Patent waivers for COVID-19 vaccines have been offered up as a suggestion as a means to address the global crisis. While in theory this would allow a shift in production from high-income nations to developing countries, achieving this requires overcoming a significant hurdle – a lack of production capacity.
Recently, World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus praised the commitment by U.S. President Joe Biden to support the temporary waiver on patent laws related to COVID-19 vaccines. India, along with South Africa, was one of the nations that put forward the suggestion.
The original proposal was made by the two countries at the World Trade Organization (WTO) on October 2, 2020, for intellectual property rights (IPR) exemptions on several items for COVID-19, including drugs, vaccines, protective gear, ventilators and diagnostic kits. While the suggestion has since been met with extraordinary international support, many experts have suggested that it is nothing more than political point-scoring. Sir Robin Jacob, chair of intellectual property law at University College London, said there was “no evidence” that other companies would suddenly be able to make the vaccines
“There’s almost nobody you could license to. They couldn’t do it — you need a huge plant, huge skills, patent or not, it doesn’t matter…If they take people off manufacturing the vaccine now to teach someone in Bangladesh to build a factory that takes three to four years, they won’t be around to make the vaccine now.”
On May 5, the United States Trade Representative said the government “supports the waiver of those protections for COVID-19 vaccines” in “service of ending this pandemic”. Other countries, such as France, Russia and New Zealand have also backed the proposal. Germany, home to BioNTech, the company that created the vaccine marketed by Pfizer, has said it opposed a waiver because “the protection of intellectual property is a source of innovation and must remain so.”
As per the opinion of many experts in the field, patent restrictions themselves are not the issue. Rather, it is the resources and the expertise to make the vaccine. This fact is demonstrable. Moderna has already waived the patent rights to its vaccine. This took place in October of last year, giving six full months for other companies to take advantage of the free patent. Moderna has noted the lack of companies able to rapidly manufacture a similar vaccine and secure approval for their own production of the vaccine.
The patent, in regards to the production of vaccines, is simply the first hurdle. There are numerous other factors that must be considered, including the expertise needed to make the vaccine, supplies of raw materials, adequate production facilities, quality control measures, and cold chain infrastructure to facilitate rollout of the vaccine. Simply handing out patent-free blueprints does not equip developing nations with the capacity to make the vaccine and so, will not aid in addressing the current COVID-19 crisis.
By contrast, partnerships between the Western companies producing the bulk of the vaccines and already established vaccine production companies within developing countries have proven effective. The Serum Institute of India (SII), for example, is currently collaborating with AstraZeneca in order to produce their vaccine candidate Covishield. This allows AstraZeneca to take advantage of the well-established capacity of SII to produce large volumes of vaccine doses — in a country that is currently in dire need of more vaccine supply.
The shortage of COVID-19 vaccinations, and the inequity therein, is a global issue. India, being one of the world’s largest producers of vaccines, has been a core component in both the international response and the resultant lack of vaccines. At the end of last year India joined an international partnership called COVAX. The aim of the initiative, co-led by the WHO, Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and UNICEF, is to provide vaccines across developing nations to ensure that global vaccine rates rise, as opposed to just those in wealthier nations.
The efforts of the coalition were severely hindered by the sudden emergence of the second wave of COVID-19 in India. At this stage, India halted exports of vaccines to other nations in an effort to bolster immunity domestically. Currently, India has reaffirmed its commitment to continue vaccine supplies to COVAX, bringing hope that the partnership will continue its work unhindered to improve equity in vaccine access across the world. This cause is to be aided substantially by an announcement from the U.S. of twenty million doses of the Pfizer Inc/BioNTech SE, Moderna Inc and Johnson & Johnson vaccines, on top of sixty million AstraZeneca Plc doses already set aside as donations to other countries.
It is partnerships such as these that offer hope that vaccines will be made readily available across the globe. However, India, despite reaffirming commitment to the scheme, has reportedly not delivered any new vaccines since March. As the single largest contributor, this will continue to hinder the efforts of COVAX. While the news may be grim, the production and distribution of vaccines, particularly to developing nations and rural communities is often arduous. To report that the patent waiver will be an instant fix to this undermines and underrepresents the scale of the issue.