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Brussels, 24th September 2010

Corporate Responsibility in the field of Pharmaceuticals

The process on corporate responsibility in the field of pharmaceuticals will be set up to initiate a momentum among the Member States, industry and other relevant stakeholders by considering in a balanced approach societal and industrial challenges. Given the experiences of the G10 process and of the High Level Pharmaceutical Forum, the Process on corporate responsibility in the field of pharmaceuticals should facilitate discussions on ethics and transparency of the sector but also on non-regulatory conditions for better access to medicines after their marketing authorisation.

The process will comprise three independent platforms:

A - Transparency and ethics in the sector

The objective of the platform on ethics and transparency will be to exchange information and potentially achieve a common understanding in terms of best practices.

B - Access to medicines in Africa

The platform on access to medicines in Africa should facilitate reflection on the contribution of European companies, their added value and the challenges they face. By looking at the needs of the concerned countries, the platform should identify how stakeholders, and in particular industry, could contribute further. This platform will not duplicate initiatives already in place.

C - Access to medicines in Europe, in the context of pricing and reimbursement

The platform on access to medicines in Europe will be dedicated to enhance collaboration among the Member States and relevant stakeholders (see below) in order to find common non-regulatory approaches to ensure timely and equitable access to medicines after their marketing authorisation.

The platform will gather a number of concrete initiatives that could in particular facilitate pricing and reimbursement of innovative treatments after their marketing authorisation or that could contribute to a responsible environment for access.

Projects will be put in place for concepts to be developed and ideas to be tested. Projects will focus on concrete experiences of stakeholders and will explore non regulatory conditions for better access to medicines after their marketing authorisation. Lessons learnt in each project might feed into recommendations to the Steering Group concerning pricing and reimbursement of medicines.

The members of the platform will be proposed to contribute to the following projects:

1. Mechanism of coordinated access to orphan medicinal products

Members will be invited to develop the concept of a coordinated access to orphan medicinal products based on the set up of programmes between companies and groups of competent authorities and results of the ongoing project on a mechanism for clinical added value on orphan medicinal products. A pilot project could be set up in a second stage.

2. Capacity building on contractual agreements for innovative medicines

The objective will be to clarify the various approaches existing in the contractual agreements ensuring access to innovative medicines. Based on the initial mapping, members could pursue the exercise by developing further exchanges of practices and knowledge sharing.

3. Facilitating the supply in small countries

The objective will be to clarify the specific non regulatory bottlenecks for the access of medicines in small markets with all concerned parties with a view to defining possible specific approaches on pricing and reimbursement of medicines in these countries.

4. Promoting a good governance for non- prescription drugs

The objective will be to identify the necessary elements to ensure informed and adequate uptake of medicines after a change of their classification from being subject to medical prescription to not subject to medical prescription.. The members will in particular investigate the role of competent authorities, pharmaceutical companies, consumers and patients and healthcare professionals.

5. Market access for biosimilars

The upcoming emergence of biosimilars (a new biological medicinal product claimed to be “similar” to a reference medicinal product) may create new market dynamics. The objective of this project will be to define what the necessary conditions within the pharmaceutical environment are to ensure informed adequate uptake of biosimilars.

In order to steer the process in a given way, the platform will be driven by a Steering Group. The Steering Group will generate momentum for effective development of its projects and put forward experienced-based recommendations.

The following stakeholders’ organisations would be invited to take part of the platform on access to medicines in Europe: 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.

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