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PHARMACEUTICAL LAW

Pharmaceutical law, alongside industrial property law, is another of the key areas to which CEFI devotes its activities.

Pharmaceutical law

Pharmaceutical Law, alongside Industrial Property Law, is another of the key areas to which CEFI devotes its activities.


The primary objective of the CEFI Foundation is to promote and protect innovation. The pharmaceutical sector is one of the most innovation-driven industries and presents numerous legal complexities and distinctive characteristics. CEFI has been dedicated to the study of Pharmaceutical Law for 44 years.

Throughout the various stages of a medicinal product’s lifecycle, significant legal issues arise that require careful examination and interpretation.

CEFI structures its activities in the field of Pharmaceutical Law primarily through studies, reports, position papers, its specialist journal Cuadernos de Derecho Farmacéutico (Pharmaceutical Law Review), and its annual Pharmaceutical Law Course, which continues to strengthen its position as a leading forum for the study of legal issues relating to medicinal products.

With regard to studies, reports and position papers, CEFI addresses topical issues of legal significance and interest. Examples of its work in this field include papers on transparency in medicinal product pricing; questions and answers concerning biological and biosimilar medicinal products; and the effective marketing of generic medicines, interim measures, regulatory inaction and proposals for improvement.

The journal Cuadernos de Derecho Farmacéutico examines current legislative, doctrinal and case-law developments relating to medicinal products in Spain and the European Union. Pharmaceutical Law constitutes the journal’s principal area of focus.

The Pharmaceutical Law Course brings together leading experts in the field of medicinal products from the pharmaceutical industry, law firms and public authorities to discuss current legal and regulatory issues affecting the sector. The course is organised around panel discussions that provide a practical perspective, offering participants a comprehensive understanding of the subjects addressed while encouraging active engagement and dialogue between attendees and speakers.

Topics covered include innovation and the protection of Industrial Property Rights, regulatory matters, marketing authorisations, medicinal product pricing, public procurement and competition law.

Data protection, advertising, biosimilar medicinal products and market access are also recurring subjects of analysis in our courses, providing opportunities to examine the key legal and regulatory challenges arising in these areas.

At CEFI, we are fully 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 application of social networks in the healthcare sector, as well as issues such as artificial intelligence and ethics committees.

With the aim of addressing all aspects of medicinal products and involving all stakeholders in the process, we have also focused our attention on patient associations and their relationship with healthcare authorities, their collaboration with the pharmaceutical industry, and their role in clinical research. The role of the patient as the ultimate recipient of medicines is undoubtedly of key importance.

In order to remain up to date, CEFI monitors legislation and court decisions affecting the European and national pharmaceutical markets. We analyze their legal implications and, where appropriate, prepare specific legal reports.

We participate in public consultation and hearing procedures for draft legislation affecting pharmaceutical law and seek to foster cooperative relationships with public authorities and entities that share CEFI’s objectives. In the section Foundation > Activities > Public Consultation on this website, you can review the specific procedures in which we have participated. Notable examples include submissions on successive Draft Orders updating the reference pricing system for medicines within the National Health System; submissions regarding the Action Plan to promote the use of market-regulating medicines in the National Health System, namely biosimilar and generic medicines; submissions on the Royal Decree on the pricing and reimbursement of medicines; submissions on the Draft Royal Decree-Law approving the consolidated text of the Medicines Guarantees Act; and submissions by the CEFI Foundation on the Draft Royal Decree regulating the availability of medicines in special situations.

Through this set of activities, and as has been recognized over nearly 40 years of existence, CEFI seeks to be—and has been regarded as—an independent, rigorous Center of Studies with a legal and technical profile that adds value to the study of pharmaceutical law.