If the vision of the Sustainable Development Goals (SDGs) is that Mother Earth is heading for trouble and we must collectively solve global problems, then the underfunding of global public goods (GPGs) must be addressed. As the world becomes increasingly globalized, the need for global public goods increases: from action on climate change, financial stability, limiting the spread of diseases, management of conflicts, responding to natural disasters, terrorism, and cyber-warfare. At some level even the eradication of extreme poverty and more inclusive and sustainable development could be considered a global public good because more poverty and unequal development breeds conflict, increases environmental stress, state failure, terrorism, and piracy, thereby increasing the need for the global public goods required to address these issues.

Missing in the recently agreed Addis Ababa Action Agenda (AAAA) and in the Paris Conference of Parties (COP21) are steps that should be taken at a global level that will positively impact many countries, such as:

• A global set of standards on migration to curb exploitation and human rights standards for the migrant population;
• Better coordination of monetary and fiscal policies so as to avoid huge volatility in financial markets, which have large costs on vulnerable countries;
• Strengthened global disaster response mechanisms to handle increasing climate volatility and natural disasters;
• No agreement on a global tax institution demanded by many developing countries and civil society groups; and,
• No progress on carbon taxation.

There is considerable underfinancing of GPGs as it is difficult to get countries to pay for activities outside their borders. Official Development Assistance (ODA) has fallen well short of the agreed target of 0.7 percent of GDP—and in fact is closer to just 0.2 percent. GPG funding from ODA is estimated at only about 10 percent of the total. This problem even afflicts other sources of financing. Multilateral development bank (MDB) financing also underfunds regional, multi-country projects for addressing regional public goods as countries are unwilling to use their country allocations for multi-country projects even if the return on them is higher than the marginal country project.

Global thematic funds to support specific development challenges—Global Alliance for Vaccination and Inoculation (GAVI), Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), Global Environmental Fund (GEF) and earlier funds like the Consultative Group for International Agricultural Research (CGIAR)—have been successful in addressing specific development challenges through projects in specific countries, especially for agriculture, the environment, and health. They have also drawn in private philanthropic financing in addition to public resources. But global funding for global public goods has not had the same success, and systematic and sustained financing for disasters, biodiversity, desertification, and even for Ebola outbreaks has been difficult.

The Green Climate Fund, which will begin its work this year and will devote 50:50 share of funding for adaptation and mitigation has very limited funding so far – despite the commitment to provide $ 100 billion per year over and above ODA. But neither the AAAA, nor the SDG’s address many of the trade-offs involved between climate change and poverty eradication. COP 21 also did not provide greater guidance on these matters – despite high expectations that it would. Given the need for rapid economic growth to eradicate poverty for the LDC’s  as well as their need to deal with huge adaptation costs, it probably makes sense not to focus excessively on mitigation in these countries. These countries would increase their global carbon footprint by at best 2-3 percent of the total carbon emissions. The big tradeoffs will arise in the need for rapid growth in middle-income countries to address poverty and their increased emissions, which will accompany faster growth.

Protection of biodiversity is given specific mention in the AAAA, and the Global Strategic Plan for Biodiversity for 2011-20 is endorsed along with its 20 Aichi biodiversity targets. But progress in meeting these targets is slow and at current trends unlikely to be achieved. The AAAA does not address this slow progress or suggest ways to accelerate it. It does endorse the U.N. Convention to Combat Desertification and the African Union Green Wall Initiative; but again with no specificity on how progress on these commitments will be accelerated. The same is true of the attention on oceans and marine resources, where the U.N. Convention on the Law of the Sea is mentioned but with no concrete steps on how to finance, enforce, and protect vulnerable areas, especially the small island developing states (SIDS).

