France: Recent Developments in Pharmaceutical and Bioethics Law

Last Updated: 16 December 2004
Article by Christian Belloin and Camille Ricaud

CLINICAL TRIALS: LAW ON FRENCH HEALTH CARE POLICY

Law n° 2004-806 dated 9 August 2004 relating to health care policy implements the EU Clinical Trials Directive 2001/20/EC of 4 April 2001 on medicinal products for humans and reforms the French law n° 88-1138 "Huriet-Sérusclat" of 20 December 1988 on the protection of clinical trial subjects.

The amending law modifies the existing provisions of the French Public Heath Code in the following areas:

Protection of clinical trial subjects

Specific clinical trial subjects are now strictly protected including are minors and incapacitated adults who are either covered by a legal protection measure or unable to give their informed legal consent. They can only participate in clinical trials if clinical trials presenting the same level of efficiency cannot be carried out on other clinical subjects and subject to the following conditions:

(a) either the potential expected benefit for these clinical trial subjects justifies the risks incurred; or

(b) the potential expected benefit for other minors or individuals in the same situation justifies these clinical trials.

Prior authorisation process for clinical trials

In most cases, a favourable opinion of an ethics committee ("Comité de protection des personnes") and an approval of the competent national authority, "L'Agence française de sécurité sanitaire des produits de santé", are required for any clinical trial launched by any sponsor. Both approvals can be requested simultaneously.

The applicable decree setting the time period between the filing of the sponsor's requests and the responses from the Authorities has not been yet implemented. However, Directive 2001/20/CE has scheduled a maximum period of 60 days. The priority for the French Authorities, in order to remain competitive as compared to other EU countries, is to elect a short time period.

Sponsors' liability regime

The new law has amended the sponsors' liability regime. Under the previous legislation, the liability of the sponsor differed, depending on whether or not there was an individual direct benefit for the clinical trial subjects. The new law has deleted the wording which has made this distinction up until now, and replaced it with a "benefit/risk" evaluation.

This will have consequences for insurance coverage. The amendment of this provision took effect immediately upon enactment of the new law. Sponsors must therefore review their insurance coverage in this respect.

The French Authorities have not yet confirmed if a sole sponsor must be appointed to assume liability for a clinical trial set up throughout several EU countries. Under the new law companies outside the EU must appoint a legal representative to carry out clinical trials in any EU country. This new provision could lead to such legal representatives.

Investigational medicinal products

The definition of an investigational medicinal product provided by Directive 2001/20/CE has been inserted in the section of the French Health Code relating to medical products for human use (that is, Article L.5121-1-1).

The legal and regulatory provisions of the French Health Code require that imports of investigational medicinal products from countries outside the EU to be licenced by the head of the competent French Authority ("Agence française de sécurité sanitaire des produits de santé"). In order to obtain such a licence, the request for an authorisation to import such products must provide, inter alia, the names and addresses of the individual and the legal entity responsible for importing the investigational medicinal products. The legal entity in charge of importing the investigational medicinal products must be a pharmaceutical company ("établissement pharmaceutique") of which one of the managers must be a pharmacist. The pharmacist must certify that the investigational medicinal product has been manufactured in accordance with GMP guidelines.

Clinical trials data will be transferred to a centralized EU-database called "Eudract"

The new law has specific implications for the protection of clinical trial subjects. However, it will only be possible to evaluate the real impact of this reform once the applicable decrees have been implemented.

GENERIC SUBSTITUTION AND PHARMACEUTICAL REIMBURSEMENT POLICY: LAW REFORMING THE FRENCH HEALTH INSURANCE SYSTEM

In light of the increasing deficit of the French Health Insurance System (E9.7 billion for 2002 and E11.6 billion for 2003) and in order to curb escalating costs and reduce the cost of supplying medicinal products, the French Government has decided to carry out a wide-ranging reform of the French Health Insurance System and to change existing provisions governing generics and the pharmaceutical reimbursement policy.

