Saudi deputy crown prince and defense minister Mohammad bin Salman is just wrapping up a heavily hyped visit to Washington, aimed at reinforcing the kingdom’s partnership with the United States. Recent years have frayed what is traditionally the central strategic relationship for Riyadh, principally over the Obama administration’s nuclear diplomacy with Iran.

Since the conclusion of the Iranian nuclear deal last July, the perennial antagonism between Riyadh and Tehran has reached a dangerous pitch, fueling the violence that rages in Syria, Iraq, and Yemen and the undercurrent of instability that saturates the region. And the fallout of their rivalry has left its mark well beyond the boundaries of the Gulf, exacerbating volatile energy markets and, by extension, the global economy. 

Within OPEC, Riyadh and Tehran are eyeing each other warily, and their continuing differences torpedoed a proposed ceiling on oil production at OPEC’s latest meeting. The outcome was not surprising; a similar effort to agree on a production freeze between the group and a handful of non-OPEC producers fizzled in April. In the meantime, any incentives for drastic measures to address soft oil prices have abated as oil prices creep back up to approximately $50 a barrel. 

Iran and Saudi Arabia have plenty of reasons to continue pumping for the foreseeable future. Since the lifting of nuclear-related sanctions in January, Iranian leaders have been determined to make up for lost time and lost revenues, already defying expectations by quickly raising production to levels that hadn’t been reached since November 2011 and aggressively cutting prices in hopes of winning back its pre-sanctions export market. 

The centrality of oil to the legitimacy and autonomy of both regimes means that these plans are little more than publicity stunts.

Meanwhile, Saudi Arabia appears prepared to continue pumping at record-high levels, part of a larger strategy aimed at maintaining market share and driving down non-OPEC production. The two states’ economic incentives are compounded by their fierce geostrategic and sectarian rivalry, which has intensified, as evidenced by the standoff over Iranian participation in the annual pilgrimage to Mecca.

But even as the two states duel over oil production and prices, both Saudi Arabia and Iran are conspicuously planning for a post-oil future. Leaders in both countries have decreed an end to the era of oil dependency, endorsing ambitious blueprints for restructuring their economies that—if implemented—would ultimately transform state, society, and the wider region. The centrality of oil to the legitimacy and autonomy of both regimes means that these plans are little more than publicity stunts. Still, just imagine for a moment what it would mean for Iran, Saudi Arabia, and the Middle East if these grandiose agendas were adopted.

Competing and complementary visions

Tehran’s plan actually dates back more than a decade, with the 2005 release of its “20 Year Perspective” (sometimes called “Vision 2025”). The plan laid out extravagant expectations: rapid growth and job creation, diversification away from oil, a knowledge-based economy. Intervening developments—sanctions that targeted Iran’s oil exports and helped expand non-oil trade—have only bolstered the rhetorical commitment of Iran’s supreme leader, Ayatollah Ali Khamenei, to a “resistance economy” in which oil exports constitute a minor part.

“One of our most serious losses is dependence on oil,” Khamenei bemoaned in a 2014 speech. “I am not saying that oil should not be used. Rather, I am saying that we should reduce our dependence on selling crude oil as much as we can.” 

Not to be outdone, Saudi Deputy Crown Prince Salman announced Saudi “Vision 2030,” to address what he described as “an addiction to oil.” The plan, which has met with equal doses of fanfare and skepticism since its announcement last month, aims to create a “thriving economy” and end Saudi dependence on oil revenues by 2020. Vision 2030 includes provisions to sell off a small stake in the kingdom’s state oil company, Saudi Aramco, and create the world’s largest sovereign wealth fund to manage the country’s income, as well as goals of creating 450,000 new private sector jobs, cutting public sector wages, and tripling the country’s non-oil exports all within the same abbreviated time frame.

Jeopardizing domestic stability

There is one hitch, however: these aspirations, though laudable, are preposterously unmoored from current political and economic exigencies. The institutions of governance and the structure of power in resource-rich states such as Saudi Arabia and Iran are organized around the state’s role as purveyors of vital social and economic goods. Riyadh and Tehran distribute cash handouts, provide jobs in already-bloated state bureaucracies, and levy few taxes. Diversifying away from reliance on oil would essentially require Riyadh and Tehran to radically curtail this distributive role, inviting historic social and political changes that could ultimately compromise regime ideology and weaken state legitimacy. 

[T]hese aspirations, though laudable, are preposterously unmoored from current political and economic exigencies.

In Saudi Arabia, the supply of these benefits is central to the monarchy’s legitimacy. To diversify away from oil, which currently accounts for over 70 percent of government revenues, Riyadh would have to drastically cut spending, far more than it already has. Not only would this further slash subsidies and hike fees, it would also effectively force Saudi workers—two-thirds of whom are employed by the state—to take up private sector jobs, 80 percent of which are currently staffed by expatriates. To accomplish this transition would require fundamental changes to the incentive structure for the Saudi labor force: a much broader willingness to accept low-skill, low-wage jobs, as well as the requisite improvements in education and productivity to support larger numbers of Saudi nationals moving into private sector positions.

For the Saudi economy to be truly competitive, Riyadh would have to initiate dramatic changes to a central component of the Saudi social compact—women’s rights and freedoms. The Vision 2030 document boasts that over 50 percent of Saudi university graduates are women and pledges to “continue to develop their talents, invest in their productive capabilities and enable them to strengthen their future and contribute to the development of our society and economy.” 

But the domestic Saudi labor force is overwhelmingly male, and even the plan’s modest aspirations to raise female participation in the workforce from 22 to 30 percent are likely to run into logistical and social obstacles. Shortly after announcing Vision 2030, Deputy Crown Prince Salman said Saudi Arabia is not yet ready to let women drive. A diversified economy will not emerge in the kind of constricted social environment mandated by the Saudi interpretation of sharia (Islamic law). 

Iran’s Islamic Republic doesn’t have the same degree of gender segregation, but Iran’s official interpretation of Islam has still constrained female participation in the workforce. Iran employs an equally low percentage of women—according to a 2014 U.N. report around 16 percent—and women’s unemployment is more than double that of men (nearly 20 percent).

A Saudi man walks past the logo of Vision 2030 after a news conference in Jeddah, Saudi Arabia June 7, 2016. Photo credit: Reuters/Faisal Al Nasser.

The bigger challenge for Iran will be truly opening up its economy to foreign direct investment. This remains hotly contested among the leadership, even in the aftermath of the nuclear agreement and the lifting of related sanctions. While there is some consensus around the need for foreign capital and technology, hardliners including Khamenei are determined to insulate Iran from any accompanying cultural influence and dependency. As the supreme leader recently inveighed, the global economy is “a plan and system that has been devised mainly by Zionist capitalists and some non-Zionists with the purpose of usurping the economic resources of the whole world...If a country merges its economy with the global economy, this is not a source of pride, rather it is a loss and a defeat!”

This deeply-rooted paranoia has provided a convenient platform for the Islamic Republic to galvanize citizens’ loyalty to the state and hostility to outside interference. And it also inhibits the liberalization that makes foreign investment possible: measures to enhance transparency and security, develop more attractive legal and fiscal frameworks, shrink the role of the state, and undertake an array of other structural reforms. Without these measures, Tehran will struggle to capitalize on its extraordinary reengagement with the world. 

