News

The European Regulation (EC) N°1924/2006 of 20 December 2006 on Nutrition and Health Claims made on Foods is applicable since last 1st July 2007.

Its provisions aim to regulate the use of nutrition and health claims on foods included in commercial communications.

The public targeted by these communications is extremely wide, as far as the Regulation protects the final consumer.

For a better understanding, the European legislator proposes new clear definitions for important concepts, as "claim", "nutrition claim", "health claim" and "reduction of disease risk claim".

A legal treatment very close to the one applying to misleading advertising and publicity is provided for concerning all these "claims". It's not in vain that the new Regulation completes the general Directive 2001/13/EC relating to labelling and prohibiting the use of  information that may mislead the consumer.

It's up, from now on, to the producers, to take any appropriate measures in order to be able to prove, if requested, that the "claims"  they include in their communications are scientifically funded.

Human blood samples can be taken in order to constitute a human biological material collection ("Collection d'Echantillons Biologiques Humains", or "CEBH", in French), for research use.

In France, any human blood sample taken for such purposes must be done in conformity with the provisions of Article L1221-8-1 of the French Public Health Code ("Code de la Santé Publique" or "CSP").

According to this provision, such human blood samples shall:

- solely entail a negligible risk;
- be taken, exclusively, by a physician or under his/her responsibility;
- imply the previous donor's consent, duly informed about the destination of his/her blood samples;
- not have financial counterparts.

It appears important to note that the person responsible for the taking of blood samples shall abide by the legal provisions related to the compulsory insurance of donors provided for by the French Huriet-Sérusclat law (Article L1221-10 of the French CSP).

Also, those wishing to constitute a « CEBH » shall take into consideration provisions of Article L. 1243-3 of the French CSP, recently clarified by a Decree N° 2007-1220 of 10th August 2007, as well as by an Order of 16th August 2007, instituting a standard file for administrative declarations for conservation and preparation of human body's samples for scientific use.

From the 27th of August 2006 (order n°2006-477 of the 26th of April 2006), new laws and regulations with regards to the insurance have to be applied.

The main modifications are the following :

-  Modification of the application field of the law
-  Standardisation of the responsibility system (abolition of the notion of the direct individual benefit
-  Increase of the minimum guarantee amount that the insurer must give
-  Modification of the guarantee duration

Biomedic Insure has adapted its insurance polices to be in conformity with this news rules

For more information, don't hesitate to contact us.

The transposition of the "Directive 2001/20/CE from the European Parliament House and of the Council from 4st April 2001 concerning the approximation of the legislative, statutory and administrative provisions of the Member States relating to the implementation of the good clinical practices concerning clinical trials on drugs for human use" was planned to be in force before the 1st May 2004.

From now on, this Directive requires an insurance obligation, each Member State being free to precise or not the insurance conditions. At today's date, several Member States have transposed this Directive, with the publication or not of the implementation decree relating to the insurance. Each Member State shall still extend the plan to all the clinical trials, if it requires so.

Biomedic Insure has analysed the Directive consequences for each Member State, and will be in position to provide specific insurance policies for all these countries with local compulsory insurance

 In France, this directive was transposed in the context of the new law n°2007-808 of the 9th of August 2004 concerning the Politic of the public health

The "Directive 2001/20/CE from the European Parliament House and of the Council from 4st April 2001 concerning the approximation of the legislative, statutory and administrative provisions of the Member States relating to the implementation of the good clinical practices concerning clinical trials on drugs for human use" requires one legal representative located in one of the Member States, for extra community sponsors.

In order to help those sponsors, Biomedic Insure has entered into a partnership with the company Medpass International :

"Biomedic Insure has a longstanding relationship with MedPass International, a company offering Authorized/Legal Representative services to sponsors of EU clinical trials located outside the European Economic Area (www.medpass-ar.com). If you are in need of such services, please don't hesitate to contact us on +33 2 97 69 19 19 for further information".

Sarah Sorrel,
CEO of Medpass International