August 18, 2011
At the request of the Petrie-Flom Center, I am posting this announcement:
"The Petrie-Flom Center is an interdisciplinary research program at Harvard Law School dedicated to scholarly research at the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research and bioethics. The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy or bioethics. Our prior fellows have found employment as law professors at Harvard, UC Berkeley, BU, UCLA, Cornell and the University of Arizona. More information on the Center can be found here."
"Petrie-Flom fellowships are full-time, two-year residential appointments offering a $60K annual stipend and other research support. Fellows devote their full time to scholarly activities in furtherance of their individual research agendas. The Center does not impose teaching obligations on fellows, though in appropriate cases voluntary teaching opportunities may be made available. For further information on the program and eligibility requirements, please see the full Call for Applications here. Completed applications must be received by 9:00 a.m. on November 14, 2011." (FP)
Worth Reading This Week
Nathan Cortez, Can Speech by FDA-Regulated Firms Ever be Noncommercial? SSRN/AJLM
Tim Vogus et al, Doing No Harm: Enabling, Enacting, and Elaborating a Culture of Safety in Health Care, SSRN
Anupam B. Jena et al, Malpractice Risk According to Physician Specialty, NEJM
Amanda C. Pustilnik, Pain as Fact and Heuristic: How Pain Neuroimaging Illuminates Moral Dimensions of Law, SSRN/Cornell L.Rev.
Perspectives on ACA Challenges
August 17, 2011
Tobacco Companies Challenge FDA Graphic Warnings
Not surprisingly, especially after the Supreme Court's decision in Sorrell v. IMS Health, major tobacco companies have challenged the FDA's new graphic warnings for cigarette packs. But even with the Court's heightened scrutiny for regulations of commercial speech, the FDA should prevail. The Court has clearly distinguished between restrictions of speech and mandatory disclosures that are designed to ensure that the public is not misled. Indeed, just last year, in Milavetz, the Court upheld required disclosures for professionals providing consumer assistance with bankruptcy proceedings. Pharmaceutical manufacturers still must disclose side effects of their drugs after Sorrell, and tobacco companies will have to provide adequate warnings about the risks of cigarette smoking.
August 16, 2011
Drinking Water Contaminants and Small Businesses
Many health and environmental groups are urging the Environmental Protection Agency to regulate perchlorate in drinking water. According to the Environmental Working Group report, perchlorate, the main ingredient of rocket and missile fuel, contaminates drinking water supplies, groundwater or soil in hundreds of locations in at least 43 states. EWG estimates that the drinking water of 20 million Americans is affected. The Environmental Protection Agency has not yet set a standard for this chemical under the Safe Drinking Water Act.
On October 10, 2008, the EPA published a preliminary determination not to regulate perchlorate, but after receiving comments, has been reconsidering whether to regulate ever since. In 2009 EPA requested more comments in a supplemental request. In July, EPA Deputy Administrator Robert Perciasepe was encouraged to move forward with the regulation during a Senate Environment and Public Works Committee hearing. According to the environmental news reporting service Greenwire, industry opposes regulation by claiming exposure to low levels of the chemical are not harmful, and that reports of widespread contamination are due to improvements in perchlorate detection that can find even trace -- and safe -- amounts of the chemical in water. However, a number of studies suggest otherwise, including those used by the California Department of Public Health to justify regulating the chemical in its state program.
Perchlorate is a specific example of one of EPA’s failure to identify and regulate contaminants under the SDWA, a failure documented by the General Accounting Office in a report entitled EPA Health Risk Assessments issued in July. Like so many of the regulatory efforts I have mentioned here this year, the costs of protecting the public health are again pitted against raising the costs of doing business. Not surprisingly, the next step in the process is for EPA to scrutinize how regulating perchlorate will affect business. EPA is required now to form a small business advocacy review (SBAR), consisting of obtaining comments from “small entity representatives” (SERs) when drafting a rule that could have a "significant economic impact." SERs are selected from government, nonprofits and businesses. Bigger businesses and other entities will continue to provide input during the formal notice and comment periods, but this step will reinforce EPA’s mandate to focus more closely on the economic impacts of decisions purported to be for the benefit of public health.
