Media coverage of the Islamic State frequently refers to the group’s violent and seemingly archaic justice system without considering the institutional structures that enable this violence, or the broader function that it serves in the group’s ambitious state-building project. Legal institutions make it easier for the group to capture and retain territory by legitimizing its claim to sovereignty, justifying the expropriation of the property and land of enemies, and building goodwill with civilians by ensuring accountability.

The Islamic State’s legal system purports to strictly apply the divinely revealed body of Islamic law known as Sharia, which it regards as the only legitimate basis for governance. Although its legal system is frequently characterized as medieval, it has instrumentally supplemented the original text of the Quran with the modern rules and regulations that are needed to govern a 21st century state and punish modern day offenses—for example, traffic violations. It has the same three features that are present in any modern legal system: police, courts, and prisons.

In a region that has long been plagued by corruption, the Islamic State has attempted to ingratiate itself with civilians by claiming that its legal system is comparatively more legitimate and effective than the available alternatives. However, two emerging vulnerabilities—the system’s susceptibility to corruption and propensity for extra-legal violence—are increasingly undermining the Islamic State’s ability to obtain the trust and cooperation of civilians. Counterinsurgency efforts should be designed to undermine the legitimacy of its institutions. Long-term solutions in the region must involve a fundamental reorganization of political and legal institutions in ways that promote legitimacy and rule of law.

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• The legal foundations of the Islamic State

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On July 20 and 21, defense ministers from several nations will gather in Washington, D.C. at the invitation of U.S. Secretary of Defense Ash Carter. The meeting will bring together representatives from countries working to confront and defeat the Islamic State (or ISIL). French Defense Minister Jean-Yves Le Drian will be among those at the summit discussing how to accelerate long-term efforts to fight ISIL in Iraq and Syria. The close relationship between France and the United States has provided a solid base for security cooperation for decades, and in recent years, France has become one of America’s strongest allies in fighting terrorism and a prominent member of the international coalition to defeat ISIL.

On July 20, the Foreign Policy program at Brookings hosted Minister Le Drian for a discussion on French and U.S. cooperation as the two countries face multiple transnational security threats. Since becoming France’s defense minister in 2012, Le Drian has had to address numerous new security crises emerging from Africa, the Middle East, and within Europe itself. France faced horrific terrorist attacks on its own soil in January and November 2015 and remains under a state of emergency with its armed forces playing an active role in maintaining security both at home and abroad. Le Drian recently authored “Qui est l’ennemi?” (“Who is the enemy?”, Editions du Cerf, May 2016), defining a comprehensive strategy to address numerous current threats.

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Media coverage of the Islamic State has focused on the group’s grotesque use of violence and archaic governance style. Less attention has been paid, however, to the institutions that make those practices possible—institutions that lend the group legitimacy, at least in the eyes of supporters, as a sovereign state. In her new Brookings Analysis Paper, “The legal foundations of the Islamic State,” Mara Revkin argues that legal institutions play a critical role in the Islamic State’s state-building project. Those structures help the group take and keep territory, as well as provide a measure of accountability to the people living under its rule.

Lesser evil?

Revkin writes that “the Islamic State has attempted to ingratiate itself with civilians by claiming that its legal system is comparatively more legitimate and effective than the available alternatives.” The Syrian and Iraqi governments, Revkin explains, are often perceived as being highly corrupt and ineffective. The Islamic State is able to gain civilians’ favor by arguing that its political and legal institutions are more legitimate than those of the Syrian and Iraqi governments or rival armed groups. She adds: “some Syrians and Iraqis seem to prefer the legal system of the Islamic State to the available alternatives not because they agree with its ideology, but simply because they regard it as the lesser evil.” 

The Syrian and Iraqi governments...are often perceived as being highly corrupt and ineffective.

Revkin writes that for the Islamic State, shariah law is “the only legitimate basis for governance.” In cases where shariah fails to address modern-day problems, she explains, religiously legitimate authorities appointed by the Islamic State—such as military commanders, police officers, and the caliph himself—can issue legal decisions as long as they do not conflict with the divine rules of shariah or harm the welfare of the greater Muslim community. Alongside this is a system of rules and regulations to “govern civilians, discipline its own officials and combatants, and control territory” in areas of rights and duties, behavior, property, trade, and warfare. 

Making the state possible

Legal institutions help the Islamic State advance three main state-building objectives, in Revkin’s view: 

1. First, they support the Islamic State’s territorial expansion by “legitimizing [its] claims to sovereignty, justifying the expropriation of the property and land of enemies, and building goodwill with civilians.” 
2. Legal institutions also allow the Islamic State to enforce compliance and accountability of its own members and maintain internal control and discipline. Revkin describes various types of punishments the Islamic State uses to discipline its own members—these punishments are important, she writes, because “no government can establish itself as legitimate and sovereign without policing the behavior of the people who are responsible for implementing its policies.”
3. Finally, Revkin explores the legal institutions surrounding the Islamic State’s tax policies, which are “critical to financing the Islamic State’s governance and military operations.” Courts and judges, she explains, are crucial to “administering and legitimizing” taxation and justifying “economic activities that might otherwise resemble theft.” 

Weaknesses in the system

Although the Islamic State claims to have legitimate governing authority, based on a defined legal system, that system faces vulnerabilities. Revkin writes, for instance, that reports of corruption and extra-legal violence are “threatening the organization’s long-term sustainability and undermining its ability to win the trust and cooperation of civilians.”

Amid recent signs that the group is losing strength, Revkin argues that it’s struggling to maintain its own moral standards. To further weaken the Islamic State, she recommends working to undermine those institutions. The trouble is, as Revkin points out: “the Islamic State came to power largely by exploiting the weakness and illegitimacy of existing institutions” in Iraq and Syria. Thus, a sustainable plan for ultimately destroying the organization must also involve strengthening political and legal institutions in those countries. 

