Advertising of medicines

General information
Advertising can be presented in several forms, including:

• medical journals
• magazines
• newspapers
• television advertisements
• Internet advertising
• posters in London underground trains.  

The MHRA's Advertising Standards Unit routinely scrutinises medical journals, magazines to the general public and also the Internet for the promotion of licensed medicines. Also, advertising is selectively checked prior to issue, complaints are investigated, and advice is provided to industry, health professionals and other regulatory bodies. The Unit also provides advice to several sections within the Vigilance and Risk Management of Medicines Division, in particular relating to product information.

The advertising of medicines is controlled by a combination of statutory measures (with both criminal and civil sanctions), enforced by the MHRA and self-regulation through Codes of Practice for the pharmaceutical industry, administered by trade associations. The MHRA as Licensing Authority has a statutory duty on behalf of Ministers to consider breaches of The Medicines Act 1968 and Regulations on the promotion of medicines. Its key function is to protect public health by promoting the safe use of medicines, ensuring that they are honestly promoted as to their benefits, uses and effects, in compliance with current legislation.

The legal base for the control of advertising is contained in The Medicines (Advertising) Regulations 1994 and The Medicines (Monitoring of Advertising) Regulations 1994, both as amended. The Regulations implement Title VIII of Directive 2001/83/EC on the advertising of medicines for human use.  A list of the legislation relevant to medicines advertising can be accessed below:
› Advertising of medicines: The legislative framework

The Regulations lay out different requirements for advertising to the public and advertising to health professionals. Advertising to the public is permitted for medicines legally classified pharmacy sale (P) or general sale list (GSL). The Regulations prohibit the issue of any advertisement to the general public which is likely to lead to the use of a prescription only medicine (POM).  Advertising issues are, in the majority of cases resolved administratively, with prosecution reserved for serious cases, for example, where there is a safety issue or a company is uncooperative or repeatedly offends.


Annual reports on advertising
These annual reports are published to meet a commitment given to the Health Select Committee as part of the Government response to their report on ‘The influence of the Pharmaceutical Industry’. It aims to contribute to the Agency's policy of transparency in the regulation of medicines advertising.
› Maintaining High Standards in Medicines Advertising Regulation - Annual Report September 2006 - August 2007 (156Kb)
› Promoting High Standards in Medicines Advertising Regulation - Annual Report September 2005 - 2006 (302Kb)

The regulatory framework
The MHRA works with other statutory regulators and self-regulatory bodies to ensure advertising is fully compliant with EC and UK medicines law. These include:

• Advertising Standards Authority (general advertising).
• Proprietary Association of Great Britain (over the counter medicines).
• Prescription Medicines Code of Practice Authority (prescription medicines).

A Memorandum of Understanding (67Kb) setting out the arrangements for the regulation of the promotion of medicines for prescribing has been agreed between the MHRA, the Prescription Medicines Code of Practice Authority (PMCPA) and the Association of the British Pharmaceutical Industry (ABPI):

The Medicines Advertising Liaison Group (MALG) is a forum consisting of bodies involved in the regulation of medicines advertising that meets about twice a year to discuss current issues in advertising control. The group includes representatives from the Advertising Association, Advertising Standards Authority, Broadcast Advertising Clearance Centre, Committee of Advertising Practice, Proprietary Association of Great Britain, Prescription Medicines Code of Practice Authority, Radio Advertising Clearance Centre, the Health Food Manufacturer’s Association, the British Herbal Medicine Association and the MHRA.

Minutes of the meetings of MALG
›  Medicines Advisory Liaison Group (MALG) minutes - 2 October 2007 (46Kb)
›  Medicines Advisory Liaison Group (MALG) minutes - 29 March 2007 (55Kb)
›  Medicines Advisory Liaison Group (MALG) minutes - 20 September 2006 (48Kb)
›  Medicines Advisory Liaison Group (MALG) minutes - 24 January 2006 (56Kb)
›  Medicines Advisory Liaison Group (MALG) minutes - 21 July 2005 (40Kb)
›  Medicines Advisory Liaison Group (MALG) minutes - 21 January 2005 (18Kb)

Vetting of advertising material
The Regulations allow the MHRA to require sight of advertising before it is issued.

Circumstances where vetting may be required include:

• where a newly licensed product subject to intensive monitoring, is placed on the market; 
• where a product is reclassified product, such as from prescription only (POM) to pharmacy (P); or
• where previous advertising for a product has breached the Regulations.

Within the first criterion above and as a matter of policy, the MHRA has committed to vet initial advertising for all new active substances. This implements recommendations by the Health Select Committee in its report, “The Influence of the Pharmaceutical Industry.”

