Coronavirus: "The risk of drug stock-outs is real"

Text by: Caroline Paré Follow | Ophélie Lahccen

The coronavirus epidemic is marked by a recurrent observation: that of the risk, even of the reality of the shortage. Lack of masks, tests, respirators ... Concerns also relate to the tensions in terms of supply of drugs. How to explain it and how to prevent it from happening again in the future?

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The professor Rémi Salomon is Head of Pediatric Nephrology at the Hospital Necker Sick Children in Paris. He is the president of the AP-HP Medical Establishment Commission .

The doctor Thomas Borel is Scientific Director of LEEM (drug companies), pharmaceutical industry union.

Both were invited to the Priority Health show on RFI, Thursday, April 16.

Two weeks ago, you expressed your fear of missing certain essential drugs, Professor Rémi Salomon. Is this still the case today?

Prof. Rémi Salomon: The fear is always present. In the "world before", there were already very often, these problems of shortage of drugs, including essential drugs. Last year, there was talk of a lack of corticosteroids, which are essential for the management of many chronic diseases. Vaccines are also regularly out of supply. A France Assos Santé survey of French people in December 2018 indicated that a quarter of them said they had faced drug shortages. This problem therefore already existed. Obviously, today, when all the countries of the world consume, for the same reasons, the same drugs, the risk of stock-out is real.

On the one hand, there are these quasi-structural shortages in the supply of certain drugs and, on the other hand, this crisis caused by the explosion in demand. Thomas Borel, on which molecules is there a particular tension today?

Dr. Thomas Borel: I would like to clarify that Les entreprises du medicament (Leem) brings together large companies, but also many small companies that have production sites in the territory. The current situation is completely new. There is global tension over certain priority molecules: those used to manage respiratory distress in intensive care, such as curares and certain sedatives used in anesthesia-resuscitation services, which are currently used to manage patients with Covid-19.

These tensions are present in France, but also in many countries of the world. For the moment, the chain is keen and continues, with flawless mobilization, to optimize the supply to the various establishments in France and to the overseas departments.

How do manufacturers react ? Does that mean that the factories are running at full speed ?

Dr. Thomas Borel: This tension is international, so there are several aspects. First of all, of course, the factories are running at full speed with all the employees who are mobilized. There are more than 40,000 in France, working in drug production factories. This makes it possible to have business continuity plans, including when a certain number of them may be directly affected by the coronavirus. It is a permanent action of the companies in production unit.

In addition, there is an inventory management at the international level, of large pharmaceutical laboratories in order to optimize the provision of these stocks in the countries which are currently most affected by Covid-19.

Do the manufacturers of medicines in France inform the health authorities of the tensions, the risks of shortage? Is there an obligation to provide this data?

Dr. Thomas Borel: Today, information on molecules and priority drugs is daily. Each company informs the National Medicines Safety Agency (ANSM) every day of the stocks and availability of these drugs. The latter then organizes the information and regulates at best the availability of the products of the various health establishments concerned in the territory.

Outside of any regulatory field, it is a public health mission that falls to healthcare companies. These companies are extremely anxious to have the most relevant distribution possible of the drugs available, according to the evolution of the regions affected by the epidemic and the needs of the resuscitation services and the carers who take care of patients in these services. . Exchanges are therefore daily between the drug companies and the ANSM.

We know that most of the molecules are produced in India and China. This necessarily makes the sector more vulnerable ... Will the drug industry rethink this, based on this vulnerability observed today?

Dr. Thomas Borel: Absolutely. A large majority of the active ingredients that make up the drugs are produced outside of Europe. It is undeniable and it has already been widely underlined. Since the start of the crisis in Hubei province, companies have been very mobilized to monitor the active ingredients from this region. This made it possible to better anticipate the supply of products. Our companies are very mobilized on the issue of tensions and stock-outs.

Over a year ago, we brought a number of proposals to the attention of all stakeholders, including the government. One of them concerned the reindustrialisation of European territory. Not just French territory, because the subject must be looked at on the European perimeter. It is clear that there must be a reindustrialization policy, which is stronger and more incentive for companies to invest on European territory. This would bring essential drugs closer to our needs, to patients and to healthcare systems.

We are talking about capacities, but also about health sovereignty… Do caregivers have a say when they are deprived of the means to, quite simply, treat?

Pr Rémi Salomon: Certainly! If we don't have drugs, it's complicated ... I am convinced that the entire pharmaceutical industry is mobilized. This shortage problem is not new. I have before me a report from the National Academy of Pharmacy from March 2013, which warns of this problem. The Academy remade a note at the beginning of the epidemic, on February 12, 2020, to recall the urgency of relocating production as much as possible.

It's been a long time since we outsourced production. It should be remembered that a drug is first of all chemistry to manufacture what is called the active principle. 80% of this first step is done outside of Europe and especially in China. Then we shape the drug. This stage is mainly done in India. Afterwards, the drug arrives, for the final stages of production, in North America or Europe. This is a problem which must be considered on a European scale.

Why did you outsource all these stages of drug production ?

Prof. Rémi Salomon: We relocated 20-30 years ago to reduce production costs, but not only. We remember Seveso. This chemical industry is a polluting industry. There has been a desire to remove this polluting industry from our countries in countries where the environmental requirements were lower, even if they are becoming more so today.

There are several thousand active ingredient production sites in China and they are moving around a lot. This also poses a problem in finding the place where the raw materials are made. There is a need today to relocate what can be. It is a complex and time-consuming process. The sooner we do it, the better. We are not immune to a second wave of the Covid-19 epidemic. If the second wave arrives in 4 or 6 months, we will be pleased to have started the relocation process. In the meantime, there are things that we can do more quickly: go get the raw material in China or India.

It is the importance of having transparency throughout the production chain. These are things that can help European countries a lot. It is up to the public powers to coordinate. This is the meaning of the call we made with 8 other large European teaching hospitals: we must manage stocks together and also initiate relocation.

Until we can relocate, we must be able to know exactly where the active ingredients are produced in China and India. This will allow us to put the much-needed essential drugs back into production. If there were a complete rupture of a sedative or muscle relaxant (used in resuscitation but also for surgical procedures), it would be a disaster.

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