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

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

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

To the streets, again

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

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

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

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

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

Final straws?

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

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

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

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

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

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

Abstract

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

Call to Action: The Importance of Expanded Access Programs

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

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

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

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

Laying the Groundwork with Shared Experiences

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

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

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

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

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

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

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

Development of Structural Principles: The Four A's 

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

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

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

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

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

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

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

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

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

Regulatory Considerations

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

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

An Expanded Role for the FDA

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

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

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

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

Next Steps

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

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

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

References

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• The Four A's of Expanded Patient Access

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While the future impact of rising powers such as Brazil, Russia, India and China is uncertain and the shifting political landscape in the Arab world is still playing out, the influence of these emerging nations is a central fact of geopolitics.

Already the global financial crisis, the Copenhagen climate negotiations, and the debate over Iran sanctions have illustrated the potential, the pitfalls, and above all the centrality of the relationship between American power and the influence of these rising actors and developing democracies.

In a new paper, Senior Fellow Bruce Jones, director of the Managing Global Order Project at Brookings, argues the greatest risk lies not in a single peer competitor but in the erosion of cooperation on issues vital to U.S. interests and a stable world order. U.S. power is indispensible for that purpose but not sufficient. No longer the CEO of Free World Inc., the United States is now the largest minority shareholder in Global Order LLC.

On March 15, the Brookings Institution and Foreign Policy magazine hosted the launch of Bruce Jones’s paper "Largest Minority Shareholder in Global Order LLC: The Changing Balance of Influence and U.S. Strategy." Panelists explored the prospects for cooperation on global finance and transnational threats; the need for new investments in global economic and energy diplomacy; and the case for new crisis management tools to help de-escalate inevitable tensions with emerging powers.

Susan Glasser, editor in chief of Foreign Policy, moderated the discussion. After the presentations, panelists took audience questions.

Video

• Relative Shift in U.S. Balance of Power
• Shifting Coalitions of Consensus
• Paradox of Power for U.S.
• U.S. Needs To Get Serious about Development and Energy

Audio

• Shifting Balance of Power: Has the U.S. Become the Largest Minority Shareholder in the Global Order?

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20110315_global_order

As the G-20 Summit concluded in Brisbane, Australia on November 16th, it set a target to achieve an incremental jump in global GDP growth of 2 percent by 2018 and made commitments to creating a Global Infrastructure Investment Initiative (GIII) to address an estimated $5 trillion per year in infrastructure needs around the world. 

It is a valid policy idea to expose the gap between current and potential rates of economic growth to the public. That the Australians put the spotlight on this growth gap was the central achievement of their G-20 Summit in Brisbane. It is a contribution to the global effort to energize the global economy and generate both greater and smarter growth. The question is, will it work? 

The gap between potential and actual growth has more to do with the patterns and sources of growth than the rates of growth. It is certainly necessary to continue to use monetary and fiscal policy to stimulate aggregate, demand-driven growth, but it will not be not sufficient.  

The people-problem in global growth has to do with structural obstacles: market dynamics of globalization tend to increase income inequality; technologies can be labor displacing rather than labor absorbing; and the knowledge-economy requires technical skills that are more sophisticated than investment-driven industrialization.  

As a result, the focus is now on structural policies and reforms, an issue on which the OECD has been an international leader. OECD Secretary General Angel Gurria jointly released an OECD report with Australia Minister of Finance Joseph Hockey in February of this year. At the G-20 Summit in Brisbane, Gurria said that it was possible that the global growth effort by the G-20, which the OECD and IMF are monitoring, could “overshoot” the 2 percent target.  

Discussing structural reforms tends to “get in the weeds” quickly, since the details vary by each country’s circumstances—as made clear by Brisbane’s G-20 Action Plan. Going from the Brisbane G-20 Summit to regional, ministerial, and national agendas and actions becomes the next phase in this effort to boost global growth by shifting the patterns and sources of growth. 

A key component in closing the growth gap will be the aforementioned Global Infrastructure Investment Initiative. The GIII is the culmination of a long discussion involving the G-20, the World Bank, the regional development banks, the private sector and others on how to accelerate much-needed investment in infrastructure—globally, and on a scale that can make a difference, especially in an era of fiscal policy constraints.  

The relationship between private and public investment in global infrastructure and other global growth projects is tricky. Just because many governments face reduced flexibility with fiscal policy at the moment does not mean that the responsibility for infrastructure investment can or will or should be picked up by private investors, much less private financial institutions and markets. The public and private sector each have a vital role. One will not work without the other.

Yet rules and norms do have to be worked out to incentivize private investment in infrastructure. This work is well underway and embodied in the Brisbane GIII. Incremental investment in global infrastructure adds up over time, and prudent direction of financing toward the most impactful projects can be a big boost to global growth and directly have an impact on peoples' lives. This is the kind of people-oriented action G-20 leaders were looking for in Brisbane.

Setting incremental “reach goals” is not just a word game or publicity play. It has proven to be a means of mobilizing resources, policies and efforts by diverse actors to stimulate higher-order results than might otherwise have happened. Just engaging in projecting likely growth outcomes can set the bar too low. In fact, all global goal setting is meant to motivate and mobilize momentum for just such incremental efforts. 

Taken together, a combination of structural reforms, infrastructure investment and continued growth-oriented monetary and fiscal policies can make a real difference in boosting global growth. This combination makes the Brisbane target of an additional 2 percent of global GDP growth by 2018 a feasible, even if ambitious, goal.

Event Information

The year 2015 will be a milestone year, with the adoption of the Sustainable Development Goals (SDGs) and the post-2015 development agenda by world leaders in September; the Addis Ababa Accord on financing for development in July; and the conclusion of climate negotiations at COP21 in Paris in December. The draft Addis Ababa Accord, which focuses on the actions needed to attain the SDGs, highlights the key role envisaged for the multilateral development banks (MDBs) in the post-2015 agenda. Paragraph 65 of the draft accord notes: “We call on the international finance institutions to establish a process to examine the role, scale, and functioning of the multilateral and regional development finance institutions to make them more responsive to the sustainable development agenda.”          

