Improving access to potential COVID-19 drugs and vaccines: TRIPS Art. 31 bis

·      The COVID-19 pandemic has resulted in a race to develop a potential drug or vaccine that can deter its effects. These drugs or vaccines will be considered intellectual property under Art. 28 of the Trade-Related Intellectual Property Rights Agreement (“TRIPS”), and may not be sold without the permission of the patent holder. However, it remains important that any such treatment is accessible to countries that do not have the requisite monetary or manufacturing capacities, particularly small and developing States.

·      In order for COVID-19 treatment to be widely accessible, the TRIPS agreement contains a mechanism for voluntary and compulsory licensing. Voluntary licensing, under Art. 31(b) of TRIPS, allows parties other than the patent holder to obtain authorization from the patent holder “on reasonable commercial terms” to sell the otherwise patented treatment. However, this requirement of authorization is waived in situations of national emergency, or situations of extreme urgency. In such situations, compulsory licensing is permitted. Compulsory licensing allows companies other than the patent holder to sell or import the drug or vaccine in question without the permission of the patent holder. The 2001 Doha Declaration para. 5(c) suggested that each WTO Member has a right to determine what constitutes a national emergency, and public health crises such as HIV/AIDS and other epidemics can represent emergencies. COVID-19 is a WHO-declared pandemic and should qualify under para. 5(c) of the Doha Declaration.

·      However, Art. 31(f) of TRIPS limited such compulsory licensing “predominantly for the supply of [each individual State’s] domestic market,” which created problems for countries that do not have domestic manufacturing capacities––thereby being unable to benefit from compulsory licensing. To assist small and developing States that do not have such domestic capacities, the WTO adopted a 2005 amendment (now Art. 31 bis) that allows Member States to export and import drugs produced under compulsory licensing. In essence, WTO Member States that have signed on to Art. 31 bis will be able to participate as eligible exporters and/or importers of potential COVID-19 drugs or vaccines.

·      It is worth noting that some countries have criticized the Art. 31 bis mechanism as being cumbersome. Further, the mechanism has only been used once by Rwanda to import a generic HIV drug from Canada, which some considered a slow and arduous process. However, that should not deter small and developing States from signing Art. 31 bis since the mechanism for drug production and delivery can likely be expedited in the face of the current global pandemic.

·      As of June 19, 2020, the amendment has only been adopted by 104 WTO Member States, out of the 164 total WTO Member States. IILA urges small and developing States, particularly, in the time of COVID-19 to avail themselves of all possible opportunities at accessing potential treatment to the virus. Signing on to the Art. 31 bis amendment and enacting any necessary domestic legislation will be an important step in that direction.