In France the Ministry of Health has outlined a proposal to overhaul the country’s regulations on reimbursement, marketing, and safety of prescription drugs.
Details are incomplete, but Xavier Bertrand, the Minister of Health, highlighted these provisions:
- A new law on transparency and conflict of interest, to be called the “French Sunshine Act”;
- Pharma companies will be “held responsible for off-label use management with financial consequences”;
- For reimbursement, new drugs will be required to have an active comparator in Phase 3 studies,
- Products that have been on the market for some time will need to have a benefit/risk valuation prepared;
- A new tax will be created on pharma to finance physician medical education;
- A limit on sales reps beginning in hospitals (no personal detailing - only in group meetings) that may be extended to physician offices.
We’ll see. As General De Gaulle said, “How can you govern a country which has 246 varieties of cheese?”
Or, perhaps more to the point, “I have come to the conclusion that politics are too serious to be left to the politicians.”
Bien sûr -- and especially when it comes to healthcare.
Please pass the cheese.
