10/27/2010

French biologists resist invasion by legions of labs

John Brosky reports

Facing the risk of an invasion by big international operations, French medical laboratories drew inspiration for their defence from a national hero - Asterix. While the newly launched reform of the French laboratory system will bring the traditionally independent medical labs into conformance with international quality standards, the law builds an elaborate defence against foreign operators to protect what the head of the Syndicat des Biologistes (SDB) describes as ‘our tradition of the Village Gaulois’.

The Druid Panoramix would be proud

‘We are a Latin people at heart, and very attached to the idea of medical services delivered on a human scale, not by an industrialised process,’ said Jean Bégué, the sécretaire général of SBD, the association of French lab directors in a European Hospital interview.

According to Jean Bégué, there are more than 4,000 medical biology clinics in France for a population of 64 million, ‘too many if we look at the example of other European countries, such as Germany where 400 labs serve a larger population of over 80 million’.

A case before the European Court of Justice in Luxembourg, challenging France’s first line of defence, a prohibition of ownership of clinical labs by corporations or limited liability groups, is expected to be decided in October, 2010. ‘We have every reason to believe we will prevail,’ he pointed out.

Yet, even if this first line is broken by the court decision, France has constructed a labyrinth of provisions in the reform law Hospitals, Patients, Territories and Health that should pose formidable barriers for non-French companies. Each of the 26 regional health authorities created by the law have powers over decisions regarding how many laboratory services can be set up in their territory and each region can dictate the kinds of services offered.

Jean Bégué

The articles reforming clinical labs also state that a single lab group may not be present in more than three different regions. ‘We are completely in agreement with these articles in the law to avoid the possibility that there are any large-scale companies,’ Jean Bégué stated, on behalf of SDB. ‘We don’t want to see only 400 labs in France. We have traditionally maintained a cottage industry for medical biologists and we do not want to lose the direct contact with patients that this model affords. This is not protectionism,’ he pointed out. ‘It is the preservation of a form of exercising the profession. We prefer even a semi-industrial structure rather than to see factories built, and none of us wants to become a salaried employee of an anonymous corporation.’

As a member of the scientific committee for the upcoming Journées Internationales de Biologie (set for 2-5 November, in Paris) Jean Bégué will be a featured speaker during the European Roundtable., when he will explain: The consequences of the French reform of medical biology on laboratory staff: towards a new profession for Laboratory Technicians.

This is the first revision to the rules governing French clinical biology in 33 years and ‘it is deep reform of the business, one that will not be easy to realise,’ he said, acknowledging that many of the changes ‘are long overdue, though it seems to us the pendulum has now swung too far in the other direction.’

True to another Latin tradition, the new law will take effect gradually, coming into full effect in 2016.

It could well take six years for clinical labs to bring about the required restructuring of operations, personnel qualification, and upgrading processes to meet quality standards.

For many lab directors, who are also independent owners of their clinics, there will be a painful process of consolidation the law is forcing with a strategy to gather the clans inside the walls of the Village Gaulois.

Lab owners are asked to affiliate their operations with colleagues to form larger group with a regional focus. Their existing operations will then become part of a network of neighbourhood access points for clinical services prescribed by doctors.

The group will share a central technical platform for analysis and each medical biologist will be responsible for interpreting results from tests collected at his or her centres.

Rather than go through the consolidation and then the accreditation process, the owner of a lab operation in France, who is approaching retirement age, is looking to sell at this moment, said Jean Bégué. And, he added, other labs that hope, in the Latin tradition, that the severity of the reform will be renegotiated, relaxed or ignored before the 2016 deadline ‘are following a poor strategy’.

Info

Part of a major overhaul of the French healthcare system, in the law ‘Hospitals, Patients, Territory and Health’ passed in 2009, the articles affecting clinical biology labs will affect every aspect of operations:

* Diagnostic testing recognised as a medical act, putting clinical biologists on the same level as radiologists.
* Lab directors are responsible for the entire process from taking samples through transport to analysis and, significantly, the interpretation of results.
* Accreditation to ISO standards required of all public and private labs by 2016.
* Regional health authorities must approve the nature of services offered and establishment of new lab operations.
* Labs may not be owned by corporations or limited liability groups.

10/30/2007