Against this backdrop, on April 18, 2015, the Global Economy and Development program at Brookings held a private roundtable with the leaders of the MDBs and other key stakeholders to discuss the role of the MDBs in supporting the post-2015 development agenda.

The meeting focused on four questions:

1. What does the post-2015 development agenda and the ambitions of the Addis and Paris conferences imply for the MDBs?


Given the ability of the MDBs to leverage shareholder resources, they can be efficient and effective mechanisms for scaling up development cooperation, particularly with respect to the agenda on investing in people and to the financing of sustainable infrastructure. New roles, instruments and partnerships might be needed.

2. How can MDBs best take advantage of the political attention that is being paid to the various conferences in 2015?   


The World Bank and selected regional development banks have launched a series of initiatives to optimize their balance sheets, address other constraints and enhance their catalytic role in crowding in private finance. And new institutions and mechanisms are coming to the fore. But the responses are not coordinated to best take advantage of each MDB’s comparative advantage.

3. What are the key impediments to scaling up the role and engagement of the MDBs?


Views on constraints are likely to differ but discussions should cover policy dialogue, capacity building, capital, leverage, shareholder backing on volume, instruments on leverage and risk mitigation, safeguards, and governance. 

4. How should the MDBs respond to the proposal to establish a process to examine the role, scale and functioning of the multilateral and regional development finance institutions to make them more responsive to the sustainable development agenda?   


A proactive response and engagement on the part of the MDBs would facilitate a better understanding of the contribution that the MDBs can make and greater support among shareholders for a coherent and stepped-up role.

Event Materials

• Participant List
• MDB PostEvent Summary

Editor's note: This blog piece is based on findings from the new book Governance in an Age of Abundance: Experiences from the Extractive Industries in Latin America and the Caribbean, which will be launched at a Brookings public event later today. A Spanish version of this post is available on the Inter-American Development Bank's website. 

The myth of Sisyphus represents in Greek mythology a metaphor for pointless and interminable efforts. Sisyphus was condemned by Zeus to push a huge boulder up a steep hill. Every time he was close to reaching the top, the boulder was made to roll back down the hill and to the starting point, so that Sisyphus had to start all over again, in perpetuity.    

This metaphor may sound familiar to countries rich in natural resources. In many of these countries, citizens have hoped for generations that the revenue derived from extractive industries (oil, gas and mining) would translate into concrete benefits. Instead, rents from extractive industries have frequently been misused, either through wasteful state spending or public and private corruption. In many countries, heavy dependence on revenues from extractive industries has produced economic and political distortions. Also, revenues are all too often centralized at the national level, leaving local communities to wonder about the benefits of hosting extractive industries.

Overcoming the ‘Resource Curse’

The good news is that there are countries that have found a way to overcome the so-called "resource curse." In Norway, for example, the revenue deriving from the extractive industries supports a majority of government investment in education and health, as well as the pension system. While many resource-rich states can make the same claim, what makes Norway unusual is that it has been able to do so while minimizing corruption, mitigating economic distortions and ensuring efficiency in government spending at the same time.  

How did Norway do it? A look at the Natural Resources Governance Index (NRGI), developed by the Natural Resource Governance Institute, provides a possible explanation: by strengthening governance in the extractive sector. This implies establishing a robust legal and regulatory framework, agile mechanisms to promote transparency and disseminate information, effective safeguards and rigorous controls, and an overall institutional environment that is business-friendly and conducive to greater accountability in the public sector. And this is not a phenomenon unique to Norway, but it is replicated in other countries with large extractive sectors, such as Australia, Botswana and Canada.

Extractive Industries in Latin America and the Caribbean

Latin American and the Caribbean are at a crucial juncture in their effort to strengthen governance in the management of natural resources. On the one hand the above-mentioned NRGI, which measures the quality of extractives governance in 58 resource-rich countries, shows that among the eleven world leaders in quality of extractives governance, more than half are countries from the region (Brazil, Mexico, Chile, Colombia, Trinidad and Tobago and Peru). This is especially good news if one considers that Latin America and the Caribbean is the main source of metals at a global level, and that it holds the second largest oil reserves in the world. Latin America and the Caribbean are also remarkable because many countries have managed to develop large extractive sectors while at the same time avoiding the secessionist conflicts over extractives that plague resource-rich countries in other regions of the world.

On the other hand, Latin America still has to resolve some important issues. Overall, the region still falls short on rule of law and corruption measures in comparison to OECD (Organisation for Economic Co-operation and Development) countries. Social conflicts related to the exploitation of natural resources remain a sensitive issue in the region, especially when extractive industries operate in territories where indigenous communities have a significant interest and presence. Citizen demands regarding the control and mitigation of environmental impacts by governments and corporations are increasing, especially in terms of land use and conservation of water resources and forests. And many Latin Americans are increasingly demanding good governance and transparency in state spending.

Transparency is Key to Improving Governance

The recent IDB book Governance in an Age of Abundance: Experiences from the Extractive Industries in Latin America and the Caribbean (IDB, 2014), edited by Juan Cruz Vieyra and Malaika Masson, analyzes these challenges, particularly in light of recent initiatives to strengthen transparency in the governance of natural resources in the region.

The book focuses on two main themes. The first is on how best to improve governance in the extractives sector, especially in a way that promotes inclusive growth and takes into account the concerns of citizens. The key to this is governance mechanisms that include checks and balances to ensure that the needs of local communities are taken into account. The second theme of the book is a focus on evaluating concrete governance proposals, which include improved legislation, licensing arrangements, contracting procedures, and fiscal regimes. Underlying these two themes is a strong argument in favor of strengthened government capacity to produce, use, and disseminate accurate and timely information about the extractive sector.

