Covid-19 vaccine: Compulsory licensing key to equal access

Vaccine hesitancy in rural india
Poor health infrastructure, digital divide, low literacy levels and misinformation about Covid-19 have resulted in vaccine hesitancy that could derail the Covid response in rural India.

Covid-19 vaccine: The Covid-19 pandemic is undoubtedly the worst public health emergency since the Spanish flu outbreak of 1918. The coronavirus disease has resulted in more than 85 million infections and 1.8 million deaths worldwide. According to WHO statistics, the latest wave of the pandemic saw 4 million Covid cases and 72,000 deaths. The unprecedented damage to human lives and the economy is justification enough for compulsory licensing of coronavirus vaccines. The Indian government should issue compulsory licensing of Covid-19 vaccines to ensure rapid access to all who need immunisation. World Health Organization (WHO) should endorse this call as early as possible to prevent further loss of lives and economic destruction.

Compulsory licensing is a tool to ensure access to essential drugs and medicines to the most needy. Through this process, a government allows someone else to produce a patented product or process without the patent owner’s consent. It is one of the flexibilities in the field of patent protection included in the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, the WTO’s global agreement on intellectual property.

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Trade issues over Covid-19 vaccine

The Doha Declaration on the TRIPS Agreement and Public Health, ratified by WTO members in 2001, helped frame the intellectual property system’s health policy context. The Doha Declaration confirms that countries are free to determine the grounds for granting compulsory licences and determining what constitutes a national emergency. Covid-19 pandemic perfectly justifies calling for compulsory licensing of vaccines and commodities.

Speedy access to COVID-19 tests, medicines and vaccines are among the 10 priority global health issues to track in 2021, according to WHO. Due to an unprecedented speed of innovation, there are many promising vaccines in the pipeline. But a road map to ensure access to these innovations for all who needs is yet to be in place. The Access to Covid-19 Tools (ACT) Accelerator, a collaboration initiated by WHO to accelerate development, production, and access to tests, treatments, and vaccines. Trade laws and other technicalities such as patents should not present a barrier to rapid access to Covid-19 tools, including vaccines.

WHO prescriptions and accompanied actionable practical steps for implementing the ‘WHO Manifesto for a healthy recovery from Covid-19’ aim at creating a healthier, fairer and greener world while investing in maintaining and resuscitating the economy hit by the effects of Covid-19. The ACT has targeted distribution of 2 billion vaccine shots, 245 million treatments, testing for 500 million people in poor countries, and strengthening of healthcare systems. A rigid patent regime should not present obstacles to this urgent life-saving task, at the time of global public health calamity.

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Covid-19 vaccine apartheid?

The ACT Accelerator unites governments, scientists, businesses, and health organisations such as the Bill & Melinda Gates Foundation, CEPI, FIND, GAVI, and The Global Fund, UNITEDAID, Welcome Trust, the WHO, and the World Bank. However, the vaccines bring out glaring global health inequities as well. “South African officials have alerted that the world is heading towards a state of vaccine apartheid, whereby rich countries would be able to immunise large sections of their population with vaccines now coming on the market – to which developing countries would not get rapid and widespread access.

The United Nations Secretary-General Antonio Guterres called this emerging extreme inequity in access to Covid19 vaccine as vaccine nationalism. It is a term being used to describe that many developed countries are only thinking about their population. The UN chief called for vaccines to be treated as a global public good, available to everyone, everywhere on the planet, especially in Africa.

The Covid-19 Pandemic can be overcome only when no one is left behind. It seems every rich country is following -for-itself approach seem the norm. WHO should urgently call for national governments to provide ‘compulsory licencing facility to ensure global health equity. South Africa and India have called for the World Trade Organization (WTO) to suspend intellectual property (IP) rights related to Covid-19 to ensure that all the countries could access and afford the vaccines, medicines, and other new technologies needed to control the Pandemic.

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Time to act for equal access

As the least developed countries (LDCs) can now delay protecting pharmaceutical patents until at least 1 January 2033, some could straightway manufacture generic versions of the vaccines and commodities. Countries like Bangladesh have facilities to manufacture advanced vaccines, and related commodities must explore manufacturing of the generic versions of Covid-19 vaccines and commodities.

