The European Commission has adopted revised proposals clarifying the information that drugmakers may supply to the public on prescription-only medicines.
The new proposals, which amend those put forward by the Commission in 2008 and respond to requests from the European Parliament, would maintain the current advertising ban on prescription medicines. They also propose that:
- only "certain" information on prescription drugs would be permitted, such as that on the label and on packaging leaflets, plus information concerning prices, clinical trials or instructions for use;
- information on prescription-only drugs would be permitted through limited channels of communication, such as officially-registered internet websites or printed information made available when specifically requested by consumers. Publication in general print media would not be allowed;
- the information must fulfill recognised quality criteria - it must, for example: be unbiased; meet the needs and expectations of patients; be evidence-based, factually correct and not misleading: and be understandable; and
- as a general principle, information which has not previously been approved will need to be verified by the competent authorities prior to dissemination.
The Commission comments that patients are increasingly interested in learning more about they medicines they take, and they want more of a say in how they are treated. But at the same time, they are confronted with a growing volume of information from a variety of sources, and often find it difficult to identify which information is reliable. Increased use of the internet make the need for clarity even more important, it adds; online information on medicines must be accurate and reliable.
"The revised proposals put rights, interests and safety of patients first," said John Dalli, the European Commissioner for Health and Consumer Policy. They "oblige industry to provide certain key information to patients and set clear rules for additional voluntary information on prescription medicines," and they "further strengthen the control of authorised medicines," he said.
The European Public Health Alliance (EPHA), which had dismissed the Commission's previous proposal as "a disguised way of giving pharmaceutical companies enough flexibility to promote their products directly to the public, in order to boost the sector's growth," said it "cautiously" welcomed the new version, describing it as "controversial and long-awaited."
The new tone of the proposal takes the public health perspective on board and this is welcome, said the non-governmental organisation (NGO), which also noted its "satisfaction" at the obligations which the new proposals would place on the industry.
However, added EPHA secretary general Monika Kosinska: "it is of the utmost importance that this is regulated by law and not by the pharmaceutical industry themselves, despite the opt-outs that we can see built in to this draft."
Moreover, she said the role of the internet should be limited to providing access to the patient information leaflet and safety information from a single portal, and that providing it on pharmaceutical company websites "would be misleading, confusing and inappropriate."
The European Consumers Organisation (BEUC) also gave the revised proposals a cautious welcome, noting that "the most detrimental provisions for consumers, such as printed communication,” had now been dropped, but also warning of a number of provisions that could still allow for "disguised advertising."
Also, the proposed approval and monitoring system will be very burdensome and costly, added BEUC director general Monique Goyens. "If the European Medicines Agency [EMA] does not validate the material within 60 days, the information submitted will be considered approved," she said, and asked: "but what will happen if they are suddenly overloaded with material to assess?"
In its response, the European Federation of Pharmaceutical Industries and Associations (EFPIA) urges European Union (EU) member states to adopt a "pragmatic" approach to tackling the current inequality of access to quality information. Modern society already has access to a great deal of information via the internet, and future discussions should examine ways to ensure that EU citizens seeking information on their disease or therapy "should be able to access it in both user-friendly formats and in their own language," it says.
EFPIA also emphasises the need for a viable legal framework, which should not require "added and unnecessary bureaucracy" but should instead build on existing best practice within the EU.
The industry group says that it continues to support the application of quality criteria that will distinguish information from advertising and ensure patients can receive helpful, non-promotional information on medicines. Robust control systems are important and can be complemented by a Europe-wide code of practice, which would "outline quality assessment procedures, including pre-approval of all communications by registered physicians or pharmacists, ex-post monitoring systems (involving third parties) as well as effective enforcement procedures," it suggests.
The Commission’s revised proposals will now be debated by both the European Parliament and the Council of Ministers.