Proposals for Amendments to Medicines Legislation to Simplify the Information Required to be Included in some Advertisements to Prescribers and Suppliers of Medicines

Introduction

1. We are writing to consult you about a proposal to simplify the information requirements for advertising of medicinal products to prescribers and suppliers of medicines. It is proposed to increase the number of cases where an advertisement for a medicine can include a pointer to where to find detailed prescribing information, rather than the information itself being included it in the advertisement.

2. This change only affects advertising directed at healthcare professionals and other medicines retailers. No changes are proposed to the requirements for advertising to the public.

3. The consultation will help to inform a final decision on the proposal. Any change would be achieved by amendments to the Human Medicines Regulations 2012.

Application to England, Wales, Scotland and Northern Ireland

4. This consultation is being made available in England, Wales, Scotland and Northern Ireland. The proposed changes to legislation would apply throughout the United Kingdom.

Background

5. Prescribers and suppliers of medicines need objective information on the licenced use of a medicine in order to be able to evaluate advertising claims and make decisions on prescribing or supply. Some of this information has to be included in the ‘small print’ in advertising.

6. Article 91 of Directive 2001/83/EC requires advertisements aimed at prescribers and suppliers of medicines to include “essential information compatible with the summary of product characteristics” (SPC). UK law defines this as a succinct summary of the information in the SPC on indication for use, dosage, contraindications, safety precautions and side effects. This is commonly known as the ‘prescribing information’. It typically appears as a section of small print across the lower part of a journal advertisement or on the back page of mailings and other items.

7. The same prescribing information content and level of detail is legally required to be included in advertising to all prescribers and suppliers of medicines. The same requirements apply to an advertisement to doctors for a new prescription only medicine as to an advertisement to supermarket buyers for a medicine available on general sale.

8. An ‘abbreviated advertisement’ format is currently permitted, but only for small size advertisements in journals and similar publications. The prescribing information is replaced by a statement that “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at [web site address]”.

9. Full details of the UK legal requirements for information to be included in advertisements to prescribers and suppliers of medicines are provided in Annex 1.

10.Industry incurs significant costs in updating and reprinting advertising when there is a change to the prescribing information. This may be caused by, for example, an updated safety warning following action taken by the MHRA on reports of adverse reactions observed during safety monitoring of a new medicine.

Proposals

11.These proposals arise from suggestions put forward in the MHRA medicines Red Tape Challenge in 2012 by the over-the-counter (OTC) medicines trade association, the Proprietary Association of Great Britain (PAGB). MHRA has subsequently held informal discussions about the proposals with PAGB and with the Association of the British Pharmaceutical Industry (ABPI), representing research-based companies marketing prescription medicines.

12.The Red Tape Challenge proposals suggested additional circumstances where the abbreviated advertisement format may be suitable for use. The changes are designed to reduce the administrative and cost burden to industry to keep their advertisements current. Informal consultation replies have suggested that the industry expects to make savings as a result of the proposal.

13.MHRA has agreed to consult on proposals to allow increased use of the abbreviated advertisement format for advertising to prescribers and suppliers of medicines. We are particularly interested to hear from healthcare professionals and other medicines retailers about whether you are content with the proposals and how you consider they will affect your ability to access information on the medicines being promoted.

14.We are consulting on three options put forward by industry as follows:

A. Extension of the use of abbreviated advertisement format to all general sale list (GSL) medicines.

15.Medicinal products on general sale have been classified as GSL by the MHRA because they can with reasonable safety be sold without the supervision of a pharmacist. Retailers of these products are not required to have specialist knowledge of the medicines they supply. It may therefore be sufficient to include a pointer to a website where the full SPC information can be found if needed as described in paragraph 8 above, rather than including the prescribing information. This would apply to the whole range of products on the general sales list including traditional herbal and homeopathic remedies.