While Saudi Arabia has maintained a more consistent and mutually beneficial pattern of foreign investment, its leadership too will have to revamp its approach if it is to broaden its economic base. For Riyadh, the challenge is less one of attracting foreign capital than of developing a sustainable influx of technology and expertise to develop sectors other than energy. The kingdom will also have to overcome serious regulatory hurdles and a proclivity for mammoth (and often white elephant) projects.

Compromising regional clout

Riyadh and Tehran will need to balance their economic aspirations and their approach to the region, too. Historically, their role in global energy markets has largely shielded both states from the fallout of regional instability. The world’s need for reliable oil at reasonable prices has inculcated the commitment of outside powers to secure transportation of resources and considerable autonomy for Riyadh and Tehran from the implications of their own policies. 

As a result, Saudi Arabia and Iran can fund nefarious activity across the region, violate the civil and human rights of their citizens and other residents, and carry out belligerent foreign policies without severe repercussions for their oil revenues. Only in the past five years has Tehran seen the limits of the world’s reluctance to jeopardize its investment with a major oil exporter; and the recent reversal of the U.N. condemnation regarding the Saudi-led coalition in Yemen demonstrates that Riyadh remains insulated.

Saudi Arabia and Iran can fund nefarious activity across the region, violate the civil and human rights of their citizens and other residents, and carry out belligerent foreign policies without severe repercussions for their oil revenues.

Regional developments make the prospect of economic diversification even less likely, as sensitivity to such developments will only increase if either country successfully develops its non-oil sectors. At the same time, regional stability is a basic prerequisite for economic diversification. Robust growth and good governance throughout the Middle East would provide the optimal context for the economic transformation of Iran and Saudi Arabia, since the marketplace for their non-oil exports is concentrated in the immediate neighborhood. But such transformation would require both countries to put economic priorities that serve their general populations above the ideological and religious agendas—supported by oil rents—that propel their regional and international influence and that provide a large portion of their autonomy in foreign policymaking. 

Technocrats in both countries understand this intuitively. At a 2015 conference on Iran’s economy, President Hassan Rouhani wondered “How long can the economy pay subsidies to politics?” He added that the country’s economy “pays subsidies both to foreign policy and domestic policy. Let us try the other way round for a decade and pay subsidies from the domestic and foreign policy to the economy to see [what] the lives and incomes of people and the employment of the youth will be like.” The problem, of course, is political will: neither country is prepared to elevate the interests of its people over the demands of ideology.

Imagining an unlikely future

Can either Iran or Saudi Arabia really kick the oil habit? It seems exceptionally unlikely. Even as Khamenei extols the need for inward-focused development, Tehran is racing to expand crude output level to four million barrels per day by March 2017. 

Oil enabled the creation of the modern Middle Eastern state and fueled the rise of both countries to regional predominance. Oil is a vector for their regional rivalry, and it provides prestige and funds to be used in other arenas of competition. A genuine diversification of the two largest economies in the Middle East and North Africa would jeopardize their revenue streams and domestic legitimacy, as well as their efforts to assert their primacy across the Islamic world.

[N]either country is prepared to elevate the interests of its people over the demands of ideology.

“All success stories start with a vision,” Deputy Crown Prince Salman is quoted as saying on the Vision 2030 website. But vision is insufficient to bridge the gap between aspiration and reality; a serious agenda to implement either the Saudi or the Iranian vision would require painful compromises to regime ideology and a fundamental overhaul of the institutions and the structure of power in both countries. 

Imagine, though, for a moment, that these far-fetched ambitions were quite serious, and that both the Saudi and Iranian leadership were determined to do what was necessary to truly wean their economies off oil dependence. Consider what it might mean for the region if these grandiose ambitions were not simply the illusions of overpriced consultants and embattled technocrats—if a leadership emerged in one or both of the Middle East’s most powerful actors prepared to invest political capital in a genuine transformation of priorities and policies. What might be possible if Tehran and Riyadh sought to compete for economic opportunities instead of fueling violence and sectarianism around the region? If instead of a vicious sectarian and geopolitical rivalry, these two old adversaries engaged in a race to the top?

What will it take to move these visions from wishful thinking to reality? More than rhetoric, to be sure. But even the articulation of improbable objectives will have its impact. As documented in a recent book, Iran’s post-revolutionary experience demonstrates that the regime’s reliance on promises of economic gains has generated public expectations for effective and accountable governance. Now Iranians and Saudis have been told by their leaders—who happen to be officially infallible—that the time has come to transcend oil. What might happen if they believe it?

The terrible attack in Nice on July 14—Bastille Day—saddened us all. For a country that has done so much historically to promote democracy and human rights at home and abroad, France is paying a terrible and unfair price, even more than most countries. My colleagues Will McCants and Chris Meserole have carefully documented the toll that France, and certain other Francophone countries like Belgium, have suffered in recent years from global terrorism. It is heart wrenching.

From what we know so far, the attack was carried out by a deeply distraught, potentially deranged, and in any case extremely brutal local man from Nice of Tunisian descent and French nationality. Marital problems, the recent loss of his job, and a general sense of personal unhappiness seem to have contributed to the state of mind that led him to commit this heinous atrocity. Perhaps we will soon learn that ISIS, directly or indirectly, inspired the attack in one way or another as well. My colleague Dan Byman has already tapped into his deep expertise about terrorism to remind us that ISIS had in fact encouraged ramming attacks with vehicles before, even if the actual manifestation of such tactics in this case was mostly new. 

This attack will again raise the question: Why France? On this point, I do have a somewhat different take than some of my colleagues. The argument that France has partly brought these tragedies upon itself—perhaps because of its policies of secularism and in particular its limitations on when and where women can wear the veil in France—strikes me as unpersuasive. Its logical policy implications are also potentially disturbing, because if interpreted wrongly, it could lead to a debate on whether France should modify such policies so as to make itself less vulnerable to terrorism. That outcome, even if unintended, could dance very close to the line of encouraging appeasement of heinous acts of violence with policy changes that run counter to much of what French culture and society would otherwise favor. So I feel the need to push back.

Here are some of the arguments, as I see them, against blaming French culture or policy for this recent string of horrible attacks including the Charlie Hebdo massacre, the November 2015 mass shootings in Paris, and the Nice tragedy (as well as recent attacks in Belgium):

• Starting with the simplest point, we still do not know much about the perpetrator of the Nice killings. From what we do surmise so far, personal problems appear to be largely at the root of the violence—different from, but not entirely unlike, the case with the Orlando shooter, Omar Mateen.
• We need to be careful about drawing implications from a small number of major attacks. Since 2000, there have also been major attacks in the Western world by extremist jihadis or takfiris in New York, Washington, Spain, London, San Bernardino, Orlando, and Russia. None of these are Francophone. Even Belgium is itself a mixed country, linguistically and culturally.
• Partly for reasons of geography, as well as history, France does face a larger problem than some other European countries of individuals leaving its country to go to Syria or Iraq to fight for ISIS, and then returning. But it is hardly unique in the scale of this problem.
• Continental Europe has a specific additional problem that is not as widely shared in the United Kingdom or the United States: Its criminal networks largely overlap with its extremist and/or terrorist networks. This point may be irrelevant to the Nice attack, but more widely, extremists in France or Belgium can make use of illicit channels for moving people, money, and weapons that are less available to would-be jihadis in places like the U.K. (where the criminal networks have more of a Caribbean and sub-Saharan African character, meaning they overlap less with extremist networks).
• Of course, the greatest numbers of terrorist attacks by Muslim extremists occur in the broader Muslim world, with Muslims as the primary victims—from Iraq and Syria to Libya and Yemen and Somalia to South Asia. French domestic policies have no bearing on these, of course.

