis on identifying and supporting more credible local partners, instead, and trying to get out of the way. 

Invest now, see dividends later

On the positive side of the ledger, even with the limited resources available, new (albeit small-scale) grassroots initiatives have been developed in cities ranging from Mombasa to Maiduguri and Denver to Dakar. These are aimed at building trust between local police and marginalized groups, creating positive alternatives for youth who are being targeted by terrorist propaganda, or otherwise building the resilience of the community to resist the siren call of violent extremism. 

Perhaps even more promising, new prevention-focused CVE networks designed to connect and empower sub-national actors—often with funds, but not instructions, from Western donors—are now in place. These platforms can pool limited resources and focus on connecting and training the growing number of young people and women working in this area; the local researchers focused on understanding local drivers of violent extremism and what has worked to stem its tide in particular communities; and mayors across the world who will gather next month for the first global Strong Cities Network summit. Much like GCERF, these new platforms will require long-term funding—ideally from governments, foundations, and the private sector—to survive and deliver on their potential. 

Somewhat paradoxically, while the United States (working closely with allies) has been at the forefront of efforts to develop and resource these platforms overseas and to recognize the limits of a top-down approach driven by national governments, similar innovations have yet to take root at home. More funding and innovation, both home and abroad, can make a huge difference. For example, it could lead to more community-led counter-narrative, skills-building, or counselling programs for young people at risk of joining the Islamic State. It could also help build trust between local police and the communities they are meant to serve, lead to more training of mainstream religious leaders on how to use social media to reach marginalized youth, as well as empower young filmmakers to engage their peers about the dangers of violent extremism. And national prevention networks that aren’t limited to just government officials can help support and mentor communities looking to develop prevention or intervention programs that take local sensitivities into account. Without this kind of rigorous effort, the large sums spent on defeating terrorism will not pay the dividends that are badly needed. 

For months, Europe has been dealing with the hectic, day-to-day struggles of managing a massive migrant crisis. While those challenges dominate in the short term, European leaders must also start thinking about medium- to long-term reforms to the European Union’s asylum and migration policies.

European governments have made clear that they want to reform the Common European Asylum System. The European Commission has proposed reforms of its own, which to become laws would need to be approved by both the Council and the European Parliament. But while these proposals are certainly steps in the right direction, they don’t go far enough in addressing structural weaknesses in Europe’s migration and asylum policies.

Positive momentum in a number of key areas

There are several areas where the Commission has already proposed good reforms:

1. The Commission is proposing to recast a directive aimed at standardizing the processing of asylum procedures across Europe into a fully-fledged regulation. This is good news. The persistent variation in the implementation of asylum procedures across the EU highlights this necessity. Unlike directives, which need to be transposed into national legislation, regulations are immediately and simultaneously enforceable across all member states. 
2. A directive specifying the grounds for granting international protection is to be replaced by a more stringent regulation, which is also a good thing. It’s problematic that asylum seekers from the same country of origin enjoy dramatically different acceptance rates across EU member states. Combined, these changes should force member states to comply with international standards on asylum procedures and increase opportunities for migrants to get asylum (particularly in countries that have applied more restrictive criteria).
3. The Eurodac system, which establishes a pan-European fingerprinting database, is now likely to be expanded as well. It would store data on third-country nationals who are not applicants for international protection. But implementation is again a challenge, since Croatia, Greece, Italy, and Malta already struggle to fingerprint new arrivals (something over which infringement proceedings are still ongoing). 
4. To attract highly skilled professionals, the Commission is working to make the EU Blue Card scheme more appealing. While member states will retain the right to set their own annual migrants quota, Blue Card procedures and rights will be harmonized across the EU. The minimum length of an initial contract offer will be lowered to six months, salary thresholds will be reduced, and the Blue Card will be offered to migrants granted asylum. Other measures—including a directive aimed at students and researchers and another facilitating intra-corporate transfers—are also steps in the right direction. 
5. Finally, the Commission has proposed making permanent a pan-European resettlement scheme that was launched during last summer’s migrant crisis. That’s also a good thing. The framework would harmonize resettlement procedures and financially incentivizes member states to favor the European framework over national ones. At the same time, it would allow asylum seekers to move to Europe without risking their lives trying to cross the Mediterranean. However, given that member states will still determine how many people to resettle annually, the long-term impact of the scheme remains to be seen. 

German Interior Minister Thomas de Maiziere watches as a migrant from Babel in Iraq has his fingerprints taken, during a visit to Patrick-Henry Village refugee centerin Heidelberg, Germany. Photo credit: Reuters/Kai Pfaffenbach.

