Pharmaceutical Group of the European Union

Members Area

ENVI adopted Information to Patients Dossier

Patients should get better information on prescription drugs following a vote in the European Parliament that aims to better educate consumers and protect them from hidden advertising.

In September, the Parliament's committee on public health rewrote the proposal, specifying which data firms must make available to the public and obliging the member states to provide objective information on medicines.

EU lawmakers overwhelmingly adopted two reports by Swedish MEP Christofer Fjellner (European People's Party) on the revision of existing EU legislation on patient access to health and medicine information.

The proposals now go to the member states for approval. EU health ministers will discuss the proposed rules on 6 December. If approved, they will then become law.

According to the Parliament's version of the bill, pharmaceutical firms would have to provide information about drug characteristics on labels and package leaflets.

They also would have to publish a drug assessment report as well as information on diseases and health conditions to be treated by the product. These requirements would be mandatory instead of optional, as originally proposed by the Commission.

All of the information would be screened by national health authorities within 90 days. The member states would also create websites so patients can have objective and unbiased facts about the drugs. Printed material would be available on request.

Parliament also shrank the grey area between information and advertising, opting to ban information on prescription medicines in newspapers as well as on television and radio. Overt advertising of prescription drugs is already banned in the EU.

Parliament ensured a ''proper balance between improving access to information available from companies and preventing the exertion of undue commercial influence,'' said Greg Perry, director-general of the European Generic and Biosimilar Pharmaceutical Industry Association (EGA).

An amendment that would have excluded information on drugs given by doctors and pharmacists was scrapped, much to the relief of consumer advocates who feared companies could hand out promotional materials.

''The pharmaceutical industry should not use the doctor's office and pharmacies to promote their products,'' said Monique Goyens, director-general of consumer lobby BEUC.

Companies will be allowed to provide other "non-promotional information" on the environmental impact of a product or price changes, but only with the permission of national regulators.