In October 2020, India and South Africa presented a proposal in favour of a waiver to certain TRIPS chapters and provisions, now co-sponsored by another 10 countries and supported by over 100 WTO Members. The stated aim is to ensure that intellectual property rights (IPRs) do not create barriers to the timely access to affordable medical products. This dialogue among trade negotiators took stock of the current state of play of the proposal and considered options going forward.
State of Play
Prior to discussions, perspectives on the state of play were shared by David Vivas Eugui, Legal Officer at UNCTAD. It was recalled that the waiver is quite broad in terms of the type of IPRs and products covered. At the same time, it is quite specific in terms of the disease, i.e. limited to COVID-19. It is also meant to be a temporary and exceptional measure and not a permanent modification of the TRIPS Agreement.
The United States supports the waiver on intellectual property protections for vaccines for COVID-19, as well as with text-based negotiations. It also supports a wide coverage of IP categories, but limited to the subject matter of Covid-19 vaccines. A different approach is adopted by the EU, which proposes to use as a basis the Doha Declaration on the TRIPS Agreement and Public Health (2001) and make use of TRIPS Articles 31b) and 31bis. The implications of the European approach would include: (i) favouring the track of a national emergency or other circumstances of extreme urgency’, for which no authorisation from the title holder is needed although adequate remuneration will be required; (ii) It would apply to both vaccine and medicines.
According to the presenter, some of the key technical issues to consider in these discussions include: (i) a wide waiver might more easily avoid any potential legal hurdle later, although the current status implies the use the TRIPS and Public Health Declaration; (ii) a WTO Declaration is a non-binding instrument, while a waiver is a permission granted by WTO members allowing a WTO member(s) not to comply with their existing commitments under defined conditions; (iii) Besides vaccines, consideration should also be given to relevant ingredients, application devices, cooling machinery etc.; (iv) a general waiver could help respond to future pandemics, although the probability of consensus for such a solution is very low; (v) While a waiver may be a useful legal instrument, countries still need financial, technical, distribution and manufacturing capacities to make it work; (vi) Compulsory licensing may be used to negotiate a favourable voluntary agreement with better prices and delivery agreements, keeping in mind that this would require both importing and exporting countries to modify their national legislation on the matter.
With regard to importation, manufacturing and distribution, it was indicated that while manufacturing may be a solution for the medium and long term, the immediate response would realistically rely on importing. Importers would first need to identify the suppliers of the “generic vaccine”, and cooperation from the title holders will remain needed. Building local manufacturing capacities may be a difficult task in many developing countries. A possible avenue may entail expanding COVAX support to enable the creation of regional vaccines manufacturing hubs, which could provide a safety net to quickly respond to the need of the hour.
In summary, some of the main takeaways from discussions included: (i) the priority should be to agree on the waiver by the time of the 12th WTO ministerial conference, otherwise its utility may be significantly reduced ; (ii) delegates emphasised the need to keep the focus of the original proposal, i.e. not limiting its scope to vaccines only; (iii) it will be important not to lose sight of key steps to take at the national level, i.e. members will need to start undertaking legislative and capacity mappings; (iv) Members should already consider how to build regional capacities for future pandemics.