There is no doubt that good work by counterterrorism and intelligence forces is crucial to preventing future attacks. France has done well in this regard—though it surely can do better, and it is surely trying to get better. There is also no doubt that promoting social cohesion in a broad sense is a worthy goal. But I would hesitate, personally, to attribute any apparent trend line in major attacks in the West to a particular policy of a country like France—especially when the latter is in fact doing much to seek to build bridges, as a matter of national policy, with Muslims at home and abroad. 

There is much more to do in promoting social cohesion, to be sure, even here in America (though our own problems probably center more on race than on religion at the moment). But the Nice attacker almost assuredly didn’t attack because his estranged wife couldn’t wear a veil in the manner and/or places she wanted. At a moment like this in particular, I disagree with insinuations to the contrary.

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

Downloads

• The Four A's of Expanded Patient Access

The consequences of the global financial crisis still ripple through the international system after the initial surge in global economic cooperation and governance immediately following the crisis. The ultimate effects have been that, while some elements of the international system of institutions have gotten stronger, the system as a whole is now seen as weaker, fractured, and driven more by geopolitical conflict than by institutional norms and frameworks.

The issue is how to move the global policy agenda forward in such a way that substantive progress induces institutional strengthening. The next two years offer new opportunities for creating a positive symbiosis between policy advance and systemic improvements.

I. The U.N. global agenda

The United Nations global agenda has three tracks that relate to each other and provide opportunities to pull the world together around an integrated, comprehensive strategic vision for the world’s people and strengthen the international system in the process.

The first track is the elaboration of a sustainable development agenda for each and all countries, not just developing countries, but advanced industrial economies and emerging market countries too. This effort is already well underway and will result in a summit of global leaders in September 2015 at the U.N. General Assembly (UNGA) in New York. This process entails a set of Sustainable Development Goals (SDGs) for 2030 to be developed and affirmed by and for all countries, and which succeed the Millennium Development Goals (MDGs) that culminate in 2015 and applied only to developing countries. This post-2015 goal-setting process will provide the substantive, cross-cutting, multidimensional agenda for the next 15 years. It is simultaneously a social, economic, and environmental agenda that relates goals to each other in functional terms requiring coordination among public and private sectors, ministries, civil society groups, and international institutions.

The second track is the financing for development (FFD) track, which goes well beyond reliance conceptually and practically on foreign aid or official development assistance as in the past. FFD for the SDGs includes a focus, first and foremost, on domestic sources of finance beyond government revenues. FFD is engaged in searches for innovative sources of finance, private sector mobilization of resources, creative market incentives and mechanisms, initiatives by civil society organizations, and development of entrepreneurial and small- and medium-size business opportunities that address global issues. This effort resulted in a global leaders meeting in Addis Ababa, Ethiopia in July of 2015 that reached agreement on the major thrusts for mobilizing resources for the post-2015 agenda (Kharas and MacArthur (2014)).

The third track is the global climate change negotiations currently under way to achieve a global agreement on the United Nations Framework Climate Change Convention (UNFCCC), which will result in a global summit in Paris in December of 2015. While these detailed negotiations on climate are a separate track, it is clear that the sustainable human development trajectories being put forward in the post-2015 agenda impact and are crucially affected by the efficacy of the climate change arrangements worked out in the UNFCCC agreements in 2015.

Whereas these three tracks operationally are going forward separately, the substantive aspects of each track affect and are affected by the content of the other two. The ultimate convergence of these three streams of activities and actions will have to occur in the beginning of 2016 at the global, regional, and national levels if the implementation phase is to be successful. A business-as-usual approach will not be satisfactory if at the global level, for example, the international institutions are unable to coordinate their work, or if at the national level ministries remain within their “silos” of sectoral expertise and responsibility.

Synergies exist between goal areas that cannot be realized without coordination across sectors and institutions, impacting goal achievement (see OECD 2014 PCD). A systemic approach is necessary at all levels to address the global challenges identified in the post-2015 agenda.

II. The G-20 summits for 2015 and 2016

A major opportunity presents itself in terms of providing impetus, momentum, and leadership for these large work streams and their convergence by linking the G-20 presidency of Turkey for 2015 with the G-20 leadership of China in 2016. Turkey and China working together in tandem within the G-20 Troika over the next two years to explain, support, and sustain the mobilization effort toward the post-2015 agenda could be a major contribution to it but also strengthen the global system of international institutions in the process. For the Turkish G-20 summit, scheduled to take place in November 2015 in Antalya, between UNGA in New York in September and the UNFCCC in Paris in December, Turkey could use part of its G-20 summit to have the leaders of the world’s largest advanced and emerging market economies explain to the world the nature, importance, and relevance of the SDGs to domestic concerns and priorities of ordinary people.

A weakness of G-20 summits thus far has been that G-20 leaders have become trapped by finance ministers’ issues and discourse and have failed to connect with their publics on larger issues of direct concern to people everywhere. The post-2015 agenda provides an opportunity for G-20 leaders to lead their people in understanding how global efforts relate to domestic conditions and why dealing only domestically with issues will not suffice to advance the human agenda where the global interface is extremely palpable. G-20 leaders, under Turkey’s leadership, could step out beyond the technical jargon of finance ministries and central banks, as important as those issues continue to be, and directly address the longer-term, fundamental conditions that affect the lives and livelihoods of all people. They would thereby strengthen their own leadership profile internally by explaining the global dimensions of domestic issues as means of creating public support for the sustainability issues in the post-2015 agenda.

Past experience with the International Development Goals (IDGs) of the 1990s and the Millennium Development Goals since the early 2000s  demonstrates that linking the goal-setting effort to the implementation phase yields powerful results by capturing the political momentum of the goal setting phase and carrying that energy forward directly into implementation efforts. If Turkey and China were to work together in 2015 and 2016, thereby bridging the goal-setting year in 2015 to the beginning of the implementation phase in 2016, they could provide the catalytic leadership and continuity that would maximize the staying power of the momentum from one phase to the next.

China, for its G-20 summit preparations in 2016, could focus on developing a road map, in concert with the other countries and international organizations and especially with the United Nations, that would explicitly keep alive the activities, groups, and initiatives manifested in the goal-setting phase into the next phase of implementation beginning in 2016. These combined efforts by Turkey and China could jump-start societies focusing on accelerating efforts to transform their societies by mobilizing policies and resources for highly related goal areas of direct benefit to their people.

The immediate effects of coordinated sequential efforts by Turkey and China in their respective G-20 years to advance the post-2015 agenda would be to strengthen the relationship between the G-20 and the United Nations on the agenda itself and to strengthen the G-20 summits by having leaders lead on issues of central concern to their people, strengthening the G-20 as a leadership forum in the process. For these results to occur, Turkey and China would need to begin to work together now to develop concordance in their individual efforts and initiate activities that would benefit greatly by beginning now and running through 2016 and beyond.

