Advertising of medicinal products, including ATMPs, is mainly regulated by National laws apart from minimum binding requirements established by EU Law.
Nevertheless, those minimum requirements provided for the main rules in the field of advertising of ATMPs:
The advertising of ATMPs to the general public is prohibited.
The advertising of ATMPs without marketing authorization is prohibited.
The advertising of ATMPs to persons qualified to prescribe or supply medicinal products is allowed under strict conditions. These conditions mainly include min-imum information to be included in advertising, obligations for medical sales rep-resentatives, obligations for marketing authorisation holders, limitations of in-ducements to persons qualified to prescribe or supply medicinal products.
In addition, EU law imposes several obligations on Member States, especially to establish adequate and effective methods to monitor the advertising of medicinal products, to enable the courts or administrative authorities to act in the public interest in case of misleading advertising, and to determine and impose penalties in case of infringements of EU law on advertising of medicinal products.
Thus, Member States are free on the choices of means to respect their obligations, and apart from the common EU requirements, the regulation of advertising of ATMPs may differ according to each national Member States, e.g. priori vetting or not to monitor the advertising of medicinal products.
Stakeholders
Advertiser: the person or organization who is organizing the advertising of a medicinal product it is commercializing.
General public: the potential consumers of medicinal products
Marketing authorization holder: “The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States.” EMA Glossary here.
Medical sales representative: a person employed by a firm in order to promote and sale a medicinal product.
Member States: States that are Members of the European Union, and as such are in charge of implementing and overseeing the implementation of the EU legislation via their National competent authorities.
Person qualified to prescribe or supply medicinal products: the person allowed to prescribe or supply medicinal products in accordance with national law, e.g. doctors, pharmacists.
Scientific service: a service established by the marketing authorization holder within his undertaking, which is in charge of information about his medicinal products placed on the market.
Definitions
Advertising of medicinal products: “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products” (Article 86.1 of Directive 2001/83/EC consolidated).
This definition includes in particular:
“the advertising of medicinal products to the general public,
advertising of medicinal products to persons qualified to prescribe or supply them,
visits by medical sales representatives to persons qualified to prescribe medicinal products,
the supply of samples,
the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,
sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.” (Article 86.1 of Directive 2001/83/EC consolidated).
This definition excludes:
“the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,
correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product,
factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims,
information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.” (Article 86.2 of Directive 2001/83/EC consolidated).
Challenges
Apart from common EU requirements, the regulation of advertising of ATMPs differ according to each national Member States. It implies that a company wishing to advertise its authorized ATMPs to persons qualified to prescribe or supply medicinal products will have to comply with the National laws of each Member State in which it wants to advertise its product for commercialisation.
Opportunities and incentives
Opportunities and incentives have to be looked for at the National levels, and early contact with National Medicines Agencies where the marketing authorization holder is planning to commercialise its ATMPs should be the best option to be aware and comply with national requirements on advertising of medicinal products.
Interactions with regulators
Given that the advertising of medicinal products is mainly regulated by national laws apart from minimum requirements provided by EU law, interactions with regulators should be looking for at National level though each National medicines agency. (See the list of National medicines agencies in Actors and Networks)
Practical steps
Given that the advertising of medicinal products is mainly regulated by national laws apart from minimum requirements provided by EU law, practical steps will differ according to each National Member State. Thus, this section is detailing the common binding EU requirements that apply in every Member States of the European Union.
Prohibition of advertising of ATMPs to the general public
Given that ATMPs raised particular risks, they have to be administered to patients in hospitals under supervision of medical practitioners. In that sense, they are medicines available on prescription only, most of the time under restricted medical prescription and their advertising to the general public is strictly prohibited in accordance with EU law (Article 88.1 of Directive 2001/83/EC consolidated).
Prohibition of advertising of ATMPs without marketing authorization
EU law prohibits any advertising of an ATMP in respect of which a marketing authorization has not been granted (Article 87.1 of Directive 2001/83/EC consolidated).
Rules for advertising of ATMPs to persons qualified to prescribe or supply medicinal products
General EU binding rules for advertising:
compliance with the particulars listed in the summary of product characteristics for all parts of the advertising (Article 87.2 of Directive 2001/83/EC consolidated)
encouraging “the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties”
Possibility for Member States to “require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies” (Article 91.1 of Directive 2001/83/EC consolidated).
