Healthy Skepticism Library item: 11198

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

EU Commission launches pharmaceutical consultation
PMLive.com 2007 Aug 6
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=5669

Full text:

The EU Commission has launched a consultation on the future of pharmaceuticals for human use in the EU, as a part of its programme to improve the regulatory, non-regulatory and research, technology and development framework for drugs in the region.

The commission has identified three major challenges impacting the pharmaceutical sector in Europe: the globalisation of the sector; the smooth functioning of the internal market; and advances in science and technology.

The commission said that due to structural factors, such as labour costs, much worldwide R&D investment in the field is slowly moving to the US and Asia on a global level.

For the internal market, the commission highlighted obstacles to the free movement of medicines, especially the safety of medicines. Recent analysis demonstrated the existence of multiple and sometimes inefficient requirements as regards pharmacovigilance in the EU. The commissioned advised that the challenge was to strengthen and rationalise drug safety monitoring, while avoiding unnecessary requirements that would delay patients’ access to treatments.

The increasing involvement of patients in monitoring their own health was a developing trend in the industry and the Commission said that patients needed better access to quality information.

The commission lastly identified advances in regenerative medicine, personalised treatments and the development of nanomedicines as trends all affecting the way medicines are tested and eventually prescribed.

Key questions asked by the commission concern other challenges to the industry, such as what measure could be implemented to ensure the safety of medicines supplied to the EU, how to improve the EU’s international competitiveness and how the EU regulatory framework can be applied to emerging technologies.