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Aleksanda Solyga-Zurek for PMR: Open license for coronavirus drugs?

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Will there be a global pool of exclusive rights for tests, drugs and vaccines for coronavirus? As Dr Aleksandra Solyga-Zurek, European and Polish patent attorney from Patpol, says in an interview with PMR, the idea has already been supported by WHO. It is worth noting that without this solution, pharmaceutical companies have recently come under great pressure.

Voluntary pool of exclusive rights

Costa Rica’s President Carlos Alvarado and the Minister of Health Daniel Salas Peraza have proposed the creation of a global pool of exclusive rights for coronavirus tests as well as drugs and vaccines against COVID-19. These would be freely available and openly licensed on favourable terms for all those in need. This proposal received the support of the WHO and, according to the organisation’s Director-General, Tedros Adhanom Ghebreyesus, work is underway to refine the details of the project.

In most countries, there are already legal regulations in place that allow the authorities to force a wider use of patented solutions if the public interest so requires. This mainly concerns various types of compulsory licences. However, joining the above-mentioned pool of exclusive rights and allowing the use of an open licence would be voluntary – stresses in an interview with PMR dr Aleksandra Solyga-Zurek, European and Polish patent attorney from Patpol patent office.

Such initiatives have already appeared before, in the case of drugs against diseases such as HIV and tuberculosis. The Medicines Patent Pool and Unitaid now also support actions to open up access to drugs against COVID-19.

Pharmaceutical companies under pressure

Dr. Solyga-Zurek points out that pharmaceutical companies are already under great pressure to facilitate third party access to their solutions. An example from recent weeks is the AbbVie company, which has resigned from enforcing its rights to the Kaletra antiviral drug. This happened after the state of Israel decided to allow equivalents on its territory, despite the remaining patent in force. Also, under pressure from the public in the US, Gilead resigned from the exclusive rights drug Remdesivir, which was recently granted orphan status.

Another example is Roche, which has come under pressure from the Dutch government to make available the composition of a lysis buffer necessary to perform rapid tests for coronavirus. Indeed, Roche has a share of about 80% of the domestic testing market and was not supposed to be able to supply sufficient quantities of reagents. The latter case is interesting because the lysing buffer itself is not patent-protected and the company has argued that it does not want to be produced by others because of concerns about the quality of such a product – patent attorney explains.

Can a compromise be reached?

There is no doubt that for pharmaceutical companies, which have in many cases incurred significant costs in organising multiannual clinical trials and placing the product on the market, it is difficult to decide on any release of exclusive rights in many cases. – After all, the mere cost of producing a drug is often only a fraction of the actual investment in developing the active substance from scratch. However, there is no doubt that access to appropriate drugs, especially in poorer regions, is insufficient and such a situation cannot be accepted – adds Dr Solyga-Zurek.

In the opinion of the patent attorney from Patpol, initiatives such as exclusive rights pools, which enable the entitled persons to systemically make their solutions available under certain conditions (e.g. for a specific, not exorbitant fee), may constitute a good compromise. However, the entitled person, while still using his solution, does not completely block its use where he is not able to respond to the demand. At the same time, while retaining some control over the conditions under which other parties use the licence.

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