07 May 2021: UPSC Exam Comprehensive News Analysis

E. Editorials

Category: SCIENCE AND TECHNOLOGY

1. Intellectual property waiver for Covid-19 vaccines

Context:

• The United States under the Biden administration has announced support for waiving patents on COVID-19 vaccines and will pursue negotiations for the same at the World Trade Organization.

Background:

Patents:

• A patent is an exclusive monopoly granted by a government to an inventor for a limited, pre-specified time. It provides an enforceable legal right to prevent others from copying the invention.
• Patents can be either process patents or product patents.
  • A product patent ensures that the rights to the final product are protected, and anyone other than the patent holder can be restrained from manufacturing it during a specified period, even if they were to use a different process.
  • A process patent enables any person other than the patent holder to manufacture the patented product by modifying certain processes in the manufacturing exercise.
• India moved from product patenting to process patenting in the 1970s. But due to obligations arising out of the TRIPS Agreement, India had to amend the Patents Act in 2005, and switch to a product patents regime across the pharma, chemicals, and biotech sectors.

Proposal for a temporary waiver:

• In October 2020, India and South Africa had asked the WTO to waive certain conditions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement that could impede their access to affordable medical products to combat Covid-19.
• The countries had asked the TRIPS Council to recommend a waiver on the implementation, application and enforcement of four sections in the second part of the agreement. These sections — 1, 4, 5, and 7 — pertain to copyright and related rights, industrial designs, patents, and the protection of undisclosed information.
• The demand had also been raised by human rights bodies and global advocacy groups. However, the appeals to do away with intellectual property rights have been unsuccessful so far in the face of lobbying by powerful pharmaceutical companies.

Details:

• The U.S. administration has stated that though it believes strongly in intellectual property protections, it supports the waiver of those protections for the COVID-19 vaccine given the need of the hour to end the pandemic.
• The move is aimed to get as many safe and effective vaccines to as many people as fast as possible.
• United States Trade Representative has said that the US will pursue “text-based negotiations” on the waiver at the World Trade Organization (WTO).
  • Text-based negotiations involve negotiators exchanging texts with their preferred wording and then thrashing out a consensus on the working.

Significance:

Movement towards global consensus:

• The opposition to IP related waivers has come from the developed nations and their industries. The U.S. support for the temporary waiver would go a long way in building a global consensus for the proposed IP waiver.
  • The European Union, which had earlier opposed the waiver, has now stated its intent to discuss the US-backed proposal.

Push for global vaccine production:

• Doing away with intellectual property rights will help scale up vaccine production.
• The IP waiver might open up space for large scale production of COVID-19 vaccines with emergency use authorisations (EUA) — such as those developed by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson and Bharat Biotech —in middle-income countries.
  • Most production is currently concentrated in high-income countries; production by middle-income countries has been happening through licensing or technology transfer agreements.
• Hence, this will be a big step in overcoming vaccine shortage.

For related information refer to:

CNA dated April 13, 2021: Scaling up vaccine production

Ensure cheaper vaccines:

• Doing away with intellectual property rights will pave the way for cheaper versions of the vaccine to enter the market.
• The waiver would allow any company which possesses the required technology and infrastructure to produce vaccines. This will lead to cheaper and more generic versions of COVID-19 vaccines. It will mean that vaccines will be more affordable.

Ensure universal vaccination:

• Vaccine experts and human rights groups have warned that the longer Covid circulates in developing nations, there is the greater chance of more vaccine-resistant, deadly mutations of the virus emerging. An Oxfam International report warns that mutations could render current COVID vaccines ineffective in a year or less.
• This necessitates the need to vaccinate all. Open sharing of technology and intellectual property could increase global vaccine coverage.

Challenges:

Time-consuming process:

• The negotiations at WTO may take time given the consensus-based nature of the institution and the complexity of the issues involved.
  • All 164 WTO members must agree on the draft, and any one member can veto it.

Questions over production capacity:

• It must be noted that the mere elimination of IP protections may not necessarily speed up the production of the vaccines.
• Ramping up production capacities will be a lengthy process and most analysts expect this to take at least a few months.

