The debate surrounding net energy metering (NEM) and the appropriate way to reform this policy is under scrutiny in many U.S. states. This is highly warranted since NEM policies do indeed need reforming because NEM often results in subsidies to private (rooftop) solar owners and leasing companies. These subsidies are then “paid for” by non-NEM customers (customers without private rooftop solar installations). The fundamental source of the NEM subsidy is the failure of NEM customers (customers with private rooftop solar installations) to pay fully for the grid services that they use 24/7. These subsidies are well-documented and underpin much of the regulatory reform efforts underway across the United States.[1]

In a recent Brookings paper, “Rooftop solar: Net metering is a net benefit,” Mark Muro and Devashree Saha contend that net metering is a net benefit for non-NEM customers.[2] I fundamentally disagree with their findings, and argue that NEM is not a net benefit; it is, in fact, a tariff that much of the time results in a subsidy to NEM customers and a cost shift onto non-NEM customers. As Executive Director of the Institute for Electric Innovation, a non-lobbying organization focused on trends in the electric power industry, I have followed this debate and written about it for several years.

Much of the talk about NEM focuses too often on the “value” of the energy that is sold back to the grid by a NEM customer. In reality, the amount of energy sold back to the grid is relatively small. The real issue is the failure of NEM customers to pay fully for the grid services that they use while connected to the grid 24/7, as shown in Figure 1.[3] Customers need to constantly use the grid to balance supply and demand throughout the day, and the cost of these grid services can be sizeable. In fact, for a typical residential customer in the United States with an average electricity bill of $110 per month, the actual cost of grid services can range from $45 to $70 per month–however, the customer doesn’t see that charge.[4] That means, in the extreme, if a customer’s energy use “nets” to zero in a given month because the customer’s private solar system produced exactly what the customer consumed, that customer would pay $0 even though that customer is connected to the local electric company’s distribution grid and is utilizing grid services on a continuous around-the-clock basis.[5]

Although exactly netting to zero energy in a month is highly unlikely, this example demonstrates the point that the customer would pay nothing, despite using grid services at a cost ranging from $45 to $70 per month. Over the course of one year, this customer could receive a subsidy resulting from NEM of between $540 and $840. Over the life of a private rooftop solar system, which ranges from 20 to 25 years, this is a significant subsidy resulting from NEM.

Granted, this is an extreme example, and most NEM customers will pay for some portion of grid services. However, the fundamental source of the NEM subsidy is the failure of NEM customers to pay fully for the grid services that they use 24/7, and the cost of these services can be quite substantial. When a NEM customer doesn’t pay for the grid, the cost is shifted onto non-NEM customers.[6] It is a zero-sum game; plain and simple. This is the elephant in the room.

This issue was directly addressed by Austin Energy when the company implemented a “buy-sell” arrangement for the private rooftop solar customers in its service territory. The rationale for the buy-sell approach is that the customer buys all of the energy that is consumed on-site through the electric company’s retail tariff and sells all of the energy produced by their private rooftop solar system at the electric company’s avoided cost. This addresses the “elephant in the room” because, by buying all energy consumed at the retail tariff, the customer does pay for grid services that are largely captured through the retail tariff. It is an unfortunate fact that under ratemaking practices today in the United States, the majority of fixed costs (i.e., grid and other costs) are captured through a volumetric charge.

Hence, I fundamentally disagree with the Muro/Saha paper–NEM does need to be reformed. NEM is not a net benefit; it is a tariff that the much of the time results in a cost shift onto non-NEM customers. One of the first studies to quantify the magnitude of the NEM subsidy was conducted by Energy+Environmental Economics (E3) for the California Public Utilities Commission (CPUC) in 2013. There was no mention of this analysis for the CPUC in the Muro/Saha paper. The E3 study estimated that NEM would result in a cost shift of $1.1 billion annually by 2020 from NEM to non-NEM customers if current NEM policies were not reformed in California.[7] A cost shift of this magnitude–paid for by non-NEM customers–was unacceptable to California regulators. As a result, California regulators set to work to reform rates in their state; many other states followed suit and conducted similar investigations of the magnitude of the NEM subsidy.

In reviewing NEM studies, Muro and Saha chose to focus on a handful of studies that show that net metering results in a benefit to all customers. In this small group of NEM studies, they included a study that E3 conducted for the Nevada Public Utilities Commission (PUC) in 2014–perhaps the most well-known and cited of the five studies included in the Muro/Saha paper. Very soon after the E3 Nevada study was published, the cost assumptions for the base-case scenario which showed a net benefit of $36 million to non-NEM customers (assuming $100 per MWh for utility-scale solar) were found to be incorrect, completely reversing the conclusion. The $36 million benefit associated with NEM for private rooftop solar turned into a $222 million cost to non-NEM customers when utility-scale solar was priced at $80 per MWh.[8] Today, based on the two most recent utility-scale contracts approved by the Nevada PUC, utility-scale solar has an average lifetime (i.e., levelized) cost of $50 per MWh, meaning that the NEM cost shift would be far greater today. In February 2016, the Nevada PUC stated that “the E3 study is already outdated and irrelevant to the discussion of costs and benefits of NEM in Nevada…”[9] Hence, because the E3 study for the Nevada PUC that the Muro/Saha paper included has been declared outdated and irrelevant to the discussion and because costs for utility-scale solar have declined significantly, that study does not show that NEM provides a net benefit.

No doubt there is an intense debate underway about NEM for private rooftop solar, and much has changed in the past two years in terms of both NEM policies and the growth of private solar projects:

• First, several state regulatory commissions now recognize that the NEM cost shift is both real and sizeable and that all customers who use the grid, including NEM customers, need to pay for the cost of the grid. As a result, many electric companies have proposed and state regulatory commissions have approved increases in monthly fixed charges over the past few years; this partially addresses the issue of NEM customers paying for the cost of the grid services that they use.
• Second and related, getting the pricing right for distributed energy resources of all types is important because we expect those resources to grow significantly in the future. Work is underway in this area and it is one focus of the New York Reforming the Energy Vision proceeding; but there is still much to be done.

