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PHARMACEUTICAL LAW

CENTRE OF STUDIES FOR THE PROMOTION OF RESEARCH (CEFI)

Pharmaceutical law, together with intellectual property, is another of CEFI’s main areas of activity.

Pharmaceutical Law

Pharmaceutical law, together with intellectual property, is another of CEFI’s main areas of activity.

The main purpose of the CEFI Foundation is to promote and protect innovation. The pharmaceutical sector is one of the innovative sectors par excellence and from a legal point of view it has a number of unique characteristics. CEFI has been dedicated to the study of pharmaceutical law for 38 years.

Important legal issues arise throughout the various stages of a medicinal product’s life cycle and these need to be studied and evaluated.

CEFI’s pharmaceutical law work mainly centres around studies, reports, position papers, the journal Cuadernos de Derecho Farmacéutico (Pharmaceutical Law Review) and the Pharmaceutical Law Course, which each year consolidates its position as a benchmark in the study of legal issues related to medicinal products.

In its studies, reports and position papers, CEFI addresses issues of topical and legal interest. Examples of our work in this respect are the documents on medicine price transparency, on questions and answers about biological and biosimilar medicines, and on the effective marketing of generic medicinal products, precautionary measures and inactive sets of medicines, and proposals for improvement.

The journal Cuadernos de Derecho Farmacéutico addresses current issues of regulatory, doctrinal and jurisprudential interest with respect to medicinal products in Spain and the European Union, with pharmaceutical law being its main area of focus.

The Pharmaceutical Law Course is the meeting point for leading experts in the pharmaceutical field, coming from industry, law firms and government and discussing current issues related to pharmaceuticals. The course is based on round table discussions, offering a practical overview of the issues, which permits a holistic approach to the topics analysed and encourages participation between attendees and speakers.

The topics examined include innovation and the protection of intellectual property, regulatory aspects, medicinal product authorisations and pricing, procurement, and competition.

Data protection, advertising, biosimilar medicines and market access issues related to medicinal products are also regularly discussed in our courses as a way of exploring the key issues that arise in these areas.

 

At CEFI we are well aware of the changes brought about by new technologies and we also devote time and resources to studying the importance of digital media and the applicability of social networks to the healthcare sector, as well as topics such as artificial intelligence and ethics committees.

In our quest to address all medicine-related aspects and to involve all relevant players in the process, we have also devoted attention to patients’ associations and their relationship with the health authorities, their collaboration with the pharmaceutical industry and their role in clinical research. The role of the patient as the recipient of the medicinal product is also relevant, of course.

To keep up to date, at CEFI we monitor regulations and court rulings relating to the European and Spanish pharmaceutical markets, analysing the legal implications and, if necessary, writing specific legal reports.

We participate in the hearing and public information procedures for draft legislation affecting pharmaceutical law and strive to foster a cooperative relationship with government bodies and entities that share CEFI’s goals. In the section The Foundation > activities > public information procedure on this website you can review the specific procedures in which we have participated. We highlight the opinions on the successive draft orders for updating the reference price system for medicinal products in the Spanish National Health System (NHS); the opinions on the Action Plan to promote the use of market-regulated medicines in the NHS: biosimilar medicines and generic medicines; the opinions on the Royal Decree on the price and financing of medicinal products; the Draft Royal Decree-Law enacting the consolidated text of the Law on Guarantees and the CEFI Foundation’s opinions on the Draft Royal Decree governing the availability of medicinal products in special situations.

With these activities we strive to make CEFI an independent and rigorous centre of studies with a legal/technical profile that adds value to the study of pharmaceutical law. And indeed, this is exactly how we have been regarded throughout our almost 40-year history.

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