Trips Agreement Article 73

The COVID-19 pandemic has led governments to consider measures to deviate patents and other intellectual property rights (IPRs) to facilitate the production and distribution of vaccines, treatments, diagnostics and medical depositives. This paper examines whether pandemic-19 COVID can be considered an “emergency in international relations” and how WTO member states can invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as a legal basis to deviate from ipRs for provision or enforcement are required by types of employment elsewhere. It concludes that the pandemic is an emergency in international relations within the meaning of Article 73 (b) (iii) and that this provision allows governments to take the necessary steps to protect their essential security concerns. In most countries, drugs and vaccines must be authorised by the authorities, and to obtain this, the manufacturer must submit to the national drug regulatory authority a file with data for clinical trials demonstrating the efficacy and safety of the product. These data are often subject to long periods of protection or “exclusivity” – particularly in countries with trade agreements with the US or the EU – for example in the EU from the date of authorisation to market. Subscribe to this free diary for more articles on this topic 2. Amendments aimed solely at adapting to a higher level of protection of intellectual property rights, obtained in other multilateral agreements and adopted by all WTO members under these agreements, may be available on the basis of a council consensus proposal for TRIPS for activities in accordance with Article X, paragraph 6 , the WTO agreement. For the purposes of this contribution, I assume that COVID-19 can be considered an “emergency situation in international relations” as interpreted in both cases. Therefore, suppose that States can, if they wish, invoke Article 73, point b) iii) to suspend the application of patent rights in order to facilitate the production or importation of patented drugs or vaccines in response to COVID-19. I would, however, propose here that Article 73, point b) iii) not be a realistic option for a number of States for the following three reasons. Some countries – Malaysia, Chile and Colombia, for example – have recognized the importance of ensuring that data exclusivity provisions do not impede the appropriate use of compulsory licences and have included explicit exceptions in their pharmaceutical or patent legislation to facilitate the registration of generic drugs where necessary to protect public health.