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INDEXED WORLD HEALTH ORGANIZATION А21 /P &B /16 9 May 1968 ORGANISATION MONDIALE DE LA SANTÉ ORIGINAL: ENGLISH TWENTY -FIRST WORLD HEALTH ASSEMBLY Agenda item 2.11.2 PHARMACEUTICAL ADVERTISING Report by the Director -General 1. In resolution WНА2О.35, the Twentieth World Health Assembly requested the Director -General to study the ethical and scientific criteria that, from the medical point of view, should govern the advertising of drugs, and to report thereon to the Executive Board and to the Twenty - first World Health Assembly. 2. At its forty -first session the Executive Board had before it a progress report by the Director -General together with a survey of the legislation on pharmaceutical advertising in twenty -two countries which had been published by WHO in 1961.1 The Executive Board was informed that the Secretariat had commenced the revision of this survey which had been rendered necessary by new legislation enacted in many countries since 1961. The revised survey, as it will be published in Volume 19 (1968) of the International Digest of Health Legislation, is attached. 3. The new survey covers the legislation on pharmaceutical advertising in twenty -six countries. It has made it possible to identify more precisely the principles applied by Member States to the regulation of pharmaceutical advertising and to suggest the formulation of criteria with a view to ensuring their widest possible acceptance. 4. As the analysis of existing legislation shows, medical advertising (also called "technical" advertising) was virtually unrestricted in a number of countries until quite recently, whereas advertising addressed to the public is generally subject to more or less strict legislative provisions. Nevertheless, certain fundamental principles emerge that are applicable both to the advertising intended for the public and to that addressed to the medical and allied profes- sions. In many countries a trend is developing towards compulsory prior approval of advertise- ments for pharmaceutical products. 5. The media used by the pharmaceutical industry to reach the public include daily newspapers and periodicals, radio, cinema and television' advertisements in pharmacies or on public thoroughfares belong to the same category. Advertising to the medical profession is generally effected through the professional press, medical congresses, through personal contacts by the producers' representatives, as well as by special leaflets, literature and drug samples sent directly to individual members of the medical profession. Information on the package or insert leaflets of a drug or a pharmaceutical speciality must be considered as falling under the cate- gories of advertising to the medical profession as well as the public. Furthermore, the actual subject matter of the advertising, as evidenced by the legislation in several countries, is not limited to the strictly pharmaceutical field, but also comprises advertisements for cures, accessories or objects allegedly possessing curative, diagnostic or preventive virtues. 6. As requested in resolution ЕВ41.R24, a revised draft outline has been prepared of the ethical and scientific criteria that, from the medical point of view, should govern the advertising of drugs. The following outline takes into account the comments and views put forward by the Board at its forty -first session. 1 International Digest of Health Legislation, 1961, 12, 4 -54. А21 /P &B /16 page 2 ETHICAL AND SCIENTIFIC CRITERIA FOR PHARMACEUTICAL ADVERTISING All advertising on a drug should be truthful and reliable. It must not contain incorrect statements, half -truths or unverifiable assertions about the contents, effects (therapeutic as well as toxic) or indications of the drug or pharmaceutical speciality concerned. Advertising to the medical and related professions In describing the properties of a drug and its use, stress should be laid on rendering facts and data, whereas general statements should be avoided. Statements should be supported by adequate and acceptable scientific evidence. Ambiguity must be avoided. Promotional material should not be exaggerated or misleading. A full description, based on current scientific knowledge, should include infor- mation on the producer and sponsor of the product advertised; full designation (using generic or non- proprietary names) of the nature and content of active ingredient(s) per dose; action and uses; dosage, form of administration, and mode of application; side effects and adverse reactions; precautions and contra -indications; treatment in case of poisoning; and references to the scientific or professional literature. A fair balance should be maintained in presenting information on effectiveness on the one hand and adverse reactions and contra -indications