The book identifies transparency as a key tool to improve the quality of governance in the extractive sector. This is not an easy task, because effective governance of this sector requires states to manage across a complex set of policy domains. Transparency is part of the solution to this problem by making data available to a wider set of stakeholders. This allows for improved coordination inside of government and helps civil society and the private sector to make informed contributions to public policy and hold governments accountable. For example, Colombia, through its Maparegalías initiative, is putting all the information about how money from extractive industry royalties are being spent, community by community, with everything placed online on an interactive map for easy access. But to make the most out of transparency, states need to address shortfalls in human capacity to use newly available data effectively in the public sector. This is particularly true at the sub-national level in many Latin American and Caribbean countries. Ultimately, as transparency improves and governments use data to operate more effectively and efficiently, citizen trust and confidence in the ability of the public sector to manage the wealth produced by extractive industries will improve. 

The findings of the book point towards two key challenges for governments related to designing and implementing transparency initiatives:

1. Governments need to make data more easily available and more accessible to stakeholders. This includes addressing the quality and timeliness of information. It also means improving the ease of use of data, both in terms of the formatting of data and navigability of the platforms that present it.
2. Governments need to be creative about soliciting feedback from stakeholders in the extractive sector. It is not enough to merely present data to the public. Governments should actively seek out input from citizens. This will ultimately mean investing in public and private capacity to analyze available data so that stakeholders can make informed contributions to governance.

These recommendations present the best way for governments in Latin America and the Caribbean to emerge from the paradoxical Sisyphean trap that resource abundance has all too often posed.

The authors are grateful to Pablo Bachelet, Juan Cruz Vieyra, Francesco De Simone and Martin Walter for their comments. 

Event Information

During the past decade, an abundance of wealth in minerals and hydrocarbons in Latin America and the Caribbean has translated into substantial revenues and macroeconomic growth. However, operations in the extractive sector have also led to significant challenges, such as corruption, negative social outcomes and environmental impacts.

On November 4, the Latin America Initiative and Energy Security Initiative at Brookings, with the Inter-American Development Bank (IDB), hosted a discussion on governance and institutional capacity in the extractive sector in Latin America and the Caribbean, drawing on findings from the publication Transparent Governance in an Age of Abundance: Experiences from the Extractive Industries in Latin America and the Caribbean, published by the IDB. Edited by Malaika Masson and Juan Cruz Vieyra, the book presents transparency as a central element to bolster governance quality and state legitimacy in the context of an increasingly demanding citizenry.

 Join the conversation on Twitter using #LatAmResources

Audio

• Transparent Governance in Latin America’s Extractive Industries

When the head of the world’s largest investment fund raises fundamental questions about U.S. corporations, we should all pay attention.

In a letter earlier this week to the Fortune 500 CEOs, BlackRock Chairman Larry Fink criticized the short-term orientation that he believes shapes too much of today’s corporate behavior. “It concerns us,” he declared, that “in the wake of the financial crisis, many companies have shied away from investing in the future growth of their companies. Too many have cut capital expenditure and even increased debt to boost dividends and increase share buybacks.” And he concluded, “When done for the wrong reasons and at the expense of capital investment, [returning cash to shareholders] can jeopardize a company’s ability to generate sustainable long-term returns.”

Fink is correct on all counts. In a new Brookings paper out today, University of Massachusetts economist William Lazonick states that the 454 companies listed continuously in the S&P 500 index between 2004 and 2013 used 51 percent of their earnings to buy back their own stock, almost all through purchases on the open market. An additional 35 percent went to dividends. “Buybacks represent a withdrawal of internally controlled finance that could be used to support investment in the company’s productive capabilities,” he said.

This is bad for the economy in two ways. As the growth of the U.S. workforce slows dramatically, economic growth will depend increasingly on improved productivity, must of which comes from raising capital investment per worker. Failing to make productivity-enhancing capital investments will doom our economy to a new normal of slow growth.

Many business leaders say that they are reluctant to make long-term investments without reasonable expectations of growing demand for their products. That brings us to the second way in which corporate short-termism is bad for the economy. Most consumer demand comes from wages. If employers refuse to share gains with their employees, growth in demand is bound to be anemic.

Although he clearly cares about his country, Fink is also acting as the steward of $4.8 trillion in investments. In an article published by McKinzie earlier this month, he warns that although the return of cash to shareholders is juicing equity markets right now, investors “will pay for it later when the ability to generate revenue in the long term dries up because of the lack of investment in the future.”

Unlike most other corporate leaders who express concerns about these developments, Fink is unwilling to rely on moral suasion alone. Because current incentives are so perverse, he argued, “It is hard for even the most dedicated CEO to buck this trend.” The constant pressure to produce quarterly results forces executives to go along—or risk losing their jobs. That pressure comes from investors who are, in Fink’s words, “renters, not owners, who are going to trade your stock as soon as they can pocket a quick gain.”

This logic leads BlackRock’s chairman to propose changing the tax code by lengthening to three years the the period needed to qualify for capital gains treatment while taxing trading gains at an even higher rate than ordinary income for investment held less than six months. To encourage truly patient capital, the capital gains rate would be stepped down to zero over a period of ten years.

The workplace is changing rapidly, and more and more leaders in government and private industry are required to lead those who are geographically separated. Globalization, economic shifts from manufacturing to information, the need to be closer to customers, and improved technological capabilities have increased the geographic dispersion of many organizations. While these organizations offer many exciting opportunities, they also bring new leadership challenges that are amplified because of the separation between leaders and followers. Although much has been researched and written on leadership in general, relatively little has been focused on the unique leadership challenges and opportunities presented in geographically separated environments. Furthermore, most leaders are not given the right tools and training to overcome the challenges or take advantage of the opportunities when leading in these unique settings.

