PAGB Medicines Advertising Codes Amendments to the Code May 2011

1. PAGB Medicines Advertising CodesAmendments to the CodeMay 2011

2. Why do the Codes have to be Changed? The ‘Consumer Protection from Unfair Trading Regulations’ (CPRs) and the ‘Business Protection from Misleading Marketing Regulations’ (BPRs) came in to force in 2008. The regulations place obligations both on traders and on code owners. PAGB has sought advice from two major law firms and from member companies’ in-house lawyers. The advice has been consistent and as a result the guidance on absorption, new, herbal, natural and top parity claims has been revised. Slides 5–21 show the amendments to the Codes: • slides 7-16 Consumer Code changes required as a result of the CPRs • slides 5-6, 17-20 minor code updates • slide 21 list of Professional Code changes as a result of the BPRs (these changes echo those made to the Consumer Code) Throughout the presentation, the current rule is presented first, followed by the amended rule. The amendments are highlighted in red and an explanation is given in the ‘notes’ section. In some cases, text which is identical in both the previous and amended rules has been excluded. Where text has been excluded this is noted on the slide.

3. Transition Periods • all new advertising materials must comply with the 2011 PAGB Medicines Advertising Codes by 1 December 2011 • all existing materials (including websites) must comply with the 2011 Codes by 1 June 2012 • these requirements apply to both the Consumer Code and the Professional Code.

4. Changes to the PAGB Consumer Code

5. Rule 20 – Potentially Misleading Claims 20. Advertising shall not mislead as to the nature of the product, its ingredients or indications. All advertising must make the product indication clear, as stated on the SmPC. Special care is needed to avoid confusion with advertorials where other topics, such as lifestyle factors, are discussed, or if a product is featured in a leaflet that references other conditions. Where advertising is placed in close proximity to a related editorial, the editorial content may imply benefits that are not in line with the product SmPC. Where the Marketing Authorisation holder has prior knowledge of the related editorial, the Marketing Authorisation holder should try to ensure that the editorial does not include information that is contrary to the product SmPC. Such implied benefits could confuse the consumer and result in their using the product incorrectly. Claims that a product is more effective because it is a pharmacy-only medicine, rather than GSL, are not permissible. GSL products are just as efficacious, often differing only in pack size. It is permissible to state that a product has a ‘pharmacy-only formula’ if the ingredients, or the quantities of the ingredients, are such that they are only available from a pharmacy. Current rule

6. Rule 20 – Potentially Misleading Claims 20. Advertising shall not mislead as to the nature of the product, its ingredients or indications. All advertising must make the product indication clear, as stated on the SmPC. Special care is needed to avoid confusion with advertorials where other topics, such as lifestyle factors, are discussed, or if a product is featured in a leaflet that references other conditions. Where advertising is placed in close proximity to a related editorial, the editorial content may imply benefits that are not in line with the product SmPC. Where the Marketing Authorisation holder has prior knowledge of the related editorial, the Marketing Authorisation holder should try to ensure that the editorial does not include information that is contrary to the product SmPC. Such implied benefits could confuse the consumer and result in their using the product incorrectly. Claims that a product is more effective because it is a pharmacy-only medicine, rather than GSL, are not permissible. GSL products are just as efficacious, often differing only in pack size. It is permissible to state that a product has a ‘pharmacy-only formula’ if the ingredients, or the quantities of the ingredients, are such that they are only available from a pharmacy. Claims that a product/ingredient is ‘prescription strength’ are only permitted where the product/ingredient is the same strength as a prescription-only variant and is the highest strength available over-the-counter. New rule

