Legal Basis

Not only the politics of funding but also the legal basis regarding biotechnological research has changed in the past few years. In 2003, in keeping with this trend, the French government initiated a new law for donations, which facilitates the promotion of scientific projects by private backers and reduces bureaucratic obstacles. Among other developments, a new kind of science-promoting foundation was set up (Fondation de Recherche), which allows up to 60 per cent of donated funds to be written off against tax. Furthermore, a budget of 150 million euro has been made available (in the context of the Fonds des priorités de recherche) in order to promote the establishment of such foundations: For every million euros privately donated, the state will add another million euros. In this way, since the new budget became applicable, a total of ten foundations have been set up, five of which are dedicated to the field of health. A further three foundations support cancer research, and are still in the establishment phase. The Ministry rates this small wave of new foundations as a success, there being only four scientifically oriented foundations before the initiative, and when compared with Germany, the USA or England, the previous state of affairs in France was poor.

New genetic engineering law being debated

Furthermore, there is a new genetic engineering law beeing debates which intends to implement the European guidelines 98/81/CE and 2001/18/CE regarding the use of genetically modified organisms (GMOs). The Secretary of Research Francois Goulard put forward an initial draft of the new law to the government cabinet in February. For the first time, the draft would see the oversight of GMO use by a competent authority and the construction of a national register for the production of genetically altered plants forwards (see www.ogm.gouv.fr). The government sees this a first step towards legally sound regulation. Under the new laws, it is intended to couple the authorization of the use of GMOs to a previous public discussion that has taken place on the website, in order be seen to be as transparent as possible over the increasing use of GMOs.

Liability fund concept disputed

In the draft it is also planned to introduce new measures for the labeling, market-implementation and use of GMOs. Apart from classifying GMO products according to European standards - starting from a GMO proportion of 0,9 % - the licensing of GMO products will also be limited to a maximum of ten years, and accompanying monitoring has also been suggested. On top of this, a liability fund has been set up to operate for the first five years. The bill states that farmers who cultivate genetically modified plants must pay a maximum of 100 euros per hectare as tax into the funds. Not unexpectedly, ,farmers’ representatives are fiercely disputing this point.

Advice on evaluating biotech safety

Aside from these measures, the bill also plans the creation of a Biotech Council (Conseil de biotechnologies). This will bring together the current advisory committees ‘Commission du génie génétiques’ (CGG), the ‘Commission d’étude de la dissémination des produits issus du génie biomoléculaire (CGB) and the ‘Comité de biovigilance’ under one roof as a single entity. Alongside from the evaluating the safety-aspects of GMO-use on health and the environment, the advisory body also has the task of estimating the economic and social consequences of each employment of a GMO product.

To date, a deeply felt and passionate debate has been defining the scenery in France, which has held back most farmers from cultivating GM crops. As far back as 1997, the farmers’ trade union Conféderation Paysanne (CP) began their fight against the first planting and harvesting of GM oilseed rape on land owned by the Monsanto company. What’s more, France belonged to those European countries that took part in the GMO moratorium, which lasted until 2004, and import prohibitions still exist against certain GVO products. In the autumn of 2005, seven court judgments helped to turn public opinion against the self-named ‘field-liberators’. However, the judgments were lenient: The ‘field-liberators’ were awarded the right to protect the environment from likely uncontrolled cross-pollination.

Meanwhile, seed manufacturers and scientists are striving for an implementation of the European Union guidelines. In the summer of 2005, and in a first of its kind, seed manufacturers voluntarily published figures relating to the exact number of hectares of commercially certified GM corn they were cultivating, which should force the creation of a legal basis. Like Germany, at the beginning of 2006 the French also received a reminder from Brussels that the EU guidelines have yet to be adopted into French law. The French farmer's association, FNSEA, will therefore welcome the current bill. Until now the law was adopted by the Senat and debated in a first plenary session at the parliament where it has now beeing relegated to a special committee for further discussions.

Stem cell research on condition

In 2004 the French government adopted a law relating to bio ethics that would have forbidden working with human embryonic stem cells (heS cells). Nevertheless, some researchers were permitted to work with stem cells if they submitted to specific conditions. A total of 40 authorizations were given in 2004 and 2005. In February 2006 the government adopted obligatory guidelines, which regulates research using hES cells. The basic terms are as follows: “Research on embryos and embryonic stem cells may be authorised if such research is likely to facilitate major progress in treatment and could not be carried out by an alternative approach of comparable efficacy, in the current state of scientific knowledge."

Further regulations relate to the origins of the cells. For instance, French researchers are permitted to revert to surplus heS cells if they were manufactured for an artificial fertilization in vitro in France and if the respective ‘parents’ agree. Furthermore, importing heS cells that are manufactured under the same conditions as demanded in France is permitted. The official regulation of stem cell projects is being taken over by the Agence de la Biomédicine. After a period of five years, stem cell research will be assessed afresh, and any completed approved research will be evaluated and new legislation possibly initiated.