Pharmaceutical Advertising 2022 Comparisons

Laws

Part 14 of The Human Medicines Regulations 2012/1916 (HMR) sets out the main UK laws on the advertising of medicines (The Medicines (Advertising of Medicinal Products (No 2)) Regulations 1975/1326 and The Medicines (Labelling and Advertising to the Public).

The Medicines and Healthcare Products Regulatory Agency (MHRA) Blue Guide (the "Blue Guide") explains the legal provisions and helps with interpretation and application of the laws that relate to the advertising of medicinal products.

The Cancer Act 1939 includes prohibits certain advertisements relating to cancer treatments.

General consumer advertising laws apply equally to advertising of pharmaceuticals to the public. In relation to non-broadcast advertising, these include the Trade Descriptions Act 1968 and the Consumer Protection from Unfair Trading Regulations 2008. In relation to broadcast advertising, the Broadcasting Acts 1990 and 1996 and the Communications Act 2003 apply.

However, the rules and their enforcement in relation to pharmaceutical advertising in the UK has been largely developed through self-regulatory schemes.

Self-Regulation

Advertising Standards Authority (ASA)

The ASA is responsible for administering the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code) which is written and maintained by the Committee of Advertising Practice. The Broadcast Committee of Advertising Practice (BCAP) similarly writes and maintains the Code of Broadcast Advertising (the BCAP Code). These codes relate to all advertising to the general public, but also include specific provisions relating to the advertising of medicinal products.

Industry codes

The Association of the British Pharmaceutical Industry (ABPI) Code applies to prescription medicines and is enforced by the Prescription Medicines Code of Practice Authority (PMCPA) which operates independently of the ABPI.

The Proprietary Association of Great Britain (PAGB) is the largest UK trade association for over the counter (OTC) medicines. PAGB has two codes applicable to pharmaceutical advertising:

• the PAGB Consumer Code for Medicines (for advertising directed to consumers); and
• the PAGB Professional Code for Medicines (for advertising directed to professionals).

Industry Codes

The ABPI Code applies to members of the ABPI, and the ABPI represents suppliers of more than 80% of all branded medicines used by the NHS. Membership and affiliate membership of the ABPI are conditional upon an agreement to adhere to the spirit and letter of the ABPI Code. Non-members can also formally agree to abide by the code and the jurisdiction of the PMCPA and do so to fall under the judgement and sanction of the PMCPA rather than of the UK regulator, the MHRA. Around 60 non-member companies have made such an agreement. Any person can make a complaint under the ABPI code, although most are made by competitors and by healthcare professionals.

The PAGB Code similarly applies to members of the association, and both they and authorised associate members of PAGB working with them can submit advertising copy for review and clearance to PAGB.

General Advertising Codes

The CAP and BCAP codes apply to public non-broadcast and broadcast advertising respectively. The ASA is funded by the advertising industry and has an arrangement with the communications regulator, Ofcom, pursuant to which the ASA is given responsibility to regulate TV and radio advertising. Any individual or business can complain to the ASA, but the ASA also monitors advertising.

Clearcast approves television advertising pursuant to the UK Code of Broadcast Advertising.

Radiocentre is the industry body for UK commercial radio and is responsible for ensure that medicines advertising on the radio is compliant with the UK Code of Broadcast Advertising.

Relationship with Legislation/MHRA

The MHRA works closely with the self-regulatory bodies in the Medicines and Devices Advertising Liaison Group (MDALG) which meets once or twice a year to develop guidance and a common understanding of the applicable law and publishes its minutes online.

"Advertising" is defined in regulation 7 of the HMR as "anything designed to promote the prescription, supply sale or use of that product". Regulation 7(2) of the HMR includes a list of activities that are considered to be advertising such as:

• door-to-door canvassing;
• visits by sales reps;
• supply of samples;
• inducements to prescribe or supply medicinal products;
• sponsorship of promotional meetings attended by those qualified to prescribe or supply medicinal products; and
• sponsorship of scientific congresses, including payment of travelling and accommodation expenses of persons qualified to prescribe or supply medicinal products.

Regulation 7(3) clarifies that the following are not considered an “advertisement”:

• a medicinal product's package or package leaflet;
• reference material and announcements of a factual and informative nature; or
• correspondence, which may be accompanied by material of a non-promotional nature, answering a specific question about a medicinal product.

Furthermore "publication" in relation to an advertisement is defined in regulation 277(1) of the HMR, "in relation to an advertisement, means the dissemination or issue of that advertisement— (a) orally; (b) in writing; (c) by means of an electronic communications network within the meaning of the Communications Act 2003; or (d) in any other way, and includes causing or procuring such publication by or on behalf of another person". Advertising offences all relate to "publishing" an advertisement that breaches the HMR.

The Blue Guide adds that labelling and package leaflets are not considered advertising if they meet the requirements of part 13 of the HMR. The Blue Guide also clarifies that any person, not just the manufacturer or distributor, might breach THMR if they promote a medicine, and this includes individuals, journalists, publishers and public relations agencies.

