EFPIA calls for universal adherence to European regulatory framework

(Tuesday, June 10, 2014) EFPIA, the European Federation of Pharmaceutical Industries and Associations is concerned about a decision by the Italian health authority, which allows the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure Member States adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

On June 9, the Italian Medicines Agency, AIFA, endorsed the off-label use of bevacizumab in its decision to reimburse the drug for use in the eye. All this, despite the fact that on-label treatments are currently available to Italian patients. EFPIA opposes this decision as it undermines the European regulatory framework, potentially compromising patient safety and creating legal uncertainty.

Speaking about this development Richard Bergström, Director General EFPIA, said: “Almost five decades ago the pharmaceutical regulatory framework was created, and 20 years ago the European Medicines Agency was established, to preserve the highest standard of patient safety in Europe. We are concerned about efforts by EU Member States creating secondary, national marketing authorizations for economic reasons that undermine the EU regulatory framework and could potentially put patients at risk. 

“Yesterday’s decision by AIFA questions the European Commission’s competence to authorize new medicines. To preserve the high standards of patient safety in the EU, healthcare bodies should adhere to EU law and refrain from promoting off-label use for economic reasons. These medicines have not been tested and assessed to the same stringent standards for the off-label indication, putting patients’ health and safety at risk for the sake of cost savings. 

“Promotion of economic driven off label use will discourage pharmaceutical companies from undergoing the costly and time-consuming authorization process for new indications if public authorities favour off-label use of other, cheaper medicines which have not undergone the same stringent safety and efficacy assessment.” 



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 €30.6 billion on research and development per year in Europe and directly employs 690,000 people including 115,000 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.

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