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EU moves towards stricter information rules on prescription medicines

Wed, Nov 24 2010 17:34 CET 2317 Views 1 Comment
EU moves towards stricter information rules on prescription medicines

Photo: Reuters

Patients must have better access to high-quality information on prescription medicines in the future, members of the European Parliament said, voting on draft legislation on November 24 2010.

This means providing objective information on a drug's characteristics and the treated disease or condition, while preventing unsolicited information or disguised advertising, according to a European Parliament media statement.

MEPs based their changes to the draft legislation on the fundamental principle that patients should have the right to obtain accurate and unbiased information on medicines. They clarify pharmaceutical companies’ obligations and possibilities to inform, as well as the role to be played by Eu member states.

The European Parliament adopted two legislative reports at first reading on November 24: a regulation relating to EU-level aspects (564 votes in favour, 41 against and 45 abstentions) and a directive on rules for Member States to apply at national level (558 votes in favour, 42 against and 53 abstentions). These will now go for discussion in the European Council.

Christofer Fjellner (EPP, SE), who drafted the reports for the European Parliament, said, "The most important thing we did during this process was to change the focus of the whole legislation from the rights of pharmaceutical companies to spread information to patients' right to get the information they need and want. This proposal offers only improvements when it comes to the quality and amount of information available to patients."

Companies must inform, not advertise

With no shortage of unverified information on medicines on the internet, patients need to be able to get informed from those who know the product best.

MEPs say that pharmaceutical companies must be able to provide basics, such as product characteristics, labelling and package leaflets and an accessible version of a drug’s assessment report.

Firms should also be allowed to provide certain other non-promotional information, for example on price or packaging changes, but only with the authorisation of the relevant EU member state authorities.

Overt advertising of prescription medicines is already banned across the EU, but member states’ varying interpretation of the rules means there can be a fine line between information and commercial promotion, the media statement said.

To help clear this up, MEPs say that information on prescription medicines should be prohibited not only on television and radio, as proposed by the the European Commission, but also in print media.

Health professionals must declare any links to pharmaceutical companies if they give information on medicines at public events or in the media.

Member States to provide online information

MEPs emphasise that EU member states are responsible for national rules to ensure "objective, unbiased information" is available to the general public.

This includes leaflets in packaging, an assessment report of the product and information on how to prevent such diseases and conditions. EU member states should provide dedicated websites for this information, and any material must be in a format accessible for people with disabilities.

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Comments

Anonymous Huib van den Doel Wed, Nov 24 2010 22:07 CET

The problem in BG is far worse: that anyone can buy antibiotics without prescription, so people will take antibiotics even for a common cold or just a sore throat. Many people think they can stop taking their pills when the first symptoms have gone - that's the way to create resistant bugs.


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