Advertising of Medicines

The advertising of medicines is regulated under EU derived legislation.  It is also subject to general legislation and codes of practice on advertising.

Advertising includes any form of promotion, canvassing or  inducement.  It includes advertising to the general public and to persons entitled to prescribe. It also cover;

• visits by sales representative,
• provision of samples,
• sponsorships or promotional meetings , attended by persons entitled to prescribe, sponsorship of congresses, seminars etc.,
• provision of inducements to prescribe or supply medicinal products by gifts, bonuses in money or in kind.

The legislation does not apply to the following:

• Labelling and Package Leaflet (which are subject to other very specific controls).
• Correspondence with material of a non-promotional nature answering specific queries about products,
• factual informative announcements relating to ongoing matters such as warnings, catalogues, price lists and changes.
• Books and journals, imported into Ireland containing advertising, not aimed at intended or directed to people resident in the State.
• Information in relation to human health and disease without reference to particular medicinal products.

A medicinal product may only be advertised by an entity with a marketing authorisation or certain other equivalent registrations and permits.  The advertisement must comply with the product’s  summary of product characteristics (SPC) currently in place.  Accordingly new developments may not be published until they are updated and including in the SPC.

Certain categories of medicines may not be advertised to the public including

• prescription only medicines,
• certain classes of substances whether or not requiring prescription.

Advertising may be allowed as part of a public health campaigns for vaccines undertaken or approved by the Department of Health.

The terms of authorisations of a medicine may restrict advertising of non-prescription medicines.

In case of advertisements which may be made to the general public, further restrictions apply.  They must not give information giving the impression that medical consultation is unnecessary.  They should not offer diagnosis or suggest methods of treatment by post, e-mail etc.  They must not suggest the effects of the medicine are guaranteed and do not have adverse reactions.

They must not suggest that health can be enhanced by taking the product.  They must not suggest health could be affected by not taking the product.  They must not be directed exclusively or principally at children.  They must not refer to scientific recommendations by health professionals or  celebrities, which could encourage consumption.

They must not suggest that the product is a foodstuff, cosmetic or other product.  They must not suggest the safety or efficacy is due to the fact that it is natural.  They must not set out representations of particular case histories which may lead to erroneous diagnosis.  They must not make alarming or misleading claims of recovery or use terms or images of changes in the human body caused by disease or injury or the action of a product on the human body.

It must be clear that the message is an advertisement.  The product must be clearly identified as medicinal product.Certain information must appear in the advertisement, including

• name of the product,
• if there is only one active ingredient, the common or generic name.
• information necessary for correct use
• invitation to read carefully the instructions on the package or label or leaflet.

In the case of traditional herbal medicines, certain specific indications are required.

Advertising by way of reminder which makes no claims or indications and refer to the product only, must only contain certain minimal details, including in particular the products’ international non-proprietary name, if it exists or trade mark, and advice to read carefully the instructions on the leaflet contained in the package or label.

Homeopathic medicines, may not state any claim on their labelling. The labelling or package insert  must contain

• certain wording including the words \”homeopathic medicinal product\”,
• the scientific name, followed by the degree of dilution;
• name and address of the holder of the certificate of registration;
• method of administration;
• expiry date;
• contents of sales presentations;
• storage precautions;
• batch number;
• registration number;
• advice to consult a doctor if symptoms persist.

There are specific requirements for advertisements aimed at persons who are qualified to prescribe.  They must include:

• essential information compatible with the SmPC;
• name of product and list of active ingredients beside the product name; classification for sale and supply of the product, e.g., prescription only;
• indications of a marketing authorization or certificate of traditional use registration;
• details of adverse reactions,
• precautions per the SmPC;
• dosage and method of use;
• name and address of authorisation holder;
• marketing authorisation particulars;

There are certain further requirements regarding traditional herbal medicine products.

There are requirements regarding the position, location and prominence of certain of the details.

Reminder advertisements may contain prescribed but lesser information.

Promotional aides are non-monetary gifts relevant to the practice of medicine and pharmacy for the purpose of promotion.  They may only include names of the product or its international non-proprietary name or trade mark. It must be intended only as a reminder and be supplied to persons qualified to prescribe medicinal products.  They might cover such things as pens and equivalent small inexpensive items.

Written promotional material provided to persons qualified to prescribe must include as a minimum essential information in accordance with the SmPC  classification, and the date of document. The information must be accurate, up-to-date, and sufficiently complete to enable the recipient to form a opinion as to the value of the medicine.  Quotations must be taken from recognized scientific journals and works and must be accurately reproduced.

There are requirements in relation to the conduct and training of certain persons including medical sales representatives.  They must have copy of the SmPC for each product promoted or it must be included in a reference publication delivered within the last 12 months to the relevant group of health professionals.

The representatives should draw the health professional’s attention to the relevant entries in the compendium or reference publication.  Representatives must report back on information about use of products obtained during the visits, including in particular any adverse reaction.

Authorisation holders are responsible for the representatives.  They must ensure they have adequate training and scientific knowledge.  The regulator may require specific training. The relevant SmPCs must be available.

Gifts, monetary payments or benefit in kinds supplied or offered in the course of promoting medical products must be inexpensive and relevant to the practice of medicine or pharmacy.  Hospitality may be offered to persons entitled to prescribe at promotional events, including conferences , professional and scientific events, provided that the hospitality is at a reasonable level limited to the main purposes or scientific objectives of the event, and is not extended to non-health professionals including families of health professionals.

Health professionals may not elicit or accept, prohibit inducements, sponsorship etc.This is not to the prejudice the negotiation of prices and discounts, etc. in the ordinary course of business.  They must be reflected in the relevant sales invoice.

Pharmaceutical companies, manufacturers, wholesalers, etc. must not sell or supply medicines for promotional purposes to the public.  Free samples may be given to persons entitled to prescribe but not pharmacists, subject to certain conditions.  A Sample may be provided on an exceptional basis for the purpose of gaining experience. There is a maximum of six samples per year.  There must be a written request for the sample.  There must be adequate systems of control and accountability.  The pack must be no larger than the smallest pack available on the market.  It must be labelled, \”free sample, not for sale.\”  It must be accompanied by the relevant SmPC or it must have been furnished within the previous 12 months.

Marketing authorisation holders and equivalents must maintain a scientific survey to compile and create information in relation to products received from any source.

Advertising material must be retained together with particulars of dates and channels of distribution.  This must be provided to the  regulator as required.

Self-regulatory advertising codes of practice may be approved,. They may go wider than those matters dealt with in regulation.  They may include cure activities, dealings with various organisation\’s e-mail advertising.  There are a number of codes which operat beyond the statutory positions.

Breach of self-regulatory codes may be prosecuted under the Medicines Board legislation.  Orders may be given to withdraw misleading advertisement or publish corrective statements.