CELEX: 51990PC0212
Language: en
Date: 1990-06-08
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE

N o C 163/10                           Official Journal of the European Communities                                  4. 7. 90
                                                              II
                                                      (Preparatory Acts)
                                                 COMMISSION
                  Proposal for a Council Directive on advertising of medicinal products for human use
                                               COM(90) 212 final — SYN 273
                                       (Submitted by the Commission on 12 June 1990)
                                                        (90/C 163/12)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          health, if it was excessive and ill-considered; whereas
                                                                  advertising of medicinal products to the general public,
Having regard to the Treaty establishing the European             where it is permitted, ought therefore to satisfy certain
Economic Community, and in particular Article 100a                essential criteria which ought to be defined;
thereof,
                                                                  Whereas, furthermore, distribution of samples free of
Having regard to the proposal from the Commission,                charge to the general public for promotional ends must
                                                                  be prohibited;
In cooperation with the European Parliament,
                                                                  Whereas the advertising of medicinal products to persons
                                                                  qualified to prescribe or supply them contributes to the
Having regard to the opinion of the Economic and                  information available to such persons; whereas, never-
Social Committee,                                                 theless this advertising should be subject to strict
                                                                  conditions and effective monitoring, referring in
Whereas      Council    Directive     84/450/EEC (')     has      particular to the work achieved within the framework of
harmonized the laws, regulations and administrative               the Council of Europe;
provisions of the Member States concerning misleading
advertising;                                                      Whereas medical sales representatives have an important
                                                                  role in the promotion of medicinal products; whereas
Whereas all Member States have adopted further specific           therefore certain obligations should be imposed upon
measures concerning the advertising of medicinal                  them in particular the obligation to supply the person
products; whereas there are disparities between these             visited with a summary of product characteristics;
measures; whereas these disparities are likely to have an
impact on the establishment and functioning of the                Whereas persons qualified to prescribe medicinal
internal market, since advertising disseminated in one            products must be able to carry out these functions objec-
Member State is likely to have effects in other Member            tively without being influenced by direct or indirect
States;                                                           financial inducements;
Whereas Council Directive 89/552/EEC of 3 October                 Whereas it should be possible within certain restrictive
1989 on the coordination of certain provisions laid down          conditions to provide samples of medicinal products free
by law, regulation or administrative action in Member             of charge to persons qualified to prescribe or supply
States concerning the pursuit of television broadcasting          them so that they can familiarize themselves with new
activities (*) prohibits the television advertising of            products and acquire experience in dealing with them;
medicinal products which are available only on medical
prescription in the Member State within whose juris-
                                                                  Whereas persons qualified to prescribe or supply
diction the television broadcaster is located; whereas this
                                                                  medicinal products must have access to a neutral
principle should be made of general application by prohi-
                                                                  objective source of information about products available
biting all advertising of medicinal products which are
                                                                  on the market; whereas it is nevertheless for the Member
available only on prescription;
                                                                  States to take all measures necessary to this end, in light
                                                                  of their own particular situation;
Whereas advertising to the general public even of
non-prescription medicinal products could affect public           Whereas advertising of medicinal products should be
                                                                  subject to effective, adequate monitoring; whereas
(') OJ No L 250, 19. 9. 1984, p. 17.                              reference in this regard should be made to the moni-
(2) OJ No L 298, 17. 10. 1989, p. 23.                             toring mechanisms set up by Directive 84/450/EEC;
 ---pagebreak--- 4. 7. 90                               Official Journal of the European Communities                                 N o C 163/11
Whereas each undertaking which              manufactures or       2.      All parts of the advertising of a medicinal product
 imports medicinal products should set    up a mechanism to      must be compatible with the particulars listed in the
 ensure that all information supplied     about a medicinal      summary of product characteristics.
 product conforms with the approved        conditions of use,
                                                                  3.     The advertising of a medicinal product:
 HAS ADOPTED THIS DIRECTIVE:
                                                                 — shall encourage the rational use of the medicinal
                                                                      product, by presenting it objectively and without
                         CHAPTER I                                    exaggerating its properties,
          Scope, definitions and general principles
                                                                 — shall not be misleading, within the meaning of
                                                                      Directive 84/450/EEC.
                           Article 1
 1.   This Directive concerns the advertising of medicinal
products for human use in the Community.                                                      CHAPTER II
                                                                                    Advertising to the general public
2.    For the purposes of this Directive,
                                                                                                Article 3
— the definition of 'advertising' shall be that laid down
    in Article 2 of Directive 84/450/EEC,                         1.      Member States shall prohibit the advertising to the
                                                                 general public of:
— the definition of 'medicinal product' shall be that laid
    down      in Article       1 of     Council       Directive  — medicinal products which contain psychotropic or
    65/65/EEC O ,                                                     narcotic substances, within the meaning of the inter-
                                                                      national conventions,
— the definitions of the 'name of the medicinal product'
    and of the 'common name' shall be those laid down            — other medicinal products which are only available on
    in Article 1 of Council Directive . . . / . . ./EEC,              prescription, in accordance with Council Directive
                                                                      . . . / . . ./EEC.