7. Rule 21- Speed of Absorption Claims 21. Advertising claims relating to speed of action, absorption, dissolution, distribution or other pharmacokinetic particulars, are only acceptable if supported by evidence and if in line with the product’s Summary of Product Characteristics. PAGB approves speed of absorption claims (e.g. ‘gets to work in ten minutes’) on the basis of evidence that a therapeutic level of each active ingredient reaches the site of action at the time stated. Where the product is taken orally, ‘gets to work’ claims are usually approved on the basis of a therapeutic level of the active ingredient(s) being present in the bloodstream at the time indicated. Where sub-therapeutic levels can be identified at an earlier point, advertisers could claim ‘starts to get to work in x minutes’. Where the product has more than one active ingredient, and where only one of them ‘starts to get to work’ in the time stated, advertising should make it clear which ingredient is being referred to. Please note that absorption claims cannot be extrapolated to ‘starts to work in ten minutes’ or ‘active in ten minutes’ unless there is clear evidence that consumers will start to experience relief at this point. Where a claim is closely defined, it is usual for a qualifier of ‘can’ or similar to be used to take account of any variability of response. Please note: Rule 21 also includes detailed guidance on matters such as showing time change in TV advertising, ‘fast’ and ‘instant’ claims. This guidance has not changed and hence is not included in this presentation. Current rule

8. Rule 21- Speed of Absorption Claims 21. Advertising claims relating to speed of action, absorption, dissolution, distribution or other pharmacokinetic particulars, are only acceptable if supported by evidence and if in line with the product’s Summary of Product Characteristics. PAGB approves absorption claims on the basis of evidence that a therapeutic level of each active ingredient reaches the site of action within the time stated. Advertisers must ensure that the wording of the claim is in line with their data. Where sub-therapeutic levels can be identified at an earlier point, advertisers could claim that the product ‘starts to be absorbed within x minutes’ or words to that effect. Where the product has more than one active ingredient, and where only one of them ‘starts to be absorbed’in the time stated, advertisers should make it clear which ingredient is being referred to. The phrases ‘gets into the system’ or ‘gets to work’ are sometimes used to describe the rate of absorption of the active ingredient(s). Where ‘gets to work’ is used, the advertiser must specify that the claim relates to the speed of absorption. (PAGB is of the opinion that ‘gets into the system’ is less likely to be misinterpreted and further qualification is not needed.) The criteria for ‘gets into the system’, ‘starts to get into the system’, and any qualified uses of ‘gets to work’ and ‘starts to get to work’ are as described in the paragraph above. Claims such as ‘starts to work’, 'active' or any unqualified uses of ‘gets to work’ are taken to mean that consumers will be starting to feel relief at this point (e.g. ‘Brand starts to work within 30 minutes’). Such claims must be supported by efficacy data demonstrating that the average user could expect to experience relief within the time stated. Absorption data is not appropriate to support this type of claim. Advertisers should be careful to avoid claims relating to speed of absorption, action and dissolution etc. inferring a guaranteed speed or effect. Please refer to rule 17 for details. Where a claim is closely defined, it is usual for a qualifier of ‘can’ or similar to be used to take account of any variability of response. New rule

9. Rule 27- ‘New’ Claims 27. Advertising shall not mislead about the novelty of a preparation. Claims that a product is ‘new’ can only be made for one year from the date when the product was first available for consumers to purchase.  This allows companies to say ‘new Brand X’ or ‘now available’ for one year from the date when the product was first available for purchase. PAGB accepts the use of the claim ‘new’, even where a product was previously available on prescription or where the same formulation has been previously available under a different name. However, Clearcast require companies to clarify this, (e.g. ‘newly available for purchase’ for a product which was previously only available on prescription). If the product itself is not new, then manufacturers must make it clear which aspect of the product is new. For example: • new over-the-counter product launches (e.g. ‘new Brand X’) • new licensed indications (e.g. ‘new for pain relief of common arthritic conditions’) • new formulation (e.g. ‘new Brand X formulation’) • new format (e.g. 'new Brand X capsule format’). Please note: Rule 27 also includes guidance on ‘now’ claims and on removing such claims after one year. This guidance has not changed and hence is not included in this presentation. Current rule

