Is compulsory licensing the answer to the US’ buying of all Remdesivir?

Tuesday this week, it was revealed that Gilead, the producer of Remdesivir, which is currently known as the best drug against COVID-19, had sold nearly almost all of the next three months’ production of its medication to the US health department, leaving the rest of the world without access to buy more of the drug.

Tests of Remdesivir suggest that the recovery time is cut by using the drug, and the drug is therefore crucial in order to keep countries’ health systems from collapsing. The deal between Gilead and the US health department covers 500.000 doses to be used in US hospitals.

Even though Gilead in May signed a licensing deal with nine companies covering 127 primarily poorer countries, the situation could become critical. In many European countries, the supply might get short if the stocks are not filled or if the demand for the medication increases, for example in case of a second wave.

This situation, in combination with a price of more than 3,000 USD per treatment, has initiated a debate in which for example the Danish politician Pelle Dragsted yesterday has argued that hospital pharmacies should initiate their own production.

The question is whether this scenario is actually realistic?

Indeed, governments may use a backdoor to compulsory licensing as agreed in the Doha declaration on the WHO-based TRIPS agreement, stating that governments should not be prevented from protecting public health.

Compulsory licensing enables a government to license the use of a patented invention to a third party or government agency without the consent of the patent-holder, and it could arguably be the answer to the deal made by Gilead and the US.

There is to some extend existing examples in related areas, including HIV/AIDS drugs, but the process is not simple and there are also other factors to be taken into account, including:

  • There has to be an imminent catastrophic event
  • A negotiation with Gilead has to have taken place without success

There are several serious legal challenges in this approach:

  • The current infections numbers for Europe are much lower than for the US, which argues in favor of using the initial production for US hospitals
  • The legal process of compulsory licensing is complex and will most likely be longer than three months
  • There has, to our knowledge, not been a negotiation with Gilead about long-term production and delivery of Remdesivir in Europe, and license deals for 127 poorer countries had already been made. This argues against the idea that Gilead does not want to solve the problem.

There are also economic and practical factors that have to be taken into account:

  • Gilead would have to be compensated for the compulsory license, and there would as such not be an economic benefit to making Remdesivir
  • The process for making Remdesivir is highly complex and requires approximately 70 raw materials, reagents, and catalysts and approximately 25 individual chemical steps. Such process requires highly specialised production facilities and skilled scientists, which is a long process that certainly cannot be used by the local pharmacy.
  • Remdesivir is given to very sick COVID-19 patients, which means that the quality of the potentially alternatively-produced Remdesivir is important, and ensuring that the drug does not lead to unwanted harmful side effects will be essential. This requires testing and approval from the authorities, which again takes time.

Therefore, there are currently legal, practical, and regulatory arguments against a compulsory license for Remdesivir for the treatment of COVID-19.

On top of this, there is right now a significant initiative to produce as much Remdesivir as fast as possible, especially considering that there are ongoing merger discussions between Gilead and AstraZeneca.

The questions that remain are therefore: what type of dialogue is the European politicians having with Gilead? are they having a dialogue at all?

There are factories across Europe that could assist with the production of Remdesivir, under Gileads supervision and instructions. Why not discuss a license with Gilead to have them produce Remdesivir at a quality and quantity that could solve these issues? Or maybe Gilead already has an answer to these issues and no Europeans have bothered to ask them?

Based on the above, it would in our opinion make sense to test many alternative strategies before simply arguing that a compulsory license is the solution.