On May 17, Egyptian President Abdel-Fatah el-Sissi did something Egyptian presidents have done many times before: he urged Israel and the Palestinians to renew negotiations for peace, this time by backing an international conference promoted by the French foreign minister.

But what made Sissi’s call particularly interesting is that he called on not just the leaders but also political "parties" to seize what he called “a real opportunity to find a long-awaited solution.” Sissi's call offered Israeli Prime Minister Benjamin Netanyahu an opportunity to accommodate Israel's newest best friend, Sissi, rather than the French themselves. It would not have brought peace, of course: though an international conference would offer a glimmer of hope to change some of the worst aspects of the current diplomatic deadlock, it would not solve any of the outstanding substantive issues between Israelis and Palestinians.

Sissi's reference to political parties was no coincidence: it fit perfectly with the domestic political needs of Netanyahu and of Opposition Leader Isaac Herzog, who were angling to bring the Zionist Union joint list into the government and give Netanyahu a much-needed parliamentary cushion beyond his current razor-thin coalition. 

Herzog first had to convince his own highly-reluctant party of the need to join its rival Netanyahu—and if peace was about to break out, how could they refuse? For about 48 hours it seemed like Herzog was indeed about to announce his decision to join the coalition, face the battle in his party, and become Israel's foreign minister.

Then something else happened. Rather than appointing Herzog as foreign minister, Netanyahu is now poised to bring back Avigdor Lieberman, a former foreign minister and Israel's least diplomatic politician. Lieberman won't be returning to diplomacy, however. Instead, he will get a significantly more powerful position, second only to the prime minister: minister of defense. In response, current Minister of Defense Moshe Ya’alon today resigned from the cabinet and the Knesset, refusing to take another cabinet position. He gave a scathing speech, saying that "[E]xtremist and dangerous forces have taken over Israel and the Likud movement."

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman.

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman. Herzog is left wounded and humiliated, played for a fool—the gravest sin in Israeli political culture. Netanyahu finds himself at the helm of an enlarged coalition (Lieberman brings with him five members of Knesset, after one member of his faction left the party today in protest of the move), safer from parliamentary shocks and from attacks from the right (the whole right wing is now inside the coalition. Lieberman will still likely criticize Netanyahu from within the government, but not quite as fiercely). 

A cynics’ cynic

Lieberman's pending appointment has been met with astonishment by the opposition in Israel, by many in the military which he will oversee, and indeed here in Washington—and with good reason.

Just these past few months, Lieberman has viciously attacked both Netanyahu and the military brass for what he claimed was a weak response to terrorist attacks. In but one example of many, Lieberman came to the defense of a soldier who the Israel Defense Forces (IDF) had decided to prosecute for killing a Palestinian assailant who had already been thoroughly subdued. The contrast to current Minister of Defense Moshe Ya’alon is striking: Ya’alon defended the military's decision and stressed the importance of ethical norms and of rules of engagement in the military. Ya’alon is very right wing on the Palestinian issue, but he has consistently shown an honorable stance in the face of attacks on democratic norms. 

Lieberman is ostensibly less right-wing on the Palestinian issue—sometimes. Though he is a settler himself, he has endorsed a two-state solution in very general theory, noting he would even move if peace necessitated it. His endorsement, however, has always been couched in the toughest language possible and in utter mistrust of Palestinian intentions or the chances of peace ever materializing. On the niceties of democratic norms, including military law, he is a cynics' cynic. Benny Begin, another former Likud minister and an avowed hawk, has called Lieberman's appointment “delirious.”

As minister of defense, these positions will be highly consequential. Not only will he be in charge of the military brass and its promotion, but he will have statutory authority over many affairs in the West Bank, which is under military rule. Any attempt to improve the daily lives of Palestinians (such as a project just announced to streamline checkpoints for Palestinians) will be under his purview. His open calls to bring down Hamas through a ground invasion of Gaza if there is another round of fighting with Hamas—voiced even while he was a cabinet member during the last round of fighting—will now carry the weight of the minister of defense.

What was Herzog thinking? 

For the past year, since Netanyahu formed his fourth government, Herzog had denied time and again that he was aiming to join Netanyahu rather than replace him. He bemoaned the cynicism of those who simply would not believe him. This week the masks came off. Negotiations between the sides were accelerated and Herzog began a difficult intra-party fight to justify such a move. "National unity" governments are quite common in Israel, starting with the emergency cabinet of 1967, on the eve of the Six-Day War, when a sense of imminent doom swept the country. 

These governments, however, are usually justified by either an acute crisis, like in 1967, or in order to resolve a political deadlock, such as between Shimon Peres' Labor and Yitzhak Shamir's Likud in 1984. Peres and Shamir even "rotated" the post of prime minister. Though the government was incapable of any meaningful diplomatic advances, on which it was divided, it succeeded in tackling hugely important challenges in the economy—bringing inflation down from an annual rate of over 444 percent (not a typo) in 1984, and in defense—extricating Israel from most of Lebanon, following the first Israeli Lebanon War. 

What would be the logic this time? Herzog was promising three things to his party members: a host of portfolios (jobs and titles but also influence on a range of domestic policy issues); a veto on some aspects of policy which Labor finds most damaging, including remote settlement construction and legislation seen as limiting democratic discourse in Israel; and a leading role in any negotiations with the Palestinians, staring with the French peace conference. 

The jobs for Labor would have been real. A veto on policy could have been important—Tzipi Livni, Herzog's non-Labor partner in the Zionist Union, played a crucial role in protecting democratic norms as minister of justice in Netanyahu's previous government. 

On peace, however, Herzog was offering fool's gold. Put it this way: if you think Herzog would have real autonomy to run negotiations with the Palestinians while Netanyahu is prime minister, I have two suggestions. First, ask Tzipi Livni, who had that exact task in the previous government and was accompanied to every negotiation by Netanyahu’s personal lawyer, Yitzhak Molcho. Livni, incidentally, was strongly opposed to joining Netanyahu this time around. 

Second, I have some great real-estate in a swamp in Florida I'd like to discuss with you.

Herzog had a political rationale as well. He is a natural minister and backroom politician: smart, hardworking and prone to pragmatic compromises. He is not a natural public politician. As Leader of the Opposition he has wowed no one with his charisma or ability to stand up to Netanyahu and offer a bold alternative. Better to be in the halls of power than in the open arena. With the prospects of a fierce leadership challenge in his own Labor Party, moreover, he would have bolstered his bona fides as a national leader and therefore give himself a bit more time—the most a politician in Israel can really hope for. 

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal.

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal. Having joined Netanyahu, it would have been very hard to present the party as an alternative to his rule. 

What now?

Netanyahu can now feel slightly more secure in his coalition, though once again at the mercy of the mercurial Lieberman. Lieberman will enjoy a powerful post that usually bestows its occupant with new popularity in Israel (the converse is true of the finance ministry). Finance Minister Moshe Kahlon will enjoy a wider coalition to pass his domestic legislation and budget; indeed he'd been pushing for enlarging the coalition since it was formed. 

In the opposition, Herzog is weaker than ever. After being led on by Netanyahu for months, breaking his own word on the negotiations and then losing his gamble, he is severely exposed to challenges within Labor. His party's image has taken a serious hit as well.

Herzog's weakness will allow others in the opposition to claim the mantle of alternative to Netanyahu. Already, Yair Lapid’s centrist Yesh Atid party is the main beneficiary, but others may emerge as well, especially from the ranks of former generals like Gabi Ashkenazi. 

