France

France Information Region Europe Population 64,473,140 GDP (millions USD) 2,560,255 National Policies Eggs for assisted reproduction commercial allowed Eggs for research commercial prohibited Inheritable genetic modification PROHIBITED Preimplantation genetic diagnosis social uses prohibited Reproductive cloning PROHIBITED Research cloning PROHIBITED Sex selection "social uses prohibited" is not in the list of possible values (?, PROHIBITED, regulated, Social uses prohibited, no policy) for this property. Surrogacy PROHIBITED International Agreements 1997 COE Biomedicine Convention signed 1998 COE Cloning Convention signed 2005 UN Cloning Vote no 2005 UNESCO Sports Doping Convention RATIFIED 2007 Treaty of Lisbon RATIFIED

Key laws and policies

• Bioethics Law No. 2004-800 (LOI n° 2004-800 du 6 août 2004 relative à la bioéthique) (August 6, 2004), found in:
  • Penal code, Book II - Felonies and Misdemeanors against Persons, Title I - Crimes against Humanity and Against Persons, Subtitle II - Crimes against Persons
  • Penal code, Book V - Other Felonies and Misdemeanors, Title I - Offences against Public Health, Chapter I - Offences against Biomedical Ethics
  • Intellectual Property Code, Book VI - Protection of Inventions and Technical Knowledge, Title I - Invention Patents, Chapter I - Field of Application, Section III - Patentable Inventions
• Of the Object and Matter of Contracts, Article 1128 of the Civil Code

• Law on the Donation and Use of Elements and Products of the Human Body, Medically Assisted Procreation, and Prenatal Diagnosis, No. 94-654 (LOI no 94-654 du 29 juillet 1994 relative au don et à l'utilisation des éléments et produits du corps humain, à l'assistance médicale à la procréation et au diagnostic prénatal) (July 29, 1994)

Foundational values

France's Bioethics Law of 2004 articulates three foundational values:

• Respect for the dignity of the human embryo
• Respect for all stages of life
• Human rights

Prohibited practices

The Bioethics Law of 2004 prohibits:

• Reproductive cloning, which is deemed a crime against the human race; violators may receive jail sentences of up to 30 years and fines of 7.5 million Euros (about $11m)
• Research cloning, which is punishable with up to 7 years in prison and fines
• Creation of human embryos for research purposes
• Inheritable genetic modification
• "The invasion into the integrity of the human species, eugenic behaviors intended to organize selection of human beings, and conversion of genetic characteristics leading to any change in descendants of humans."
• Sex selection, except for medical reasons

Surrogacy is implicitly prohibited by multiple statutes, including Article 1128 of the Civil Code, and explicitly by court rulings.

Permitted and regulated practices

The Bioethics Law of 2004 gives the French Biomedicine Agency (Agence de la biomédecine) regulatory responsibility for technologies and activities regarding:

• Reproductive cells
  • Assisted reproductive technologies
    • artificial insemination
    • in vitro fertilization
    • all other non-natural procreation techniques, including gamete donation. Providing eggs for assisted reproduction - including with payments - is permitted.
  • Storage of human gametes
• In vitro embryos
  • Pre-implantation genetic diagnosis
  • Storage and donation of human embryos
  • Research on embryos and human embryonic stem cells
• In vivo embryos and fetuses
  • Prenatal diagnosis
    • chromosome genetic diagnosis (study of the shape and number of chromosomes)
    • molecular genetic diagnosis (research on the DNA structure)
    • biochemical, infectiological and immunological diagnosis using samples from a foetus, its related tissues or the mother
• Birth or abortion
  • Cells procured from the blood in the umbilical cord
  • Procurement of tissues and cells from an aborted foetus for transplants or research
• Living persons
  • Genetic diagnosis on persons with symptoms (cystic fibrosis, Duchennes muscular dystrophy, haemophilia, etc.) or without symptoms (late appearing diseases such as Huntington’s Disease)
  • Genetic diagnosis based on predisposition factors (breast cancer) or the study of risks in families
  • Procurement of organs, tissues and cells
  • Organ, tissue and cell transplants
• Deceased persons
  • Procurement of organs, tissues and cells
  • Storage of tissues and cells

Regulatory activities

The French Biomedicine Agency conducts these activities regarding assisted reproductive technologies and diagnosis:

• Authorizes multidisciplinary centers for prenatal diagnosis
• Authorizes pre-implantation genetic diagnosis centers and approve practitioners
• Approves biologists to carry out prenatal diagnosis
• Approves practitioners for clinical and biological activities in assisted reproductive technologies
• Delivers official opinions on authorizations granted to centres for assisted reproductive technologies
• Sets up a monitoring scheme for clinical and biological activities associated with assisted reproductive technologies
• Evaluates activities in assisted reproductive technologies, prenatal and genetic diagnosis
• Sets up a health monitoring service for women undergoing assisted reproductive technologies, children conceived by this method, and oocyte donors
• Provides information about gamete donation
• Authorizes imports and exports of gametes or embryos

The French Biomedicine Agency conducts these activities regarding embryos and embryonic stem cell research:

• Authorizes researchers who can work on supernumerary embryos from in vitro fertilization that are no longer required by parents, under strict supervision by the Agency.
• Delivers authorizations for importing, storing and disposing of embryo tissues and cells required for research purposes. If the conditions of authorization are not respected, the agency can suspend or withdraw a permit.
• Guarantees the identification and traceability of human embryos used for research, and of embryonic stem cell lines created from these embryos or imported from abroad.
• Controls the authorized activities, with the possibility of carrying out inspections, or of suspending or definitively halting the work.
• After five years’ experience, the agency will evaluate the results and publish a report that will act as the basis for any possible extension of these authorizations.

The Agency also oversees organ procurement and transplants:

• Managing the nationwide list of patients awaiting transplants
• Managing the national register of those who refuse to be donors
• Developing the national database of volunteer donors of haematopoietic stem cells
• Developing rules for distributing donor organs
• Coordinating organ procurement, and their distribution and allocation in France and abroad
• Evaluating procurement and transplantation activities
• Organizing expert committees for authorizing procurement from living donors
• Developing information on donating, procuring and transplanting organs, tissues and cells

Accountability and governance

The French Biomedicine Agency is governed by

• A Director General "nominated by decree" for three-year renewable terms.
• An executive management board of representatives from different ministries and public health bodies, together with "key figures qualified in the agency’s fields of activity."
• A steering committee (le conseil d’orientation)

The steering committee supervises the consistency of the Agency’s medical and scientific policy, and alignment with the regulatory and ethical principles applicable to its activities. It comprises:

• scientific and medical experts
• representatives from associations
• qualified key figures
• members of different institutions (e.g., the French Consultative Committee for Ethics, and the French Consultative Commission for Human Rights)
• as well as Members of Parliament

Numerically, it is comprised of:

• 6 scientists
• 3 human tissue experts
• 6 representatives of patient groups
• 6 social scientists or ethicists.

Members are appointed for 3-year terms. The steering committee examines every research project or study on the embryo or embryonic stem cells and gives its expert opinion before the decision concerning authorization is taken.

External links

• Agence de la biomédecine