World Trade Organization TRIPS Council Needs To Reassess Mechanisms For Access To Drugs In COVID-19 Era
Healthcare workers in the Western Cape suit up to take care of COVID-19 patients.

Cape Town, South Africa  – The US government’s recent purchase of almost the entire available stock of Gilead’s remdesivir – a medicine shown to help speed up the recovery of people who are moderately sick with COVID-19 – has raised fears about whether poorer countries will also be left in the dust if a vaccine is developed.

South Africa recently appealed to the World Trade Organisation (WTO) to explore “multilateral cooperation” to find “an innovative solution” in light of such concerns.

“In anticipation that intellectual property may pose a barrier to access, several ad-hoc unilateral initiatives have emerged,” South Africa’s Dr Mustaqeem de Gama told a recent informal meeting of the WTO’s ’s Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

“However, these initiatives, while commendable, are simply inadequate to address the intellectual property barriers,” added De Gama.

For example, pharmaceutical companies with patents could opt not to join these mostly voluntary initiatives, or issue licenses for generics of their medicines to manufacturers in only a few select countries, warned De Gama.

In the case of remdesivir, Gilead has issued voluntary licenses to manufacturers to produce the medicine for 127 countries including South Africa – but Brazil, China and Mexico are excluded. A single vial of the generic version will cost US $55 according to South African reports, while the medicine in will cost US $390 per vial in US hospitals.

Taking Concerns About Access Barriers to the WTO
WTO TRIPS Council meeting, pre-pandemic.

Sidwell Medupe, spokesperson for South Africa’s Department of Trade and Industry, said that South Africa aimed to “to encourage a discussion within the WTO TRIPS Council that will promote multilateral cooperation”, including “pooling rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic.”

De Gama stressed that “an effective response to the COVID-19 pandemic requires rapid access to affordable medical products” – but many developing countries faced “legal, technical and institutional challenges in using TRIPS flexibilities.”

A key TRIPS flexibility allows governments to issue compulsory licenses to generic companies to make pharmaceutical products without the permission of patent holders.

But many countries’ own patent laws either don’t allow for compulsory licenses or involve “time-consuming” processes, warned De Gama.

South Africa itself has yet to amend its 1978 patent law to allow for compulsory licensing, despite adopting a national policy committing it to doing so two years ago.

And despite the TRIPS flexibilities, the issuing of compulsory licenses is not common – partly because pharmaceutical companies are often involved in intense lobbying of governments to prevent this.

Brazil and Thailand used compulsory licenses to get access to cheaper antiretroviral medication to address HIV, but South Africa did not take this route despite having the largest HIV positive population in the world.

Instead, South Africa largely imported cheaper ARVs via generic companies in countries such as India with the help of a number of global initiatives. These include  UNITAID’s Medical Patent Pool (MPP). Set up in 2010, the MPP negotiated with pharmaceutical companies to issue voluntary licenses to generic manufacturers to make ARVs for developing countries, particularly sub-Saharan countries.

Compulsory Licenses may be the ‘Most Powerful’ Access Instruments Available to Countries
WTO Headquarters in Geneva

Hu Yuan Qiong, senior legal and policy advisor for Médecins Sans Frontières’ Access Campaign, says that in the context of TRIPS, “compulsory licenses are the most powerful instrument that countries can use right now.”

Even some high-income countries, who don’t normally talk about these licenses, are starting to take notice.

“Many countries have talked about compulsory licenses since the start of the pandemic. We have seen countries like Germany, Canada and Australia changing their laws to make compulsory licenses easier and more automatic and comprehensive so they can quickly issue one to allow for importation, local production or whatever they need to get access to the technology to address COVID-19,” says Hu, who is based in Geneva.

Chile, Ecuador and Brazil are also considering making it easier to issue compulsory licenses.

Still, “we haven’t seen this with developing countries, although it isn’t easy to do a compulsory license in many of these countries, including in South Africa,” says Hu.

She adds that “compulsory licensing is still a territorial response that relies on national laws and how flexible the law is.”

In addition, manufacturing some medical products – such as ventilators – might involve more than one patent, “so more regional and ultimately global flexibility would be more ideal.

“From MSF’s perspective, a better solution would be to suspend the application of intellectual property rights on medical tools related to COVID-19 for the time being,” said Hu

Upfront, Global Agreements Required to Secure Access

Andy Gray, a senior lecturer in pharmaceutical sciences at the University of KwaZulu-Natal in South Africa, agrees with Hu that, in the case of the development of a vaccine or COVID-19 treatment, “country-by-country flexibility isn’t that helpful when what we need is an upfront agreement.”

“With a COVID-19 vaccine, for example, it is unlikely that one company will be able to meet global demand. So if a company develops a vaccine, it should commit to issuing voluntary licenses to other companies before it is even granted a patent,” says Gray. “There has also been a lot of public investment in the development of vaccines. A condition for the investment of public money in vaccine development should be that the company which has benefited commits to issuing voluntary licenses. This should be an upfront agreement as a condition for the use of public money.”

The COVID-19 Vaccine Global Access (COVAX) initiative announced recently by the global vaccine alliance, GAVI, has been criticised for failing to extract upfront access agreements from the pharmaceutical companies that are getting public funds for vaccine development.

In a letter to the GAVI board, 45 civil society organisations criticised COVAX for being based on a “business as usual” approach to intellectual property in which “pharmaceutical  companies are allowed to retain and pursue rights to  vaccines under development, resulting in vaccines that are  proprietary  and  under  the  monopoly  control  of  individual  companies.”

“Since  there  has  been  no  change  in  how  intellectual  property  is  handled  during  the  pandemic,  pharmaceutical  companies  are  able  to  monopolise  future  COVID-19 vaccines and decide who does and does not get access,” the NGOs warned.

A COVID-19 Vaccine Must be a ‘People’s Vaccine’
Shabir Madhi, Principal Investigator of the first Covid-19 vaccine trial in South Africa

South Africa is a key partner in a global lobby for a “people’s vaccine” for COVID-19, and it has united with 139 other countries and prominent leaders to advocate that “all vaccines, treatments and tests be patent-free, mass produced, distributed fairly and made available to all people, in all countries, free of charge.”

Announcing the initiative, South African president Cyril Ramaphosa and head of the African Union said, “As the countries of Africa, we are resolute that the COVID-19 vaccine must be patent-free, rapidly made and distributed, and free for all. All the science must be shared between governments. Nobody should be pushed to the back of the vaccine queue because of where they live or what they earn.”

The “people’s vaccine” initiative advocates for a “global agreement on COVID-19 vaccines, diagnostics and treatments” that “ensures mandatory worldwide sharing of all COVID-19 related knowledge, data and technologies with a pool of COVID-19 licenses freely available to all countries.” The World Health Organization would be responsible for overseeing this agreement.

MSF’s Hu says it cannot be business as usual with COVID-19.

“If we look at the COVID-19 vaccine, there are so many companies involved and so many people are joining clinical trials worldwide trying to find solutions,” she said. “But eventually, governments and global health institutes end up negotiating with the same pharmaceutical companies.

“It’s the same old business model,” she laments. “The vaccine and technologies are held by the same companies. It is a piecemeal solution where different countries have different laws. It’s going to be an endless story unless there is a global agreement.”

 

Image Credits: Government ZA, WTO, Kerry Cullinan.