At this very moment the TRIPS Council is discussing possible solutions to the "paragraph 6 problem" of the Doha Declaration on TRIPS and Public Health. There are a number of delegations, including the EC, that support a solution based on Article 31. There seems to be a significant lack of understanding however of the public health consequences of solutions based on Articles 31 on one hand and Article 30 on the other. Also there is a lot of emphasis on achieving an "expeditious" solution. This must not come at the expense of a practical and effective long term solution. This note aims to clarify the most important issue.
One fundamental disadvantage of an Article 31 solution is that a decision needs to be taken before a compulsory licence can be granted and export can take place. The supply of a medicine to a country in need could either be held up (for example if negotiations with the patent holder take place in the process of application for a compulsory licence) or stopped altogether (an application for a compulsory licence is no guarantee that it will be granted and can be refused, sometimes for good reasons, sometimes not).
Put yourself in the position of someone suffering from a lethal disease and in need of medicines that are unaffordable under patent. Your government has acted and issued a compulsory licence for import to your country. Would you prefer that the medicines you need could be produced and supplied to your country (a) automatically; or (b) after somebody in a different country has eventually come to a decision that, in this case, it would be allowed?
The decisions in answer (b) could have life and death consequences for millions of people. Answer (b) is the preferred option of those who favour an Art 31 solution even though it is the less swift and sure option. The best option, answer (a), is instead the Article 30 solution.
An Article 30 mechanism works in a different way from a compulsory licence. Under Article 30 of the TRIPS Agreement, certain activities can be defined under national law as exceptions to the rights of the patent holder. Performing these "excepted" activities needs no permission from the patent holder, as they are not infringements of the patent. Well known exceptions cover "experimental use" and "regulatory review" (the so-called "Bolar" exception). A "production for export" exception under Article 30 would mean that the necessary production for export could take place without being an infringement of the patent. Since the production for export would not then be an infringement, there would be no need to obtain the grant of a compulsory licence.
This means in practice that there would be no extra procedural step required in the exporting country, and no chance that permission to produce for export could be refused or delayed.
Providing a real and effective solution to the problem of paragraph 6 through an Article 30 mechanism would mean that countries without the capacity to produce their own pharmaceutical products could make just as effective use of compulsory licensing as if they had production capacity themselves. It will therefore also help them to make effective use of compulsory licensing as a credible threat in price negotiations. Crucially, only an Article 30 solution will help to put all WTO Members on the same footing in providing effective access to medicines for their populations.