Further to the new law n° 2004-810 reforming the current system which was adopted on 13 August 2004, at the beginning of September of this year, the French Health Minister also announced that the main focus of French legislation would now be to expand the market for generics.

Generics substitution policy

(a) Extension of the definition of generic medicinal products

The law, adopted on 13 August 2004, implements Directive 2004/27/CE dated 31 March 2004 which modifies Article 10 of Directive 2001/83/CE regarding the new extended definition of generic medicinal products. It should be recalled that the term "generic medicinal product" refers to a medicinal product which has the same qualitative and quantitative composition as regards active substances and the same pharmaceutical form as the reference medicinal product. Article L. 5121-1 of the French Health Code now provides that the various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance unless their properties differ significantly in terms of safety and/or efficacy. The implementation of the new definition aims to limit in particular the laboratories' practices of commercialising chemical derivatives from their active existing substances in order to keep their market shares for off-patents products.

(b) Promotion of the use of generics

Through the following measures, the French Health Minister has decided to significantly promote the use of generic products with the aim of achieving a use rate of nearly 30% by 2007, thus saving over one billion euros per year until 2007:

  1. A progressive reduction from 15 to 10 years being the time period for a drug to become a generic.
  2. A decree amending data protection for off-patent products is still being examined but should be adopted soon. This decree aims at implementing Directive 2004/27/CE of 31 March 2004 on medicinal products and therefore extending the protection not only to the products themselves, but to all of their various forms and dosages.

  3. A 10% reduction in the price of existing generics.
  4. Lower prices for newly-launched generics, that is, between 40% and 50% less than the brand-name drug as opposed to 28% at the moment.
  5. Extension of the application range for the reference price groups (the TFRs - "Tarifs forfaitaires de responsabilité") which permits off-patent products to be reimbursed at the price of generics. In the event that the generics substitution rates does not reach 60% in the first year and between 70% and 80% after two years, the TFR will be applied to the corresponding off-patent products.

Medicinal products reimbursement policy

The French Health Minister wants to save more than 2.5 billion euros per year until 2007 through the pharmaceutical reimbursement policy which is to be set up.

The new law has incorporated a new Health Authority, the "Haute Autorité en santé", which is entitled to evaluate and revaluate the level of reimbursement of medicinal products depending on their therapeutic efficiency (the "SMR" - "Service Médical rendu"). The Health French Minister will base his decision to reimburse or de-reimburse such medicinal products on the opinion of the new Health Authority.

Only pharmaceutical products with accurate packaging as defined in the applicable decree to be adopted will be registered on the list of medicinal products to be reimbursed.

A few other measures concerning the pharmaceutical industry include:

  1. Increase in the tax promotion on drugs and medical devices.
  2. Increase to 0.6% in the contribution rate for pharmaceutical companies which commercialise reimbursed medicinal products.

BIOETHICS LAW

A new bioethics law n° 2004-800 was adopted on 6 August 2004 and has revised the preceding bioethics laws which were promulgated on 29 July 1994. This law has brought about numerous amendments, the main changes in the following areas:

Therapeutics cloning

Further to the general prohibition on reproductive cloning, the new law also prohibits the cloning of human embryos for therapeutic purposes. This criminal offence will be punished by a 100,000 euros fine and a seven year prison sentence.

Research on embryos

The law is reiterated in the French Health Code as regards (1) the prohibition on conceiving embryos by cloning, and (2) the prohibition on carrying out research on embryos. However, subject to the following conditions, a couple may authorise the carrying out of research on supernumerary frozen embryos during a period of five years:

  1. the research must not damage the embryo;
  2. the embryo must be supernumerary and no longer part of a parental project;
  3. if such research is likely to result in significant therapeutics benefits;
  4. if such research cannot be carried out with equivalent efficiency by using an alternative procedure; and
  5. if such research has been authorised by the competent Authority, the "Agence de biomédicine", which is established by the new law.

Such practices are also to be subject to an applicable decree which should be implemented shortly.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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