Accelerating implementation: Several initiatives could be undertaken now that would set up the dynamics for accelerated implementation in 2016 and beyond.

• National strategies for achieving the SDGs: Encourage countries to adapt and adopt the SDGs to their respective priorities and social, political, and cultural contexts through deliberate decision processes and wide societal engagement.
• The role of parliaments: Bring parliamentarians and parliaments into the goal-setting process so that they are aware of the legislative, regulatory, and budgetary implications of the post-2015 agenda.
• The role of domestic ministries: Bring finance ministers and other domestic ministries and agencies together with foreign ministers in the goal-setting year to set in motion mutually involved functional relationships and operational guidelines to enhance implementation across sectors.
• The G-20 as broker and mobilizer: The G-20 could act as a broker between the International Monetary Fund (IMF), World Bank, World Trade Organization (WTO), Organization for Economic Cooperation and Development (OECD), and regional development banks and the U.N. and its agencies to assure not just coordination but more intensive interactions that would be designed to accelerate the mobilization of resources and as well as policies and private sector activities that would enhance implementation.
• The policy role of the OECD: The strong, substantive role of the OECD in G-20 summits on issues high on the G-20 agenda—such as structural reform, tax base erosion, development, environment, energy, employment, and social issues—position the OECD to continue to provide important substantive inputs to the G-20 in 2015 and 2016. The OECD would enhance the relationship of its 34 members with G-20 emerging market economies by OECD involvement in both the G-20 and the U.N. post-2015 agenda.
• Financial stability and the SDGs: Encouraged by the G-20 summits, the IMF, the Financial Stability Board, and the OECD could work together to integrate the financial regulatory reform agenda into the post-2015 U.N. process by clarifying the linkages between financial stability, regulatory reform, and incentives for long-term private investment in infrastructure (crucial to all the SDGs) and in productive activities which generate greater employment and growth.
• Multi-stakeholder participation in implementation: G-20 summits can facilitate multi-stakeholder processes for engaging civil society, labor, private sector, religious, academic, and expert communities not only in the G-20 summits, as is the current practice, but also in the post-2015 agenda and its implementation, connecting societal leaders with the SDG agenda.

III. The overarching importance of a single global agenda

If these efforts to bring together a wide cross-section of domestic and international agencies, public and private sector leaders, stakeholders, and civil society actors are to translate into actions that are meaningful to the lives and livelihoods of people, a single set of goals is essential. The lesson learned from the IDG-MDG experience was that the tendency to differentiate roles by identifying different institutions with different sets of goals was real. The United Nations had inadvertently put forward the Millennium Declaration at the September 2000 U.N. General Assembly that had “millennium targets” which were similar but not identical to the International Development Goals (IDGs). The IDGs had been developed in the mid-1990s by OECD development ministers and subsequently were endorsed by the World Bank, the IMF, the U.N. and the OECD. In fact, in 2000, for the first time ever, the heads of those four institutions signed, and the institutions themselves published, a joint report, A Better World For All: Progress towards the International Development Goals.

Despite the appearance of unity and in part because there was a lack of concordance between the Millennium Declaration Targets (MDTs) and the IDGs, there was a moment in March 2001 when it looked like there might be a decisive divergence between the U.N. and the Bretton Woods institutions, with the U.N. taking the lead on the MDTs and the World Bank and IMF taking the lead on the Poverty Reduction Strategy Process (PRSPs), leaving the IDGs marginalized altogether. This potential division of labor was thwarted by a decision to reconcile the differences between the MDTs and the IDGs by forging the Millennium Development Goals (MDGs), which embodied the principal elements of both. The MDGs surfaced and were endorsed by the Monterrey Summit on Financing for Development in March of 2002, keeping the major global institutions on the same page with bilateral donors and the same path moving toward achieving the MDGs in 2015.

Most people who know about the MDGs think their origins began at the U.N. in the year 2000. It is an often overlooked fact that the MDGs only came forward in 2002 to bridge the potential divide between the Bretton Woods institutions and the United Nations. If that divide had occurred, it would have been disastrous from a goal setting-goal implementation point-of-view. This history is quite important to bring forward into public light now because it illustrates divisive dangers that currently lurk under the surface threatening unity if not squarely addressed.

From the perspective of prioritizing implementation, the truth is that multiple sets of goals blur the strategic vision, fail to communicate direction, weaken effective leadership, and encourage special pleading for differentiated interests instead focusing on the common, public interest. The U.N. has the lead role in global goal setting and has strengthened its own role in the global system in recent years. However, looking forward now to the SDG implementation phase, a danger might be that the Post-2015 agenda could be seen as the creature and captive of the United Nations, whereas it must be fully endorsed and internalized within the global system of international institutions as a whole. For that to happen, it would be necessary to move now, during the goal-setting year, to include all the relevant international and domestic actors that are crucial to the implementation phase of the post-2015 agenda.

The implications of including the post-2015 agenda in the G-20 summits in 2015 and 2016:

• It would make clear to relevant publics and actors that this set of global goals is universal, applicable to advanced countries, emerging market economies, and developing countries; it is not a “development agenda” but a “sustainability agenda,” which is broader, more strategic, and higher on the policy agenda of most countries.
• It would make clear the inextricable dynamics between domestic priorities and global goals; the SDGs are not foreign policy objectives or aid targets for development; they are domestic priorities affected by global impacts and generating global spillovers that need to be managed, not neglected.
• It would make the incorporation of finance ministers and domestic ministers with foreign ministers, along with international institutions, an imperative, rather than a utopian, ideal.
• It would make obvious the need to have a wide range of international institutions dealing with health, labor, education, women, climate, and the environment on the same page with the United Nations and the Bretton Woods institutions working together toward the SDGs.
• It would link the need for multi-stakeholder participation in goal setting to the goal implementation phase to mobilize support, policies, and resources but also to reveal and work on the interconnectedness of the goals themselves taken as a whole. 

Hence, the critical imperative is that there be a single narrative, a single set of goals, for all the domestic and global players to relate to, affirm, and implement. Otherwise, a fractured global order will produce lower-yield outcomes, and competition among priorities, sectors, and actors will result in poorer goal performance than would be possible with an integrated, concerted approach where all actors are working toward the same ends.

IV. Possible G-20 Actions by Turkey and China

Turkey has developed a process for the G-20 summit scheduled for November 14-15, 2015 in Antalya. Implementation, inclusion, and investment—the three “I’s”—are the overarching themes already established. The three “I’s” ties are tightly tied to the Australian G-20 outcomes—implementing action plans to achieve the incremental growth target of an additional 2 percentage points of GDP by 2018; including lower-income people in growth and lower-income countries in the global economy; and investing in infrastructure.

Each of these priorities is supportive of and compatible with the post-2015 agenda, even though they are not yet directly addressed to it. A decision by Turkey to include the post-2015 agenda in the 2015 G-20 would be easily achieved by cross-walking the SDGs over to and into the three “I’s” and vice versa. The central priority of the post-2015 agenda is, after all, “implementation.” The overarching meaning of the six elements of the post-2015 agenda (dignity, prosperity, justice, partnership, planet, and people (U.N. SG Synthesis Report December 2014)) is their impact on “inclusion.” And “investment” in infrastructure is crucial to all of the 17 SDGs.

