“Punitive taxation”, “purely accounting logic”: for pharmaceutical laboratories, the budget threatens access to innovative medicines

The laboratories confront the government. Three measures in the social security financing bill (PLFSS) for 2026 particularly bother the union of French pharmaceutical companies (Leem): the proposed reform of early access to innovative medicines, a modification of taxation and experimentation with the referencing of certain medicines.

Early access to medicines is an exemption system that allows rapid access to innovative medicines for patients suffering from a rare, serious or disabling disease for which there is no treatment: they are 100% covered by health insurance before their marketing authorisation, which must be granted by the European Medicines Agency (EMA).

The text presented on Tuesday by the Lecornu II Government plans to limit this support to 12 months, after which, if early access is still authorized, the manufacturer must provide the medicine free of charge, and restricts the scope to medicines without marketing authorization, which “seriously” compromises their access, according to Leem. And rightly so, “only 60% of medicines with European authorization since 2020 are available in France,” recalls the union.

1.4 billion euros in price cuts

The Social Security budget for 2026 also modifies the “safeguard clause”, a contribution to health insurance paid by pharmaceutical groups when their turnover in reimbursable medicines grows faster than a progression rate defined by the State.

Progressing very steadily, with an amount of 1.6 billion euros in 2023, it will be integrated into an “already existing contribution,” indicates the text, while “an effort will be requested” from pharmaceutical groups through “price reductions of 1.4 billion euros in medicines.” Leem denounces a “punitive imposition” that “will annihilate the attractiveness of the sector”, while, according to him, drug prices in France are already “among the lowest in Europe.”

Finally, the business union denounces the experiment planned five years ago of referencing certain medications, that is, their inclusion in the list of health products recommended for hospitals. It could cause “disruptions in supply,” like in the Netherlands, which implemented it, he said.