Stricter information rules on prescription medicines
Patients must have better access to high-quality information on prescription medicines in the future, said MEPs voting on draft legislation on Wednesday. This means providing objective information on a drug's characteristics and the treated disease or condition, while preventing unsolicited information or disguised advertising.
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 Member States.
Parliament adopted two legislative reports today at first reading: 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 Council.
Christofer Fjellner (EPP, SE), who drafted the reports for 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 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. 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 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 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. Member States should provide dedicated websites for this information, and any material must be in a format accessible for people with disabilities.
Contacts:
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Christopher COAKLEY