"Don't Illegally Promote Medicines" Advises Medicine Regulator

Main Category: Litigation / Medical Malpractice
Article Date: 27 Nov 2008 - 1:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing advice for consumer websites about the rules governing the advertising of medicines. The MHRA wants to help companies to work within the parameters of the Medicines Advertising Regulations. The guidance covers all websites registered in the UK or aimed at UK consumers which provide services that may lead to the prescription and or the supply of a prescription only medicine (POM). Examples include diagnosis and treatment services for erectile dysfunction or treatment for lines and wrinkles. The MHRA's top five advice tips are:

- The Home Page - should focus on the medical conditions and services provided. It should not include direct reference and hyperlinks to named POMs.

- Prices . The cost of a specific POM should only be provided as part of the prescribing process or after a prescription has been issued.

- Icons - Icons or similar features encouraging the purchase of a POM should not be used, e.g. 'Buy now!' or a pictorial icon.

- Content - All information about medicines should be balanced and factual and set within the context of the range of treatments available. Specific POMs must not be promoted.

- Enforcement - Failure to comply with the Advertising Regulations will result in a request for the website to be amended/withdrawn.

Group Manager for Vigilance and Risk Management of Medicines, Jeremy Mean said; "The internet is used widely to provide information to consumers and to promote products and services. Our guidance is designed to give advice to advertisers who are looking to advertise their services and inform customers without promoting specific medicines and thereby coming within the scope of the Advertising Regulations."

The MHRA's Advertising Unit also published today it's third annual report "Delivering High Standards in Medicines Advertising Regulations". The report highlights a number of cases among the 190 complaints received between September 2007 and August 2008. The report and the guidance are available on the MHRA website.

Notes

- The guidance does not cover websites directed at healthcare professionals.

- Unlicensed medicines should not be advertised according to the regulation 3(1) of the Advertising Regulations which prohibits advertising of medicines for which no marketing authorisation is in force.

- This guidance is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 ("the Advertising Regulations", SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC.

- Advertising complaints which have recently been upheld, can be seen at: http://www.mhra.gov.uk/NewsCentre/CON018241

- Further information and advice is available from the MHRA Advertising Standards Unit at advertising@mhra.gsi.gov.uk and in the Blue Guide, Advertising and Promotion of medicines in the UK, available on the MHRA website. http://www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/index.htm

- The websites of pharmaceutical companies are covered by self regulatory codes of practice operated by the Prescription Medicines Code of Practice Authority and the Proprietary Association of Great Britain.

Medicines and Healthcare products Regulatory Agency