Platform on access to medicines in Europe
- Steering Group
- Mechanism of coordinated access to orphan medicinal products
- Capacity building on Managed Entry Agreements (MEAs) for innovative medicines
- Facilitating the supply of medicinal products in small markets
- Promoting a good governance for non-prescription drugs
- Market access for biosimilars
The platform on access to medicines in Europe was one of the three work areas of the Process on Corporate Responsibility in the field of Pharmaceuticals. It was dedicated to enhancing the collaboration among the Member States and relevant stakeholders in order to find common, non-regulatory approaches to timely and equitable access to medicines after their marketing authorisation.
The platform gathered a number of concrete initiatives intended to facilitate, within the current legal framework, the pricing and reimbursement of innovative treatments after their marketing authorisation, or to contribute to a responsible environment for access.
These initiatives were translated into several projects allowing all stakeholders to test ideas and develop new concepts.
To conclude projects, participating countries and stakeholders were invited to reflect on the experience gained and to propose recommendations for adoption by the Steering Group.
Scope of the initiative
In accordance with Article 168(7) of the Treaty on the Functioning of the European Union, pharmaceutical pricing and reimbursement policies fall within the competence of the Member States. Each government is responsible for the organisation of its healthcare system and is free to take measures to ensure its financial stability. The principle of subsidiarity applies in this field and must be fully respected.
All the projects undertaken under the platform were therefore based on voluntary cooperation and partnerships. The experience of the Pharmaceutical Forum has shown that such collaborative, consensus-based approaches can be very successful in this field. Participation in the projects does not commit participants to any future actions outside of the project.
The platform was chaired by the Directorate General for Enterprise and Industry of the European Commission.
The EU Member States and EFTA countries (European Free Trade Association) were invited to nominate representatives from their relevant competent authorities in charge of pricing and reimbursement of pharmaceuticals.
The following stakeholders’ organisations have been invited to participate:
- European Patients Forum – EPF
- Bureau Européen des Unions de Consommateurs – BEUC
- Standing Committee of European Doctors – CPME
- Pharmaceutical Group of the European Union – PGEU
- European Hospital and Healthcare Federation – HOPE
- Association Internationale de la Mutualité – AIM
- European Social Insurance Platform – ESIP
- European Federation of Pharmaceutical Industries & Associations – EFPIA
- European Generic medicines Association – EGA
- European Self-Medication Industry – AESGP
- European Association for Bioindustries – EuropaBio
- European Association of Full-Line Wholesalers – GIRP
The role of the Steering Group, chaired by the Commission, was to generate momentum for the platform and to ensure an effective development of its projects. The Steering Group was composed of representatives of the national competent authorities responsible for pricing and reimbursement of pharmaceuticals and of representatives of the above stakeholders. Meetings of the Steering Group were organised in close collaboration with each ongoing Presidency of the EU.
Meetings of the Steering Group
- 1st Meeting of the Steering Group – 24/09/2010, Brussels
- 2nd Meeting of the Steering Group – 17/12/2010, Bruges
- Agenda [15 KB]
- Minutes [20 KB]
- Terms of reference of the Platform on access to medicines in Europe [31 KB]
- 3rd Meeting of the Steering Group – 04/05/2011, Budapest
- 4th Meeting of the Steering Group – 14/12/2011, Warsaw
- 5th Meeting of the Steering Group – 18/04/2012, Copenhagen
- 6th Meeting of the Steering Group – 06/11/2012, Paphos
- 7th Meeting of the Steering Group – 17/04/2013, Ireland
The members of the platform have been invited to contribute to five projects. Each project is chaired by the Commission with the support of one Member State. While each project has a balanced representation of Member States, industry and other relevant stakeholders, the composition differs between projects, reflecting their distinctive nature and the different issues they address.
The following projects have been launched :
Mechanism of coordinated access to orphan medicinal products
The objective was to find collaborative ways to identify and assess the value added of orphan medicinal products. Agreement was reached on a final report. This includes “Key conclusions and recommendations”, and an indicative set of criteria, such as available alternatives or response rate against which value could be assessed, so as to ultimately facilitate access for patients.
