Lynn Neary: I'm Lynn Neary in Washington, sitting in for Neal Conan.

John Kerry may not have clinched the Democratic nomination for president in yesterday's primaries and caucuses, but his victories in five of the seven races certainly completed his rehabilitation from an also-ran to a front-runner. John Edwards and Wesley Clark also won last night, Edwards in South Carolina, Clark in a tight race in Oklahoma, where Edwards came in second. Joe Lieberman dropped out of the race altogether. Howard Dean vowed to fight on despite a dismal showing. So did Al Sharpton, who placed third in South Carolina. Dennis Kucinich barely registered with voters. All the candidates now have their eyes on the future with contests in delegate-heavy states now up for grabs.

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Lynn Neary:...With us to talk about money in politics is Anthony Corrado. He's a professor of government at Colby College in Waterville, Maine, and is spending this year as a visiting fellow at The Brookings Institution here in Washington.

Thanks for being with us.

Anthony Corrado: Well, thanks for inviting me, Lynn.

Lynn Neary: Do we know exactly how much money's been spent so far by the candidates?

Anthony Corrado: Well, so far the Democrats have raised about $170 million in private donations and public funding all together, and all of that money's now been spent. This very competitive contest has proved to be very expensive so that as we enter this crucial part of the nominating process, no candidate really has a large reservoir of cash that's available to be spent.

Lynn Neary: Yeah. Both Dean and Kerry used the same strategy, focusing on Iowa and New Hampshire, but came up with very different results, didn't they?

Anthony Corrado: Yes, they did, and it was particularly problematic for Howard Dean because what Dean decided to do was use the large store of cash that he had raised in 2003 to spend lots of money in the states that would be voting in February, as well as in Iowa and New Hampshire, and as a result spent over $3 1/3 million on television in states that were voting after New Hampshire. Whereas John Kerry basically took all of the money he had and put it into Iowa and New Hampshire and was able to get the victories he needed to spur additional fund-raising so that he right now is in the best position even though he ended up raising much less than Howard Dean prior to New Hampshire. He's now in the best position to raise and spend money in this next stage of the race.

Lynn Neary: Yeah. And what about Dean? Has he been able to--he was so well-known for his fund-raising. How has his fund-raising been since he has started losing?

Anthony Corrado: Well, his fund-raising has actually held up very well. He's raising about a million dollars a week. He's raised about $3 million since that now-infamous night in Iowa. But one of the problems that he has is that he built such a large organization that it's very expensive to maintain. And as a result he has not had money for television advertising this week. He's not doing any television advertising in the states this weekend. And he probably won't do any television advertising in Tennessee and Virginia. So he's basically gone off of the airwaves in terms of paid television, with the exception of looking towards Wisconsin, which isn't until February 17th.

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Listen to this entire program, or purchase a transcript

      

       

       

       

       

For the last several years, the US government has been negotiating a free-trade agreement known as the Trans-Pacific Partnership (TPP) with 11 other countries across the Asia-Pacific and Latin American regions, which could have major impact on the pharmaceutical market.  When finalized it will be the largest free-trade agreement in history, impacting up to one-third of world trade and roughly 40 percent of the global gross domestic product. The deal has attracted a fair share of criticism from a wide range of groups, including concerns over proposed regulations for biologic drugs in participating countries. Specifically, critics are concerned about the length of data exclusivity granted to the companies that hold the patents on these drugs. Below is a primer on biologics and how they are being addressed in the TPP.

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What are biologics and biosimilars?

Biologic drugs include any therapy derived from a biological source; a group which includes vaccines, anti-toxins, proteins, and monoclonal antibodies. Because they are typically much larger and more structurally complex than traditional ‘small-molecule’ drugs, they are also more difficult—and much more costly—to develop and manufacture. Biologics are also among the most expensive drugs on the market, costing an average of 22 times more than nonbiologic drugs. Avastin, a cancer drug, can cost more than $50,000 a year, while the rheumatoid arthritis drug Remicade can cost up to $2,500 per injection.

Given these high costs, there is substantial interest in encouraging the development of biosimilars, a term used to describe follow-on versions of an original biologic. Estimates of the potential cost savings vary substantially, but some have predicted that competition from biosimilars could reduce US spending on biologics by $44 to $66 billion over the next ten years.  In the European Union, biosimilars have been on the market since 2006, and a 2013 analysis found that, for the 14 biosimilars on the market, the average price discount was about 25 percent. By 2020, the overall cost savings are projected to total $16-$43 billion.

