International debate has been raging on whether or not to advocate waivers on patents for vaccine production, with views in favor of and against.

In view of the challenges of COVID-19 vaccination for all those worldwide who need and want the vaccine, one solution that has been proposed is to waive existing patent rights for vaccine production, since these could allegedly restrict their manufacture.

In this respect, a recent and ongoing international debate has been raging on whether or not to advocate waivers on patents for vaccine production, with views in favor of and against.

Accordingly, on April 27, Dr. Abel Nova, a family physician and member of the Spanish Society of Family and Community Medicine (SEMFYC) Bioethics Working Group, gave an interview about “vaccine passports” (read HERE), where he said that “it is urgent to eliminate patents in order to facilitate global access to vaccines”. In our view, however, the issue is not quite so straightforward.

In our view, however, the issue is not quite so straightforward.

We discussed this in a report by the Bioethics Observatory at the Catholic University of Valencia last March, in which we said that “a coalition of countries, led by India and South Africa, have asked the WHO to call on pharmaceutical companies to relinquish property rights, so that ‘generic vaccines’ can be produced”. The WHO has welcomed the proposal, although the European Union (EU) and the United States (US) take a more skeptical view, because “patents ensure that pharmaceutical companies obtain the profits needed to continue conducting research” (read HERE).

We consider that “universal vaccination” raises two issues at the outset: first, to be able to manufacture a sufficient number of vaccines so that those needed to achieve global herd immunity are available on the international market; and second, that these can be easily accessed by all countries, especially the poorest.

In terms of the first aspect, Duke University in the US (read HERE) predicts that vaccine production will reach 14 billion doses this year, a figure that, in their opinion, appears to be sufficient to vaccinate 70% of the world’s population, given that 11 billion doses would suffice.

In relation to the second aspect, this is a question of promoting social initiatives, such as COVAX, and reducing vaccine production costs, supporting pharmaceutical companies with economic incentives to facilitate this policy, although vaccine patent waivers have also been proposed.

“...patent protection of intellectual property, with its checks and balances, is not a barrier to universal vaccination, but rather is part of the solution”

On 27 April, the EU spokesman for Public Health, Stefan de Keersmaecker, said that should voluntary solutions to ensure access to COVID-19 vaccines for all countries — especially the economically weaker countries — fail, granting of ‘compulsory licenses’ could be the solution, as he believes that “patent protection of intellectual property, with its checks and balances, is not a barrier to universal vaccination, but rather is part of the solution”. What is needed, according to him, is to ramp up production; consequently, “[g]iven the technical complexity [of manufacturing COVID-19 vaccines], governments should facilitate broad industry co-operation”. This, he says, is “the best way to speed up the supply of COVID-19 vaccines in the EU and globally” and “the best way to tackle new variants of the virus”.

Patents waivers solution from UNESCO point of view

In contrast, the UNESCO Bioethics Committee, on February 24, stated that “ownership rights protect some fundamental liberties such as freedom of research and the right to property” so that the existence of patents guarantees such rights. However, it also stated that “an extraordinary context [like the current pandemic] implies the need for extraordinary measures” to ensure that vaccines reach every single country.

Nonetheless, it does not seem clear that the vaccine waiver is a positive solution for vaccine production by a greater number of countries, given its highly complex manufacturing process, particularly as concerns mRNA vaccines. The Pfizer variant, for example, uses about 280 different components, which are supplied to the company by 86 different suppliers in 19 different countries. Moreover, the number of tests required to ensure acceptable vaccine quality is certainly not available to all countries, as they lack the technology to do so.

As we can see, there are opinions from individuals and agencies in favor of vaccine patent waivers, because according to them, under the current system, vaccines do not reach all the people and countries that need them.

There are, of course, contrary opinions, such as that held by Gonzalo Ulloa, a legal expert in this field, who says that the issue is complex, and so “we cannot simplify [it] by considering only its social aspect, which it has, but it is not the only one”. He then goes on to say that “in Spain, the patent law that provides for the granting of ‘compulsory licenses’ for reasons of public interest, licenses that might solve the problem, is in effect”. However, we are not aware of whether this possibility is in force in most countries, for according to Pere Ibern of the Universitat Pompeu Fabra in Barcelona, “unfortunately this possibility has not been sufficiently developed by countries”.

More significant is the opinion of the European leaders gathered on May 8 in Lisbon (Portugal) to discuss issues related to COVID-19. Among them, of course, the issue of patent waivers for vaccine manufacture was addressed. In this regard, French President Emmanuel Macron considers that the release of patents is no “magic bullet” to resolve the problem, while along the same lines, German Chancellor Angela Merkel is of the opinion that “relaxing patent rules could harm efforts to adapt vaccines as the coronavirus mutates”, adding that this measure may have “more risks than opportunities”. At the same time, “[she doesn’t] believe that releasing patents is the solution to provide vaccines for more people” (read HERE).

From our bioethics perspective patents waivers solution efficacy:

  • In our view, at the heart of the debate lies the idea that, without patents, it will be difficult for pharmaceutical companies to make the profits needed to continue innovating and producing new vaccines; according to the Tufts Center for the Study of Drug Development, the estimated cost of developing a commercial pharmaceutical product is around $2.5 billion.
  • In order for vaccines to reach every single country, though, especially the economically weaker ones, a good solution might be to support COVAX, a non-profit WHO initiative aimed at facilitating the supply of vaccines to the population of developing countries. COVAX has so far managed to raise more than $2 billion to achieve its goals, although it considers that at least $4.6 billion more is needed to vaccinate 20% of the world’s population.

It is also interesting to understand the ethical-moral aspects raised by this debate. In this sense, the Congregation for the Doctrine of the Faith, through the “Vatican Covid-19 Commission”, indicates the need to make the vaccines “available and accessible to all, avoiding ‘pharmaceutical marginality’”, for “if there is the possibility of treating a disease with a drug, this should be available to everyone, otherwise an injustice is created”. It would be a crime against distributive justice, justice “especially for the most vulnerable and needy of all regions of the planet”. However, Nonetheless, given its function, it is important to consider the vaccine as a good to which everyone should have access, according to the principle of the universal destination of goods highlighted by Pope Francis. Furthermore, the Pope also says that “[we cannot let] the law of the marketplace and patents take precedence over the law of love and the health of humanity”

“…the goal should be to make vaccines available to all countries at a reasonable cost”

In this respect, Ngozi Okonjo-Iweala, Director of the World Trade Organization, said in an interview with the British BBC in May that “members are split between those who advocate vaccine waivers and those who argue that this is not the solution… What there is, is a problem of a shortage of raw materials and difficulty in importing and exploiting them, and also the need for more pharmaceutical plants equipped for manufacture”. Therefore, in her opinion, “the goal should be to make vaccines available to all countries at a reasonable cost”, to which we add that solutions such as the COVAX program referred to above, should also be implemented in that goal.

As we can see, this is a complex problem with many different aspects — health, economic and ethical — and its solution, we believe, should be through encouraging broad debate between the pharmaceutical companies themselves, international health organizations such as the WHO, and bioethics experts.

Just Aznar MD PhD

Institute of Life Sciences

Catholic University of Valencia