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Europe Daily Bulletin No. 10281
Contents Publication in full By article 25 / 35
GENERAL NEWS / (eu) eu/court of justice

Biomedical analysis laboratories have role in protecting public health and must remain independent

Brussels, 20/12/2010 (Agence Europe) - The Court of Justice of the EU has partly rejected a case brought by the European Commission against the French state in Case C-89/09, which was judged on 16 December. It recognised the legitimacy - for reasons of quality of services and protection of public health - of the French legislation, which limits to 25% the maximum stake which can be held by non-biologists in the capital of companies operating biomedical analysis laboratories (Selarl), as long as this limit is applied with no discrimination on the basis of nationality.

However, ruling in favour of the Commission on this point, the Court ruled that France had failed to respect its obligations on the freedom of establishment (Article 43 of the Treaty) by keeping in place until 2007 its ban on biologists from holding stakes in more than two companies created for the purposes of the joint operation of one or more biomedical laboratories.

As regards the first part of the judgement, the Court concluded that its previous case law (Cases C-531/06 and C-171/09), which justifies the fact that only pharmacists may own and operate pharmacies in Italy and Germany, is also relevant to the biomedical analysis laboratory sector, due to the similarities between the two sectors: “Just as a pharmacist dispensing the wrong medicines to a client could have serious consequences, a biomedical analysis service carried out inappropriately, late or wrongly, could lead to errors in diagnostics or treatment”. The Court is thereby legitimising the specific medical role conferred in France on biologists when taking samples and validating analyses.

Pharmacies and biomedical analysis laboratories also present similarities in terms of controlling health costs: in the same way as over-consumption or the incorrect use of medicines, the incorrect or inappropriate execution of biomedical analyses can generate unnecessary costs for social security systems and, therefore, for the state. This means that the state is justified in limiting to 25% the stake which can be owned by non-biologists in the capital of laboratories, in order to avoid certain risks: - for the quality of medical services, as non-biologists do not present the same professional guarantees as biologists in terms of qualifications and experience; - achieving the professional independence of biologists, who would otherwise not be able to oppose the instructions of non-biologists controlling the laboratory; - conflicts of interests, as non-biologists could be tempted to prioritise profitability over the quality of examinations or patient assistance. Limiting the stake they can hold is therefore justified and in proportion to the objectives pursued.

As regards the second part of the judgment, the ban on biologists from owning stakes in more than two Selarl, the Court concluded that the French provisions, which were in force on the date of the reasoned opinion of the Commission (February 2007), but which have since been modified, constitute a restriction to the freedom of establishment.

This half-tone ruling, which was welcomed by the French union biologists, who have seen their speciality recognised, will certainly put a brake on the stranglehold of purely financial investors in this essential and lucrative health sector, but will not prevent the tendency towards the grouping of laboratories on the French market, by recognising the right of biologists to own stakes in more than two Selarl. (F.G./transl.fl)

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