After the Affordable Care Act (ACA) was passed in 2010, the US Food and Drug Administration (FDA) developed an accelerated approval pathway for biosimilars, modeled after the pathway used for the approval of small-molecule generics. In order to meet the criteria for biosimilarity, the drug must share the same mechanism of action for the approved condition of use, and there must be no clinically significant differences between the two drugs in terms of purity, safety, or potency. FDA recently approved its first biosimilar, Zarxio, which is a copy of the oncology drug Neupogen.

What issues are being raised over data exclusivity in the US?

Under current FDA regulations, biologic drugs are granted 12 years of data exclusivity following approval. During this period of exclusivity, the FDA may not approve a biosimilar application that relies on the data submitted as part of the original biologic application. This form of temporary monopoly is distinct from patent protection, which is granted well before approval and is not related to clinical data.  Data exclusivity does not prevent another company from generating the data independently, but drug companies are unlikely to go to the considerable (and costly) effort of replicating a full course of clinical trials for a drug that is already on the market. (Though biosimilars may need to undergo some additional clinical testing under current FDA regulations, the amount of data required to support approval would certainly be less than what is required for an original biologic approval.)

The 12-year exclusivity period for biologics was established in the ACA following intense debate, and has continued to attract criticism. (By contrast, the period of data exclusivity is just five years for small-molecule drugs.) Supporters argue that given the greater cost and difficulty of bringing a biologic to market a longer period of exclusivity is necessary to incentivize innovation. Others argue that the resulting restrictions on competition keep drug prices unnecessarily high, inevitably putting a strain on the health system and keeping potentially life-saving drugs out of reach for many patients.

How would the TPP affect data exclusivity?

For the 11 countries besides the U.S. that are involved in the TPP, current data exclusivity protections range from zero (Brunei) to eight years (Japan). Under the Obama Administration’s current proposal, participating countries would increase those periods to match the US standard of 12 years. Curiously, this proposal directly contradicts the administration’s ongoing domestic efforts to lower the period of data exclusivity. Since the ACA passed, the Obama administration has repeatedly proposed reducing it to seven, arguing that this would save Medicare $4.4 billion over the next decade. Some have noted that, once the 12-year period is enshrined in the TPP, it will become significantly more difficult to change it through the US legislative process. Furthermore, imposing US standards on the 11 member countries would inevitably restrict competition at the global level, and many patient advocacy and international humanitarian organizations have argued that doing so would undermine the efforts of US global health initiatives like the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which rely on price competition to manage program costs.

It is unclear whether the US will be successful in its efforts. There have been reports that the issue of data exclusivity has become a significant point of contention, and the US delegation may seek to compromise on its demands. It may, for example, negotiate exceptions for the poorer countries involved in the negotiation, as the Washington Post notes. However, the details of the negotiations are largely confidential, which makes it challenging to assess the possibilities, their relative advantages, or how the US Trade Representative (which is leading the US negotiations) is balancing the need to ensure adequate incentives for innovation with the need to control drug costs and facilitate patient access to potentially life-saving therapies.

Editor's note: Elizabeth Richardson, a research associate in the Center for Health Policy, contributed to the research and writing of this post. 

       

EXECUTIVE SUMMARY

In the face of unprecedented global challenges, effective global cooperation increasingly requires a partnership between state and non-state actors. Many international institutions now involve non-state actors in arenas that were once the exclusive province of states. The paper analyzes the evolution of civil society participation in the governance of international institutions and highlights the shift from a model based on consultation toward a model of multistakeholder governance. The paper argues that consultation is a less effective approach to involving civil society in achieving the mission of these institutions and suggests that more robust forms of multi-stakeholder participation by civil society can foster greater accountability and better deliberation. It analyzes competing claims about the desirability of including civil society in the governance of international institutions and suggests that an emerging constituency model can promote more effective multi-stakeholder governance. Constituency structures are already central features of several global health institutions and are now being contemplated by institutions in other sectors, including by the Education for All—Fast Track Initiative.