The ABPI Code does not define "advertising" but defines promotion, in paragraph 1.17, as: "any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines".

This includes:

• journal and direct mail advertising;
• the activities of representatives, including any electronic or printed material used by them;
• the supply of samples;
• the provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, whether in money or in-kind;
• the provision of hospitality for promotional purposes;
• the sponsorship of promotional events/meetings;
• the sponsorship of scientific events/meetings, including payment of travelling and accommodation expenses in connection therewith; and
• all other promotion.

The PAGB Consumer Code also does not define "advertising" but includes a list of items and activities that are considered materials that are covered by the code, including social medial, text messages, websites, advertorials, and materials written by third parties but in relation to which members have had the opportunity to comment and to request amendments.

Labelling and package leaflets meeting the requirements of part 14 of the HMR are not considered to be advertising.

Disease awareness and health education campaigns that do not make product claims are not considered to be "advertising". Appendix 7 of the Blue Guide provides detailed guidance which states that these campaigns must avoid the use of brand names and must not relate just to a limited range of treatments as this is likely to lead to the prescription of a specific prescription only medicine or medicines. While a disease awareness campaign might refer to available treatment options, this should not encourage individuals to request a particular medicine, but rather should focus on raising awareness of symptoms or risk factors so that early diagnosis might be sought.

Laws

Press releases for prescription medicines are not specifically prohibited, but the MHRA requires that they should be made about a prescription medicinal product only where the press release is genuinely newsworthy. They must not be used to promote prescription only medicines, but rather should promote balanced medica coverage.

Section 7.7 of the Blue Guide requires that press releases provide the context for use of the medicine and the population for which it has been licensed, setting the product and results in the context of alternative treatments and current medical practice. Brand name use should be minimised, and the content should be factual and not sensationalised. Healthcare professional (HCP) statements should be balanced and informative, and perspectives from any patient should focus on the impact the disease has on them, and not on the specific medicine.

Appendix 5 of the Blue Guide is addressed to journalists and patient organisations writing about medicines as even though neither will usually have commercial links with the product, they can still breach the HMR. The guidance is to inform rather than to promote, to provide balanced factual and accurate reporting without encouraging readers to seek a particular product and without exaggerating the potential benefits of a medicine.

The Blue Guide accepts the need for business press releases intended to keep shareholders informed and states that these should identify the commercial importance of the information and should be factual and balanced.

Self-Regulatory Industry Codes

The ABPI code states that it is good practice to reference the summary of product characteristics with a press release, and manufacturers should consider including references "to other credible sources of information about a condition or a medicine". This is again to provide a balanced perspective.

The PAGB Code distinguishes between PR on the consumer facing part of a website, and those in a dedicated press section. Only the former requires PAGB pre-approval. However, PAGB consider that a HCP's recommendation is not acceptable in consumer-facing PR, and nor is any celebrity endorsement.

Comparisons in Advertising to the Public

Section 5.6 of the Blue Guide states that comparative claims against another named product are prohibited in advertising to the public. This means that only claims that relate to a category of products might be made in advertisements of medicines to the public.

The PAGB Codes do not permit comparisons that denigrate another ingredient, product or product category. The PAGB Consumer Code also requires that comparisons are made only where the point of difference is sufficiently significant to be meaningful to consumers. If the comparative claim is made in a context that allows a competitor to be identified, then the advertiser must provide information to the consumer which allows the consumer to verify the claim. The PAGB Professional Code requires that hanging comparisons are not made: the product category being compared should be made clear.

Comparisons in Advertising to Professionals

The Blue Guide (4.3) states that comparative claims might only be made where they relate to the licensed use, they can be substantiated and are either included in the SmPC and are not inconsistent with the SmPC. Where new data shows a comparison that is contrary to what is stated in the SmPC, the SmPC must be updated before the comparison might be made.

ABPI code requires that comparisons are not misleading, are accurate, fair and can be substantiated and do not create confusion between products or trade marks and no unfair advantage is of the reputation, brand or marks of a competitors is gained.

General Laws and Codes on Comparative Advertising

As a general legal principle applicable to all products, comparative advertising is permitted subject to compliance with the Business Protection from Misleading Marketing Regulations 2008 (SI 2008/126) and the Consumer Protection form Unfair Trading Regulations 2008 (SI 2008/1277). However, comparisons of one medicine against even a category of medicines must be approached with care. The principles under these general advertising laws include that:

• the comparison must not be misleading (meaning that it does or is likely to deceive);
• that it does not mislead by omission
• that the comparison is fair: that the products meet the same needs or are intended for the same purpose (in this case the same indication and intended patient population);
• there is an objective comparison of one or more material, relevant, verifiable and representative features of the products;
• it does not discredit or denigrate the marks or names or features of the other product; and
• it does not take unfair advantage of a trade mark, trade name or other distinguishing marks.

A breach of the general laws on comparative advertising can lead to one or more of the following actions by the competitor, although these are less likely to succeed where the comparison is to a category or medicines:

• passing-off;
• trade mark infringement;
• trade libel;
• malicious falsehood; and
• copyright infringement.

