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Position to proceed

A new package of European law governing pharmaceuticals is being stymied by debate among EU health ministers about the differences between information and advertising

books_hammerEighteen months after the European Commission launched a public consultation on the provision to patients of information relating to prescription-only medicines, it seems that agreement on the proposal remains a distant prospect. The new EU pharma package of legislation is reportedly being held up by a failure of EU health ministers to agree on this element of the new directive. The longer the debate goes on, the more apparent it becomes that the current proposal is fraught with difficulties.

The so-called pharma package includes legislation in three main areas: anti-counterfeiting, pharmacovigilance and the improvement and harmonisation of the provision of information to patients. The focus of EU ministers to date, apparently, has been on the anti-counterfeiting and pharmacovigilance elements of the proposed directive. Although this focus may have arisen primarily from a failure to agree the information to patients' provisions, it is clearly important from a patient care perspective that the anti-counterfeiting and pharmacovigilance provisions are agreed and implemented as soon as possible.

It will be interesting to see whether the discussions over the information to patients' provisions are allowed to delay the pharma package as a whole or if the anti-counterfeiting and pharmacovigilance provisions are enacted in a directive of their own.

Clear border
European Commission vice-president Günther Verheugen hit the nail on the head when he said "it is necessary to have a clear border between information and advertising". This is indeed the case, but the real difficulty, not adequately addressed in the current legislative proposal, is how to distinguish between the two. It will be easier said than done.

Whether or not information is advertising, and thus promotional, is not determined just by content but, among other things, by how it is presented, how it is used and for what purpose. This is the heart of the problem.

The Association of the British Pharmaceutical Industry's (ABPI's) code of practice for the pharmaceutical industry defines promotion as "any activity undertaken by a pharmaceutical company or with its authority which promotes the prescription, supply, sale or administration of medicines". Directive 2001/83, the main piece of EU legislation governing medicines, does not define promotion, but it does define advertising as including "any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products". 

The most obvious danger is that the provision of information about a particular medicine to patients will lead to the consumption of that product, which, on the face of it, would amount to advertising.

There are certain circumstances in which information on medicines can be made available to the public, including when it is part of a disease awareness campaign or when information is given by the prescribing doctor to patients prescribed a particular product. In the case of disease awareness campaigns, the focus of the information should be on the disease, rather than its treatment, and the information should give a balanced overview of all therapy options. In the second case, the dissemination is to a limited section of the public and is controlled by the doctor. Allowing pharmaceutical companies to provide information to the public will represent a substantial step forward from the current position.

If the Commission believes it is possible to differentiate between the provision of medicines information to consumers, by pharmaceutical companies on the one hand and advertising to consumers on the other, the proposed directive will need to set out clearly:
• What information can be provided
• How the information can be provided
• How the information can be used
• What the permitted purposes of the information provision might be
• What uses of the information might be considered to be promotional.

The Commission's legal proposal did set out criteria that information should fulfil – such as not contradicting the summary of product characteristics (SmPC) – but greater direction is needed in other areas, including how the information can be used by pharmaceutical companies.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has suggested that self-regulation might be appropriate. This would seem to make sense in that country at least, given there is a system of self-regulation in place for the promotion of prescription-only medicines. It seems sensible to have the same system for the promotion of medicines and the provision of information to the public. The relevant regulator (or self-regulatory supervisory body, as the case may be) should be in a position to take a consistent approach as to what is promotional and what is not promotional, thereby reducing the risks of inconsistent decisions – within the same country at least.

For the time being, it looks as if there continue to be differences in position between EU health ministers. If the Commission chooses to proceed with a directive covering the anti-counterfeiting and pharmacovigilance elements of the pharma package, this will be a clear indication that these differences are significant. In that case, it could be a number of years before an information to patients directive comes into effect.

The Author
Tim Worden, Taylor Wessing LLP
To comment on this article, email pme@pmlive.com

19th November 2009

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