Further details on vetting are provided in MAIL 152 November/December 2005 and the accompanying press release:
›  MAIL 152 (83Kb)
›  Press release: UK health watchdog to vet advertising materials on new medicines

If you would like to enquire about whether we wish to vet advertising materials for a particular product, please email us at advertising@mhra.gsi.gov.uk

The following leaflet provides advice for companies submitting material for vetting.
›  Tips for vetting of promotional material (35Kb)

Companies may request a meeting with the MHRA to discuss issues that arise during the vetting procedure.  Further information on scientific advice meetings and a request form are available below:
› Scientific advice for licence applicants

Monthly performance on vetting of advertising
Details of the monthly percentage of advertising pieces submitted for vetting where the MHRA provided a response to the company within the target response time of 5 working days are available below:
› Monthly performance on vetting of advertising (13Kb)

Complaints procedure
Complaints about medicines advertising may be made in writing to the MHRA Advertising Unit, enclosing where possible a copy of the advertisement or promotional material to the MHRA, Advertising Unit, 14-149 Market Towers, Vauxhall, London, SW8 5NQ .  Alternatively, complete the online complaints form below.  Complaints may also be made to the relevant self-regulatory body.
› Advertising complaint form

The Agency acknowledges receipt of all complaints and will contact the advertiser concerned to investigate the case. Full details of how the MHRA investigates complaints and the actions that may be taken are provided in Chapter 7 of the 'Blue Guide' (206Kb)

During correspondence with the advertiser the identity of the complainant will remain anonymous.

We will endeavour to complete the investigation within 30 calendar days. This time may be extended where there is detailed discussion between the Agency and the company, or when statutory action is taken.  When closing the case the Agency will provide the complainant with details of the outcome and a summary report that will then be published on our website. 

A brief summary on the outcome of each complaint investigated is published in the following section of the website:
› Advertising complaints investigations

Independent Review Panel for Advertising
The Regulations allow a procedure for review of a preliminary opinion of the MHRA that an advertisement for a medicine might be in breach of the Advertising Regulations. The aim of this Independent Review Panel (IRP) is to ensure fairness and openness in the MHRA, with regards to decisions made on advertising.

Companies will have the opportunity to make written representations to the Panel. The MHRA expects that the majority of concerns over advertising will continue to be resolved by informal negotiations with the companies concerned. The statutory right to a review of preliminary decisions together with the establishment of the Independent Review Panel for Advertising to advise Ministers, provides companies with an additional means of having a preliminary decision of their advertising material reconsidered before a final decision is taken by Ministers. The right to seek judicial review of an executive decision on advertising remains.
 
Specific guidance for companies on how to make representations  to an Independent Review Panel, has been published by the MHRA:
› Guidance on the review of advertising by the Independent Review Panel (22Kb)

Further details of the procedure can also be found in the following section of the MHRA website:
› Independent Review Panel for Advertising

MHRA Guidance Notes
In addition to regular featured updates in 'MAIL', the Advertising Unit has compiled the following guidance:
› MHRA Guidance Note 23, 'The Blue Guide: Advertising and Promotion of Medicines in the UK' (206Kb). This publication is available to download here as a pdf or from The Stationery Office (external link), price £16.50.                         

› MHRA Guidance Note 24, 'Medicines which are promoted for use during pregnancy: Guidance for the pharmaceutical industry' (113Kb), has been developed for advertisers to ensure safe and responsible advertising of medicines which are promoted for use during pregnancy. The guidance covers advertising for medicines both to the public and to health professionals and supplements the regulatory framework set out in legislation.

› MHRA Guidance Note 26, 'Disease Awareness Campaigns (DACs) guidelines' (192Kb)  - Supplementary guidance has been developed by the Agency to help ensure that information provided by pharmaceutical companies and others on health and disease does not fall within the advertising legislation by promoting medicinal products to the public, and to promote good practice.

› NEW Website advertising guidance - Draft guidance for companies offering website-based treatment services to ensure that prescription only medicines are not promoted to the public. Comments by 30 September 2008 to advertising@mhra.gsi.gov.uk.