By focusing on a select group of studies that show that NEM benefits all customers (as stated by the authors); by excluding the E3 study for the CPUC which was fundamental to the NEM cost shift debate; and by not providing an update on the NEM debate today, I believe that the Muro/Saha paper is misleading.

In the second part of their paper, Muro and Saha suggest some helpful regulatory reforms such as moving toward rate designs that “can meet the needs of a distributed resource future” and moving “toward performance-based rate-making (PBR).” Some electric companies have already implemented PBR or some type of formula rate and PBR is under discussion in several states.[10] Lawrence Berkeley National Labs is looking closely at this and related issues in its Future Electric Utility Regulation series of reports currently underway.[11]

Mura and Saha also suggest decoupling as a way forward–I disagree. In my view, decoupling is a not solution for private rooftop solar. Revenue decoupling is currently used to true-up revenues that would otherwise be lost due to declining electricity sales resulting from electric company investments in energy efficiency (EE). Decoupling explicitly shifts costs from participating EE customers to non-participating EE customers causing the same cost-shifting problem that is created by NEM. However, a fundamental difference is that the magnitude of the cost shifting onto non-NEM customers is on a much larger scale than the cost shifting due to EE. A recent study revealed that decoupling rate adjustments for EE are quite small–about two to three percent of the retail rate.^[12] In contrast, as described earlier in this paper, a NEM customer could shift a significant cost onto non-NEM customers (and the NEM cost shifting is essentially invisible to customers, which is one reason that NEM customers do not believe they are subsidized).[13]

Finally, Muro and Saha suggest that electric companies should invest in a more digital and distributed power grid. In fact, electric companies across the United States are doing just that. In 2015, electric companies invested $20 billion in the distribution system alone and this is expected to continue. Over the past five to six years, electric companies invested in the deployment of nearly 65 million digital smart meters to about 50 percent of U.S. households. In addition, electric companies are investing in thousands of devices to make the power grid smarter and more state-aware. Today, in states such as California, Hawaii, and Arizona, electric companies are investing to enable and integrate the distributed energy resources that are growing exponentially. And, in some states–where regulation allows–electric companies are offering rooftop solar or solar subscriptions to their customers.

No doubt, the electric power industry is undergoing a period of profound transformation–our power generation resource mix is getting cleaner and more distributed; the energy grid is becoming more digital; and customers have different expectations.[14]

Collaboration, good public policy, and appropriate regulatory policies are critical to a successful transformation of the power sector. In the context of this paper, this means reforming NEM so that private rooftop solar customers who use the energy grid pay for the grid. One straightforward approach is to require NEM customers to pay a higher monthly fixed charge thereby reducing the cost shift.[15] Ultimately the challenge is to make the transition of the electric power industry–including the significant growth in private rooftop solar and other distributed energy resources–affordable to all customers.

Lisa Wood is a nonresident senior fellow in the Energy Security and Climate Initiative at Brookings. She is also the executive director of the Institute for Electric Innovation and vice president of The Edison Foundation whose members include electric companies and technology companies.

While falling off the "fiscal cliff" (of automatic spending cuts and tax increases if Congress fails to act) could hurt the economy, expert William Gale says the actual result, if coupled with a temporary economic stimulus, would be greater incentives to make a better long-term budget deal.

Video

• William Gale: Combine Going Over the Fiscal Cliff with a Stimulus

France has been struck by an unprecedented three terror attacks in the last 18 months. In what’s called Operation Sentinelle, 13,000 French military personnel now patrol streets and protect key sites across the country, assisting police and other security agencies. “The fact that the armed forces are visible,” said French Defense Minister Jean-Yves Le Drian at a Brookings event on July 20, “help to reassure the French people that they are safe both at home and abroad.”

Do the challenges facing France today mean that it should reduce its engagement overseas, focusing instead on security at home? Le Drian doesn’t think so, and I agree. In a new book titled "Who is the Enemy?," he particularly emphasizes the multifaceted ISIS threat. As he said at Brookings: 

"Every war [has] two enemies…[Today’s] war [with ISIS] also sets in place two concepts of the “enemy” that are radically different: From a strategic point of view, we are dealing with a proto-state; at the heart of this entity, there is a terrorist army." 

It only further complicates matters, of course, that France faces ISIS threats on several fronts: in Syria and Iraq, on the one hand, and also on its own territory. This, Le Drian stressed, means “we must seek coherence in our military action.” It also helps explain why France remains one of the most active countries in the fight against the so-called Islamic State, as well as other extremist groups in the Middle East and in sub-Saharan Africa. In 2013 and 2014, France intervened in Mali in order to prevent jihadi groups from taking over the country. The French military also has a presence in Djibouti, Lebanon, Côte d’Ivoire, the Central African Republic, Gabon, Senegal, as well as in the Pacific (in French Polynesia and New Caledonia)—not to mention Syria, where France uses the Mediterranean Sea-based Charles de Gaulle aircraft carrier to strike ISIS targets. 

France is not a warmongering country—rather, it is responding to the fact that overseas threats come to it. Although it remains unclear to what extent the Nice attacker had connections with foreign terrorist networks, it has been established that the November 2015 Paris attacks were planned and orchestrated from Syria. This, among other considerations, has prompted France to engage further in Iraq and Syria. The rationale, as Minister Le Drian explained, is: 

“[T]rading our peace by reducing our military involvement doesn’t make sense. The more we let ISIS consolidate its presence on the Middle East, the more it will gather resources, attract fighters, and plan more attacks against us.” 

Team player

French policy isn’t just about ensuring its own security—rather, its many contributions are integrated within global efforts, including U.S.-led ones. As Le Drian said at Brookings: “I am convinced that the French-American relationship is stronger and better than ever.” France is a prominent participant of the 66-member international coalition against ISIS, and in that capacity participated in the first joint meeting of that group’s foreign and defense ministers in Washington this month. 