Most importantly, Israel's actual policy may be affected significantly by this move. Of all the governmental posts, defense is the one that has the most effect on the crucial questions of security for Israelis (and on the daily lives of Palestinians). Instead of grand peace plans Herzog was selling, Netanyahu's political brilliance has wrought one of the most hardline governments Israel has ever had.

Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to market. While important, such proposals alone do not fully recognize the broader opportunities that exist to learn more about the safety and effectiveness of drugs and devices after approval. As drugs and devices begin to be used in larger and more diverse populations and in more personalized clinical combinations, evidence from real-world use during routine patient care is increasingly important for accelerating innovation and improving regulation.

First, further evidence development from medical product use in large populations can allow providers to better target and treat individuals, precisely matching the right drug or device to the right patients. As genomic sequencing and other diagnostic technologies continue to improve, postmarket evidence development is critical to assessing the full range of genomic subtypes, comorbidities, patient characteristics and preferences, and other factors that may significantly affect the safety and effectiveness of drugs and devices. This information is often not available or population sizes are inadequate to characterize such subgroup differences in premarket randomized controlled trials.

Second, improved processes for generating postmarket data on medical products are necessary for fully realizing the intended effect of premarket reforms that expedite regulatory approval. The absence of a reliable postmarket system to follow up on potential safety or effectiveness issues means that potential signals or concerns must instead be addressed through additional premarket studies or through one-off postmarket evaluations that are more costly, slower, and likely to be less definitive than would be possible through a better-established infrastructure. As a result, the absence of better systems for generating postmarket evidence creates a barrier to more extensive use of premarket reforms to promote innovation.

These issues can be addressed through initiatives that combine targeted premarket reforms with postmarket steps to enhance innovation and improve evidence on safety and effectiveness throughout the life cycle of a drug or device. The ability to routinely capture clinically relevant electronic health data within our health care ecosystem is improving, increasingly allowing electronic health records, payer claims data, patient-reported data, and other relevant data to be leveraged for further research and innovation in care. Recent legislative proposals released by the House of Representatives’ 21st Century Cures effort acknowledge and seek to build on this progress in order to improve medical product research, development, and use. The initial Cures discussion draft included provisions for better, more systematic reporting of and access to clinical trials data; for increased access to Medicare claims data for research; and for FDA to promulgate guidance on the sources, analysis, and potential use of so-called Real World Evidence. These are potentially useful proposals that could contribute valuable data and methods to advancing the development of better treatments.

What remains a gap in the Cures proposals, however, is a more systematic approach to improving the availability of postmarket evidence. Such a systematic approach is possible now. Biomedical researchers and health care plans and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the potential for large-scale, systematic postmarket data collection. Building on these efforts could provide unprecedented evidence on how medical products perform in the real-world and on the course of underlying diseases that they are designed to treat, while still protecting patient privacy and confidentiality.

These and other postmarket data systems now hold the potential to contribute to public-private collaboration for improved population-based evidence on medical products on a wider scale. Action in the Cures initiative to unlock this potential will enable the legislation to achieve its intended effect of promoting quicker, more efficient development of effective, personalized treatments and cures.

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Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.

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• REMS_PBRC_Meeting_Agenda
• REMS BR Speaker Bios
• REMS BenefitRisk Meeting Summary
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The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

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• FINAL 1014 BrookingsFDA Agenda
• FINAL 1014 BrookingsFDA Participant List

Issuing work permits to refugees in return for donor support for jobs is seen as a “win-win-win” for refugees, host countries, and the international community. It would stem the flow of refugees to Europe, decrease the dangers of radicalization, and prevent the exploitation of refugees as a source of cheap labor. At last February’s “Supporting Syria and the Region” conference co-hosted by the U.K., Germany, Kuwait, Norway, and the United Nations, former British Foreign Secretary David Miliband called for a million work permits to be made available to Syrians, 200,000 each in Jordan and Lebanon and 600,000 in Turkey.

Turkey issued a decree in January 2016 allowing work permits for Syrians. Jordan also agreed to provide work permits for up to 200,000 Syrians over a number of years in exchange for aid and the opening of European markets to goods produced or special economic zones—all this to lead to jobs for one million Jordanians as well when other aid and spending is added in. Lebanon, whose fragile confessional politics makes the one million plus Sunni refugees a more palpable threat, has chosen not to issue work permits. Yet, according to the International Labor Organization (ILO), “around half of (working age) Syrian refugees are economically active and just one-third have access to overwhelmingly informal and low-skilled employment.” That’s around 165, 000 employed informally. The number is around 160,000 in Jordan  with 1.3 million Syrians and over 400,000 in Turkey with 2.7 million Syrian refugees.  

In Turkey and Jordan, as elsewhere, work permits are tied to employers who apply on behalf of employees once residency, registration, and health requirements are met. In both countries, employers must pay the legal minimum wage and social security payments. The permits are renewed annually. But, for the majority of Syrians working in labor markets with an abundance of local and foreign low-skill, low-wage workers, the pay is nowhere near the minimum wage. As to the promised jobs in the special zones, those will take time to materialize, and we already know that, at least in the garment sector, up to 80 percent of the workers are young women from South Asia, largely residing in dorms but at least receiving the minimum wage. Whether Syrians can adapt to this model remains to be seen. In both Jordan and Turkey, there are certain limits on the percentage of Syrians versus locals in many manufacturing and services jobs; in Jordan there is some evidence that “ghost” Jordanian workers are used to get around this requirement.

Jordan already has over 240,000 foreign workers, mainly Egyptians and Asians, who have work permits, with the total number including those working illegally may be as high as a million. There is a move to get Syrians to replace the foreign workers with permits but that seems a bit uncertain. It seems unlikely that employers will be eager to replace employees, often of long standing and for whom they have gone to the expense of getting work permits.  In Turkey, with fewer foreign workers, many locals work informally, though they tend to get paid significantly more than Syrians. The chances of employers hiking up wages to legalize Syrian employees, whether in Jordan or Turkey, are slim and the record to date appears to confirm this.   

In Jordan, the government provided a three-month grace period for workers to receive permits free of charge. Less than 2,000 permits had been granted by April. An ILO survey in Jordan, which looked at workers in the construction and agriculture sectors, noted that while 90 percent of workers had heard about the grace period, none in the agriculture sector and only 85 percent in construction had work permits, though almost all knew that getting caught might mean detention at the Azraq refugee camp. And an inability to pay social security constituted a major barrier. Often a concern is to go through employers to get the permit.  

In Turkey, the numbers are not encouraging either: By May, only 10,000 had actually registered for work permits. Refugees International reports that Turkey’s work permit program may end up benefitting 40,000 Syrians or roughly 10 percent of those actually working. The government, though, thinks that the program will eventually help all those currently working informally.

The ILO, United Nations High Commissioner for Refugees, and Refugees’ International have praised the Jordanian and Turkish governments for granting work permits. The decision was not easy and was politically charged in both countries. But the political and psychological significance of providing an opening for Syrians to slowly integrate themselves and move towards a stable future is certainly worth pursuing, even if it doesn’t bring immediate rewards. Already, Turkey allows Syrian doctors and medical personnel to work in health centers serving refugees. Over 4000 Syrian teachers have received stipends from a Ministry of Education program funded by UNICEF and western donors. And agricultural workers no longer need work permits so long as provincial governors give their approval.

