|By Tanya Baytor and Patrick Griffith
In the United States, trade policy is generally considered an economic issue. But for developing countries like the Dominican Republic, it can be a matter of life and death.
The investigatory report, “A Prescription for Failure: Health and Intellectual Property in the Dominican Republic” is the culmination of seven months of research by nine students and two professors at Georgetown University Law Center. The report sought to determine how the intellectual property provisions of the Dominican Republic – Central American Free Trade Agreement with the United States (DR-CAFTA) will affect access to medicines in the Dominican Republic. To this end, the group conducted more than 50 interviews with patients, healthcare providers, government officials, members of non-governmental organisations, lawyers, and representatives from multinational and domestic pharmaceutical industries in Santo Domingo and La Romano, Dominican Republic and Washington, DC.
DR-CAFTA, like a number of other free trade agreements the United States has negotiated with developing countries, imposes intellectual property protections that require obligations beyond those required in the 1995 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). These heightened obligations limit competition in the pharmaceutical market and result in increased prices for life-saving medicines, with devastating effects on public health.
In the Dominican Republic, the cost of medicine is a concern for the government and patients. The Dominican government spends one-fourth of its health budget purchasing medicines and government health insurance only covers about one-third of Dominicans. Thus, the burden of purchasing life-saving medicines falls largely on individual Dominicans. As the Dominican Republic attempts to extend health insurance coverage to all, heightened intellectual property protections, such as those in DR-CAFTA, could increase the price of medicines in a manner that overwhelms government efforts and leaves the burden of purchasing life-saving medicines on individuals who often do not have the means to do so.
Over and over again, we heard about how the high cost of medicines has a devastating impact on patients. In one of our interviews, a healthcare provider indicated that her hospital didn’t even want a mammogram machine until the facility could afford to offer cancer drugs. In another interview, a cancer patient in Santo Domingo stated that she hated to be a burden, but that she was only able to pay for her first course of treatment with the help of family and friends.
Further, although the Dominican Republic receives international funding, like the Global Fund, this support only subsidises a limited number of drugs and diseases. This assistance, though generous, may not always be available or sufficient, and people with whom we met expressed concerns about the ability of the Dominican government to protect public health in the event of an interruption or decrease in aid. Moreover, even with such funding, patients are not always able to secure the drugs they need because of high pharmaceutical prices. For example, our interviews suggested that some Dominican HIV/AIDS patients may be kept on first-line drugs when they should be moved to expensive second-line treatments because of cost concerns.
The Dominican government’s ability to address these public health challenges may be limited by the promotion of stringent intellectual property protections by the US government and the multinational pharmaceutical industry. Specifically, during the negotiations over DR-CAFTA, the United States used its strong bargaining position to include TRIPS-plus intellectual property provisions such as “patent extensions,” which can lengthen the term of a patent to compensate for administrative delays; “data exclusivity,” which limits the use of test data by generic manufacturers in seeking marketing approval; and “patent linkage,” which requires the agency responsible for ensuring drug safety and efficacy to also verify the non-existence of a patent.
Similar requirements in other countries have led to delays in the introduction of generic competition and have had devastating effects on access to affordable medicines. If these obligations have a similar effect in the Dominican Republic, as is projected, the public health system could be threatened and lives could be lost.
In May 2007, the Committee on Ways and Means of the US House of Representatives and the Office of the United States Trade Representative announced a New US Trade Policy. This policy withdrew obligations on trading partners to adopt certain heightened intellectual property obligations for pharmaceuticals and reaffirmed the US commitment to the Doha Declaration. The free trade agreement that the United States signed with Peru already reflects this change in U.S. policy. Bringing Dominican obligations under DR-CAFTA in line with this new US approach is needed if the country is to avert a public health crisis and lives are to be saved.
To promote access to affordable pharmaceuticals in the Dominican Republic, the recommendations of the Georgetown Human Rights Action/Human Rights Institute Fact-Finding Team include that the United States (1) bring DR-CAFTA implementation in line with the New US Trade Policy and (2) ensure that training and funding are provided in a way that strengthens the Dominican Republic’s capacity to implement pro-public health policies, including training on public health safeguards such as those provided in TRIPS and US law in addition to DR-CAFTA obligations. The Team also recommends that the Dominican Republic (1) utilise TRIPS flexibilities where necessary to protect public health and (2) further study and address the effects that intellectual property laws can have on access to medicine in the Dominican Republic.
Patrick Griffith is a third year student at Georgetown University Law Center and expects to graduate this spring with a certificate in Refugee and Humanitarian Emergencies. After receiving a bachelor’s degree in philosophy from the University of Michigan (Ann Arbor), Patrick spent two years living in Detroit and working with City Year, an Americorps program. Patrick is currently interning with the Brookings Institution and volunteering with Freedom Now, a Washington-based organisation that seeks to free prisoners of conscious worldwide through legal, political, and public relations advocacy.
Tanya Baytor is a Master of Laws student in the Global Health Law Program at Georgetown University Law Center. She is currently interning at the Global Health Policy Center at the Center for Strategic and International Studies. Tanya received her law degree from Osgoode Hall Law School in Toronto, Ontario. Prior to attending Georgetown, Tanya practised intellectual property and health regulatory law for five years at an international business law firm in Toronto.