The countries that are part of the World Trade Organization (WTO) have come in extremis to a limited agreement on patent exemption for COVID-19 vaccines after an intense six-day ministerial meeting in Geneva. The decision It comes after more than 20 months of stalled debates around the initial proposal from India and South Africa and leaves out, at least for the moment, treatments and diagnoses related to COVID-19. As the WTO celebrates the deal, activists and civil society organizations have expressed disappointment at what they see as a failure and believe it will not improve global access to anti-virus tools.
In accordance with the decision adopted by the ministerial conference of the WTO, its highest decision-making body, a country may authorize the use, without the consent of the owner of the rights, of the subject matter of a patent – which includes the ingredients and processes of manufacturing – required for the production and supply of COVID-19 vaccines “to the extent necessary” to deal with the pandemic. In other words, broadly speaking, it enables the possibility for a country to allow a company to use a patent without the owner’s authorization and without fear of legal action.
But the deal falls far short of the original October 2020 waiver proposal, supported by dozens of impoverished countries and more ambitious, which called for temporarily giving up not only intellectual property protection over patents, but also trade secrets, copyright and industrial designs.
only for vaccines
Contrary to what India and South Africa initially claimed, the measure only applies to vaccines, although the door has finally been opened so that, within a maximum period of six months, the countries decide on its expansion to cover the production and supply of diagnoses and treatments for COVID-19, something for which some members had been pushing, such as those of the African group, and which has been one of the critical points of the debate, according to commercial sources explained to elDiario.es. The World Health Organization (WHO) had also asked for an exemption to be extended to these other tools.
“Expanding the scope of products will be important for this decision to make sense,” Ellen’t Hoen, director of Medicines Law & Policy, which brings together experts in the field of access to medicines, wrote on Twitter and thinks the decision is a “diplomatic compromise” that will not materialize.
It is not clear what effect it will have. Experts and campaigners for access to medicines believe the decision would have been more useful for treatments and other health technologies, and believe that giving up intellectual property rights on vaccines is unlikely to be all that is needed to facilitate their development. and production, since the transfer of know-how is also necessary. “It’s hard to imagine anything with less benefit than this in response to a global health emergency,” has said James Love, director of Knowledge Ecology International, referring to the agreement.
Another of the elements to be cleared up was the duration, which was considered between three and ten years. Finally, the measure can be applied for the next five years, extendable depending on the circumstances of the pandemic. It will be reviewed annually.
Not all nations can use it, and this has been another controversial point. Developing countries will be able to do so, although those with “existing” vaccine manufacturing capacity are “encouraged” to “bind themselves” not to avail themselves of the decision. The eyes here are mainly on China, which on May 10 expressed his will not to benefit. In the approved document, this formula has been chosen instead of the option of excluding developing countries whose exports represented more than 10% of world dose exports in 2021, something that directly affected the Asian giant.
In a first analysis, Medicines Law & Policy notes that countries with manufacturing capacity are precisely the ones most likely to be able to implement the decision and believes that the consequences of this limitation “could be even more serious if the decision is expanded to include therapeutics.” and diagnosis”. “From a public health point of view, ideally countries with production capacity should make full use of the new mechanism and be able to manufacture and export quickly.”
After more than a year of stalled negotiations, the document that gave rise to the agreement emerged in May from an informal process carried out with the so-called ‘Quad’ – the European Union, India, South Africa and the United States. The multilateral organization works by consensus and in all this time there have continued to be major differences on how to adapt international trade rules designed to protect intellectual property rights – the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – in response to the pandemic, with the UK and Switzerland among the most reticent countries, according to sources in Geneva. At the meeting in recent days, ministers have been studying bracketed text, for example on scope, until arriving at the current version of the draft ministerial decision, which includes several changes.
The negotiations had to be extended for another day in order to reach an agreement. “Many doubted that the WTO would be able to reach a result on a TRIPS exemption for the intellectual property of COVID-19 vaccines. We’ve done it,” tweeted Katherine Tai, US Foreign Trade Representative. “The conversations were long and difficult, but we reached a significant result to get more safe and effective vaccines to those who need it most.”