Eventually delinking work permits from employers will help, and the ILO urges Jordan to do so for agricultural and construction workers. In both Jordan and Turkey, lowering social security payments would also smooth the transition. More support to vocational training, health care, education for children are other ideas being pursued. While making work permits available is not the same as a blanket “right-to-work” law for refugees, a right protected under the U.N. 1951 Refugee Convention but accepted in full neither by Jordan nor Turkey (however, the key international treaty that protects the right to work in binding form is the International Covenant on Economic, Social and Cultural Rights to which Jordan and Turkey are signatories), this is an opening and one that the international community should monitor and support. Aside from the February conference, other agreements—such as the one between the EU and Turkey and the upcoming EU deal with Lebanon and Jordan—provide suitable platforms towards improving on this initial phase.   

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I was honored today to speak at the kick off meeting of the new ReFormers Caucus. This group of over 100 former members of the U.S. Senate, the House, and governors of both parties, has come together to fight for meaningful campaign finance reform. In the bipartisan spirit of the caucus, I shared speaking duties with Professor Richard Painter, who was the Bush administration ethics czar and my predecessor before I had a similar role in the Obama White House. 

As I told the distinguished audience of ReFormers (get the pun?) gathered over lunch on Capitol Hill, I wish they had existed when in my Obama administration role I was working for the passage of the Disclose Act. That bill would have brought true transparency to the post-Citizens United campaign finance system, yet it failed by just one vote in Congress.  But it is not too late for Americans, working together, to secure enhanced transparency and other campaign finance changes that are desperately needed.  Momentum is building, with increasing levels of public outrage, as reflected in state and local referenda passing in Maine, Seattle and San Francisco just this week, and much more to come at the federal, state and local level.

President Obama is right to keep at it in Afghanistan, argues a new policy brief by Michael O’Hanlon, senior fellow and director of research for the Brookings Foreign Policy program.

Some have criticized the president’s decision to maintain a significant troop presence there (5,500 troops), instead of following through on the planned military withdrawal. But Afghanistan remains very important to American security, O’Hanlon contends, and the situation in the country is far from hopeless in spite of recent setbacks. We should reinvigorate American efforts in Afghanistan, he argues—not returning to levels seen in previous years, but ramping up somewhat from our current posture.

O’Hanlon calls Obama’s resolve in Afghanistan commendable, but writes that he and his administration are still making mistakes on U.S. policy toward the war-torn country. He advises that Washington make two specific changes to its military strategy in Afghanistan:

1. Allow U.S. and NATO airpower to target the Islamic State and the Taliban (currently, they can only fight those groups if directly attacked). The narrow rules of engagement constraining foreign forces were intended to push Afghan armed forces to defend their territory themselves. While a worthy goal, O’Hanlon says, these rules often prevent us from attacking ISIS (though the targeting strategy towards the group may be changing) as well as the Taliban. They also impose unrealistically high demands on Afghan forces and make too fine a distinction between an array of aligned extremist groups operating in the country.
2. Expand U.S. force presence from the current 5,500 troops to around 12,000 for a few years. In O’Hanlon’s opinion, our current numbers are not enough to work with fielded Afghan forces, and skimping on ground forces has contributed to security challenges in places like Helmand, for instance, which experienced new setbacks in 2015. More broadly, leaders in Washington and Brussels should stress the value of a long-term NATO-Afghanistan partnership, rather than emphasizing an exit strategy. This will signal Western resolve to the Taliban and other groups. While the next commander in chief should set the United States on a gradual path toward downsizing American troops in Afghanistan, he believes it would be a mistake for Obama to do so in the short term.

The long haul

O’Hanlon also argues that the United States needs to take a longer-term perspective on key political and economic issues in Afghanistan. On the economic front, there seems to be little thinking about an agricultural development plan for Afghanistan, associated infrastructure support, and land reform, among other challenges. On the political front, conversations often tend to focus on shorter-term issues like organizing parliamentary elections, reforming the Independent Election Commission, or modifying the current power-sharing arrangement. In the process, conversations about foundational political strategy focusing on Afghan institutions and the health of its democracy get short-changed. The parliament is in need of reforms, for instance, as is the political party system (which should encourage Afghans to group around ideas and policy platforms, rather than tribes and patronage networks).

O’Hanlon concludes that the situation in Afghanistan today, while fraught, is understandable given the Taliban’s resilience and NATO’s gradual withdrawal of 125,000 troops. We should not be despondent, he writes—rather, we should identify specific strategies that can help improve the situation. At the end of the day, Afghans must make the big decisions about the future of their country. But as long as the United States and its partners are still providing tremendous resources—and as long as security threats emanating from South Asia continue to threaten the United States—leaders in Washington should use their influence wisely.

With conflicts in the Middle East continuing unabated, refugees continue to flow out of several war-torn countries in massive numbers. The question of whether to admit more refugees into the United States has not only been a source of debate among Washington policymakers, it has also become a central question within the U.S. presidential race. Nonresident Senior Fellow Shibley Telhami conducted a survey on American public attitudes toward refugees from the Middle East, in particular from Syria, Iraq, and Libya. Below are several key findings from the poll and a download link to the survey's full results.

Downloads

• Poll: American attitudes on refugees from the Middle East
• Poll Presentation
• Key Findings
• Refugee Questionnaire

Rooftop solar is booming in U.S. cities.

One of the most exciting infrastructure developments within metropolitan America, the installation of over a million solar photovoltaic (PV) systems in recent years, represents nothing less than a breakthrough for urban sustainability — and the climate.

Prices for solar panels have fallen dramatically. Residential solar installations surged by 66 percent between 2014 and 2015 helping to ensure that solar accounted for 30 percent of all new U.S. electric generating capacity. And for that matter, recent analyses conclude that the cost of residential solar is often comparable to the average price of power on the utility grid, a threshold known as grid parity.

So, what’s not to like? Rooftop solar is a total winner, right?

Well, not quite: The spread of rooftop solar has raised tricky issues for utilities and the public utilities commissions (PUCs) that regulate them. 

Specifically, the proliferation of rooftop solar installations is challenging the traditional utility business model by altering the relationship of household and utility—and not just by reducing electricity sales. In this respect, the solar boom has prompted significant debates in states like New York and California about the best rates and policies to ensure that state utility rules and rates provide a way for distributed solar to flourish even as utilities are rewarded for meeting customer demands. Increasingly, this ferment is leading to thoughtful dialogues aimed at devising new forms of policy and rate design that can—as in New York—encourage distributed energy resources (DERs) while allowing for distribution utilities to adapt to the new era.

However, in some states, the ferment has prompted a cruder set of backlashes. Most pointedly, some utilities contend that the “net-metering” fees paid to homeowners with rooftop installations for excess solar power they send back to the grid unfairly transfer costs to the utilities and their non-solar customers.

And so in a number of states, utility interests have sought to persuade state regulators to roll back net-metering provisions, arguing they are a net cost to the overall electricity system.  Most glaringly, the local utility in Nevada successfully wielded the cost-shift theory last winter to get the Nevada Public Utilities Commission to drastically curtail the state’s net-metering payments, prompting Solar City, Sunrun, and Vivint Solar—the state’s three largest providers of rooftop panels—to leave the Nevada market entirely. The result: New residential solar installation permits plunged 92 percent in Nevada in the first quarter of 2016.

All of which highlights a burning question for the present and future of rooftop solar: Does net metering really represent a net cost shift from solar-owning households to others? Or does it in fact contribute net benefits to the grid, utilities, and other ratepayer groups when all costs and benefits are factored in? As to the answer, it’s getting clearer (even if it’s not unanimous). Net metering — contra the Nevada decision — frequently benefits all ratepayers when all costs and benefits are accounted for, which is a finding state public utility commissions, or PUCs, need to take seriously as the fight over net metering rages in states like Arizona, California, and Nevada.  Regulators everywhere need to put in place processes that fairly consider the full range of benefits (as well as costs) of net metering as well as other policies as they set and update the policies, regulations, and tariffs that will play a critical role in determining the extent to which the distributed solar industry continues to grow.

