Information to patients on prescription-only medicinal products
European Commission - MEMO/08/780 10/12/2008
Other available languages: none
Brussels, 10th December 2008
EU citizens have become more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments. EU citizens want to be able to access information on existing medicines and treatments and at the same time to be more actively involved in making decisions regarding their health. With the increased Internet use, ensuring the reliability and quality of information, particularly on websites, has become fundamental. Action at EU level will benefit EU citizens in many ways. First and foremost, the information provision will be improved and harmonized across the EU. There will be more possibilities to receive high quality objective and non-promotional information. Secondly, European citizens shall be able to receive information that is in line with EU legislation. This reduces the risk of receiving misleading and bad quality information.
EU citizens have unequal access to information across the EU. Although advertising of prescription-only medicines to the general public is forbidden, a lack of detail on information provision has led to a situation in which Member States interpret EU legislation in very different ways and have developed divergent practices on the provision of information on medicinal products. Harmonization at EU level can contribute to changing the current situation and promoting public health across the EU. This is of major importance in particular in the era of the Internet where citizens can access information from all over the world.
There are a range of sources from which patients receive information on medicinal products, most notably through consultations with healthcare professionals. However, bearing in mind that patients have become more independent and empowered as regards their own health, they also actively seek information by themselves. Consequently, other sources of information are needed.
What are the key measures proposed?
The European Commission has prepared a legal proposal on information to patients. Specifically, it proposes
The key elements of the legal proposal are:
Only certain communication channels for the dissemination of information shall be allowed:
All the information provided shall fulfil harmonized quality criteria:
The information made available will be monitored by Member States. In general, the information shall be subject to control of information prior to its dissemination. Internet sites containing information on prescription-only medicinal products shall be registered and monitored by the Member States.
When will this become law?
The proposal will now be transmitted to the European Parliament and the Council where it will be discussed and voted in the “co-decision procedure”. The legal proposal could become law at the earliest in 18 months following adoption and publication by the European Parliament and the Council.
More information on information to patients on prescription-only medicinal products
More information on the complete pharmaceutical package