In times of such crisis, one of the key priorities for any country is ensuring effective management and rapid availability of cost-effective medical supplies. Inoculating the masses completely has been one of the biggest challenges for governments across the globe.
The issue of intellectual property rights (IPRs) is posing a wide-scale challenge in manufacturing of the required drugs and vaccines.
In such a scenario, India and South Africa proposed a temporary waiver of the World Trade Organisation’s (WTO’s) agreement on trade related aspects of intellectual property rights (TRIPS). Waiver has been sought for Covid essentials such as vaccines, medicines, diagnostic kits, personal protective equipment (PPE) kits and ventilators.
What are patents and IPRs
Patent is an exclusive right granted to the inventor or maker of a product, which generally involves a new way of doing something or offers a new technical solution to a problem.
A powerful IPR, granted for a specified period of time, provides an enforceable legal right to prevent others from copying the invention.
A person can patent the final product which restrains any other person from manufacturing it even using a different process. Alternatively, a patent can also be taken for the process by which the invention has been made. In such a situation, the product can be manufactured by anyone other than the patent holder by modifying the existing process.
In India, grant of patents is governed under the Patents Act 1970. India moved from product patenting to process patenting to become a significant producer of generic drugs and ensure its global supply. However, it had to amend and introduce significant changes to the system after becoming a signatory of the TRIPS agreement.
Consequently, Patent Act 2005 came into effect across the pharma, chemicals and biotechnology sectors.
What is the TRIPS agreement
TRIPS is a multi-lateral agreement on IPR such as copyright, industrial design, patent and protection of undisclosed information or trade secrets.
It is a legal recognition of the significance of links between intellectual property and trade and the need for a balanced intellectual property system.
The agreement came into effect in January 1995 and covers all WTO member nations.
It is an attempt to narrow the gaps in the way these rights are protected and enforced around the world, and to bring them under common international rules.
The agreement establishes minimum standards of protection and enforcement that each government has to give to the intellectual property held by nationals of fellow WTO members.
What will a waiver mean
The TRIPS waiver aims to increase global vaccine production in order to take on the challenge of vaccinating the poorest of the poor and saving lives.
If WTO members agree upon a common consensus and opt for IPR waiver, it may open up the path for production of Covid vaccines and drugs on a larger scale than at present — with emergency use authorisation — especially in middle income countries.
This will open up the way for more companies to join in and start manufacturing, thereby providing a boost to supply.
Most of the production and manufacture of Covid vaccines are concentrated in developed countries as of now. Some middle income countries have been engaged in production of vaccines via licensing or technology transfer agreements.
However, even if an agreement is clinched on the implementation of certain provisions of the TRIPS agreement in relation to the prevention, containment or treatment of Covid-19, it could be months before it comes into implementation.
Besides, manufacturing Covid vaccines and drugs may continue to be a major challenge for underdeveloped countries and they may still need to depend on exports from manufacturing nations.
What does it mean for India
Sourcing essential drugs and injections for serving critical patients became a real challenge for people as well as for hospitals amidst the second Covid wave in India.
India along with South Africa had first submitted a draft proposal suggesting waiver for all WTO members.
In May this year, a revised proposal was submitted by 62 co-sponsors, including India, South Africa and Indonesia.
The new text says the waiver should apply not only to vaccines, but to treatments, diagnostics, medical devices and protective equipment, along with the material and components needed to produce them.
It also says the waiver should last for “at least three years” from the date it takes effect, following which the WTO’s General Council should determine whether it should be prolonged.
A waiver would mean that India will get access to raw material and technology that will help it to ramp up production of vaccines at such a critical juncture. This holds importance especially at a time when the government is in talks with several foreign vaccine makers like Pfizer, Moderna, Johnson & Johnson to make their vaccine available in India.
The Centre is already administering a licensed version of AstraZeneca’s drug in India. AstraZeneca collaborated with University of Oxford to create Covishield, which is being manufactured by the Serum Institute in India.
Who is backing the patent waiver and who’s not
The proposal for patent waiver received widespread support at the recent G7 summit in the United Kingdom (UK).
In a major U-turn, the United States decided to back India and South Africa in their proposal for waiving off IPR on Covid vaccines.
According to US Trade Representative Katherine Tai, “the extraordinary circumstances of Covid-19 pandemic call for extraordinary measures” as the outbreak in India threatens to unleash more vaccine resistant strains that could undermine global efforts to contain the pandemic.
This was a reversal of the US stance at the WTO where it had earlier opposed any patent waiver.
The US has now agreed to pursue text-based negotiations on the waiver at the WTO. However, such negotiations may take time given the consensus based nature of WTO. All 164 member nations must agree on the proposal and even one can block a decision.
UN secretary general Antonio Guterres last week supported the initiative to waive patent on Covid vaccines but cautioned that technology transfer must be backed by technical support.
Countries like Pakistan, Malaysia, Argentina and others believe that waiver of patents and other intellectual property rights along with access to raw material and technology will help boost production of drugs and vaccines.
The proposal has now received support from more than 120 countries including the US, China, Ukraine, France and New Zealand.
Meanwhile, the European Union, Britain, Brazil, Norway, Singapore, South Korea, Switzerland, Taiwan and Japan continue to voice their doubts about the convenience of starting negotiations and asked for more time” to analyse the proposal.
The proposal has also been opposed by pharmaceutical industry and their host countries which insisted that patents were not the main roadblocks to scaling up production. They warned that the move could hamper innovation and do little to effectively increase vaccine supplies that are hampered by trade and manufacturing barriers. .
Will it solve the problem of vaccine shortage?
Experts have not been able to come clear on this aspect yet, but drug makers and analysts have said that waiving patent rights will not help the developing countries to make vaccines faster.
Manufacturing a vaccine is a very complex procedure requiring factors such as factories with specialised equipment, skilled labour force and strict quality control, to name a few.
Besides, shortage in supply of raw materials like vials, stoppers and other components might pose a delay in the process.