Bioethics legislation

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

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Abstract

A bill, voted by the National Assembly (December 03) defines a limiting body of regulation, mainly directed at restricting research on embryonic stem cells and re-negotiating European rules regarding patents on genes, to strictly forbid any kind of patent. It is highly normative and seen as a protection of society mores and ?the human being? against so-called ?uncontrolled scientific breakthroughs? on one hand, and the ?private market? on the other hand.

Purpose of health policy or idea

The legislative framework is aimed at elaborating a specific definition of what is forbidden and what is allowed regarding organ donation, medically assisted reproduction, research on stem cells and patents on genes.

Even if some aspects of the framework are a mere technical revision of the extant body (dating back 1994), aimed at adapting the Law to day-to-day practice (mainly regarding organ donation and medically assisted procreation), the tone is mainly coercive: enactment of ethical principles, definition of new categories of crimes (a 'crime against the human species' is created) and heavy penal sanctions, and a three-fold iron-curtain around the progress of bio-sciences: after a list of what is forbidden (negative approach), a (narrow) list of what is allowed is enacted (positive approach inside the negative one), and a list of controlling bodies and their (rather unlimited) power is elaborated.

Expected outcomes are:

• an increase in the number of organ donations, mainly through post-mortem donation (restriction and control on donation by living individuals, to avoid profit-oriented behaviours);
• to restrict access to Medically Assisted Procreation to married couples or unmarried ones with evidence of 2-years of marital life
• a ban on post-mortem (in case the father dies) transfers of embryo
• a re-negotiation of Directive 98/44/CE of the European Union,  regarding patents on genes, towards no patenting of any human or animal gene;
• a quasi-ban on research on embryonic (stem or germ) cells;
• a strict ban on the production of stem cells (a penal sanction of 7 years against scientists convicted of transferring a nucleus to conduct experiment on therapeutic cloning is implemented).

Rather than incentives, it is based on sanctions and incrimination. It is directed toward biologists, physicians, and individuals (patients in need of organs and potential donors) and, to a lesser extent, insurance companies and employers (if using or trying to use genetic information on insured or employee). The only incentive is directed toward research on stem cells in the adult body (the Government wishes France to become a leader on this field).

Main points

Main objectives

Normative set of rules to protect  society against the unfettered development of biotechnologies.

Type of incentives

Bans rather than incentives, except for research on stem cells in adult bodies.

Groups affected

Scientists (biology and genetics), Pharmaceutical R&D, Patients in need of grafts, organ donors and their families, individuals seeking for medically assisted procreation

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

Being normative, this bill relies heavily on local norms believed to be universal and not to be discussed. It is also traditional in that policy-makers didn't organize a general and publicized debate based on contradictory pieces of evidence and public hearings, but, as is the tradition of the French administration, through reports and general advices from "qualified individuals". During the discussion, only a scarce (and rather spurious) body of evidence was used, and the arguments relied mainly on philosophical postulates on what ought to be. The lack of any evaluation is also characteristic of the traditional approach.

Political and economic background

The Bill enacted in 1994 mandated a revision in1999. Moreover, EU directive 98/44/CE regarding patenting of human genes has to be implemented into French Law.

The centre-left Government of Lionel Jospin started the revision process with delay; a first Bill was voted by the National Assembly in January 2002, ready to be examined and discussed by the Senate (where the majority was then centre-right). After an 11-months discussion, the Senate sent back a dramatically altered text to the new-elected (May 2002) centre-right.

National Assembly. The text voted in January 2002 was rather open to new bio-technologies and their use, as well as to research on embryonic stem cells. The revised version, discussed and voted December 2003 is much more coercive and limitative.

The motto leading the policy is a reaction, for the sake of human dignity (supposed to derived from the unpredictability of any given human being), against both the supply of new bio-technologies aimed at reproducing or altering human cells and organs and the role of private markets in organ donations, reproduction, research on genes and stem cells.

Change of government

The first bill on bioethics (voted in 1994) mandated a revision process after 5 years. The process started in 2002 (text voted by National Assembly), was delayed by the change of Government (from centre-left to centre-right) in April 2002, and then dramat

Complies with

EU regulations

The revision process was also prompted by the enactment of a European directive on genes patenting in 1998, authorizing patenting under strict conditions; while all French parties want a strict ban of any kind of patenting of genes

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

2002-2003: From consensus to conflict

2002 was characterized by a consensus (the project, proposed by the centre-left government, was voted by almost all parties) on two main points: France had to oppose (even through confrontation with the EU) any form of the patenting of genes, but scientific research on embryonic stem cells should be encouraged, even if controlled. All parties agreed on the need to write ethic statements in the forefront, then deriving rules from the principles.

