Europe votes for patients’ access to information
pharmafile | September 29, 2010 | News story | Medical Communications, Sales and Marketing | Europe, medicines information
Members of the European Parliament have voted in favour of giving patients across Europe access to ‘high quality information’ on medicines.
The vote by the European Parliament’s Environment Committee could be a breakthrough on a controversial issue which has been deadlocked for a decade.
Many MEPs have been opposed to relaxing European community laws on information to patients, fearing it would allow pharma companies to use US-style direct-to-consumer (DTC) advertising of medicines.
The European pharma body EFPIA has always distanced itself from US DTC, saying it only wants to provide relevant information to patients, and has welcomed the vote.
The Environment Committee seems to have been persuaded that change is needed, and the legislation will now be voted on by the full European Parliament in December.
The committee has made it clear, however, that only “objective, unbiased information” should be supplied to patients, and says it wants to protect them from “unsolicited information” on medicines.
Pharmaceutical companies would be included among those allowed to supply this information, but what information can be supplied, and through which channels will be hotly contested.
The MEPs propose that at least the following should be made available:
- A summary of product characteristics, a labelling and package leaflet and a publicly accessible version of the assessment report of the medicinal product
- The diseases and health conditions which are to be treated with the medicinal product
- Information on how to prevent such diseases and conditions.
Significantly, the committee also wants to oblige EU member states to give its citizens objective and unbiased information on medicines. An example of an existing service is the UK government’s website NHS Choices, but not all EU countries currently provide such high quality information.
Brian Ager, EFPIA’s president, said that the vote represents a “step forward in the long-running debate on patients’ access to information,” but the future for such legislation remains on rocky ground as Europe is deeply divided over the issue.
The basic aim of the legislation drafted by the European Commission is to ensure the availability of “good-quality, objective, reliable and non-promotional information on medicines”.
The Environment Committee says its members voted to emphasise patients’ rights to information, rather than making the provision of information an option for the pharmaceutical companies, as the European Commission originally suggested.
Information would have to be made available both in electronic and printed form, and in a format accessible for people with disabilities.
MEPs also voted that pharma companies should be required – to make available the approved and most recent contents of summaries of product characteristics, labelling and package leaflet and a publicly accessible version of the assessment report.
In addition, pharma companies may provide the general public with other well-defined non-promotional information, for example on the environmental impact of the product or on prices or pack changes, or instructions for use of the product, although they would need prior authorisation from the competent authorities.
Debate over access to information
EFPIA says it has already made clear that it does not wish to “see any ‘push’ of information on specific prescription medicines via TV, radio or print”.
The UK, Sweden, and Denmark are among the most prominent countries that want a more liberal approach, while Germany, France and Spain take a more conservative approach.
Commenting on the vote, Ager said: “The European Parliament is to be commended for its pragmatic approach to these proposals. This contrasts with the situation in a number of Member States, where there has been a reluctance to even discuss options for providing citizens and patients with improved access to information about their illnesses and treatments.”
He continued: “Such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between Member States.”
Ager concluded: “To be effective and add real value for patients, any new legislation must provide a viable legal framework. It should build on existing best practice within the EU, and not introduce costly and unnecessary bureaucracy, delivering neither real benefit in the quality of information nor public health gains.
The proposal represents one element of the EC’s 2008 ‘Pharmaceutical Package’, along with a proposal on falsified medicines and pharmacovigilance.
Further amendments, wrangling and ratification by European bodies would have to follow, but the reforms could conceivably become law by the end of 2012.
Ben Adams
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