Expertise

Serving the health industries​

(human and veterinary medicinal products, medical devices, cosmetics, food supplements, phytopharmaceutical products, etc.)

Areas of expertise

  • Research involving the human being
  • Market Access: granting, suspension and withdrawal of marketing authorisations and/or CE marking, batch recalls, ANSM controls
  • Reimbursement: inclusion on reimbursement lists, derogatory access to reimbursement (early access, compassionate use, direct access, innovation package, etc.), delisting, setting prices and paybacks
  • Hospital public contracts : assistance with the award of contracts, litigation concerning the award of contracts, pre-contractual and contractual summary proceedings, litigation concerning the execution of contracts
  • Competition: unfair practices, parallel imports, abuse of dominant position, cartels, investigations by competition authorities
  • Compliance: “anti-gift” and “transparency” measures, anti-bribery regulations
  • Ethics
  • Sector-specific taxation: assistance with audits and litigation on “URSSAF taxes” (wholesale contribution, contributions on promotional expenses, contribution on first sales, contribution on turnover, safeguard clauses)
  • European litigation: representation before the Court of Justice in Luxembourg and the European Court in Strasbourg, invocation of European law before the French courts
  • New laws (in particular the Social Security Financing Act): drafting amendments, referral to the Constitutional Council

Serving the health professionals

Areas of expertise

  • Professional rules : relations with professional bodies, discipline and ethics
  • Relations with industry : “anti-gift” and “transparency” acts, prevention of conflicts of interest
  • Health structures : regularity of operation and agreements concluded
  • Medical acts : quotations and relations with health insurance

Our interventions

In partnership with

For the health Commission

New reimbursement
models

  • Early access
  • Compassionate access
  • Direct access

Compliance

  • The « anti-gift » act
  • The « transparency » act

Price

  • LEEM / CEPS framework agreement

Other news

  • Social security financing bill / Social security financing act
  • Regulation « Covid-19 »

Some contentious decisions

constitutional council

Limitation of the base of the “safeguard clause” for medical devices
Decision No. 2019-795 DC of 20 December 2019, Social Security Financing Act for 2020

Council of state

Annulment of prescription restrictions conditioning the reimbursement of a drug
Judgment of 24 February 2020, req. n° 431889 and ruling of 8 November 2019, req. n° 423971

Annulment of the decree specifying the content of the summary of product characteristics to be provided by the manufacturer of a medical device or its representative to the ANSM
Judgment of 26 April 2018, req. n° 407982

Annulment of a price decrease in the medical devices sector
Judgment of 16 December 2016, req. n° 397908

Illegality of the decree which fixes the composition of the URSSAF amicable appeal commissions
Judgement of 4 November 2016, req. n° 398443

Annulment of the decision of the directors of the UNCAM college setting the conditions under which the prescription of a medicine may be subject to the prior agreement of the medical control
Judgment of 9 March 2016, req. n° 385130

Court of cassation

Exclusion from the basis of the tax on expenditure on the promotion of medicines of the compensation for notice not served
Judgment of 18 June 2015, appeal no. 14-18961

Exclusion from the basis of the tax on expenditure on the promotion of medicines of visits to the pharmacy
Judgment of 18 June 2015, Appeal No. 14-18960

Restitution of the tax on direct sales
Judgements  of 1 December 2011, appeals no. 10-25942 and 10-25943

european court of human rights

Illegality of a validation law
Judgment of 22 November 2010, application no. 20429/07

court of justice of the european union

Definition of the conditions under which prescription assistance software must be classified as a medical device
Judgment of 7 December 2017, Case C-329/16

Illegality of the tax on direct sales of pharmaceutical products
Judgment of 22 November 2001, Case C-53/00

Competition (abuse of dominant position)
Judgment of 12 December 2000, T-128/98

End of the exclusion of the right to deduct VAT on hotel and restaurant expenses
Judgment of 19 September 2000, Case C-181/99

jurisdiction court

Ordre de juridiction compétent pour statuer sur la délibération du conseil d’administration de l’URSSAF fixant la composition de la commission de recours amiable
Arrêt du 24 avril 2017, req. C-4077

Rankings

Chambers Pharma/Life Sciences : Regulatory, Band 2

Legal 500 Healthcare and Life Sciences : Tier 3

GD Avocats is recognized for its “solid regulatory expertise”.