2003 is characterized, in contrast, by a strong conflict: the centre-right changed position about embryonic stem cells, stating that, on this matter too, ethics principles should come first, and "realism" second. Therefore, they adopted a ban on research on embryonic cells, allowing for transitory projects on cells made available by medically assisted procreation and providing an agreement by the administration, the national advisory council on ethics, as well as to-be-implemented national agency for biomedicine. They also insisted on a specific niche for French research in biomedicine, namely on stem cells in adult bodies.

The discussion showed an opposition between the centre-left on one hand (prone to allowing more freedom for scientific research, for realism's sake) and all the other parties (centre-right, but also communists and green party, the far-right and far-left being not represented in the Parliament, due to the electoral rules) adopting the "conservative" and normative stance.

Distrust of science

The main ideology behind the idea of this bill is that of distrust of scientific research: science is seen as lacking conscience and normative capacity, therefore a clear statement on norms is required. Since France is a "lay country", this statement cannot come from elsewhere than the Parliament. It is the role of representatives to tell scientists what to do and not do. It is also the role of politics to oppose "the way things are" or tend to be, in the sake of "the way they ought to be".

The media did not take part in the debate; some MPs even complained the debate was held in total lack of interest from the general public.

• The reproductive human cloning claimed by the "Rael" sect was high on the media agenda, and used extensively by pro-ban to raise fear about the a-ethical behaviour of scientists.
• Therapeutic cloning has sometimes been coined "drug-babies", and ethical controversy was raised about the fact that an individual could not be wished for his/her own sake, but as a container of genes and organs akin to those of another human being.
• Eugenics was also sometimes referred to: pre-natal diagnostic is said to promote a bottom-up eugenics according to which the aggregation of individual micro-decisions would lead to the elimination of not-as-good-as-wished babies through abortion; this was used in the political debate to stress a limitation on the scope of examination a pregnant woman is allowed to ask on the embryo.

Philosophers and editorialists supported the pro-ethics stance of the Government, and focussed attention on the ban on patenting of genes, following President Chirac's speech before Unesco General Assembly in October 2003 (the main idea being that France stands alone against the US, as on the Iraqi war case). In fact, most of the debate focussed on the private market issue, discussions about stem cells and therapeutic cloning being considered too technical for the general public.

Scientists voiced a threat on French public research and a brain-drain process that would result, among biologists, from a strict ban on research on embryonic stem cells (including the 7-year penalty); however, this was blurred by a more general outcry from the world of scientific research against a downsizing of public budget devoted to this sector of activity.

Pharmaceutical industry (LEEM) didn't step in the debate (nothing is to be found on its website regarding the bill under discussion) and physicians were mainly concerned by a minor point, namely their obligation to disclose information on genetic disease to the patient him/herself or to the (potentially harmed) relatives of the patient.

Stakeholder positions

The main conflict opposes the centre-left (Parti Socialiste) and the scientific community on one hand, versus centre-right, communists and green party allied with ethicists on the other hand. The topic under debate regards therapeutic cloning, on which the general public is not well informed. Other topics, such as gene patenting or organ donations are mostly (and softly) discussed on the "threat of private market in health" concern: is the Government tough enough against private interests and in its defence of public goods and good will?

Members of the scientific elite (National Academy of Sciences or National Academy of Medicine) did not solemnly protest against the heavy sanctions that might threaten academic researchers (7-year sentence for producing stem cells and the 30-year sentence for reproductive cloning). The brain-drain debate rapidly became broader, regarding all realms of scientific research under strong budget pressure.

Influences in policy making and legislation

The bill was voted by the National Assembly as written and modified by the Senate. It will now be discussed again by the Senate before being definitively adopted. As mentioned earlier, the main modification occurred between January 2002 (when the bill was voted by the National Assembly) and January 2003, when it was modified by the Senate, in a more conservative sense. The discussion at the National Assembly in December 2003 did not change the overall content of the bill.

Legislative outcome

success

Adoption and implementation

The processes and chances of implementation vary widely according to the type of regulation involved:

• Regulation on organ donations relies on the availability of a not yet available electronic device allowing all individual to state his/her disagreement on organ withdrawal after death (no statement meaning agreement). Before this device is available, physicians are required to inform their patient on the need to clearly state their opposition to organ withdrawal.
• Regulation on MAP is straightforward.
• Regulation on patenting will require the re-opening of negotiations on the EU directive. The Government opted for the implementation of the directive into French Law to open this re-negotiation process. NGOs and scientists in public institutions are reluctant, fearing the implementation will not be followed by any re-negotiation, and opening the human genome to the private market.
• Regulation on cloning will rely on a newly created Agency (National Agency for Biomedicine), aimed (among other things) at controlling researchers and research projects. How this Agency, as well as the Administration and the Advisory Committees will behave and interact with scientists and patients associations on one hand, and the general public and ethicists on the other hand will be a key point in the chances of implementation and perverse effect of the bill.

