The ongoing effort to improve a patient’s ‘fundamental right to know’ reached another milestone recently after the European Commission completed the public consultation on its report on the provision of medicinal product information to patients. In response to the consultation, the European Patients’ Forum has called for pharmaceutical companies to be allowed to act as a validated non-promotional source of product information to patients.
Patient organisations have been fighting for harmonised pan-European proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products. Of particular relevance to the pharmaceutical industry is the issue of an existing legislative framework that does not permit pharmaceutical companies to respond to enquiries from patients about their medicines.
The legal situation governing information for patients has not changed fundamentally over the last 15 years. Three years ago, however, the amended pharmaceutical Directive 2004/27/EC tackled this inertia by stating: “Within three years of entry into force of Directive, the Commission shall, following consultation with patients’ and consumers’ organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision – particularly on the Internet – and its risks and benefits for patients.”
A draft report on current practices in the provision of information on medicinal products to patients went out for consultation in April.
Since 2004, several Commission initiatives and public debates have focused on the need to address the lack of a Community framework for patient information, so as to respond better to the needs of patients and the overall interests of public health. The European Patients’ Forum (EPF) was consulted extensively on the draft report and has called for a number of amendments to the proposals.
Rui Santos Ivo, the European Commissioner responsible for the report, is now collating the responses to the consultation. The draft report looked at existing mechanisms and technologies in the EU for the provision of information to patients in terms of patients’ needs, the role of the internet and the parts played by different stakeholders, he explained. The draft report identifies a number of issues stemming from the existing legal framework and different practices in the Member States.
“We have just started analysing the different contributions received,” he said. “The document also intends to set the basis for the Commission to consider a strategy on information to patients by recognising important developments in society concerning the patient’s role, rights and responsibilities, and also that access to reliable and good quality information is essential. It highlights the importance of action at EU level in order to overcome issues such as inequalities in access and EU quality standards for information.”
Provision of info by pharmas
Clearly recognising that patient organisations are key drivers for health democracy at EU level, the EPF argues that today’s patient is changing from the passive recipient or bystander to an informed and political actor.
"All patients have a fundamental and legitimate human right to access quality information about their health, medical conditions and the availability of treatments, including knowledge of the best available management of their disease,” the EFP stated. “This right implies that the same information that is available to doctors should also be available to patients.”
Among its concerns, the EPF drew attention to current legislation governing the provision of information to patients by pharmaceutical companies. “EPF and our patient allies resist strongly direct-to-consumer advertising on prescription medicines (DTCA),” it stressed. Nonetheless, the EPF believes there is increased consensus on the dividing line between access to quality information and DTCA.
“Pharmaceutical companies should be able to be a source of validated non-promotional information alongside other sources, on their products. However, it is crucial to ensure that when patients seek information from pharmaceutical companies, they get full information, including, for example, negative side-effects,” the EFP commented.
The redrafted report incorporating comments from patient representatives will be presented to the European Parliament and Council later this year.