During the Davos World Economic Forum (WEF) held last month, Vietnam Prime Minister met with Mr. Roberto Azevêdo, Director-General of the World Trade Organization to announce that the President of Vietnam Tran Dai Quang had officially signed the Amendment of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Vietnam is one of five countries to have ratified the protocol last month. Consequently, the threshold of two-thirds of ratifying nations amongst WTO members has been met, and the very first amendment to the TRIPS Agreement, which ensures developing countries’ access to affordable medicine, will now come into force. The Amendment to the TRIPS Agreement consists of Article 31bis, the purpose of which is to allow poor people access to medicine and to create a legal mechanism to allow countries which do not have the capacity to produce medicines to connect with those countries which do.

Article 31bis of the TRIPS Agreement allows member states to enforce compulsory pharmaceutical patent licensing without complying with Article 31(f) of the TRIPS Agreement in some circumstances. Article 31(f) states that any compulsory license has to be authorized predominantly for the supply of the domestic market of the Member authorizing such use. This presents obvious limitations for countries which do not possess the capacity to produce a drug, as other wealthier countries could not, in theory, produce the drugs for them. Article 31bis provides for the possibility that patented medicine be subject to a compulsory patent in developed countries for the purpose of export, to countries lacking the production capacity.

Taking to account that the protocol would mainly benefit Vietnam as an importer of the medicines which it is not capable to produce, it also provides medicine producers with the opportunity to fulfill the demand of specific pharmaceutical products of the member states’ markets, including Vietnam, without being blocked by other companies’ patents. Last but not least, with the protocol in place, pharmaceutical companies can have a clear sight of which particular type of medicines is covered by the compulsory assignment of patent license, which refrain the TRIPS policies to be abused by means of unfair competition, thanks to the clear definition explanation from the new Amendment.

To facilitate the implementing of the Article 31bis, the TRIPS’s Annex also explains key terms and requiring proceeding to comply with the new article. Full text of the Protocol Amending the TRIPS Agreement can be accessed at: https://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm

(Source: NOIP Vietnam)