After the conference, which has led to the so-called “Geneva package” – which also contains a series of decisions on subsidies for fisheries, food security and agriculture, and the reform of the WTO -, the director general of The organization, Ngozi Okonjo-Iweala, has argued that the agreement “will contribute to ongoing attempts to deconcentrate and diversify vaccine manufacturing capacity, so that a crisis in one region does not leave others isolated.” at a press conferenceHe said, “Now we have something in hand.”
The International Federation of Pharmaceutical Manufacturers and Associations has issued a statement calling the deal a “dangerous signal”.
Strong criticism from NGOs
Several voices from civil society have expressed their disappointment with the agreement, including Médecins Sans Frontières (MSF), one of the organizations that has most advocated for the exemption as a solution to the global vaccination disparity, and believes that the decision to insufficient. MSF acknowledges that some changes have been made to the agreement that “mitigate some of the most worrying elements of the previous text presented in May.” “But overall, we are disappointed that a true IP exemption could not be agreed upon, such as the one proposed in October 2020, covering all medical tools for COVID-19 and including all countries, and we are disappointed that this has not even been achieved despite suffering the devastating effects of a pandemic that has claimed the lives of more than 15 million people around the world.”
In his opinion, this agreement does not offer, in general, “an effective and meaningful solution” to help increase people’s access to necessary medical tools during the pandemic, “since it does not adequately give up the intellectual property of all” of them and does not apply to all countries. “The measures outlined in the decision will not address pharmaceutical monopolies or ensure affordable access to life-saving medical tools.” The humanitarian organization fears that it sets a “negative precedent” for future health crises.
Along the same lines, Salud por Derecho has expressed itself, which together with almost 300 organizations from all over the world, has launched a joint declaration in which they harshly criticize the European Union, Switzerland, the United Kingdom and the United States for, they say, “their main role in blocking a proposed exemption” by South Africa and India and brand the agreement as a “scandalous failure”.
According to Medicines Law & Policy, the broader features of the waiver proposed by India and South Africa were lost when, following the US turnaround in May 2021, the EU submitted its counterproposal, which focused on the use of existing so-called flexibilities. in TRIPS of compulsory licenses – a process that many countries have argued is very cumbersome – and this “became the core of the draft” that has been put before ministers. When compulsory licenses are granted, a government allows generic manufacturers to produce without authorization from the owner of the patents – whom it forces to license them on a “non-voluntary” basis.
In the opinion of Medicines Law & Policy, the decision that is now adopted allows a WTO country that meets the necessary requirements to use a patent related to vaccines without the consent of the owner of the rights – which, according to nuances, is a license mandatory–, using any national legal mechanism, such as an executive order, an emergency decree, a government use authorization or judicial or administrative orders. “This can make issuing a compulsory license easy and quick and will help the few countries that currently do not have viable compulsory license mechanisms, but it does not substantially expand the legal space that countries already have under TRIPS.”
“Let us not forget that the discussions on the exemption in the WTO have their origin in the refusal of companies such as Pfizer and Moderna to share their intellectual property, technology and know-how for the manufacture of the COVID vaccine, even with information exchange platforms. technology such as the COVID-19 Technology Access Pool (C-TAP (from the WHO and the Vaccine Technology Transfer Center), “says the organization, which believes that if the decision contributes to pushing companies to share the intellectual property and manufacturing know-how needed in the future to produce drugs and vaccines, “it may not all have been in vain.” For now, in his opinion, there are no more resources left.
Vanessa López, director of Salud por Derecho, has said that the decision largely reiterates rights already established with respect to compulsory licenses and “even inexplicably adds more administrative barriers to the use of existing flexibilities.” For James Love, the deal is an overall “limited and disappointing” outcome “more accurately described as a narrow and temporary exception to an export restriction, not a waiver.” He also believes the five-year period severely limits the usefulness of the measure. However, although he does not expect the text to affect inequality in relation to vaccines, he believes that there are some silver linings, among other reasons because it returns the attention to national governments to make a move.
Global vaccination against COVID has been marked by huge disparities. According to the WHO, around three-quarters of health workers and people over 60 years of age have been vaccinated globally, but these rates are much lower in low-income countries. Almost 18 months after the administration of the first vaccine, more than 60 countries have still not reached 40% coverage. At the moment, the supply of vaccines is sufficient, Director General Tedros Adhanom Ghebreyesus said a few days ago. The WHO and other actors have explained that, in many countries, the omicron variant has reduced the perceived risk of the virus and people and governments focus on other health priorities.