A long awaited "switch"
This was a long-standing request from many civil society stakeholders and the purpose of our previous letter to President Barroso on 13 October 2009. This transfer of competencies is a positive sign of Mr Barroso’s willingness to put citizens at the centre of European politics, as expressed in his political guidelines for the new Commission.
As a matter of fact, pharmaceuticals and medical devices cannot be considered as “normal” consumer products. The European Commission’s proposals made in December 2008 (“pharmaceutical package”) illustrate the unbalanced approach taken by DG-E: pharmaceutical companies’ short-term profitability and industrial competitiveness are favoured at the expense of public health. In order to put EU citizens’ needs and concerns first, public health should be the main driver for pharmaceutical and medical device policies in Europe.
Priorities to improve public health
If the new Commission is effectively approved by the Parliament in January 2010, MiEF and ISDB expect that the leading role of DG-SANCO will give a new start to the European Commission’s approach to health and medicines, putting patients' needs first.
The priority is to reorient the content of the legislative proposals part of the "pharmaceutical package" that puts patients at risk, namely the patient 'information' proposals (aimed to legalise 'direct-to-consumer advertising' (DTCA) for prescription medicines), and some provisions of the pharmacovigilance proposals (premature marketing authorisations becoming the rule, outsourcing the collection and interpretation of pharmacovigilance data to drug companies, a European pharmacovigilance committee (PRAAC) that has no power).
Another priority is the reorganisation of EMEA's funding and functioning, improving its transparency and accountability to the public. The European Commission will have to demonstrate that the switch from DG-Enterprise to DG-SANCO was not cosmetic but in fact reflects a new ambition for European patients.
> Click here to download the Joint Press Release (pdf 163 Ko).
©Medicines in Europe Forum, December 2009