The CAP Code states that even comparisons with an unidentifiable competitor must not mislead or be likely to mislead the consumer and the selected elements for comparison must not give the advertiser an unrepresentative advantage.

It is not permitted to provide information to patients or consumers on unauthorised medicines or unauthorised indications. All advertising must comply with the SmPC (regulation 280 HMR).

Clause 3.1 of the ABPI Code states that a medicine must not be promoted prior to grant of a marketing authorisation. Clause 11.2 of the ABPI Code states that the promotion of indications not covered by the marketing authorisation for a medicine is prohibited. Section 4.1.1 of the PAGB Consumer Code includes similar provisions.

Under the ABPI Code clause 1.17, information on unauthorised medicines or indications might only be given to HCPs in response to an unsolicited written question from that HCP but only if the response relates solely to the subject matter of the enquiry, is accurate, does not mislead and is not promotional in nature. Such responses are not considered to constitute "promotion".

Regulation 278 of the HMR does not permit the advertising of medicines without a marketing authorisation.

Clause 3.1 of the ABPI Code permits the "legitimate exchange of medical and scientific information during the development of a medicine". This is on the basis that the activity does not constitute promotion. A conference constituted of a passive audience of HCPs to which a presentation on a medicine in development is given is likely to be seen as promotional and therefore not permitted. Conversely, a small advisory board of HCPs with the relevant specialism who provide their clinical views on the indication and products in development in relation to specific requests for advice is more likely to be considered a permitted legitimate exchange on the basis that this is not a promotional activity.

See 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications.

There is a limited exception to the law and codes on prohibiting the display or provision of informant on unauthorised medicines or unauthorised indications to HCPs, which is in relation to international events/meetings held in the UK.  Clause 11.3 of the ABPI Code and paragraph 6.11 of the MHRA Blue Guide state that at such meetings, information might be provided or displayed if the following criteria are met:

• the event/meeting must be truly international, of high scientific standing and with a significant proportion of the attendees from countries outside the UK where there is a relevant licence;
• the medicine or indication must be relevant and proportional to the purpose of the event/meeting;
• the lack of UK marketing authorisation must be clearly and prominently indicated in all materials;
• approved prescribing information must be readily available for a medicine authorised in the UK, even though it will not refer to the unlicensed indication;
• the names must be given of countries in which the medicine or indication is authorised (including at least one major developed country);
• it must be stated that registration conditions differ from country to country; and
• the material must be certified as required by the Code.

Clause 3.1 of the ABPI Code permits the provision of advance information to NHS organisations where that information is solely directed to the budget decision makers (not prescribers):

• involved in the purchase of medicines;
• who need to estimate their likely budgets in advance; and
• where those changes may significantly affect their level of expenditure such as through changes in the patient pathway and/ or service delivery.

The information that might be provided must relate to a product:

• containing a new active substance; or
• a new active substance prepared in a new way; or
• is to have a significant addition to the existing range of authorised indications; or
• is to have a novel and innovative means of administration;

The communication should:

• state whether or not the medicine has a UK marketing authorisation;
• state the likely cost or savings and budgetary implications (which must represent a significant change on likely expenditure);
• be factual and limited to an adequate but succinct account of the product's properties, with mentions of other products only being made to put the new product or indication into its therapeutic context;
• not be promotional in style; and
• not include mock-up drafts of the SmPC or package leaflets.

Unlicensed medicines which are provided under a compassionate use or other early access programme cannot be promoted (Regulation 280(4) of the and Clause 11.1 of the ABPI Code). The programmes themselves cannot be promoted where this would amount to promotion of an unlicensed medicine, which will be likely in most cases, with the exception of public health campaigns, such as for the COVID-19 vaccines.

It is prohibited to publish an advertisement for a medicinal product unless there is an applicable marketing authorisation in place (Regulation 279 of the HMR).  Any advertisement for a medicinal product must (Regulation 280 of the HMR):

• comply with the SmPC;
• encourage rational use of the product by presenting it objectively and without exaggerating its properties; and
• not be misleading.

Regulations 283 to 292 of the HMR relate to the advertisement of medicines to the public.  Restrictions on such advertising include advertisements:

• likely to lead to use for the purpose of inducing an abortion (Regulation 283 of the HMR);
• likely to lead to use of a prescription only medicine (Regulation 284 of the HMR);
• for narcotic of psychotropic substances (Regulation 285 of the HMR)
• that state or imply the necessity of a medical consultation or surgical operation;
• that offers to provide a diagnosis or suggest a treatment by post or electronic communication;
• that could lead to erroneous self-diagnosis;
• that suggest the effects of the medicinal product:
1. are guaranteed;
2. are better than or equivalent to those of another identifiable treatment or medicinal product; or
3. are not accompanied by any adverse reaction;
• that uses in terms that are misleading or likely to cause alarm, pictorial representations of changes in the human body of the disease or injury or the action of the medicinal product on the human body;
• the suggest the health of a person who is not suffering from any disease or injury could be enhanced by taking the product, or that their health could be affected by not taking the product;
• that suggest the medicinal product is a food, cosmetic or other consumer product or that its safety or efficacy due to it being natural;
• including recommendations by scientists, HCPs or celebrities; and
• that are directed principally at children.