France remains a key member of the joint military operation Inherent Resolve in Iraq and Syria, which has damaged or destroyed over 26,0000 ISIS-related targets since August 2014. The Charles de Gaulle carrier—with 26 aircrafts on board—has been an essential part of that coalition mission. Following specific instructions from U.S. Defense Secretary Ash Carter and his counterpart in Paris, Minister Le Drian, French and U.S. intelligence agencies cooperate closely in intelligence-sharing. And just last week, President François Hollande announced that France will soon be supplying artillery to Iraq to support its fight against ISIS. Beyond the Iraq-Syria theater, France is cooperating with the United States and other partners in Libya, another country that is both a victim and source of extremist threats. 

The French Defense Ministry’s efforts to double-down on protecting French citizens within France, therefore, has not reduced its overseas role. Particularly now that the United Kingdom will leave the European Union, France’s military role has never been so important. France—along with Germany, which recently suggested it would raise its defense spending significantly—should continue to play a leading role as one the top defense actors in the West. 

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. 

Last month’s decision by the Palestinian Authority to schedule municipal elections in early October hardly registered in the West Bank and Gaza Strip, much less here in Washington. In light of Hamas’ recent decision to take part in the process, however, those elections have suddenly taken on new meaning. While the election of some 414 village, town, and city councils across the West Bank and Gaza Strip will not change the face of the Palestinian leadership or alter the diplomatic impasse with Israel, local elections have the potential to unlock the current paralysis within Palestinian politics.

Although Palestinian law calls for local elections to take place every four years, they have only been held twice since the creation of the Palestinian Authority (PA) in 1993, only one of which could be deemed genuinely competitive. The first and only local elections to take place in both the West Bank and Gaza Strip were held in 2004-05, in which Hamas—in its first foray into electoral politics—made major gains. Local elections were again held in 2012, although this time Hamas boycotted the process, preventing the vote from taking place in Gaza and allowing Fatah to declare a sweeping, if somewhat hollow, victory. 

Hamas’ decision to take part in this year’s local elections was therefore something of a surprise. Indeed, Hamas initially expressed dismay at the announcement, accusing the leadership in Ramallah of acting without consulting the other parties. Moreover, should the elections proceed as planned on October 8, they would be the first competitive electoral contest in the occupied territories since Hamas defeated Mahmoud Abbas’s ruling Fatah faction in the 2006 legislative election. Those elections triggered an international boycott of the PA which eventually led to the split between Fatah and Hamas and the current political paralysis.

If nothing else, Hamas’ entry into the elections averts another needless internal crisis in Palestinian politics. A boycott by Hamas would likely have further entrenched the political and geographic division between the Fatah-dominated West Bank and Hamas-ruled Gaza Strip, while dealing yet another blow to the beleaguered National Consensus Government, which despite being accepted by both factions in April 2014 has yet to physically return to Gaza. Movement on the reconciliation track could also help push the long-stalled reconstruction of Gaza, which has yet to recover from the devastating war of 2014.

Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other...[and Fatah] has little to gain from “winning” another electoral process that is largely uncontested.

What explains Hamas’ apparent change of heart? For one, Hamas may believe it has an advantage over Fatah, which continues to suffer from widespread perceptions of corruption and incompetence—a perception reinforced by the collapse of the peace process as well as the unprecedented unpopularity of President Abbas. Hamas may also view the upcoming vote as a way to gauge its current standing and future prospects in anticipation of long-awaited legislative and presidential elections. Either way, Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other. 

Hamas’ decision to participate in the elections is welcome news for Palestinian voters eager to see the return of competitive elections and a revival of political life after years of stagnation. It even helps Fatah, which has little to gain from “winning” another electoral process that is largely uncontested. More important, as the party that lost both parliamentary elections and a civil war in 2006-07 and that remains the chief proponent of a failed process, Fatah desperately needs a political victory of some kind as well as a basis on which to stake its claim to legitimacy and continued grip on power.

That said, it is important not to overstate the significance of local elections, which in the end will do nothing to address the deeper problems facing Palestinians in the occupied territories, whether from Israel’s continued occupation and its ever-expanding settlement enterprise or the ongoing political dysfunction within their own ranks. On the other hand, the prospect of the first competitive Palestinian elections in a decade represents a small but significant ripple in the otherwise stagnant waters of Palestinian politics.

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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Many clinicians have terrific ideas for improving the quality and cost of health care, but often don’t know how to navigate the frequently baffling landscape of payment and delivery reform options. To address this need in clear, practical terms, we are pleased to announce the third MEDTalk event in the “Merkin Series on Innovations in Care Delivery.” The series is designed to support clinicians and policymakers who’ve always wondered how delivery reform occurs, but didn’t know where to begin.

Our third case drew on the experiences of the Community Asthma Initiative, an enhanced pediatric asthma intervention, and their efforts in sustainability. The event featured seven brief “TED-style” talks that consider the challenges of delivering pediatric care, while tackling non-medical factors that drive suboptimal care, improving patient and family quality of life, and reducing costs. The agenda included firsthand experiences from patients, payers, policymakers, and clinical leadership from Massachusetts and Arkansas. Sustainable improvement strategies and the financial mechanisms available to encourage innovations in asthma were explored.

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• MEDTalk: Pediatric Asthma and Transforming Care for the Most Vulnerable
• A Day in the Life: The Patient Experience
• Challenge Accepted: Delivery of Asthma Care in a Triple Aim World
• The Community Asthma Initiative: A Case Study in Clinical Innovation
• Paying for Asthma Care: Options for Tackling Challenges
• State Medicaid Innovation: Opportunities and Barriers
• A Tale of Success: How to Get the Payer on Board
• Lessons Learned and the Path Forward
• Question and Answer Session

The Centers for Medicare and Medicaid Services (CMS) recently released more detailed ACO-level data for participants in first two years of the Pioneer ACO Model. The program, which is designed for health systems with more experience assuming financial risk for patient populations, has generated savings and improvements in quality measures, but has also struggled to retain participants. The program began with 32 provider organizations; following a series of recent announcements there are now 19 total participants.

