Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Legal proposal to allow pharmaceutical companies to provide information to patients on prescription-only medicines – a controversial discussion ***

Dr. Nicole Max (Abschlußjahr: 2009)

Language: English

Citizens of the EU have become more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments, especially in the Internet. With increased Internet use, ensurance of reliability and quality of information has become utmost important since information is sometimes provided by dubious sources and might contain poor-quality and even misleading information which can be accessed from all over the world.

The provision of information on medicinal products to patients has been a contentious issue for years. Although advertising of prescription-only medicines to the general public is forbidden, gaps and shortcomings in the current legislation (Directive 2001/83/EC) regarding information provision caused a situation in which Member States interpret EU legislation in different ways and have developed divergent practices on the provision of information on medicinal products. Thus, information that is freely available in some countries may be banned in others.

The Commission has concluded that there is a need for actions on EU level. The aim is to improve and harmonise information provision across the EU since better informed patients will lead to healthier societies by prevention, early diagnosis, and better treatment of disease as well as improved compliance.

The first legislative proposal (adopted 10th December 2008), which is due to be debated in the European Parliament and the Council, is a draft directive amending Directive 2001/83/EC and Regulation (EC) No 726/2004. It would allow, for the first time, that pharmaceutical companies can make information on their prescription-only medicines available to the general public, while maintaining the existing advertisement ban (Article 88 of Directive 2001/83/EC).
According to the draft directive only certain information like approved SPC, PIL, labelling and information not going beyond the elements of approved texts but presented in a different way are allowed. Additionally, information on environmental impact (e.g. price, adverse reactions etc.) and medicinal product related information (e.g. Non-Interventional Studies) can be given. All information provided must fulfil harmonised quality criteria. The information has to be objective and unbiased, based on evidence, up-to-date, reliable and understandable taking into account general needs and expectations of patients. Comparative information on medicinal products is strictly ruled out. The information cannot be disseminated over the radio or on TV or by direct mailing, but may be provided by unsolicited health-related publications, company websites and by way of written answers to questions from the public. There are specific rules on Internet websites which shall be registered and monitored by the Member State of registration and recognized by other Member States. Cases of disagreement shall be referred to the Pharmaceutical Committee. In general, the information is subject to control prior to its dissemination, except if the content is already approved by the Member State or equivalent level of monitoring can be ensured through a different mechanism (e.g. by self- or co-regulation).
Most stakeholders agree with the principles behind this proposal. Citizens should have the opportunity to access accurate, reliable, authorised and non-promotional information on prescription-only medicines but this information should be provided by independent sources, in a transparent, comparative and high-quality manner and free from commercial interests. For many opponents this aim cannot be achieved by the proposed draft directive.

It is feared that the suggested system will be overly burdensome for Member States without leading to significant improvements in the quality of the information. In addition, many Member States complain that the distinction between information and advertising is not sufficiently clear. Thus, the proposals do not provide adequate guarantees to prevent that the advertising ban will be circumvented. Pharmaceutical companies might produce biased, misleading messages promoting excessive consumption of expensive, but perhaps unnecessary new medicinal products as it has been experienced by the US and New Zealand, which both allow direct-to-consumer advertising.

On the other hand, pharmaceutical companies strongly desire to be able to provide more information directly to patients about their prescription-only medicines than currently allowed. They do not want US-style advertising but insist that they must have a role, along with other organisations, in informing patients about treatments and conditions.

Pages: 54; Annexes: 3, pages: 8