A consensus agreement among World Trade Organisation members has been reached to waive certain international IP protection commitments in the field of covid-19 vaccines. The deal comes after a tense week of negotiations at the WTO’s 12th Ministerial Conference, and more than 18 months after a partial TRIPS suspension was advocated by India and South Africa.
WTO members agreed last night to temporarily change the TRIPS Agreement, a move based on the proposal tabled in recent months by the US, EU, India and South Africa. This new agreement seeks to enhance the flexibility of countries to circumvent patent rights relating to covid-19 vaccines, and stipulates the following relaxations of international treaty obligations relating to compulsory patent licensing:
- A member state can issue a single compulsory licence for multiple patent rights relating to the production or supply of a vaccine. Compulsory licences issued during the waiver may by updated to include more patents retrospectively.
- Eligible countries may bypass patents without first engaging in negotiations with rights holders.
- There is no requirement for products manufactured under these provisions to predominantly supply the domestic market.
- Remuneration for patentees may reflect the not-for-profit purpose of the compulsory licences.
- Regulatory data exclusivities may also be bypassed to further the objectives of compulsory patent licences.
- Patents may be circumvented by any instrument on a member’s statute: legislative action, executive order, emergency decree etc.
The WTO conference, initially set to end 15 June, was extended by one day in an attempt to clinch agreements on IP reforms and several other contentious proposals. To the chagrin of several advocacy groups and lower-income countries, however, the agreed IP waiver is less far-reaching than the original proposal.
India and South Africa’s original proposal contained measures to suspend multilateral trade secret protection and covered therapeutics and diagnostics as well as vaccines. The newly agreed text also states that only “developing countries” that supply less than 10 percent of the world’s covid-19 vaccine exports can take advantage of the enhanced compulsory licensing powers.
An agreement on the TRIPS waiver was by no means guaranteed coming into the Ministerial Conference. The compromise proposal has been criticised by many of the original supporters of a covid IP waiver, who argue that it does not go far enough. Despite being a party to the middle-way proposal, India hardened its stance this week, calling for the waiver to apply also to diagnostics and therapeutics. The country’s commerce and industry minister, Piyush Goyal, argued that a ramping up of therapeutics and diagnostics manufacturing was now more important than expanding vaccine production. What’s more, several long-standing opponents of any IP waiver, such as the UK and Switzerland, restated this position at the beginning of the conference.
A consensus has been achieved, however, with the parties agreeing to debate a potential extension of the measures to diagnostics and therapeutics over the next six months. Reports are that the waiver is intended to last for five years.
For reasons IAM has explained elsewhere, it is not clear whether these provisions will have any significant impact on vaccine manufacturing or on public health efforts to tackle the effects of covid-19. Even Goyal stated this week that vaccines are no longer scarce and many are now being wasted due to expiration.
Yet the agreement reflects a major shift in approach to international IP policy, especially among developed, Western countries. It is difficult to imagine that the proposals would have gained the necessary momentum without President Biden’s historic policy shift in May 2021. The European Union’s support seemed unlikely until relatively recently. Perhaps Germany’s change of government at the end of 2021 also played a significant role in building TRIPS waiver consensus.