Consumer advertising is required to identify clearly that it is an advertisement, and the product is a medicinal product (Regulation 291 of the HMR).

Under the Cancer Act 1939, Section 4 specifically prohibits the publication of any advertisement offering to:

• treat any person for cancer; or
• prescribe any remedy for cancer; or
• give any advice in connection with the treatment of cancer.

Licensed vaccine products approved by health ministers as part of a government-controlled vaccination campaign are exempt from the prohibition on advertising prescription-only medicines.

Laws

Regulation 291(2) of the HMR requires any advertisement of a medicinal product to include the following (see Annex 3 of the MHRA Blue Guide also):

• the name of the product;
• if there is only one active ingredient, the common name of the active ingredient;
• information necessary for the correct use of the medicinal product;
• an express and clear invitation to read carefully the instructions on the package or the package leaflet, as applicable; and
• for products with a Great Britain licence that are not also licensed in Northern Ireland or are prescription-only in Northern Ireland, a statement that the product is not available of not available without prescription in Northern Ireland, as applicable.

The advertisement should be clear that the material or message is an advertisement and the product advertised is a medicine.

MHRA Blue Guide (Appendix 3) provides detailed guidance on advertising medicines which might be promoted for use during pregnancy.  The appendix applies both to consumer and professional advertising. 

Self-Regulation

The PAGB Consumer Code (Section 1.5.15) includes the following additional requirements for including in advertisements for non-prescription-only products:

• therapeutic indication in line with the SmPC;
• products for conditions that are difficult to self-diagnose should state that people should obtain a doctor's diagnosis before using the product for the first time, particularly where this is stated in the SmPC;
• smoking cessation products should refer to the need for willpower to quit smoking successfully; and
• promotion of medicines during pregnancy are only acceptable where a positive statement in Sections 4.1 or 4.6 of the SmPC supports such use, and advertisements must encourage a cautious approach; and
• any other wording required as a condition of the marketing authorisation.

Guidance on the Law

The MHRA Blue Guide includes guidance for patient organisations in Appendix 5. This sets out the expectation that they will have robust procedures to ensure that they retain their independence from pharmaceutical companies, even if those companies provide them with support.

This means that any information provided by patient organisations should be under their editorial control to avoid it becoming promotional in nature and therefore subject to the medicinal product advertising laws. Patient organisations should also not actively encourage patients to seek a particular product from their doctor.

Patient organisations are also likely to be subject to Charity Commission rules.

ABPI Code

Pharmaceutical companies are required to respect the independence of patient organisations and are not to promote or request the promotion of a particular prescription only medicine (Clause 27.1). They must not influence the text of patient organisation material to favour its own interests (Clause 27.4) but might contribute to the drafting of patient organisation materials from a fair and balanced scientific perspective.

There must be a written agreement for all sponsorships, donations and grants to patient organisations (Clause 23.2).

The ABPI Code includes disclosure requirements imposed on manufacturers for interactions with patient organisations (Clause 4.4, 24.6 and 29). Manufacturers are required to document and annually publish on the company website on a national or European level:

• summary details of the monetary value of support to patient organisations, including in relation to sponsorship of events/meetings (Clause 10.11); and
• fees and expenses for the provision of contracted services by individuals representing patient organisations and the total amount paid per patient organisation per calendar year.

It is prohibited to provide gifts to individuals associated with patient organisations (Clause 3.5). Donations and grants are only permitted to patient organisations if they (Clause 24.3):

• are made for the purpose of supporting healthcare, scientific research or education;
• do not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines;
• are prospective in nature;
• do not bear the name of any medicine (the company name is acceptable); and
• are the subject of a written agreement detailing all the main elements of the arrangement (Clause 27.2) and which is certified.

Information Required by law

Schedule 30 of the HMR details the information to be included in advertisements to HCPs. This includes:

• the number of the marketing authorisation;
• the name and address of the marketing authorisation holder;
• for an advertisement in Great Britain, a statement that the product is authorised under a UKMA(GB);
• the classification of the product:
1. general sale (G);
2. prescription only (POM);
3. pharmacy only (P);
• the name of the medicine;
• the list of active ingredients, using their common names and placed immediately adjacent to the most prominent display of the name of the product;
• one or more indications consistent with the marketing authorisation;
• a succinct statement of the SmPC (which must be printed in a clear and legible manner and placed so that their relationship to the claims and indications can be readily appreciated by the reader) on:
1. adverse reactions, precautions and relevant contra-indications;
2. dosage and method of use relevant to the indications in the advertisement; and
3. if not obvious, the method of administration; and
• the cost of either a specified package or quantity or recommended daily dose (except if more than 15% of the publication circulates outside the UK).

Schedule 30 of the HMR is clarified by Annex 4 of the MHRA Blue Guide.

