EXECUTIVE SUMMARY Proposal for a Directive of the European by Sfusaro



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02.01.22E PGEU20
                                       EXECUTIVE SUMMARY

    Proposal for a Directive of the European Parliament and of the Council
  amending Directive 2001/83/EC on the Community code relating to medicinal
                            products for human use.

          Comments of the Pharmaceutical Group of the European Union

The Pharmaceutical Group of the European Union (PGEU) represents the community
pharmacists in the 15 member states and also has the support of the organisations representing
community pharmacists in other countries of the European Economic Area and the applicant
countries for membership of the EU. PGEU represents community pharmacists in 27
European Countries.

Community pharmacists are the health professionals most directly involved in the supply of,
and provision of advice about, medicines to the citizens of member states. Clearly, the PGEU,
on behalf of its members, has a vital interest in the proposals for the revision of the EU
legislation covering medicinal products, particularly those aspects which relate to their
quality, safety, efficacy, classification, distribution and promotion. The PGEU welcomes
many of the proposed revisions but has serious concerns on some proposals, especially those
relating to advertising of medicines.

This submission is based on the Commission’s proposal to amend Directive 20001/83/EC on
the Community Code relating to medicinal products for human use.

                                          PGEU main concerns:

   Proposal to amend Article 88 to allow “information” on prescription-only
   medicines for the treatment of AIDS/HIV, asthma and diabetes to be provided
   directly to the public by pharmaceutical manufacturers.

    The Commission insists that the current ban on Direct to consumer advertising (DTCA)
    of POMs will continue and only the provision of “information” will be permitted.

    However the Commission proposes changes concerning provision of so-called
    “information” under the Title VIII, relating to “Advertising”. In the opinion of the PGEU
    this appears to be completely out of place as it undoubtedly contributes towards
    compounding the confusion between information and advertising. This confusion is
    further compounded by the text of the proposed Article 88. In the new paragraph 2 of this
    Article, the Commission proposes to allow “communication of information on certain
    medicinal products”, under strict conditions. In the view of the PGEU the conditions, as
    laid down by the Commission, do not guarantee the provision of sound, objective and
    balanced information, but are likely to allow the opposite.
    It is widely recognised that the current ban on DTCA for prescription only medicines
    does not, in law, affect the ability to provide information. Therefore if the aim is to
    provide better and more accessible information to patients and patients support groups,
    there is no need to change legislation.

    In addition, in the section headed “Information” in the English version of the
    Commission’s Explanatory Memorandum of the proposal it is stated: “It is proposed that
    there should be public advertising of three classes of medicinal products”. This clearly
    demonstrates the inevitability of blurring the distinction between advertising (by
    definition designed to create demand) and objective information (designed to ensure
    effective treatment with minimum adverse effect). The PGEU understands that this
    wording might be the result of a mistranslation. However, the proposed text of Article 88
    will result in the position as set out in the English version of the Explanatory
    Memorandum being reached, if the Commission’s proposal is proceeded with.

    Patients and consumers groups have clearly stated that they want to have access to
    balanced, objective, comparable information about pharmaceutical treatments and
    alternative treatments. The pharmaceutical industry comprises individual manufacturers.
    A manufacturer cannot be expected to provide balanced information about his products,
    those of competitors and alternative treatments.

    It is essential to maintain a clear distinction between information and advertising. There is
    nothing in the current text of the Directive that prevents the provision of balanced
    information to patients about medicines and medical treatments. The PGEU firmly
    supports the provision of such information.

    DTCA for prescription-only medicines, based on the experience in the USA will
    substantially increase pressures on state and third party expenditure for pharmaceuticals.

    Health professionals and many patients support/ consumer groups oppose DTCA of
    prescription-only medicines.

            PGEU Recommendations on the proposal to amend Article 88:

1. The current text of Article 88 of Directive 2001/83/EC, banning DTCA of all prescription
   only medicines should be retained. The proposed amendments to Article 88 should not be
   proceeded with. This includes the proposal to remove the second subparagraph 2 of the
   current text. If this is deleted, it would allow certain serious indications to be mentioned
   in the advertising of non-prescription medicines.

2. All information about prescription only medicines made available to the public, additional
   to what is officially available from the Marketing Authorisation procedure, should be
   preauthorised by the EMEA or national medicines regulatory authorities.

3. Summaries of Product Characteristics and Package Information Leaflets should be made
   more conveniently accessible to citizens in reader friendly formats. Community
   pharmacies could be a channel for the distribution of these materials. In all cases, advice
   should be given to seek assistance from a physician or pharmacist if clarification or more
   information is required.

                Deletion of “Wholesale” from the heading of TITLE VII

The provisions under this TITLE were originally in Directive 92/26/EC on the wholesale
distribution of medicinal products. All provisions under this TITLE refer to wholesale
distribution with the exception of one sentence in Article 82, which clearly refers to
distribution to the public.

A change in heading could create confusion and uncertainty concerning the scope of this

                         PGEU Recommendations on Title VII

    1. The heading should revert to the original text “Wholesale distribution”.

    2. If the heading is not reinserted, articles 78,79,80 and 81 will need to be amended to
       make it clear that they refer to a “wholesale distribution authorisation” and not to a
       “distribution authorisation”. The latter term, in the absence of “wholesale” in the
       heading, could be interpreted to refer to retail as well as wholesale distribution.


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