The three pillars for Turkey’s 2015 agenda are: (i) strengthening the global recovery and lifting potential growth (the 2 percent target); (ii) enhancing resilience (financial regulatory reform]; and (iii) buttressing sustainability. Clearly, the third pillar on sustainability opens the door for the incorporation of the post-2015 agenda into the Turkey G-20, if Turkey wishes to do so. And the other two pillars fully support the sustainability agenda and are linked to it, or need to be.

For China, the post-2015 agenda presents a unique opportunity for the Chinese government to seize on a global agenda that has specific, strong, and visible links to the domestic concerns of the Chinese people. China could use the 2016 G-20 summit both to provide international leadership for global cooperation and to demonstrate the connection of global issues to domestic conditions through their impact and spillover effects. Because the post-2015 agenda is a universal agenda, by prioritizing it in its G-20 summit, China would be embracing the multiplicity of its own identity as a developing country but also as a dynamic emerging market economy that is destined to eventually play a global leadership role equivalent to advanced countries.

Furthermore, China seems intent on being a competitive nation in various spheres while at the same time being cooperative in others. The G-20 summit presidency for China in 2016 provides China with an opportunity to strengthen its role in international cooperation by being ambitious in the reach of its agenda for the G-20 in 2016, by its conduct as a member of the G-20 Troika for the next three years, and as the host government for the G-20 in 2016. By choosing to support Turkey in its consideration of incorporating the post-2015 agenda in the G-20 summit in 2015 and by China itself addressing the implementation issues in 2016, China would be reaping the demonstrably higher-yield gains generated by linking the SDG goal-setting phase in 2015 to the implementation phase in 2016.

Integrating the three tracks of SDG goal setting, financing for development, and progress on climate change actions is complementary but complex. While challenging, China has sufficiently high stakes in the outcomes of all three of these tracks to have a national interest in leading a global effort over the next three years to energize the convergence of agendas and institutional mandates necessary to generate bigger outcomes for people everywhere, including in China.

V. Results: Strengthening global governance and leadership

What follows from the analysis here is that the decision to include the post-2015 agenda in the Turkey and China G-20 summits would be a choice about the substance but also about the process of global economic governance, in which the G-20 has a leadership role. To do so in the way outlined here, would:

• Strengthen the global system of international institutions by bringing them together around a single comprehensive, integrated sustainability agenda;
• Create synergies between the United Nations and the other international institutions rather than identifying the post-2015 agenda with the U.N. alone and relying unnecessarily on the U.N. for its implementation;
• Connect G-20 leaders with a broader human and planetary agenda beyond economics and finance, which in turn would connect G-20 leaders with their publics as they visibly address the domestic concerns of their people in their global context; and
• Strengthen the role of the G-20 in global economic governance by putting the G-20 out in front as a broker among stakeholders, a catalytic coordinator of relevant domestic and international actors, and a leader on behalf of the concerns, lives, and livelihoods of people.

Selected References

Colin I. Bradford (2002), “Toward 2015: From Consensus Formation to Implementation of the Millennium Development Goals. Issues for the Future: The Implementation Phase”, Development Economics Department (DEC), The World Bank, December 2002.

Colin I. Bradford (2014), “The Changing World Economy and Global Economic Governance”, power point presentation at the Korean Delegation seminar “The OECD and Global Governance”, OECD, Paris, December 11, 2014.

Colin I. Bradford (2014), “Global Economic Governance and the Role of International Institutions”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014.

Colin I. Bradford (2015), “Governance Innovations for Implementing the Post-2015 Sustainable Development Agenda: Conference Report”,  Brookings Institution, Washington, D.C., March 30, 2015.  http://www.brookings.edu/~/media/Events/2015/03/30-post-2015-sustainable-development-agenda/330-PostReportFinal.pdf?la=en   

Ye Yu, Xue Lei and Zha Xiaogang (2014), “The Role of Developing Countries in Global Economic Governance---with a Special Analysis on China’s Role”, Second High-level Policy Forum on Global Governance:  Scoping Papers, UNDP Beijing China, 22 October 2014. Authors are from the Shanghai Institutes of International Studies.

Homi Kharas and John McArthur (2014), “Nine Priority Commitments to be Made at the UN’s July 2015 Financing for Development Conference in Addis Ababa, Ethiopia,” October 2014. http://www.brookings.edu/research/papers/2015/02/united-nations-financing-for-development-kharas-mcarthur

OECD (2014), “Policy Coherence for Development and the Sustainable Development Goals”, Paris: OECD, 10 December 2014, prepared for the 8^th Meeting of the National Focal Points for Policy Coherence for Development (PCD) held at the OECD on 17-18 December 2014. 

What makes the Trans-Pacific Partnership (TPP) consequential?

Since the onset of the 21st century, countries from every corner of the world have vigorously negotiated free trade agreements (FTAs) based on the principle of preferential market access (as opposed to the most-favored nation obligation of the WTO). This has resulted in a veritable avalanche of such trade deals, with close to 400 FTAs notified to the WTO in the past 20 years. If the negotiation of preferential trade agreements is now the dominant trend in the trading regime, and almost no country has escaped contagion from the FTA syndrome, why does one agreement in particular—the TPP—remain the focal point of policy debates on trade?

Chart 1. Multilateral trade regimes and FTA proliferation

The TPP generates most attention because it has spurred the emergence of mega trade agreements (as compared to the mostly small bilateral trade deals that had characterized the FTA wave), and has offered a new platform to advance the trade agenda as negotiations on the Doha Round continue gridlocked. The TPP has come a long way from its humble beginnings as a trade grouping of four small open economies (Brunei, New Zealand, Chile, and Singapore). Today, it comprises 12 nations, covers 26 percent of world trade, and is expected to generate global income gains in the neighborhood of $492 billion by 2030.

Chart 2. From humble beginnings to mega trade deal

But the significance of the TPP is not to be grasped by numbers alone. Consider the following defining traits of this trade agreement:

1. Its high level of ambition for tariff liberalization vowing to disallow sectoral carve-outs. While it is true that sensitive sectors asserted their political weight by deferring or limiting tariff elimination (e.g., autos for the United States and five agricultural commodities for Japan), the commitment of TPP countries to eventually eliminate 99-100 percent of tariff rates is indeed impressive. Japan does stand out for a lower level of committed tariff elimination (95 percent); but again this is the highest level of liberalization that Japan has ever committed to in any trade negotiation.
2. Its comprehensive set of rules to target non-tariff barriers by introducing disciplines on issues such as regulatory coherence, state-owned enterprises, competitiveness, supply chains, etc. With 30 chapters and over 5,000 pages of text, grasping the reach of TPP rules will certainly take time. However, a quick glance does reveal novel, and needed, disciplines in important areas of the economy. For example, the e-commerce chapter establishes a binding obligation for governments to allow free data flows, disallows forced localization of data servers (except for the financial sector), and mandates that all countries must provide a legal framework to protect personal information. Another important innovation is the TPP provision that governments cannot require the transfer of source code from private companies operating in their market.
3. Its expansive vision as an Asia-Pacific platform with aspirations to set global standards. Its open architecture with a docking mechanism to encourage further member expansion and its explicit aim to establish a trans-regional platform that bridges Asia and North and South America are strong selling points for the TPP. It undercuts the oft-mentioned fear of using preferential trade agreements to create closed-off regions, and it gives its rules and standards the opportunity to disseminate far and wide.
4. Last but not least, the TPP has emerged as a central policy priority for both the U.S. and Japan to hone their international economic competitiveness and achieve broader foreign policy goals. In the area of foreign economic policy, the TPP is one of the most compelling frameworks to encourage China to deepen its market reforms and sign on to more ambitious liberalization commitments. The TPP, therefore, has emerged as a central arena for the interaction of the three giants of the world economy.

