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Better informed

The European Commission is proposing improvements in patient information
The European Commission has carried out a public consultation on its proposals about the provision of information on medicinal products to patients. The key objectives of the proposed changes are:
  • to establish a framework for the provision of good-quality, objective, reliable and non-promotional information on prescription-only medicines to members of the public
  • to maintain the prohibition on the advertising of prescription-only medicines to consumers
  • to avoid unnecessary bureaucracy in implementing the new framework.
  • The Commission reported in 2007 on current practice in patient information. It pointed out that there are no EU quality standards for information provided. It raised concerns about the lack of harmonisation of the type of medicinal products information available on the internet.

    It also reported that member states disseminate information to patients in different ways. In some countries this is through public bodies ñ such as regulatory authorities ñ and in others through publicñprivate partnerships, which often include a pharma company. The report states that a lack of information may lead to patients making uninformed choices. Increasing the quality and appropriateness of information available would help: Öto achieve better health conditions and also to contribute to a more efficient use of resources.

    Key objectives
    The consultation states that the fundamental objective of the changes, to be proposed in detail to the European Parliament and Council by the end of 2008, is to provide rules to harmonise the provision of medicinal product information to patients across member states.

    The proposed changes will not amend the prohibition on advertising of prescription-only medicines to the public. It will set out clear criteria for distinguishing between advertising and information relating to a product which is regarded as non-promotional. The latter can be provided to the public.

    Information criteria
    Information about a drug should be compatible with the summary of product characteristics (SPC) and patient information leaflet (PIL), and should not go beyond the key elements specified in them.

    The consultation also suggests that other limited medicine-relating information could be given, such as details of scientific studies.

    How the monitoring of this provision of information will be approached should depend on whether the relevant patient or consumer has requested the information or not.

    If they are passively receiving the information, this is referred to as a 'push' by the information provider. If they are actively seeking the information, this is known as 'pull' by the patient.

    'Push' information providers are to inform the relevant body about their activities before action is taken.

    'Soft pull' provision is where a patient has searched for and located information about a product from the relevant provider. This may be directly via a website or through a third party who has recorded the information and made it available. This should be notified to the relevant body, who will then monitor it.

    'Pull' is where a patient or consumer asks a pharmaceutical company a question about a specific product. The relevant body should follow up any complaints it receives about the company's response.

    Any information provided should be: objective and unbiased, patient-oriented, evidence-based, up-to-date, accessible, transparent, relevant and consistent with approved information.

    The consultation recommends that comparisons between products should not be permitted.

    Monitoring body
    It is proposed that each member state sets up a national co-regulatory body. Its role should be to adopt a code of conduct on the provision of information to patients, and monitor relevant industry activities.

    This body should consist of public authorities and a mix of healthcare professionals, patient organisations and the pharmaceutical industry.

    There are two options for monitoring, either the industry could self-regulate, or regulation could be carried out directly by national medicines regulatory authorities.

    Areas still unclear
    There are areas where the scope of the Commission proposal is still unclear. In relation to the push of information to patients it does not indicate how much information the provider needs to supply in advance to the relevant national body. Is it sufficient to notify the fact, and general terms, of the push, or is the Commission, in effect, proposing a pre-vetting system whereby the exact material is reviewed and pre-approved by the relevant body? If it is the latter, this may represent a considerable delay for the information provider, and a significant administrative burden for the relevant body.

    The level of guidance provided by the Commission on the distinction between advertising and the provision of non-promotional information is not spelled out. The consultation states that, clear criteria should distinguish the information that is allowed from the information that is not allowed.

    The possibility that the Commission will expressly permit the push of information through television and radio is referred to in the consultation. However, the details of how this may work are, as yet, unknown.

    Offering opportunity
    The closing date for responses to the consultation was April 7 this year. The Commission is currently preparing a legislative proposal that will be presented for adoption in October.

    Although the implementation of the legislative changes is at least a couple of years off, the changes are likely to represent an opportunity for the industry.

    However, at the moment, neither the scope of that opportunity, nor the administrative burden that may be attached to it, are clear.

    The Author
    Tim Worden
    is an associate at Taylor Wessing LLP

    30th May 2008

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