The Commission’s recently published work programme for 2010 contains several issues of interest to the industry for homeopathic and anthroposophic medicinal products: 

• Communication on a European Plan for Research and Innovation: this will propose an indicator to track innovation and specify a policy framework for developing European Research and Innovation Partnerships
  
  
• Reviewed Directive on veterinary medicinal products: to improve consumer safety and animal health protection and the competitiveness of the veterinary industry
  
  
•  Revision of the Directive on the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems: examine ways to adapt the requirements of the Directive in order to improve the functioning of the internal market for medicines, taking into consideration the development of national pricing and reimbursement policies
  
  
•  Proposal for a Competitiveness and Innovation Framework Programme 2014-2020 (CIP II):  to improve competitiveness and sustainable growth, addressing speeding up the adjustment of industry to structural changes, encouraging an environment favourable to initiative and to the development of enterprises (particularly SMEs)
  
  
•  Proposal 8th EU Research & Development Framework Programme for the period 2014- 2020: will contain main orientations and proposals for specific programmes and rules for participation.
  
  
•  Communication on smart regulation: presenting the Commission's priorities for smart regulation covering actions to simplify existing legislation and reduce administrative burdens.
  
  

Commission to review the 2004 Clinical Trials Directive
The current EU's Clinical Trials Directive has been severely criticised for resulting in higher costs and a heavier administrative burden while the benefit to patients, researchers or industry are not clear. The Commission has responded to these criticisms, and aims to review the Directive and put in place more effective regulation by October 2011. It has not yet been decided whether some of the more problematic elements in the current Directive will be simplified or whether an entirely new regulation will be put forward.

The Commission has funded a project under the Seventh Framework Programme (FP7), the ICREL project, which aims to obtain a coherent picture of the effect of the Directive on the pharmaceutical industry, academics, research ethics committees and medicines regulators. One of ICREL’s findings is that all stakeholders have had to increase their staff and resources in order to cope with the new requirements; moreover, the costs of clinical trials have risen quite substantially.

With Brazil, Russia, India and China rapidly developing their clinical trials infrastructure, it is becoming even more important to attract and keep industry and researchers in Europe. India, for instance, has invested heavily in research and as a consequence, its pharmaceutical sector is growing.

The Commission has published a roadmap outlining its commitment to addressing the shortcomings in the Directive.

Christine Marking
ECHAMP Public Affairs Consultant