posted 26-04-2006 print
A US Free Trade Agreement could threaten access to medicine in Thailand
New stringent drug patent and marketing rules being negotiated in a Free Trade Agreement (FTA) between the US and Thailand would limit competition and reduce access to affordable medicines in Thailand.
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Oxfam | April 2006
by Gawain Kripke and Stephanie Weinberg
Summary and recommendations
Even though the world faces the threat of potential new epidemics like avian influenza, the effects of trade rules on public health attract little attention. Governments recently reaffirmed their commitment to meet the Millennium Development Goals which include combating HIV/AIDS, malaria and other major diseases, yet little attention is given to the implications of United States Free Trade Agreements (US FTAs) with developing countries such as Thailand, for access to affordable medicines to treat those diseases. These FTAs do much more than regulate tariffs for cross-border trade in goods and services: they change the rules of intellectual property protection in ways that will undermine public health by limiting access to affordable medicines.
This report seeks to draw attention to the potential effect on access to medicines of new intellectual property rights protections in US FTAs. It is part of Oxfam’s broader critique of trade rules in FTAs that have adverse effects on development and poverty reduction.
Thailand is a positive example of a developing country that has created effective programs to address the HIV/AIDS epidemic, having invested in prevention and treatment early on. More than 1 million women, men, and children have contracted HIV in Thailand and more than 500,000 people have died of AIDS since the outbreak of the epidemic. Thailand’s prevention efforts, which helped avoid more than 5 million new infections, are widely recognized as a success story among developing countries. Nevertheless, there are still around 20,000 new infections each year, with half of new adult infections occurring among women.
By preventing a much larger epidemic, Thailand avoided much larger treatment costs. For every baht invested in prevention and treatment in the 1990s, Thailand saved 43 baht in added treatment costs. In 2000 the Ministry of Public Health created the National Access to Antiretroviral Program for People Living with HIV/AIDS (NAPHA), providing a wide range of triple-drug antiretroviral (ARV) therapy. Two years later, the Government Pharmaceutical Organization (GPO) began producing its first ARV triple drug ’cocktail’ called GPO-vir for 1,200 baht ($ 31) per patient per month, compared with 18,620 baht ($ 490) for imported, brand-name drugs.
As a result of these efforts, the Thai government has been able to provide ARV drugs to increasing numbers of people who need them. The most important factor making this possible has been the government’s ability to procure inexpensive generic drugs. With the introduction of GPO-vir, the HIV/AIDS treatment program was expanded more than eight-fold from 2001- 2003 with only a 40 per cent increase in budget. Thanks to the availability of these generic medicines, the government is able to offer life-saving HIV/AIDS medicines to approximately 80,000 people,with plans to expand the program in coming years.
But as Thailand maintains and scales up treatment of people with HIV/AIDS, there is trouble on the horizon. Over time, increasing numbers of Thailand’s population with HIV/AIDS will need access to ’second-line’ ARVs, because viruses typically develop resistance to drugs after a period of time, and treatment with ’first-line’ regimens will eventually fail. Local production of GPO-vir is legal because these first-line drugs were invented before Thailand introduced patent protection for medicines in 1992 and, therefore, they could not be patented in the country. However, second-line therapies were developed more recently and are patented in Thailand, where they cost, on average, 14 times more than first-line treatments.
Thus, the future of treatment program in Thailand could be threatened if the United States succeeds in pressuring the Thai government to accept stringent new drug patent and marketing rules during FTA negotiations. US pressure to strengthen intellectual property protection is not new in Thailand: it dates back 20 years and includes denying trade preferences under the US General System of Preferences in 1989 and 1991. Facing intense pressure, Thailand amended its existing patent law in 1992 to allow patents on pharmaceuticals, and extended patent life from 15 to 20 years. The law was amended again in 1999 to comply with the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
As permitted by TRIPS, the Thai patent law currently allows flexibilities that help lower the price of medicines, such as compulsory licensing, which allows the government to override a patent to meet public health needs. According to a recent World Bank report, ’…by exercising compulsory licensing to reduce the cost of second-line therapy by 90 per cent, the Royal Thai Government would reduce its future budgetary obligations by 3.2 billion discounted dollars (127 billion discounted baht) through the year 2025.’
But it is likely that provisions in a US-Thailand FTA would limit the government’s flexibility to issue compulsory licenses, and would create a number of other obstacles to production and marketing of generic drugs. These new intellectual property rules exceed Thailand’s obligations under TRIPS and could undermine the country’s ability to provide affordable ARVs and other medicines to its population.
The US proposal on intellectual property rights for medicines in the US- Thailand FTA includes provisions similar to those in other US FTAs. In some cases, provisions are stronger than in most previous agreements and include, for example, extension of the patent term, protection of test data, and linkage between marketing approval and patent status. Additional provisions that have been included in some previous US FTAs, such as restrictions on the grounds for compulsory licensing, expansion of the patent scope, and limits to challenging potentially invalid patents, will further limit the use of important existing flexibilities in drug patent and marketing rules. The incorporation of these so-called ’TRIPS-plus’ rules into this FTA could seriously hamper Thailand’s HIV/AIDS programs, thus depriving thousands of people of effective treatment.
Oxfam recommends that no intellectual property provisions beyond the commitments established in TRIPS be included in any trade agreement between the United States and developing countries, such as Thailand. US-Thailand FTA negotiations should be halted in order to carry out and take into account independent studies on the potential impact of proposed provisions on public health. Any future negotiations should involve greater transparency, including public disclosure of the negotiating text, and should take into account concerns and proposals of civil society stakeholders. In negotiating any trade agreement with the United States, Thailand should ensure that it can maintain and enact laws and create policies which uphold the right to public health and which promote broad access to safe, effective and affordable medicines. No trade agreement should negotiate away public health.
source link: Oxfam