Fortunately, such cost-benefit analyses have become an important feature of state rate-setting processes and offer important guidance to states like Nevada.  So what does the accumulating national literature on costs and benefits of net metering say?  Increasingly it concludes— whether conducted by PUCs, national labs, or academics — that the economic benefits of net metering actually outweigh the costs and impose no significant cost increase for non-solar customers.  Far from a net cost, net metering is in most cases a net benefit—for the utility and for non-solar rate-payers.

Of course, there are legitimate cost-recovery issues associated with net metering, and they vary from market to market. Moreover, getting to a good rate design, which is essential for both utility revenues and the growth of distributed generation, is undeniably complicated.  If rates go too far in the direction of “volumetric energy charges”—charging customers based on energy use—utilities could have trouble recovering costs when distributed energy sources reach higher levels of penetration. On the other hand, if rates lean more towards fixed charges—not dependent on usage—it may reduce incentives for customers to consider solar and other distributed generation technologies.  

Moreover, cost-benefit assessments can vary due to differences in valuation approach and methodology, leading to inconsistent outcomes. For instance, a Louisiana Public Utility Commission study last year found that that state’s net-metering customers do not pay the full cost of service and are subsidized by other ratepayers. How that squares with other states’ analyses is hard to parse.

Nevertheless, by the end of 2015, regulators in at least 10 states had conducted studies to develop methodologies to value distributed generation and net metering, while other states conducted less formal inquiries, ranging from direct rate design or net-metering policy changes to general education of decisionmakers and the public. And there is a degree of consensus.  What do the commission-sponsored analyses show? A growing number show that net metering benefits all utility customers:

• In 2013 Vermont’s Public Service Department conducted a study that concluded that “net-metered systems do not impose a significant net cost to ratepayers who are not net-metering participants.” The legislatively mandated analysis deemed the policy a successful component of the state’s overall energy strategy that is cost effectively advancing Vermont’s renewable energy goals.

• In 2014 a study commissioned by the Nevada Public Utility Commission itself concluded that net metering provided $36 million in benefits to all NV Energy customers, confirming that solar energy can provide cost savings for both solar and non-solar customers alike. What’s more, solar installations will make fewer costly grid upgrades necessary, leading to additional savings. The study estimated a net benefit of $166 million over the lifetime of solar systems installed through 2016. Furthermore, due to changes to utility incentives and net-metering policies in Nevada starting in 2014, solar customers would not be significantly shifting costs to other ratepayers.

• A 2014 study commissioned by the Mississippi Public Services Commission concluded that the benefits of implementing net metering for solar PV in Mississippi outweigh the costs in all but one scenario. The study found that distributed solar can help avoid significant infrastructure investments, take pressure off the state's oil and gas generation at peak demand times, and lower rates. (However, the study also warned that increased penetrations of distributed solar could lead to lower revenues for utilities and suggested that the state investigate Value of Solar Tariffs, or VOST, and other alternative valuations to calculate the true cost of solar.)

• In 2014 Minnesota’s Public Utility Commission approved a first-ever statewide “value of solar” methodology which affirmed that distributed solar generation is worth more than its retail price and concluded that net metering undervalues rooftop solar. The “value of solar” methodology is designed to capture the societal value of PV-generated electricity. The PUC found that the value of solar was at 14.5 cents per kilowatt hour (kWh)—which was 3 to 3.5 cents more per kilowatt than Xcel's retail rates—when other metrics such as the social cost of carbon, the avoided construction of new power stations, and the displacement of more expensive power sources were factored in.

• Another study commissioned by the Maine Public Utility Commission in 2015 put a value of $0.33 per kWh on energy generated by distributed solar, compared to the average retail price of $0.13 per kWh — the rate at which electricity is sold to residential customers as well as the rate at which distributed solar is compensated. The study concludes that solar power provides a substantial public benefit because it reduces electricity prices due to the displacement of more expensive power sources, reduces air and climate pollution, reduces costs for the electric grid system, reduces the need to build more power plants to meet peak demand, stabilizes prices, and promotes energy security. These avoided costs represent a net benefit for non-solar ratepayers.

These generally positive PUC conclusions about the benefits of net metering have been supported by research done by a national lab and several think tanks. Important lab research has examined how substantially higher adoption of distributed resources might look.

In a forward-looking analysis of the financial impacts of net-metered energy on utilities and ratepayers, Lawrence Berkeley National Lab found that while high use of net-metered solar generation may decrease utility shareholders' earnings, it will have a "relatively modest" impact on ratepayers. The report examined solar penetration levels that are "substantially higher than [those that] exist today" — 10 percent compared to today's 0.2 percent — and concluded that “even at penetration levels significantly higher than today, the impacts of customer-sited PV on average retail rates may be relatively modest." The report further said that utilities and regulators "may have sufficient time to address concerns about the rate impacts of PV in a measured and deliberate manner"

Similarly, a growing number of academic and think tank studies have found that solar energy is being undervalued and that it delivers benefits far beyond what solar customers are receiving in net-metering credits:

• For instance, a review of 11 net metering studies by Environment America Research and Policy Center has found that distributed solar offers net benefits to the entire electric grid through reduced capital investment costs, avoided energy costs, and reduced environmental compliance costs. Eight of the 11 studies found the value of solar energy to be higher than the average local residential retail electricity rate: The median value of solar power across all 11 studies was nearly 17 cents per unit, compared to the nation’s average retail electricity rate of about 12 cents per unit.

• A 2015 cost-benefit study of net metering in Missouri by the Missouri Energy Initiative found that even accounting for increased utility administrative costs and the shifting of some fixed expenses, net metering is a net benefit for all customers regardless of whether they have rooftop solar. The study used values for two kinds of costs and two benefits and concluded that net metering’s “net effect” is positive. The typical solar owner pays only 20 percent less in fixed grid costs and costs the utility an estimated $187 per interconnection. Meanwhile, solar owners benefit the system through reduced emissions and energy costs.

• Likewise, a study by Acadia Center found the value of solar to exceed 22 cents per kWh of value for Massachusetts ratepayers through reduced energy and infrastructure costs, lower fuel prices, and lowering the cost of compliance with the Commonwealth's greenhouse gas requirements. This value was estimated to exceed the retail rate provided through net metering.

• In yet another study, researchers at the University at Albany, George Washington University, and Clean Power Research have found that solar installations in New York deliver between 15 and 40 cents per kWh to ratepayers. The study noted that these numbers provide economic justification for the existence of incentives that transfer value from those who benefit from solar electric generation to those who invest in solar electric generation.

In short, while the conclusions vary, a significant body of cost-benefit research conducted by PUCs, consultants, and research organizations provides substantial evidence that net metering is more often than not a net benefit to the grid and all ratepayers.

As to the takeaways, they are quite clear: Regulators and utilities need to engage in a broader and more honest conversation about how to integrate distributed-generation technologies into the grid nationwide, with an eye toward instituting a fair utility-cost recovery strategy that does not pose significant challenges to solar adoption.

