Statement from Indian Civil Society Calling on Government of India to Support Innovation and Access to Covid-19 Diagnostics, Therapeutics and Vaccines

DOCUMENT

New Delhi, 24 June 2020

COVID-19 was declared a pandemic by the WHO on 11th March 2020. There is an urgent need for policies that will effectively encourage and regulate research, production and access to diagnostics, therapeutics and vaccines for COVID-19 to ensure that they are accessible to all without any discrimination.

We appreciate the fact that the Government of India has initiated policies and mobilized funding for COVID-19 Research and Development (R&D) for diagnostics, therapeutics and vaccines. Prominent among these policies and efforts is the funding for various vaccine candidates from Department of Biotechnology (DBT)- Biotechnology Industry Research Assistance Council (BIRAC)1, ‘Research Strategy for immediate response and long-term preparedness to combat COVID-19 infection’; setting up of the COVID-19 Research Consortium2; Council of Scientific and Industrial Research’s (CSIR) work on the synthesis of drugs under clinical trials for generic manufacturers.3

While various government research institutions, pharmaceutical companies and universities across the world - including in India - race to develop vaccines, therapeutics and diagnostics against COVID-19, there is a growing concern on accessibility, affordability and availability of these medical products for people and the most vulnerable communities in developing countries.

The current public health emergency specifically demands a shift from ‘business as usual’ practices of the pharmaceutical Industry. Entrenched in proprietary control of data, know-how and Intellectual Property (IP) run counter to the need of the hour: increased openness in the sharing of research knowledge, data and IP - based on the ethos of ‘science benefiting all of humanity’.

In this context, we highlight the call from UN Secretary-General and various world leaders to treat COVID-19 diagnostics, therapeutics and vaccines as global public goods. However, India needs to proactively support this call and pave the strategic roadmap to ensure that the same translates into action nationally and internationally.
Concerns on access primarily emanate from the lack of clarity on how to achieve open sharing of research knowledge, data and IP - both at the national and the global level – desperately needed to accelerate scientific progress and scaling up of manufacturing for COVID-19 diagnostics, therapies and vaccines.

In this regard, we call upon the government of India:

1. To take measures at the international and national level to ensure support for open innovation for COVID-19 related drugs, diagnostics, and vaccines development. An international project COVID-19 Technology Access Pool (C-TAP)4 to share IP, scientific data, and know-how to fight the coronavirus pandemic was launched by the World Health Organization. India while supporting this initiative should call for binding norms to be adopted by the WHO and its member states to ensure that sharing of data, know-how and IP is applicable to all stakeholders – public and private – involved in developing COVID-19 medical tools.

2. To ensure that the DBT-BIRAC COVID-19 Research Consortium and other initiatives by DST, CSIR, Indian Council of Medical Research (ICMR) and the office of the Principal Scientific Advisor follow the approach of the erstwhile Open Source Drug Discovery in India for sharing data and know-how and further ensure that the government retains the rights to issue non-exclusive licenses to manufacturers, for the products developed from such funding.

3. To invoke provisions5 under Indian Patents Act to ensure that patents granted by Indian patent office on COVID-19 related diagnostics, treatment and vaccines are identified and are revoked immediately in public interest or compulsory licenses are issued without prior negotiation or government use provisions are invoked, or inventions and/or patents are acquired by the government for public purposes which will facilitate efficiency in access and increase manufacturing capacity for any COVID-19 related diagnostics, treatment and vaccines. In this regard government should also urgently remedy the erroneous grant of patents to the drug remdesivir under Section 66 of the Patents Act.6

4. To require the submission of all license agreements7 related to COVID-19 related diagnostics, treatment and vaccines including Gilead’s license agreement8 on remdesivir and scrutinize the same to assess their impact on access to the medical products for patients globally. While Indian companies commercially benefit from the agreement with Gilead, it is not acceptable that India, which claims to be the ‘pharmacy of the world’ should support an agreement that leaves out 70 countries, nearly half the world population, from benefiting from generic competition on a COVID-19 drug from India. The agreement undermines India’s role as a leader in global public health.

5. To ensure that any of the COVID-19 related diagnostics, therapeutics and vaccines, whether patented or not be made available free of cost to patients in the public and private sector. In this context, we would like to draw your attention to drugs that are being used and recently included in India’s clinical management protocol9 to treat COVID-19 disease. We request the government to ensure that there is no profiteering by private hospitals and companies from the pandemic who are selling such drugs to patients. An example of such profiteering is the price charged by Roche for the drug tocilizumab prescribed in the private sector to severe COVID-19 patients with Cytokine-Release Syndrome (CRS)10 at INR 60,000 (approx. USD 600) for a vial11. Multiple sources of tocilizumab are needed to increase manufacturing capacity and decrease the price of the drug. We also urge the government to invoke the provisions of the Drug Price Control Order, to ensure prices for COVID-19 diagnostics, treatment and vaccines are controlled based on the cost of manufacture. [ . . . ]

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Indian CSO Statement Calling on Government of India to Support Innovation and Access to Covid-19 Diagnostics, Therapeutics and Vaccines | 24 June 2020