Possibility for Member States to “decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may […] include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder.” (Article 91.2 of Directive 2001/83/EC consolidated)
To know more about the choices made by Member States in their respective national laws, please see the information on advertising of medicinal products providing by each National Medicines Agency. (Seelist of links to National Medicines Agencies in Actors and Networks)
Obligations regarding the minimum information to be included in advertising:
“To be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned”. (Article 92.2 of Directive 2001/83/EC consolidated)
To faithfully reproduced and to indicate the precise sources of “Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works” used in the documentation transmitted as part of the promotion of the product to persons qualified to prescribe or supply it. (Article 92.3 of Directive 2001/83/EC consolidated)
To be “given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicinal products which they promote” (Article 93.1 of Directive 2001/83/EC consolidated).
To “give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement” (Article 93.2 of Directive 2001/83/EC consolidated).
To “transmit to the scientific service […] any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit” (Article 93.3 of Directive 2001/83/EC consolidated).
To “establish, within his undertaking, a scientific service in charge of information about the medicinal products which he places on the market.”
To “keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination,”
To “ensure that advertising of medicinal products by his undertaking conforms to the requirements” Title VIII a of Directive 2001/83/EC consolidated
To “verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them” as mentioned above
To “supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities”,
To “ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with” .
Obligations for Member States:
To “ensure that there are adequate and effective methods to monitor the advertising of medicinal products.” (Article 97.1 of Directive 2001/83/EC consolidated)
These methods
can be “based on a system of prior vetting” such as in France.
“Shall in any event include legal provisions […] [to] take legal action against [unlawful] advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings”
To “confer upon the courts or administrative authorities powers enabling them in cases where they deem such measures to be necessary, taking into account all the interests involved, and in particular the public interest:
to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising, or
if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication,
even without proof of actual loss or damage or of intention or negligence on the part of the advertiser.” (Article 97.2 of Directive 2001/83/EC consolidated)
Member States can select one of these two options. (Please refer to National laws to see what option has been chosen by the Member State you are interested in.)
These measures “be taken under an accelerated procedure, either with interim effect or with definitive effect.” (Article 97.3 of Directive 2001/83/EC consolidated)
They “may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision:
to require publication of that decision in full or in part and in such form as they deem adequate,
To “not prohibit the co-promotion of a medicinal product by the holder of the marketing authorisation and one or more companies nominated by him” (Article 98.3 of Directive 2001/83/EC consolidated)
To “take the appropriate measures to ensure that the provisions of [EU law on advertising, i.e. Title VIIIa of Directive 2001/83/EC consolidated] are applied and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of Title be infringed”. (Article 99 of Directive 2001/83/EC consolidated)
Limitations of inducements:
Giving the priority to “Existing measures or trade practices in Member States relating to prices, margins and discounts”, additional EU requirements may apply if they do not affect such national laws:
“no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to [persons qualified to prescribe or supply medicinal products] unless they are inexpensive and relevant to the practice of medicine or pharmacy” (Article 94.1 of Directive 2001/83/EC consolidated). However, this provision “shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be strictly limited to the main scientific objective of the event; it must not be extended to persons other than health-care professionals” (Article 95 of Directive 2001/83/EC consolidated).
“Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than health-care professionals.” (Article 94.2 of Directive 2001/83/EC consolidated)
“Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited” above (Article 94.3 of Directive 2001/83/EC consolidated)
Although “Member States may also place further restrictions on the distribution of samples of certain medicinal products” (Article 96.2 of Directive 2001/83/EC consolidated), “Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:
(a) the number of samples for each medicinal product each year on prescription shall be limited;
(b) any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent;
(c) those supplying samples shall maintain an adequate system of control and accountability;
(d) each sample shall be no larger than the smallest presentation on the market;
(e) each sample shall be marked ‘free medical sample — not for sale’ or shall show some other wording having the same meaning;
(f) each sample shall be accompanied by a copy of the summary of product characteristics;
(g) no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Conventions of 1961 and 1971, may be supplied” (Article 96.1 of Directive 2001/83/EC consolidated).
European Union Legislation
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67-128, CELEX number: 32001L0083, as amended.
Original text (available in the 24 official languages of the EU)
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