Medicines For Europe

EU Legislative Interests

Medicines for Europe plays an important consultative part in European healthcare policy-making and provides key educational role for its members. Medicines for Europe and its members work with European national governments - including national medicine regulatory authorities - and the EU institutions to develop sustainable solutions for pharmaceutical care and to increase Europe’s competitive strength in the global pharmaceutical medicines market. Medicines for Europe is engaged to work on a variety of EU pharmaceutical policies and legislative proposals, which include, but is not limited to:  the implementation of the pharmaceutical and IP strategies; The implementation of the SPC Manufacturing Waiver, which was introduced in July 2019; the broad review of the pharmaceutical incentives (e.g. Bolar, variations, orphan and paediatric medicines, etc.); the review of the SPC legislation (i.e. Unitary SPC, SPC legal review, Biotech Act, etc.) and the patent system; the industrial policy to stimulate more investments in Active Pharmaceutical Ingredients’ production in Europe and critical medicines, including European and national funds both for critical medicines as well as biotechnologies (Critical medicines act and biotech act); the possible review of the Transparency Directive on pharmaceutical; health security including all related activities organised by Health Emergency Preparedness and Response (HERA) of the European Commission; the rules on pharmaceuticals’ public procurement and medicines markets; environmental policies related to pharmaceuticals, including discussions around pharmaceuticals in the environment and sustainability and the water strategy; all competition policies aimed to ensure off-patent medicines timely access to the market; all policies related to shortages of medicines; education and policies, including also biosimilar medicines; the development of information and awareness around value added medicines; the EMA work around generic, biosimilar and value added medicines; the work of the Pharmaceutical Committee more generally; trade and international agenda; European and national digital agenda.

Communication Activities

List of activities • conferences, webinars, communication campaigns and workshops organisation • membership services and publications (EU Members Brief and highlights) • scientific, legal and economic assessment reports • EU and International representation

Interests Represented

Promotes their own interests or the collective interests of their members

Member Of

- Consultative status with World Intellectual Property Organization (WIPO) - Founding Member of International Generic and Biosimilar Medicine Association (IGBA) - Member Federation of European and International Associations Established in Belgium (FAIB) - Founding Member of the European Medicines Verification Organisation (EMVO) - Observer of the Organisation for Economic Co-operation and Development (OECD)

Organisation Members

http://www.medicinesforeurope.com/medicines-for-europe/#section-5

Additional Information

The grants indicated above are part of a total grant of 208.062 Euro that is spread over a 5 year period. While in the financial year 1/2023-12/2023 there was no grant (considered 'current financial year' above), on 4 February 2024 Medicines for Europe received a grant of 20 505,91 EUR, still part of the same total grant.