— the 'summary of product characteristics' shall be the
    summary approved by the competent authority which            2.       Member States shall prohibit the mention in adver-
    granted the marketing authorization in accordance            tising to the general public of therapeutic indications for
    with Article 4b of Directive 65/65/EEC.                      which self-medication is not suitable, in particular:
3.    For the purposes of the application of this                — tuberculosis,
Directive, the advertising of medicinal products includes,
in particular:                                                   — sexually transmitted diseases,
— information of a commercial nature for health care             — other serious infectious diseases,
    professionals, in whatever form, which may promote
    the prescription or supply of medicinal products,
                                                                 — cancer,
— visits by medical representatives to persons allowed to
    prescribe or supply medicinal products,                      — chronic insomnia,
— any incitement to prescribe or supply medicinal                — diabetes and other metabolic illnesses.
    products by the gift, offer or promise of any benefit
    or bonus, whether in money or in kind, including             3.      The prohibition referred to in paragraph 1 shall not
    invitations to travel or to congresses.                      apply to vaccination campaigns approved by the
                                                                 competent authorities of the Member States.
                           Article 2
                                                                 4.      The prohibition referred in paragraph 2 shall apply
1.    Any advertising of a medicinal product in respect of       without prejudice to Articles 2, 3 and 14 of Directive
which a marketing authorization has not been granted in          89/552/EEC.
accordance with Community law is prohibited.
                                                                 5.      Member States shall prohibit the free distribution of
                                                                 medicinal products to the public for promotional
(') OJ No L 11, 9. 2. 1965, p. 369/65.                           purposes.
 ---pagebreak--- No C 163/12                             Official Journal of the European Communities                                    4.7.90
                           Article 4                              — the legal prescription status of the medicinal product,
Without prejudice to Article 3, all advertising to the
general public of a medicinal product shall:                      — the retail price of the various presentations,
 (a) be set out in such a fashion that it is clear that the       — if appropriate, conditions of coverage by the social
     message is an advertisement, and that the product is              security systems.
     clearly identified as a medicinal product;
                                                                  2. The advertising of a medicinal product to persons
(b) include the following minimum information:                    qualified to prescribe or supply such products may,
                                                                  notwithstanding paragraph 1, include only the name of
     — the name of the medicinal product, incorporating           the medicinal product, if its sole object is to recall to the
         or followed by the common name if the                    latter.
         medicinal product contains only one active
         ingredient,
                                                                                             Article 7
     — the information necessary for correct usage of              1. Any documentation relating to a medicinal product
         the medicinal product, such as indications for use       which is transmitted as part of the promotion of that
         and special precautions, or, failing this, an            product to persons qualified to prescribe or supply it
         express invitation to read the package leaflet           shall include as a minimum the particulars listed in
         carefully.                                               Ankle 6 (1).
                           Article 5                              2. All the information contained in the documentation
The advertising of a medicinal product to the general             referred to in paragraph 1 shall be accurate, up-to-date,
public shall not contain any material which:                      verifiable and sufficiently complete to enable the
                                                                  recipient to form his or her own opinion of the thera-
                                                                  peutic value of the medicinal product concerned.
(a) gives the impression that a medical consultation or
     surgical operation is unnecessary, in particular by
     offering a diagnosis or by suggesting treatment by           3. Quotations as well as tables and other illustrative
     mail;                                                        matter taken from medical journals or other scientific
                                                                  works for use in the documentation referred to in
(b) suggests erroneously that the effects of taking the           paragraph 1 shall be faithfully reproduced and the
     medicine are guaranteed, or are better than another          precise sources indicated.
     treatment;
(c) suggests that the normal good health of the subject                                      Article 8
     can be enhanced by taking the medicine, or that it            1. Medical sales representatives shall be given
     could be affected by not taking the medicine;                adequate training and shall have sufficient scientific
                                                                  knowledge to be able to provide precise and complete
(d) is directed solely or mainly at children;                     information about the medicinal products which they
                                                                  promote.
(e) refers to a recommendation by scientists or health
     professionals;
                                                                  2. During each visit, medical sales representatives shall
(f) suggests that the medicinal product is a foodstuff or         provide the persons visited with the summaries of
     a cosmetic, or vice versa;                                   product characteristics in respect of each medicinal
                                                                  product which they present.
(g) suggests that the safety or efficacy of the medicinal
     product is due to the fact that it is 'natural'.             3. Medical sales representatives shall transmit to the
                                                                  scientific service referred to in Article 12 (1), any infor-
                                                                  mation about the use of the medicinal products they
                        CHAPTER III                               promote, especially about adverse reactions, that is
                                                                  reported to them by the persons they visit.