A survey of leaders within a geographically dispersed military organization confirmed there are distinct differences in how remote and local leaders operate, and most leadership tasks related to leading those who are remote are more difficult than with those who are co-located. The tasks most difficult for remote leaders are related to communicating, mentoring and building personal relationships, fostering teamwork and group identity, and measuring performance. To be effective, leaders must be aware of the challenges they face when leading from afar and be deliberate in their engagement.

Although there are unique leadership challenges in geographically dispersed environments, most current leadership literature and training is developed on work in face-to-face settings. Leading geographically dispersed organizations is not a new concept, but technological advances over the last decade have provided leaders with greater ability to be more influential and involved with distant teams than ever before. This advancement has given leaders not only the opportunity to be successful in a moment of time but ensures continued success by enhancing the way they build dispersed organizations and grow future leaders from afar.

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• Proximity to the flagpole: Effective Leadership in geographically dispersed organizations

La fuite des informations du cabinet juridique Mossack Fonseca dans l’affaire des « Panama Papers » a fait et fera la une des journaux pendant des semaines à fur et à mesure de la révélation de nouveaux noms des personnes impliquées. Le scandale a placé le Panama sur le devant de la scène et a donné un aperçu inédit du monde de l’argent caché et de l’évasion fiscale. Afin de mieux saisir le contexte général, il est important de faire la distinction entre la corruption légale, révélée par l’affaire des « Panama Papers » et la corruption illégale, exposée par le scandale Unaoil. Le moment est venu pour les gouvernements de prendre des mesures radicales contre l’une et l’autre.  

Les États-Unis, le Royaume-Uni et plusieurs autres pays annonceront leurs engagements pour lutter contre la corruption lors du sommet anticorruption le 12 mai, dont le Premier ministre David Cameron affirme qu’il changera la donne. La question est de savoir si ces engagements se traduiront par des mesures concrètes à l’égard des types de corruption les plus coûteux qui, aujourd’hui, se prolifèrent à l’échelle mondiale.  

Malheureusement, le monde s’engage souvent dans des  sommets, riches en communiqués, en appels à la coordination et à l’échange d’informations. Parfois, ces sommets mettent en place une initiative inefficace supplémentaire : donnant l’opportunité de créer et promouvoir des articles et photos qui servent les objectifs politiques précis de certains leaders politiques. Voyons si ce sommet sera diffèrent.

Au-delà du Panama

Le cabinet juridique Mossack Fonseca et son pays respectif, le Panama, ne sont que deux éléments dans le vaste et complexe ensemble de « facilitateurs » de la corruption et de l’évasion fiscale à l’échelle mondiale.     

Pour ceux qui sont à la recherche de refuges discrets et de sociétés-écrans, la puissante nation des États-Unis (qui sans surprise n’apparaît pas beaucoup dans les Panama Papers) est une des destinations les plus attrayantes du monde : par example, dans l’état du Delaware la loi requiert  moins de documents pour établir une société-écran que pour obtenir un permis de conduire. Comme on le voit dans l’illustration ci-dessous, c’est cette opacité, conjuguée à la taille du refuge qu’offrent les États-Unis, qui met le pays à la troisième place des juridictions les plus secrètes parmi une centaine évaluée par l’indice d’opacité financière (FSI). Le Panama est à la treizième place.

Illustration 1 : Indice d’opacité financière 2015 (Juridictions sélectionnées, d’après le réseau pour la justice fiscale)

Source : Indice d’opacité financière du Réseau pour la justice fiscalehttp://www.financialsecrecyindex.com/introduction/fsi-2015-results

Ce graphique présente les 40 juridictions les moins performantes ainsi que quatre juridictions choisies pour leurs meilleurs résultats (à droite des pointillés). L’indice présente un score de secret qualitatif basé sur une quinzaine d’indicateurs et une mesure quantitative de l’importance d’une juridiction dans les exportations de services financiers à l’échelle mondiale. 

Le Royaume-Uni est un important facilitateur de corruption : il n’a engagé aucune action contre ses juridictions et protectorats d’outre-mer qui servent de refuge aux richesses illicites, comme le démontrent clairement les  « Panama Papers ». Les Iles Vierges britanniques, par exemple, est le lieu préféré  de milliers de sociétés-écrans établies par Mossack Fonseca.  

Au-delà des refuges fiscaux 

L’affaire des « Panama Papers » ne concerne qu’indirectement les aspects essentiels de la question de la corruption mondiale, qui ne sont liés ni au Panama ni à la fiscalité. Nous devons envisager les scandales suscités sous un angle plus large et reconnaître les immenses et complexes réseaux de la corruption, qui lient de plus en plus les élites économiques et politiques mondiales.

La grande corruption

Les puissants individus qui s’engage dans la corruption à haut niveau, c’est-à-dire la corruption à large échelle ne sont pas inquiétés par l’affaire des « Panama Papers ». On trouve parmi ces individus des dirigeants kleptocrates ainsi que des oligarques qui exercent une influence majeure sur les affaires gouvernementales. Souvent, ces acteurs interagissent et s’associent, en formant des réseaux public-privé très puissants qui font passer pour un jeu d’enfant la définition traditionnelle de la corruption comme étant une transaction illégale entre deux parties.

Dans ces réseaux élitistes, la corruption excède largement le comportement immoral du fraudeur type, puisqu’elle utilise l’abus de pouvoir pour accumuler biens et pouvoir, souvent par le pillage direct des ressources publiques, la confiscation d’actifs ou la corruption à grande échelle. Le scandale à plusieurs milliards de dollars qui touche le géant pétrolier Petrobas au Brésil illustre la complexité de ces réseaux d’entente, et les moyens avec lesquels, la corruption à large échelle  peut provoquer des dégâts politiques et économiques d’ampleur historique dans un pays. 