on the other. Advertising to the public Advertisements should not be permitted for prescription drugs, for the treatment of certain diseases and conditions which can be treated only by a doctor and of which certain countries have established lists, or in a form which brings about fear or distress, or which declares specific remedies to be infallible, or suggests that they are recommended by members of the medical profession. ATTACHMENT The revised survey of legislation as referred to in document А21 /Р &В/16 is reproduced • hereunder and will be published in the International Digest of Health Legislation, 1968, vol. 19. -2- PHARMACEUTICAL ADVERTISING A survey of existing legislation CONTENTS Page General review of legislation 3 Legislation of various countries: Argentina 11 Australia 12 Austria 16 Belgium 17 Canada 18 Colombia 22 Denmark 23 El Salvador 25 France 26 Germany (Federal Republic of) 28 Hong Kong 31 India 32 Ireland 35 Japan 36 Netherlands 38 New Zealand 41 Norway 45 Peru 47 South Africa 48 Spain 50 Sweden 52 Switzerland 54 United Arab Republic 56 United Kingdom 57 United States of America 62 Yugoslavia 71 -3- General review of legislation In 1961, WHO published a survey of legislation on pharmaceutical advertising aimed at clarifying the principles which, in various countries, provide the basis for the legal measures for dealing with one of the problems with which public health administrators are confronted. This problem has, since that date, been the subject of numerous inquiries, both at the national and the international level. Examination of the reports of these inquiries shows that both advertising intended for the medical and allied professions, and advertising to the public, have been frequently criticized. There have been protests, throughout the world, against excessive self- medication and the excessive consumption of drugs and medicines. Some medicines, of which many can hardly be said to be harmless to health, are consumed in large quantities, in spite of all the efforts made in the field of the health education of the public to prevent such abuse. Since many years, public health administrations have endeavoured to improve the standard and quality of pharmaceutical advertising. On the international level in this respect, should be mentioned the Directive proposed by the Council of the European Economic Community for homogenizing the relevant legislative texts of its Member countries. A trend towards enacting specific regulations on pharmaceutical advertising may be observed in certain countries. Nevertheless, in many cases the legislative provisions governing pharma- ceutical advertising continue to be included in instruments of wider scope, particularly those governing manufacture of and trade in pharmaceutical products and sometimes also advertising on television, poisonous and dangerous substances, etc. It is of interest, in-this connexion, that the various countries dealt with in the previous comparative survey of legislation on pharmaceutical advertising, published in 1961, have subsequently either made fundamental changes in their legislation, or introduced special legislation in this field. An examination of the dates of the items of legislation discussed in this survey, and given in brackets after the name of each of the countries mentioned below, shows that the majority of countries have either amended previous legislation, or introduced new legislation, on pharmaceutical advertising in the last few years. This is the case for the following countries: Argentina (1964), Belgium (1964, 1965), Canada (1962, 1964), Colombia (1961, 1962, 1964), El Salvador (1959, 1963), Federal Republic of Germany (1961, 1965), France (1963), Japan (1960, 1964, 1967), Norway (1963, 1964), Peru (1960, 1962), South Africa (1965, 1967), Spain (1963, 1964), Sweden (1962, 1963), United Arab Republic (1960), United States of America (1962) and Yugoslavia (1965). Definition of pharmaceutical advertising Before any attempt is made to study the principles and standards to which pharmaceutical advertising must conform, as laid down in the legislation of the various countries dealt with in this survey, it is necessary to consider the various possible meanings of this term. These depend, in the first place, on the scope of what is considered to be pharmaceutical advertising, i.e. which products, devices or procedures, if any, in addition to pharmaceutical products, as such, this form of advertising is defined as covering, and in the second place, on the advertising techniques which are covered by the legislation. Scope of pharmaceutical advertising While certain countries, such as Argentina and Colombia, limit the scope of pharmaceutical advertising essentially to the advertising of pharmaceutical products, as

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