Last month, CMS announced that the Pioneer Program was able to yield total program savings of $96 million in its second year and resulted in ACOs sharing in savings of $68 million. CMS also reported that the Pioneers were able to improve mean quality scores by 19 percent and increased performance on 28 of 33 measures between performance year one and performance year two.

Financial Results

The latest financial results provide more participant-level data and allow for a new level of analysis of performance across all these ACOs. In year one of the program, financial performance for individual Pioneers ranged from a gross loss of $9.31 million to a gross savings of $23.34 million. Thirteen Pioneers reduced costs enough to qualify for shared savings, with an average of $5.85 million returned to the ACOs, ranging from $1.00 million to $14.00 million. One ACO owed shared losses of $2.55 million. The remaining eighteen ACOs were within the minimum savings or loss rate and did not earn shared savings or owe money to Medicare due to losses.

Following year one, nine Pioneer ACOs either left the Medicare ACO program entirely, or moved to the lower risk Medicare Shared Savings Program (MSSP). Eight of the nine Pioneers that left the program failed to reduce spending in their first year. Out of the remaining 23 participants in the second performance year, three of these ACOs opted to defer reconciliation until the end of Performance Year 3. The 20 Pioneers with final Performance Year 2 data had financial performance ranging from a gross savings of $24.59 million to gross losses of $6.26 million. Fourteen ACOs reduced spending in Performance Year 2, eleven of which reduced enough to qualify for shared savings. The average shared savings for these ACOs was $6.55 million, ranging from $1.22 million to $13.41 million. Three Pioneers shared losses, averaging $2.33 million back to the Medicare program.

The table below shows the breakdown of ACOs according to whether they reduced spending, increased spending, shared in savings, or owed money back to Medicare due to losses. More than half of the Pioneers were able to reduce spending in year one (18/32) and year two (14/23), with more than one-third of total ACOs earning shared savings in each year as well.

The data also suggest that those ACOs that were most successful in reducing spending in the first year were also more likely to reduce spending in their second year. As the chart below shows, three ACOs that earned shared savings in year one owed money back to Medicare due to losses in year two, while no ACO that had shared losses in year one was able to attain shared savings in year two.  

Quality Results

CMS also released ACO-level performance on all 33 measures for Pioneer participants in year one and year two. The 23 ACOs that remain in the Pioneer Program showed overall improvement in average quality scores from the first to second performance year. The ACOs also improved overall on 28 of 33 measures, as the chart below shows.

The quality domain with the greatest improvement in year two was Domain 4 (At Risk-Populations) which saw an overall improvement from 67.5% to 83%. The marked improvement in this domain suggests that ACOs are making progress at better coordinating and delivery care for high-risk patients, many of whom have multiple chronic conditions. Chronic care management for conditions such as diabetes, coronary artery disease, and hypertension is critical for the continued success of accountable care efforts. All other domains saw average quality improvement as well, summarized below.

Likewise, almost all of the individual Pioneer ACOs improved their performance on quality measures from year one to year two. Of the ACOs that remained in the program for year two, all but one ACO was able to improve its overall quality score in its second year.

Additionally, the percentage of Pioneer ACOs performing in the 80^th or 90^th percentile in quality scores also increased from year one to year two, as shown in the chart below.

Putting Together Financial and Quality Results

In year one of the Pioneer Program there appeared to be no direct correlation between average quality scores and gross savings or losses for individual ACOs. This may not be unexpected, especially since Pioneer ACOs in their first year are eligible for shared savings simply by reporting their quality. In subsequent years, however, the ACO’s quality score impacts the level of shared savings that the Pioneers are eligible to receive, so we might expect a bit more alignment between quality and financial performance. Average quality scores and level of savings or losses for each of the 32 first year Pioneer ACOs is below.

After year two, there still does not appear to be a direct relationship between higher quality scores and level of savings or losses in the Pioneer Program. Further examination of results begs additional questions about why certain ACOs clustered in different parts of the grid relative to others.

Of those ACOs in the red circle above— higher total savings and relatively average quality scores—two of the ACOs are from the Boston area and the remaining ones from other large metropolitan areas (New York City; Orange County, CA; Phoenix, AZ; and Detroit, MI). The average per capita Medicare spending for the counties corresponding to these ACOs is $11,544, compared to an average of $10,384 for counties corresponding to all 23 of the Pioneer participants.

Meanwhile those ACOs within the yellow circle had the highest quality scores, but also experience financial losses or slight savings. Many of these ACOs are from less densely populated areas, such as Maine, Wisconsin, and Illinois. There are a number of factors that could be contributing to their quality success, but little financial savings—healthier patient populations, a smaller or more engaged patient population, financial baselines impacted by lower per capita spending in these areas, or other factors driven by their region. Further analysis of these ACOs and the other public and private ACO programs, including both their characteristics and regional market characteristics, will provide needed further insights on the factors most likely to drive success.

Next Steps

These ACO-level data reflect the range of experiences across Pioneer participants. Some ACOs have sustained positive performance to date, while others have seen diminishing rates of return. Those organizations more committed to clinical transformation, patient outreach, and organizational change may be more likely to do better, but further analysis of differences in performance could enable the Pioneer Program and ACOs to achieve bigger impacts over time.

