European Federation of Pharmaceutical Industries and Associations

EU Legislative Interests

Any health or pharmaceutical policy stemming from the European institutions, such as - but not exclusive - Industrial Policy, Pharmaceutical Strategy, pharmaceutical, orphan and paediatrics legislation, Horizon Europe Research Programme, HTA policy, IP policy, One Health Approach to tackle AMR, COVID-19 outbreak measures. EFPIA also follows ongoing trade negotiations and legislative files relevant to the innovative pharmaceutical industry (such as Green Deal, Water Framework Directive, Welfare of animals in scientific testing etc). Main EU legislative proposals or policies targeted (a non-exhaustive list) A Pharmaceutical Strategy for Europe – over 50 legislative and non-legislative proposals • Directive 2001/83/EC on the Community code relating to medicinal products for human use • Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency • Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products. • Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use In addition, we also follow for example: • Clinical Trial Regulation • EMA Fees Regulation • Europe’s Beating Cancer Plan • European Health Data Space • HERA Regulation • SPCs Regulation revision

Communication Activities

EFPIA communications activities include: • Publishing new evidence (etc. reports, leaflets, infographics) on the policies mentioned above on efpia.eu • Drafting blog post to share opinions • Organising events including EFPIA members and external stakeholders • Disseminating our key messages through media and social media

Interests Represented

Promotes their own interests or the collective interests of their members

Member Of

BIAC British Chamber of Commerce DIA EACD EAPM ECPA EPAA - European Partnership for Alternative Approaches to Animal EPC FAIB FEAM - Federation of European Academies of Medicine Friends of Europe Kangaroo Group Patients Access Partnership TOPRA THE EUROPEAN HOUSE – AMBROSETTI

Organisation Members

EFPIA’s constituent entities include: • 38 corporate members (companies) • 37 member associations (national associations) • 16 SMEs • 31 Partners in Research http://www.efpia.eu/about-us/membership

Additional Information

According to our calculations, the declared above amount as per guidelines, is correct. The estimate of annual costs related to activities covered by the register covers personnel related expenses as well as the costs related to intermediary activities.