France
France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.
A French spending bill that would tax drug company turnover would create a “catastrophic competitiveness gap” between France and its European neighbors, warns Leem, the French pharmaceutical industry group.
Economic woes in France mean that tough and unpopular choices impacting the biopharmaceutical industry are inevitable, according to industry expert Alexandre Regniault.
France’s social security financing bill for 2026 is due to be presented in parliament in the coming weeks.
The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.
A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.
France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice.
Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.
France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.
HAS, the French health technology assessment body, has issued positive recommendations for several orphan drugs, including for Vyloy, which was provisionally rejected for reimbursement in the UK last year.
The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
Debate on how to manage drug spending continues in France despite an ongoing disagreement between industry and the government about whether there was €1.2bn overspend on medicines in 2024.
The collapse of the French government brings more uncertainty for the pharmaceutical industry.
The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.
France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile.
The French pharma industry body Leem says that the scale of its contribution to health insurance cost savings is undermining the industry’s financial sustainability.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
New requirements proposed by the French regulator are intended to increase the impact and effectiveness of the pictogram showing the risks of taking medicines in pregnancy.
Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.