The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO), which establishes rules on a non-trade issue in a trade regime, has been controversial since inception. Patents on medicines empower drug firms to charge exorbitant prices for 20 years, ostentatiously to recover investment made for the invention, but also enabling them to skim enormous profits from patients who can pay, while supplying at lower prices to poorer ones through a well established differential pricing system in the pharmaceutical industry at their whim and fancy. The civil society, however, has been driven for long to establish the primacy of public health over trade and Intellectual Property Rights (IPRs). The controversy has resurfaced during the ongoing Covid19 pandemic.
The HIV-AIDS pandemic had become a full blown global health problem by the time the developed world industry started looking for rewards from TRIPS in the late 1990s. The result was a human rights crisis of major proportions, persuading some poor countries to find flexibilities in the TRIPS rules to provide public health solutions for their citizens. A few developing countries like India opted for delay in providing product patents for drugs until 2005 by offering exclusive marketing rights in the meanwhile to those who had obtained patents elsewhere, while most accepted product patents for drugs. One such country, South Africa, had a HIV-AIDS crisis at hand.
By late 1990s, one in five South Africans was HIV-AIDS infected, as were 45 percent of its military personnel. With US Dollar 2600 per capita income, none could afford a USD 1000 a month dose of antiretroviral treatment available then. No wonder, then, that the government amended its law in 1997 enabling parallel imports of HIV-AIDS drugs from cheaper sources, primarily the generic manufacturers in India. This resulted in big pharma companies taking South African government to court and the US government joining hands and pressurising the government. AIDS activists struck back, led by Ralph Nader, Representative Jesse Jackson and the Congressional Black Caucus, resulting in the US government demurring and entering into an agreement promising not to pressurize the African nation on such imports.
In due course, the 9/11 attack on the US by Al Qaida in 2001 happened. The US wanted to have a new round of negotiations in the WTO at all costs, and as part of the deal, the ability of developing countries to import generic equivalents of patented drugs and issue compulsory licenses for serious public health crises was reaffirmed in what is now famous as the Doha Public Health Declaration. The Declaration had to be carved into legal rules under the WTO. For that, the negotiations were contentious. The United States and other developed countries got away with a mechanism of dilution that was so unimplementable that only one case of supplies by Canada to Rwanda has since been approved under the system, and that too did not work well as humanitarian drug supplies paved a smoother way.
Fifteen years later, the Covid19 pandemic has struck hard, much more egregiously than HIV-AIDS. Although IPRs, particularly patents, are still relevant in the background, public debate is no longer on whether and how to straddle the IPR hump, but how to invest enough in the research and development of a treatment of the disease and a vaccine to prevent its continuing onslaught. Even pharmaceutical majors are fighting shy of openly claiming the need for patent protection and seeking public funding for research and committed buyers of the eventual successful candidate.
The bigger game is the development of a vaccine so that the entire world population can be inoculated and the planet saved from this malice. Many global institutional frameworks have been stymied or just walked over in recent times. The United States has walked out of the WHO; its squabbles with China delayed by three months the only UN Security Council resolution on COVID 19. The United States government has not only infused billions of US dollars of public funds into vaccine research by private pharmaceutical companies like Moderna, Johnson & Johnson, AstraZeneca and Novavax, it is busy contracting advance purchases of the successful candidate. Similar contracts have been entered into by the United Kingdom, Japan and other rich countries.
These efforts at the national level, mostly in the rich countries, are being characterised as ‘vaccine nationalism’. Billions of dollars are being spent by rich countries to corner the first batches of potentially successful Covid19 vaccines for their citizens, leaving poor country patients in lurch, waiting first for a vaccine to come, and then it being made available by a multilateral mechanism at an affordable enough cost, as happened for Polio, Measles or Diphtheria decades ago.
In a way, it is might is right at present. The Guardian reported last month that Moderna’s mRNA vaccine could sell for 70 dollar a dose, a price hardly affordable for any patient in a poor country. In this situation, it is an availability potential for developed countries and affordability potential for developing countries that matters in all global efforts to invent, manufacture, secure and distribute a vaccine or a treatment for Covid19. And developing countries have been largely left to fend for themselves. Patents find little mention in these debates.
It is time for the global community to take the next steps to dilute the TRIPS Agreement to save public health from IPRs. A single country’s HIV-AIDS crisis and the legislative option it resorted to brought about enough public ire to seek and get an amendment to the TRIPS Agreement fifteen years ago. This time, the cause is much more serious, involving a much larger part of the planet, nay, the planet itself. It is time to seriously ponder whether medicines should be covered by the patents regime at all, and if so, what should be the responsibility of both governments and drug companies for the world’s patients. Either the WTO or the WHO, if not the UN itself, should take up this issue post haste.
Atul Kaushik is a Former Additional Secretary, Government of India and WTO Negotiator.
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Primacy of Public Health is essential on all other aspects