Between 2017 and 2020, 160 so-called innovative drugs [that contribute to new or existing medical treatments] have been authorised by the European Medicines Agency (EMA) to enter the EU. 105 of these innovations made their way to the Luxembourg market, an average of 26 per year. This puts Luxembourg in the top 10 on the continent for access to medical innovations.
"I don't know the exact figure for the last 12 months, but it must be much lower," says Sonia Franck, secretary general of Innovative Medicines for Luxembourg (IML), an association representing 61 laboratories that partake in research and development--like Pfizer, AstraZeneca, Bayer, Johnson & Johnson or Novartis. "Since October 2021, the release of these innovative drugs has been blocked by the social security ministry," she says.
To fight lung or breast cancer, leukaemia
First alerted about this blockage by some of its members in Autumn 2021, IML has seen the problem grow month after month. So much so that a small internal study carried out this summer among its members determined that "86 innovative medicines had been (or would be by the end of December) affected". Many of these are, in fact, repackaged versions of drugs already on the market. However, 32 of them are also new molecules, and therefore supposed to bring therapeutic innovation for serious diseases such as lung cancer, breast cancer, multiple sclerosis and leukaemia.
In its communication, IML mentions an estimated delay of 9 to 12 months (compared to the delays observed before October 2021) in accessing these products for a Luxembourg patient. The social security ministry--which is responsible for setting the price for medication--considers this estimation an exaggeration.
A dialogue of the deaf
This is not the only point on which these two entities disagree. For the past year, relations have been strained between, on the one hand, an association whose mission is to promote, in Luxembourg, the therapeutic innovations of its members and, on the other hand, a ministry which, like the government as a whole, has had to deal with the multiple crises that have affected the country in recent months. Each playing its own role, these two organisations have not progressed at the same pace in this joint dossier on innovative medicines.
And between a meeting by video conference last January that was not followed up, a lack of clarity regarding the carrying out of an independent legal study, and multiple unanswered emails, the situation has deteriorated on both sides, and even become a little more heated. IML is trying to find solutions while the government never really explained where the problem lies.
A procedure exists, but...
There is a regulation in the statutes of the CNS that allows an attending physician to request the payment of a drug with a marketing authorisation, even if it is not reimbursed, when it is necessary for the treatment of an insured person. In other words, a Luxembourg patient can, under certain conditions, have access to blocked medicines.
As this procedure is rather cumbersome to set up, it is destined to remain an exception. All the parties involved in this dossier agree on this plan. They also agree that a satisfactory solution must be found to a problem that originates, in part, on the other side of the border with Belgium.
The Belgian way
Although Luxembourg imports its medicines, 85 to 90% of them come from Belgium. The reasons for this are primarily historical but this agreement also benefits from a Belgian market and its very attractive prices.
The vast majority of innovative medicines therefore arrive in Luxembourg via the Belgian route. When they are approved by the EMA, the social security ministry has to request a price. "This price, excluding taxes, may not be higher than that granted by the authority of the country of origin", explains the text.
Thus, the Luxembourg price can only be set after the Belgian decision on the matter. In Belgium, the setting of a maximum price is the responsibility of the economy ministry. However, in parallel, a pharmaceutical company wishing to have its drug reimbursed may submit a second application to Inami, the Belgian equivalent of the CNS, to have an insurance-covered price determined. This is a process so highly codified that it can take up to 300 days following the decision of the economy ministry to be completed.
In Luxembourg, the CNS only decides on the reimbursement and the conditions of reimbursement, and therefore has no impact on the official price of the drug.
The law and the way our pharmaceutical companies make their applications have not changed. We do not understand...
The setting of two prices in the Belgian system leads to delays as the release of the drug depends on the time needed by the Inami to determine its price. In addition, “they now have to wait for the official publication of the reimbursed price in the Moniteur Belge [like the Journal Officiel in Luxembourg] to finally obtain a price in Luxembourg, says Franck. “This is despite the fact that Luxembourg law and the way in which our pharmaceutical companies make their applications have not changed. I must admit that we do not understand..."
We are obviously not saying that these companies are falsifying documents, but we can't take everyone's word for it.
The answer must be found at the level of the social security ministry which apparently remained rather vague on the issue during its rare exchanges with IML. The problem could in fact be linked to a change in procedure that took place at the end of April 2021 in Belgium and the obligation to use a new digital tool. It would now be impossible for the ministry of Claude Haagen (LSAP) to verify that the marketing date entered by the pharmaceutical company in its Luxembourg price-setting application corresponds to that indicated to the Belgian economy ministry.
"We are obviously not saying that these companies are falsifying the documents they give us, but in a state governed by the rule of law, we cannot take everyone's word for it," the ministry explained. What's more, it appears that some applicants have already committed some irregularities in this area... As a result, the ministry now prefers to wait for the publication of all the data in the Moniteur belge in order to be certain that they are indeed official. Which means more delays.
A revision of the regulation is coming
Aware that the situation cannot remain as it is and considering this problem a priority, the social security ministry insists that it is in contact with its Belgian colleagues in order to find a solution. It adds that a revision of the procedures, and even of the regulation setting them out, is underway. This revision could already take place before the end of 2022, or even during 2023.
This would be a win-win situation for everyone. Starting with pharmaceutical companies, which would no longer have to worry about the threat of no longer offering some of their innovative products on Luxembourg territory.
A longer version of this article is available in French on Paperjam.