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- Recently, the EU, India, South Africa and the US reached a compromise over the TRIPS waiver, called the ‘Quad Agreement’, over easing patents on COVID-19 vaccines.
- The deal is the most important international legal solution proposed thus far to alleviate the problem of IP rights in the way of preventing or treating COVID-19.
- In practical terms, we need to see how much the agreement will ease access to vaccine patents over the TRIPS agreement. This may not be much.
Recently, the EU, India, South Africa and the US reached a compromise over the TRIPS waiver, called the ‘Quad Agreement’, over easing patents on COVID-19 vaccines.
As we wait for the official text, it has already been reported that a limited agreement has been struck. The deal will waive patents on vaccines and will be reconsidered six months later to include diagnostics and therapeutics as well.
The agreement also touches on data exclusivity – but without any significant relief. Data exclusivity is a right that drug manufacturers claim over clinical trial data and prevent generic manufacturers from relying on the same data to secure approvals.
The patent waiver will be available to developing countries, which exported fewer than 10% of all COVID-19 vaccines exported worldwide in 2021. The same criteria applies to countries to be eligible to receive vaccines produced by other countries under the same deal.
For better or for worse, the TRIPS waiver remains the most important international legal solution proposed thus far to alleviate the problem of intellectual property (IP) rights standing in the way of the prevention, containment and treatment of COVID-19.
The idea was good: to dilute or suspend obligations on countries to protect and enforce IP, as imposed by the TRIPS Agreement, in view of the pandemic. The TRIPS agreement is the broadest multilateral IP agreement in the world. It binds nearly 170 countries and is administered and enforced by the World Trade Organisation (WTO).
In its history of nearly 30 years, the agreement has brooked significant criticism, especially with respect to provisions that provide strong IP rights protection to drugs with unworkable flexibilities, thus impeding access to medicines in developing countries.
Recognising these issues, the TRIPS waiver – when first proposed at the WTO in 2020 – was expansive in its vision and intended to address all types of IP rights, including prevention, containment and treatment. It immediately came under heavy criticism from developed countries as well as Big Pharma. After extensive negotiations in 2021, the US, under the Biden administration, agreed to back a waiver addressing all IP rights for vaccines. But this still remained unacceptable to the EU bloc.
Too little, too late
The new version that has emerged now is however too little, too late. In addition to patents, trade secrets and manufacturing know-how have been repeatedly cited as barriers to transfer the tech necessary for others to develop vaccines. In the field of vaccines, it is common to find under-disclosure in patent applications and an over-reliance on trade secrets and manufacturing know-how, which limit the ability of generic manufacturers to take advantage of the waiver. Yet trade secrets and know-how find no mention in the Quad agreement.
Patents and trade secrets have emerged as the biggest barriers to vaccine development, but the WTO, in an initial note on the production and distribution of vaccines, had also identified copyright, trademarks, industrial design and test data as relevant IP. Published scientific data, technical standards and specifications and other knowledge are all subject to copyright.
At the beginning of the COVID-19 pandemic, several solutions were put in place by libraries, institutions and even the biggest publishers of scientific journals, to lift paywalls temporarily on journal articles that might be related to the disease, its spread, etc. But even despite such voluntary measures, Indian researchers in science and social science disciplines still found websites like Sci-Hub and LibGen indispensable during the pandemic.
In practical terms, we also need to see how much the Quad Agreement will ease access to vaccine patents over the TRIPS agreement. This may not be much – if only because Big Pharma seems ready to welcome it, should it be approved by consensus at the WTO.
Knowledge Ecology International, a reputed international NGO, has pointed out that the Quad only helps dilute restrictions relating to vaccine exports in the TRIPS agreement. Countries also have to issue an authorisation to opt into the waiver and will be required to ‘list’ all patents covered under the authorisation.
A single vaccine product can be covered by multiple patents, however. One World IP Organisation study showed that there exist nearly 11,000 families of patents in the field of vaccines. More recently, WIPO also reported an extraordinary rise in patenting activity during the pandemic.
We are yet to vaccinate everyone in the world, even as new waves keep emerging. In India, booster doses are not yet being administered to all those aged 18-60 years, even as vaccines are also being approved for children. Worldwide, developed countries’ populations remain far ahead in the number of boosters doses administered, while only 14.4% of people in low-income countries have received one dose.
Therapeutics for COVID-19 treatment are also still either in trials or are still being developed. Given the politicking and delays around the TRIPS waiver, it is likely that access to therapeutics will mirror the mess that is access to vaccines.