10. Rule 27- ‘New’ Claims 27. Advertisers shall not mislead consumers about the novelty of aproduct. Claims that a product is ‘new’ can only be made for one year from the date when the product was first available for consumers to purchase. Advertisers may say ‘new’, ‘or ‘now available’ for one year from the date when theactive ingredient (or the combination of active ingredients)was first available for purchase.Where the product, active ingredient, or combination of active ingredients was previously only available on prescription, advertisers may say ‘newly available for purchase’ or ‘now available without prescription’. If the active ingredient (or the combination of active ingredients) has previously been available for purchase, then advertisers must make clear which aspect of the product is new. For example: • 'new format’ – the format is new but the formulation has been previously available • ‘new Brand X formulation’ - the formulation is new to Brand X, but may also be available from other brands • ‘new for pain relief of common arthritic conditions’ - the product has been licensed for an additional indication • ‘new orange flavour’ – this is acceptable whether or not competing brands are available in orange. In some cases it may be possible to use a ‘new’ flash and to explain which aspect of the product is new elsewhere in the advertisement. For example, where the product is the first product in the range to have a particular active ingredient, it may be possible to include a ‘New*’ flash and to say in a sufficiently visible place elsewhere in the advertisement ‘*New to Brand X’. Such qualifying statements should be positioned close to the original claim. The acceptability of the qualifier will depend on which aspect of the product is ‘new’. For example, it would not be acceptable to use a ‘New*’ flash and to add ‘*New tablet size’ as a qualifier. New rule

11. Rule 31- Herbal Claims 31. Advertising shall not suggest that a product is herbal unless all of the active ingredients are plants or extracts of plants. Products can only claim to be herbal if all of the active ingredients are of plant origin. However, it is not necessary for the excipients to be of plant origin. If only one of the active ingredients is herbal then the advertising could state that the product contains a herbal ingredient. Current rule

12. Rule 31- Herbal Claims 31. Advertisers shall not suggest that a product is herbal unless it complies with the definition of ‘herbal medicinal products’ as set out in EU Directive 2004/24 EC (as amended). Advertisers may only claim that a product, substance or preparation is herbal if it meets one of the following criteria: • ‘Herbal medicinal product: any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.’ • ‘Herbal substances: all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances.’ • ‘Herbal preparations: preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.’ Where the active ingredients are of plant origin but do not comply with the criteria set out above, advertisers may state that the active ingredients are ‘of plant origin’ or words to that effect. New rule

13. Rule 32- Natural Claims 32. Advertising shall not claim that a product is ‘natural’ unless all of its components are naturally occurring. ‘Natural’ can be used to describe those elements that are naturally occurring (e.g. ‘natural ingredient’). Products can only claim to be natural if the product is 100% natural, i.e. all of the ingredients and excipients are naturally occurring. If, however, only the active ingredient is natural, the claim must be limited to that ingredient (e.g. ‘Brand X contains a natural ingredient’). PAGB also accepts phrases such as ‘works naturally’ and ‘acts naturally’, for products that have a natural action on the body’s physiology. For example, a bulk-forming laxative could claim to ‘act naturally’ even if the product is not made from natural active ingredients. The majority of natural claims fall into one of four categories: • products in which all of the active ingredients and excipients are naturally occurring. These products may make claims such as: 'natural Brand X', ‘made from natural ingredients' and 'a natural choice' • products in which all of the active ingredients are natural. These products may make claims such as: 'natural remedy', 'natural relief' or 'natural laxative' • where only one of the ingredients is natural, advertising may claim 'contains natural ingredient Y' or 'contains natural flavours', etc. • products that have a natural mode of action, i.e. an action that mimics a physiological mechanism of the body. Such products may claim 'works naturally' and 'acts naturally’. Please note: Rule 32 includes guidance on claims such as ‘nature’s remedy’ together with a reference to further information. This guidance has not changed and hence is not included in this presentation. Current rule

