With drug shortages once again on the rise in France, Pierre Olivier Variot, president of the Trade Union of Dispensing Pharmacists, urges authorities to be more proactive. He calls for better traceability from production to sale to guarantee drug access in France. He also calls for measures to encourage manufacturers to produce in France.

Medscape: The number of pharmacy supply disruptions lasting at least a week has almost doubled since the start of the year, going from 6.5% to 12.5% of the number of reference medicinal products, according to Les Échos. As a pharmacist, do you often face this problem?

Variot: Yes, definitely. I must have a hundred drugs out of stock, ranging from antibiotics to cancer drugs to insulin. There have been shortages for 5 or 10 years, but in the past few months, the situation has been rapidly getting worse. There are shortages in many drug classes, including generic drugs.

Medscape: What is causing these stock shortages?

Variot: There can be several reasons. First, there may be a mismatch between demand and production. That’s what happens with paracetamol. Right now, there’s huge demand, and production can’t keep up. There can also be stock issues when one, two, or three batches of a drug don’t pass the checks and are destroyed, creating a shortage.

There can also be a shortage when a drug is frequently exported. Right now, in Europe, drugs are the cheapest in France. When a manufacturer produces 1000 boxes and reserves 100 for France, 100 for Germany, and 100 for Italy, it’s in their best interest to sell 70 to France and the other 30 where they can sell them at a higher price. This is what’s happening. That’s why the French National Agency for Medicines and Health Products Safety (ANSM) has created a list of medicinal products of major therapeutic interest and is asking the laboratories that produce these products to have a minimum stock in France that can be readily available. Manufacturers who don’t make this stock available could face a fine. Another reason for the shortages concerns intermediaries. These are often resellers who can carry out parallel exports because they too have an interest in selling more to German pharmacists than to French ones to earn a little more money.

Medscape: Are these shortages the direct or indirect consequence of the conflict between Ukraine and Russia?

Variot: Russia isn’t a major drug exporter, but there is indeed a rebound effect in relation to the conflict. Due to the massive hike in energy costs, when drug prices are so low, some pharma companies can end up working at a loss and stop producing as a result. [Editor’s note: Leem, the French industry association that represents drug companies operating in France, told La Tribune that in recent months it had recorded “on average, a 25% increase in production costs.”]

Medscape: Can these shortages persist?

Variot: I’m worried they’ll get even worse! A measure from the French Social Security Financing Bill (PLFSS 2023) stipulates that request for tenders must be submitted for certain drugs, including generic drugs. The pharmaceutical company with the cheapest request for tender will win, and only this company will be reimbursed. The drugs not selected will no longer be reimbursed, which will only exacerbate the problem. The idea of “whatever it costs” no longer holds; we’ve reverted back to “who has to pay what.” [Editor’s note: Faced with opposition from pharmaceutical companies and pharmacists, the French government recently announced that this measure would be put in place on an experimental basis.] This is what’s happening in the countries that have already adopted this measure, ie, Denmark, Sweden, the Netherlands, and some German states. We run that risk when only one pharmaceutical company produces a drug. Imagine if we adopted this measure for paracetamol! Today, eight or nine countries produce paracetamol. If only one country produced it, you wouldn’t be able to produce it for everyone. It simply wouldn’t be possible.

Medscape: Because of the massive hike in energy costs, when drug prices are so low, some pharma companies can end up working at a loss and stop producing as a result. Have the authorities, including the ANSM, been sharing less about the shortages in recent months? Is there a lack of information?

Variot: No, because they were under the impression that the issue had been resolved. But we’re at risk of moving backwards, not forwards.

Medscape: Are pharmacists sufficiently informed about drugs that have run out of stock? How do you deal with frustrated patients who can’t access their prescribed treatment?

Variot: We estimate that 2 working hours are lost every day in pharmacies due to shortages. How do we manage? Sometimes we prescribe generic drugs as a substitute and we provide education to explain the switch. However, when we’ve run out of the treatment and the generic drug, we call the pharmaceutical company to see if they can help us out on an emergency basis. Sometimes they send it out to us, and we have the treatment within 3 or 4 days. And sometimes they’re not able to because there is no drug at all. We then call the doctor to see which drug class we can replace the treatment with.

Medscape: Today, is there no way of knowing the availability of a drug at another pharmacy?

Variot: No, no one has a full vision of available stock, but we should have a new feature in a few weeks. When a drug goes out of stock, our machine will suggest that we order it directly from the pharmaceutical company. This automation will help us save time.

Medscape: Do you ever find yourself without a satisfactory solution for patients?

Variot: We always find a solution, but sometimes it’s an imperfect solution, with other drugs and with other effects. The patient must get used to the drug again, or sometimes the dosage needs to be changed.

Medscape: From your point of view, what measures could be put in place to improve the situation?

Variot: We should be able to have more clarity. Let’s take the example of the 1000 boxes produced by a manufacturer, 100 of which are for France. Today, we know that 100 boxes were produced but we don’t know if these 100 boxes were actually delivered to pharmacies and sold to French people. If we know that 100 have been delivered and how they have been distributed between the wholesalers and resellers, then we will know where the issues are coming from and we can fix them. If we’re kept in the dark, then things will never get any better. We need better traceability from production to sale. At the very least, if we note a shortage at 100 boxes, we will know that 120 are needed. ANSM needs to police this, too! And if that doesn’t work, it should impose fines when manufacturers don’t have the medicinal products of major therapeutic interest readily available. ANSM has planned to impose fines, and the amount to be paid will also be increased.

Medscape: Does this new tense situation raise the question of France’s sovereignty regarding drug production, in your opinion?

Variot: Of course. We need to facilitate drug production in France, perhaps by increasing the price. Drugs can no longer be manufactured in France today because they’re too expensive. Take Levothyrox [levothyroxine] as an example. With Levothyrox, there was only one generic, because only one pharmaceutical company produced it, as it wasn’t very profitable. Somewhere along the line, it ceased to be profitable at all, and the pharmaceutical company stopped manufacturing it. When we had the blunder with Levothyrox a few years ago, we no longer had a generic to turn to. We had to import the drugs from Greece, Germany, and Russia. If you don’t produce the drug, at some point it becomes a problem. When you have a box that costs 40 cents or a euro, the manufacturer doesn’t know how to do it and at some point decides to stop producing it. Production is moving elsewhere, to China and India. This has an environmental impact and poses serious problems.

This article was translated from the Medscape French edition.

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