Organisations question EC changes on drug information for patients
Medical and consumer organisations are raising concerns about plans by the European Commission to allow drug companies to provide information on prescription only drugs directly to the public. The drug industry is also questioning how the system would work in practice.
The initial reactions to measures that would allow drug companies to supply factual information on prescription only drugs to the public emerged last week at a conference in Brussels organised by the European Commission and the Organisation for Professionals in Regulatory Affairs.
The draft legislation, tabled last December, covers the type of information that may be given; the channels through which it may be supplied; the quality criteria and conditions to be met; the monitoring mechanisms to be put in place; and the sanctions to be applied in cases of non-compliance.
The conference was the first major opportunity for different groups to present their views in the same forum. The European Commission argued that citizens should have equal access to good quality non-promotional material, no matter where they live in Europe.
For the medical profession, Lisette Tiddens-Engwirda, secretary general of the Standing Committee of European Doctors, welcomed moves to empower patients but emphasised the importance of the doctor-patient relationship. “Healthcare professionals should remain the principal source of health information to patients,” she said. She also warned against a US style “horror scenario” whereby doctors and pharmacists came under pressure from the public to prescribe certain drugs.
Consumers’ organisations were even more opposed to the idea. Ilaria Passarani, the head of the health department of the European Consumers’ Association, argued that the future legislation was “based on an unworkable distinction between information and advertising.” Instead she argued for a comprehensive strategy on health information that would enable patients to choose and compare different treatments.
Paul Woods, the global compliance policy director for the drug company AstraZeneca, said that the draft legislation was close to the industry’s position and insisted that information to patients should be judged on its content and effect, not its source. He noted that nothing in the proposal went further than was already allowed in some European countries. But he questioned how prior vetting of information to the public would work in practice and called for clarification of what types of publication would be included in the proposal.
Despite the varying reactions to the proposal, the conference confirmed widespread agreement on several key principles of European practice: that the existing ban on advertising medicinal products should remain; that information should not be provided on television or radio; and that there is no desire to reproduce in Europe the freedom that drug companies have in the United States.
6/3/9, BMJ 2009;338:b894