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Patent liberalization in vaccines: how the pandemic has changed the rules of the game for the pharmaceutical industry and the consequences for investment, the industry and the population

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Andersen presented the event "Patent liberalization: impact on industry and society", the first meeting organized by the firm's Pharma & Life Sciences group, with the collaboration of FarmaIndustria and the Spanish Patient's Forum

The pandemic caused by COVID-19 has had, among its main consequences, started a race in the pharmaceutical industry to develop vaccines that would put a stop to the rapid spread of the virus worldwide. Despite the various options currently available, the impossibility of reducing the number of cases in certain areas, such as Latin America or India, has led to the idea of liberalising the patents on these vaccines, to broaden the possibilities of dealing with the spread of the virus.

This decision, which has both supporters and detractors, has generated a series of doubts about the impact it could have on the investment made by the pharmaceutical companies and laboratories that develop the vaccines, as well as the consequences for the market, the industry and the patients themselves.

In order to lay the foundations to shed light on this issue, Andersen, and specifically through the new Pharma & Life Sciences specialist group, organised the webinar "Patent liberalisation: impact on industry and society", which was attended by Francisco Fernández (Director of Communication at FarmaIndustria), Santiago Alfonso (Vice-President of the Spanish Patients' Forum), as well as José Ignacio Olleros y Elena Sevila from Andersen.

José Ignacio Olleros introduced all the speakers by thanking them for their presence at the first event of the new area of the Pharma & Life Sciences firm dedicated to offering services in the pharmaceutical and health sectors, with renowned experts in the field.

The context in which this debate arises, according to Elena Sevila, can be placed at the end of 2020, "when South Africa and India presented an initiative at the World Trade Organization to suspend the intellectual property rights of vaccines, which has been joined by more than 100 countries", she explained, adding that "the turning point has been Biden's announcement in favour of the liberalisation of these patents".

The debate is still open today, with new actors positioning themselves in favour or against: "the European Parliament has positioned itself in favour of liberalisation, President Sánchez has spoken about it and has even gone further by mentioning the transfer of knowledge and technology," continued Elena Sevila, who also explained how "these forums allow us to move forward and to know what the interests of the parties are".

From an industry perspective, Francisco Fernández stressed the importance of the current moment "nine months after 11th March 2020, the first vaccine against COVID-19 was already being administered. The development of a drug takes an average of eight to ten years, so this says a lot about the extent to which the model of drug research and development in the world, based on industrial protection, works or not.

On this basis, the global pharmaceutical industry created a global alliance, under the auspices of the WHO, to work together on the development of these vaccines. "There were three major commitments made by the industry: research into the COVID-19 drug - with public and private collaboration; production - a major challenge because vaccine production is much more complex and takes longer, so companies decided to invest in their own plants and, in parallel, agreements were made with plants around the world that could take on production; and, finally, access to them," said FarmaIndustria's Director of Communications.

In terms of production and agreements, work began to start with companies that could take on part of the production. "This was the key," continues Fernández, "because the question was that this production implied, on the part of the developers, a scientific transfer of knowledge and technology, which would allow the producers to take on the production, with the safety and quality requirements available in any vaccine laboratory, which has been done through cooperation agreements between developers and producers, setting up a production capacity far superior to that which the world of vaccines in general had".

Currently there are already 310 agreements between companies, with approximately 35 countries involved (China, India, South Africa, Brazil, Pakistan, Egypt amongst others), which have plants capable of producing, which will allow 12 to 13 billion vaccines to be available in the world by 2021, enough to achieve herd immunity.

As for the debate on whether to liberalise patents or not, Francisco Fernández explained that, in his experience, it is not appropriate: "what we have is an urgency to produce vaccine doses. Any measure to cancel patents takes time that we do not have, we need vaccines to be available now," he said, adding that "due to their complexity, not everyone is prepared to take on the production of vaccines in conditions of safety and efficacy, so the work done through voluntary licensing and agreements between companies is what should work and, in fact, is working".

The patients' perspective was provided by Santiago Alfonso, who explained that "it is precisely the patients who are interested in having a vaccine soon, especially on the part of risk groups".

"Vaccines save lives, it is something that we have already normalised, and although measures are being taken we do not know when this will end, but what is clear to us is that medicines improve people's quality of life," said the Vice-President of the Spanish Patients' Forum, adding that "today the producer that we must look after most is the pharmaceutical industry, because of what it is doing in the face of COVID-19".

Santiago Alfonso commented that "patients are very satisfied with the results of the vaccines, we want research to continue, and the public is willing to pay for it", adding that "the important thing is solidarity, helping the countries where they are needed, perhaps not so much from the point of view of liberalisation as being able to help them to buy them".

Elena Sevila explained how on previous occasions, within the WTO, "a suspension of industrial and intellectual property rights has been achieved, but for the purposes of repercussions in the third world, this crisis is in reality global, and it has been demonstrated that it is not necessary to be a developing country to be affected by it", and added that "it is not necessary to rethink the patent model, because in reality it helps innovation, but it is important that the stakeholders in this sector debate what is happening and know what to do in these cases". On this possible liberalisation, "although there is no clear risk that everyone could produce, it is important to take into account pharmacovigilance in all these processes," he concluded. 

Santiago Alfonso explained that this same situation, of possible uncertainty in the event of liberalisation or access to patents, was experienced with generic medicines, and for patients this "is experienced with a certain uncertainty, but many things are produced elsewhere and there is no problem; safety mechanisms are simply necessary, and they do exist".

Francisco Fernández closed the debate, stating that "we currently have total security that the approved drugs have all the guarantees, so the challenge for us with respect to vaccines is who can manufacture them, produce them, and give us the same guarantees, not only in the West, but can be transferred to other countries".

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