It is hard to know what the third performance year of the Pioneer program will show, but as noted earlier, the Pioneer Program has already lost over a third of its original 32 participants. Despite the decline in participation and mixed results so far, CMS remains optimistic and committed to the program, and the overall number of Medicare, Medicaid, and privately-insured individuals in ACO arrangements continues to rise. We can anticipate a proposed rule impacting the MSSP, likely later this Fall, which will impact elements of the Pioneer ACO program. Regulatory changes that may help increase the ability of the Medicare ACO programs to support better care while ensuring sustainability include: adjustments to attribution methods, benchmark calculations, collection and sharing of data with ACOs, updating performance measures, linking to other ongoing payment and delivery reforms, and creating more financial sustainability for program participants. The current Pioneer program can be a key step toward effective payment reform, but further steps are needed to assure long-term success.

Editor’s Note: The National Perspectives on Global Leadership (NPGL) project reports on public perceptions of national leaders’ performance at important international events. This fifth installation of the NPGL Soundings provides insight on the issues facing leaders at the Seoul G-20 Summit and the coverage they received in their respective national media. Read the other commentary »

The fifth G-20 Summit held in Seoul seems to show signs of a gradual maturing of the process and the forum as a mechanism for communication among leaders and a means of connecting leaders and finance ministers with their national publics, judging from National Perspectives on Global Leadership (NPGL) country commentaries. These growing strengths — looking from the G-20 capitals toward the Seoul summit contrasted with looking from the summit toward the countries — seemed particularly impressive at this Seoul summit, which was characterized by the most intense policy conflicts yet at a G-20 meeting.

Policy Conflicts and the Trajectory of G-20 Summits

The responses to the first question — “Did coverage seem to threaten or enhance the viability of G-20 summits?” — seemed to indicate that, despite the conflicts over external imbalances and currency policies, these issues did not threaten the viability of the G-20 summits as much as one might have expected. Given the focus of the NPGL project on national leadership, what is interesting about this positive result is that the coverage in the media was not just of the debate itself, but the portrayal of their national leader at the summit.

With the exception of an excellent and balanced article on Saturday, November 13 in The Washington Post by Howard Schneider and Scott Wilson, the coverage in Washington and in the Financial Times would lead readers to conclude that the Seoul G-20 Summit was less successful than anticipated, and did not enhance the viability of G-20 summits as much as the Koreans hoped it would.

“Agreements did not have to be worked out,” Andrew Cooper wrote, quoting Canadian Prime Minister Stephen Harper, “this month or next month in order to avert [a] cataclysm…I’m confident we will make progress over time.”

Olaf Corry reported from London that UK Prime Minister David Cameron was quoted in The Guardian as saying that rebalancing “is being discussed in a proper multilateral way without resort to tit-for-tat measures and selfish policies.”

U.S. President Barack Obama said in his press conference that “in each of these successive summits we’ve made real progress.”

Lan Xue and Yanbing Zhang wrote that Chinese President Hu Jintao “highlighted the importance of (the) framework (for strong, sustainable and balanced growth) and also pointed out that it should be further improved,” a far cry from a rejection of it.

“In contrast to previous summits,” Peter Draper reported from Johannesburg, “President Zuma’s interventions did receive some press coverage at home…To judge from this coverage, he seems to have played his cards reasonably well and to have been visible.”

Melisa Deciancio commented from Buenos Aires that ”Cristina Fernandez’s contribution to the G-20 summits has always been substantive…She has also called the members of the (G-20) to work together, cooperate and avoid entering into conflict in relation to the ongoing currency war between China and the U.S.”

“Both (German Chancellor Angela) Merkel and (finance minister) Schaeuble spent considerable effort to explain the positive aspects of summit agreements and praised the ‘spirit of cooperation,’” reported Thomas Fues from Germany.

In each of the cases above, the leader offered a positive interpretation of the Seoul G-20 Summit and the G-20 summit process even in the context of intense policy disputes, which constrained the practical agreements that could have been reached, especially on the global economic adjustment issues. This optimistic stance indicates a forward movement by G-20 leaders on a metric of global leadership in Seoul that the four previous NPGL “Soundings” had found to be wanting at previous summits.

In some countries, the problem continued with the press focusing on the shortcomings and failures of the Seoul G-20 Summit, including the coverage in the influential Financial Times. G-20 leaders were, however, more aggressive in pushing against the media’s interpretation of weakness and failures at the G-20, advancing an alternative narrative that focused on the gradual progress being made and stronger relationships developing with each G-20 summit experience. Leaders now need to assure that the G-20 “framework” and the “mutual assessment process” (MAP) of peer review that goes with it, are able to deliver a credible way forward for global economic adjustment by the time of the French G-20 Summit in November 2011.

Global Economic Adjustment as a Visible Theme

With regard to question two — “How was the rebalancing issue dealt with?”— the common thread running through each of the country commentaries is reflected in Olaf Corry’s comment that “explicit mention of the G-20’s formal ‘framework for strong, sustainable and balance growth’ is very sparse in UK public debate, but the themes it highlights definitely shine through.” The one exception may have been the explicit, detailed understanding of the issue conveyed by Schneider and Wilson in their Washington Post article titled “G-20 nations agree to agree; Pledge to heed common rules; but economic standards have yet to be met.” (See U.S. country commentary.)

The G-20 framework and the MAP may not have received much visibility or coverage from the media, but the intensity of the currency wars, the debate about U.S. quantitative easing (QE 2) and the differences over current account targets were all widely covered, and the message communicated to most publics was that global imbalances are a real problem for all countries and a concerted global economic adjustment is essential. The G-20 leaders will, therefore, have to do far more than simply explain the process to their publics; they need to continue to push each other and their economic officials to reach agreement on a path forward by the time of the French summit in November of 2011.

The difficulty of reaching agreement is reflected in a comment by Ryozo Hayashi of Japan who wrote, “Therefore, it sounds wise to let these countries (the U.S. and China) keep their current policy paths with a political commitment to avoid a currency war and for the G-20 to agree to develop economic indicators. It may become urgent or it may become irrelevant as the situation develops. Given the difficulty of establishing agreed economic indicators, the time element would be important.”