The basis of the compulsory licence issue is balancing the inventor’s rights and the public and public interest. In Covid vaccines, most of the vaccine inventors have already received substantial sums as the government guaranty. The pharmaceutical industry and many high-income countries (HICs) opposed the move, which they say will stifle innovation when it is needed most. However, unlike other pharma innovations, the Covid19 vaccine has been compensated with many governments’ public funds.

India has set precedence on compulsory licence to address its population’s treatment needs. The compulsory licence was granted by the India Patent Office on 9 March 2012 to Hyderabad-based Natco Pharma for the production of a generic version of Bayer’s Nexavar, an anti-cancer agent popularly used in the treatment of liver and kidney cancer. It was legally established that only 2% of the cancer patient population had easy access to the drug and that Bayer was selling the drug at the exorbitant price of Rs 280,000 for a month’s treatment. Natco Pharma has assured that the tablets would be sold at Rs 8,880 per month. It was settled that 6% of the drug’s net selling price would be paid to Bayer by Natco Pharma as royalties.

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India has an ambitious plan for a massive vaccination campaign, and a national-wide trial run was effectively conducted to test the health system’s readiness. During the first quarter of the year, India hopes to cover about one-quarter of the population. The first 30 million people vaccinated will be healthcare providers and other frontline workers.

According to the media reports, the Serum Institute, the Indian Pharmaceutical company that is producing the AstraZeneca-Oxford vaccine, has managed to make only about one-tenth of the 400 million doses it had committed before the end of the year. We are in a situation that we have a vaccine, but the regulatory authorities are not raising to the expectation and to ensure rapid manufacturing of the vaccine by as many players.

Considering the experience of the government of India, in issuing ‘Compulsory licencing’ for life-saving medicines, the government may, in the public interest, direct the Drug Controller General of India (DGCI) to authorise any licensee in respect of Covid19 vaccines and commodities to manufacture in India and export if needed as per the request of LDCs

The TRIPS agreement elaborates on the conditions for issuing compulsory licences in Article 31. The person or institution applying for licence must have tried to negotiate with the patent holder for a voluntary licence on commercial terms. The DGCI must take urgent steps to ensure the smooth implementation of the Compulsory licencing of Covid19 Vaccines and commodities.

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Access to Covid-19 vaccine: India has a role to play

India is the pharmacy to the world. The life-saving role played by Indian pharmaceutical firms in some of the Least developed countries (LDCs) is a real success story in global health. The compulsory licence will enable the manufacture and export of pharmaceutical products to any country that has insufficient manufacturing capacity for the product. India already has signed MOUs with 60 developing countries on health-related technical collaboration. Most of these countries need rapid access to Covid-19 vaccines and commodities.

According to WHO, there are currently more than 200 Covid-19 vaccine candidates in development and 27 of them are on clinical trials. To promote a global approach to vaccine distribution, WHO collaborates with business, global health organisations and scientists to speed up the pandemic response. COVAX (led by WHO, GAVI and CEPI) is expected to facilitate equitable access and distribution of vaccines to protect people across the world.

WHO manifesto for a healthy recovery from Covid-19 indicated that the crisis has shown that people will support even complicated policies if decision making is transparent, evidence-based, and inclusive, and has the precise aim of protecting their health, their families and their livelihoods — rather than serving special interests.

Calling for compulsory licensing of Covid-19 vaccines and commodities is clearly within the scope of the WHO Manifesto for a healthy recovery from COVID-19. The government of India should take the lead and ensure that vaccines is accessible to all in India and to the people in developing countries who are experiencing a vaccine apartheid.

(Dr Joe Thomas is associate dean, faculty of sustainability studies, and head, School of Public Health, MIT World Peace University, Pune.)

References (All accessed on 03/01/21)

WTO TRIPS and public health

WTO Compulsory licensing of pharmaceuticals and TRIPS,the%20patent%2Dprotected%20invention%20itself.

WHO 10 global health issues to track in 2021

WHO Manifesto for a healthy recovery from COVID-19. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.

WHO Director-General’s statement on the IHR Emergency Committee on Novel Coronavirus (2019-nCoV). 30 January 2020

Vaccine Apartheid. Nov 16, 2020

South Africa and India push for COVID-19 patents ban
VOLUME 396, ISSUE 10265, P1790-1791, DECEMBER 05, 2020

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Dr Joe Thomas is Professor of Public Health, Institute of Health and Management, Victoria, Australia. Opinions expressed in this article are personal.