Healthcare companies, including pharmaceutical laboratories, operate in a heavily regulated environment and often have to seek the assistance of a lawyer specialising in pharmaceutical law.
The current legal regime applying to medicinal products is mainly based around two European texts: Directive 2004/27/EC of 31 March 2004 amending the community code relating to medicinal products for human use, and Regulation (EC) No 726/2004 of 31 March 2004. This regulation lays down the procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. The legal regime for medicinal products is standardised in France under articles L. 5111-1 et seq of the French Public Health Code.
Actors in the pharmaceutical sector must integrate these regulations from both European Union authorities and French authorities.
The applicable laws also affect:
the regulation of medication or healthcare products,
the conditions of relationships with healthcare professionals,
health security,
and even patient protection.
Cabinet Barbey will accompany you every step of the way in your doubts regarding pharmaceutical law.
Cabinet Barbey boasts highly specific expertise in the field of pharmaceutical law. The firm supports and advises actors in the healthcare industries in order to help them operate in full compliance with current regulations.
Our clients include :
Pharmaceutical laboratories
Clinical research companies (contract research organisations, or CROs).
Outsourcing companies in the health sector (contract manufacturing organisations, or CMOs).
Our competencies in pharmaceutical law
+ Agreements and general conditions
Agreements relating to the supply of medicinal products: manufacture, industrial outsourcing, shaping, contract manufacturing, purchase and supply.
Agreements relating to the sale of medicinal products: distribution, sales representative, co-marketing, relationships with wholesale distributors, marketing authorisation (MA) transfer agreements, medical check-up services.
Partnership and/or cooperation agreements: R&D, shaping, outsourcing, promotion, co-promotion, co-marketing, distribution, etc.
General conditions of sale and use.
Agreements relating to industrial property: licensing (out-licensing and in-licensing), assignment, technology transfer, depositing Soleau envelopes, confidentiality or secrecy agreements (NDAs) regarding patents, designs and models, marks and other intangible elements.
Agreements relating to setting up clinical trials: with CROs, relationships with research ethics committees, single contracts.
Research agreements with healthcare professionals.
+ Advice on regulations
Determining the legal definition of health products (borderline products).
Advice on regulations that apply to medicinal products: placing them on the market, clinical studies, advertising.
Implementation of ownership transparency legislation and the French anti-gift law (DMOS).
Assistance and advice to pharmaceutical laboratories regarding the procedure for submitting marketing authorisations (MA).
Regulatory assistance throughout clinical trials.
Expanded access request forms.
Assistance adapting to French and foreign health authority regulations.
+ Advice on health data
Reviewing and negotiating agreements with health data hosting service providers.
Drafting different formal paperwork for the CNIL (French data protection agency): declarations, requests for authorisation of processing health data for research, requests for an opinion.
Implementation of online health platforms.
Access to open data health databases.
+ Disputes
Manage cases of liability for defective products before regional conciliation and compensation services or courts of law.
Disputes relating to copyright infringements of medication.
Appeals against health authority rulings (appeals to higher authorities, legal appeals, cases before administrative courts).
Medicinal product liability.
Astrid Barbey, member of the Paris bar association
Astrid Barbey
Founder of the firm
Thanks to years spent practicing in both England and France in renowned law firms such as FTPA and Baker McKenzie, in addition to her work as an in-house lawyer for the pharmaceutical company AstraZeneca, Astrid Barbey has gained invaluable knowledge as both a lawyer and decision-maker, which she now draws on to help her own firm’s clients.
Astrid Barbey boasts extensive experience working with clients in the healthcare and life sciences sectors (health products, pharmaceutical industry, medical devices, biotechnology), in particular on an international level.
Astrid Barbey holds professional diplomas in European business law from the University of Nancy (France) and Lancaster University Law School (United Kingdom).
Cabinet Barbey is a leader in the fields of:
1.
Health, Pharma & Biotechnologies
Regulatory law
2.
Health, Pharma & Biotechnologies
Digital health
3.
Competition & Distribution
Health and pharma industry
Contact our business lawyers
tél : + 33 1 83 62 36 99
26 avenue de la Grande Armée - 75017 Paris
Accès : Argentine / Ch. De Gaulle-Etoile