ABPI Code

Clause 12 of the ABPI Code restates the above list and adds the following items to be included in promotional materials:

• any warning issued by the Medicines Commission, the Commission on Human Medicines, the Committee on Safety of Medicines or the MHRA and that is required to be included in advertisements;
• the date the prescribing information was drawn up or last revised;
• the INN must appear immediately adjacent to the most prominent display of the brand name in bold type of a size such that a lower-case x is no less than 2mm in height or in type of such a size that the non-proprietary name or list of active ingredients occupies a total area no less than that taken up by the brand name;
• in digital material the prescribing information might either be included directly or via a clear and prominent, direct, single click link;
• promotional material on the internet must include a clear prominent statement as to where the prescribing information can be found;
• prescribing information must appear on at least one of the pages in a printed journal advertisement and for those pages where it is not visible, there should be a reference on the outer edge of the page for where to find the prescribing information, with lower case x no less than 2mm in height;
• the prominent statement "Adverse events should be reported. Reporting forms and information can be found at [website address which links directly to the MHRA Yellow Card site]. Adverse events should also be reported to [relevant pharmaceutical company]"; and
• where required the inverted black equilateral triangle for products requiring additional monitoring.

Note that for an abbreviated advertisement to HCPs, meaning one that does not exceed 420cm2, truncated information might be included rather than the full lists above (regulation 295 of the HMR). These are referred to as "short form" advertisements in the Blue Guide and for which all information in Annex 5 must be given. These advertisements might only appear as an integral part of a publication and cannot be a loose insert or placed on the internet. Some innovative products which are new to the market in the last two years might be subject to an agreement with the MHRA that a short form advertising form will not be used.

Information Prohibited by Law

The Blue Guide prohibits advertising which states or implies that a product is "safe" (paragraph 6.6).

Promotional material to HCPs might refer to published studies, if clear references are given. The materials might also refer to "data on file" if this data is not contrary to the SmPC and this must be provided within ten working days of a response to a request from an HCP (Clause 14.3 ABPI Code).

The European Union SmPC guideline Section 4.1, Therapeutic Indications states: “If the product’s indication depends on a particular genotype or the expression of a gene or a particular phenotype, this should be stated in the indication.” European Union SmPC guideline Section 5.1, Clinical Particulars, provides a summary of clinical trial information. Sometimes the predictive biomarker which was used and its brand name and or manufacturer are included, but the practice is not consistent and is not an absolute requirement. Once the In vitro Diagnostics Regulations 2017/746 (IVDR) are in force and companion diagnostics are regulated under it, those diagnostics will recognise in their instructions for use (IFU) the specific medicines for which they are authorised companions.

Advertisements referring to medicinal products used in combination products must not include claims for the medicinal product that are not in the SmPC.

Reprints might not be provided proactively unless the articles have been peer reviewed (Clause 16.5 ABPI Code). Reprints should be accompanied by prescribing information listed in Clause 12.2 of the ABPI Code.

Medical science liaisons (MSLs) are subject to the same rules as any other employee of a manufacturer and therefore not permitted to proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals. Only discussions which are unsolicited individual written enquiries might be responded to.

Prior Authorisation/Vetting by the MHRA

Medicines advertising is not generally subject to prior authorisation by the MHRA. Prior vetting of advertisements can be requested by the MHRA and is sometimes undertaken in the following circumstances:

• a newly authorised product, subject to additional monitoring, is placed on the market (this is always applied for new active substances);
• upon reclassification; and
• where there have been previous advertising breaches.

Industry Bodies

The ABPI or PMCPA do not as a rule authorise or vet advertisements, although the PMCPA monitors published advertising and meetings.

PAGB membership is conditional upon all over-the-counter medicines advertising aimed at consumers being approved by PAGB prior to release (PAGB Consumer Code 1.4).

Other Self-Regulatory Bodies

Clearcast clears finished television advertisements against the UK Code of Broadcast Advertising. Radiocentre clears all advertisements featuring health claims and for medicines, medical devices and treatments before they are broadcast on the radio. The ASA offers a free but non-compulsory advice service against the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing.

Regulation 281(2) of the HMR requires that authorisation holders establish a scientific service to compile and collate all information relating to the product. Regulation 281(3) of the HMR requires medical sales representatives to be given sufficient training and to have sufficient scientific knowledge to ensure the information they provide is as precise and complete as possible.

The ABPI Code requires members to establish a scientific service with a registered medical practitioner or a pharmacist registered in the UK and who will collate information received about the product (Clause 4.1).

Clause 8 of the ABPI Code requires all promotional materials to be certified by a registered medical practitioner or pharmacist registered in the UK, or a dentist for dental products. The certifier must be independent of the creation of the advertising and their details and qualifications must be notified in advance to the Advertising Standards and Outreach Unit, Vigilance and Risk Management of Medicines Division of the Medicines and Healthcare products Regulatory Agency (MHRA), and to the Prescription Medicines Code of Practice Authority (PMCPA). Changes in the names of nominated certifiers must be promptly notified.