Far more needed but little appetite among national capitals

There are several policy areas where far more should be done: 

1. There is at least one area where the EU is still planning reforms but of a far more limited nature, and that’s on the current directive on basic standards for housing, healthcare, and employment. In private conversations, EU officials stress that the sheer numbers of migrants make it hard for even the best-performing countries to implement this directive. Put simply, member states do not have the political will to do more than what they are already doing. The EU is therefore, understandably, proposing a more moderate reform: it aims to improve reception conditions throughout the EU without dictating to member states how to do so.
2. Less privileged migrants must be provided with safe avenues to contribute to Europe’s economy. Legislation allowing seasonal workers into the Union for a maximum of between five and nine months within any twelve-month period already goes in this direction. Forums connecting local industry associations and countries of origin to better match labor demand and supply would also be welcome. Armenia, Azerbaijan, Cape Verde, Georgia, Morocco, Moldova, and Tunisia—which enjoy mobility partnerships with the EU—would benefit from such an approach. More can be done if the political will amongst European capitals is there.
3. Finally, Europeans must ensure that migrants feel welcome to stay. The EU is aware of the need to adequately integrate third-country nationals, but European capitals are in the driver’s seat when it comes to integration. Directives aimed at facilitating family reunifications, integrating long-term residents, and streamlining administrative processes do what they can in this respect. However, the paths to integration and to welcoming foreigners chosen by European countries are exceedingly different, and for the time being likely to remain so. Because of this and until policymakers put integration at the top of their national agendas, foreign nationals will likely continue to struggle. 

Dublin: Still the elephant in the room

The Dublin regulation, which outlines which member state should be responsible for handling asylum applications, still must be radically revised. This is the elephant in the room and the core of the current asylum refugee framework. Member states should consider the Commission’s proposals for a corrective mechanism in case of migrant surges, a new system for allocating applications across the EU based on a distribution key or, ideally, the centralization of competences to the European Asylum Support Office. 

Informal conversations with top national and European officials suggest that the corrective mechanism is the most likely proposal to be accepted by the member states and therefore adopted. Under such an agreement, Dublin would be maintained, but automatic relocations would start in case of exceptional migrant surges—with hefty fines imposed by the Commission on those member states refusing to play their part. Unfortunately, this is not good enough. Such an approach does not address the underlying structural unfairness and unsustainability of a system that leaves the burden of processing arrivals overwhelmingly on frontline states. 

The current situation exemplifies a significant failure of governance that harms the interests of migrants and member states alike. At present, the Dublin Convention largely ignores the needs of migrants in terms of family reunification, language skills, and cultural integration. Unfortunately, the corrective mechanism for the Dublin Convention does nothing more than provide some relief in case of acute emergencies. Meanwhile, it leaves frontline states to continue facing on their own a crisis that only Europe as a whole could solve. “European leaders” still think and act through national perspectives.

Moving along despite European governments

The European Commission faces both legal and political constraints that limit its scope of action. Whenever it can, it is pushing for a significant overhaul of European asylum and migration policies. However, once more, its initiatives are hampered by the so-called “interests” of the member states. For the time being, we are likely to see some degree of integration in the fields of asylum and migration policies. But because of national vetoes, progress is slow and proposals are often watered down. 

The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just  82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation.

On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways:

1.  The BTD program is viewed positively by drug companies, researchers, advocates, and others 

Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources.

Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to  further improve prescription drug policy and medical decision-making.

2.  BTD requests far outnumber those that actually meet the qualifying criteria

Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies.

One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides.

3.  There is no single threshold for determining what defines a breakthrough therapy

About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements.

4.  Early communication with FDA is strongly recommended for BTD applicants

Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better  and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests.

5.  FDA may need more resources for implementing the BTD program

“For a not-for-profit it’s the equivalent of venture capital,” said Sir Ronald Cohen, chairman of the Global Social Impact Investing Steering Group, about impact bonds in his keynote address at a recent event at the Brookings Institution. Impact bonds combine results-based financing and impact investing, where investors provide upfront capital for a social service and government agencies, or donors, agree to pay investors back based on the outcomes of the service. At their best, they could allow for innovation, encourage performance management and adaptability, promote learning through evaluation, and create a clear case for investing in what works. However, impact bonds thus far have had immense transaction costs and there are risks that poor execution of the impact bond mechanism could have negative consequences for beneficiaries.

It has been six years since the first impact bond was implemented in March of 2010, and the field is beginning to move from an exploratory stage to looking at systemic change, as Tracy Palandjian, CEO and co-founder of Social Finance U.S. described. The event, “The Global Potential and Limitation of Impact Bonds,” served as a point of reflection for stakeholders at this pivotal stage of the field, bringing together over 500 individuals in the room and on the webcast, including practitioners developing impact bonds around the world. While context matters, there were notable similarities in the motivations and challenges across regions.