Leadership at Summits and Its Linkages to Domestic Political Support

What emerged more clearly at this summit than in previous G-20 summits was the degree to which the role of individual countries and their leaders (or finance ministers) in G-20 processes had domestic political valence in their home countries.

“The amount of attention devoted by the media to this summit was considerably more than previous ones,” wrote Andres Rozental, “partially because the Calderón administration will host the G-20 in 2012 and Mexico is now part of the G-20 ‘troika.’”

Thomas Fues commented that “The media also appreciatively noted that Germany had been asked to co-chair the G-20 working group on the international currency system, tasked with formulating policy proposals” for the French G-20 Summit.

In South Africa, Peter Draper also found that the press paid attention to the fact that it co-chairs the G-20 working group on development with South Korea, and “the importance of this group’s work to the future of the G-20.”

“In terms of summit diplomacy,” wrote Andrew Cooper, “Harper’s main success was in gaining the role for Canada as one of the co-chairs (with India, supported by the International Monetary Fund [IMF]) with respect to the process of working out a set of economic indicators that all members of the G-20 could use as guideposts for a stable global economy.”

This is all evidence that G-20 activities now generate positive repercussions in domestic public opinion.
Other dimensions of linkages between international committee positions assumed at G-20 summits and domestic political capital are beginning to emerge as the G-20 matures.

In South Africa, Finance Minister Gordhan’s strong criticism of U.S. QE2 in the international press seems “to have added to his growing reputation at home” commented Peter Draper.

German Finance Minister Schaeuble’s criticism of the U.S. Federal Reserve’s move as “clueless,” “forced Merkel to reiterate unswerving support of her key official” at the Seoul summit, Thomas Fues noted.

Cristina Fernandez has consistently and adroitly used her substantive policy positions at G-20 summits to buttress her position at home. Argentina is head of the G77, so Argentine support for development increases its status as a leader of the South and her domestic prestige. Argentine discontent with the IMF has been legend since the 1990s; support of President Fernandez for the G-20 framework and MAP process arises as an alternative to the IMF article IV exercise, which most Argentines are against, reported Melisa Deciancio.

Conclusion

Despite media attention being riveted on the showdown between the United States, Germany and China on currency manipulation and external imbalances at the Seoul G-20 Summit, leaders defended the G-20 processes for working through these issues over time, rather than emphasizing the failure to reach agreement at Seoul. The leaders and their finance ministers found that taking an aggressive stance on key issues paid dividends in terms of their domestic political support.

Explicit efforts by leaders to link international policies to domestic politics is a positive step forward for G-20 summits toward a greater engagement between leaders and their publics. NPGL observers have been watching this dimension of G-20 summitry in London, Pittsburgh, Toronto and now Seoul. (See: www.cigionline.org; Papers; “Soundings”)

The challenge going forward will be finding a way to align the global economic adjustment policy with domestic political linkages in a consistent and reinforcing manner, that will allow for policy convergence rather than the divergence manifested at the Seoul G-20 Summit.

The U.S. nominee for the World Bank presidency, South Korean-born physician Jim Yong Kim, is one of three candidates for the post, along with Nigerian Finance Minister Ngozi Okonjo-Iweala and former Colombian finance minister Jose Antonio Ocampo. According to Colin Bradford, the presence of several viable candidates—from different parts of the world—for the World Bank presidency means that the entire international community could have a say in selecting the next World Bank president, rather than the U.S. nominee being automatically confirmed. This change in the nominating process, says Bradford, is good for the Bank because it reflects growing demands for representation from emerging economies.
 

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• Change World Bank Nominating Process

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The Millennium Development Goals were adopted in 2000 to encourage and monitor global social and economic developments through 2015. This frame has guided international development activities for the past decade and there is now a growing discussion on what the post-2015 international development framework should look like, and how economic, social and environmental pillars of development can be integrated.

On May 2, Global Economy and Development at Brookings hosted a discussion on the purpose of new development goals, the trade-offs in selecting specific indicators and the difficulties in integrating alternative development concepts into a single framework. The discussion also examined how events like the Rio+20 conference in Brazil can be used to advance the U.S. global development agenda. Panelists included Andrew Steer, incoming president, World Resources Institute; David Steven, nonresident fellow, Center for International Cooperation, New York University; Richard Morgan, director of Policy, United Nations Children’s Fund; and Brookings Nonresident Senior Fellow Colin Bradford. Brookings Senior Fellow Homi Kharas, deputy director of Global Economy and Development, moderated the discussion.

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• What Should Sustainable Development Goals Look Like?

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• Uncorrected Transcript (.pdf)

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• 20120502_sustainable_development

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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.

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• Participant List
• MDB PostEvent Summary

By 2020, Millennials will comprise more than one of three adult Americans. It is estimated that by 2025 they will make up as much as 75 percent of the workforce.  Millennials’ desire for pragmatic action that drives results will overtake today’s emphasis on ideology and polarization as Boomers finally fade from the scene. Thus, understanding the generation’s values offers a window into the future of corporate America.

Morley Winograd and Michael Hais outline the cultural force of the Millennial generation on the economy as Millennials increasingly dominate the nation’s workplaces and permeate its corporate culture. Winograd and Hais argue that the current culture on Wall Street is becoming increasingly isolated from the beliefs and values of America’s largest adult generation. The authors also include data on Millennials’ ideal employers, their financial behaviors, and their levels of institutional trust in order to provide further insight into this important demographic.

Key Millennial values shaping the future of the American economy include:

• Interest in daily work being a reflection of and part of larger societal concerns.
• Emphasis on corporate social responsibility, ethical causes, and stronger brand loyalty for companies offering solutions to specific social problems.
• A greater reverence for the environment, even in the absence of major environmental disaster.
• Higher worth placed on experiences over acquisition of material things.
• Ability to build communities around shared interests rather than geographical proximity, bridging otherwise disparate groups.

