Pharmaceutical law, together with industrial property, is another of the main areas to which CEFI devotes its activities.
Pharmaceutical law, together with industrial property, is another of the main areas to which CEFI devotes its activities.
Pharmaceutical law, together with industrial property, is another of the main areas to which CEFI devotes its activities.
The principal purpose of the CEFI Foundation is the promotion of innovation and its protection. The pharmaceutical sector is one of the most innovative sectors par excellence and, from a legal perspective, it presents many specific features. CEFI has been dedicated to the study of pharmaceutical law for 38 years.
Throughout the different stages of a medicinal product’s life cycle, legally relevant issues arise that must be examined and interpreted.
CEFI structures its activity in the field of pharmaceutical law mainly through studies, reports, position papers, the journal Cuadernos de Derecho Farmacéutico, and the Pharmaceutical Law Course, which each year continues to consolidate its position as a benchmark for the study of legal issues relating to medicines.
With regard to studies, reports, and position papers, CEFI addresses topical issues of legal relevance. Examples of this work include documents on transparency in medicine pricing, questions and answers on biological and biosimilar medicines, and analyses on the effective commercialization of generic medicines, interim measures, regulatory inaction, and proposals for improvement.
The journal Cuadernos de Derecho Farmacéutico addresses current issues of regulatory, doctrinal, and case-law relevance relating to medicines in Spain and in the European Union. Pharmaceutical law is the core focus of Cuadernos de Derecho Farmacéutico.
The Pharmaceutical Law Course serves as a meeting point for leading experts on medicines from industry, law firms, and public authorities to discuss current issues related to medicinal products. The course is structured around roundtable discussions, offering a practical perspective that provides a comprehensive view of the topics analyzed and encourages interaction between attendees and speakers.
Topics covered include innovation and the protection of industrial property, regulatory matters, marketing authorizations and pricing of medicines, contracting, and competition.
Data protection, advertising, biosimilar medicines, and market access issues are also regularly analyzed in our courses, addressing the key challenges that arise 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.