From the state PUCs’ perspective, until broad changes are made to the increasingly outdated and ineffective standard utility business model, which is built largely around selling increasing amounts of electricity, net-metering policies should be viewed as an important tool for encouraging the integration of renewable energy into states’ energy portfolios as part of the transition beyond fossil fuels. To that end, progressive regulators should explore and implement reforms that arrive at more beneficial and equitable rate designs that do not prevent solar expansion in their states. The following reforms range from the simplest to the hardest:

• Adopt a rigorous and transparent methodology for identifying, assessing, and quantifying the full range of benefits and costs of distributed generation technologies. While it is not always possible to quantify or assess sources of benefits and costs comprehensively, PUCs must ensure that all cost-benefit studies explicitly decide how to account for each source of value and state which ones are included and which are not. Currently methodological differences in evaluating the full value of distributed generation technologies make comparisons challenging. States start from different sets of questions and assumptions and use different data. For instance, while there is consensus on the basic approach to energy value estimation (avoided energy and energy losses via the transmission and distribution system), differences arise in calculating other costs and benefits, especially unmonetized values such as financial risks, environmental benefits, and social values. In this regard, the Interstate Renewable Energy Council’s “A Regulator’s Guidebook: Calculating the Benefits and Costs of Distributed Solar Generation” and the National Renewable Energy Laboratory’s “Methods for Analyzing the Benefits and Costs of Distributed Photovoltaic Generation to the U.S. Electric Utility System” represent helpful resources for identifying norms in the selection of categories, definitions, and  methodologies to measure various benefits and costs.

• Undertake and implement a rigorous, transparent, and precise “value of solar” analytic and rate-setting approach that would compensate rooftop solar customers based on the benefit that they provide to the grid. Seen as an alternative to ‘traditional’ net-metering rate design, a “value of solar” approach would credit solar owners for (1) avoiding the purchase of energy from other, polluting sources; (2) avoiding the need to build additional power plant capacity to meet peak energy needs; (3) providing energy for decades at a fixed prices; and (4) reducing wear and tear on the electric grid. While calculating the “value of solar” is very complex and highly location-dependent, ultimately PUCs may want to head toward an approach that accurately reflects all benefits and costs from all energy sources. Value of solar tariffs are being used in Austin, Texas (active use) and Minnesota (under development).

• Implement a well-designed decoupling mechanism that will encourage utilities to promote energy efficiency and distributed generation technologies like solar PV, without seeing them as an automatic threat to their revenues. As of January 2016, 15 states have implemented electric decoupling and eight more are considering it. Not surprisingly, it is states that have not decoupled electricity (such as Nevada) that are fighting net metering the hardest. Typically, decoupling has been used as a mechanism to encourage regulated utilities to promote energy efficiency for their customers. However, it can also be used as a tool to incentivize net metering by breaking the link between utility profits and utility sales and encouraging maximum solar penetration. Advocates of decoupling note that it is even more effective when paired with time-of-use pricing and minimum monthly billing.

• Move towards a rate design structure that can meet the needs of a distributed resource future. A sizable disconnect is opening between the rapidly evolving new world of distributed energy technologies and an old world of electricity pricing. In this new world, bundled, block, “volumetric” pricing—the most common rate structure for both residential and small commercial customers—can no longer meet the needs of all stakeholders. The changing grid calls, instead, for new rate structures that respond better to the deployment of new grid technologies and the proliferation of myriad distributed energy resources, whether solar, geothermal, or other.  A more sophisticated rate design structure, in this regard, would take into consideration three things: (1) the unbundling of rates to specifically price energy, capacity, ancillary services,  and so on; (2) moving from volumetric bloc rates to pricing structures that recognize the  variable time-based value of electricity generation and consumption (moving beyond just peak versus off-peak pricing to  fully real-time pricing); and (3) moving from pricing that treats all customers equally to a pricing structure that more accurately compensates for unique, location-specific and technology specific values.

• Move towards a performance-based utility rate-making model for the modern era. Performance based regulation (PBR) is a different way of structuring utility regulation designed to align a utility’s financial success with its ability to deliver what customers and society want. Moving to a model that pays the utility based on whether it achieves quantitatively defined outcomes (like system resilience, affordability, or distributed generation integration) can make it profitable for them to pursue optimal grid solutions to meet those outcomes. The new business model would require the PUC and utilities to make a number of changes, including overhauling the regulatory framework, removing utility incentives for increasing capital assets and kilowatt hours sold, and replacing those incentives with a new set of performance standard metrics such as reliability, safety, and demand-side management. New York’s Reforming the Energy Vision  proceeding is the most high-profile attempt in the country to implement a PBR model.

Options also exist for utilities to address the challenges posed by net metering:

• Utilities, most notably, have the opportunity to adjust their existing business models by themselves owning and operating distributed PV assets (though not to the exclusion of other providers).  On this front, utilities could move to assemble distributed generation systems, such as for rooftop solar, and sell or lease them to homeowners. In this regard, utilities have an advantage over third-party installers currently dominating the residential rooftop solar industry due to their proprietary system knowledge, brand recognition, and an existing relationship with their customers. Utilities in several states such as Arizona, California, and New York are investigating or have already invested in the opportunity.

• Furthermore, utilities can also push the envelope on grid modernization by investing in a more digital and distributed power grid that enables interaction with thousands of distributed energy resources and devices.

Ultimately, distributed solar is here to stay at increasing scale, and so state policies to support it have entered an important new transitional phase. More and more states will now likely move to update their net-metering policies as the cost of solar continues to drop and more homeowners opt to install solar panels on their homes.

As they do that, states need to rigorously and fairly evaluate the costs and benefits posed by net metering, grid fees, and other policies to shape a smart, progressive regulatory system that works for all of the stakeholders touched by distributed solar.

Utilities should have a shot at fair revenues and adequate ratepayers. Solar customers and providers have a right to cost-effective, reliable access to the grid. And the broader public should be able to expect a continued solar power boom in U.S. regions as well as accelerated decarbonization of state economies. All of which matters intensely. As observes the North Carolina Clean Energy Technology Center and Meister Consultants Group: “How key state policies and rates are adapted will play a significant role in determining the extent to which the [solar PV] industry will continue to grow and in what markets.”

On Tuesday, May 24, Nigerian Central Bank Governor Godwin Emefiele announced that the country will adopt a more flexible foreign exchange rate system in the near future. This move signals a major policy shift by Emefiele and President Muhammadu Buhari, who had until this point opposed calls to let the naira weaken. Many international oil-related currencies have depreciated against the dollar as oil prices began their decline in 2014. Nigeria, however, has held the naira at a peg of 197-199 per U.S. dollar since March 2015, depleting foreign reserves and deterring investors, who remain concerned about the repercussions of a potential naira devaluation. Following the announcement, Nigerian stocks jumped to a five-month high and bond prices rose in anticipation that a new flexible exchange rate regime would increase the supply of dollars and help attract foreign investors.

For now it remains unclear exactly what a more flexible system will entail for Nigeria, however, some experts suggest that the Central Bank may introduce a dual-rate system, which allows select importers in strategic industries to access foreign currency at the current fixed rate, while more generally foreign currency will be available at a weaker, market-related level. This new regime raises a number of questions, including how it will be governed and who will have access to foreign currency (and at what rate). On Wednesday, Nigeria’s parliament requested a briefing soon from Emefiele and Finance Minister Kemi Adeosun to provide additional clarity on the new system, although the date for such a meeting has not yet been set.

Earlier this month, Kenya announced plans to close the Dadaab refugee camp, located in northeast Kenya, amid security concerns. The move to close the camp has been widely criticized by international actors. United States State Department Press Relations Director Elizabeth Trudeau urged Kenya to “uphold its international obligations and not forcibly repatriate refugees.” The United Nations High Commissioner for Refugees stated that the closure of the refugee camp would have “devastating consequences.” Despite these concerns, this week, at the World Humanitarian Summit, Kenya stated that it will not go back on its decision and confirmed the closure of the refugee camps within a six-month period.

