Countries across the globe are racing towards developing a successful vaccine for COVID-19. Various governmental research institutions, pharmaceutical companies, and even universities are working around the clock to research fast diagnostics, effective treatment, and vaccines. However, given the large scale demand, concerns have raised on profiteering of medicines and affordability of vaccines which will disproportionately affect marginalized communities. The fight against COVID-19 must make diagnostics, therapeutic, and vaccines that are affordable, accessible and available to all. United Nations Secretary-General, amongst various other world leaders, have propagated to treat COVID-19 diagnostics, therapeutics, and vaccines as global public goods.
In this spirit, Indian civil society has appealed to the Government of India to take necessary as per existing law and policy mechanisms to regulate prices and ensure smooth supply. It has requested the government to create a space that fosters innovation and access to treatment and diagnostics. The signatories include notable the whos and who of the Indian health rights movement, several lawyers, and grassroots activists. The appeal notes “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”.
Focussed research for innovation in COVID-19
Government of India has formulated policies and mobilized funding for Research and Development in COVID-19. The same is currently led by initiatives from Department of Biotechnology and Biotechnology Industry Research Assistance Council (BIRAC) COVID 19 Research Consortium. Similar initiatives by the Department of Science Technology, Council of Scientific and Industrial Research, Indian Council of Medical Research have received public funding for innovation and knowledge building in the battle against COVID-19.
The underlying need today is to ensure an open environment for innovation and access to pool of knowledge. The appeal calls upon the government to ensure data sharing and knowledge between these research initiatives through open source information. It also advises the government to retains the right to issue non-exclusive licenses to manufacturers of products that are a result of this funding. It also highlights the necessity of rapid sharing of genome sequencing of SARS-COV-2 viruses by ICMR and CSIR to understand and evaluate the developments in drugs and vaccines.
Restricting intellectual property and profiteering for public benefit
The drug remdesivir has been granted patent. This runs counter to the idea of fostering open innovation environment and ensuring consistent availability of necessary COVID-19 drugs for the masses. To remedy this, the government can revoke the license in public interest by its power under Section 66 of Indian Patents Act. This is furthered buttressed by Section 92 which provides for granting of compulsory licenses in a national emergency and for non-commercial use by public. The Government is empowered to use invention for its purposes by Section 100.
The costs of pandemics need to account for the interests of justice. The society is adversely affected by profiteering of drugs by private hospitals and companies. The appeal highlights the high charges of drug tocilizumab by company Roche. While the manufacturing cost of a vial of this drug is approximately INR 3050, the same is being sold for INR 60,000 to severe COVID-19 patients. The appeal hence calls for price control at cost of manufacturing through Drug Price Control Order. This has to be supplemented with diversification of manufacturing to decrease the price manufacturing itself.
Regulating new drugs
The market is going to see many new investigational drugs, like remdesivir. WHO notes that it is important to introduce these drugs after a scientific risk-benefit analysis and informed consent of the patient. Further, results and effects of such investigational drugs should be promptly shared with the scientific community and public. The appeal highlights the need for rules-based ecosystem in India on lines with the ‘monitored emergency use’, which is a WHO protocol for experimental drugs. Additionally, CDSCO must fully disclose all pertinent data on approvals and permission granted.
The war against COVID-19 has only just begun and the way forward will require strategic and inclusive policies. As the appeal highlight, “With effective leadership, India can contribute to R&D underway to develop effective diagnostics, treatments and vaccines for COVID-19 by scaling up their manufacture to meet global needs and ensuring policies and norms so that they can be accessed and distributed to people who need them most in developing countries.”