Nations urged to waive vaccine patents while drugmakers say rules are fair

Successfully developing vaccines within a year of the Covid-19 pandemic outbreak was an unprecedented achievement, but their rollout to low- and middle-income countries continues to drag.

As of March, of the more than 10bn Covid-19 vaccination doses administered worldwide, only 1 per cent were in low-income countries, according to the United Nations.

Some countries have blamed global intellectual property rules for this disparity. To address this problem, in 2020, India and South Africa proposed to waive, for at least three years, IP rules on Covid vaccines. That would allow poorer countries to develop their own vaccines at a lower cost, without being sued by drugs companies.

And, since then, the World Trade Organization has been trying to get its 164 members to agree to waive some of the IP rules in Trade-Related Aspects of Intellectual Property Rights, or Trips, the international agreement signed in 1994 that established the WTO. More than 100 countries are thought to back a revised Trips proposal, with the US, European Union, India and South Africa leading negotiations.

At the time of going to press, there was speculation that the Geneva-based WTO may announce an agreement on the waiver at its ministerial conference on June 12-16.

People in developing countries waited a very long time for access to much less effective vaccines. We can’t allow that to happen again

Medicine patents have been waived before, most notably for affordable generic drugs to treat HIV/Aids. But the proposed Covid vaccine waiver would be on a bigger scale and could lead to IP waivers for other areas, including diagnostics and therapeutics.

At present, the system of giving pharmaceutical companies a 20-year monopoly on inventions means rich countries get earlier access to life-saving medicines that are too expensive for poor countries, critics say.

Peter Maybarduk, director at Public Citizen, a non-profit consumer advocacy organisation, says maintaining a “restrictive” regime patent during the pandemic emergency was “crazy”.

“People in developing countries waited a very long time for access to much less effective vaccines,” he explains. “We can’t allow that to happen again.” 

Options for reforming medical IP include replacing the patent system with grants and prizes to reward medical innovation, creating fewer patents, and making it easier to challenge “bad” ones, Maybarduk says.

Yet drug companies and lawyers argue that patent rules, although not perfect, are fair and already flexible — governments can override them by issuing “compulsory licences”, for example. IP rules encourage medical innovation for expensive work with a high failure rate, they say.

Waiving vaccine patents would stifle innovation, they warn, and fail to address problems including limited vaccine manufacturing and distribution facilities in poor and middle-income countries.

Others question the main justifications for the waiver: to prevent large pharmaceutical companies suing poor countries for patent infringements, and to avoid a future shortage in vaccine supplies.

Pharmaceutical companies are unlikely to sue a poor country for patent infringement, some experts argue, because it would be a public relations disaster. In March, Moderna said it would never move to enforce its Covid-19 vaccine patents in low- and-middle-income countries.

“The amount of patent litigation in low- or middle-income countries is pretty low,” notes Camilla Balleny, partner specialising in patent litigation in life sciences at Carpmaels & Raynsford, a European IP law firm.

Distribution, however, is a significant problem, says Thomas Cueni, director-general of International Federation of Pharmaceutical Manufacturers & Associations. “Today, we have a surplus of vaccines and still they are not reaching the people who need them. It’s a matter of distributing them.”

In a statement to the Financial Times before the WTO’s ministerial conference, its deputy director-general, Anabel González, says its members are “working tirelessly” to iron out remaining differences and conclude negotiations for an IP response to the pandemic. “There is still work to do to ensure that we have the support of the entire WTO membership.”

But will it be worth the effort? Olivier Wouters, assistant professor of health policy, at the London School of Economics and Political Science, says that, if rich countries were to give low- and middle-income countries money to buy vaccines and build infrastructure to make and distribute them, it would be more helpful than changing patent rules. “Waiving patents is not a silver bullet,” he says.

Some of this infrastructure — and increased co-operation — is already in place.

In May, Pfizer said it would provide all its current and future patent-protected medicines and vaccines currently available in the US or EU to 45 lower-income countries on a not-for-profit basis. Its rival, Moderna, meanwhile, is investing $500mn in a plant in Kenya to manufacture medicines based on the mRNA technology it used to develop its Covid-19 vaccine.

The UN-backed Medicines Patent Pool also aims to increase access to life-saving medicines for low- and middle-income countries. In South Africa, the “mRNA technology transfer hub”, created by the World Health Organization, helps manufacturers in such countries to produce their own vaccines.

But, regardless of whether a patent waiver for vaccines is agreed, experts say that the debate about the IP lessons from the pandemic is set to continue. “It’s time to start the discussion,” says Kathleen Van Brempt , chair of the European Parliament’s Special Committee on the Covid-19 pandemic. “[I’m] not against IP rights but there needs to be limits to IP rules especially during a pandemic.”