Monitoring and evaluation

Since the Bill is seen as normative and principle-based, no re-evaluation is seen as needed (as explicitly stated by the Government during the discussion: norms don't change due to technical progress). Evaluation is seen as valueless since what occurs in the real world is of no importance compared with what ought to be in the world of norms, principles and ideal.

However, a reviewing mechanism will take place in 2009, regarding the research projects on embryonic stem cells: since the authorization is seen as transitory and subject to evidence of efficacy (relative to research on stem cells in adult body), the re-evaluation process will decide on whether projects running in 2009 should continue, as well as whether new projects might be authorized.

Expected outcome

Among the 4 subjects touched by the bill, only organ donations is seen as consequentialist (rather than procedural). The expected final outcome is an increase in the proportion of patients in need of a graft who obtain it; the indirect outcome is an increase in the volume of donated organs. As mentionned earlier, this indirect outcome will obtain only if a widespread specific device allows hospitals and sanitary authorities to consider any lack of explicit denial of organ donation as an implicit agreement (currently, without clear statement, the relatives decide whether organ might be withdrawn from the corpse).

Necessary as this condition is, it is not sufficient: the number of available grafts will also vary according to preferences in the general public. Last, some experts point that, would the volume of donations increase dramatically, hospitals might not be technically ready to manage this increased flow and to provide adequate grafts to patients. The main issue might be that of hospital organization to transform ogans into grafts rather than that of volumes supplied (on this issue, see IGAS and IGER).

The ban on theraeutic cloning will necessarily achieve its indirect objective (the objective being the ban). The main goal of encouraging a niche for French research seems preposterous, however, since scientific evidence shows that cells in the adult body cannot produce any kind of human cell, as can embryonic stem cells (Gros, 2000). Therefore, the ban will succeed, at the expense of French research in biology. An interesting indicator would be the level of brain-drain and patents emanating from French researchers specific o biology (compared with other realms, and with the past trend, through differences in differences).

Last, the explicit outcome regarding genes patenting, namely the re-negotiation of an EU directive is a matter largely out of the scope of the French Government. As of now, 7 countries out of 15 already comply to the regulation, and the EU itself is committed to international regulation (WTO on intellectual property rights): even if in Europe as a whole patenting of genes was banned, other countries would still be allowed to grant monopolies to firms or researchers having described parts of the human genes. European firms or researchers would simply play on an unlevelled field against other firms.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

The main impact will be on the scientific community.

References

Sources of Information

 Sénat (Senate), www.senat.fr/doslegman/pjl01-189_travaux.html, parliamentary reports, commission reports and discussed texts, plus a synthesis of the parliamentary history of the bills on bioethics since 1994.

National Assembly, www.assemblee-nat.fr/12/cri/2003-2004/ : the complete verbatim of discussions on the bill, December 2003.

Parliamentary Office for Technology and Science Assessment (OPECST): www.assemblee-nat.fr/rap-oecst/bioethique/r1407-01.asp#_Toc443973735.

"Rapport sur l'application de la loi 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 », by Alain Claeys et Claude Huriet, Office Parlementaire d'Evaluation des Choix Scientifiques et Techniques, 1999.

General Inspection of Social Affairs (IGAS) and General Inspection of Education and Research (IGER), www.ladocumentationfrancaise.fr/brp/notices/024000374.shtml, « Conservation d'éléments du corps humain en milieu hospitalier », by Françoise LALANDE, Valérie DELAHAYE-GUILLOCHEAU, Marc OLLIVIER, Elisabeth DUFOURCQ Paris; Inspection générale des affaires sociales; 2002; 88 pages; 30cm.

Report to the Ministry of Research, www.ladocumentationfrancaise.fr/brp/notices/014000287.shtml,  « Les cellules souches adultes et leurs potentialités d'utilisation en recherche et en thérapeutique : comparaison avec les cellules souches embryonnaires », Working Party chaired by François Gros, November 2000.

President of the Republic, speech delivered at UNESCO General Assembly, October 2003, www.elysee.fr/magazine/actualite/sommaire.php?doc=/documents/discours/2003/D031014.html.

National Advisory Council on Ethics, website (advices and reports) www.ccne-ethique.fr/francais/start.htm.

Author/s and/or contributors to this survey

Michel Grignon (CREDES)

Empfohlene Zitierweise für diesen Online-Artikel:

Michel Grignon (CREDES). "Bioethics legislation". Health Policy Monitor, May 2005. Available at http://www.hpm.org/survey/fr/a3/1