August 15, 2011
Social Media and Drug Promotion
For some time the FDA has been working on guidelines relating to the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." Along the way there have been public hearings, here, and missed deadlines, here. In the meantime pharmaceutical companies have been able to promote their wares online in relative safety thanks to a safe harbor provided by Facebook. Specifically, Facebook allowed pharmaceutical product pages to have comments turned off. Starting today that privilege has been revoked and the drug pages must have "open" Walls. The issues that arise are comprehensively explored by Christian Torres in the Washington Post, here. In brief, allowing others to inject praise on a drug's page could upset the FDA's requirement that marketing be balanced and, potentially, open the door to users posting about off-label uses, and impacting the manufacturer's duty to report adverse events (presumably by requiring proactive monitoring of critical posts). Given that there is something of a regulatory vacuum, product pages are disappearing faster than you can click "like." There is even a "Deathwatch" site, here, that is keeping track of the pages that the pharmaceutical companies have taken down. [NPT]
August 14, 2011
Guest Blogger Eleanor D. Kinney: Greetings from Indianapolis (alas not Puerto Vallarta)!!
El 6 de Agosto
Greetings from Indianapolis (alas not Puerto Vallarta)!!
This is my last blog on health care in Mexico and North America. In this blog, I want to talk about the implications of free trade agreements for the health care sectors of the three countries of North America – The United States, Canada and Mexico.
In 1947, twenty-three countries agreed to the General Agreement on Tariffs and Trade (GATT) to promote free trade in the world. Initially, GATT only addressed trade in goods. However, since the Uruguay Round in 1994, the General Agreement on Trade and Services (GATS) also addresses trade in services, capital, and intellectual property. The trade agreements in the Uruguay round also established the World Trade Organization. (World Trade Organization, Legal Texts).
The basic theory of free trade agreements is that free trade among private persons and enterprises is to be promoted and, as a corollary, public monopolies providing goods and services are to be discouraged. This theory is at odds with the state of affairs in almost every national health care sector in the world. In these health care sectors, private actors have demonstrated that they are not able to provide affordable and high quality health care services for all in need. In almost every country of the world, states have had had to subsidize health coverage for certain segments of the population – namely, the elderly, disabled and poor. Often this subsidy is accomplished through a public health insurance program.
The impact of free trade agreements on the accessibility and affordability of health care services is a concern in the three countries of North America with their varied health care systems. As discussed in prior blogs, the three health care sectors of North America are quite different and independent. Canada has an established public universal health insurance program. The US health care sector is undergoing reform to address major gaps in health coverage. Mexico too is expanding coverage in its less modern but advancing health care sector.
In 1993, the United States, Canada, and Mexico adopted and ratified the North American Free Trade Agreement (NAFTA). NAFTA is open to any country in the world, including members of the European Union, upon meeting certain criteria. NAFTA applies to all economic sectors including social services. The national governments of the three state parties must “ensure that all necessary measures” are taken in order to give effect to the NAFTA’s provisions, including their observance by state, provincial, and local governments.
The preamble of NAFTA expressly recognizes — as a cardinal principle — the right of parties “to preserve their flexibility to safeguard the public welfare.” However, NAFTA does not contemplate the growth of public programs or the inauguration of new public programs. Both Chapter 11 (Investments) and Chapter 12 (Cross Border Trade in Services) provide that the operative provisions of each chapter do not apply if there are existing nonconforming measures, or the party establishes non-conforming measures within two years of NAFTA’s adoption — so long as these nonconforming measures are reserved in the appropriate annexes of NAFTA.
In Chapter 11, NAFTA requires that parties and their political subdivisions provide investors of other North American countries with national treatment and also most favored nation treatment. NAFTA Chapter 11 also contains a provision that parties may not “directly or indirectly nationalize or expropriate an investment of an investor of another Party in its territory or take a measure tantamount to nationalization or expropriation of such an investment…except under circumstances such as for a public purpose.”
Chapter Eleven of NAFTA facilitates the settlement of investment disputes. Specifically, Chapter Eleven permits an investor of one NAFTA Party to seek money damages for measures of one of the other NAFTA Parties that allegedly violates Chapter Eleven. Investors may initiate arbitration against the NAFTA Party under the Arbitration Rules of the United Nations Commission on International Trade Law or the Arbitration (Rules of the International Centre for Settlement of Investment Disputes ("ICSID Additional Facility Rules"). Department of State, NAFTA Investor-State Arbitrations.
The invocation of these investment provisions on the part of American health care providers is not a hypothetical possibility. It is noteworthy that an American entrepreneur, Melvin Howard, has brought an action against Canada under NAFTA for trade restrictions barring his investment in for-profit health care facilities in British Columbia. In Centurion Health Corporation v. Government of Canada, the plaintiff claims that the Canadian public health insurance program violates the national treatment rule under NAFTA Article 1102 and the most favored nation rule under NAFTA Article 1103. Centurion Health Corporation v. Government of Canada, Revised Amended Statement of Claim (Feb. 2, 2009). The case is now before a NAFTA Investor-State arbitration proceeding.
