Market review Generic medicines policy 2023 – Policy Statement

The Generic Market Access Committee (Generic medicines Group, a Medicines for Europe sector group) undertook a 2023 Generic medicines market review consisting of updates on generic medicines policy across Europe (28 European countries).
The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions (e.g., pricing and reimbursement, procurement of medicines) to ensure access to medicines across Europe.

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Position on the Proposal for a Regulation of the European Parliament and of the Council on Packaging and Packaging Waste

Medicines for Europe welcomes the introduction of harmonised labelling, notably regarding recycling symbols which are sometimes already present in national legislations or the blue box – for example, in Bulgaria, France, and Austria.
The proposal, however, also introduces a requirement to provide information on the material composition, as well as information regarding the manufacturer and its contact details. We are concerned by the introduction of that information as there is limited space available on the packaging of pharmaceutical products.

 

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Towards a European Medicines Security Act

Final recommendations from “Ensuring equitable and sustainable access to medicines through a secure and resilient supply”

Medicines for Europe, the European off-patent medicines association, and CAFF, the Czech generic and biosimilar medicines association, have organised under the auspices of the Czech Presidency of the Council of the European Union a seminar on 10 November 2022 entitled “Ensuring equitable and sustainable access to medicines through a secure and resilient supply”.

The event has been organised in line with the main objectives stated in the European Commission pharmaceutical and updated industrial strategies for Europe, which have been published setting up clear goals for the European Union that delivers on access, availability and affordability while achieving a great open strategic autonomy, also taking into account the Covid-19 pandemic lesson learned.

 

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Position Paper – Unitary SPC & Unified Mechanism for the Granting of SPCs

Medicines for Europe letter to EC on Divisionals & Patent Linkage re Fingolimod – 13.04.2022

Note on Transferable Vouchers – April 2022

Advancing Medicines repurposing in the EU

Repurposing has emerged as an important strategy to address unmet medical need. Yet, there is still significant untapped potential for its application in the EU.

 

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Policy recommendations on uptake of biosimilar medicines in the retail market

Positioning Statements on Physician-led Switching for Biosimilar Medicines