14. Rule 32- Natural Claims 32. Advertisers shall not claim that a product is ‘natural’ unless all of its components are naturally occurring. ‘Natural’ can also be used to describe the particular elements of a product that are naturally occurring (e.g. ‘natural ingredient’). Advertisers may only claim that a product is natural if the product is 100% natural, i.e. all of the ingredients and excipients are naturally occurring. If, however, only the active ingredients are natural, the claim must be limited to those ingredients (e.g. ‘Brand X contains [name of ingredient], a natural active ingredient’ or ‘Brand X contains the natural active ingredients [name of ingredient] and [name of ingredient]’. The majority of ‘natural’ claims fall into one of three categories: • products in which all of the ingredients and excipients are naturally occurring, e.g. ‘natural remedy’, ‘natural Brand X’, ‘natural laxative’, ‘made from natural ingredients’, ‘a natural choice’ • products in which the ingredient referred to is of natural origin, e.g. ‘contains natural ingredient Y’ • products which have a natural mode of action i.e. an action which mimics a physiological mechanism of the body e.g. ‘works naturally’ and ‘acts naturally’.A bulk forming laxative could claim to ‘act naturally’ even if the product is not made from natural active ingredients. New rule

15. Rule 43- Top Parity Claims 43. Supportable top parity claims are acceptable. Such claims are valid where the evidence indicates that no other product within the therapeutic category is superior. In cases where there is no evidence to suggest that any product is superior to the advertised product, then a top parity claim may be used. These claims are more complex to assess than other comparative claims because they are approved on the basis that there is insufficient evidence to refute the claim. Top parity claims are valid in the following circumstances: (1) where comparative studies have been carried out and indicate that no product is superior to the one being advertised (2) where there are no comparative studies, then top parity claims may be used as long as there is no evidence suggesting that another product is likely to be superior to the one being advertised. In order to use a top parity claim, advertisers must ensure that they are aware of all similar over-the-counter products, both branded and generic. Advertisers must ensure they have reviewed the published evidence relating to the proposed claim for each product/ingredient. Advertisers should be able to demonstrate that they have taken a systematic approach to reviewing the available evidence relating to competitor products. It should be noted that when looking at top parity claims head-to-head comparative studies are preferable to single ingredient (or single product) data. However, there may be occasions when single ingredient studies and/or the pharmacological properties are sufficient to indicate that a claim is likely to be misleading. Companies considering using these claims should be aware that that the nature of the evidence for top parity means that top parity claims are open to challenge. If the challenge is successful, the claim will need to be withdrawn. Advertisers should also be aware that, whilst PAGB approves top parity claims on the basis of there being no evidence that suggests another product is likely to be superior, other organizations have, on occasions, required comparative data to demonstrate that no other product is superior. Please note: Rule 43 includes a definition of top parity claims, a recommendation to maintain an awareness of new products and new evidence and a reminder to use PAGB’s Guideline on Top Parity Claims. This guidance has not changed and hence is not included in this presentation. Current rule

16. Rule 43- Top Parity Claims 43. Top parity claimsare only acceptable when they are supported by positive evidence. PAGB permits top parity claims where studies have been carried out which show that no other product within the same therapeutic category is superior to the one being advertised. In order to make a top parity claim, advertisers must ensure that they consider all similar over-the-counter products, both branded and generic. Advertisers must ensure they have review all published evidence relating to the proposed claim for each product/ingredient. Advertisers should be able to demonstrate that they have taken a systematic approach to reviewing the available evidence relating to competitor products. Evidence for top parity claims typically consists of comparative studies or meta analysis. It should be noted that whilst head-to-head comparative studies are preferable to single ingredient (or single product) data there may be occasions when single ingredient studies and/or the pharmacological properties are sufficient to determine whether or not a claim is acceptable. Companies who are using top parity claims must ensure that they proactively maintain an awareness of new products and ingredients and new evidence so that previously approved advertising does not continue to be used once new evidence and/or new products mean that the top parity claim has become invalid. For further information on top parity claims, please refer to PAGB's ‘Guideline on the Use and Substantiation of Top Parity Claims'. Please also refer to PAGB’s Guideline on Top Parity Claims. New rule

