Can I trust the advertising?
The advertising and promotion of medicines is strictly regulated to ensure that it encourages a responsible approach to self-medication and is not misleading.
Advertising has to comply with medicines-specific regulations and codes, as well as the general advertising controls that apply to all consumer products. Further information about how advertising in general is regulated can be found on the Advertising Standards Authority (ASA) website.
PAGB member companies must comply with the PAGB Medicines Advertising Codes when advertising over-the-counter medicines. These reflect the law and go beyond that to provide further self-regulatory controls.
All companies have to have their consumer advertising checked against the Advertising Codes and approved by PAGB before it can be published or broadcast. This includes print, television and radio commercials, direct mail materials, point-of-sale materials, sales promotions, brand–related sponsorship materials, website and social media materials.
The claims made in medicines advertising
Medicines advertising often makes claims about the product. For example, what the product can be used to treat, how fast the product works and how long it works for.
One of the most important principles of the PAGB Consumer Code is that all claims must be in line with the product’s Summary of Product Characteristics (SmPC). So, for example, if the SmPC states that relief is obtained from a product at 30 minutes, then PAGB would be unable to agree a claim that the product offers relief in 15 minutes.
The SmPC is part of the Marketing Authorisation that is granted by the Medicines and Healthcare products Regulatory Agency (MHRA) when the product is licensed and approved for sale. The rigorous licensing process is laid down by the Medicines Act 1968 and EU legislation, with the applicant company providing evidence to show the product meets strict criteria in terms of safety, efficacy and quality.
Some types of claims will not be covered by the SmPC such as ‘the fastest acting pain relief tablet’, ‘unique one daily dose’, ‘nothing acts faster’ etc. and these are individually considered by PAGB. In these cases, the company must submit all known available evidence in order to provide substantiation for the claim. Evidence likely to be acceptable includes published data in a peer-reviewed journal, standard textbooks, such as ‘Martindale: The Complete Drug Reference’ and ‘British National Formulary’ and unpublished company data that has been approved by the company’s medical or regulatory departments.
Packaging
As with the advertising, the information on the labels and packs of medicines is controlled by the SmPC and specific legislative requirements.
Certain statutory information is required on the packaging, including the name of the medicine, route of administration, authorised indications (what it can be used to treat), dosage and warnings. Other packaging information that is useful for the patients can also be included on the packaging. However, this must be in line with the SmPC and not of a promotional nature.
Food supplement advertising
Some nutritional supplements are licensed as medicines and are subject to the same advertising rules as above. However, most vitamin and mineral products are legally classified as food supplements and are regulated under food law. Food supplements advertising cannot make medicinal claims i.e. claims that the product can prevent, treat or cure disease.
As with medicines, PAGB members have to have their food supplement advertising pre-approved by PAGB against the Codes with any claims made about the product substantiated with appropriate evidence.
The way in which food supplement advertising is regulated has changed enormously over the last few years because of new European legislation about health and nutrition claims. A health claim is a direct, indirect or implied claim that consumption of any product making the claim carries a specific health benefit (e.g. calcium helps in the development of strong teeth and bones) and a nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a nutrient or other substance (e.g. high in vitamin C, low in fat).
The Regulation (EC) No 1924/2006 on Nutrition and Health Claims made on Foods (NHCR) was adopted in 2006 with the aim of harmonising the claims made about food across EU member states and achieve a higher level of consumer protection. This means that nutrition and health claims now have to be agreed at EU level and put onto a central list of permitted claims before they can be used in the advertising, promotion and labelling of food products.
The scientific assessment of claims by the European Food Safety Authority (EFSA) is currently under way and the approved health claims list for vitamins, minerals and other substances (excluding botanicals) is expected to be published in mid-2012.
Until then, several complex transition periods are in place about the types of claims that can and can’t be made. For further information please contact copyclearance@pagb.co.uk