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In 2005, billionaire hedge fund manager Eddie Lampert acquired a large portion of Sears Holdings, the parent company of Sears and Kmart, among other brands. In 2008, Lampert reorganized the company into 30 autonomous business units that would operate like independent businesses, with their own IT contracts, marketing officers, and most importantly, annual financial statements. The idea was that having each unit compete for resources would drive better decision-making and boost profits overall. The exact opposite happened. The divisions turned against one another, making decisions that benefited their divisions at the expense of others. In the year after Lampert’s acquisition of Sears, the company thrived, but two years later, profits tanked, the share price plummeted, and hundreds of stores were closed. As Jillian Popadak explains in a new paper about corporate culture and firm value, erosion of corporate culture may be to blame.

It’s not the case that decentralization is always bad—some large technology companies take this approach—but in Sears’s case, the reorganization changed the norms and culture for employees, dis-incentivizing collaboration at the expense of the overall firm. Popadak notes that former Sears employees speak to this: they said the change created a “warring-tribes culture” that lacked cooperation, and “the result was confusing to the customer.” Media accounts tell a similar story. Accounts detail managers cutting floor staff to save money, intense rivalries over the space in the weekly circular, resulting in nonsense product combinations, and a paltry one percent investment in capital expenditures. Popadak argues this is an example of how important implicit norms can be when they are working to create value at the company. When the explicit emphasis on performance was introduced, it “overpowered the implicit values to collaborate, satisfy the customer, and not act selfishly.”

How can you tell if a firm’s culture creates long-term value, or even measure something so seemingly unquantifiable? Popadak argues that while corporate governance measures are designed to change the explicit rules at a company, the culture is a set of implicit rules that govern employee behavior: the expectations employees have about what it takes to be successful at the firm. In her paper, Popadak collected millions of reviews from job sites like Glassdoor.com, Payscale.com, and CareerBliss.com by year and firm, and then used the text of the reviews to create measures of firm culture based on six categories: adaptability, collaboration, customer-orientation, detail-orientation, results-orientation, and integrity. She then assessed how these measures changed when a firm underwent a governance change.

Popadak writes of this graphic, “The figure shows that firms with stronger shareholder governance exhibited statistically significant increases in results-orientation but decreases in customer-orientation, integrity, and collaboration in the year following the governance change.” In the short term, a move to results-orientation boosts sales growth and payout in the short term, but in the long term, there are “significant declines in intangible value, customer satisfaction and brand value.” Ultimately, Popadak concludes that sacrificing corporate culture for short-term payoff may not be worth it.

Capitalism has provided unprecedented wealth and prosperity around the world, but a growing community is raising concerns about whether the promise of the capitalist system to achieve a more shared and durable prosperity can be achieved without systemic changes in the way for-profit corporations are governed and managed. The change in public opinion has become evident among workers, consumers, and investors, as well as through new policies enacted by elected officials of both parties: more than ever before, the public supports businesses that demonstrate positive social change and sustainable development. These new attitudes have begun to take root in corporations themselves, with a growing community of investors, business leaders, and entrepreneurs expressing a fiduciary duty to create value not only for shareholders but for society. However, businesses and investors seeking to harness these opportunities face significant institutional and normative barriers to achieving their goals.

In a new paper, the co-founders of non-profit B Lab, Andrew Kassoy, Bart Houlahan, and Jay Coen Gilbert, write about this overarching culture shift, the importance of and impediments to effective impact governance and impact management to make this shift meaningful and lasting, and how a rapidly growing community of responsible businesses has overcome these barriers, is maximizing its social impact, and is creating pathways for others to follow. The impact and growth of the B Corp movement will be maximized not only through increased adoption by business leaders, but also through the unique roles played by research institutions, the media, policy-makers, investors, and the general public. With enough support, this movement may soon transform shareholder capitalism into stakeholder capitalism, in which businesses can more easily live up to their potential to create a more shared and durable prosperity for all. 

This paper is published as part of the Center for Effective Public Management’s Initiative on 21st Century Capitalism. It is one of more than a dozen papers written by academics and practitioners about the changing role of the corporation and the importance of improving corporate governance. The authors of this paper are the co-founders of B Lab, a nonprofit organization that oversees the certification of B Corporations, and a major subject of this paper. The perspectives put forth in this paper are solely those of the authors, based on their professional expertise in this area.

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The recent fall in world oil prices undoubtedly has an impact on the politics of the Middle East, where many states rely heavily on oil to fund their governments and to float their economies more generally. One can cite serious domestic and regional disruptions that have followed severe oil price declines in the recent past. Will the current period of dropping prices result in domestic upheaval and regional war? Is the price drop part of a Saudi power play against its regional rivals?

Read Sultans of Swing? The Geopolitics of Falling Oil Prices

In this Policy Briefing, F. Gregory Gause, III answers the above questions by analyzing the regional impact of previous declines in the price of oil. He argues that Saudi Arabia is merely continuing its policy of only considering production cuts to arrest falling prices if other producers join them. Gause also finds that, despite memorable exceptions, oil-dependent regimes are actually more stable than their non-oil counterparts, including during periods of lower prices.

In considering the Middle East, Gause identifies a pattern of the region’s oil producers negotiating agreements on production cuts, rather than coming to blows, when faced with low prices. He stresses that if Iran, and perhaps Russia, approach Saudi Arabia about negotiating an oil deal, the United States should encourage such talks, and be ready to expand them to include the largest strategic picture of the Middle East.

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Indian Prime Minister Narendra Modi’s recent visit to the United Arab Emirates revealed New Delhi’s intention to bolster bilateral relations with the Gulf states. It was the first visit by an Indian prime minister in over 30 years, demonstrating the country’s renewed focus on expanding ties with the region it has always called “West Asia.” Although India and the Middle East share a long history of trade, immigration and cultural exchange, relations have yet to reach their full potential.