Multi-stakeholder approaches to governance are likely to become more widespread in the years to come in order to harness the contributions of a plethora of private actors engaged in responding to a wide range of global challenges. Even with enhanced cooperation between states, it is increasingly clear that non-state actors are essential to responding to key challenges across a wide range of sectors. Although it is possible to imagine expanded cooperation between state and non-state actors without opening up the governance structures of international institutions, it is less likely that these institutions will be successful in the longrun without a shift toward greater multi-stakeholder involvement in the institutions themselves.

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May’s jobs gains, released this morning, show that only 38,000 new jobs were added this May, down from an average of 178,000 over the first four months of the year, and the least new jobs added since September 2010.

This year’s monthly job gains and losses can indicate how the economy is doing once they are corrected to account for the pattern we already expect in a process called seasonal adjustment. The approach for this seasonal adjustment that is presently used by the Bureau of Labor Statistics (BLS) puts very heavy weight on the current and last two years of data in assessing what are the typical patterns for each month.

In my paper “Unseasonal Seasonals?” I argue that a longer window should be used to estimate seasonal effects. I found that using a different seasonal filter, known as the 3x9 filter, produces better results and more accurate forecasts by emphasizing more years of data. The 3x9 filter spreads weight over the most recent six years in estimating seasonal patterns, which makes them more stable over time than in the current BLS seasonal adjustment method.

I calculate the month-over-month change in total nonfarm payrolls, seasonally adjusted by the 3x9 filter, for the most recent month. The corresponding data as published by the BLS are shown for comparison purposes. According to the alternative seasonal adjustment, the economy actually lost about 4,000 jobs in May (column Wright SA), compared to the official BLS total of 38,000 gained (column BLS Official).

In addition to seasonal effects, abnormal weather can also affect month-to-month fluctuations in job growth. In my paper “Weather-Adjusting Economic Data” I and my coauthor Michael Boldin implement a statistical methodology for adjusting employment data for the effects of deviations in weather from seasonal norms. This is distinct from seasonal adjustment, which only controls for the normal variation in weather across the year. We use several indicators of weather, including temperature and snowfall.

We calculate that weather in May had a negligible effect on employment, bringing up the total by only 4,000 jobs (column Weather Effect). Our weather-adjusted total, therefore, is 34,000 jobs added for May (column Boldin-Wright SWA). This is not surprising, given that weather in May was in line with seasonal norms.

Unfortunately, neither the alternative seasonal adjustment, nor the weather adjustment, makes todays jobs report any more hopeful. They make little difference and, if anything, make the picture more gloomy.

a. Applies a longer window estimate of seasonal effects (see Wright 2013).
b. Includes seasonal and weather adjustments, where seasonal adjustments are estimated using the BLS window specifications (see Boldin & Wright 2015). The incremental weather effect in the last column is the BLS official number less the SWA number.

      

During his presentation at the University of Michigan/Urban Land Institute Real Estate Forum, Christopher B. Leinberger discusses the impact walkable urbane places has and will have on metropolitan development patterns, the market reasons for this change and how to strategically manage it.

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Editor's Note: In an interview with La Repubblica's Rosalba Castelletti, Jonathan Laurence discussed the significance of the revelations that the United States has continued to spy on Germany, and what they mean for the future of the transatlantic relationship.

"È un momento delicato, ma non penso che la Germania abbia interesse ad esagerare le tensioni con gli Stati Uniti". A sostenerlo è Jonathan Laurence, professore di Scienze politiche al Boston College ed esperto di Relazioni transatlantiche presso il think tank Brookings Institution di Washington.

Professor Laurence, quest'episodio come inciderà sulle relazioni tra i due Paesi?

"La situazione è tesa. Berlino stavolta non ha espresso solo la consueta indignazione, ma ha compiuto un atto formale con l'espulsione del capo dei servizi segreti, perché è la terza volta che il popolo tedesco apprende di essere spiato dagli americani. La prima volta è successo con il Datagate, la seconda con l'intercettazione del cellulare della cancelliera e ora con due spie tedesche al soldo degli americani".

In cosa differisce quest'ultimo caso dai precedenti?

"Non si tratta di programmi d'alta tecnologia, ma di spionaggio più "vecchia maniera": documenti in cambio di soldi. Stavolta poi non c'è in ballo un problema di sicurezza internazionale. È un nuovo colpo per la reputazione Usa perché ancora una volta si dimostra indifferente alla sensibilità europea riguardo alla raccolta di dati".

