Why launch a new consultation on pharmaceuticals?
The consultation on the future of pharmaceuticals for human use touches a wide range of issues beyond the issue of information to patients. However, the purpose of DG Enterprise remains to foster the competitiveness of the European Pharmaceutical sector.
According to DG Enterprise, three main challenges need to be met by pharmaceutical companies:
globalisation of the pharmaceutical sector. This implies fighting cross-border threats to health, but also strengthening corporate competitiveness by removing regulatory and non regulatory barriers to trade.
smooth functioning of the internal market, with the removal of regulatory and non-regulatory obstacles to the free movement of medicines.
advances in science and technology, which need to be translated into the EU pharmaceutical framework.
What are the specific targets of DG Enterprise?
DG Enterprise is considering the following actions:
greater harmonisation of national pricing and reimbursement schemes;
rationalising drug safety monitoring in order to avoid unnecessary requirements that would impair patient’s access to treatments;
analyse patient’s safety aspects of medicines in the distribution chain;
enable patients to access medicinal information held by the industry; This however could seriously undermine the quality of the information made available to patients according to health and consumer NGOs.
Next steps
Contributions should be sent to nicolas.rossignol@ec.europa.eu before 12 October 2007.
Given that the consultation was launched in the middle of the summer and most organisations interested (specially networks of NGOs) need more than 12 weeks to carry out their internal consultations, several organisations have asked for an extension of the deadline to respond (see EPHA’s letter to the European Commission below).
The Commission intends to issue a Communication during 2008 outlining its vision and strategy for the pharmaceutical sector with concrete actions to adapt the current EU framework to the needs of the pharmaceutical industry.
More information on EPHA’s website:
EPHA Consultation Response on "Information to Patients", April 2008
EPHA response to the Pharma Forum consultation on information to patients
