The COVID-19 pandemic has re-ignited the debate on using waivers of patent protection on medical products as a way to address gross and deadly inequities in access. Not since the peak of the HIV pandemic, when antiretroviral treatment was the preserve of the rich, has this debate been as passionate. Position-taking this time around is something of a surprise.
India and South Africa, speaking on behalf of a wider group of low- and middle-income countries, proposed in October last year that the World Trade Organization (WTO) waive patent protection on vaccine products, in terms of the global Trade-Related Aspects of Intellectual Property Rights (TRIPS) provisions.
While support for this position grew among countries of the Global South (President Cyril Ramaphosa told Parliament recently it was supported by 100 countries), wealthier countries and multinational pharmaceutical countries were united in opposition. Until last week.
Towards the end of the week, the Biden Administration in the US made an announcement that took many by surprise. It expressed unequivocal support for the waiver of COVID-19 vaccines-related intellectual property rights.
While stressing that this was only due to the extreme circumstances of the pandemic and asserting the US’s general support for the intellectual property rights of pharmaceutical companies, Trade Representative Katharine Tai said: “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”
In contrast, 27 leaders of the European Union gave no such support at the weekend as Indian Prime Minister Narendra Modi made a further appeal for the waiver. The EU did not dismiss his plea but said the patent waiver needed to be addressed along with other factors, such as production capacity, licensing and exportation of vaccines. European Commission President Ursula von der Leyen said: “This is not something that will, within the next month or perhaps the next year, bring any vaccines. But we need vaccines now.”
She pointed out that “some regions” (a disguised reference to the United States) had not exported any locally produced vaccines while the EU had exported 50% of its output.
Individually, various European leaders have strongly opposed any relaxation of intellectual property rights in the pharmaceutical sector because this could reduce the incentive for major pharmaceutical companies to undertake research and spearhead innovation.
Pope Francis, meanwhile, weighed in from a moral perspective, condemning the “virus of individualism” and its “variants” – “closed nationalism” and putting “the laws of the market or intellectual property over the laws of love and the health of humanity”.
The matter is undoubtedly complex and the debate has a long way to run. It is, perhaps, instructive to consider how pharmaceutical companies ultimately responded to the worldwide campaign of activism for affordable ARVs. Several leading companies granted voluntary licences for manufacture in countries severely affected by HIV. Others expanded their own generic operations and a dual pricing structure was introduced to make ARVs affordable in low- and middle-income countries.
In South Africa, Aspen Pharmacare seized this opportunity and became one of the biggest global suppliers of ARVs, focused on the African market. A decade later Aspen, which is not an established vaccines manufacturer, has become the first South African company to compound a vaccine – the Johnson & Johnson product – for our domestic needs.