Controversy rages over whether to remove patents on vaccines

Suspension or settlement: the debate on patents and COVID-19

photo_camera Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

In the midst of the pandemic, vaccines have become the most valuable commodity 

The long-awaited COVID vaccines arrived in Latin America for the first time on March 1 through COVAX, destined for Colombia, one of the few countries in the world to receive doses from this platform. While more than 29 million and 66 million doses have been administered in Europe and the United States respectively, only 4 million have been inoculated in all African countries. Patents play a major role in this access gap, with South Africa and India submitting a proposal to the WTO for temporary suspension of patents on tools to fight COVID-19. This means making use of compulsory licensing, but there is also another option that rich countries seem to be leaning towards: voluntary licensing. 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Let's start with the basics 

The first question to answer on this issue is, what are patents? Every invention has Intellectual Property Rights (IPRs), also called patents. Vaccines and medicines are no exception. IPRs allow the creator of the invention to control the use of his invention for the duration of the patent, i.e. 20 years. The holder can decide whether to share the intellectual property with third parties - in exchange for a monetary return - or he can choose not to share the profits and prevent others from researching, manufacturing or distributing his products. 

Intellectual property rights are important for the discoverers of these new technologies, as they encourage further technological developments, thanks to the flow of income that allows them to exploit their innovations while recovering the costs they have incurred.
 

Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

In the midst of a pandemic like the one we are living through, vaccines have become the most valuable commodity, and in several ways: Evaluate Pharma's forecast for 2021 indicates that sales of vaccines against COVID will amount to between 10 and 15 billion dollars. Therefore, neither pharmaceutical companies nor rich countries are interested in reducing the profits that would come with a patent elimination like the one still under discussion in the WTO. 

The main problems with patents are that they make products more expensive and delay delivery because of bureaucratic procedures. These are undoubtedly two major obstacles for developing countries that could not make purchasing agreements and do not have the same economic resources as other countries. Aisling McMahon, a medical law specialist at Maynooth University in Ireland, argues in her article published in The BMJ that while patents are considered necessary incentives for the development of health technologies, the degree of control given to patent holders must be questioned and modified in some way: "For any sense of global normality to return, everyone must have affordable access to effective future vaccines, drugs and COVID-19 diagnostics as soon as possible. This is in our interest. However, current patent practice could plausibly be used to obstruct or delay this," she says. 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

A proposal including compulsory licensing 

South Africa and India first presented their request for the temporary suspension of patents on all tools that are useful in the fight against COVID on 16 October 2020, at a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), part of the World Trade Organisation (WTO). This first meeting has been followed by several others that have ended with the same result: countries recognise unimpeded access to medicines, vaccines and other tools against the pandemic, but still cannot agree on how to achieve this. The patent ban would be temporary, "should continue to apply until there is widespread vaccination throughout the world, and the majority of the world's population has developed immunity," say advocates of the proposal in a document.

Such concessions are called compulsory licences, which are in force under Article 31 of the TRIPS agreement, and give third parties the right to produce, import and sell the necessary products without the consent of the patent owner. Countries such as Israel and Canada have already made use of such licences to approve the domestic use of some drugs for the treatment of COVID-19 without seeking permission from the patent holders. Compulsory licensing could be a solution if patent holders refuse to share their patents, but it has several drawbacks. The main one, according to McMahon, is that they are limited to a national level, so that in each state they are granted in one way or another. As a result, compulsory licences are of limited territorial effectiveness, especially if major powers such as the EU do not apply them. 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Organisations such as Médecins Sans Frontières support this measure, arguing that “all COVID-19 health tools and technologies should be true global public goods, free from the barriers that patents and other intellectual property impose". However, not all views are the same: Aisling McMahon believes that the only effective outcome of compulsory licensing would be the threat of compulsory licensing, as this would encourage patent holders to negotiate a more reasonable price or offer; although under compulsory licensing the patent holder receives remuneration, this is set by the state and is not always satisfactory to them. This happened in Israel with AbbVie's drug Kaletra, which was used to treat patients with COVID-19. When Israel issued a compulsory licence, the pharmaceutical company was quick to relent and eventually removed the patent. 

In order for the proposal to win WTO approval, it requires a vote in favour by 123 states. At the vote on February 24, 58 countries backed the proposal, not even half the number of votes needed. The elimination will continue to be negotiated at upcoming meetings of the TRIPS Council. The total number of doses of COVID-19 vaccines administered in those countries that have rejected the proposal amounts to more than 198 million. This is equivalent to more than 80% of the total number of doses that have been inoculated worldwide. This makes it clear that developing countries, which have supported or sponsored the patent elimination, are not receiving the vaccines as quickly as the rest of the world.
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

The Global Access Fund for COVID-19 Vaccines, known as COVAX, finally shipped 117,000 vaccines to Colombia on March 1, making it the first country in Latin America to receive doses through this platform. The African continent received its own supplies on February 24 and 26: 600,000 doses for Ghana and more than 500,000 for Côte d'Ivoire, which has already begun its vaccination campaign.

