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.
Royal College of Physicians of Edinburgh Response to the Medicines and Healthcare Products Regulatory Agency (MHRA) on Consultation MLX 384: Proposals for Amendments to Medicines Legislation to Simplify the Information Required to be Included in some Advertisements to Prescribers and Suppliers of Medicines
The Royal College of Physicians of Edinburgh (“the College”) is in international College which has 50% of its UK Fellows and Members working in the NHS in England. The College is pleased to respond to the MHRA on Consultation MLX 384 concerning proposals to amend the Medicines legislation. Our answers to the questions are as follows:
Question 1 – Do you agree with the proposal to permit all GSL product advertising to use an abbreviated format? If not, please give your reasons.
Yes.
Question 2 – Do you agree with this proposal? If not, please give your reasons.
Partly. However, if there are specific safety concerns about a particular medicine, there should be flexibility to impose a longer time period than two years. Also, if the company for some reason (eg tactically) has not actively marketed/sold significant amounts of the product in the UK during the first two years, there should be flexibility to impose a longer time period than two years. This would need to be defined.
Question 3 – What is the minimum period an ingredient must have been available OTC for before the abbreviated format of advertisement can be used?
Agree, minimum of 2 years.
Question 4 – Do you agree with the proposal to implement the minimum period for extended information through the individual marketing authorisation? If not, what alternative would be satisfactory?
Yes. Also agree that training materials for health professionals should always contain the full prescribing information.
Question 5 – Do you consider that the changes set out above to introduce abbreviated advertising formats should also apply to advertisements for P or GSL products that are being promoted for prescription supply? If so, please give your reasons.
No.
Question 6 – Do you agree with the proposal to permit a link to the full SPC in electronic advertisements instead of a link to the prescribing information? If not, please give your reasons.
Yes.
Question 7 – What do you consider to be the utility of the prescribing information in advertisements for medicines? Do you ever look for information in it and why? How does it affect your practice?
Main utility is instant and easy access to dosage and administration details, confirmation of generic name/ingredients, contraindications, indications and cost information. One of our expert Fellows has indicated that she does look for information in the prescribing information in advertisements to clarify one or more of these points, often particularly NHS cost, which is not always clear from discussions with pharmaceutical representatives.
Question 8 – Do you consider that the cost of the product should continue to be included in advertising for medicines to be supplied on prescription?
Yes, it is very important for prescribers to be aware of costs if they work within the NHS.
Question 9 – Do you agree with these assessments of the cost impact of these proposals on healthcare professionals and medicines retailers? Please provided details of any costs you consider would be incurred.
Yes.
Question 10 - Do you agree with the estimated savings for proposals A and B? The MHRA would be grateful for any further detail on the estimates provided.
Yes.
Question 11 - Do you agree with the estimated savings for proposal C? The MHRA would be grateful for any further detail on the estimates provided.
Yes.
Question 12 - Can you think of any costs or effects? Please provide a clear description of who you think would be impacted and in what way.
No.