The camp houses 330,000 refugees, a majority of whom fled from conflict in their home country of Somalia. Kenya insists that the camp poses a threat to its national security, as it believes the camp is used to host and train extremists from Somalia’s Islamist group al-Shabab. Kenya also argued that the developed world, notably the United Kingdom, should host its fair share of African refugees. This is not the first time Kenya has threatened to close the refugee camp. After the Garissa University attacks last April, Kenya voiced its decision to close the refugee camps, although it did not follow through with the plan.

From May 23-27, Lusaka, Zambia hosted 5,000 delegates and participants for the 2016 Annual Meetings of the African Development Bank (AfDB), with the theme, “Energy and Climate Change.” Held in the wake of December’s COP21 climate agreement and in line with Sustainable Development Goals 7 (ensure access to affordable, reliable, sustainable and modern energy for all) and 13 (take urgent action to combat climate change and its impacts), the theme was timely and, as many speakers emphasized, urgent. Around 645 million people in Africa have no access to electricity, and only 16 percent are connected to an energy source. To that end, AfDB President Akinwumi Adesina outlined the bank’s ambitious aim: “Our goal is clear: universal access to energy for Africa within 10 years; Expand grid power by 160 gigawatts; Connect 130 million persons to grid power; Connect 75 million persons to off grid systems; And provide access to 150 million households to clean cooking energy."

As part of a push to transform Africa’s energy needs and uses, Rwandan President Paul Kagame joined Kenyan President Uhuru Kenyatta on a panel to support the AfDB’s “New Deal on Energy” that aims to deliver electricity to all Africans by 2025. Kenyatta specifically touted the potential of geothermal energy sources. Now, 40 percent of Kenya's power needs come from geothermal energy sources, he said, but there is still room for improvement—private businesses, which make up 30 percent of Kenya’s on-grid energy needs, have not made the switch yet.

As part of the meetings, the AfDB, the Organization for Economic Cooperation and Development (OECD), and United Nations Development Program (UNDP) also launched their annual African Economic Outlook, with the theme “Sustainable Cities and Structural Transformation.” In general, the report’s authors predict that the continent will maintain an average growth of 3.7 percent in 2016 before increasing to 4.5 percent in 2017, assuming commodity prices recover and the global economy improves.  However, the focus was on this year’s theme: urbanization. The authors provide an overview of urbanization trends and highlight that successful urban planning can discourage pollution and waste, slow climate change, support better social safety nets, enhance service delivery, and attract investment, among other benefits.

For more on urbanization in sub-Saharan Africa, see Chapter 4 of Foresight Africa 2016: Capitalizing on Urbanization: The Importance of Planning, Infrastructure, and Finance for Africa’s Growing Cities.

Introduction

The global community has set itself the challenge of meeting the Millennium Development Goals (MDGs) by 2015 as a way to combat world poverty and hunger. In 2007, the halfway point, it is clear that many countries will not be able to meet the MDGs without undertaking significantly greater efforts. One constraint that needs to be overcome is that development interventions—projects, programs, policies—are all too often like small pebbles thrown into a big pond: they are limited in scale, short-lived, and therefore have little lasting impact. This may explain why so many studies have found that external aid has had weak or no development impact in the aggregate, even though many individual interventions have been successful in terms of their project- or program-specific goals.

Confronted with the challenge of meeting the MDGs, the development community has recently begun to focus on the need to scale up interventions. Scaling up means taking successful projects, programs, or policies and expanding, adapting, and sustaining them in different ways over time for greater development impact. This emphasis on scaling up has emerged from concern over how to deploy and absorb the substantially increased levels of official development assistance that were promised by the wealthy countries at recent G8 summits. A fragmented aid architecture complicates this task; multilateral, bilateral, and private aid entities have multiplied, leading to many more—but smaller— aid projects and programs and increasing transaction costs for recipient countries. In response, some aid donors have started to move from project to program support, and in the Paris Declaration, official donors committed themselves to work together for better coordinated aid delivery.

The current focus on scaling up is not entirely new, however. During the 1980s, as nongovernmental organizations (NGOs) increasingly began to engage in development activities, scaling up emerged as a challenge. NGO interventions were (and are) typically small in scale and often apply new approaches. Therefore, the question of how to replicate and scale up successful models gained prominence even then, especially in connection with participatory and community development approaches. Indeed, the current interest among philanthropic foundations and NGOs in how to scale up their interventions is an echo of these earlier concerns.

In response to this increased focus on scaling up—and its increased urgency—this policy brief takes a comprehensive look at what the literature and experience have to say about whether and how to scale up development interventions.

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Abstract

Scaling up of development interventions is much debated today as a way to improve their impact and effectiveness. Based on a review of scaling up literature and practice, this paper develops a framework for the key dynamics that allow the scaling up process to happen. The authors explore the possible approaches and paths to scaling up, the drivers of expansion and of replication, the space that has to be created for interventions to grow, and the role of evaluation and of careful planning and implementation. They draw a number of lessons for the development analyst and practitioner. More than anything else, scaling up is about political and organizational leadership, about vision, values and mindset, and about incentives and accountability—all oriented to make scaling up a central element of individual, institutional, national and international development efforts. The paper concludes by highlighting some implications for aid and aid donors.

An annotated bibliography of the literature on scaling up and development aid effectiveness was created by Oksana Pidufala to supplement this working paper. Read more »

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Recent political movements within the United States have raised concerns about the health of American democracy. With hyper-partisanship dividing the country and Donald Trump—the most unlikely, unsuitable, and unpopular presidential nominee of a major party in American history—securing the Republican nomination, the question emerges of whether democracy in America has gone awry.  And if so, is it too much or too little democracy that’s to blame?

To help address those questions, in this paper, Thomas E. Mann summarizes and discusses the findings of Christopher Achen and Larry Bartels’ ambitious treatise on American democracy: “Democracy for Realists.” Achen and Bartels contend that the traditional conception of voters as rational, attentive decision-makers does not hold against empirical evidence. Instead, voters are best understood as members of partisan groups, which influence their perception of candidates, issues, and even simple facts. According to Achen and Bartels, perceived social identities drive voting decisions, rather than rationality.

Mann notes that most scholars would agree that voters do not follow the expectations of idealistic models, but draws attention to competing theories that are far less damning to voters’ rationality. In particular, the research of Paul Sniderman and Arthur Lupia suggests that voters are far more capable than Achen and Bartels would assert. In their view, voters have enough rationality and information to ensure a well-functioning democracy.

As Mann summarizes the arguments:  Achen and Bartels believe that citizens and elections are held to impossible, idealistic standards in the folk theory of democracy, which perpetuates myths and works against government responsiveness. Sniderman and Lupia, on the other hand, are offended by those who dismiss citizens as ignorant and incompetent; they seek to defend voters’ dignity and demonstrate the rationality and efficacy of their behavior in American democracy.

What does this scholarship tell us about the coming presidential election, and the future of American democracy?  Ultimately, Mann concludes that Achen and Bartel’s perspective is not anti-democratic, even if it is built on a belief that too much importance is placed on the often random and myopic outcomes of elections.  Instead, Mann believes that “Democracy for Realists” reveals the real democratic deficit facing America is one stemming not from too much democracy, but  from “asymmetry in political resources and representation of different segments of American society.” Truly understanding this problem and its root cause is a step toward strengthening American democracy. 