E i tedeschi sono forse i più sensibili, visto che hanno sperimentato lo spionaggio della Gestapo e della Stasi...

"Di fatti. L'attuale cancelliera ha fatto il suo debutto in politica proprio dopo il crollo della Stasi. Ecco perché dobbiamo aspettarci che la Germania dichiari a gran voce la sua collera".

Cosa può fare l'amministrazione Usa per riparare?

"Qualcosa di più che cercare infruttuosi colloqui bilaterali o accordi di non spionaggio reciproco. La Germania non è ingenua, sa che i servizi americani hanno bisogno di operare soprattutto dopo il 2001, ma vuole che si lavori insieme. Non credo però che cerchi il conflitto. Berlino e Washington hanno bisogno l'una dell'altra sia sulle sanzioni contro la Russia in merito alla crisi Ucraina sia sull'accordo di libero scambio".

      

One of the foundational notions of digital financial services has been the distinction between payment rails and services running on the rails. This is a logical distinction to make, one easily understood by engineers who tend to think in terms of hierarchies (or stacks) of functionalities, capabilities, and protocols that need to be brought together. But this distinction makes less sense when it is taken to represent a logical temporal sequencing of those layers.

It is not too much of a caricature to portray the argument —and, alas, much common practice— like this: I’ll first build a state-of-the art digital payments platform, and then I’ll secure a great agent network to acquire customers and offer them cash services. Once I have mastered all that, then I’ll focus on bringing new services to delight more of my customers. The result is that research on customer preferences gets postponed, and product design projects are outsourced to external consultants who run innovation projects in a way that is disconnected from the rest of the business.

This mindset is understandable given limited organizational, financial and human resource capabilities. But the problem with such narrow sequencing is that all these elements reinforce each other. Without adequate services (a.k.a. customer proposition), the rails will not bed down (a.k.a. no business case for the provider or the agents). In businesses such as digital payments that exhibit strong network effects, it’s a race to reach a critical mass of users. You need to drive the entire stack to get there, as quickly as possible. Unless, you develop a killer app early on, as M-PESA seems to have done with the send money home use case in the Kenyan environment.

It is tough for any organization to advance on all these fronts simultaneously. Only superhero organizations can get this complex job done. I have argued in a previous post that the piece that needs to be parceled off is not the service creation but rather cash management: that can be handled by independently licensed organizations working at arms length from the digital rails-and-products providers.

What are payment rails?

Payment rails are a collection of capabilities that allow value to be passed around digitally. This could include sending money home, paying for a good or a bill, pushing money into my or someone else’s savings account, funding a withdrawal at an agent, or repaying a loan. The first set of capabilities relates to identity: being able to establish you are the rightful owner of the funds in your account, and to designate the intended recipient in a money transfer. The second set of capabilities relates to the accounting or ledger system: keeping track of balances held and owed, and authorizing transactions when there are sufficient funds per the account rules. The third set of capabilities relates to messaging: collecting the necessary transaction details from the payment initiator, conveying that information securely to the authorizing entity, and providing confirmations.

Only the third piece has been transformed by the rise of mobile phones: we now have an increasingly inclusive and ubiquitous real-time messaging fabric. Impressive as that is, this messaging capability is still linked to legacy approaches on identity and accounting. Which is why mobile money is still more an evolution than a revolution in the quest for financial inclusion.

The keepers of the accounts —traditionally, the banks— are, of course, the guardians of the system’s choke points. There is now recognition in financial inclusion circles that to expand access to finance it is not enough to proliferate the world with mobile phones and agents: you need to increase the number and type of account keepers, under the guise of mobile money operators, e-money issuers or payment banks. But that doesn’t change the fundamental dynamics, which is that there still are choke point guardians who need to be convinced that there is a business case in order to invest in marketing to poor people, that there are opportunities to innovate to meet their needs, and that perhaps all players can be better off if only they interoperated. A true transformation would be to open up these ledgers, so anyone can check the validity of any transaction and write them into the ledger.

That’s what crypto-currencies are after: decentralizing the accounting and transaction authorization piece, much in the same way as mobile phones have decentralized the transaction origination piece. Banks seek to protect the integrity of their accounting and authorizations systems —and hence their role as arbiters of financial transactions— by hiding them behind huge IT walls; crypto-currencies such as Bitcoin and Ripple do the opposite: they use sophisticated protocols to create a shared consensus for all to see and use.