Supply chain constraints:

• Besides patents, there are other roadblocks to scaling up the production of vaccines and ensuring their distribution. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has pointed to challenges in scaling up the production and distribution of Covid-19 vaccines.
• Challenges include trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chain, and the unwillingness of rich countries to share doses with poorer nations.
• The scarcity of raw materials has been a growing issue for ramping up production; several manufacturers have been relying on specific suppliers, and alternatives are limited.
  • Countries like the US had blocked exports of critical raw materials used in the production of some Covid-19 vaccines using regulations like the American Defence Production Act. This led to a delay in the production of COVID vaccines by some companies in India.

Economic ability of developing states to acquire vaccines:

• Given the propensity of high-income countries to acquire “most of the supplies” there is the overwhelming possibility of global vaccine inequality. This could impact the very basis of calls for a temporary waiver of IP rights- ensuring global access to quality vaccines.
  • The United States has been reportedly having an excess of over 80 million doses of various vaccines while the developing world continues to face vaccine shortages.

Arguments against the move:

Dis-incentivize further research:

• Pharma companies including Pfizer and AstraZeneca have opposed the proposed waiver arguing that eliminating IP protections would undermine the global response to the pandemic, including the ongoing efforts to tackle new variants. It could dis-incentivize research into the ever-evolving SARS-CoV-2.

Minimal impact on vaccine production:

• The mere elimination of IP protections may not necessarily speed up the production of the vaccines given the lack of currently available production capacity.

Questions over quality:

• The pharma companies of the western nations have been arguing that the lifting of patents would be a compromise on control of safety and quality standards for vaccine manufacturing.
• The pharma companies argue that the waiver could create confusion that could potentially undermine public confidence in vaccine safety and create a barrier to information sharing.

Flexibilities available in TRIPS:

• Arguments against a temporary waiver for IP rights contend that there are already existing flexibilities available in TRIPS that can be utilized by middle-income countries. The temporary waiver would amount to a large dilution of IP rights and may lead to similar calls in future thus permanently impacting the IP rights under the TRIPS arrangement.

Counter arguments:

Financial viability of pharma companies not at stake:

• WHO Director-General, Tedros Adhanom Ghebreyesus has argued that the waiving of the patents do not mean the innovators will not get anything — they stand to get a royalty for the products they manufacture.

Previous case of generic medicine production:

• The argument that middle-income countries do not have the capacity to speedily produce vaccines goes against earlier moves towards a patents regime for generic drugs. Experts said the same reasoning can be used now for the production of vaccines.
• A number of companies from different countries have said they are ready to produce the vaccines if a temporary waiver is provided.
  • Countries including Canada, South Korea, and Bangladesh have shown interest in making COVID-19 vaccines if they can get a patent waiver.

Concerns over quality do not hold:

• The quality of the vaccines can always be assessed and regulated.
• The continued association of western companies with Indian companies for manufacturing their vaccines in India is indicative of the quality of products produced in India.
  • Between 1972 and 2005, India had adopted process patenting rather than product patenting, and built up a huge generic industry. India which is a significant producer of generic drugs on a global scale has enabled companies like Cipla to provide Africa with anti-HIV drugs in the 1990s.

Ineffectiveness of available flexibilities:

• The developing countries may face institutional and legal difficulties when using flexibilities available in the TRIPS Agreement.

Recommendations:

Negotiations should include all COVID-19 related interventions:

• Notably, the proposal for temporary waiver was for all COVID-19 interventions, including testing diagnostics and novel therapeutics. The IP waiver negotiations should include other interventions going forward.

Ensuring equitable access:

• Given the available evidence pointing to the ill effects of inequitable vaccine access, there should be an increased emphasis on ensuring more equitable distribution of the vaccine doses available.

Conclusion:

• In view of the ongoing global health crisis and the need for extraordinary measures in extraordinary circumstances of the Covid-19 pandemic, the temporary waiver of IP rights seems to be the right way forward in the global fight against the pandemic.
• If patents are waived, it will definitely be a shot in the arm to increase the scale and speed of vaccine rollout across the world.

For related information refer to:

CNA dated April 28, 2021: A patently wrong regime