August 25, 2009
12:01 a.m. Eastern Time
Europe Has Expanded Its Lead Over The United States In Pharmaceutical Research Productivity
Separately, Researchers Find That Intellectual Property Rules Are Restricting Access To Generic Drugs In Guatemala; Third Study Encourages Participation Of Outside Experts In Pharmaceutical Patent Reviews In Developing Countries
Bethesda, MD -- It is widely believed that the United States has eclipsed Europe in pharmaceutical research productivity. However, a comprehensive data set of all new chemical entities approved between 1982 and 2003 shows that the U.S. never overtook Europe in research productivity, and in fact Europe is pulling further ahead, according to a study published today on the Health Affairs Web site. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.948
The study is one of three released by Health Affairs dealing with prescription drugs and intellectual property. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.948/DC2
The U.S. share of approved new drugs did increase in the decade from 1993 to 2003, as compared to the previous decade from 1982 to 1992, but that simply reflected the fact that the pharmaceutical industry poured more of its research dollars into American labs, says study author Donald Light, a professor of psychiatry at the University of Medicine and Dentistry of New Jersey and the Lokey visiting professor at Stanford. Over both decades, the U.S. share of approved new drugs lagged behind its share of research funding.
On a dollar-for-dollar basis, Europe was more productive in discovering new drugs than the U.S. was, and the European productivity advantage was greater in the period from 1993 to 2003 than it had been in the period from 1982 to 1992. Japan outstripped both Europe and the United States in pharmaceutical research productivity over these twenty years.
“Congressional leaders and others concerned about high prices of new patented drugs will be heartened by this analysis, because lower European prices seem to be no deterrent to strong research productivity,” writes Light. He cites previous research showing that pharmaceutical companies are able to recover research costs and make a “good profit” at European prices, and he rejects the notion that Europeans are “free-riding” on American pharmaceutical research investments.
Case study of CAFTA shows trade rules limit availability of generics. In a second study, researchers document for the first time that trade rules reduce access to generic drugs in a low-income country. Using recent Ministry of Health data, they report that in Guatemala, some generics have been withdrawn from the market while others have been denied entry altogether due to intellectual property rules contained in the Central American Free Trade Agreement. As a result, the cash-strapped Guatemalan public sector must purchase higher priced brand-name drugs to fight diseases such as diabetes and HIV/AIDS, say Ellen Shaffer and Joseph Brenner, co-directors of the Center for Policy Analysis on Trade and Health. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w957
The authors point specifically to CAFTA’s “data exclusivity” rules which provide brand-name drugs monopoly protection which, on top of existing patent protections, further contribute to higher prices. Generic drugmakers typically rely on the clinical trial data already generated by brand-name manufacturers to demonstrate the safety and efficacy of their products. But CAFTA prohibits generic drug manufacturers from using the brand-name clinical trial data for a fixed period of years, sometimes even after the brand-name drug is no longer under patent. Because of these rules, Guatemalans end up paying for brand-name drugs at costs up to hundreds of times higher than generics that were once available or that could be manufactured were it not for CAFTA rules.
Shaffer and Brenner argue that the United States should declare its intention not to implement the CAFTA data exclusivity rules. “More broadly, the United States should support Guatemala in exploring methods to obtain lower-price medicines from both donors and the market,” they write. The authors note that the World Health Organization has endorsed replacing intellectual property regimes with public health approaches, including reinvigorating local pharmaceutical production to stimulate technology transfer to developing nations.
Allowing outside experts to challenge patent applications in developing nations. In a final study, researchers analyze the role outside experts can play in pre-grant and post-grant review of pharmaceutical patents in developing countries. Tahir Amin, a co-director of I-MAK, the Initiative for Medicines, Access, and Knowledge, and coauthors conclude that public health is best served by allowing outside experts – members of the public apart from the inventor and examiners in the patent office – to challenge patent applications before they are granted. http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w969
In the past, several countries such as India and Brazil have been able to supply low-cost prescription drugs to developing nations, in part because their governments did not grant pharmaceutical patents. Recently, however, the World Trade Organization has mandated that these countries’ governments permit patents on pharmaceutical products, leaving countries to determine how to comply with the WTO requirements while trying to weed out patents and patent applications that would grant monopoly protection to insufficiently innovative drugs.
Amin and colleagues survey the limitations and benefits of various methods of preventing nonmeritorious patents from being issued. They note that a number of developing nations (but not the United States) allow outsiders to review patent applications to determine whether the product has already been disclosed, suggested, or made obvious by common knowledge, earlier patents, or published literature.
While this system increases administrative costs for already stressed patent offices, it is likely to be cheaper than relying on challenges to patents after they have been granted, when they enjoy a presumption of validity, Amin and coauthors say. The researchers also note that the mere filing of oppositions to pharmaceutical patent applications can cause drug manufacturers to lower prices. They add that there is no evidence that allowing outside experts to challenge patent applications has led to frivolous delay tactics.
After the embargo lifts, you can read the article by Amin and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w948
You can read the article by Shaffer and Brenner at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w957
You can read the article by Light at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w969
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Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org.
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