WRITTEN QUESTION E-1633/01

by Chris Davies (ELDR) to the Commission

(12 June 2001)

Subject: Patient information on medicines

Given that patients have access to a wide range of medicinal and health information via various sources, and specifically the internet, and given the importance of an informed patient, does the Commission have any plans to review and assess the role and value of patient information? Furthermore, does the Commission have any plans to introduce any new initiatives or pilot schemes that will allow the pharmaceutical industry to provide patients directly with greater access to information on medicines?

Does the Commission have any plans to introduce any amendments to existing advertising and/or medicines directives so as to provide patients with greater access to information?

With the expansion of the internet and the increasing popularity of health-related websites offering information and advice, does the Commission have any plans to review and assess the role and value of patient information from all sources?

Answer given by Mr Liikanen on behalf of the Commission

(18 September 2001)

With the spread of the new information technologies, the public has access to a much wider range of information which it is very difficult to monitor. In the case of medicines, and public health in the broader sense, there is strong demand from certain patients who should, therefore, be able to have access to good-quality information.

Article 3 of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use(1) lays down that advertising to the general public is prohibited for medicinal products which are available on medical prescription only.

On 19 July last, the Commission adopted a proposal to amend the aforementioned Directive and transmitted it to Parliament and the Council for adoption.

As part of the ongoing pharmaceutical review, for instance, the Commission proposes that the possibilities of disseminating information for patients on prescription-only medicinal products should be extended in order to meet the patients' legitimate needs. Patient information on some of these products would be possible in a precisely determined and strictly monitored framework. This would involve certain medicinal products intended for the treatment of conditions such as Aids, diabetes or broncho-pulmonary illnesses. The choice of conditions depends on various criteria such as patient demand, the role of health professionals in the pathology, the chronic nature of the illness and the characteristics of the target populations. This type of information would be limited to principles of good practice adopted by the Commission in liaison with the competent authorities of the Member States and would depend on the establishment, at Member State level, of procedures for self-regulation by the pharmaceutical industry. It is also proposed that the Agency for the Evaluation of Medicinal Products be entrusted with monitoring the application of good practice and with coordinating the monitoring of this type of information. There will naturally be an evaluation after an establishment phase of five years in order to determine the follow-up to this trial and propose any changes which might be necessary with a view to improving its application.

(1) OJ L 113, 30.4.1992.