Industry complaint against French off-label use law
Undermining the rigorous EU authorisation process for medicines.
Brussels, 31 August 2015
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have today filed a complaint with the European Commission against the French “RTU Regime”, whose first implementing act for economic reasons  will be effective as of 1 September 2015. The regime allows the French medicines regulator (ANSM) to issue a temporary authorisation for use of a product in an unauthorised indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment. This development is troubling and contravenes European Union law and jurisprudence.
EFPIA, EUCOPE and EuropaBio are concerned that government initiatedoff-label use of medicines on economic grounds circumvents the robust EU authorisation process for medicinal products, which sets rigorous standards for market approval for specific medical needs based on the benefit to risk ratio. This emerging trend compromises their standard of quality, safety and efficacy and could put patients’ health at risk.
The French rules follow the introduction of similar legislation in Italy last year. These measures not only undermine the EU regulatory framework but also contradict the jurisprudence of the Court of Justice of the EU, which prohibits Member States from supporting off-label use for economic purposes. .
Off-label prescribing of medicines should only occur in very specific situations where there is a concrete medical need for an individual patient and making sure that all safety measures and precautions have been respected. Furthermore, patients should be made fully aware of the potential benefits and risks associated with the use of an off-label medicine and explicitly consent to its prescription.
Richard Bergström, Director General, EFPIA commented on this development, stating: “It is simply not acceptable for policy makers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk. The pharmaceutical industry collectively calls on the European Commission to address this public health issue urgently and preserve those safeguards that have been put in place.”
Alexander Natz, Secretary General of EUCOPE, said: “It should be up to the physician to make the decision about the individual patient’s treatment and not the legislator or payer. We therefore call on the European Commission to stop national developments infringing EU law. We must adhere to the highest standards of patient safety enshrined in the EU’s regulatory framework and have to ensure that the use of medicines is driven by patients’ medical needs rather than budget considerations.”
Nathalie Moll, Secretary General of EuropaBio, said that “Medicines in the EU undergo rigorous clinical trials before being authorised in order to safeguard patient safety. The standards for quality, safety and efficacy that are successfully applied through this regulatory system would be undermined by Member States purely for economic gains. What we are seeing in Italy and now in France may impact patient safety and sends a dangerous message that the assessment and supervision procedures laid down in European legislation are not respected.”
EFPIA, EUCOPE and EuropaBio feel it is essential the European Commission ensures that economic considerations do not take precedence over public health and patient safety.
For further information, please contact:
Mobile: +32 2 626 25 55
Dr. Oliver Sude
Legal Counsel | EU Affairs
Phone: +32 2 282 0475
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests €30.5 billion on research and development per year in Europe and directly employs 707,000 people including 116,000 in R&D units in Europe. EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
EUCOPE represents via its member associations such as the German Pharmaceutical Industry Association (BPI), the British Ethical Medicines Industry Group (EMIG) or the Swedish Association IML, more than 900 members. Companies from Sweden, the UK, Italy, Greece and Germany are represented on the board of the association, many of them SMEs. EUCOPE membership includes innovative family owned companies such as B.Braun, Ferring, Norgine or Grifols as well as innovative companies active in the field of biotechnology and rare diseases such as Alexion, Celgene, Biogen Idec, Otsuka, Intercept, Vertex, BioMarin or Sobi. EUCOPE, inter alia, represents its members with respect to international governmental organisations in particular towards the EU institutions and agencies. EUCOPE is a recognised stakeholder by the European Commission, by CMDh and by EMA.