Terms of reference [49 KB]
- Final report [531 KB]
- Key conclusions & recommendations [321 KB]
- Transparent value framework [420 KB]
Capacity building on Managed Entry Agreements (MEAs) for innovative medicines
This group had a threefold objective: first, to collect quantitative information on existing MEAs, then to categorise these different MEAs schemes and thirdly to assess their usefulness in light to their financial implications. The final outcome is a Report elucidating the above mentioned aspects.
Terms of reference [41 KB]
Managed entry agreements for pharmaceuticals : The European experience [3 MB]
by Alessandra Ferrario & Panos Kanavos, London School of Economics and Political Science, EmiNet
Facilitating the supply of medicinal products in small markets
The small markets examined during the work of this group were: Cyprus, Estonia, Iceland, Latvia, Lithuania, Malta and Slovenia. The group discussed possible solutions to increase availability of certain products in the previously mentioned small markets in Europe. Among others, it dealt with issues related to pricing and reimbursement practices, distribution procedures and other requirements to be complied with, when placing a medicinal product on a smaller market. A “Position Paper and Recommendations” identifying possible solutions was developed, for example sharing information amongst all parties concerned on supply problems.
Terms of reference [25 KB]
- Position paper & recommendations [334 KB]
Promoting a good governance for non-prescription drugs
The group examined the role of various actors in identifying the necessary elements to ensure availability, uptake and informed use of non-prescription medicines. It was also acknowledged that there is a diversity of factors affecting access to non-prescription medicines. In the final report the group advocates the significant role that these medicines can play in self-care in the existing framework governing non-prescription medicines.
Terms of reference [21 KB]
Report [874 KB]
Market access for biosimilars
The project group focusing on biosimilar medicinal products was invited to take stock of the availability of biosimilar medicinal products in European national markets and to define the necessary conditions for an informed uptake and adequate patient access to these products.
Terms of reference [39 KB]
- Table with information on the reimbursement status of biosimilar medicinal products in EEA countries [47 KB] As stated in the Terms of Reference, "it can be relevant to clarify to what extent biosimilars – in the different EEA countries - are hospital-only medicines or primary sector medicines, since pricing and reimbursement structures/decisions varies between the two sectors". Therefore, the project group conducted a survey among the Member States and EEA countries from May 2011 until January 2013 in order to gather the information on reimbursement status of authorised biosimilar medicinal products.
- Study on Biosimilar accessible market : Size and biosimilar penetration [597 KB] prepared by IMS Health, London. In this document IMS Health presents quantitative data and analysis on the size and growth of the biosimilar accessible market in Europe to date.
Consensus Information Document: What you need to know about Biosimilar Medicinal Products [2 MB] with a Q-&-A for patients, physicians and payers, now also available in German, Spanish, French, Italian, and Portuguese. This multi-stakeholder consensus document has been developed to provide comprehensive information on the concept of biosimilar medicinal products, including science, regulatory and economic aspects. All elements in this document are relevant to decision makers such as scientific societies, healthcare professionals and competent authorities, as well as to patients and their representative organisations.
Please note that that the answer on how to find the relevant information on biosimilar medicines on the EMA website (questions 11 and 12 of the Q&A for Physicians) is outdated. Information on biosimilars can be found on the EMA webpage.
In the margin of the Group's work a survey was also conducted from December 2011 to June 2012 by the European Generic medicines Association (EGA) to identify the good practices and obstacles related to the uptake of biosimilar medicines in Member States and EEA countries.
The outcome of the survey demonstrated the need for clear and unbiased information from an independent source, targeting all stakeholders, on the scientific concept of biosimilars, their approval process and their safety and efficacy. The consensus information document elaborated by the Group is intended to help serve this purpose. For further information please consult the website of EGA.
In December 2010 the Council of the European Union invited the Member States and the European Commission to "take the initiative of updating the 2004 priority medicines report, in cooperation with World Health Organization (WHO) experts". The purpose of the "Priority Medicines for Europe and the World" report is to study pharmaceutical innovation from a public health perspective, and to prepare a public-health-based medicines development agenda. The Prioritisation working group is mandated to guide the revision process, associating closely Member States, the European Commission and relevant stakeholders with the revision of the report.
Terms of reference [18 KB]