Intellectual property rights held by international pharmaceutical companies on COVID-19 vaccines may be relaxed for up to five years, according to a proposal by the European Union (EU) in the backdrop of a festering two-year-old dispute at the World Trade Organisation involving India, U.S., South Africa and the EU.
This reprieve will, however, not apply to COVID-19 drugs and diagnostic devices, though the EU proposes a “discussion” on this in the next six months and also rebuffs India’s original demand for a complete waiver on intellectual property restrictions on covid therapeutics.
This waiver will allow pharmaceutical companies in developing countries to not only make but also, further down, export vaccines without explicit permission from the patent holders, says a version of the negotiation text that The Hindu has viewed.
A discussion on the text is expected in the fortnight ahead, a person familiar with the proceedings, but who declined to be identified, told The Hindu.
Though India, along with South Africa, was among the proponents of the original waiver in 2020, it is unclear to what extent this proposal will benefit Indian manufacturers, who have in the last year, not only entered into licensing arrangements with global pharmaceutical companies but also developed indigenous vaccines. Nearly 100 countries including the United States support the Indian position but the EU has
Many developing countries, including India, already have a system of compulsory licensing regime, whereby exigencies can permit the government to authorise production of a drug or vaccine irrespective of whether it is protected by patents.
India has also administered over a 1.7 billion vaccines locally and has exported at least 30 crore vaccines to neighbouring countries as well as supplied to the international COVAX facility. A clause in the current text says that these “waivers” would apply to developing countries that have not exported more than 10% of the COVID-19 vaccine doses in 2021 and it is unclear if India is included in this definition.
A person aware of these developments said that as the provisions only applied to “patented” products and as firms such as Moderna and Pfizer had not patented their vaccines in India, it would not necessarily facilitate their manufacture in India.
“More than the patent, it’s the manufacturing know-how that matters. This aspect, which falls under trade secret, may continue to be withheld,” the person added.
Biswajit Dhar, an expert on international trade and Professor at the Jawaharlal Nehru University and who saw the draft document said that the current format wasn’t progressive. “This is in essence the same as the provisions on compulsory licensing. India has historically been a leader of developing countries’ positions at the WTO. In this matter there has been no real push by India. This lethargy might have serious consequences in future negotiations.”
Another person who’s close to TRIPS negotiations proceedings told The Hindu on condition of anonymity that India was “playing it safe” at the global tables. “The pandemic isn’t over yet. More than patent waivers, Indian industry is worried about the supply lines (of components necessary to make drugs and diagnostics) being cut off by the West if we are adamant on a complete waiver. We have now plenty of vaccines but drugs are a different deal.”
Background to talks
The negotiations began after India sent a letter to the Director-General of WTO Ngozi Okonjo-Iweala on December 23 asking for a virtual, ministerial conference to be held on the issue of the TRIPS waivers, to accelerate talks on the original India-South Africa proposal submitted in October 2020.
There has since been a four-way, ministerial consultation in January, and meetings by officials of key players U.S., EU, India and South Africa were ongoing, as The Hindu reported last month, to look at various proposals, of which the U.S.-EU proposal for “geographical exclusions” were high on the agenda. These included talks to devise a patent waiver regime that would exclude India.
There were also suggestions to limit the kind of medical products to counter COVID-19 that would be on the list of waivers, as well as restricting the waivers to a certain part of the Intellectual Property (IP), and not a full product and patent waiver.
Pharmaceutical bodies in India have been divided on the question of a waiver. The Organisation of Pharmaceutical Producers of India, that is made up of Indian subsidiaries of Western pharmaceutical companies, has been critical of a waiver.
“Waiving of IP rights will neither lead to increased production of vaccines or increased deployment nor practical solutions to fight the virus of COVID-19 vaccines since IP is not the barrier to adequate availability of vaccines in India. Waiving of intellectual property rights could impact patient safety by opening doors for counterfeit vaccines to enter the supply chain,” said a statement issued in May 2021. “Our topmost priority should be to address the supply side constraints, including IP barriers, to augment the manufacturing of vaccines, therapeutics and diagnostics, essential for treatment, prevention and control of the ongoing pandemic.”
The Indian Drug Manufacturers Association, on the other hand, has supported, with a caveat, the waiving off of IP rights for COVID-19 drugs to expand availability.
“What is more important is grant of voluntary licences by the patent holders to Indian companies with sufficient expertise in this field and similarly transfer technology to Indian companies against reasonable royalties,” the organisation said in a position paper last May.
Bharat Biotech, the makers of Covaxin, had told The Hindu in a statement that it was for “voluntary” technology transfer partnerships.
Ashwani Mahajan, of the RSS-affliated Swadeshi Jagran Manch and a participant at previous WTO negotiations said in a letter to Commerce Minister, Piyush Goyal, that India’s TRIPS waiver outcome must ensure that global companies also share their trade secrets (the manufacturing knowhow) to facilitate global production. “It should coer bother patented and products pending patent applications...The WTO Secretariat is notorious for its support of US and EU positions and consequently misleaing and inaccurate legal analyses....India shouldn’t agree to any text until it has been fully vetted and endorsed by India’s technical experts,” said the letter on 18th February.
India and South Africa jointly had sponsored a proposal in October 2020 and this was updated, with representation from several low- and middle-income countries — though with the notable omission of China — to expand the scope of the waiver to “all health products and technologies” and to have the waiver in place for at least a year.
The patent protections result from provision of the TRIPS to which WTO members are bound to.