The following promotions/ materials must be certified to say that the final form of the material has been examined and that they believe it complies with the ABPI Code, is not inconsistent with the marketing authorisation and SmPC and is a fair and truthful presentation of the facts about the medicine:

• all events or meetings involving travel outside the UK;
• educational material for the public or patients which relates to diseases or medicines but is not intended as promotion for those medicines;
• material relating to working with patient organisations;
• material relating to collaborative working;
• material and items for patient support and associated supplementary information; and
• the written agreement for donations and grants.

Material in continuous use must be recertified at least every two years.

Training

The ABPI Code Clause 9 requires all employees and contractors engaging in the preparation or approval of the Code to be fully conversant with the Code and with pharmacovigilance requirements. All sales representatives must be given adequate training and have adequate scientific knowledge and must take an exam within their first year of employment and pass it within two years to at least level 3. Details of the numbers of representatives who have passed an examination and the exam status of the others must be provided to the PMCPA on request.

The Legal Position

The MHRA considers that material posted on UK websites and/or aimed at the UK audience is subject to UK medicines advertising legislation (paragraph 5.10 of the Blue Guide).

Prescription only medicines might only be advertised on websites directed at HCPs (as determined by the nature of the content). It is not a requirement that such material is access restricted but is preferred (paragraph 6.3 of the Blue Guide). Websites with content for both consumers and including HCP advertising should have separate sections and should be clearly marked for the target audience. Where HCP materials are openly available, adequate non-promotional information should be provided in public areas to avoid consumers needing to access the sections for HCPs. There should be no direction of the public to materials for prescription only medicines that are intended for HCPs. Journals intended for HCPs and published online are considered as directed to HCPs, but each page should state that they are so directed.

Company Websites

The Blue Guide paragraph 7.5 provides guidance on company websites and permits the following to be included in the publicly available areas:

• disease-related information;
• patient information leaflets (PILs), SPCs and public assessment reports (PARs) for their POM products; and
• other non-promotional reference information about the product that fairly reflecting current evidence about the product and its benefit risk profile.

The ABPI Code applies to websites of:

• a UK company/with a UK company's authority, or
• an affiliate of a UK company, or with the authority of such a company, and it makes specific reference to the availability or use of the medicine in the UK (Clause 1.2 of the ABPI Code).

Clause 12.6 ABPI Code requires that internet material includes a clear prominent statement of the location of the prescribing information.

Consumer Internet Advertising

PAGB (1.5.12, rule 53) consider that the following fall within the remit of its Consumer Code and an off-line version needs to be provided for review:

• brand websites and social media, including brand home pages (but not if the product is not mentioned);
• banner advertising;
• press releases intended for internet publication which are under the editorial control of the company; and
• pay-per-click advertising, such as that used on internet search engines.

Note that user reviews are not considered "advertising" unless adopted by the company, which they will be considered to be if the company curates the content, even if simply deleting certain reviews.

All internet content must include the essential information outlined in 4.2 Information Contained in Pharmaceutical Advertising to the General Public, but where there are significant space restrictions it may be acceptable to include the essential information one click away (PAGB 1.5.15).

Space limited advertising is not considered appropriate for making:

• comparative claims other than sales claims;
• claims which require additional qualification;
• direct invitations to use a product; or
• encourage user to read further information such as “Find out more about Brand X”.

Where mobile advertisements consist of a series of swipable or scrollable tiles, it may be acceptable to place the essential information on the tile at the end of the series.

See 7.1 Regulation of Advertising Medicinal Products on the Internet.

Note that all paid-for posts (even without full creative control by the company) must be identified as advertising by using #ad. Care must be taken with retweets and "likes" to avoid celebrity endorsement of products, meaning companies should only do so if there is no implication that they used the product (PAGB Code 1.5.9).

See 7.1 Regulation of Advertising Medicinal Products on the Internet.

There are no specific permissions or prohibitions on posting disease awareness information and/or materials online, so that the general rules apply, see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.

There are no specific rules for online meetings in relation to pharmaceutical products.

The UK Bribery Act 2012 (Bribery Act) is the general law prohibiting the making of offers, promises or financial or other advantage to another person where the advantage is intended to induce improper performance of a function or activity and/ or where it is known or believed that acceptance of the advantage would itself constitute the improper performance of a relevant function or activity (Section 1). It is equally an offence to request, agree to receive or accept that advantage (Section 2). The provisions apply to people both in public service and to private businesses and both individuals and entities can be subject to sanctions of the Bribery Act.

The Bribery Act has extra-territorial effect so that acts engaged in abroad by individuals or companies with sufficient proximity to the UK will also fall within the remit of its provisions.

There is a separate offence of "bribery of foreign public officials", which in the context of medicines can include regulators, and those employed by public hospitals (Section 6).

Companies commit a criminal offence under the Bribery Act if they fail to prevent bribery (Section 7). It is a complete defence to that offence if the company can show that it had in place adequate procedures designed to prevent persons associated with the company (anyone performing services for or on behalf of the company, such as employees, agents or subsidiaries) from undertaking the questionable conduct. This underlines the need for good corporate governance, compliance policies and procedures.