The United States as a Pacific power

The U.S. expects to reap important economic benefits from the TPP. It is a trade agreement that taps into the areas of competitive strength of the American economy: agricultural exports, trade in services, the digital economy, to name a few. Econometric studies put the expected income gains of the TPP for the U.S. in the order of $131 billion per year, and to the extent that the TPP becomes a global standard, these gains will grow. Indeed, the TPP is the centerpiece of the American trade agenda. Its success is required for continued momentum in the on-going trans-Atlantic trade negotiations, but it could also influence other important trade initiatives. For example, TPP disciplines on services and state-owned enterprises are expected to influence deliberations on the Trade in Services Agreement, a plurilateral trade negotiation carried out under the aegis of the WTO.

From the point of view of global governance, the TPP is a litmus test of the U.S. ability to provide leadership at a time of great complexity in the world economic order: one where supply chains have emerged as a main driver of production and trade, where emerging economies are increasingly vocal in the management of the global economy, and where the test of updating Bretton Woods institutions looms large. Through the TPP, the U.S. can display its convening power to negotiate novel trade rules, to devise new institutional forms that complement and spur on the multilateral regime, and to be proactive and not just reactive to initiatives from rising economic powers.

But the TPP is also a pillar of U.S. Asia policy, one that solidifies the U.S. commitment to remain an engaged Pacific power. This trade agreement increases the appeal of the rebalancing policy by defining it not just as a reorientation of military resources toward a region undergoing a significant power transition; but also as the pursuit of a common endeavor: furthering economic interdependence with rules that match the realities of the 21st century economy, and potentially establishing a bridge toward China with the prospect of TPP membership.

Japan is an essential partner for the U.S. to achieve these important goals. Japan came late to the TPP negotiations (in the summer of 2013), but it transformed the economic and political significance of this deal. Japan’s participation allowed the TPP to qualify as a mega trade agreement. For the U.S. alone, the projected economic gains with Japan on board tripled. This is not surprising given the size of the Japanese market and the fact that the U.S. and Japan do not have a bilateral trade agreement; nor has Japan ever accepted these levels of liberalization. Moreover, prior to Japan joining the TPP there were doubts as to whether this could indeed become an Asia-Pacific platform of economic integration since no major Asian economy was participating. Japan’s entry put those objections to rest.

Japan as a reviving power

For Japan as well, the TPP negotiations have had salutary effects on its trade diplomacy and on the pursuit of central domestic and foreign policy priorities. Prior to joining the TPP, Japan’s trade strategy had achieved modest results: it lagged behind its peer competitors in negotiating an FTA network that covered a substantial share of its trade, it had faced difficulty in persuading Southeast Asian countries to adopt many WTO+ rules, it had received the cold shoulder from the U.S. and Europe as it proposed the negotiation of trade agreements, and remained deadlocked with China over the membership configuration of an East Asian trade grouping. The TPP altered the parameters of Japanese trade policy. It allowed the country to negotiate preferential access to main markets of destination, to disseminate next frontier trade rules, and to undertake concurrent mega trade negotiations. As a reaction to Japan’s courting of TPP membership, China recalibrated its trade policy to speed up the launch of trilateral trade negotiations in Northeast Asia and was now amenable to a 16-member trade grouping upholding the principle of ASEAN centrality (Regional Comprehensive Economic Partnership or RCEP), and the Europeans also came to the negotiation table.

As a full participant in the mega FTA movement, Japan can aim high in order to pursue signature objectives such as:

• Negotiate deep integration FTAs that enhance the international competitiveness of Japanese global supply chains. An assessment of Japan’s core competencies in the 21st century should start with the recognition that a significant share of industrial capacity has been relocated overseas. On-shoring of manufacturing operations is not a viable goal given projected demographic trends. Rather, the aim should be to sustain and strengthen Japan’s role in global supply chains (the leading force of international production and trade today). Japan’s international diplomacy has a role to play here by negotiating deep FTAs that meet the needs of fragmented production chains. Additionally, deep FTA commitments will also help Japan address its own domestic inefficiencies such as the modest liberalization of the services sector.
• Lock-in structural reforms. One of the main benefits of linking the domestic structural reform agenda to international trade commitments is that it will be harder to roll back the reforms if and when political circumstances change (this is indeed a major lesson of the failure to institutionalize Prime Minister Junichiro Koizumi’s reforms). Importantly, the TPP negotiations do not conform to the old-style gaiatsu pattern where a reluctant Japan would deflect U.S. pressure for it to change its ways. This time Japan has eagerly sought to be at the TPP table and has—of its own accord—identified the synergies between the new trade commitments and its own efforts to reform the domestic economy.
• Manage the transition from “regime-taker” to “regime-maker.” With the stagnation of the WTO, we have moved to a system of decentralized competition whereby different clusters of countries seek to define the standards for economic integration. The costs of a passive trade policy are much higher today than in a most favored nation (MFN) world where preferential trade agreements were the exception and not the rule. The expectation of steady liberalization benefits through successive multilateral trade rounds has been sharply revised. Therefore, countries that want to avoid the discriminatory effects of existing preferential trade deals and to improve access to important markets through additional elimination of tariffs and the adoption of rules that address behind-the-border barriers have resorted to an active FTA diplomacy. More broadly, Japan has much to win from displaying leadership in international economic governance, in a manner that resonates with the goals of the Abe administration to play a proactive role in world affairs.

For all the shared interests between the U.S. and Japan in the TPP project, negotiations over long divisive market access terms proved difficult and frustratingly long. Of course, a host of other issues also kept the larger TPP membership apart. Biologics especially was the last topic to close in the final TPP ministerial held in Atlanta in October 2015, and negotiations went to the wire. Despite all these difficulties, the ability to strike a TPP deal last fall represents a big win for the trade regime which has not seen a success of this magnitude in two decades. Since its creation, the WTO has not updated the rules of international trade and investment, and the Doha Round lingers on life support. Many were skeptical that a major trade negotiation tackling front and center the complex and unwieldy behind-the-border agenda could succeed. This is the most powerful message coming from Atlanta: it can be done.

With a TPP deal in hand there is greater hope that we can manage the tectonic changes in international trade governance. The transformation of the trade agenda (increasingly about regulatory matters) and the limitations of the WTO as a negotiation forum, have called into question the pure multilateral ideal—one set of binding rules for 150+ countries. Instead, the center of action is now on what we call “variable geometry” arrangements where subsets of countries negotiate next-frontier rules: the plurilaterals in the WTO and the preferentials through mega trade agreements. The emerging system for trade governance is not risk-free, and much effort will be required to forestall potential dangers: fragmentation (if TPP-like standards do not disseminate widely) and exclusion (if less developed countries are bypassed by the FTA wave).