Private philanthropic foundations have played important catalytic roles, such as efforts by the Ford Foundation and the Rockefeller Foundation to help jump-start the Green Revolution in the 1960’s, and the eventual creation of the CGIAR. A somewhat similar role has been played by the Bill & Melinda Gates Foundation for global public health. But no such foundations exist for many underfunded issues, such as disaster relief, peacebuilding, and desertification. These types of activities can be much better funded by more globalized revenue sources. The AAAA does not even mention the need for any such revenue sources.

A key GPG is peacekeeping, international security, and the prevention of conflict. Surprisingly, military spending is also not touched upon in the AAAA but has increased sharply. It dropped in the late 1990s following the end of the Cold War, from $1.5 trillion to around $1 trillion globally, but has increased again to almost $ 2 trillion today. Cutting military expenditure—especially in many developing countries where it exceeds 4 percent of GDP—would be an important step and shifting some of those resources to peacekeeping and conflict prevention would improve public spending.

With the AAAA pushing for new modes of financing, its surprising that for GPG financing more global sources of finance are not considered. At least four such options exist and could go a long way towards financing the SDGs. The first is a carbon tax or auctioning of carbon emissions permits. This is an idea with huge appeal as it will also help dissuade use of fossil fuels and could lower emissions globally, but is opposed by all the major emitters. Carbon taxes have been used in several countries to reduce fossil fuel use without any damage to long-term growth. Emission permits have also been used in some countries to reduce emissions of some harmful chemicals. But they have not been used internationally.

The second is a so-called “Tobin tax,” a tax on all foreign exchange transactions, which might also discourage destabilizing short-term volatile capital movements. The third is to add a pollution tax on all shipping and air travel – whose pollutions costs are not fully captured by existing taxes and fees imposed on them. The fourth is to allow issuance of SDRs to finance GPG’s.

Unfortunately, all these proposals are currently opposed by the major G-20 countries for various reasons. While several European countries—and even some developing ones—have introduced carbon taxes, still more remain opposed to carbon taxation. The Tobin tax idea has been around now for several decades and is considered an anti-globalization proposal even if its revenues were to be used to finance GPGs.  At times in the past, some countries have imposed a tax on foreign exchange transactions, with the explicit purpose of slowing down volatility in capital markets.

Global taxation has the connotation of supra-nationality, which many rich country legislatures—especially in the U.S.—would oppose. One way around this might be to specify how these resources would be used or to use them through MDBs where the richer countries have a controlling vote. To some extent the Global programs—GAVI, GFATM, CGIAR, and now the Green Climate Fund—have done that, but their financing remains much too dependent on national budgets and not on automatic revenue-raising mechanisms. National lotteries have been used in some countries to raise resources for specific causes; global lotteries could be an option for financing some specific global goods. But the world must move to some global means of revenue-raising if it wants to address GPGs seriously. Private financing, innovative financing, and public-private partnerships touted in the AAAA and COP21 can be crowded in, but without more international public financing to address market failure, financing the SDG’s will be difficult.

The world needs to heed Ben Franklin advice in another context “We must hang together or surely we will hang separately.”

Event Information

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

Event Materials

• Bio sheet
• REMS CE Meeting Agenda
• REMS_CE_Meeting_Discussion_Guide_Final
• REMS CE Meeting Summary

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18 titled, “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

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Event Information

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

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

Event Materials

• REMS_PBRC_Meeting_Agenda
• REMS BR Speaker Bios
• REMS BenefitRisk Meeting Summary
• REMS BenefitRisk communication white paper

Good afternoon Chair Ayotte, Ranking Member Cantwell, and Members of the Subcommittee. Thank you very much for the opportunity to testify today on the important topic of domestic unmanned aircraft systems (UAS).

I am a nonresident senior fellow in Governance Studies and the Center for Technology Innovation at the Brookings Institution. I am also a National Fellow at the Hoover Institution at Stanford, and a professor at UCLA, where I hold appointments in the Electrical Engineering Department and the Department of Public Policy. The views I am expressing here are my own, and do not necessarily represent those of the Brookings Institution, Stanford University or the University of California.

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