Legal Requirements

​

 

Discarded human tissue collection and its use has to meet specific legal requirements.

 

 

Alphenyx complies with the Council of Europe regulations for Protection of Human Rights and Dignity of the Human Being with regards to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

In France, Biomedical Research involving Human Being is regulated by the French Public Health Code, and in particular Article L. 1241-1 and following, the provisions of law No. 2004-800 of August 6, 2004, Decree 2007-1220 of 10 August on the collection, preparation, storage and disposal of elements of the human body.

 

 

Alphenyx possesses the required accreditations for the collection, transformation, storage, use and/or cession of human-origin tissues and body fluids for research use only:

 

• Issued from the French Ministrey of High Education, Research an Innovation (MHERI)

 

•  with the approval of the Committee of Person Protection (French National Ethic Committee).

 

As requested by law, the user itself must comply with local laws, regulatory requirements and other obligations related to the handling and use for research of Human Biological Samples within their facilities.

 

​

Our authorizations comprise:

 

- DC-2014-2147 : an authorization to use Human Biological Samples in our premises for our own research projects and our clients/academic partners projects.

 

- AC-2014-2141, first renewal AC-2019-3567 and its last renewal N° AC-2024-6570, valid for 5 years: an authorization to provide derivative models from Human Biological Samples to our users for Research Use Only.

 

- IE-2014-749, first renewal IE-2019-1077 and its last renewal IE-2024-4099, valid for 5 years: an authorization to export derivative models from Human Biological Samples to our users for Research Use Only. Each new user located outside France has to be declared by Alphenyx to MHERI.

 

Alphenyx complies with all the requirements of the General Data Protection Regulation (GDPR) and the French Data Protection Act (Loi Informatique et Libertés) applicable to the collection and processing of personal and health data (clinical and biological) of voluntary donors.

 

The informed consent form provided to each voluntary donor contains all the information related to the protection of their personal and health data (clinical and biological) as well as their rights concerning privacy and medical confidentiality.

​

Furthermore, Alphenyx has appointed a Data Protection Officer (DPO) registered with the CNIL, whose contact details are provided to each voluntary donor.