WHO Director-General Tedros Adhanom Ghebreyesus has published an article in The Guardian in which he welcomes the arrival of the vaccines in Ghana, but warns that there is still too much inequality between rich and poor countries in terms of access to the vaccine. He argues, once again, for temporarily suspending patents, making use of "all our manufacturing muscle" and settling indecision with his famous "if not now, when? 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Voluntary licensing 

But there is another option: voluntary licensing. Several experts argue that this type of licensing is more effective because it has the consent of the patent holder. However, this could also pose a difficulty, precisely because if the patent holder refuses, there is nothing to be done. For Aisling McMahon, voluntary licences are the best option in times of pandemic, because if such licences were to be pooled in different parts of the world, the advantages could be realised, this time on an international level. She is echoed by the authors of an article on intellectual property published in the journal Nature, who conclude that "government compulsory licensing may be the only realistic mechanism for making intellectual property rights (IPR) widely available".
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Again, Médecins Sans Frontières disagrees with McMahon and the other experts, noting in a report published in October that while voluntary licences help make treatments more accessible, they do come with geographical limitations (as well as a lack of transparency, as companies are reluctant to publish the agreements). 

According to the organisation, such voluntary licences cannot be applied equally in all countries, as the agreements leave out low- and middle-income powers and countries where generic medicines are manufactured. The most recent example was the signing of voluntary licences by Gilead to some generic companies for the COVID-19 drug Remdesivir. Many developing countries were left out of the agreement, so that they cannot buy these cheaper generic versions. The reason is that several of these countries have generic production capacities, and this directly excludes them. 

Rich members such as the UK, the US and the EU that voted against the South African and Indian proposal, claiming that the patent system is currently essential to ensure that new vaccines are incentivised and denying that intellectual property is a barrier to access, opt to reach agreements with patent holders and through the tools that already exist. They refer to article 31 bis of the TRIPS declaration, an article that allows states to import patented inventions made under compulsory licence elsewhere under certain circumstances. Countries advocating the elimination of patents have dismissed this option as a complex, resource-intensive process that many states lack.
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Tension between the EU and pharmaceuticals 

After the latest tensions between the pharmaceutical companies and the EU over delays in vaccine dose deliveries, the situation could turn around. Several voices within the community point to compulsory licensing, if the situation with the pharmaceutical companies is not resolved, to ensure the distribution of vaccines. 

European Council President Charles Michel said in January that "if a satisfactory solution cannot be found, I believe we should explore all options and make use of all legal means and enforcement measures at our disposal under the Treaties". He is referring to Article 122 of the Treaty on the Functioning of the European Union, which could be legally interpreted to oblige vaccine manufacturers to share their patents, i.e. make use of compulsory licensing. Michel says he has passed on the suggestion to Commission President Ursula von der Leyen. 
 

Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

German Economics Minister Peter Altmaier also spoke on the issue in a TV programme in which he said he was ready to talk about "coercive measures" if pharmaceutical companies stopped cooperating, although compulsory licensing would not help to increase production imminently. 

The Italian government committed in mid-December 2020 to "promote a derogation on the basis of the Marrakesh agreement for COVID-19 vaccines from the TRIPS Agreement's ordinary regime on patents and intellectual property", which means supporting South Africa and India's proposal. 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

The failure of exchange platforms 

We have a history of what happens when you rely on the goodwill of property rights holders. During the early months of the pandemic, platforms were set up to share patents for anti-pandemic technologies, using voluntary licensing. It is possible that the reason for their limited success is due to their reliance on the collaborative intentions of patent holders.

The WHO created the COVID-19 Technology Access Pool (C-TAP), a forum for the sharing of intellectual property rights, knowledge, data... and anything else that could be of help in the pandemic. It was launched in May 2020 and, according to an investigation by The Guardian, the platform has not received a single contribution since then. In fact, it has the backing of only 40 countries (fewer than those currently approving the elimination of patents), with the US and the UK, for example, voting against it. The WHO remains committed to the operation of the platform, in its equity statement for COVID vaccines it specifically calls for vaccine manufacturers to share their expertise in C-TAP. It remains to be seen whether this call, almost a plea, will be successful. 
Suspensión o acuerdo: el debate sobre las patentes y la COVID-19

Another older platform that serves the same function as C-TAP is the UN-supported Medicines Patent Pool (MPP). Unfortunately, since it included COVID-19 treatments, it has also failed to negotiate any agreement on this issue. 

The need for everyone to be able to be vaccinated against COVID-19 has already been mentioned on numerous occasions. In a society as globally connected as ours, the fact that half of the countries cannot afford to have access to vaccination jeopardises the longed-for end of the pandemic. Experts are calling for a change in the way countries with less purchasing power obtain vaccines. Even rich countries, which oppose elimination, recognise that a solution must be found, which could come in the form of voluntary licensing. 

Vaccination is thus of social but also economic importance to all; Médecins Sans Frontières estimates that $10 billion of public money has been invested globally "in R&D, clinical trials and manufacturing of the six major COVID-19 vaccines". 

The debate on the temporary suspension continues in the TRIPS council chambers. Meanwhile, Jonas Salk, inventor of the polio vaccine, teaches us something from 1955. Salk decided that his vaccine would not be patented, and when asked by journalist Edward Murrow who owned the patent, he replied: "Well, the people, I would say. There is no patent. Would you patent the sun?".
 

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