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.
1. 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).
2. 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).
3. 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”
- to “not be misleading” (Article 87.3 of Directive 2001/83/EC consolidated)
Minimum information to be included in advertising:
- In accordance with binding EU Law:
- “essential information compatible with the summary of product characteristics;
- the supply classification of the medicinal product” (Article 91.1 of Directive 2001/83/EC consolidated)
- In accordance with National laws:
- 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. (See list of links to National Medicines Agencies in Actors and Networks)
Obligations regarding the minimum information to be included in advertising:
- “To sate the date on which it was drawn up or last revised” (Article 92.1 of Directive 2001/83/EC consolidated)
- “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)
Obligations for medical sales representatives (Article 93 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).
Obligations for marketing authorization holders (Article 98 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 require in addition the publication of a corrective statement.” (Article 97.4 of Directive 2001/83/EC consolidated)
- 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).