In our presentations of our research and subsequent panels, we focused on the potential value and challenges of combining results-based financing and impact investing through an impact bond. Shri Naveen Jain, mission director of the National Health Mission of Rajasthan, India, who is working to develop an impact bond for maternal and child health services across his entire state, pointed out that the value of a results-based financing contract to him was in the added transparency it provides—the government is able to see what they are paying for, keep service providers accountable, and incentivize providers to achieve better outcomes. Louise Savell, a director at Social Finance U.K., the entity that first put impact bonds on the map, explained that results-based financing contracts are often arranged such that only one portion of the contract is based on results. This, she explained prescribes a model and does not allow for flexibility; furthermore, it forces service providers to bear a significant risk. Impact bonds allow for the entirety of payments to be based on results, which gives the provider full flexibility (at least in theory), but puts the risk of service performance on the investor. The shift of risk to investors could be particularly useful for service delivery in conflict affected areas, where donors are often highly concerned about how money will be used, mentioned Francois de Borchgrave, co-founder and managing director of Kois Invest, who is working on an impact bond with the International Rescue Committee of the Red Cross. The panelists also emphasized that impact bonds are more powerful than results-based financing contracts alone because, if successful, they pay real financial returns to investors. This draws a great deal of attention from policymakers and the public, and the added scrutiny helps in making the investment case for preventive interventions highly explicit. Mayor Ben McAdams of Salt Lake County, Utah said that “data and evidence is bridging a partisan divide” in his state—when the case for investment is clear, policymakers from both sides of the aisle are willing to invest. Impact bonds do not necessarily add value by increasing the total amount of funding available for social services, because investors are repaid if outcomes are achieved. Rather, impact bonds could help increase the outcomes achieved with given funding.

Overall there was agreement that impact bonds have enormous potential to lead to more outcome-focused financing that focuses on preventive interventions and incentivizes collaboration. However two critical considerations for the use of impact bonds arose throughout the day.

The first consideration discussed was whether or not impact bonds can support innovation or scale. As found in our first report, impact bonds have been relatively small in scale in terms of capital and beneficiaries. The average upfront investment in impact bonds to date is $3.7 million, reaching an average of 1,900 beneficiaries. They also have not, on average, focused on particularly innovative interventions—in fact they have almost all had a relatively strong base of evidence behind them. Views on the panel differed on whether the uses of impact bonds could be expanded—if they could be used for highly innovative pilot programs or proven large scale programs. One perspective was that impact bonds could indeed provide seed capital to test new ideas for service delivery. This would require investors who are willing to test not only the innovation but also this relatively new financing mechanism. Given the high transaction costs that impact bonds entail, however, this may not be the most efficient use of resources. Impact bonds could also reach more beneficiaries per transaction (greater scale) with changes in public procurement and the creation of markets for tradeable impact bond assets. Government can play a role in facilitating larger impact bonds by creating central government outcome payment funds, providing tax breaks for investment in impact bonds, and enabling the development of investment vehicles, all of which are being implemented in the U.K. Impact bonds could also help effective social services reach scale by encouraging government to fund programs at scale after the impact bond is over or by improving data use and performance management in government-funded services broadly.

A second, and related, discussion happened around evaluation methodology—which may differ depending on whether the impact bond is intended to test an innovative intervention or scale an intervention already backed by significant evidence. The “gold standard” randomized controlled trial (RCT) is the only methodology that eliminates the possibility that impact could be attributed to something other than the intervention, though the majority of impact bonds thus far use evaluation methodologies that are less rigorous. The panelists explained that it is important, however, to consider the status quo—currently, less than 1 percent of U.S. federal spending on social services has been shown to be effective. The same is true in low- and middle-income countries, where there are relatively few impact evaluations given the number of interventions. At the end of the day, the government agency acting as the outcome funder must decide on the importance of attribution to trigger payment through the impact bond in view of the already available evidence of program effectiveness and weigh the criticism that might ensue in the absence of a valid counterfactual.

Though impact bonds are a potentially useful tool in the toolbox of many financing mechanisms, there are some significant constraints to their implementation. The biggest barrier to impact bonds and other results-based contracts is the administrative hurdle of contracting for outcomes. Peter Vanderwal, innovative financing lead at the Palladium Group, and Caroline Whistler, co-president and co-founder of Third Sector Capital Partners, both stated that governments often are unable or do not know how to contract for outcomes, and there is a need to invest in their capacity to do so. Appropriation schedules are part of this challenge, governments are often not allowed to appropriate for future years. When an audience member asked how we go about changing the culture in government to one of contracting for outcomes, Mayor McAdams answered that impact bonds may have a contagious effect—contracting for outcomes will be the expectation in the future. Additionally, the transaction costs of establishing the partnership are large relative to other mechanisms, though they may be worthwhile. Jim Sorenson, of the Sorenson Impact Center, pointed out that service provider capacity and data collection systems could be barriers to the development of future impact bonds. There is also still a long way to go in developing outcome measures and in particular in calibrating those outcome measures to low- and middle-income countries.

The influence that impact bonds have on the provision of quality services globally depends on the quality of implementation. With a rapidly growing market, there will inevitably be “bad” impact bonds in the future. To ensure that impact bonds are used as effectively as possible, governments and the research community have a pivotal role to play in asking the right questions: Will a results-based contract help improve outcomes in this particular case? What should the outcomes be to avoid perverse incentives or potentially negative externalities? And would an impact bond structure add value?