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Products to patients

A summary of all the responses to the European Commission consultation has now been published

In April this year, the European Commission carried out a public consultation on proposals about the provision of information on medicinal products to patients. The objectives and criteria behind this were examined in detail in 'Better Informed.'

A summary of all the responses to the consultation has now been published and a new 'pharmaceutical package' is expected to be made available in late October/early November this year. This will include a Directive on making information available to patients about pharmaceuticals.

LACK OF HARMONY
The Commission identified a lack of harmonisation in the European Union as to the type of information on medicinal products available on the internet. It suggested that an increase in the quality and appropriateness of the information could contribute to better health conditions and a more efficient use of resources.

DTC ADVERTISING
One point, of particular interest to marketers, was the Commission's claim that its proposals would not amount to a change to the ban in Europe on the advertising of prescription-only medicines to consumers. However, many commentators believed that the proposals would at least lead to a situation where consumers had access to information that was more promotional than factual in nature.

The Commission also proposed different levels of regulation according to whether the information was being 'pushed' to the consumer or 'pulled' by the consumer. In particular, the proposal document suggested that the pushing of information to consumers through television and radio was under consideration – controversial to say the least.

FORMAL RESPONSES
The Commission received 185 formal responses, many of which are available to view on its website. About one-third of these came from healthcare professionals and organisations, with just over a third coming from a combination of patient organisations and regulators. The remainder came from  pharma, consumer organisations, media and patient information organisations, and consumer organisations. The Commission has produced a summary of the responses showing that the overall consensus was that there is a:

"need to provide citizens of EU member states with understandable, objective, high-quality and non-promotional information about the benefits and risks of their prescription-only medicines."

Not surprisingly, the issues that elicited the most comment were the role of the pharmaceutical industry as an information provider, and the possible use of television and radio as channels for disseminating information.

ROLE OF PHARMA
Nearly half of respondents felt that this pharmaceutical industry is not an appropriate source of information for prescription-only medicines.

Concern was expressed as to the impact that such an arrangement would have on the doctor-patient relationship – which many organisations see as an important fundamental in healthcare – as well as the doctor's freedom to prescribe an appropriate medicine for a particular patient.

Respondents also noted pharma's conflict of interest in supplying information about their own products. Some questioned whether it is possible for the industry to provide the unbiased information patients need to make informed decisions about their medication.

THE DIVIDING LINE
The EC stated in its consultation document that it will set out clear criteria for distinguishing between advertising and non-promotional information.

Many respondents commented  that this would be a very challenging exercise. The Standing Committee of European Doctors (CPME) expressed, "very considerable doubts that this is possible." 

Other respondents felt that the very act of attempting to make such a difficult distinction would open the door to the possibility of abuse.

TV AND RADIO
A mere 7 per cent of respondents supported TV and radio as acceptable channels by which to distribute  information on prescription-only medicines. In addition to the inherent difficulties in drawing a dividing line between promotional and non-promotional information, it was felt that TV and radio are simply not appropriate media for this sort of information.

It was interesting that most pharma company respondents did not support the concept of TV and radio as information channels and neither did EFPIA.

NEW PACKAGE
The new pharmaceutical package is expected to contain the Directive on information to patients concerning pharmaceuticals, as well as regulations and proposals relating to pharmacovigilance and ways to combat counterfeiting.

The mere fact that the Directive on information to patients is being proposed as part of a bigger package has in itself sparked some comment that the legislation will receive less public and parliamentary scrutiny than it deserves.

In light of the responses to the proposal, it is difficult to imagine that the use of TV or radio  will be included in the new Directive.

LEGISLATION LAYER
As the legislation will take the form of a Directive, it will need to be incorporated into the national laws of each EU member state, giving rise to another 'layer' of legislation, in which, without doubt there will be national variations.

The Author
Tim Worden is an associate at Taylor Wessing LLP

16th November 2008

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