Innovation in vaccine production can have an impact only if it is accessible to all.
Patents and access to life-saving drugs has always been an emotive and contentious issue. The right to healthy life is a moral minimum, and to find a rational basis to deny it is deeply offensive to the idea of life itself. At the same time, pharma corporations and institutions claim patents are a just recompense for their investments, overriding concerns over equitable and wider access to life-saving drugs. Patent claims over vaccines and access to them is a case in point.
Last week, in an ethically conscious move, the US government declared support for a patent waiver on Covid-19 vaccines. The terms, duration and modalities of the waiver are yet to be worked out and the devil — or the messiah — could well be in the detail. More importantly, the waiver is yet to get the WTO’s approval, and opposition to the Biden plan from European countries threatens to deadlock talks on such a waiver. Germany, for instance, has said that a patent waiver sets a bad precedent and may inhibit private research and innovation.
In democratic forums of the world, we can elevate health as a human right, or a constitutional right, but the truth of the matter is that this right is hostage to patent rights of innovators. The patent holder and its gatekeepers would say, as German Chancellor Angela Merkel remarked in response to the US proposal: “The protection of intellectual property is a source of innovation and must remain so in the future.” Pharmaceutical companies reacted with anger to the US decision, and shares of Chinese and American vaccine manufacturers tumbled.
Patents incentivise innovation by securing monopoly profits of multinational, multi-billion pharma companies, and by making it illegal for competitors to produce cheaper and more affordable, generic versions. WTO makes an exception to its own pronounced ethic of “free trade” to forestall free competition and sanction profits at monopoly levels. The moral justification has always been that patents protect not so much the economic interests of the pharma companies but that these economic interests are means to a greater end — more research, greater and better disease control. However, if drug discovery indeed is a means to a greater end, one may well ask: What good is an innovation if it does not serve the bulk of the world’s people?
A useful reminder from two decades back helps put the issue in perspective. In 2000-2001, in a face-off with pharma giants, under whose patent grip 12 million HIV patients had lost lives in Africa, the Indian pharma corporation, Cipla, successfully appealed to the world for a patent waiver to allow supplies of anti-HIV AIDS drugs to Africa at under one dollar a day. A brilliant documentary, Fire in the Blood, captures the utter destruction of disease and the heroic efforts of Yusuf Hamied, chairman of Cipla, to make generic antiretroviral (ARV) drugs available and accessible to dying millions of Africa.
From then on, India has lived up to its reputation of being the “pharmacy of the world”, supplying affordable and generic drugs to poor nations. Nearly 70 per cent of medicines produced in India are exported to developing countries; 75-80 per cent of all medicines distributed by the International Dispensary Association (IDA) to developing countries are manufactured here. India ranks second on the list of countries from which UNICEF purchases medical supplies. Eighty per cent of ARVs used by Médecins Sans Frontières (MSF) are purchased in India and are distributed in treatment projects in over 30 countries. Globally, 70 per cent of the treatment for patients in more than 80 developing countries has come from Indian suppliers. The US President’s Emergency Plan for AIDS (PEPFAR), also purchases ARVs from India for distribution in developing countries, resulting in cost-savings of up to 90 per cent.
It is helpful then for the world to take note of how profits, innovation and greater global good can still be combined. President Biden and his government’s decision to support patent waiver for Covid-19 vaccines may not find favour with corporations and the EU today. They may well assert their sovereign right and wield arguments about international and legal obligation. But as India struggles amidst death and devastation, the last thing the country — and other developing nations — need from the affluent world is lessons on how the patent system serves the greater public good.
It is nobody’s case that a patent waiver is a magic wand that will solve all problems of production and distribution in the immediate future. The scale of the problem is mammoth. Before the pandemic, the demand for vaccines was around 5.5 billion doses a year; it has now gone up to three times that figure. In such circumstances, a patent waiver on Covid-19 vaccines, as the UK-based cell biologist Anne Moore puts it, may not be a sufficient condition but a necessary one.
The waiver is likely to have two important trigger effects. First, of course, it would remove barriers of access to Covid-19 drugs, vaccines and other treatments. Relaxing Article 31 of the TRIPS law would enable developing countries with insufficient or no manufacturing capacity to freely import pharmaceutical products. Sans patent linkages in the regulatory process, emergency approvals would be readily available to generic producers of patented medicines. It will allow for easier technology transfers, less stringent licensing terms and increased access of vaccine manufacturers across the world to raw materials needed to make and deploy vaccines. As Lancet reports, “manufacturers of monoclonal antibody therapeutics that are under patent protection, such as Regeneron and Eli Lilly, have locked up most of their capacity in bilateral deals”. In other words, unless concrete steps are taken to address intellectual property barriers, disparity in access is certain.
The second related effect would be to make processes and products, adopted by countries to vaccinate their populations, immune from claims of illegality under the IP law. Pfizer’s battles with MSF in India and SK Bioscience in South Korea have had an effect in access to pneumonia vaccines. A similar situation may arise with Covid-19 vaccines unless steps are taken to address IP barriers.
A temporary vaccine-patent waiver — including for the publicly funded Bharat Biotech’s Covaxin — should also serve as a reminder that what we face today is not a manifestation of an exceptional legal event. It is rather the legal normal that sanctions the full force of intellectual property to routinely trump the soft and utterly malleable human right to health. Tensions between intellectual property and public health emerge not out of competing moral claims but out of competing institutional claims. As a moral claim, right to health far outweighs a claim for rewards for innovation and returns on investment.
This column first appeared in the print edition on May 13, 2021 under the title ‘Case for waiver in pandemic’. The writer teaches political science at Janki Devi Memorial College, DU, and is the author of Knowledge as Property: Issues in the Moral Grounding of Intellectual Property Rights
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