ReinhartMarvilleTorre

Health & Biotechnology

The Health & Biotechnology team supports a number of players in the health sector: international laboratories, healthcare establishments, biotechnology SMI/SMEs, etc.

It assists these players in their Corporate transactions (acquisition, restructuring, creation) and in all their contractual obligations and relations and represents them in disputes relating to their activities.

Since 2007, it has also participated in major debates on the development of biomedicine.

Health products

Personal data protection

  • Strategy of “compliance” for the processing of companies’ personal data
  • Management of personal data processing operations in the information technologies and e-commerce sectors
  • Design and implementation of a regulatory strategy for processing personal data (particularly sensitive data)

Cosmetics, dietary supplements, medical devices

  • Product qualification
  • Clinical trials: contractual relations with investigators, clinical trial contracts and good practices, informed consent
  • Relations with supervisory authorities (French Health Products Safety Agency (AFSSAPS), French Food Safety Agency (AFSSA), General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRG) and LNE-GMed)
  • Labelling, CE marking, presentation, advertising
  • Commercial litigation, liability litigation, criminal litigation (illegal practice of pharmacy, misleading commercial practices and falsification)
  • EU litigation (monopoly of pharmacists and free movement of goods)
  • Lobbying in the context of transposition of EU legislation into domestic law

Human reproductive materials

  • Regulations governing collection, storage, preparation and use
  • Negotiation of private and public-private partnerships (pharmaceutical laboratories, hospitals and institutions)
  • Lobbying the legislator
  • Relations with supervisory authorities (French Health Products Safety Agency (AFSSAPS), French Biomedicine Agency (Agence de la Biomédecine) and French National Blood Service (EFS))

Drugs

  • Procurement, disposal and acquisition of marketing authorisations
  • Advertising aimed at the public and healthcare professionals
  • Manufacturing activity (raw materials, pharmaceutical establishments, head/acting pharmacist, shaping)
  • Wholesale and retail distribution

Healthcare professionals

  • Relationships of healthcare professionals with healthcare establishments
  • Good practice of healthcare professionals
  • Medical liability litigation

Corporate/Licence

  • Mergers and Acquisitions
  • Joint Venture
  • Creation of specific structures: foundations and organ banks