The European Commission’s proposed package of pharmaceutical legislation will undermine patient safety, is designed to favour the industry and has scant regard for patients, claims a draft opinion to be presented today at a meeting of the European Committee of the Regions (CoR).

This industry bias is underlined by the fact that the package was drawn up by the Commission’s Directorate General (DG) for Enterprise and Industry rather than by DG Sanco (health and consumer protection), which usually deals with health issues, says the opinion, which has been drawn up by the CoR’s Commission for Sustainable Development (DEVE) and will be presented by the group’s rapporteur, Swedish European Parliamentarian Susanna Haby, a member of the European People’s Party (EPP).

The DEVE says it “welcomes” the initiatives set out in the Commission’s pharmaceutical package, pointing out that it had asked DG Enterprise to present a policy on medicines and criticised DG Sanco’s 2008 White Paper - entitled Together for Health: A Strategic Approach for the EU 2008-2013 – for not addressing the issue of pharmaceuticals.

However, it says, the proposed directive does not consider the role played by local and regional authorities, even though they are responsible for health care services in many EU member states.

Moreover, while the European-based pharmaceutical industry plays an important role, both as a scientific base for the health care sector and as an economic player, the opinion states: “the pharmaceutical industry’s principal task is to develop medicinal products that satisfy patients’ needs. Companies’ investment efforts should therefore focus on investment in R&D.”

Information to patients provided by the industry must comply with quality standards and should preferably be approved in advance, either by the member state where the product is authorised or at EU level in the case of centrally-authorised products, it says.

Europe’s ban on direct-to-consumer (DTC) advertising of prescription medicines should not only be maintained but extended to ads related to campaigns for vaccination and other public health issues, it says; information on these products should be subject to the same legislation as other prescription drugs, except for preventive travel vaccines, which should retain their exemption from the advertising ban.

“Vaccination campaigns and other campaigns in the interest of public health carried out by the industry should not be allowed, on public health protection grounds and on the ground of the risk of overuse of medicines without medical supervision,” says the DEVE.

The Commission package says drugmakers should not be able to make information on their prescription drugs available to the public through television or radio, but only through medicines-related Internet websites and health-related publications. But, says the opinion, the concept of “health-related publications” is difficult to pin down, so these channels should be removed from the proposal. As it stands, this presumes that each member state should define which publications would be included, with the obvious risk of different interpretations, it says.

Turning to the Commission’s proposals to protect the supply chain from counterfeit products, the DEVE calls for parallel trade in safe products to be continued, as this helps to keep prices lower, and also asks it to ensure that the directive does not delay the entry of generics to the marketplace.

The Commission should also monitor price developments, to ensure that its proposed measures do not lead to higher prices, and they need to “strike a balance between increased safety and growing costs,” it adds.