The MHRA has worked closely with health professionals, advertising regulators, patient groups and industry to develop guidance for advertisers on medicines in all the deregulated categories. This guidance, 'Advertising of OTC medicines for formerly restricted therapeutic indications - Best Practice Guidance for the Pharmaceutical Industry', has been published by the Proprietary Association of Great Britain (PAGB) and is available on their website at www.pagb.org.uk. (external link)

Advertising issues
The Advertising Unit regularly publishes guidance on good practice to advertisers on topical issues and to clarify policy in areas of concern in 'MAIL', the MHRA's updating journal for medicines.  Copies of articles on medicines advertising issues recently published in 'MAIL' are available below (the latest article is published in full and links to the relevant issues of 'MAIL' are given for previous articles):

Vetting advertising for new active substances - MAIL 152 November/December 2005

In April 2005 the Health Select Committee* recommended ‘that all promotional material for a new product be pre-vetted by the MHRA prior to publication’. The Government accepted the Committee’s
recommendation to vet promotional material for all new active substances**.

Vetting of all new active substances
From 7 November 2005, marketing authorisations (MAs) granted for new active substances will have their promotional material vetted. A request for vetting of promotional material is usually triggered
following the presentation of an application for an MA to the Commission on Human Medicines (CHM). The Advertising Unit will write to the company requesting their agreement to submit promotional
material for vetting. The MHRA has statutory powers to compel a company to submit its promotional material for vetting, if necessary. The vetting for new products can be planned into the licensing
timetable, need not delay the launch of a product and is normally considered by the Agency in a matter of days.

Submitting material for vetting
The duration of vetting is commonly around six months, but this may be reduced or extended depending on the quality of the initial advertising material submitted and other relevant factors.
Promotional material may be submitted for vetting once the summary of product characteristics (SPC) has been finalised. Promotional material should have already undergone a full set of internal quality control and compliance checks before submission to the MHRA. It should include information on the target audience such as the public or person qualified to prescribe or supply medicine and relevant references.

MHRA recommendations for vetting of promotional material
We recommend key promotional pieces such as the detail aid, healthcare professional and consumer advertisements, where appropriate, are submitted during the initial stages of vetting, so that the MHRA has an understanding of the key messages to be used in the promotional campaign, other pieces can then be quickly cleared when subsequently submitted. Scientific advice meetings to discuss any concerns or unresolved issues about promotional messages in promotional material during the initial stages of vetting may be requested by the company, details are contained in the 'Scientific advice for licence applicants' section of the MHRA website. Where possible an electronic version should be submitted via e-mail along with a hard copy of the promotional material. Once the electronic portal has been opened for general use this should be used to submit promotional material. The MHRA will endeavour to provide its comments within five working days. However, where this is not possible the Agency will inform companies of when they are likely to receive comment.

Subsequent MHRA action?
Where advertising material is vetted, the opinion of the MHRA is based upon the information provided and current knowledge. The MHRA has a statutory function to monitor advertisements and to consider complaints made in the future. The MHRA, therefore, reserves its right to reconsider its view of a promotional item in light of new concerns.

Advice on advertising issues is available from Beryl Keeley, Product Information and Advertising Unit Manager, on 020 7084 2765.

**The Government’s Response to the Health Committee’s Report,  'The influence of the pharmaceutical industry'.
*The House of Commons Health Committee. The influence of the pharmaceutical industry, 2005, London, TSO (The Stationery Office).

› Announcing the availability of a new medicinal product – MAIL 151 September/October 2005 (289Kb)

› Advertising: Presentation of clinical data – MAIL 148 March/April 2005 (172Kb)

› The new Blue Guide: advertising and promotion of medicines in the UK – MAIL 148 March/April 2005 (172Kb)

› Advertising: Naming of competitor company in outcome reports of complaints investigated - MAIL 146 November/December 2004 (132Kb)

› Advertising: corrective statements - MAIL 146 November/December 2004 (132Kb)

› How we investigate complaints – MAIL 145 September /October 2004 (172Kb)

› Advertising to the public: Linked medicines - MAIL 144 July/August 2004 (150Kb)

› Scientific Advice Meetings - MAIL 144 July/August 2004 (150Kb)

› Advertising medicines: Prescribing information - MAIL 143 May/June 2004 (140Kb)

› Advertising medicines: As safe as placebo? - MAIL 142 March /April 2004 (237Kb)

› Advertising: multi-buy offers - MAIL 142 March/April 2004 (237Kb)

› "Fast-acting" and “24 hour” relief claims - MAIL 141 January /February 2004 (143Kb)

› Advertising: Reports of completed investigations to be published – MAIL 140 November/December 2003 (542Kb)

› Medicines which are promoted for use during pregnancy – publication guidance -  MAIL 135 January/February 2003 (570Kb)

› Advertising: The work of the unit - MAIL 130 March/April 2002 (2441Kb)

Contact for further information
Further advice on the advertising of medicines can be obtained from The Advertising Unit, MHRA, 14-149, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, e-mail advertising@mhra.gsi.gov.uk.