17. Rule 53- Internet Advertising All web-based promotional materials over which the companies have full editorial control must comply with the Code and must be submitted to PAGB for approval. What the Code does not cover The following items do not need to be submitted to PAGB for approval: • legal notices and disclaimers - these materials are not intended to promote brands and hence do not require PAGB approval. Similarly, website registration forms that do not promote brands do not require PAGB approval.. Please note: Rule 53 includes extensive guidance on Internet advertising. This guidance has not changed and hence is not included in this presentation. Current rule

18. Rule 53- Internet Advertising All web-based promotional materials over which the companies have full editorial control must comply with the Code and must be submitted to PAGB for approval What the Code does not cover The following items do not need to be submitted to PAGB for approval: • Facebook posts and Twitter messages which do not mention the product, do not contain any direct or implied claims or any references to the therapeutic category • legal notices and disclaimers - these materials are not intended to promote brands and hence do not require PAGB approval. Similarly, website registration forms that do not promote brands do not require PAGB approval. New rule

19. Rule 57- Exceptions where not all of the Essential Information is Required Sponsored links that appear on Internet search engines are items over which advertisers have full editorial control and are, therefore, viewed as advertisements. These items must be submitted to PAGB for approval. Companies are not required to include the essential information in sponsored links where all of the following circumstances apply: • when the consumer clicks on the link, they are taken directly to a web page that contains the essential information in a format that is both prominent and clearly legible (please refer to rule 58 on legibility of essential information, p36-37) • where the only medicinal claims (please refer to section 5.1.1 for a definition of ‘medicinal claims’, p63) made are a factual statement relating to the product indication, or a simple reference to the therapeutic category. Consumer-preference claims (please refer to section 5.1.2 for a definition of ‘consumer preference claims’, p63), new claims and sales claims may be included without necessitating the inclusion of consumer essential information • if an umbrella brand is included but not a product name, any statement relating to the product indication or therapeutic category must apply to the whole brand. Please note: Rule 57 includes extensive guidance on where consumer essential information is and is not required to be included in advertising. The remainder of the guidance has not changed and hence is not included in this presentation. Current rule

20. Rule 57- Exceptions where not all of the Essential Information is Required Sponsored links that appear on Internet search engines are items over which advertisers have full editorial control and are, therefore, viewed as advertisements. These items must be submitted to PAGB for approval. Companies are not required to include the essential information in sponsored links where all of the following circumstances apply: • when the consumer clicks on the link, they are taken directly to a web page that contains the essential information in a format that is both prominent and clearly legible (please refer to rule 58 on legibility of essential information, p36-37) • where the only medicinal claims (please refer to section 5.1.1 for a definition of ‘medicinal claims’, p63) made aresimple, factual statements, for example claims relating to the product indication, or a reference to the therapeutic category • consumer-preference claims (please refer to section 5.1.2 for a definition of ‘consumer preference claims’, p63), new claims and sales claims may be included without necessitating the inclusion of consumer essential information • if an umbrella brand is included but not a product name, any statement relating to the product indication or therapeutic category must apply to the whole brand. The following claims would not be acceptable for inclusion in pay-per-click advertising without the addition of the essential information: • comparative claims, including top parity and superiority claims • claims which require additional qualification • direct invitations to use a product such as ‘try Brand X’.

21. Changes to the PAGB Professional Code

22. PAGB Professional Code Changes The changes to the Consumer Code described in slides 5-16 are echoed by corresponding changes in the Professional Code. The changes to the Professional Code are required as a result of the Business Protection Regulations 2008*. *Guidance on ‘prescription strength’ has been added to assist members preparing advertising materials. This change is not a result of the Business Protection Regulations.