Europe tightens patient information proposals
European restrictions on patient access to medicines information are still on track to be relaxed, but the proposed changes have been tightened up this week after further deliberation by the European Parliament.
MEPs said information on prescription medicines should be prohibited not only on television and radio, as proposed by the Commission, but also in print media.
They also want health professionals who give information on medicines at public events or in the media to declare any links they have to pharmaceutical companies.
The changes were part of two legislative reports the Parliament adopted yesterday. These will now be discussed by the European Council, with a full vote on the proposals by the Parliament expected next month.
Christian Democrats MEP Christofer Fjellner, 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.”
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 new legislation as it stands would still allow “objective information on a drug’s
characteristics and the treated disease or condition”, but it would prevent “unsolicited information or disguised advertising” from pharma, MEPs said.
The draft legislation passed the committee stage in September and has now been further amended to clarify pharma companies’ obligations, the possibilities to inform patients, as well as the role to be played by Member States.
EFPIA say questions still remain
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.
European pharma industry body EFPIA has always distanced itself from this, saying it only wants to provide relevant information to patients.
It broadly welcomed the Parliament’s new vote, but said questions remained.
Brian Ager, director general of EFPIA, said: “Modern society already has access to a great deal of information via the internet; future discussions should examine ways to ensure that high quality information is accessible to all in their own language, to benefit Europe’s patients and public health.
“To achieve real progress for patients, it is vital that any new legislation provides a viable legal framework. It should not require added and unnecessary bureaucracy; instead it should build on existing best practice within the EU.”
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