European Parliamentarians have backed Commission proposals to ban information on prescription drugs being made available on radio and television, but also to extend the ban to print media.
This is a major change approved by Members of the European Parliament (MEPs) this week to the Commission’s long-delayed Directive on Information to Patients, which seeks to allow drugmakers to provide, for the first time, information on medicines directly to patients. MEPs also approved another amendment requiring health professionals to declare any links to pharmaceutical companies if they provide information on medicines at public events or in the media.
These changes were included in legislative reports adopted at first reading in Parliament this week. The first report, dealing with a regulation relating to European Union (EU)-level aspects of the proposals, was approved in a 564-41 vote in favour with 45 abstentions, while the second, a directive on rules for EU member states to apply at national level, was also overwhelming approved - 558-42 in favour, with 53 abstentions.
The version of the legislation approved by the MEPs would allow “objective information on a drug’s characteristics and the treated disease or condition,” but not “unsolicited information or disguised advertising.”
“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,” said Swedish European People’s Party (EPP) MEP Christofer Fjellner, who drafted the reports for Parliament. “This proposal offers only improvements when it comes to the quality and amount of information available to patients,” he added.
Patients need to be able to get information from those who know the medicine best, said MEPs. Drugmakers should be able to provide basics information, such as on product characteristics, labelling and package leaflets, plus an accessible version of a drug’s assessment report, and should also be allowed to provide certain other non-promotional information, for example on price or packaging changes, but only with the approval of the individual member state authority, the legislators added.
While direct-to-consumer (DTC) advertising of prescription drugs is banned throughout the EU, interpretation of the rules by member states has varied, and Parliament’s solution is an outright ban on prescription drug information not only on television and radio, as the Commission proposes, but also in print media.
A further amendment (no 88), which sought to exclude from the Directive information on drugs which is provided to the patient by doctors, nurses and pharmacists, was rejected by the legislators.
Amendment 88 was particularly controversial, with critics such as Monique Goyens, director general of the European Consumers Organisation (BEUC), warning that it would allow drugmakers to publish “any kind of information, without any form of monitoring.”
“The pharmaceutical industry should not use the doctor’s office and pharmacies to promote their products. We fear an undue influence on the doctor/patient relationship. The adoption of the amendment would set up the worst-case scenario - promotional information given by those people whom patients trust the most,” said Ms Goyens, speaking ahead of the vote.
Commenting after the vote in Parliament, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said the MEPs had adopted a “constructive approach” and urged member states to “adopt a similarly pragmatic approach to address the existing inequality of access to quality information.”
The vote is “clearly a step in the right direction, but many questions remain,” said EFPIA’s director general, Brian Ager. “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,” he added.
EFPIA has always pointed out that it does not wish to see any “push" of information on specific prescription medicines via television, radio or print media. However, it adds: “those citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language.”
The European Generic medicines Association (EGA) said it was “particularly pleased” that MEPs had adopted a text which would restrict companies to only providing information on their own medicines. “This will prohibit misinformation campaigns from being conducted by companies against medicinal products of other companies which have obtained a marketing authorization from competent authorities,” said the EGA
The draft legislation passed the committee stage in September, and the amended version approved by Parliament this week will now be sent to the European Council. The EU health ministers are set to discuss the proposals on December 6.