Le secteur pétrolier offre de nombreux example de corruption à large échelle. Les dirigeants de la société Unaoil, dont un scandale similaire a récemment fait surface,  ont sans doute été soulagés par l’affaire des « Panama Papers » Unaoil est une société monégasque  « facilitatrice » de droit qui a versé des pots-de-vin et influencé des responsables gouvernementaux dans différents pays pour le compte de compagnies multinationales se disputant de juteux contrats d’approvisionnement. Bien qu’éclipsé par l’affaire du Panama, le cas d’Unaoil est aussi emblématique les enjeux inhérents à la lutte contre la corruption mondiale. Il illustre par exemple la pratique fortement enracinée des responsables gouvernementaux irakiens qui demandent des dessous de table en échange de l’attribution de contrats, ainsi que l’empressement des entreprises à verser ces pot-de-vin.

Les élites corrompues, notamment celles qui sont impliquées dans le scandale Unaoil, utilisent souvent des structures telles que les sociétés-écrans et les paradis fiscaux (et les investissements immobiliers ou autres) pour dissimuler leur biens mal-acquis. Toutefois, si l’affaire des Panama Papers incite à plus de vigilance sur les flux financiers illicites et engendre la réforme de ces structures financières opaques, la corruption à large échelle se poursuivra dans nombreux endroits.  Il est à noter que les retombées politiques se sont concentrées dans des pays relativement bien gouvernés, qui ont instauré des systèmes anticorruptions et de responsabilisation, comme en témoignent les démissions du Premier ministre islandais, du ministre de l’industrie espagnol et du dirigeant de la section chilienne de Transparency International. 

En revanche, le président Vladimir Poutine a balayé d’un revers de la main les fuites d’information sur la Russie, les considérant comme une conspiration occidentale contre sa personne. En Chine, le débat et la diffusion de ces informations ont été étouffés par la censure des médias ; en Azerbaïdjan, la révélation des détails concernant les intérêts miniers de la famille du président Aliyev ne menace guère sa mainmise sur le pouvoir. Il est à espérer que les réformes découlant de l’affaire du Panama dissuaderont les fraudeurs ainsi que les entreprises et les particuliers aux pratiques immorales de dissimuler leur argent bien mal acquis. Toutefois, les dirigeants corrompus continueront à bénéficier de l’impunité.

Corruption légale et captation de l’État   

Les Panama Papers ont mis en lumière le type de corruption qui est sans doute le plus dévastateur et le plus dure à contrecarrer : la corruption légale et la captation de l’État.  Partout dans le monde, de puissantes élites économiques et commerciales influencent indûment les lois et les politiques, en redessinant les règles du jeu pour leur propre bénéfice, un phénomène aussi connu sous le nom de « privatisation de la politique publique et des lois ». Une pratique qui génère des revenus exorbitants pour les élites, renforce leur pouvoir et exacerbe les disparités politiques et économiques d’un pays.

Les pays riches en ressources naturelles fournissent de nombreux exemples. En Angola, en République démocratique du Congo, au Nigéria et au Venezuela, par exemple, les élites politiques ont utilisé des sociétés publiques exploitant les ressources naturelles pour servir leur népotisme, souvent - mais pas uniquement - par des moyens légaux.

Dans beaucoup de pays industrialisés, le système fiscal est en lui-même un exemple de captation de l’État. Il est dans l’intérêt des élites de conserver un réseau mondial de sociétés offshore et de paradis fiscaux secrets pour pouvoir dissimuler leur patrimoine - qu’il ait été acquis légitimement ou non. Les preuves d’évasion fiscale aux États-Unis sont révélatrices : selon Zucman, depuis les années 1950, le taux réel de l’impôt sur les sociétés a été réduit de 45 à 15 pour cent, alors que le taux nominal est seulement passé de 50 à 35 pour cent. Et les sociétés américaines font un usage optimal des paradis fiscaux à l’étranger : d’après un nouveau rapport d’Oxfam, les 50 plus grandes multinationales américaines ont rapporté en 2008 que 43 pour cent de leurs revenus réalisés à l’étranger provenaient de cinq paradis fiscaux, représentant seulement 4 pour cent des effectifs étrangers de ces sociétés. En outre, Bourguignon rappelle que les taux d’imposition fédéraux des Américains les plus riches ont diminué de 15 pour cent entre 1970 et 2004.

Le risque de corruption légale aux États-Unis est important, l’argent privé pouvant très facilement influencer les affaires publiques. Suite à l’arrêt Citizen United rendu par la Cour suprême en 2010 [qui permet la participation financière des entreprises aux campagnes politiques], les fonds privés issus de poches bien garnies dirigent de plus en plus les campagnes électorales. Les moyens par lesquels l’argent privé influence les représentants publics pourraient encore se multiplier, si les formes de corruption traditionnellement considérées comme illégales devenaient légales. Selon une décision en instance de la Cour Suprême, il pourrait désormais être légal pour les responsables publics d’accepter les dons en nature des particuliers (ce qui pourrait annuler la condamnation d’un ancien gouverneur de l’État de Virginie accusé précisément de ce délit).  

Quelles mesures prendre ?     

En Bref, Il n’y a pas de solutions simple  et directe, d’autant plus que les décideurs tirent profit de ce statu quo.  Mais l’opportunité de réforme et la pression publique sont actuellement présentes. Comme nous l’avons évoqué, la question de la lutte contre la corruption entraîne souvent des mesures symboliques et l’annonce par David Cameron d’une nouvelle agence mondiale anticorruption pourrait très bien tomber dans cette catégorie. Les pays comme les États-Unis et le Royaume-Uni devraient plutôt prendre des mesures concrètes pour réformer leurs propres pratiques et pousser leurs partenaires à faire de même, qu’il s’agisse des dépendances de la Couronne et des territoires britanniques d’outre-mer, de l’Union européenne et des membres du G20 ou des bénéficiaires d’une aide internationale.

