Lawmakers tighten rules on drug information to patients

Swedish MEP Christofer Fjellner (European People's Party), who drafted the Parliament reports, said MEPs had ''changed the focus of the whole legislation from the rights of pharmaceutical companies to spread information to patients' right to get the information they need and want''.

Czech leftist MEP Jiří Maštálka (GUE/NGL) criticised the Commission's original proposal for not being patient-centred and said that MEPs had switched the focus to consumer rights rather than industry's right to advertise products – but that work remains.

''Despite these improvements, the proposal falls short in some areas (for example information on clinical trials) as it let industry set the information agenda and choose the medicines and diseases on which information should be provided. We will continue to work to defend consumers' rights to high-quality and non-promotional information on medicines," she added.

EFPIA, the voice of the research-based pharmaceutical industry in Europe, sees the Parliament's reports as a step forward but warned that new EU legislation must be practical and not create extra or unnecessary bureaucracy. Any material provided by industry should be subject to rigorous control irrespective of who is providing the information to the patient, it added.

''The European Parliament has demonstrated a constructive approach to this proposal, which is to be commended. We urge member states to adopt a similarly pragmatic approach to address the existing inequality of access to quality information. Modern society already has access to a great deal of information via the Internet; future discussions should examine ways to ensure that high-quality information is accessible to all in their own language, to benefit Europe's patients and public health,'' commented EFPIA Director-General Brian Ager.

The EGA, the representative body of the European generic and biosimilar pharmaceutical industry, said the Parliament's text ''will restrict companies to only providing information on their own medicines. This will prohibit misinformation campaigns from being conducted by companies against medicinal products of other companies which have obtained marketing authorisation from competent authorities,'' it added.

The European Patients' Forum (EPF), which represents 44 patients' organisations across the EU, called the Parliament's text a ''substantial improvement'' on the Commission proposal as it switches the focus from the rights of industry to the rights of patients to access quality, non-promotional medicine information.

''EPF hopes the current political momentum will be maintained to achieve important change in this area that will benefit the patients and the health systems in the long run, and we commit to work with the institutions in the next stage of the legislative process to further refine the proposal, in order to ensure tangible benefits for patients will be achieved,'' it added.