This weekend included both World Malaria Day (yesterday) and World Intellectual Property Day (today). In recognition of both, we're taking a look at not-yet-ratified Article 31bis of TRIPs (the agreement on Trade Related Aspects of Intellectual Property). The aim of Article 31bis is to increase developing countries' access to generic versions of important patented medicines.
[left: stuffed malaria]
TRIPs has always included a special provision allowing for compulsory patent licenses in certain situations. (Article 31.) The reason for the addition of Article 31bis was because the original provision limited the licenses to uses "predominantly for the supply of the domestic market." (Art. 31(f).) The problem with the original article is that most of the countries needing access to patented medications for deadly diseases do not have the ability to manufacture the drugs in their own countries. That means even if they get the compulsory license, they will still not have access to the medicines. [Same problem for countries who are not yet required to patent pharmaceuticals. (Art. 66.1, date of compliance extended to 2016 by Doha.)]
Article 31bis was devised at the Doha round negotiations in 2001. The General Council adopted the provision in 2005, but it has not yet been ratified by the required number of WTO members and so is not actually part of TRIPs. However, it is still sort of usable. A 2003 declaration by the General Council waves the "predominantly for the supply of the domestic market" part of Article 31. In order to waive this provision, the importing member must be eligible under certain guidelines (mostly Least Developed Countries) and notify the Council for TRIPs of all specifics relating to the medicines it wishes to import. The exporting member must notify the Council of TRIPs of its willingness to grant the required license and of all particulars relating to its shipment of the medicines.
This all sounds pretty nice and simple, but in practice, it really hasn't turned out that way. Only one member, Rwanda, has ever used the 2003 declaration to import patented medicines. The actual legal meaning of this set-up remains a mystery. First, there is the vague language in the original article, Art. 31, that limits using a patent without first attempting negotiations to "national emergenc[ies]." (Art. 31(b).) How likely is a WTO panel to decide something is not a 'national emergency' after a country's government has declared it so?
Second, Article 31bis has never been ratified and is not part of the TRIPs agreement. This may seem like it is not that big of a deal since the 2003 declaration waves the problematic part of Article 31. But the declaration only adds to the confusion, and that brings us to: Third, what is this declaration? It is not part of the TRIPs agreement. It is not public international law (which WTO panels look to when deciding cases). It is a declaration by the Council. What does that mean?
Logistically, these are concerns that do not matter until someone challenges the use of the declaration. Rwanda was able to use the declaration without any problems. Perhaps if any other members should try, they would also encounter no opposition to using the declaration. Guess we shall just have to wait and see.