Read "Dealing with Delhi: How culture shapes India’s Middle East policy"

In this policy briefing, Kadira Pethiyagoda highlights the importance of an under-reported aspect of the relationship – culture. The author explains the role it plays in India’s policies toward the region, particularly under the current government, and argues that Gulf states need to understand the impact of Indian values and identity. Pethiyagoda provides recommendations on how the Gulf states can, through better understanding the cultural drivers of Indian foreign policy, build stronger ties with India, thereby advancing both economic and strategic interests.

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Americans who use defined contribution retirement savings plans (for example, 401(k) or 403(b) plans) or Individual Retirement Accounts will see their retirement security enhanced by two recently announced regulatory initiatives. The first is a series of Treasury Department/IRS proposed regulations that such individuals to use annuity-like guaranteed lifetime income products. The second is a final Department of Labor rule requiring complete fee disclosure to employers sponsoring retirement saving plans. Together, the two initiatives will give current retirement savers and future retirees more flexibility in structuring their retirement incomes, while making it possible to avoid excessive or hidden fees.

Four Treasury/IRS proposals, which were developed under the leadership of our former RSP colleague Mark Iwry, deal with several of the most pressing issues faced by employers and savers that currently reduce the use of annuities. The first proposal would reduce barriers to giving retiring savers the option of annuitizing part of their account balances. Currently, people need to annuitize either the entire balance or none at all. People are naturally wary of annuitizing the entire amount because it leaves them with little in the way of a cash cushion for emergencies. By choosing to annuitize part of the balance, people can retain a lump sum for emergency or other purposes.

A second proposal would remove a technical impediment to using longevity annuities, an annuity that is typically purchased close to retirement but does not begin to pay benefit until the retiree reaches age 85 or a similar age. Longevity annuities enable retirees to manage their money for a set period of time, secure in the knowledge that the longevity annuity will provide income after that, should they live longer than expected.

The third proposal would allow an individual to begin to partially annuitize their savings well before retirement. Starting to annuitize early by buying small pieces of an annuity over twenty or so years allows the saver to avoid having to make a “once and for all” decision and allows the savers to spread out the interest rate risk over time. This option had been subject to a requirement that the saver get a notarized statement from his or her spouse (if any) concerning whether the annuity covers just the saver or both the saver and his or her spouse. The proposal allows this to be handled by the issuing insurer when payments would begin rather than when purchases begin.

The fourth proposal would apply to relatively rare case where the employer has both a retirement savings plan and a traditional defined benefit pension, and would allow an employee to buy a low-cost annuity through the employer’s DB pension.

These four regulatory changes are positive developments. The changes announced today eliminate unintentional barriers to the use of lifetime income products without dictating how individuals should use them. Some may choose to partially annuitize at retirement, some to use longevity annuities to protect them in later years, and some to begin to buy annuities well before retirement. Whatever the choice, the proposals open up new options to future retirees, and should encourage even more market innovations.

At about the same time, the Department of Labor released final regulations requiring providers to disclose all direct and indirect fees to the employer sponsoring a 401(k) plan. The regulations will add needed transparency on fees that will enable increased competition to produce better results for employers and employees.

Despite removing a required template of charges, the new regulations nevertheless give employers a complete and accurate picture of all charges they have to pay, including indirect fees paid by the provider to others. Currently, many indirect fees are not disclosed even though they may reduce the earnings of participants. Endorsed by industry and consumer groups, the disclosures will enable employers who use this information properly to meet their fiduciary responsibility to choose a responsible fee level. What is even more important, the full disclosure will enable employers to structure their 401(k) plan so that individual savers can get the best returns possible, and not be subject to unreasonable fees.

While much more remains to be done to improve retirement savings plan, the steps taken by the proposed Treasury/IRS regulations and the Department of Labor’s final regulations will help savers to improve retirement security.

The new 2013 budget unveiled by President Obama on Monday again contains the Automatic IRA, which was developed by Brookings' Retirement Security Project in conjunction with The Heritage Foundation. This year's version again includes an important change that will also encourage more employers to offer a 401(k) account to their workers. However, important changes to the Saver's Credit, which had been in previous budgets failed to make it this year.

Nearly half of American workers - an estimated 78 million- currently have no employer-sponsored retirement savings plan. The Automatic IRA is a simple, easy to administer and understand system that is designed to meet the needs of small businesses and their employees. Employers facilitate employee savings without having to sponsor a 401(k)-type plan, make matching contributions or meet complex eligibility rules. Employees are enrolled automatically into an IRA with a simplified system of investment choices and a set automatic savings level. However, they retain complete control over all aspects of the account including how much to save, which investment choice to use, or even to opt out completely. Automatic IRAs also offer savings options for the self-employed, for independent contractors, as well as providing those who are changing jobs the ability to continue their retirement savings.

The new 2013 budget would also double the size of the tax credit that employers receive in return for starting a new 401(k) plan from $500 annually for three years to $1,000 annually for the same period. This increase will ensure that the credit covers more of an employer's costs, and should encourage more employers to offer such a plan. This is a very good move, but the credit could be still further expanded to $1,500 for three years as will be proposed by a new House bill coming from Rep. Richard Neal. As Congress examines the proposal, it will have the opportunity to also expand the smaller credit that would be offered to employers that start an Automatic IRA to ensure that they are fully reimbursed for all expenses connected with starting and operating such an account for their workers.

A disappointing development is the failure to again include proposals to expand and improve the Saver's Credit by making it fully refundable. The Saver's Credit is an incentive for middle-and lower-income taxpayers to save in 401(k)-type accounts or IRAs. Retirement Security Project research found that more than 69 million taxpayers had income that was low enough for them to be eligible for the Saver's Credit in 2007. However, nearly 45 million of these filers actually failed to qualify for the credit because they had no federal tax liability. If the Saver's Credit was made refundable as RSP has proposed and deposited directly into the account as a match for savings, those 45 million taxpayers could have taken advantage of the program and had significantly higher retirement savings.