Intellectual Property Rights - 1

Intellectual property rights (IPRs) have become synonymous with the debate on generic drug production and trade. After discussions over patent exemptions reached an impasse at the end of 2002 WTO members scrambled to come to some agreement in time for the Cancun Ministerial Meeting. The prospects looked bleak after members missed their deadline for an agreement on developing countries' access to essential drugs. By the end of August 2003, trade delegates supported an agreement that allowed developing countries to import generic drugs for the treatment of diseases that are public health threats.[1] While the agreement is heralded as a success because it addresses a major concern of small developing countries, some criticize the agreement for adding red-tape for developing countries who want to file for a patent exemption.

Agreement on Pharmaceutical Patent Exemptions

The Agreement on Implementation of Paragraph 6 of the Doha Declaration on IPRs enables developing countries to import a generic drug if they can provide evidence of the public health concern, demonstrate the inability of the domestic pharmaceutical industry to produce the drug itself, and prove that it will only use the drug for public, non-commercial purposes. Developing countries are satisfied that the agreement does not limit them to emergency situations or designate only a short list of diseases for which generic drugs can be produced. Instead, it permits them to produce or import drugs to address the particular diseases that affect their countries.

NGOs such as Médecins Sans Frontiéres, Oxfam, and Third World Network have criticized the agreement for adding more bureaucratic burdens to the process of issuing compulsory licenses.[2] These NGOs argue that the obstacles of proof will fall on developing countries who scarcely have the time, money, or other resources to present their case before the WTO. Furthermore, it is unclear how developing countries who want to import generic drugs could prove that their domestic pharmaceutical industry is unable to satisfy domestic demand. The primary concern is that the WTO will only approve import requests from countries that lack domestic industries altogether and reject requests based on the inefficiency of domestic industry. Lastly, the distinction that generic drugs may only produced for "public, non-commercial purposes" is vague and open for contention. Some NGOs argue that it will be impossible to stimulate the production of affordable generic drugs if there is no economic incentives.