Premièrement, il faudrait prendre la corruption légale et la captation de l’État au sérieux 

La transparence peut changer les règles du jeu, particulièrement si elle s’attaque aux réseaux d’influence par lesquels la politique se « privatise ». La divulgation des contributions financières aux campagnes électorales, des conflits d’intérêts, des avoirs détenus par les hommes politiques et les responsables publics (et de leurs avis d’impôts), des délibérations et votes parlementaires sont autant de moyens d’éviter les abus et de révéler les réseaux cachés qui sont à l’œuvre. La publication récente de la première salve de l’Organisation de Coopération et de Développement Economiques (OCDE) est encourageante : son rapport « Le financement de la démocratie », s’attache à quelques études de cas. La suite logique serait d’habiliter l’organisation à développer des normes et mener des évaluations sur le financement politique de tous les pays de l’OCDE.

La transparence ne sera utile que si les citoyens peuvent mener un examen attentif de leurs gouvernements et dialoguer avec eux.  L’espace civique est en danger dans de nombreuses juridictions où les activistes et les journalistes sont la cible d’intimidations, de poursuites, voire pire. Garantir la liberté d’expression et de réunion devrait être l’affaire de tout acteur international concerné par la lutte contre la corruption ou la gouvernance économique. Par exemple, lors de l’examen des demandes de financement de gouvernements ayant un piètre bilan en matière de protection de la société civile - comme c’est le cas de l’Angola et de l’Azerbaïdjan - la Banque Mondiale et le Fonds Monétaire International, ainsi que les donateurs comme les États-Unis, devraient privilégier la responsabilisation citoyenne et des réformes de transparence plus ambitieuses.

En outre, la corruption à large échelle ne s’évincera pas en l’absence de poursuites ou d’autres sanctions efficaces contre ceux qui se laissent corrompre ou contre les facilitateurs et les intermédiaires de la corruption qu’ils soient avocats, comptables ou entremetteurs comme Unaoil. Bien sûr, les autorités chargées d’appliquer la loi doivent aussi rester vigilantes vis-à-vis des sociétés qui versent les pots-de-vin et à cet égard, les gouvernements - notamment les membres de l’OCDE instaurant, à des degrés divers, la Convention de l’OCDE sur la lutte contre la corruption - feraient bien d’imiter la mise en œuvre effective de la loi américaine sur la corruption dans les transactions à l’étranger (FCPA). Mais les individus corrompus et les facilitateurs n’ont pas été suffisamment surveillés et sanctionnés.

Deuxièmement, il faudrait se débarrasser des zones d’ombre.

Les leçons tirées des événements récents, de la crise financière de 2008 à l’affaire des Panama Papers, indiquent que les principaux acteurs internationaux ne devraient pas permettre que de vastes fractions de l’économie mondiale échappent à un examen attentif. Les États-Unis et le Royaume-Uni (et ses territoires d’outre-mer) devraient répondre aux appels à mettre fin à l’opacité et aux paradis fiscaux.  Quelques premières tentatives  émergent, telle que la décision du gouvernement américain demandant aux banques de révéler l’identité des individus se cachant derrière les sociétés-écrans. Des mesures plus ambitieuses seront toutefois nécessaires, ceci comprend des dispositions législatives.  

La transparence sur la propriété réelle doit devenir une procédure opérationnelle standard, avec des États qui suivent l’exemple du Royaume-Uni, des Pays-Bas et d’autres pays qui ont établi des registres publics et soutiennent le projet d’un registre mondial. Quant aux pays riches en ressources naturelles, un bon point de départ serait d’établir des registres spécifiques au secteur. Cette pratique est maintenant imposée par l’Initiative pour la Transparence dans les Industries Extractives.

Au sein du secteur extractif, les gouvernements des pays d’accueil devraient soumettre les négociants de matières premières à des exigences de divulgation des paiements lorsqu’ils font affaire avec les gouvernements et les entreprises publiques. Les gouvernements de pays comme la Suisse, le Royaume-Uni et Singapour, qui abritent des acteurs du monde de l’entreprise, ont une lourde responsabilité, particulièrement dans le contexte actuel de faible prix des matières premières, où les négociants concluent de nouveaux contrats profitables avec des pays producteurs de ressources à court d’argent. Eclaircir telles zones d’ombre les rendra moins vulnérables aux abus.

Troisièmement, il faudrait donner la priorité à la transparence et au contrôle lors de l’allocation de ressources publiques.

Lorsqu’un gouvernement attribue des ressources pour l’exploitation, il doit le faire de façon tout à fait transparente. L’initiative Open Contracting Partnership a fait de grandes avancées dans la définition d’une norme de référence pour de telles informations, notamment en matière d’orientation sur les questions de l’ouverture des données, des identificateurs des sociétés et de la propriété réelle.

Les recherches sur la corruption dans les secteurs pétrolier et minier menées par le Natural Resource Governance Institute montrent que de multiples allocations à forte valeur nécessitent un examen attentif et une divulgation du contrat. Elles comprennent l’attribution des permis d’exploration et de production, mais aussi des droits d’exportation, d’importation ou de transport, qui ont été associés à la corruption dans des pays comme l’Indonésie, la République du Congo et l’Ukraine. La plupart des affaires liées au secteur pétrolier et portées devant les tribunaux dans le cadre de la FPCA aux États-Unis ont surgi à l’occasion de l’attribution de marchés de service, un segment de l’industrie pétrolière qui concernait également les scandales Unaoil et Petrobras. La transparence devrait être le « paramètre par défaut » de toute transaction allouant des ressources publiques. Il est nécessaire d’exercer un contrôle supplémentaire des régimes de taux de change mis en œuvre et abusifs, qui génèrent des revenus pour quelques-uns et engendrent des disparités économiques majeures, comme c’est le cas actuellement au Nigeria, au Venezuela et en Égypte.

