PIJIP Research on Medicine and Trade Disputes

COMPULSORY LICENSING DISPUTE IN THAILAND

Between late 2006 and early 2008, the Thai Ministry of health issued compulsory licenses on seven drugs - two for AIDS, one for heart disease, and four for cancers. At the urging of the branded pharmaceutical industry, the US Trade Representative has pressured Thailand to revoke the licenses (for instance, through inclusion of Thailand in the 2007 - 2009 Special 301 Reports), as have certain government officials of the European Union.

HEPATITIS C AND ACCESS TO PEGYLATED INTERFERON

Another lifesaving treatment is being denied to the world’s poor through global pricing that provides access only to the nation’s wealthy. A biologic drug called pegylated interferon can cure Hepatitis C (HCV) in over half of the patients that take it. But at a global price of over $20,000 a year, only a small portion of the world’s 150 million people living with HCV can afford access. 

KOREA-US FREE TRADE AGREEMENT

Korea and the United States signed the Korea-US Free Trade Agreement in June 2007. Like other recent free trade agreements, the Korean FTA includes intellectual property provisions that exceed WTO rules on patents and registration data, designed to delay the entry of generic drugs into the Korean market. Additionally, the Korea-US FTA includes a chapter on pharmaceuticals and medical devices which imposes rules on the reimbursement of drugs under Korea's national insurance.

INDIAN AMENDMENTS TO PATENT ACT AND TRIPS-IMPLEMENTATION LEGISLATION

To meet its TRIPS obligations in 2006, India passed amendments to its Patent Act that allow product patents (formerly, only processes were patentable). Soon after, Novartis unsuccessfully sued the government for not recognizing 'second use' patents for known substances. Disputes continue over the protection of test data and patent-health linkage.

BRAZIL (time line on compulsory licensing)

Brazil has one of the developing world's most successful antiretroviral treatment programs for people with AIDS. It is made possible by local production of generic medicines. The United States has engaged in a series of trade disputes with the Brazilian government over compulsory licenses (and threats of compulsory licenses) used to ensure a supply of affordable generics.

CANADA TO EXPORT GENERIC ANTIRETROVIRALS PRODUCED UNDER COMPULSORY LICENSE TO RWANDA

Apotex has been awarded a tender from the Rwandan Government for the triple combination AIDS drug "Apo Triavir". It is the first company to provide this medicine to Africa the WTO's 2003 agreement to allow medicines produced under compulsory license to be exported.

SECOND GENERATION ANTIRETROVIRALS

As the number of people on HAART increases, more will develop resistance to first-line treatments and will require second-generation medicines. Second generation antiretrovirals are far more likely to be patented, and therefore lack generic competition

COMPETITION (ANTITRUST) LAW AND ACCESS TO MEDICINES

PIJIP is building a competition law and intellectual property backup project to p commission expert economic and legal research into competition law theories that support access to needed medicines in developing countries, and sponsor international conferences and meetings to test and share ideas at the intersection of intellectual property, competition law and access to medicine.

TRIPS-PLUS INTELLECTUAL PROPERTY IN FREE TRADE AGREEMENTS

In bilateral and regional Free Trade Agreements (FTAs), the US government negotiates levels of intellectual property protection that exceed those required in the TRIPS Agreement. Among these TRIPS-Plus provisions are requirements of data exclusivity to delay generic entry, patent extensions beyond 20 years to make up for the time in which a patent or regulatory approval is pending, and linkage between countries' patent office and health regulatory authorities.

US GOVERNMENT DOCUMENTS ON INTELLECTUAL PROPERTY, TRADE AND HEALTHCARE

Collection of government documents from the US Trade Representative, Congress, and other branches including the most recent Special 301 Report, the 2007 New Trade Policy for America, bills relating to US Trade policy and the Doha Declaration on the TRIPS Agreement and Access to Medicines, letters from Members of Congress opposing USTR efforts to negotiate TRIPS-plus IP rules in bilateral and regional free trade agreements, Executive Order #13155 prohibiting USTR from attacking African countries using compulsory licenses for antiretrovirals, and more.