MEDICINES FOR EUROPE

Medicines for Europe, representing generic, biosimilar and value-added medicines manufacturers, supports the objectives of the initiative to tackle practical challenges and bottlenecks companies encounter in complying with EU legislation, linked to administrative and reporting burden. We reiterate our concerns over measures harming the availability, accessibility and affordability of medicines, and notably the Urban Wastewater Treatment Directive EPR system. This scheme will place disproportionate financial burden on generic medicines, which account for 70% of medicines dispensed in Europe but represent less than 19% of the market value, while being expected to shoulder around 60% of total…

Medicines for Europe represents the generic, biosimilar and value-added medicines manufacturers in Europe. We welcome the opportunity to contribute to the call for evidence on the future reform of the Union customs legislation. Generic, biosimilar and value-added medicines play a crucial role for patient access to equitable treatments and healthcare sustainability in Europe and globally. In the European Union, off-patent pharmaceuticals account for 70% of prescribed medicines. The Covid-19 crisis confirmed the strategic importance of this sector and the need to facilitate the cross-border flow of generic, biosimilar and value-added medicines. We share the Commission’s goal of ensuring…

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.