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EU vote on access to health information

The European Parliament votes today on legislation to improve patient access to health information – part of the EC's 'pharmaceutical package'

The European Parliament (EP) votes today on legislation to improve patient access to health and medicines information.

The legislation is part of the European Commission's (EC) 2008 'pharmaceutical package' – comprising proposed regulations on counterfeit medicines, pharmacovigilance and patient access to information.

The EP voted in favour of the pharmacovigilance measures earlier this month.

Increasing patient access to information, while maintaining the existing advertising ban on prescription-only medicines, is the second stage of the 'pharmaceutical package'.

According to the EC, these proposed measures were made in response to EU citizens becoming 'more empowered and proactive consumers of healthcare, increasingly seeking information about medicines and treatments.'

Proposed actions in the legislation include:

• Only certain information about prescription-only medicines to be allowed, including summaries of products characteristics, and information on the environmental impact of the medicine
• Only certain communication channels for the dissemination of information to be allowed, including health-related publications as defined by the Member State of publication and internet websites on medicinal products
• All information provided to fulfil certain quality criteria, including being unbiased, reliable and understandable.

Speaking on today's vote, Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it "represents a step forward in the long-running debate on patients' access to information."

He continued: "However, 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 EFPIA has already listed a set of proposals to reform the current situation regarding patient access to information. Included in these measures is a set of criteria to distinguish 'information' from 'advertising' as well as a code of practice to require effective quality assessment procedures and effective enforcement procedures.

Today's vote will be analysed by the EFPIA, with detailed conclusions to follow.

More information on the 'pharmaceutical package' can be found via the EC: http://ec.europa.eu/health/human-use/package_en.htm

28th September 2010

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