The eighth meeting of the Strategic Council for the Healthcare Industries (CSIS), between the French government and representatives of the healthcare industry, took place on 10 July 2018. The CSIS agreed on certain measures as part of a long-term roadmap to help France regain its attractiveness as an international centre of health innovation and excellence. These measures are set out in a CSIS press report and pertain to:
- Ensuring rapid patient access to innovations. The waiting time for patient access to new medicines will be reduced to 180 days from the current 530 days (the 18th longest period in the EU). The government also commits to extending the temporary authorisation for use (ATU) to include extensions of therapeutic indications, and to making reimbursement criteria clearer and more efficient.
- Supporting research and development. The report highlights accelerating clinical trial authorisation procedures, facilitating staff mobilisation between the public and private sector, creating a health data hub to optimise the use of available health data, developing a sector of excellence for biotechnology and innovative therapy medicines, and investing EUR 2 billion in innovation through public and private investment.
- Boosting the attractiveness of France as a pharmaceutical hub. The CSIS commits to the adoption of regulatory parameters that will apply within a three-year period, thus providing a stable framework for health investments. In addition, there is a commitment to achieve a minimum annual increase of 3% for innovations (and 0.5% of turnover) as well as proper conventional negotiations between the government and the industry.
In a press release issued on the same day, LEEM, the French pharmaceutical industry association, recognised that the above measures constitute much-needed reforms that will hopefully lead to France regaining its position as a pharmaceutical hub, but stated the measures must be supplemented by a relaxation in the budgetary constraints imposed on the industry as well as a return to reasonable growth (at present pharmaceutical companies contribute 50% of health expenditure savings for only 15% of health insurance costs). In addition, although LEEM welcomes the introduction of a supervisory body that will monitor the implementation of the measures and report directly to the prime minister, it cautions that this body must be consistent with the industry initiatives to ensure that the agreed measures do not just remain at the “political intention” level.
The French prime minister also published a press release on the outcome of the meeting.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2018 Issue (Thomson Reuters).