Pull Back on Stringent Intellectual Property Rules in Trade Deals Encouraging

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WASHINGTON — International aid agency Oxfam America is encouraged by recent news reports indicating that the Democratic leadership in the US Congress is working to pull back the stringent intellectual property protections included in the free trade agreements (FTAs) negotiated by the Administration with developing countries, such as Peru and Colombia, an effort that would restore a balance between promoting innovation and protecting public health.

Oxfam applauds Chairmen Charles Rangel and Sander Levin for spearheading the effort to scale back the “TRIPS-plus” rules currently included in FTAs with Colombia, Peru and Panama, which go far beyond existing intellectual property rules at the World Trade Organization. Media reports however, indicate that the pharmaceutical industry has been actively lobbying against any such changes in intellectual property rules, arguing it would undermine the goal of getting medicines to developing countries. Yet new Oxfam research refutes such claims.

In a recently-released study entitled “All Costs, No Benefits: How the US-Jordan FTA Affects Access to Medicines,” Oxfam highlights new data from the five years in which the US FTA with Jordan has been in effect to show that TRIPS-plus rules have contributed to a significant increase in medicine prices in Jordan.

“Medicine prices have increased 20% in Jordan since the free trade agreement was signed in 2001, and higher medicine prices are now threatening the sustainability of government public health programs,” said Stephanie Burgos, Trade Policy Advisor for Oxfam America. “At the same time, higher levels of intellectual property protection have done nothing to improve foreign direct investment, enhance local research and development, or increase accessibility of new medicines.”

In particular, Oxfam found that one TRIPS-plus measure, data exclusivity, delayed generic competition in Jordan for 79% of medicines newly launched by 21 multinational pharmaceutical companies between 2002 and mid-2006, medicines that would have otherwise been available in an affordable generic form. Best selling medicines to treat diabetes and heart disease in Jordan now cost anywhere from two to six times more than in Egypt, a neighboring country without TRIPS-plus rules preventing generic competition, according to the report.

Data exclusivity is a new system of monopoly power, separate from patents, that blocks the marketing approval of generic medicines for five or more years. Drug regulatory authorities are prevented from using the clinical trial data of the patented medicine to show the safety and efficacy of an equivalent generic drug, thereby delaying or preventing generic competition. Other TRIPS-plus intellectual property rules that should be removed from FTAs include patent extensions and linkage of the patent status with marketing approval, prohibiting the registration of generic medicines until the patent has expired. These rules delay the introduction of affordable, generic medicines and have a detrimental effect on access to medicines for the poorest.

“Congressional Democrats have done well to listen to concerns raised for years by public health and development advocates that stringent new intellectual property rules will limit access to affordable medicines,” said Burgos. “Now we have clear evidence that as a result of data exclusivity measures in Jordan, additional expenditures are required by both the public health system and individuals for many new medicines needed to treat numerous non-communicable diseases that are leading causes of death and disability in that country. This is an opportunity for the Administration to take heed and remove TRIPS-plus provisions from current and future trade deals.”

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