The World Health Organization (WHO) has called it “vaccine apartheid”: developed economies who can pay for COVID-19 vaccines have much higher rates of vaccination than developing economies. Only 21 percent of people in low-income countries have received at least one COVID-19 vaccine dose, partly because pharmaceutical companies have refused to temporarily waive their IP rights over the vaccines. To end the unjust divide, in 2020 South Africa and India submitted a proposal to the WTO seeking temporary waivers of the enforcement and implementation of intellectual property (IP) rights to improve access and affordability of vaccines and other treatment products for COVID-19. Two years later, a severely watered-down version of what might have been leaves cost as a major barrier to vaccine uptake. Developed economies did not join a consensus of more than 60 developing-economy WTO members supportive of waivers. Instead, rules were amended so WTO members can issue a compulsory licence of a patented vaccine. This means all WTO members will be able to manufacture and distribute the vaccines if they so wish – but they must pay the patent holders before they can do so. The pandemic has made it evident that IP rights can limit access to affordable medicines. Several intergovernmental organisations, including the WHO, have consistently reminded us that “no-one is safe until everyone is safe”. But access to vaccines and therapeutics at prices patients can afford has been a recurrent concern for the global community since the Agreement on Trade Related Aspects of Intellectual Property (TRIPS Agreement) was adopted by the WTO in 1994. The TRIPS Agreement strengthened protection and enforcement of IP rights, which means holders of IP have enhanced opportunities to extract rents from the users of proprietary products. IP holders claimed rents were vital to incentivise their research and development efforts. Over the years, though, evidence of excessive rent-seeking by IP holders has only grown, and patent monopolies have strengthened without a commensurate mechanism for protecting the interests of the users of IP. The first major global initiative to counter pharmaceutical companies’ unfair practices came during the 1990s, against the backdrop of the HIV/AIDS pandemic. The exceptionally high prices charged for antiretroviral therapy by several large pharmaceutical companies in South Africa was one of the most glaring examples of how patients’ interests can easily be cast aside, even during a pandemic. In South Africa at the time the per-capita GDP was US$3550, but the cost of a year’s supply of the antiretroviral medicines marketed by these companies to the South African health service was US$10,000 per person -- well beyond the financial capacity of the average patient. The South African government amended its law to include provisions ensuring medicines were available at affordable prices. Another provision enabled compulsory licences to produce medicines in South Africa. A total of 40 major pharmaceutical companies challenged the amendments, arguing they violated South Africa’s constitution and its commitment to the TRIPS Agreement. In 1998 the companies contended before South Africa’s High Court that the rights granted to patent owners by the agreement would be severely limited if the amendments were implemented.
Developing countries, led by India, South Africa and Brazil, responded by suggesting additional flexibilities for the TRIPS Agreement to enable WTO member countries to address public health concerns. They proposed the TRIPS Agreement and Public Health, which was backed by 60 developing countries, including 41 belonging to the African Group. The proposal was adopted at the Doha Ministerial Conference in 2001.
The Doha declaration was important on several counts.