The UK's NHS publishes provisions on conflicts of interest for compliance by entities within and individuals employed by the NHS. These include Managing Conflicts Of Interest: Revised Statutory Guidance For CCGs 2017 and Managing Conflicts Of Interest in the NHS Guidance For Staff and Organisations, which include notification requirements on those individuals.

Laws

Regulation 300(1) of the HMR provides that "a person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer or promise to such persons any give, pecuniary advantage or other benefit unless it is (a) inexpensive; and (b) relevant to the practice of medicine or pharmacy". HCPs are also not permitted to solicit or accept such gifts (Section 300(4)). There are similar restrictions on the provision of hospitality at meetings, which must be strictly limited to provision to HCPs and for the main purposes of the meeting but is defined to include sponsorship of attendance and payment of travelling or accommodation expenses. Breaches of these provisions are a criminal offence.

The ABPI Code

Clause 19 of the ABPI Code prohibits inducements and inappropriate payments and the provision of items to HCPs and other relevant decision makers.

MHRA Blue Guide

Paragraph 6.15 discusses Section 300 of the HMR and defines "inexpensive" to mean items not costing the company more than GBP6 and representing a similar value to the recipient. Items relevant to the practice of medicine are those that have a clear business use, such as pens, notepad, calculators, diaries, calendars and coffee mugs.

ABPI Code

Clause 19.2 permits patient support items to be provided to HCPs (not admin staff) if they are documented and certified in advance. The items must be inexpensive (no more than GBP10 excluding VAT) and directly benefit patient care, may include the company but not any product name unless essential for the item's correct use. The items must not be given out from exhibition stands.

Separately, patient access schemes are permitted if they meet requirements of the ABPI Code.

Promotional aids might be given to HCPs and other decision makers. Under the ABPI code, in contrast to the MHRA Blue guide, it is not permitted to provide mugs, stationery, computer accessories, diaries or other items for use in the home or car, and equally items for use with patients such as surgical gloves are not permitted, nor must toys for waiting children be provided. Thus, only literature intended for patients might be provided in relation to prescription medicines. Memory sticks might be provided with saved promotional material as long as the volume of memory capacity is compatible with that material. It is also not permitted to provide HCPs with text books, unless part of a donation or grant for research and compliant with the relevant provisions. Equally, the provision of items to practices for long term or permanent loan should be avoided.

Laws

Regulation 298 of the HMR permits the giving of samples solely to those qualified to prescribe medicinal products and for the purpose of acquiring experience in dealing with the product in question. There are then additional conditions applied to the giving of samples:

• on an exceptional basis only;
• in response to a written request from, and signed and dated by, the recipient;
• only a limited number of samples of the product in question are supplied to the recipient in that year;
• the sample is no larger than the smallest presentation of the product that is available for sale in the relevant region (Great Britain or Northern Ireland);
• it is marked “free medical sample – not for resale” or bears a similar description;
• is accompanied by a copy of the summary of the product characteristics; and
• the product is not a narcotic or psychotropic substance.

ABPI Code

Clause 17.2 reiterates the legal provisions, but adds further conditions:

• no more than four samples of a particular medicine to be provided to an individual health professional during a single year;
• samples of a particular medicine may be provided for no longer than two years after the HCP first requested it, except if it is an extension of an existing product, when that might be "new" if, eg, additional strengths and/or dosage forms, but not simply additional pack sizes;
• samples sent by post must be secured against opening by young children; and
• samples must not be provided simply as an inducement, but for the sole purpose of treating patients.

Companies are required to have adequate systems of control and accountability for the samples they distribute. These must show the number of samples supplied to each HCP.

See 8.2 Legislative or Self-Regulatory Provisions for the legal provisions and which are restated in the Blue Guide at paragraph 6.16 and note that the Blue Guide defines "advertising" to include sponsorship of meetings.

See 3.3 Provision of Information to Healthcare Professionals for the content of international meetings.

ABPI Code

The ABPI Code permits companies to hold, sponsor or support delegates to attend events and meetings that meet the Code requirements. There are several conditions applicable to these meetings and events:

• the event/meeting must have a clear educational content;
• the programme not the associated hospitality or venue should attract delegates;
• the content must be appropriate and relevant;
• the venue must be appropriate and conducive to the main purpose of the event/meeting and not lavish or extravagant;
• any associated subsistence (food and drink), accommodation and travel costs must be strictly limited to the main purpose of the event/meeting, of secondary consideration, appropriate and not out of proportion to the occasion (see Clause 10.7);
• companies must not sponsor, support or organise entertainment (such as sporting or leisure activities, etc); and
• any hospitality provided must not extend to an accompanying person unless that person qualifies as proper delegate or participant at the meeting in their own right.

The cost of any subsistence (food and drink) provided must not exceed GBP75 per person, excluding VAT and gratuities.

Pharmaceutical companies are not permitted to sponsor cultural, sports or other non-scientific events in relation to or which are concurrent with scientific conferences (ABPI Code, Clause 10.1) as this would be considered an improper inducement (see 9.1 Gifts to Healthcare Professionals).