             Advertising to health professionals
                           Article 6                                                         Article 9
1. Any advertising of a medicinal product to persons              1. In the course of promoting medicinal products to
qualified to prescribe or supply such products shall              persons qualified to prescribe them, it shall be prohibited
include:                                                          to give, proffer or promise to such persons, directly or
                                                                  indirectly, any gifts, pecuniary advantages or benefits in
— the particulars listed in the summary of product                kind, with the exception of objects of an insignificant
    characteristics,                                              intrinsic value.
 ---pagebreak---  4.7.90                                Official Journal of the European Communities                           No C 163/13
 2. Persons qualified to prescribe or supply medicinal           — require either the publication of a corrigendum, or
 products shall not solicit or accept any inducement                  the publication in whole or in part and in a form
 prohibited under paragraph 1.                                        which it shall deem adequate, of the decision
                                                                      ordering the discontinuance of an advertisement.
 3. The prohibition referred to in paragraph 1 applies
 without prejudice to the regulations of the Member              3. Under the legal provisions referred to in paragraph
 States concerning prices, profit margins and discounts.          1, Member States shall ensure that any decision taken in
                                                                 accordance with paragraph 2 shall state in detail the
                                                                 reasons on which it is based and shall be communicated
                           Article 10                            in writing to the person concerned, mentioning the
                                                                 remedies available at law and the time limit allowed for
Where medicinal products are being promoted to                   the exercise of such remedies.
persons qualified to prescribe or supply them, free
samples shall be provided to such persons only on the
 following conditions:                                           4. This Article shall not exclude voluntary control of
                                                                 advertising of medicinal products by self-regulatory
                                                                 bodies and recourse to such bodies, if proceedings before
 (a) two samples at the most may be provided every year          such bodies are in addition to the judicial or adminis-
      to any person qualified to prescribe or to supply          trative proceedings referred to in paragraph 1.
      medicinal products;
 (b) any supply of samples must be in response to a                                          Article 12
      written request, signed and dated, of the recipient;        1. The person responsible for marketing shall establish
                                                                 within his undertaking a scientific service in charge of
(c) the samples shall be identical to the smallest presen-       information about the medicinal products which he
      tation on the market;                                      places on the market.
 (d) the samples shall be marked 'free medical sample —          2.     The person responsible for marketing shall:
      not for resale' or with another legend of analogous
      meaning;                                                   — make available to the bodies responsible for moni-
                                                                      toring advertising of medicinal products a sample of
(e) the samples shall be accompanied by a copy of the                 all advertisements emanating from their undertaking
      summary of product characteristics;                             together with a statement indicating the persons to
                                                                     whom it is addressed, the method of dissemination
                                                                      and the date of first dissemination,
 (f) no samples of medicinal products containing psycho-
      tropic or narcotic substances within the meaning of        — ensure that advertising of medicinal products by his
      international conventions may be supplied.                     undertaking conforms to the requirements of this
                                                                     Directive,
                         CHAPTER IV                              — verify that medical sales representatives employed by
                                                                     his undertaking have been adequately trained and
                  Monitoring of advertising                          fulfil the obligations imposed upon them by Article 8
                                                                     (2) and (3),
                           Article 11
 1. Member States shall ensure that there are adequate           — supply the bodies responsible for monitoring pharma-
and effective methods to monitor advertising of                      ceutical advertising of medicinal products with the
medicinal products. Such methods shall include legal                 information and assistance these require to carry out
provisions under which persons or organizations                      their responsibilities,
regarded under national law as having a legitimate
interest in prohibiting any advertisement inconsistent           — ensure that the decisions taken by the bodies charged
with this Directive may take legal action against such               with monitoring advertising of medicinal products
advertisement, or bring such advertisement before an                 are immediately and fully complied with.
administrative authority competent either to decide on
complaints or to initiate appropriate legal proceedings.
                                                                                            Article 13
                                                                 1. Where the provisions of the Directive have not
2. Under the legal provisions referred to in paragraph           been observed, and a warning notice served on the party
1, Member States shall confer upon the courts or admin-          concerned has remained without effect, the competent
istrative authorities powers enabling them:                      authorities of a Member State may suspend the authori-
                                                                 zation to market the medicinal product concerned,
— to order the discontinuance, correction or withdrawal          without prejudice to any other sanction which may be
     of any advertisement inconsistent with this Directive,      applied under national law.
 ---pagebreak--- N o C 163/14                          Official Journal of the European Communities                              4. 7. 90
2.    All decisions taken pursuant to paragraph 1 shall          1992. They shall forthwith     inform the Commission
state in detail the reasons on which they are based. A          thereof.
decision shall be notified to the party affected by it, who
shall at the same time be informed of the remedies
available at law and the time limit allowed for the             2.    Measures taken in accordance with paragraph 1
exercise of such remedies.                                      shall make express reference to this Directive.
                         Article 14
                                                                                        Article 15
1    Member States shall take all the steps necessary to
comply with this Directive with effect from 1 January           This Directive is addressed to the Member States.