Moreover, the TPP deal opens a new and promising chapter in U.S.-Japan relations. It is certainly more than a U.S.-Japan trade agreement—it represents the ability of 12 countries at varying levels of development and with very different regulatory regimes to agree on the most substantive trade liberalization to date. But it is also true that at the core of the TPP, the U.S. and Japan as the largest and most developed economies have acted as an engine of negotiations. The TPP marks a milestone in U.S.-Japan relations, as an effective instance of cooperation to upgrade the international economic architecture. In the TPP, the U.S. and Japan are on close alignment on the rules area of the talks and were able to reach an agreement on market access issues that in the past had proven intractable.

Ratification, reform, and reach

None of these effects will be long lasting nor will they reach their full potential, if TPP countries (and the U.S. and Japan in particular) do not double down on the next crucial steps. For simplicity sake, these can be dubbed the three “Rs” of ratification, reform, and reach.

Ratification

Ratification rules in the TPP require that six countries representing 85 percent of combined GDP approve the agreement before it enters into force. Therefore, to meet this numerical requirement both the U.S. and Japan must ratify. However, for the U.S., TPP ratification will represent a steep political battle in the midst of an American presidential election year. Despite public opinion polls showing that most Americans see in international trade an opportunity, the politics of trade agreements are fractious. Long-standing opposition by environmental groups and unions to trade agreements has resulted in their active mobilization against the TPP. And the debate on the merits of trade agreements has only become more heated as critics suggest that trade globalization is to be blamed for growing income inequality and the erosion of state regulatory powers.

For both national parties, the TPP is a divisive issue. While President Barack Obama has made TPP negotiation and ratification a central priority of his administration, Democrats in Congress have not backed his trade initiative in large numbers, in part due to the opposition of the party’s traditional base, labor unions. The internal dynamics of the Republican Party have shifted dramatically, complicating the odds for the TPP. The Republican Party has become less cohesive with the emergence of the Tea Party wing determined to deny Obama a legacy-making trade agreement. The support of key Republican figures in the Senate has also waned due to dissatisfaction over the tobacco carve-out from investor-state dispute settlement and the exclusivity period for biologics. And the business community has also criticized these provisions, offering only qualified support for the TPP deal.

The U.S. has yet to fail in ratifying a negotiated trade agreement. And a vote down on the TPP would be singularly costly for the credibility of U.S. foreign policy and the evolution of the international trade regime.

Reform

One of the most powerful benefits of trade agreements is the ability of governments to use them as commitment devices to implement needed economic changes. Reform is in fact the crucial issue for Japan as it tries to leave behind stagnant growth. Economic revitalization certainly goes beyond agricultural reform, to encompass the host of productivity-enhancing measures across all areas of the economy, the internationalization of services, the promotion of inward direct investment, and the further upgrading of regional and trans-regional production networks.

Yet, farming countermeasures adopted in the wake of the TPP deal have raised doubts about the government’s resolve to transform its agricultural sector. Japan’s TPP market access commitments do include a 56,000-ton import rice quota (to grow eventually to 78,400 tons). But the government promptly announced an increase in stockpiling purchases to match the TPP quota, effectively preventing a drop in the price of rice and market adjustment. This artificial support preempts the modernization of the agricultural sector since it enables part-time farmers to continue operating in tiny plots, hindering the emergence of commercial farming. The government also submitted a generous 2016 supplementary budget with 312 billion yen earmarked for agricultural TPP countermeasures. But informed experts question its impact in boosting farming competitiveness since public works allocations still loom large (30 percent of outlays will go to land reclamation projects).

Just as the electoral cycle has not facilitated TPP ratification in the U.S., the looming Japanese Upper House election in July is not conducive to moving past prior trade compensation practices.

Reach

The release of the TPP text has clarified a very important point: membership can be extended not only to APEC economies but also to other countries that are willing to meet TPP disciplines. Enlargement will be critical to avoid the above-mentioned risks of fragmentation and exclusion by helping disseminate TPP standards. In the short and medium term, the conclusion of the TPP talks is expected to have two main effects: increase the list of potential applicants, and encourage a higher level of ambition among on-going trade negotiations.

The number of economies expressing an interest in joining the TPP has grown to include South Korea, Taiwan, Indonesia, Thailand, the Philippines, Colombia, and Costa Rica, among others. Regarding the second wave of accession the key issue will be readiness to undertake the ambitious liberalization commitments of the TPP, and the list of prospective applicants shows wide variation on this score. The conclusion of TPP talks also creates an incentive for the updating of existing FTAs and/or scaling up the level of ambition in ongoing trade negotiations, as countries outside the TPP want to secure export markets, attract foreign direct investment, and embed their companies in global supply chains.

In the long run, the key challenge will be to devise an effective strategy to engage emerging economies, such as China, India, and Brazil. This is still the gaping hole in the U.S. plans to develop trans-Pacific and trans-Atlantic trade groupings. Certainly, putting in place the TPP and the Transatlantic Trade and Investment Partnership is the first step in such strategy since it changes the incentive structure for these countries to entertain further market liberalization. But at the end of the day, these emerging economies must reach the determination that it is in their national interest to abide by these economic standards, and find the political will to tackle vested interests. This is a tall order indeed.

The most pressing question may well be how China will position itself vis-à-vis the TPP. Can we expect it to act on past precedent and seek TPP accession just as in the past it used WTO membership to advance economic reforms? Or will it choose instead to champion the negotiation of a Free Trade Area of the Asia-Pacific (FTAAP) after both the TPP and RCEP materialize, in order to play a more proactive role in the international economic architecture—more in conformance with the recent launch of the Asian Infrastructure Investment Bank?

The recently struck TPP agreement underscores the potential of furthering U.S.-Japan cooperation to supply needed international economic governance. However, the overview of remaining challenges also shows that clinching a TPP deal is just the first step.

This article originally appeared in the March/April 2016 issue of Economy, Culture & History Japan SPOTLIGHT Bimonthly.

Downloads

• The high stakes of TPP ratification: Implications for Asia-Pacific and beyond

Unlike prime-age Americans, who have experienced declines in employment and labor force participation since the onset of the Great Recession, Americans past 60 have seen their employment and labor force participation rates increase.

In order to understand the contrasting labor force developments among the old, on the one hand, and the prime-aged, on the other, this paper develops and analyzes a new data file containing information on monthly labor force changes of adults interviewed in the Current Population Survey (CPS).