The other set of capabilities in the digital rails, identity, is also still in the dark ages. Let me convince you of that through a personal experience. My wallet was stolen recently, and it contained my credit card. I can understand the bank wanting to know my name, but why is the bank announcing my name to the thief by printing it on the credit card, thereby making it easier for him to impersonate me? The reason is, of course, that the bank wants merchants to be able to cross check the name on the card with a piece of customer ID. But as you can imagine, my national ID got stolen along with my credit card, and because of that the thief knows not only my name but also my address. That was an issue because I also kept a key to my house in the wallet. None of this makes sense: why are these “trusted” institutions subverting my sense of personal security, not to mention privacy?

The problem is that the current financial regulatory framework is premised on a direct binding of every transaction to my full legal identity. As David Porteous and I argue in a recent paper, what we need is a more nuanced digital identity system that allows me to present different personas to different identity-requesting entities and choose precisely which attributes of myself get revealed in each case, while still allowing the authorities to trace the identity unequivocally back to me in case I break the law.

The much-celebrated success of mobile money has so far really only transformed one third (messaging) of one half (payment rails) of the financial inclusion agenda. We ain’t seen nothin’ yet.

      

       

       

       

       

       

       

       

       

       

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.

       

       

       

       

       

Baltimore provides a prime example of how metropolitan areas around the nation are turning to clean, green industries as a source of vibrant, sustainable growth. Expert Jennifer Vey outlines how such communities can identify their assets and capitalize on them to revitalize their economies.

Video

• Baltimore as a Case Study in Metro Economic Recovery

Audio

• @ Brookings Podcast: Baltimore as a Case Study in Metro Economic Recovery

      

       

       

Editor’s Note: In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. Dhruva Jaishankar writes that with all the questions about what happens next, there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This piece was originally posted by The Huffington Post.

In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. What kind of relationship will the UK now forge with the EU, and how will that affect economic relations and migration? Will Scotland and Northern Ireland opt to leave? What is the future of British politics, given turbulence within both the Conservative and Labour Parties? Will a successful Brexit set a precedent for other EU members -- perhaps even some eurozone members-- to leave the union? What are the long-term economic consequences of the resulting uncertainty? Will Brexit even happen at all, given the absence of a clear post-referendum plan, the apparent unwillingness of 'Leave' campaign leaders to invoke Article 50 of the Lisbon Treaty, and the fact that the referendum was advisory and non-binding? Answers to these questions will make themselves evident in the coming weeks, months, and years.

[D]igital democracy... has contributed to polarization, gridlock, dissatisfaction and misinformation.

But there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This claim deserves an explanation.

When historians look back at the world of the past 25 years, they will likely associate it not with terrorism or growing inequality but with the twin phenomena of the "rise of the rest" (particularly China and India) and of globalization. Globalization involves the easier, faster and cheaper flow of goods, people, capital and information. One big enabler of globalization is the internet, the global network of networks that allows billions of people to cheaply and easily access enormous amounts of digital information. The rise of service and high-technology industries, trade liberalization, container shipping, and the development of financial markets have also been important enablers, as is the increased ease and lower cost of travel, particularly by air.

Many technology optimists have assumed that globalization would lead to the democratization of information and decision-making, and also greater cosmopolitanism. Citizens would be better informed, less likely to be silenced, and able to communicate their views more effectively to their leaders. They would also have greater empathy and understanding of other peoples the more they lived next to them, visited their countries, read their news, communicated, and did business with them. Or so the thinking went.

[L]eaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere.

But there has been little to justify such panglossianism. There is some evidence for a correlation between greater information, political democratization and economic progress, in that all three have advanced steadily, if at different paces, over the past two decades. But that correlation is weak. Instead, digital democracy -- the ability to receive information in almost real time through mass media and to make one's voice heard through social media -- has contributed to polarization, gridlock, dissatisfaction and misinformation. This is as equally applicable to the countries in which modern democracy took root -- in the United States and Europe -- as it is to India, the biggest and most complex democracy in the developing world.