Pour espérer un impact réel, il faudra aussi s’attaquer frontalement au principe d’impunité, puisque la transparence et la liberté d’expression sont certes nécessaires, mais insuffisantes.  Et les Etats, y compris les États-Unis et le Royaume-Uni, devront adopter des réformes pour lutter contre la corruption légale et l’opacité sous toutes ses formes, que ce soit en s’attaquant à la mainmise de l’argent en politique ou aux « zones d’ombre » entourant les négociants pétroliers installés à Genève et Londres. 

Un engagement ambitieux à lutter contre la corruption et l’impunité n’est pas seulement une nécessité actuelle, mais aussi une revendication de nos sociétés, comme l’ont montré les événements au Brésil et ailleurs. Ce pourrait être le moment décisif de faire de réelles avancées à l’échelle mondiale.  

This piece is also available in English and Spanish. 

The Syrian uprising has changed significantly since the first signs of localized armed resistance began emerging in late April 2011. Western states and regional countries opposed to President Assad’s rule failed to manage the formation of an organized and representative political and military opposition body over the past three years. Instead, fragmentation of first the opposition, and then the conflict as a whole, has come to pose numerous serious threats to regional and international security and stability.

In a new Policy Briefing by the Brookings Doha Center, Charles Lister analyzes the Western-backed opposition, the spreading influence of jihadi militants, and the evolving capabilities of pro-government forces. With a definitive military victory seemingly out of reach for all sides of the conflict, Lister argues these parties will remain at a standoff until a political solution is reached. However, as armed groups multiply on either side, even an agreement between government and opposition will be unlikely to end the violence.

Lister concludes that Western and regional countries should focus on two core policy objectives. First: the international community should bolster a cohesive opposition that can challenge the Assad regime in battle as well as in negotiations. Second: the international community should aid Syria’s neighbors in managing the violent spillover of the conflict, particularly curtailing the potential for Syria-based jihadi groups to expand their operations beyond the country.

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Brookings Doha Center Analysis Paper, December 1, 2014

Intense turmoil in Syria and Iraq has created socio-political vacuums in which jihadi groups have been able to thrive. The Islamic State in Iraq and al-Sham (ISIS) had proven to be the strongest and most dynamic of these groups, seizing large swathes of territory in Syria and Iraq. Shortly after routing Iraqi forces and conquering Mosul in June 2014, ISIS boldly announced the establishment of a caliphate and renamed itself the Islamic State (IS). How did IS become such a powerful force? What are its goals and characteristics? What are the best options for containing and defeating the group?

In a new Brookings Doha Center Analysis Paper, Charles Lister traces IS’s roots from Jordan to Afghanistan, and finally to Iraq and Syria. He describes its evolution from a small terrorist group into a bureaucratic organization that currently controls thousands of square miles and is attempting to govern millions of people. Lister assesses the group’s capabilities, explains its various tactics, and identifies its likely trajectory.

According to Lister, the key to undermining IS’s long-term sustainability is to address the socio-political failures of Syria and Iraq. Accordingly, he warns that effectively countering IS will be a long process that must be led by local actors. Specifically, Lister argues that local actors, regional states, and the international community should work to counter IS’s financial strength, neutralize its military mobility, target its leadership, and restrict its use of social media for recruitment and information operations.

Nearly two years after ousting President Muhammad Morsi, Egypt’s military continues to crack down on the Muslim Brotherhood. Much like during Egypt’s 1952-54 political transition, the recent interactions between the powerful armed state bureaucracy and the influential religious organization have had a major impact on the country’s political trajectory. In both instances, the military and Muslim Brotherhood initially cooperated before ultimately clashing violently. How has each entity determined what approach to take toward the other? What does a continued imbalance in civil-military relations mean for Egypt’s future?

In a new Brookings Doha Center Analysis Paper, Omar Ashour examines the legacies and patterns of cooperation and conflict between the leaderships of Egypt’s military and the Muslim Brotherhood. Relying on extensive field research, he analyzes how each entity has made its critical decisions regarding the other by applying various decision-making models. Ashour considers the impact of cost-benefit analysis, organizational dynamics, factional disputes, and psychological factors to gain a deep understanding of the leaders’ motives.

Read "Collusion to Crackdown: Islamist-Military Relations in Egypt"

Ashour concludes that Egypt's prospects for social stability and economic recovery will remain bleak if the relationship between the military and the Muslim Brotherhood is not redefined within institutional, democratic rules of political competition. He argues that Egypt’s military should embrace a balanced civil-military relationship to realize broad, long-term benefits and avoid otherwise inevitable and costly clashes with segments of Egyptian society. As for the Muslim Brotherhood, Ashour recommends that it reevaluate its recent decisions and work to develop a sustained, solid, and cross-ideological civilian front that can pressure the military to leave politics and allow for democratization.

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International jihad has undergone a wholesale internal revolution in recent years. The dramatic emergence of the Islamic State (IS) and its proclamation of a Caliphate means that the world no longer faces one Sunni jihadi threat, but two, as IS and al-Qaida compete on the global stage. What is the relationship between the groups and how do their models differ? Is IS’s rapid organizational expansion sustainable? Can al-Qaida adapt and respond?

Read "Jihadi Rivalry: The Islamic State Challenges al-Qaida"

In a new Brookings Doha Center Analysis Paper, Charles Lister explores al-Qaida and IS’s respective evolutions and strategies. He argues that al-Qaida and its affiliates are now playing a long game by seeking to build alliances and develop deep roots within unstable and repressed societies. IS, on the other hand, looks to destabilize local dynamics so it can quickly seize control over territory.

Lister finds that the competition between IS and al-Qaida for jihadi supremacy will continue, and will likely include more terrorist attacks on the West. Accordingly, he calls for the continued targeting of al-Qaida leaders, the disruption of jihadi financial activities, and greater domestic intelligence and counter-radicalization efforts. Lister concludes, however, that state instability across the Muslim world must be addressed or jihadis will continue to thrive.

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