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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

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Editor’s note: This post is adapted from a forthcoming full-length case study; the second in a series from the Engelberg Center’s Merkin Initiative on Physician Payment Reform and Clinical Leadership designed to support clinician leadership of health care delivery, payment, and financing reform. The case study will be presented during the Merkin Initiative’s “MEDTalk” event on July 9 from 10:30 AM to 12:30 PM EDT, featuring live story-telling and knowledge-sharing from patients, providers, and policymakers.

Oncology practices and hospitals across the nation struggle with providing sustainable, comprehensive, and coordinated cancer care. Clinical leaders with strategies and models to improve the quality and value of health care often don’t know how to navigate the landscape of payment and delivery reform options to sustain their innovations.

We use a case study approach to investigate and tell the story of the New Mexico Cancer Center (NMCC), an independent cancer center that is experimenting with innovative ways to improve patient-centered oncology care. We identify challenges for creating sustainable and supportive payments models, and we share the broader strategic and policy lessons for adopting alternative payment models.

The Clinical Scenario: Living With Cancer

Vicky Bolton, a 58-year-old full-time medical legal coordinator from Albuquerque, has stage 4 adenocarcinoma lung cancer. She started chemotherapy in 2003 and has consistently received treatments over the last 11 years. Vicky is one of 13 million Americans currently living with cancer, with more than 1.6 million new diagnoses added each year.

Although Vicky’s condition is currently stable, she is at high risk for venous thrombosis (blood clots), life-threatening infections, and other complications, which put her at high risk for repeated hospitalizations. In the past six months, she has taken advantage of “after hours” care on three occasions as an outpatient at NMCC. Fortunately, each of her providers and services — oncology, radiation therapy, labs, x-rays, and internal medicine — are centralized in a single location at NMCC, reducing the need for emergency room (ER) visits or hospitalizations for these episodes.

The Challenge: Controlling Spending While Improving Patient-Centered Care

Cancer is the second leading cause of death in the U.S. Forty-one percent of Americans will be diagnosed with cancer during their lives. Cancer care is also expensive, accounting for $125 billion of total health care spending annually. In 2011, Medicare alone spent nearly $35 billion in fee-for-service (FFS) payments for cancer care, representing 9 percent of all Medicare FFS payments.

The high costs of cancer care are driven by issues that plague the entire health system: uncoordinated care delivery, duplication of services, fragmentation, and volume-based payments. A common impact of these drivers in oncology is the use of the ER to relieve symptoms associated with adverse effects of chemotherapy or other treatments that can also result in hospitalization.

For example, research shows that the most common reasons for cancer patient ER admissions are pain, respiratory distress, nausea, and vomiting. More than half of the ER visits occurred on weekends or in the evening, and over 60 percent resulted in hospital admission. This suggests that if a patient’s symptoms could be managed at home or in the community, costly hospital admissions could be avoided. ER visits, where patients are exposed to germs and infections as they wait — often hours — to be admitted, can have catastrophic outcomes for patients that are actively in treatment since they have weakened immune systems and are more prone to infections.

In addition to the inherent issues with fee-for-service (FFS) payments — with payments incentivizing volume of procedures rather than the value of care delivered — the current payment system further exacerbates problems: If a practice provides higher-value care to patients at a lower cost to the overall system (that is, they perform fewer services and have lower revenue), the financial winner is the payer who reimburses fewer services, not the practice (which merely has less revenue). This combination of the misaligned incentives of FFS and the lack of financial benefit for improving care while reducing costs means that many practices simply cannot afford to make the transformations needed without other funding mechanisms.

The Real World: How Has An Independent Cancer Center Responded To These Challenges?

NMCC delivers care to roughly 2,700 patients and provides care to one in three New Mexicans with cancer. The changes that the center has made have focused on reducing the impact of fragmentation of care on their patients (Table 1).

A key innovation was enhancing comprehensive after-hours and weekend care on site and creating a telephone and urgent care triage program to avoid expensive emergency room and inpatient care, which NMCC termed the COME HOME model.

As part of its redesign process in 2012, NMCC – along with six community oncology practices — secured a $20 million Center for Medicare and Medicaid Innovation (CMMI) Health Care Innovation Award (HCIA), for a three-year period. The award has an explicit aim of reducing ER visits by 50 percent and hospitalizations by 20 percent to justify the program costs.

Table 1: Care Redesign Elements Undertaken by NMCC

The Key Levers: How Can COME HOME Be Sustained?

On the heels of the Affordable Care Act (ACA) and numerous quality and payment focused initiatives in the private sector, health care organizations need to enhance the competitiveness and efficiency of their systems in the marketplace.

Alternative payment models (APMs) such as Accountable Care Organizations (ACOs), bundled payments, and patient-centered oncology medical homes (PCOMH) are just a few of the initiatives supported by public and private payers to align care redesign and payment reform and encourage continuous improvement. (Clinical pathways, a strategy recently embraced by WellPoint, offer PCOMH-like incentives to encourage adherence to practice guidelines, a strategy primarily geared to encourage higher-value chemotherapy practice.)

Broader or larger case-based payments may also provide stronger incentives to limit costs, to help assure that promising delivery reforms actually lead to cost reduction, but this exposes oncologists to greater levels of financial risk, as shown in Table 2. Consequently, implementing payment reforms that are viewed as feasible and desirable by both providers and payers is difficult.

Table 2: Comparison of Alternative Payment Models for Oncology

The Path Ahead: How Can These Models Assist NMCC?

NMCC currently receives approximately $70,000 per month from the CMMI grant and has not yet identified a clear strategy to sustain the delivery reforms in the COME HOME care model past the end of the grant (July 2015). As for payment reform options, NMCC has been unable to contract as part of a comprehensive ACO due to local health care market conditions.

Clinical pathways are geared primarily to guidelines and chemotherapy adherence, and are not designed to provide funding for after-hours care or triage programs that are intended to achieve offsetting savings through avoiding costly complications. Possible remaining options include:

• PCOMH: Using the data it gathers, NMCC intends to quantify the additional costs the COME HOME model requires, and the savings that it achieves. Based on that estimate, NMCC could suggest a per-member per-month (PMPM) payment from a private insurer to cover the costs of providing higher quality care. To encourage participation, NMCC could also enter into a risk-sharing agreement, in which overall costs of inpatient care and ER visits would be compared against a target. The PMPM payment could be at-risk if the targets are not achieved after a certain period of time.

• Bundled Payments: NMCC could potentially use the medical home approach with risk sharing (described above) as a first, interim step toward a bundled payment system, NMCC’s long-term preferred model. Computing actuarially sound expected costs for the bundled payments would require merging claims data with clinical data (for example, ICD-9 codes fail to distinguish between subtypes of breast cancer that have radically different treatments). A bundled payment pilot might be performed for high volume cancers, such as breast and lung.

Lessons Learned

The experience of innovative pioneers like NMCC can shed some light on potential barriers to conceptualizing and implementing sustainable clinical redesign. The lessons learned have been sorted into three main categories: relationships with payers and networks, payment model selection, and data collection and quality improvement considerations.

Relationships with payers and networks. Though counterintuitive, merely demonstrating significant value from care design, perhaps from lower utilization of inpatient and emergency department utilization, does not automatically create a financial pathway for sustainable delivery reform. To do so, innovative providers should consider involving lead payer partners early on to help identify end-points of interest to payers and potential payment strategies that may emerge later.

Providing support for health care delivery reforms requires new activities by payers towards aligning their payments with value, rather than volume and intensity of services. However, fragmented health care markets face the challenge of the “free rider” problem: payers may be unwilling to shoulder delivery transformation costs that may benefit other payers’ clients while they wait for CMS or others to make the financial investment, pay for the program evaluation, and enact policy change). Other challenges include payer inertia and long lag times between care redesign and subsequent data demonstrating results.

