International 08/05/2021

Pandemic breaks taboo on pharmaceutical patents

Experts warn that in addition to the formula, the manufacturing system must be transferred and the quality and supply of materials must be guaranteed

3 min

BarcelonaShould patents on covid-19 vaccines be released? For months India and South Africa have been demanding it, with the support of a hundred countries in the South. As happened years ago with antiretrovirals to combat AIDS, they claim that only in this way they will be able to immunise their populations. Until now they have met with the frontal opposition of the rich club, who represent the interests of their powerful pharmaceutical industries. But the equation has changed this week with the U.S. President Joe Biden's turnaround, who was pressured by the dramatic situation in India and Latin America, when 252 million doses have already been administered in the United States, which has so far refused to export its stockpiled vaccines. But big pharma has come out to defend its monopoly at all costs. The final decision is due to be taken next month at a meeting of the World Trade Organisation (WTO).

How does the patent system work?

As with other inventions, when a laboratory develops a new drug, it can obtain patent exclusivity for 20 years and protection of the data on how the drug is made and its efficacy and safety characteristics for 10 years. After this period, other laboratories can manufacture and market it as a generic drug, which lowers prices. If the temporary suspension of patents were applied to vaccines and other treatments and materials for covid-19, as called for by India and South Africa, states would be able to license it to their laboratories without the patent owners being able to do anything about it. "This would mean creating an international legal framework for sharing knowledge: the pharmaceutical companies that hold the patents would have to share by law the formulas of the vaccines, make them public and make the technology transfer", Raquel González, from Médecins Sans Frontières, explains to ARA. "This cannot be in the hands of just a few companies if we want to take advantage of the world's production capacity".

What should laboratories share?

Margarita Arboix, professor of pharmacology at the UAB and former member of the committee of experts of the European Medicines Agency (EME), warns: "The patent is not the only problem, because if only the formula is released but the entire manufacturing system is not explained, laboratories will need months to be able to produce vaccines and right now we don't have time. What is needed is to release all the vaccine dossiers, for social and public health reasons".

Pfizer vaccine doses.

Could we increase vaccine production?

Pharmaceutical companies say that lifting patents is not the solution. The Spanish employers' association Farmaindustria warned on Thursday in a statement that "the process of manufacturing vaccines is very complex and requires specific knowledge, cutting-edge technology, appropriate facilities, trained human teams and experience that is currently only available to a few companies worldwide". The companies that hold the patents are reaching collaboration agreements between companies through which the company that holds the patent agrees with a third company to cede the technology, usually in exchange for a percentage of the profits it will obtain.

However, many say that this is not enough. "We have all the reactors and purification tools necessary for the production of RNA vaccines. If we had the antigen, production could start immediately", Abdul Muktadir, president of the Bengaluru-based Incepta Pharmaceuticals, told Health Policy Watch in an interview a few days ago. In Canada, John Fulton, spokesman for Biolyse Pharma, which manufactures cancer treatments, has made himself available to produce 20 million doses of Janssen's vaccine annually.

Another problem is that of raw materials, given that vaccines contain dozens of components. Moderna's director, Stéphane Bancel, argued a few days ago at a round table organised by the international federation of pharmaceutical manufacturers: "We are under pressure to supply ourselves, if there are more players demanding raw materials, this will not improve the situation".

Is the business of laboratories or innovation at risk?

In the first quarter of 2021 the vaccine has brought revenues of 2.9 billion dollars for Pfizer (the same for its German partner BioNTech), while the company, which has already sold more than 430 million doses in the world, continues to sign million-dollar contracts. "We are paying twice for vaccines: billions of public money were put into developing them and governments now have to pay some laboratories under a patent to recover an investment they did not make", explains Germán Velázquez, former director of the World Health Organization's drug programme.

The patent liberalisation debate
  • Arguments in favour -Global vaccine production would grow -Southern countries could be immunised earlier -Reduce the risk of vaccine-resistant virus mutations -Public investment would be recouped -Voluntary mechanisms have not worked
  • Arguments against -The manufacturing process is very complex -Raw materials would be more difficult to source -Quality could not be controlled -No incentive to innovate -Voluntary mechanisms are preferable