Trade policymakers must take care that free trade agreements do not undercut existing public health insurance programs or thwart the establishment of new public health insurance programs. Regarding the first concern, private providers and insurers should not be able to gain extraordinary profits from public programs. Private health care providers and insurers have been able to make money in an imperfect health care services market. Yet neither providers nor insurers have been able to meet the needs of all citizens. They thus should not be allowed to cherry pick privately funded patients at the expense of public programs.
Regarding the second concern, investment protection rules such as those in NAFTA of Chapter Eleven should not be invoked if a country establishes a public health insurance program to meet coverage needs of any portion of the population now and in the future.
Guest Blogger J. Janewa OseiTutu: Public Health and Intellectual Property - Seizure of Generic Drugs in Transit
In May 2010, Brazil and India filed complaints against the European Union (“EU”) and the Netherlands at the World Trade Organization (“WTO”) over the confiscation of generic drugs in transit. A settlement of the dispute between India and the EU was announced at the end of July 2011.
The EU border seizures were part of its intellectual property enforcement program. The drugs in question were not patent protected in either the point of origin or the final destination. Brazil and India cited a number of provisions under the WTO Agreement on Trade-Related Intellectual Property Rights (“TRIPS”) and the General Agreement on Tariffs and Trade (“GATT”) in support of their complaints. In its WTO request for consultations, pursuant to the WTO Understanding on Rules and Procedures Governing the Settlement of Disputes (“DSU”), Brazil complained about the confiscation by Dutch authorities of a shipment of a generic drugs from India that were destined for Brazil. The shipment was seized in Amsterdam and returned to India. Brazil complained that many similar shipments had been seized while in transit through the Netherlands and alleged inconsistency with TRIPS and GATT. Similarly, India complained about the Dutch seizures of generic drugs originating from India and destined for developing countries like Nigeria and Peru.
Brazil and India relied on different provisions of TRIPS in making their complaints. In its complaint, Brazil (unlike India) did not identify specific developing country issues or the relationship between intellectual property and public health as part of the basis for its complaint. I will focus on the Indian complaint, which has been settled, because it raises important arguments about the appropriate balance in TRIPS, the concerns of developing countries, and the need to interpret TRIPS provisions in light of the 2001 Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration on Public Health”).
In paragraph 5 of its complaint, India argued that the regulations leading to the seizures of the generic drugs had a “serious adverse impact” on the ability of developing countries to protect public health and to ensure that their citizens would have access to the medicines they need. As part of its complaint, India cited article 7 of TRIPS, which identifies, as an objective of intellectual property protection, the promotion of innovation “in a manner conducive to social and economic welfare” and to a balance of rights and obligations. Article 8 of TRIPS, which was also cited, sets out the principles of the agreement, and provides that WTO member states may take measures to protect public health. In addition, India referred to article 12 (1) of the International Convention on Economic, Social and Cultural Rights, which recognizes that everyone has a right to the highest attainable level of physical and mental health.
Various commentators have argued for the need to interpret TRIPS in light of its principles and objectives as set out in articles 7 and 8 of the agreement. It would have been interesting to see how a WTO dispute resolution panel would approach the health and development issues raised in India’s complaint. A WTO panel last had the opportunity to address the balance between intellectual property rights and public health in the Canada-Pharmaceuticals dispute, which was decided in 2000. That case was analyzed and decided primarily based on the rights and interests of the patent holder. Arguably, however, if TRIPS is interpreted in light of its principles and objectives, and in light of the Doha Declaration on Public Health, a WTO panel hearing such a case today would need to take into account the balance between public health, access to medicines and the private rights of the patentee. I discuss this further in my forthcoming piece, Value Divergence in Global Intellectual Property Law, 87 Ind. L. J. (2012)
Despite its efforts to examine the relationship between TRIPS and public health, it is not clear that a trade organization, like the WTO, would be prepared to take the lead in this regard, nor that it is the appropriate forum. Yet, in the current environment, where the trend is to increase intellectual property protection and enforcement through bilateral trade agreements, and agreements like the Anti-Counterfeiting Trade Agreement or the Trans-Pacific Partnership Agreement, a WTO panel decision favoring public health could serve as a helpful signal for developing countries, health organizations, and their advocates, that TRIPS does indeed recognize the need for balance.