The ascent of digital democracy around the world has some shared features. One characteristic is that access to greater information has, rather counterintuitively, contributed to a "post-fact" information environment. Nick Cohen -- speaking of British pro-"Leave" journalists-turned-politicians Boris Johnson and Michael Gove --called out their use of bold claims, their contempt for practical questions, their sneering disregard for expertise, and their transgressions of the bounds of political spin. These tactics are not all that dissimilar to Donald Trump's assertions about Barack Obama's birth certificate or immigration policies, or Subramanian Swamy's insinuations about the nationality of senior Indian policymakers.

But leaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere. A recent example springs to mind. There is a widespread belief on Indian social media that US presidential candidate Hillary Clinton is somehow anti-India, pro-Pakistan, and/or anti-Modi. I am no supporter of Ms. Clinton, but as someone who worked on foreign affairs in Washington and knows many of her advisors, I found these claims baffling. In fact, Clinton's political opponents (whether Barack Obama in 2008 or Donald Trump in 2016) have accused her of being too close to India, while Pakistanis often view her as critical of their country and Prime Minister Modi appears to enjoy cordial relations with her. After some inquiries, and a few tips, I managed to trace these sentiments to a single publication, a poorly sourced and misleading column that gained widespread circulation upon its release. The article's contents were deemed sufficiently credible to have now become instilled as absolute fact in the minds of many Indians active online. In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

Another outcome of digital democracy may be a variation of what the psychologist Barry Schwartz has called the paradox of choice. Quite possibly, the greater abundance of political choice leads to less satisfaction, and the result is citizens increasingly voicing their displeasure with their available political and policy choices. The political platforms of mainstream parties rarely adhere entirely to individual voters' views. That may explain why many voters are gravitating towards parties, factions or leaders who offer the simplest messages, and project themselves as alternatives to the mainstream.

A third result of digital democracy, and one that has been better documented, is the political echo chamber. Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices. As the psychologist Nicholas DiFonzo has noted, "Americans across the political spectrum tend to trust the news media (and 'facts' provided by the media) less than their own social group." This makes it easier for views and rumours to circulate and intensify within like-minded groups. Similar digital gerrymandering was evident in the EU Referendum in Britain and the polarization is palpable in the Indian online political space.

Finally, instant information has increased the theatricality of politics. With public statements and positions by governments, political parties and individual leaders now broadcast to constituents in real time, compromise, a necessary basis of good governance, has become more difficult. When portrayed as a betrayal of core beliefs, compromise often amounts to political suicide. Political grandstanding also contributes to legislative gridlock, with elected representatives often resorting to walkouts, sit-ins, or insults -- all manufactured for maximum viral effect -- instead of trying to reach solutions behind closed doors. Even as ease of travel allows legislators to spend more time in their constituencies, making them more sensitized to their constituents' concerns, less gets done at the national or supranational level. It is a trend that, once again, applies equally to the United States, Europe, and India.

Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring. The tone of democratic politics increasingly reflects that of anonymous online discourse: nasty, brutish, and short. And successful politicians are increasingly those who are able to take advantage of the resulting sentiments. Exploiting divisions, appealing to base instincts, making outlandish claims, resorting to falsehoods, and pooh-poohing details and expertise. All that could just as easily describe the playbooks of populists around the world, on the right and left: Marine Le Pen, Frauke Petry, Donald Trump or Subramanian Swamy as much as Jeremy Corbyn, Beppe Grillo, Bernie Sanders or Arvind Kejriwal.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring.

In all these cases, populists are willing to cross the lines that mainstream parties have flirted with, becoming forces that the centre cannot hold. US Republicans fanned the anti-immigration sentiments that first the Tea Party and then Trump are only taking to their natural conclusions, just as mainstream Democrats' economic protectionism has been seized upon by Sanders. Cameron's euroscepticism, explained away initially as constructive criticism, spiralled out of control with Brexit, just as those who pronounced the death of New Labour helped paved the way for Corbyn. Will the same one day apply in India, to the economic populism of the Congress, of which Kejriwal has become a new torchbearer, or to the chauvinism of the right, which Swamy now threatens to run away with?

