pharmaceutical law

The pharmaceutical industry is highly regulated and is subject to three major challenges: compliance with strict standards, strong global competition driven by constant innovation and research, and economic pressure raising market access and commercial issues. Pharmaceutical law is at the heart of these challenges, as the recent Covid-19 crisis shows.

Cross-functional knowledge of the entire pharma & biotech ecosystem

Capitalizing on the experience of its partners in health authorities, pharmaceutical companies and law firms dedicated to the health industries, ELSI has developed a sharp expertise and a recognized practice on regulatory issues and problems, in their economic, commercial and competitive context, thus giving it a transversal approach and mastery of the pharmaceutical sector.

As a player in the field of pharmaceutical law, ELSI has extensive experience in the health industry and assists its clients in the development, negotiation, implementation and protection of their commercial policy and economic activities.

With its particular expertise in administrative law applied to health products, ELSI assists its clients in matters related to market access, pricing and reimbursement (Market Access) and advertising of health products, as well as in all procedures related to inspections. Our team assists operators in their dealings with the health authorities.

In addition to the regulatory aspects, ELSI is also involved in liabilityissues.

Pharmaceutical law, Our main areas of practice

  • Product qualification / borderline products
  • Setting up and monitoring clinical trials
  • Early access
  • Positioning, Marketing authorization procedures
  • Regulatory support to national and European authorities (ANSM, EMA, European Commission and others)
  • Advertising, medical information & e-communication
  • Assistance in the design, validation of shortage management plans (SMP)
  • Pharmacovigilance: subcontracting, PASS, arbitration procedures, re-evaluation of the risk/benefit ratio, signal procedures ...
Contract & commercial policy (Drafting, proofreading, follow-up and advice)
  • Contracts related to marketing: pharmaceutical operation, licence, distribution, single agreement, commercial agency, sales commission, mandate, promotion, co-promotion, co-marketing
  • Other commercial contracts: services, partnership agreements, cooperation agreements, market research, confidentiality agreements (NDA), general terms and conditions of sale (GTC) and use (GTU)
  • Unfair competition: free-riding, denigration, violation of advertising rules
Anti-gift law
& health transparency
  • Audit of the anti-gift law, compliance and transparency in health
  • Drafting of procedures
  • Agreements
  • Subcontracting
Market access
  • Registration on the lists of medecines that are eligible for reimbursable
  • Support in the design and validation of files with the HAS transparency commission (evaluation, re-evaluation, patient registers)
  • Support in the design and validation of dossiers with the CEPS
Health data
  • Identification of personal data
  • GDPR compliance
  • Personal data policy
  • Securing contracts
  • Support for digital projects
Pharmaceutical establishments (opening, inspections)
  • Support for the preparation, conduct and management of the aftermath of an ANSM inspection
  • Support and implementation of shortage management plans (SMP) and management of stock shortages
  • Responsibilities of the Responsible Pharmacist (RP)
Litigation and liability
  • Product liability: French non-judicial procedure and litigation procedure
  • Negotiation & transaction
  • Appeals against decisions of health authorities
  • Commercial litigation

Pharmaceutical law under a predominantly regulatory constraint

Regulated by the provisions of Directive 2001/83/EC of 6 November 2001 and Regulation (EC) 726/2004 of 31 March 2004, transposed into the Public Health Code, the marketing of medicinal products is subject to a very strict regulatory framework from the early stages of their development until they are actually placed on the market and monitored post-marketing.

Its rules adapt and evolve according to the different types of products concerned, implying in particular compliance with specific national or European procedures, specific early access conditions, the establishment of specific vigilance monitoring, and controlled communication, which must be taken into account both in the market access strategy and throughout the product life cycle. Pharmaceutical law also sets the pace for the life of pharmaceutical establishments, imposing a specific regulatory framework depending on the activities carried out: including authorisation to open, the presence of a pharmacist in charge, a pharmacovigilance officer, compliance with good practice, accompanied by permanent control by the national and European health authorities through inspections, giving rise to specific procedures (including injunctions, suspensions of authorisation and financial penalties).

The pharmaceutical industry is constantly evolving and has to adapt to new rules, such as the early access reform and the anti-gift and transparency system, while at the same time facing market issues and the implementation of a customised commercialdistribution and competition policy.

The constraints linked to the sector imply mastering the regulatory framework of medicinal products' regulation and understanding its technical and scientific specificities, as well as its economic and commercial issues. Specialised in pharmaceutical law, ELSI assists its French and foreign clients, pharmaceutical companies, MA holders, manufacturers, biotechs, pharmaceutical operators, clinical research companies (CROs), wholesalers and other economic operators, in advising, strategising, and securing the legal and regulatory aspects of all aspects of the life cycle of their products and activities, both as advisors and in litigation.

Discover our expertise & services


Marketing, advertising, health police, establishments, anti-gift & transparency



Contract law, commercial, advertising, distribution, restrictive practices, anti-competitive practices


Litigation and liability disputes

Commercial litigation, defective products, appeals against authorities' decisions, communication & crisis management


personal data - health data

GDPR, CNIL methodology, health data hosting
securing contracts, support for digital projects



Legal and regulatory updates, skills upgrading, find out about all our customised training offers


ANTI-GIFT & transparency

Our outsourcing offer, the subcontracting of your anti-gift activities & health transparency


consulting & subcontracting subscriptions

Subscriptions to regulatory advice, audit packages, find out about all our subscription and subcontracting offers


interim management

Transformation, temporary surge, implementation of new processes, crisis management



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