The paper documents notable differences among age groups with respect to the changes in labor force transition rates that have occurred over the past two decades. What is crucial for understanding the surprising strength of old-age labor force participation and employment are changes in labor force transition probabilities within and across age groups. The paper identifies several shifts that help account for the increase in old-age employment and labor force participation:

• Like workers in all age groups, workers in older groups saw a surge in monthly transitions from employment to unemployment in the Great Recession.
• Unlike workers in prime-age and younger groups, however, older workers also saw a sizeable decline in exits to nonparticipation during and after the recession. While the surge in exits from employment to unemployment tended to reduce the employment rates of all age groups, the drop in employment exits to nonparticipation among the aged tended to hold up labor force participation rates and employment rates among the elderly compared with the nonelderly. Among the elderly, but not the nonelderly, the exit rate from employment into nonparticipation fell more than the exit rate from employment into unemployment increased.
• The Great Recession and slow recovery from that recession made it harder for the unemployed to transition into employment. Exit rates from unemployment into employment fell sharply in all age groups, old and young.
• In contrast to unemployed workers in younger age groups, the unemployed in the oldest age groups also saw a drop in their exits to nonparticipation. Compared with the nonaged, this tended to help maintain the labor force participation rates of the old.
• Flows from out-of-the-labor-force status into employment have declined for most age groups, but they have declined the least or have actually increased modestly among older nonparticipants.

Some of the favorable trends seen in older age groups are likely to be explained, in part, by the substantial improvement in older Americans’ educational attainment. Better educated older people tend to have lower monthly flows from employment into unemployment and nonparticipation, and they have higher monthly flows from nonparticipant status into employment compared with less educated workers.

The policy implications of the paper are:

• A serious recession inflicts severe and immediate harm on workers and potential workers in all age groups, in the form of layoffs and depressed prospects for finding work.
• Unlike younger age groups, however, workers in older groups have high rates of voluntary exit from employment and the workforce, even when labor markets are strong. Consequently, reduced rates of voluntary exit from employment and the labor force can have an outsize impact on their employment and participation rates.
• The aged, as a whole, can therefore experience rising employment and participation rates even as a minority of aged workers suffer severe harm as a result of permanent job loss at an unexpectedly early age and exceptional difficulty finding a new job.
• Between 2001 and 2015, the old-age employment and participation rates rose, apparently signaling that older workers did not suffer severe harm in the Great Recession.
• Analysis of the gross flow data suggests, however, that the apparent improvements were the combined result of continued declines in age-specific voluntary exit rates, mostly from the ranks of the employed, and worsening reemployment rates among the unemployed. The older workers who suffered involuntary layoffs were more numerous than before the Great Recession, and they found it much harder to get reemployed than laid off workers in years before 2008. The turnover data show that it has proved much harder for these workers to recover from the loss of their late-career job loss.

Download "Labor Force Dynamics in the Great Recession and its Aftermath: Implications for Older Workers" »

Downloads

• Download "Labor Force Dynamics in the Great Recession and its Aftermath: Implications for Older Workers"

Event Information

On June 23, voters in the United Kingdom will go to the polls for a referendum on the country’s membership in the European Union. As one of the EU’s largest and wealthiest member states, Britain’s exit, or “Brexit”, would not only alter the U.K.’s institutional, political, and economic relationships, but would also send shock waves across the entire continent and beyond, with a possible Brexit fundamentally reshaping transatlantic relations.

On May 6, the Center on the United States and Europe (CUSE) at Brookings, in cooperation with the Heinrich Böll Stiftung North America, the UK in a Changing Europe Initiative based at King's College London, and Wilton Park USA, will host a discussion to assess the range of implications that could result from the United Kingdom’s referendum. 

After each panel, the participants will take questions from the audience.

Join the conversation on Twitter using #UKReferendum

Audio

• Brexit—in or out? Implications of the United Kingdom’s referendum on EU membership

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20160506_uk_eu_brexit_transcript

The terrible attack in Nice on July 14—Bastille Day—saddened us all. For a country that has done so much historically to promote democracy and human rights at home and abroad, France is paying a terrible and unfair price, even more than most countries. My colleagues Will McCants and Chris Meserole have carefully documented the toll that France, and certain other Francophone countries like Belgium, have suffered in recent years from global terrorism. It is heart wrenching.

From what we know so far, the attack was carried out by a deeply distraught, potentially deranged, and in any case extremely brutal local man from Nice of Tunisian descent and French nationality. Marital problems, the recent loss of his job, and a general sense of personal unhappiness seem to have contributed to the state of mind that led him to commit this heinous atrocity. Perhaps we will soon learn that ISIS, directly or indirectly, inspired the attack in one way or another as well. My colleague Dan Byman has already tapped into his deep expertise about terrorism to remind us that ISIS had in fact encouraged ramming attacks with vehicles before, even if the actual manifestation of such tactics in this case was mostly new. 

This attack will again raise the question: Why France? On this point, I do have a somewhat different take than some of my colleagues. The argument that France has partly brought these tragedies upon itself—perhaps because of its policies of secularism and in particular its limitations on when and where women can wear the veil in France—strikes me as unpersuasive. Its logical policy implications are also potentially disturbing, because if interpreted wrongly, it could lead to a debate on whether France should modify such policies so as to make itself less vulnerable to terrorism. That outcome, even if unintended, could dance very close to the line of encouraging appeasement of heinous acts of violence with policy changes that run counter to much of what French culture and society would otherwise favor. So I feel the need to push back.

Here are some of the arguments, as I see them, against blaming French culture or policy for this recent string of horrible attacks including the Charlie Hebdo massacre, the November 2015 mass shootings in Paris, and the Nice tragedy (as well as recent attacks in Belgium):

• Starting with the simplest point, we still do not know much about the perpetrator of the Nice killings. From what we do surmise so far, personal problems appear to be largely at the root of the violence—different from, but not entirely unlike, the case with the Orlando shooter, Omar Mateen.
• We need to be careful about drawing implications from a small number of major attacks. Since 2000, there have also been major attacks in the Western world by extremist jihadis or takfiris in New York, Washington, Spain, London, San Bernardino, Orlando, and Russia. None of these are Francophone. Even Belgium is itself a mixed country, linguistically and culturally.
• Partly for reasons of geography, as well as history, France does face a larger problem than some other European countries of individuals leaving its country to go to Syria or Iraq to fight for ISIS, and then returning. But it is hardly unique in the scale of this problem.
• Continental Europe has a specific additional problem that is not as widely shared in the United Kingdom or the United States: Its criminal networks largely overlap with its extremist and/or terrorist networks. This point may be irrelevant to the Nice attack, but more widely, extremists in France or Belgium can make use of illicit channels for moving people, money, and weapons that are less available to would-be jihadis in places like the U.K. (where the criminal networks have more of a Caribbean and sub-Saharan African character, meaning they overlap less with extremist networks).
• Of course, the greatest numbers of terrorist attacks by Muslim extremists occur in the broader Muslim world, with Muslims as the primary victims—from Iraq and Syria to Libya and Yemen and Somalia to South Asia. French domestic policies have no bearing on these, of course.

There is no doubt that good work by counterterrorism and intelligence forces is crucial to preventing future attacks. France has done well in this regard—though it surely can do better, and it is surely trying to get better. There is also no doubt that promoting social cohesion in a broad sense is a worthy goal. But I would hesitate, personally, to attribute any apparent trend line in major attacks in the West to a particular policy of a country like France—especially when the latter is in fact doing much to seek to build bridges, as a matter of national policy, with Muslims at home and abroad. 

There is much more to do in promoting social cohesion, to be sure, even here in America (though our own problems probably center more on race than on religion at the moment). But the Nice attacker almost assuredly didn’t attack because his estranged wife couldn’t wear a veil in the manner and/or places she wanted. At a moment like this in particular, I disagree with insinuations to the contrary.