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The AIDS fight offers a COVID vaccine patent pathway

In order to achieve global herd immunity and prevent new strains of COVID-19 from emerging, possibly for years to come, vaccines need to be affordable and available in massive quantities throughout the globe. This can happen through patent owners voluntarily licensing their products to other companies, especially Indian producers who are experienced at mass-producing low-cost medications. This can also be done by temporarily suspending patent rights for COVID vaccines, an option that is being pursued by India and South Africa through the World Trade Organization (WTO) and one that is legal in the event of a public health emergency, according to that organisation’s own rules. One way or the other, India and the world need several Indian pharmaceutical companies, not just the Serum Institute of India, to gain the right to make these vaccines if we are going to see an end to this pandemic any time soon.

Turning point in the HIV fight

Decades of struggles over patent rights and access to medications for HIV/AIDS demonstrate that it is possible to navigate patent restrictions using something called “voluntary licenses” where a patent holder decides to license a product to other producers. The United Nations’ Medicines Patent Pool and the World Health Organization’s COVID-19 Technology Access Pool are important tools in an effort to promote voluntary licensing for COVID products that so far have been ignored by pharmaceutical producers. Sharing patent rights through voluntary licensing would need to involve India’s large pharmaceutical sector whose production capacity helped make treatments for AIDS more affordable in low-income countries and helped mitigate that pandemic.

 

In the 1990s, the WTO began implementing a global intellectual property regime known as the Trade Related Aspects of Intellectual Property Rights agreement, or TRIPS. While TRIPS alarmed public health experts because of its potential to raise the price of essential medicines, voluntary licensing agreements between pharmaceutical producers were able to bring down the price of AIDS medications despite the TRIPS regulations.

Responding to anti-TRIPS activism from low-income countries and realising they would not be able to profit off of low-income markets anyway, some manufacturers placed licensing agreements to produce AIDS drugs for which they owned patent rights in the UN-affiliated Medicines Patent Pool. Several India-based companies then used these voluntary licences to manufacture these drugs on a massive scale and sold them at prices they determined. In the case of Gilead, which placed more products in the Patent Pool than any other producer, their licences required the licensee to pay Gilead a royalty of 3% of the sales of the drug and limit sales to low-income countries. This effort brought down the price of key AIDS medications in these countries. Most significantly, tenofovir, a first-line treatment for HIV/AIDS, has come down in price from $200-$500 per person per year to $39 per person per year in low-income countries now that 13 India-based pharmaceutical companies are producing it.

Context of health emergency

It is also possible for governments to issue what are called “compulsory licenses” which override patent rights to allow local production or import of drugs by generic manufacturers in the event of a public health crisis. Since 2003, this right has been enshrined in the Doha Declaration addendum to the WTO’s TRIPS agreement and this is what India and South Africa are lobbying for, having recently been joined by the United States though not as of yet the European Union (EU). The Doha addendum, Section 5c, offers AIDS, malaria and tuberculosis as examples of what qualifies as a health emergency. By this standard, COVID-19 should easily qualify. In fact, not invoking Doha exemptions in this unprecedented health crisis would make this agreement meaningless. We may thus find compulsory licences being issued in several countries for vaccines and treatments for COVID-19, although manufacturers in India say they prefer to work with voluntary licences because there is more good will between companies while compulsory licences often come with a legal battle brought by the patent holder. Voluntary licences also enable production to begin more expeditiously as they usually are accompanied by “technology transfer” meaning that the patent holder reveals to the licensee how to manufacture the medication, sparing the licensee the lengthy and costly process of figuring out how to reverse engineer the product.

 

The COVAX option

Some favour ensuring access to COVID-19 vaccines through the COVAX programme, which was established to purchase vaccine doses and donate them to low-income countries but does not involve modifying patent rights. Similar ventures during the AIDS crisis were chronically underfunded and had only minor effects on that pandemic compared to the voluntary licensing and mass production of antiretroviral drugs from Indian producers. COVAX is also currently underfunded and the Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, warned that people in the lowest-income countries might have to wait until 2022 to get vaccinated through this programme, which may actually be optimistic since COVAX has shipped around 68 million doses so far.

Similar concerns to those presented here were raised in last year’s annual meeting of WHO which established a patent-sharing pool for COVID products, the COVID-19 Technology Access Pool. So far, no patent holders have joined this effort which is why India and South Africa called on the WTO to temporarily waive patent protections for COVID-19. Meanwhile, the UN Medicines Patent Pool stands ready to accept voluntary licences having added a placeholder for COVID-19 on the list of diseases they address. Hopefully, the EU will join the efforts by India and South Africa at the WTO, and pharmaceutical producers will realise, as some did during the AIDS pandemic, that voluntary licensing comes with better public relations and that they are not going to make money off low-income countries regardless of patent enforcement.

 

A key step

Furthermore, the billions of dollars in government aid given to companies to help develop COVID-19 treatments should entail an obligation to enable the mass production of affordable vaccines. After all, as legal scholars have long explained, patents are not ironclad ownership rights. They are a temporary contract that balances the public interest with the claims of the innovator. This is not just a question of social justice and ensuring life-saving therapies are available to the world’s poor. It is a necessary step to prevent deadlier, more contagious and possibly vaccine-resistant variants of COVID-19 from proliferating in an under-vaccinated world.

Murphy Halliburton, Professor of medical anthropology at Queens College and the Graduate Center, City University of New York, is the author of India and the Patent Wars: Pharmaceuticals in the New Intellectual Property Regime


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Printable version | Jun 10, 2022 12:01:41 am | https://www.thehindu.com/opinion/op-ed/the-aids-fight-offers-a-covid-vaccine-patent-pathway/article62106233.ece