Industry and Entrepreneurship
Transparency of measures regulating the prices of medicinal products
01.03.2012: Proposal for a Directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems repealing Council Directive 89/105/EEC (the so-called Transparency Directive), COM (2012)84
The underlying policy objective is to improve the functioning of the internal market for medicines. The aim of the review is to update the directive dating back from 1989, taking into account the case-law developed by the European Court of Justice, the outcomes of the Pharmaceutical Sector Inquiry and of the pharmaceutical market monitoring as well as developments in the market and in national pricing and reimbursement regulations.
High-level process in the field of public health
Platform on access to medicines in Europe (launched on 24 September 2010) – it was further elaborated with six working groups addressing the following issues:
- Promoting good governance for non prescription drugs
- Facilitating supply in small markets
- Mechanisms of coordinated access to orphan medicinal products
- Market access for biosimilars
- Capacity building on managed entry agreements for innovative medicines
- Prioritisation of medicines
Each of the groups met on different occasions during 2012, with the aim to deliver their conclusions in 2013.
Platform on Ethics and Transparency – this platform was launched in 2011. The COM acted as a facilitator of this process which for the first time has gathered and let to an agreement amongst all stakeholders (industry, health professionals, patient organisations, competent authorities).
06.11.2012: Adoption of a Decalogue of Guiding Principles on relative measures that can increase ethical and transparent behaviour in the pharmaceutical sector as a final result of these works.
Platform on access to medicines in developing countries with a focus on Africa (established in 2011) – two working groups have been set up in 2012: (1) on patent information; and (2) on local capacity building, in cooperation with United Nations Industrial Development Organization (UNIDO) and World Health Organization (WHO). Both workings groups met on different occasions during 2012 with the aim to reach their deliverables by mid-2013.