IHS Global Insight Perspective | |
Significance | France's Health Minister Xavier Bertrand yesterday unveiled major changes for the French healthcare system. |
Implications | New rules come into force for the reimbursement of drugs at the national level. At the European level, France proposes stricter approval rules. |
Outlook | Changes expected in the regulatory and reimbursement domain are a blow for the industry. The law should be presented before parliament later this year. |
France's Health Minister Xavier Bertrand yesterday (23 June) announced a major overhaul of the drug policy in France. The reform—which has an objective: that there is no new "Mediator" in future—will be based on three pillars:
- The prevention of conflicts of interest and transparency of decisions;
- The doubt that shall always benefit patients;
- The information of patients and healthcare professionals.
Conflicts of Interest and Transparency
As part of the first pillar, the decision to change the name of AFSSAPS (Agence française de sécurité sanitaire des produits de santé) has been made. The name of the agency will be amended to ANSM (Agence nationale de sécurité du medicament or National Agency for Drug Safety) to emphasise its main role of promoting and ensuring safety. This is also a means to break away from the name which is associated with the Mediator scandal and currently a synonym of malfunctioning and discontent in France. The reform also tackles the problem of the financing of the agency, which is currently almost exclusively financed by the pharmaceutical industry. ANSM will be financed by subventions from the French state which will directly perceive taxes and charges from the industry. And to emphasise the government's ambition to deal with conflicts of interest, a French "Sunshine Act" will be introduced. As part of this Act, all financial relationships and agreements between manufacturers, physicians, experts, healthcare firms, patients' associations and specialised media will have to be disclosed.
Moreover, the health ministry aims to restrict the number of participants in commissions in order, mainly, to avoid the "diffusion of responsibility". The transparency of commissions' debates and decisions will be improved with the publication of meeting agenda and reports within 15 days, the publication of minority opinions and the video recording of meetings with health safety issues.
Change in Marketing Authorisation and Reimbursement Rules
In line with the IGAS report, the government wants to prevent products assessed against placebo to enter the market (see France: 22 June 2011: IGAS Proposes Major Drug Reform in France, 2010 Reimbursement Cut Decree Partially Cancelled). This measure will need to be approved at a European level in accord with the European Medicines Agency. But the idea would be to condition marketing approval to the presentation of comparative data against standard of care (if it exists). Such major change will in all probability take time to be introduced at the European level and, in the meantime, the health ministry will impose more stringent reimbursement rules at the national level. In order to get reimbursed, medicines will have to demonstrate that it is at least as effective as available and reimbursed alternative therapeutic options. For drugs of insufficient clinical value (SMR, Service Médical Rendu), new rules come into effect: no reimbursement will be granted, unless approved by the health minister itself.
Another important announcement is the development of health technology assessment (HTA) reviews at the Transparency Commission (HAS).
Outlook and Implications
The French health Ministry has described the move as a "reform of major scale". Measures announced are less drastic than certain proposals issued by experts commissioned by the government. Changes expected in the regulatory and reimbursement domain are nevertheless a real blow for the industry. The proposal to condition marketing approval to the presentation of comparative data against standard of care reflects a vision largely spread among payors that a medicine should only be funded if it is at least as effective as standard of care. In that sense, the French proposal aims to bring the vision of payors more in line with the regulatory approach. Under the new approval process, only novel molecules of same or superior therapeutic added value compared to a reference drug would gain access to the European market.
In terms of reimbursement, placebo-controlled studies will no more be sufficient to secure reimbursement in France and the Transparency Commission will be asked to boost its efforts in terms of health economics studies. Since its creation in 2008, the SEMESP (Evaluation médico-économique et santé publique) has issued only two drugs' health economics analyses (for anti-hypertensive drugs and statins), reflecting its low activity/weight within the French reimbursement landscape. The announcement of a development of its activity means nothing concrete for now, but it indicates that an evolution towards a more health economics approach can be expected in France. A draft law is planned to be presented before parliament this autumn.