About us
The MEDICINE EVALUATION COMMITTEE (MEDEV) was established in 1998 by representatives of the social health insurance organisations in Austria, Finland, Germany, Luxembourg, The Netherlands, and Switzerland to facilitate informed discussions and exchanges on pharmaceutical policy developments in the EU.
The European Social Insurance Platform (ESIP) in Brussels was commissioned with the role of coordinating the activities of the Committee.
MEDEV is a network of 22 national authorities from 18 Member States and Norway bringing together all the relevant institutions (national HTA agencies and social health insurers-payers) responsible for the assessment, pricing and reimbursement of medicines in Europe. MEDEV forum includes all those involved in the decision-making processes turning access to medicines into a reality for patients across Europe.
The overarching mission of MEDEV is to further the sustainable provision of medicines to patients who are publicly insured.
Cooperation & Exchange
MEDEV provides an informal platform for exchanges between national bodies responsible for the assessment, pricing and reimbursement of medicines to support them in their role at national level. This includes:
- Rapid assessments of (new) medicinal products of common interest
- Exchanges on ongoing and planned assessments for reimbursement, methodologies and pharmaceutical policy
- Review of EU-level activities impacting on national assessment, pricing and reimbursement
- Timely analyses of drug related trends and innovations, and political and legal initiatives of the European Institutions
Expertise
MEDEV provides an informal platform for consultation at EU level, offering specific expertise in the following areas:
- Pricing & reimbursement Pharmaceutical
- Policy advice & analysis
- Access to Medicines e.g. MoCA (Mechanism of Coordinated Access to Orphan Medicinal Products) .
Collaboration
MEDEV collaborates closely with the following organisations and networks:
- European Social Insurance Platform (ESIP)
- European Network on Health Technology Assessment (EUnetHTA)
- European Medicines Agency (EMA)
- European Commission (EC)
- European Parliament (EP)
- World Health Organisation (WHO) Regional Office for Europe
- Piperska Group
Rebalancing incentives for truly rare diseases
In view of the upcoming revision of the EU pharmaceuticals legislation (expected in Q1 2023), ESIP & MEDEV published a joint position on the EU legislation on medicines for rare diseases (orphan medicinal products - OMPs). The ESIP & MEDEV position includes a compilation of amendments to Regulation (EC) 141/2000 & Regulation (EC) 847/2000 and the accompanying position paper.
The ESIP & MEDEV amendments aim to address the unintended consequences in terms of market distortions brought about by the existing legal framework, such as concentration of R&D in specific disease areas (of higher profit), artificial segmentation of conditions into smaller subgroups as well as increasingly high price demands. The consolidated chart focuses on rebalancing the incentives systems, steering research and development towards areas of truly rare diseases and unmet needs.
To ensure that the revised legislation is fit for purpose we recommend to:
- Adjust the prevalence criterion for orphan designation in order to focus incentives on the development of therapies for truly rare diseases: lower the threshold for single indications (to 1:10,000), introduce a threshold for all authorised indications combined (of 5:10,000);
- Revise and clarify the definition of ‘significant benefit’ laid down in Regulation (EC) 847/2000: ‘major contribution to patient care’ should be deleted, since it cannot be easily defined;
- Maintain the profitability criterion for the re-evaluation of market exclusivity (ME), by setting a threshold for the volume of sales (to 1 billion EUR per year) for all combined indications;
- Clarify and strengthen criteria for maintaining ME: combining profitability, prevalence, proof of a clinically meaningful benefit, submission of pricing and reimbursement (P&R) applications in all EU Member States within 2 years after marketing authorisation (MA);
- Anticipate the review of ME criteria at the end of the second year after MA and henceforth annually;
- Entrust the EMA with these regular reviews, followed by the termination of ME if the criteria above are no longer met.
Find our sets of ESIP-MEDEV amendments to the OMPs legislation and the accompanying position paper.
This position complements our detailed ESIP-MEDEV amendments to the EU general pharma legislation, published in June 2022 - here the key messages.