Health – Biotechnologies

 

Our expertise is recognized by the whole profession. De Gaulle Fleurance & Associés is one of the leading law firms in the strategic field of health.

 

We intervene at all stages of a health product’s life (drugs, medical devices, but also raw material for pharmaceutical purposes, in vitro diagnosis devices, biological products and products resulting from biotechnologies, cosmetic products, patient data…) and for all operators both in France and abroad (including pharmaceutical laboratories, manufacturers of medical devices, public or private research institutes, academic players, biotechnological companies, investors, service providers, competitiveness clusters…).

 

We provide assistance to our clients with respect to all issues relating to health law in three key areas.

 

Transactions

Drafting, negotiation and advice with respect to all contracts relating to health products and services:

  • Research: technology transfer agreements, licences, assignments, joint ownership agreements and other intellectual property contracts, collaboration agreements, consortium, services agreements…
  • Development: co-development contracts, agreements with CROs, agreements with investigators and associations in favour of clinical trials, contracts with hospitals and other clinical and preclinical trials centres, development of new pharmaceutical forms …
  • R&D funding: financing agreement with French and European government entities (NRA agreements, Oséo, FP…).
  • Industrial contracts: implementation or transfer of a production site, purchase of active substance, shaping, transport…
  • Marketing: purchase or operating licence for products (« in » and « out »), distribution agreements, transfer of marketing authorisations co-promotion, co-marketing, medical examinations, direct sale, distribution, pharmaceutical warehouse, setting up of internet platforms…
  • Supply of goods and services required for the operating and exploiting of companies: general terms and conditions, outsourcing, technical support, maintenance contracts, technical reviews, access to scientific and commercial databases…

 

Regulatory aspects

Both in France and in Europe, in sectors such as:

  • Health personal data.
  • Biomedical research, bioethics and genetics.
  • State aids relating to R&D public financing.
  • Drugs’ marketing autorisations.
  • Reimbursement and price-setting of health products.
  • Relations with health professionals (regulations relating to granted advantages).
  • Advertising health products and financial sanctions of the economic committee for medicinal products.
  • Procurement proceedings relating to the purchase of health products by public health institutions.
  • Conventional or non-conventional relations with authorities, organisations and agencies involved in the health sector.
  • Regulations for healthcare facilities.

 

Litigation

We assist our clients before civil and criminal French jurisdictions in cases such as:

  • Disputes and expert reports with respect to liability and defective products.
  • Disputes relating to administrative authorisations and decisions (illegality proceedings, administrative summary proceedings) or compensation proceedings.
  • Disputes relating to hospital public procurements (pre or post contractual).
  • Intellectual property disputes arising from or implemented in the health sector (including patents, copyrights, trademarks and designs).
  • Commercial disputes (comparative advertising).

 

Our other assets in the health sector

  • Strengthening our teams’ expertise in order to innovate, anticipate and comprehend legal issues from a global and integrated perspective (including in terms of corporate, finance, tax, real estate, competition, new technologies and labour law in addition to the above mentioned competences).
  • A pragmatic approach of the issues encountered by our clients thanks to our lawyers’ practical and professional experience acquired in the pharmaceutical industry, the medical device sector, the finance sector and the French senior administration.
  • Strong relations with administrative authorities in the fields of health, new technologies and personal data protection (CNIL) or professional organisations (including LEEM).
  • An international goodwill implying a constant update with regards to the developments in the health or research sectors worldwide while relying on a tried and highly skilled non-exclusive network of foreign law firms, which enables us to manage international cases without the constraints of a closed network.

 

We are regularly cited in reference rankings such as Chambers and Partners, The Legal 500 and Décideurs.

 

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