Healthy Skepticism Library item: 13738

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor L.
Pharma 'inappropriate source of general Rx info,' EU told
Pharma Times 2008 May 28
http://www.pharmatimes.com/WorldNews/article.aspx?id=13581&src=EWorldNews

Full text:

The pharmaceutical industry is not an appropriate source of general information on prescription medicines to the public, mainly because of potential conflicts of interest relating to financial matters, according to nearly half the responses to the European Commission’s now-completed public consultation on the provision of medicines information to patients.

Responses received from health care professionals and payers were “mostly suspicious” of drugmakers as information suppliers, while those from media, patient information organisations and the industry itself were generally supportive. A significant minority suggested that, if there was a clear distinction between advertising and information, companies would be a valuable source of such information because they know the product.

Most responses agreed that drugmakers should be allowed to publish on their websites Summaries of Product Characteristics (SPCs) and patient information leaflets (PILs), for example. However, many of then, especially from health professionals and regulators, were apprehensive that manufacturers could focus this information on newer products, because they would have stronger economic interests in doing so. “Information about ongoing studies shall by no means be communicated to the public, as they are likely to create massive uncertainty in patients,” the Commission adds.

While the general view of responders was that information to patients should not be able to go beyond the key elements specified in SPCs and PILs, media and patient groups believed it should go further, asking what the benefit of producing further information would be if it cannot present anything different from that already contained with PILs.

The industry suggested that non-promotional information should be categorised thus: – pro-active information (push), which is provided unsolicited to the public, should be limited to general information on diseases, for example awareness and prevention but not mentioning specific medicines; – reference information on diseases and medicines (pull), which is sought by patients and citizens as in a library, for example through the Internet; – reactive information, which is supplied in response to spontaneous enquiries received from patients and citizens; and – support information, which is supplied with or subsequent to a prescription for a specific medicine, for example to support concordance with the prescribed product.

Views were mixed on whether comparisons between products should be permitted, with some responders adamant that drugmakers should not be allowed to provide information that compares different products, while others felt such comparisons could be very useful for patients and help them to take more responsibility for their health care.

Regulators warned the Commission that the proposed information monitoring mechanism would create more work for them, and that a co-regulatory mechanism can be expensive and lead to different codes of conduct in the various member states. However, the states should be free to decide what form, composition and executive powers the co-regulatory body – or any type of body – should have, it was stressed, and the consumer and patient groups suggested that one of the most important tasks of the EU Advisory Committee could be to provide a model code of conduct.

This Committee should be composed of key stakeholders, iespecially patients, the Commission was told, but responses from the industry warned of the danger with this model of developing a patchwork of very different interpretations and implementations in national laws.

- The consultation was launched on February 5 as part of Commission plans for a legal proposal to ensure “good-quality, objective, reliable and non-promotional” information on prescription-only medicines to the public and harmonise the existing situation in member states.