EC moves towards “direct to consumer” advertisingBMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7306.184 (Published 28 July 2001) Cite this as: BMJ 2001;323:184
Pharmaceutical companies will be able to provide information on prescription drugs directly to patients with AIDS, diabetes, or asthma under legislative proposals tabled by the European Commission.
Announcing the scheme, the enterprise commissioner, Erkki Liikanen, insisted that it was not intended to undermine the existing ban on public advertising of prescription medicines in Europe.
“This is not direct to consumer advertising. We are not introducing advertising for prescription drugs. I am against direct marketing as massive advertising could place a lot of pressure on the health costs that are covered by public authorities,” he said.
Companies will be able to offer details of their medicines—possibly on websites or in specialised publications—for the three long term, chronic diseases only if they are requested to do so by patients or patient groups. They would also have to abide by a code of conduct, which will be drawn up by the end of the year.
The pilot scheme is one of a number of proposals made by the commission as part of a wide ranging overhaul of the European Union's pharmaceutical legislation, which has been in place since 1995. However, before any changes can be made to existing procedures, they must first be approved by EU governments and the European parliament.
Liikanen insisted that the reform package was designed to guarantee the highest possible level of health protection for European citizens, while encouraging innovation and competitiveness in the pharmaceutical industry. It aims to accelerate both the centralised authorisation procedure—which involves the commission and the London based European Medicines Evaluation Agency—and individual national procedures by reducing existing delays.
“We want to increase the availability of new and innovative medicines on the European market, while at the same time ensuring that the basic criteria of safety, quality and efficacy are met,” explained Liikanen.
The commission is proposing to follow the United States by introducing a fast track registration procedure for products of major therapeutic interest, allowing them to be assessed and authorised quickly and efficiently. It is also recommending the possibility of conditional marketing authorisation. This would enable a company to market a product for one year if there is an important expected health benefit for the patients concerned, provided that the company undertakes to carry out additional monitoring and clinical studies.
A third innovation would introduce a Europe-wide system to make medicines available before they are authorised, on grounds of compassionate use. The commission maintains that this would ensure that patients are not discriminated against on the basis, in particular, of the location of clinical trials performed by a particular company.
The reform package also recommends various changes to the European Medicines Evaluation Agency. These are designed to extend the agency's role beyond its existing remit of evaluating whether medicinal products should be given marketing authorisation to allow it to provide scientific advice to pharmaceutical companies.