European Commission Releases Working Document Addressing Competitiveness of the European Pharmaceutical Industry

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-08-2014 09:14


The European Commission (EC) has launched a comprehensive public exchange of views to strengthen the competitiveness of the European Union's pharmaceuticals industry.

​The Staff Working Document forms part of the EC's efforts to contribute to growth and to foster the EU’s competitive role globally. It is a follow-up to the Communication of October 10, 2012 in which the EC announced its intention to “launch a policy strategy agenda to strengthen the competitiveness of the pharmaceutical industry."

The EC's Staff Working Document identifies the main challenges for the European pharmaceutical industry, such as health threats, high R&D costs, issues related to intellectual property, increased competition in the global marketplace, constraints in public budget, ethical behavior, and demographic changes. The document is partly based on the experiences made in the “Process on Corporate Responsibility in the Area of Pharmaceuticals”. This initiative was concluded in 2013. The new document identifies policy areas where actions have been already undertaken and which are worth exploring in more detail in the future, inter alia with regard to :

  • setting priorities with regards to the development of new therapies;
  • ensuring long-term sustainability of the pharmaceutical sector, notably fostering public-private cooperation, for example through innovative mechanisms such as the Managed Entry Agreements;
  • facilitating the availability of specific medicines, such as orphan drugs or biosimilars;
  • fostering transparency and ethical behavior in the sector, on the basis of the List of Guiding principles approved in 2012 by all stakeholders;
  • improving access to medicines worldwide; and
  • reinforcing the presence of the European pharmaceutical industry in the global market

As a first step the EC intends to organize an event in autumn 2014 in order to prepare future policy decisions by bringing together relevant decision makers from public European and member states’ administrations responsible for industrial competitiveness, health, research and innovation with patients, healthcare professionals, trade unions, and industry representatives.

Source: European Commission


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