The Commission launches a public consultation on the future of pharmaceuticals for human use in Europe. The pharmaceutical sector has been and remains a key strategic sector in Europe. The future of this sector is a crucial matter for the EU.

The objective of DG INFSO when calling its stakeholders to contribute to this consultation is to raise awareness on the importance of ICT solutions in a future regulatory framework for pharmaceuticals, particularly in the area of safety of medicines

The Commission intends to improve the regulatory, non-regulatory and RTD framework for pharmaceuticals. For example, specific initiatives in the field of pharmacovigilance and variations have already been announced.

Contribution from all stakeholders -Patients organisations, Member States authorities, international bodies, industry associations and individual companies -innovative, generic and self-medication sectors-, healthcare professionals, or any other person or legal entity interested in this field- are welcome.

Stakeholders who are not established within the EU are equally invited to comment.

Comments from Small and Medium-sized Enterprises (SMEs) involved in the pharmaceutical sector are especially welcomed.

Contributions should preferably not exceed 5 pages.

KEY QUESTIONS

  • Do you agree with the analysis of the main challenges outlined above? Do you see other challenges?
  • Do you see other areas than those already targeted by the Commission where regulatory action should be taken?
  • What would you suggest as concrete measures to ensure the safety of medicines supplied in the EU, addressing in particular counterfeit medicines, and provision of high quality and affordable medicines also to third countries?
  • What can be done to improve Europe‚Äôs international competitiveness?
  • What can be done to foster convergence and transparency as regards pricing and reimbursement in the EU?
  • Do you think the current EU regulatory framework can accommodate emerging technologies like regenerative and personalised medicine, as well as nanobiotechnology?
  • Deadline to contribute: 12 October 2007

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