ABPI Code

The ABPI code permits donations and grants to institutions, but not to individuals. These are permitted for supporting healthcare, scientific research or education and must not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines. They must be prospective in nature and each subject to a specific and certified written agreement. The company must keep a record of the donation or grant, and they must be disclosed annually (see 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value).

MHRA Blue Guide

Paragraph 6.14 of the Blue Guide provides guidance on examples to which regulation 300 of the HMR will apply. Thus, cash returns to individuals and other personal benefits "in lieu" of discounts such as preferential loans, share options, shopping vouchers, gifts or special prices for travel, insurance, office equipment or computer software would constitute an offence under the HMR. Equally a points scheme based on the volume of purchases is likely to be a breach.

The Blue Guide also clarifies that the offence might be committed by corporate and unincorporated bodies as well as individuals and includes manufacturers and distributors of medicines, including wholesale dealers.

ABPI Code

The ABPI Code adds that schemes which enable health professionals to obtain benefits in relation to the purchase of medicines are not acceptable, even if they are presented as alternatives to financial discounts. This would include the provision of gift vouchers, but also personal rebates.

It is possible for companies to pay for bona fide services provided by HCPs. The requirement not to bribe an HCP to inappropriately prescribe is subject to the provisions of The Bribery Act (see 8. Pharmaceutical Advertising: Inducement/Anti-bribery). Furthermore, the ABPI Code, Clause 24 imposes the following conditions:

• a prior written agreement must be agreed specifying the legitimate need, the services and the payment to be made;
• the criteria for selection of the particular HCP (and the number if several) must relate to the services and their expertise and be necessary to achieve the need of the company;
• the company must maintain records of the services and payments;
• remuneration for the services must be reasonable and reflect the fair market value of the services provided; and
• the agreement must also require the HCP to declare that they are contracted by the company when they write or speak in public about the company, including if they are an employee of the company whilst continuing to practise medicine.

The NHS conflicts of interest codes (see 8.2 Legislative or Self-Regulatory Provisions) require that their employees and contractors notify hospitality and fees for services received from manufacturers.

The Manufacturers are not under any obligation under the laws or codes to provide prior notifications of their activities with HCPs and HCOs.

Transparency is not currently a legal requirement in the UK but is one that is imposed under the ABPI Code. The code requires public annual disclosure of sums paid and benefits given to health professionals and other relevant decision makers and health care organisations such as:

• (Clause 24.4) UK individuals, organisations, etc for contracted services, such as HCPs and individuals contracted to patient organisations;
• (Clause 4.4) patient organisations;
• (Clause 4.5) individual members of the public, including patients and journalists;
• (Clause 10.10) support of UK health professionals and other relevant decision makers in relation to attendance at events/meetings;
• (Clause 10.11) contributions to costs related to events/meetings (sponsorship) paid to healthcare organisations, patient organisations or organisations managing an event/meeting on their behalf (even if the identity of a support HCP is unknown to the company) and individuals representing patient organisations (including donations, grants and collaborative working (Clause 20.5)); and
• (Clause 25.4) payments made to contracted individuals in relation to market research.

Individuals must be identified, and fees and expenses reported separately.

Disclosures must be made annually on a publicly available website within six months of the end of the calendar year to which they relate and must remain in the public domain for at least three years. Records of disclosures must be retained for at least five years after the end of the calendar year to which they relate.

The ABPI Code is intended to apply to companies promoting medicines in the UK. Therefore, companies that do not yet have products on the market will not be members of the ABPI and will not be subject to the transparency requirements.

The MHRA enforces the HMR and can choose to do so through the courts. Regulation 303 of the HMR provides for criminal penalties of unlimited amount or imprisonment for up to two years for breaches of the laws regarding samples, medical sales representatives and inducements or hospitality. The MHRA can also require that a corrective statement is issued.

The MHRA generally only takes matters to court in the most egregious cases as it prefers to work with companies to ensure that they promote correctly and will therefore more likely impose a vetting requirement on repeat offenders.

The Bribery Act is also applicable to inducements and hospitality may be enforced by the Serious Fraud Office.

The ABPI Code is operated by the independent PMCPA which handles complaints about breaches through its own processes. Sanctions imposed include one or more of:

• the audit of a company's procedures for compliance with the Code;
• a requirement for the pre-vetting of future material;
• recovery of material from those to whom it has been given;
• the issue of a corrective statement;
• a public reprimand;
• advertising in the medical, pharmaceutical and nursing press of brief details of a public reprimand; and
• suspension or expulsion from the ABPI.

The UK does not have a regime for unfair competition actions. However, complaints can be made by competitors to any of the MHRA, the PMCPA or PAGB, depending on which is appropriate given the product and/ or the nature of the complaint.

See 11.1 Pharmaceutical Advertising: Enforcement Bodies.

See 11.1 Pharmaceutical Advertising: Enforcement Bodies.

The MHRA is particularly interested in websites offering medicinal treatment that extend to advertising pharmaceutical products. They are also concerned with the advertising of unlicensed medicines.