Brexit is not anti-globalization so much as a product of globalization. It is also a product of democracy rather than an affront to it. But it is a democracy of a different sort, one that many of its ideological forebears anticipated. When James Madison warned of "the superior force of an interested and overbearing majority," or John Stuart Mill cautioned against "a social tyranny more formidable than many kinds of political oppression," or BR Ambedkar argued (in a slightly different context) that "political tyranny is nothing compared to social tyranny," they could just as easily have been speaking in 2016 as in 1787, 1859, or 1936. Democrats around the world may not yet be married to the mob, but plenty have been betrothed.

None of this should be interpreted as some kind of nostalgia for an older, simpler world. That world was not necessarily simpler, but it was more violent and chaotic, prejudiced and unfair, and poor and backward. It may be hard to discern amid the smoke and noise, but there are some benefits to digital democracy. Information is no longer in the hands of the few. It is easier than ever to bring injustices to light. And the same process can throw up mainstream leaders from backgrounds that are far from privileged, such as a Barack Obama, Angela Merkel, or Narendra Modi. Two of the three, Obama and Modi, rose to power on the backs of unprecedented social media movements.

But representative democracy as we have come to know it is under threat, and Brexit represents the first major casualty. Rather than fight the tide, a collective rethink is needed about how to make democracies resilient and productive in the digital age. It won't be easy.

       

       

       

Contributors: Alice M. Rivlin and Christine Dang-Vu

Recent data suggest that Accountable Care Organizations (ACOs) are improving important aspects of care and some are achieving early cost savings, but there is a long way to go. Not all ACOs will be successful at meeting the quality and cost aims of accountable care. The private sector has to date allowed more flexibility in terms of varying risk arrangements—there are now over 250 accountable care arrangements with private payers in all parts of the country—with notable success in some cases, particularly in ACOs that have been able to move farther away from fee-for-service payments. Future growth of the Medicare ACO program will depend on providers having the incentives to become an ACO and the flexibility to assume different levels of risk, ranging from exclusively upside arrangements to partial or fully capitated payment models.

Given that the first three year cycle of Medicare ACOs ends in 2015 and more providers will be entering accountable care in the coming years, the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) affecting the Medicare ACO program.

In anticipation of these coming changes, the Engelberg Center for Health Care Reform has identified the "Top Eight ACO Challenges" that warrant further discussion and considerations for ensuring the continued success of ACOs across the country. To support that discussion, we also present some potential alternatives to current Medicare policies that address these concerns. These findings build on the experiences of the Engelberg Center’s ACO Learning Network members and other stakeholders implementing accountable care across the country.  In some cases, the alternatives might have short-term costs, but could also improve the predictability and feasibility of Medicare ACOs, potentially leading to bigger impacts on improving care and reducing costs over time.  In other cases, the alternatives could lead to more savings even in the short term. In every case, thoughtful discussion and debate about these issues will help lead to a more effective Medicare ACO program.

Top Eight ACO Challenges

1. Make technical adjustments to benchmarks and payments
2. Transition to more person-based payments
3. Increase beneficiary engagement
4. Enhance and improve alignment of performance measures
5. Enable better and more consistent supporting data
6. Link to additional value-based payment reforms
7. Develop bonus payments and other incentives to participate
8. Support clinical transformation

Downloads

• Issue Brief: Improving the Medicare ACO Program

      

Payment reform in health care is confusing, but the goal is simple: How can health care providers change their economic incentives to encourage value over volume? If you've wondered about how these new payment models work, we’re here to help. And if you want to see Dr. Patrick Conway, the head of the Center for Medicare and Medicaid Innovation, talk about it more in depth at our most recent MEDTalk event about oncology care reform, click here.

Where are we now?

Fee-for-Service. Traditionally, health care providers are paid in a "Fee-for-Service" (FFS) model. This is exactly what it sounds like: every time you have a blood test, a doctor's visit, a CT scan, or any other service, you (and your insurance company) pay separately for what you have received. Over the course of a long treatment or a chronic condition, that can add up to a huge expense.

The Fee-For-Service System

It is well known that FFS is draining the entire health care system. When paying for volume, a sick patient is worth more than a healthy patient , and this status quo results in uncoordinated care, duplication of services, and fragmentation. After all, the more doctors and providers do, the more they get paid.

Reformers hope to replace the traditional FFS model with something better, and they’ve come up with many different models of payment that could allow this to happen. (Note to reader:  these are simplified explanations; policy enthusiasts can learn much more about them through the Engelberg Center’s Merkin Initiative).

