CONTEXT 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.
TO ENSURE VACCINE AFFORDABILITY AND AVAILABILITY
- Patent owners can voluntarily license 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).
- Hence, India and the world, in one way or the other, need several Indian pharmaceutical companies, to gain the right to make these vaccines if we are going to see an end to this pandemic any time soon.
AIDS FIGHT OFFERS A PATHWAY
- Decades of struggles over patent rights and access to medications for HIV/AIDS have demonstrated that it is possible to navigate patent restrictions using “voluntary licenses”.
- 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.
- 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 this the patent owners voluntarily license their products to other producer companies who are experienced at mass-producing low-cost medications. Such licences require the licensee to pay the IP holder some amount of royalty on the sales of the drug.
- In the 1990s, the WTO began to implement 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.
As a response to anti- TRIPS activism:
- Responding to anti – TRIPS activism from low income countries, the patent holders realised that they would not be able to profit off of low-income markets.
- As a result, 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.
- For eg. Gilead, placed more products in the Patent Pool than any other producer,
- These product licences require the licensee to pay Gilead a royalty of 3% of the sales of the drug and limit sales to low-income countries.
- This in turn has brought down the price of key AIDS medications in these countries.
COMPULSORY LICENSING DURING HEALTH CRISIS
- It is also possible for governments to issue “compulsory licenses” during a health crisis.
- Using Compulsory licenses, the government can override the patent rights and allow local production or import of drugs by generic manufacturers in the event of a public health crisis.
- The provision of compulsory licensing has been enshrined in the Doha Declaration addendum to the WTO’s TRIPS agreement.
- The Doha addendum, Section 5c, offers AIDS, malaria and tuberculosis as examples of what qualifies as a health emergency.
- Given the health crisis brought out by COVID-19 it could easily qualify as a health emergency.
PREFERENCE FOR VOLUNTARY OVER COMPULSORY LICENSING
- Manufacturers in India prefer to work with voluntary licences because there is more goodwill between companies while compulsory licences often come with a legal battle brought by the patent holder.
- Also, Voluntary licences enable production to begin more expeditiously as they usually are accompanied by “technology transfer”.
- i.e. 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
- The COVAX programme which was established to purchase vaccine doses and donate them to low-income countries, have been favoured by some to ensure access to COVID-19.
- But the issue with this option is that it does not involve modifying patent rights.
- Similar ventures opted during the AIDS crisis were chronically underfunded.
- They had only minor effects on that pandemic compared to the voluntary licensing and mass production of antiretroviral drugs from Indian producers.
- Similar to these ventures, COVAX is also currently underfunded.
PATENT SHARING POOL
- A patent-sharing pool for COVID-19 products, the COVID-19 Technology Access Pool was proposed at the last meeting of the WHO.
- Also, the UN Medicines Patent Pool has also been opened up to accept voluntary licences for COVID-19 vaccines and medicines.
- The companies which place their products in this list would allow other manufacturers to pursue the production of such products without fear of prosecution over IPR infringement.
- However, so far, no patent holders have joined these efforts.
- Government funding given to companies to develop COVID-19 treatments should entail an obligation to enable the mass production of affordable vaccines.
- 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.
- Hence, there is a need to take necessary steps to prevent deadlier, more contagious and possibly vaccine-resistant variants of COVID-19 from proliferating in an under-vaccinated world.