New Health Bill adopted by French Parliament

• France

• Intellectual property
• Health and life sciences - Bio and pharma articles

11-06-2015

On 14 April 2015, the French National Assembly adopted the new bill on modernisation of the health system.

The bill was presented to the Council of Ministers in October 2014, and is intended to improve the conditions for national health services.

The French Government wants to innovate the country’s health care services, in particular for prevention matters and improving individuals rights. The new bill contains several provisions aimed to reform the old French health system such as:

• Bringing French clinical trial practices in line with EU Clinical Trial Regulations.
• The possibility for the health technology assessment body, HAS, to organise early consultations at the request of companies developing innovative pharmaceutical products with a new mechanism of action and for an insufficiently covered medical need. This would be implemented before the start of clinical trials.
• The right of the drug pricing committee, CEPS, to enter into framework agreements with bodies representing patients, enabling them to consult and exchange information on the setting of prices of reimbursed medicines and other health products. These agreements would be made for renewable three-year periods. The organisations can apply for participation to the negotiations of the agreements or to become party to an agreement in force.
• The obligation for the marketing authorisation (authorisation de mise sur le marché) holder, and not only for the exploiting company (exploitant) to ensure an appropriate and continuous supply of medical products.

Other measures included in the reforms are:

• The right for people who have previously suffered from cancer to apply for bank loans without referring to their former illness (so-called “droit à l’oubli”).
• Better nutritional information on the food products with a logo and a colour code.
• Increasing the applicable fines up to €45,000 to prevent alcoholism in young people.
• The prohibition of smoking in cars in the presence of children, and the removal of logos from cigarette boxes.
• The experimentation of public drug consumption rooms for 6 years.
• Improved detection of HIV with auto-tests available in pharmacies.
• Helping youth health formation, facilitating access to emergency contraceptive pills and removing the 7-day waiting period imposed to women going through abortions.
• Developing the direct payment of health services to health professionals (doctors) by the French NHS (Sécurité Sociale) and health care insurers in 2017 (so-called “tiers payant”).
• Creating the possibility of class/multi-party actions for damages where groups where damage is caused to health.

Introducing a presumption of consent to organ donations for all adults and a possibility to express their opposition.

The French Health Minister, Marisol Touraine, declared that the bill should be adopted by the French Parliament and entered into power by the end of the year.