1.5.1 General principles

RULE 1: The PAGB Professional Code for Medicines applies to advertising directed wholly or mainly at persons qualified to prescribe or supply and those that work for such person.

Persons qualified to prescribe or supply (PQPS)

This Code applies to the advertising of over-the-counter medicines wholly or mainly to Persons Qualified to Prescribe or Supply (and appropriate administrative staff) and where the object of the advertising is to influence sales and/or recommendations to the general public.

For THMs, this includes herbal practitioners involved in selling medicines to the public.

N.B. Advertising intended to influence the writing of prescriptions is covered by the ABPI Code of Practice, not by this code (See 1.3.1).

Advertising under the Professional Code is aimed at Persons Qualified to Prescribe or Supply (PQPS), and can be regarded as any advertisement primarily intended to promote sale or recommendation of an OTC medicine to a consumer/patient.

The PAGB Professional Code for Medicines does not cover the advertising of over-the-counter medicines aimed wholly or mainly at the public. This is covered by the PAGB Consumer Code.

A full definition of Persons Qualified to Prescribe or Supply can be found in section 6.2 of the MHRA Blue Guide which is available online.

Students

Students of the above professions are not considered to be persons qualified to prescribe or supply.

Administrative staff

Administrative staff and students of the above professions, for example those working in doctors’ surgeries or pharmacies, are permitted to see advertisements aimed at persons qualified to prescribe or supply.

Mixed readership

Where advertising is placed in journals with a mixed readership, it is the main audience that determines the status of the readership, and hence which Code applies. For example, the British Medical Journal may be read by consumers. However, the majority of the readership will be doctors and, therefore, the PAGB Professional Code for Medicines will apply.

Websites

Websites that contain advertisements/information aimed at professionals should make it very clear that the site is for professionals only. Where websites contain materials both for professionals and consumers, there must be a clear differentiation between what is aimed at consumers and what is aimed at professionals.

RULE 2: A medicine must not be promoted prior to the granting of the Marketing Authorisation or registration under the THMR Scheme.

For example it is not acceptable to supply a photograph to a journal to announce a product launch prior to receipt of the Marketing Authorisation or registration under the Traditional Herbal Medicines Registration (THMR) Scheme and labelling approval. Similarly, teaser advertising is prohibited where it relates to a product that has not yet been granted a Marketing Authorisation.

The legitimate exchange of medical and scientific information during the development of a medicine is permitted, provided that any such information does not constitute advertising.

Where lead times are particularly long, it may be acceptable to provide retailers with limited, factual, information and a pack shot or mock-up clearly labelled ‘draft’ to enable them to plan stock. Such information should be provided on a one-to-one basis and not, for example, as an article in a journal.

For innovative over-the-counter medicines being reclassified for the first time from prescription only to pharmacy sale or from pharmacy to general sale, limited factual information for the sole purpose of enabling listing for the product may be provided to potential trade buyers. The content of such material should not be promotional.

RULE 3: All advertising must be in line with the product's Summary of Product Characteristics.

Advertising must comply with the product’s Marketing Authorisation (which includes the Summary of Product Characteristics (SmPC)).

While the actual wording of the claim does not have to be present within the SmPC, all claims must be consistent with the SmPC. For example, if the SmPC states that relief is obtained at 30 minutes, then a claim that the product relieves in 15 minutes would be unacceptable, despite supporting evidence. In order for the claim to be made, a variation to the SmPC would need to be agreed by the MHRA. If the SmPC does not mention speed of action, then the claim may be made as long as it is supported by appropriate evidence.

Subjective claims, such as taste (e.g. ‘great tasting throat lozenge’) and claims based on market research (e.g. ‘seven out of ten people found Brand X relieved their symptoms’) are usually not relevant to the SmPC and so no variation to the SmPC is required.

RULE 4: Advertising shall be true and shall not mislead. It shall not contain any exaggerated claims, either direct or implied.

Both the claims used and the overall impression given by the advertisement must be in line with the degree of improvement the average user should expect. Claims for benefits that cannot be expected to be achieved by the majority of users are prohibited.

Advertising for THMs must make it clear that the product is a registered traditional herbal medicine. All advertisements must include the statement: ‘Traditional herbal medicinal product for use in [specify one or more indications for the product consistent with the terms of the registration] exclusively based on long-standing use as a traditional herbal remedy.’

When using before-and-after pictures of a sufferer using a product, the visuals should not imply or show complete eradication of the condition, nor can the visuals imply that a product can be used to treat more serious forms of disease than the Marketing Authorisation would allow.

Claims such as ‘90% of users felt better with Brand X’ are only permitted when backed with substantiation relating to normal over-the-counter usage. For example, it would not be acceptable to imply that 90% felt better after one dose if the research is based on continued use.

RULE 5: Advertising shall not bring the over-the-counter medicines industry into disrepute, nor should it undermine or prejudice the confidence of recipients. All activities must acknowledge the status of the recipient.

Shocking or offensive advertisements

This rule includes issues such as taste and decency (i.e. avoidance of offence). Examples quoted as unacceptable in the PAGB Consumer Code may be taken as a benchmark, but are not necessarily unacceptable for advertising to professionals. On this basis, full or partial nudity may be acceptable if related to the use of the product. However, it would not be acceptable if used purely for attracting attention to an advertisement. In the case of a complaint, copy would be considered on a case-by-case basis.

Tailored to the audience

Advertising should be tailored to the audience to whom it is directed. For example, advertising devised for general practitioners may not be appropriate for GSL retailers.

RULE 6: Advertising shall not undermine current healthy-lifestyle advice.

It is not acceptable for advertisers to undermine evidence-based healthy lifestyles or health-promoting behaviour, such as exercise, healthy eating or smoking cessation. Similarly, advertising must not promote behaviour that could be damaging to health (e.g. smoking, dietary practices known to be detrimental to health, excessive drinking or a sedentary lifestyle).

RULE 7: An advertisement may only refer to the Medicines and Healthcare products Regulatory Agency, the Department of Health, the European Medicines Agency or any other MHRA advisory committees in order to state that the product is licensed. No other reference to these bodies is acceptable unless specifically required by the Licensing Authority.

Advertisers may state that a medicine is ‘licensed’ or ‘authorised’, or for THMs, ‘registered’. However, it is not acceptable to suggest that a medicine has been specifically endorsed or approved by the Department of Health, the MHRA, the European Medicines Agency (EMA), the Commission on Human Medicines (CHM) or any other MHRA advisory committees. Advertisers must not suggest that a particular medicine is superior or ‘special’, because it has been granted a Marketing Authorisation.

Acceptable claims

The following claims are likely to be acceptable:

‘Brand X is a licensed medicine’
‘licensed/authorised for the treatment of…’
‘licensed/authorised by the MHRA/Department of Health’
‘licensed/authorised by the MHRA/Department of Health for the treatment of…’
‘the only product licensed/authorised by the MHRA/Department of Health for the treatment of…’ (where applicable to the product).

For THMs the following claims are likely to be acceptable:

  • Brand X is a registered traditional herbal medicine’
  • ‘Brand X is an authorised traditional herbal medicine’
  • ‘authorised by the MHRA/Department of Health as a traditional remedy for the treatment of…’

Unacceptable claims

The following claims would not be acceptable:

  • ‘approved by the MHRA/Department of Health’
  • ‘approved by MHRA/Department of Health for the treatment of…’