Here are four widely proposed and increasingly popular alternative payment models:

Accountable Care Organizations (ACOs) are groups of providers across different settings– primary care, specialty physicians, hospitals, clinics, and others – who chose to come together to jointly share responsibility for overall quality, cost, and care for a large patient population. These providers recognize that poorly coordinated care from these entities can lead to increased costs from things like redundant tests and overlapping care.

Accountable Care Organization Model

Here’s how it works in basic terms: the ACO physicians bill the way they always do, but the total costs get compared to an overall target. Plus, they have to measure some of their patient outcomes, to prove that they hit certain quality benchmarks. If costs are higher than the target, the ACO may get penalized. In the end, if they are under the cost target and satisfy their quality measures, they get a share of the savings.

By bringing all of these providers under the umbrella of an ACO, caregivers can all be on the same page, and the patients ideally receive coordinated care with a focus on prevention – since providers are encouraged to keep their patients healthy and not just earn more by doing more tests and procedures.

Bundles: A health care bundle estimates the total cost of all of the services a patient would receive per episode over a set time period for a certain problem, like a knee replacement or heart surgery. For example, a payer such as Medicare or an insurance company could calculate that a hypothetical 30-day bundle for a knee replacement surgery costs $10,000.

Without Bundled Payment...

The payer reduces the total cost of the episode by 2-3%, and hands the bundle over to the provider – in the knee surgery example, that becomes $10,000 minus 2%, so $9,800. The provider is then responsible for all costs of treatment – whether or not it exceeds the amount of money they were originally given. This encourages the provider (collaborating with the entire care team) to help the patient avoid preventable complications like a hospital readmission by better managing a patient’s care.

With a Bundled Payment...

If the provider keeps costs low, they can keep the margin on the bundle, while the insurance company already saved by reducing the cost of the episode by a small percentage when they created the bundle. So, in our example, if the provider was able to meet quality benchmarks and the total cost of the 30-day episode was $9,000, they get to keep the extra $800.

Patient-Centered Medical Homes set themselves apart by providing set monthly payments on top of existing funding models, in order to fund a highly coordinated team of primary care professionals, which may include, depending on the patient’s needs, physicians, nurse practitioners, medical assistants, nutritionists, psychologists, and possibly even specialists. The team works closely to build a strong relationship with each other,with their patients and their caregivers.

Patient-Centered Medical Home Model...

This extra money can be used to hire nurses or agencies to give special care and attention (by phone or home visits, for example) to high-risk patients, with the goals of reducing emergency room visits and other preventable problems in the long run. Other enhancements might include email communication with patients, more time to call and coordinate care between primary care doctors and specialists, and so on. In the end, the savings from better coordinated care make the extra monthly payments worthwhile.

Pathways, an idea which has gained traction in oncology care, provides a system of choices and decision making tools for providers and patients in order to prescribe the most effective and least costly treatment. For example, let’s say there are two cancer drugs proven to have the same effectiveness, with no differentiation in side effects, but one of them costs less than the other.

Same Effectiveness, Different Cost...

Like the medical home, the pathways model uses a “per-patient” add on fee (often much larger than for medical homes focused on primary care, since cancer patients need intensive treatment) that might encourage the provider to prescribe the less expensive of two equally effective treatments.

How Pathways Creat Savings...

 

 

 

 

 

 

When this is implemented on a broad scale, the savings could add up for payers, and defray the cost of the add-on fees.

Please feel free to use any of these images in your own work, presentations, or educational efforts, and to view and download the interactive versions here.  The images should be attributed to The Merkin Initiative on Clinical Leadership and Payment Reform at Brookings.

      

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).

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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.)

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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.

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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.)

Companies can track expanded access requests in order to guarantee that the patient has received follow-up and that the communication loop has been closed. One large pharmaceutical company conducted an internal audit of its expanded access procedures and found that the largest problem was that employees did not know where to find information. Another representative noted that it is important to maintain consistency across patients and the process of requesting a drug.

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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.

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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.

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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.

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References

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• The Four A's of Expanded Patient Access

       

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

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

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

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

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

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

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

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

Policy Solutions

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

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

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

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

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

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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.

      

Event Information

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

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

The meeting focused on four questions:

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


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

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


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

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


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

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


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

Event Materials

• Participant List
• MDB PostEvent Summary