Large ACOs and other integrated payer-provider plans, including those large enough to form Medicare Advantage plans, are moving forward on negotiating payment and delivery reforms. This may be more difficult for innovative, smaller practices, even if they can provide higher-value clinical services. In turn, this may have anti-competitive consequences, such as discouraging delivery innovation that leads to “demand destruction” of high-cost hospital-based services. Private and public payers should be particularly interested in developing models that enable smaller, specialized providers like oncology practices to undertake key delivery reforms.

Sustainable Payment Model Selection. While substantial attention has been paid to primary care focused APMs, specialty-focused APMs are needed for practices like NMCC. Their development should be a high priority for public and private payers. Clinical transformation grants, such as those offered by CMMI, should include clear pathways for transitioning to APMs if initial cost savings targets or projections are met. Otherwise, delivery system innovations are at high risk of failure despite evidence of improved value.

Data Collection and Quality Improvement Considerations. Timely sharing of actionable information from claims and other administrative data remains a major challenge, with complex and varied procedures for obtaining claims from payers; smaller practices are particularly challenged in interpreting the claims data. Some states, such as Maryland, Massachusetts, Vermont, and Colorado (among others) are proceeding with creating all-payer claims databases. (Maryland, for example, offers almost instantaneous provider feedback from claims through their CRISP database.)

Others, such as Minnesota, are using “distributed” approaches in which multiple payers and systems produce measures in consistent ways. As NMCC’s early efforts illustrate, practices can produce more clinically sophisticated performance measures. Strategies to achieve consistent methods for sharing key data on cost and quality need to be expanded to encourage quality improvement and payment reform.

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

Abstract

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

Call to Action: The Importance of Expanded Access Programs

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

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

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

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

Laying the Groundwork with Shared Experiences

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

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

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

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

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

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

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

Development of Structural Principles: The Four A's 

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

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

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

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

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

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

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

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

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

Regulatory Considerations

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

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

An Expanded Role for the FDA

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

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

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

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

Next Steps

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

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

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

References

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• The Four A's of Expanded Patient Access

It is well recognized across the health care industry that the major goals of the Affordable Care Act (ACA) include not only expanding health insurance coverage, but also improving the quality of care and the patient health care experience. A key strategy in achieving these goals is improving the efficiency and delivery of care through innovative financing mechanisms and new delivery models, such as Accountable Care Organizations (ACOs), patient-centered medical homes (PCMHs), bundled payments for acute and post-acute care, and population-based models that aim to improve the health of entire communities. These alternative models emphasize quality and outcomes, while moving care away from the traditional and predominant method of fee-for-service (FFS).¹

The Frontline Work Force
Many conversations focused on the implementation of these models typically emphasize the role of physicians. However, the success of these models relies heavily on the support and manpower of a multidisciplinary team; particularly "frontline health care workers." Frontline workers may include medical assistants (MAs), medical office assistants, pharmacy aides, and health care support workers. Oftentimes, they provide routine, critical care that does not require post-baccalaureate training.²

For example, MAs can play an important role in a medical home model. Upon discharge from the hospital, frontline workers can provide direct outreach to patients that are at high risk for readmission, and discuss any lingering symptoms, worsening of conditions, or medication issues. If necessary, MAs can assign a high-risk patient to a social worker, care coordinator or nurse.³

In a team care environment, frontline health care workers are essential for taking over routine tasks and allowing physicians to employ their specialized skills on their most complex patient cases, which allows all team members to work at “the top of their license”.⁴ Frontline workers can also bridge the gap between patients and a multitude of providers and specialists; help deliver care that is culturally and linguistically appropriate; and provide critical patient education and outreach outside of regular office visits. 

A Workforce in Need of Reform
While team-based care is widely accepted as an industry norm, its current infrastructure is not well-supported. While the frontline workforce represents nearly half of all health care professionals, they are markedly underpaid, underappreciated, and lack formal training to transition into higher-skilled and/or higher paid positions.

A recent study by the Brookings Metropolitan Policy Program “Part of the Solution: Pre-Baccalaureate Healthcare Workers in a Time of Health System Change” demonstrates this glaring disparity between current frontline workforce investment and its value to health reform efforts. The study analyzes the characteristics of the top ten ‘pre-baccalaureate health care workers’ (staff that holds less than an associate’s degree) within the US’s one-hundred largest metropolitan areas (see Table 1).

Table 1: Top ten pre-baccalaureate health care workers in the US’s top one-hundred metropolitan areas

Personal care aides represent a striking example of the underinvestment in frontline workers. The study shows that personal care aides have the lowest levels of educational attainment compared to their peers (32% have no more than a high school diploma), and have the lowest median earnings ($20,000 annually). Meanwhile, The Center for Health Workforce Studies’ (CHWS) estimates that this profession is among the top three national occupations with the highest projected job growth between 2010 and 2020. They are also in highest demand: between 2010 and 2020 there will be an estimated 600,000 personal aide vacancies.⁵ According to this study, MAs are also among the least educated and lowest paid frontline professions. Ninety percent lack a bachelor’s degree and a significant share (29%) are classified as ‘working poor.’

Policy Solutions

A number of policy solutions can be applied to enhance the frontline worker infrastructure. Our recommendations include:

Invest in front line health care workforce training and education. Case studies from a recent Engelberg Center toolkit, outlines how providers are training their frontline workforce to master fundamental skills including care management, patient engagement, teamwork, and technological savviness.

For example, a New Jersey ACO carried out clinical transformation by investing in new frontline staff, and by redefining the role of medical assistants to include health coaching. The return on investment for employers is potentially large. After injecting a substantial initial investment into this project, this ACO saw a 12.3% decrease in net health care costs within the first year of the program’s implementation; as well as significantly improved efficiency, quality of care and patient experience. As the educational curricula for frontline professions are largely variable, more attention should also be spent on the quality of educational content to train these occupations, as well as on developing an understanding of how delivery systems are augmenting traditional educational curricula.

2. Active inclusion of frontline health care workers in payment reform. Although the services of frontline health care workers are beginning to play a role in new payment models, typically frontline staff does not benefit directly from any bonus payments or shared savings incentives. However, their increasingly valuable role in the care team may warrant allowing frontline health care staff to be included in the receipt of shared savings and/or bonus payments based on the achievement of specifically tailored performance and outcomes targets.

The increasing demand for frontline health care workers, driven in part by the ACA’s payment and delivery reforms, will likely spell out a brighter future for these occupations, whose services had routinely been undervalued and underpaid. Future policy efforts should be focused on extending educational grants that have been aimed at primary care and nursing to frontline workers, as well as considering dedicating portions of shared savings to enhancing the earning potential for frontline workers. Some efforts, such as the U.S. Department of Labor’s recent rule to grant wage and overtime protections to home health and personal care aides, are early suggestions of a shift toward greater respect and empowerment for these occupations. It is yet to be seen what effects the continuation of such efforts will have on their high projected attrition trends.

Event Information

The Brookings Institution and the American Enterprise Institute (AEI) collaborated to ask: if you were to redesign Medicare without spending more money, what would you keep and what would you change? A new report on a Center for Healthcare Decisions program provided insight into the public’s willingness to restructure Medicare in the face of tightening budget constraints. Using an interactive, computer-based system, program participants faced the challenge of making Medicare more responsive to the needs of current and future beneficiaries.

Were participants willing to accept limits on their choice of provider or reduced coverage of low-value medical care? Would they accept the need for greater personal responsibility in their use of health services? Would they agree that Medicare should adopt other policies to promote fiscal responsibility?

Watch event video.