Pharmaceutical Advertising 2024 Comparisons

Laws

Part 14 of the Human Medicines Regulations 2012 (SI 2012/1916) (HMR) sets out the main UK laws on the advertising of medicines, together with: the Medicines (Advertising of Medicinal Products (No 2)) Regulations 1975 (SI 1975/1326) and the Medicines (Labelling and Advertising to the Public) Regulations 1978 (SI 1978/41).

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 a prohibition on certain advertisements relating to cancer treatments.

General consumer advertising laws equally apply 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 have been largely developed through self-regulatory schemes.

Self-Regulation

The 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. These advertising bodies can take action in any matters they consider appropriate, and the codes therefore have effect as if the law, albeit that there are no criminal sanctions for their breach.

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. The 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 in doing so to fall under the judgment 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, and 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 ensuring that medicine advertising on the radio is compliant with the UK Code of Broadcast Advertising.

Relationship With Legislation/the 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 a 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 as follows: “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 under the HMR 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, may breach the HMR 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 considered as materials that are covered by the Code, including social media, 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 to 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 may 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 may 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 media 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 to 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 (SmPC) in 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 PMCPA social media guidance of 2023 states that public reports and announcements should be non-promotional, accurate and presented in a factual and balanced way and not misleading, with business press releases identifying the business importance of the information.

The PAGB Code distinguishes between PR on the consumer-facing part of a website and that in a dedicated press section. Only the former requires PAGB pre-approval. However, the PAGB considers that an 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 may 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 be 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 (Section 4.3) states that comparative claims may only be made where they:

• relate to the licensed use;
• can be substantiated; and
• are either included in the SmPC or 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 can be made.

The ABPI Code requires that comparisons are:

• not misleading;
• accurate, fair and can be substantiated; and
• do not create confusion between products or trade marks, and no unfair advantage over the reputation, brand or marks of a competitor 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 from 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 (ie, must not deceive or be likely to deceive);
• the comparison must not mislead by omission;
• the comparison must be fair – the products must meet the same needs or be intended for the same purpose (in this case, the same indication and intended patient population);
• there must be an objective comparison of one or more material, relevant, verifiable and representative feature of the products;
• the comparison must not discredit or denigrate the marks, names or features of the other product; and
• the comparison must 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 with a category of 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 (Regulation 279 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 may 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, which includes “advertising” at a scientific conference.

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 consisting 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.

The ABPI Code applies to events for UK residents that are held outside the UK. The materials for these events are required to be compliant with the ABPI Code as well as any local requirements.

Section 6.11 of the Blue Guide and Clause 11 of the ABPI Code permit the use of advertising material relating to products or indications not licensed in the UK at international symposia, conferences and meetings addressed to UK residents, including those held in the UK, where:

• the event is truly international and of high scientific standing;
• the medicine or indication is relevant and proportional to the purpose of the event/meeting;
• a significant proportion of the attendees are from countries outside the UK, and from countries where the product and indication are licensed, on the condition that this includes at least one major developed country and the list of countries in which it is authorised are provided, with the statement that registration conditions differ by country;
• the ABPI rules on certifying are complied with;
• the material clearly and prominently indicates that the product or indication is unlicensed in the UK; and
• for an unlicensed indication, the UK prescribing information is readily available for a medicine authorised in the UK.

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

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 may be provided must relate to a product:

• containing a new active substance, or containing a new active substance prepared in a new way;
• that is to have a significant addition to the existing range of authorised indications; or
• that 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.

See 3.3 Provision of Information to Healthcare Professionals.

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

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). Under Regulation 280 of the HMR, any advertisement for a medicinal product must:

• 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 on 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 or psychotropic substances (Regulation 285 of the HMR);
• that state or imply the necessity of a medical consultation or surgical operation;
• that offer 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 are guaranteed, are better than or equivalent to those of another identifiable treatment or medicinal product, or are not accompanied by any adverse reaction;
• that use, 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;
• that 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 is due to it being natural;
• that include recommendations by scientists, HCPs or celebrities; and
• that are directed principally at children.

Consumer advertising is required to clearly identify 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;
• 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 also Annex 3 of the MHRA Blue Guide):

• 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 carefully read 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 or not available without a 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.

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

Self-Regulation

The PAGB Consumer Code (Section 1.5.15) includes the following additional requirements for inclusion 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;
• 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.

The ABPI Code

Pharmaceutical companies are required to respect the independence of patient organisations and are not permitted to promote or request the promotion of a particular prescription-only medicine (Clause 27.1). They must not influence the text of patient organisation materials to favour their own interests (Clause 27.4) but may 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 at 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). Under Clause 24.3, donations and grants are only permitted to patient organisations if they:

• 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 to the HMR details the information to be included in advertisements to HCPs. This includes the following.

• 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); and
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.
• The cost of either a specified package, quantity or recommended daily dose (except if more than 15% of the publication circulates outside the UK).

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

The 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 may 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 a 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 Yellow Card | Making medicines and medical devices safer (mhra.gov.uk). Adverse events should also be reported to [relevant pharmaceutical company]”.
• 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 420 square centimetres, truncated information may 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, for which all information in Annex 5 must be given. These advertisements may 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 previous two years may 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 may refer to published studies if clear references are given. The materials may 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 same laws and codes apply to advertising combination products that include medicinal products as to standalone medicinal products. Therefore, advertisements referring to medicinal products used in combination products must not include claims for the medicinal product that are not in the SmPC. Section 6.4 of the Blue Guide states that prescribing information for more than one product used in combination or for the same indication may be combined into a single schedule if this does not compromise the necessary safety messages.

There are no separate rules governing the advertising of medicines with companion or complementary diagnostics.

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 that 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, which is relevant in Northern Ireland.

Reprints may 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 and therefore should not be provided if they relate to unlicensed medicines or uses.

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

Prior Authorisation/Vetting by the MHRA

Medicine 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 the 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 medicine advertising aimed at consumers being approved by the 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, 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 MHRA, and to the 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 the certifier believes 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 materials covered by 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 number 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 a UK audience is subject to UK medicines advertising legislation (paragraph 5.10 of the Blue Guide).

Prescription-only medicines may only be advertised on websites directed at HCPs (as determined by the nature of the content). It is not a requirement for such material to be access-restricted, but this 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 reflects current evidence about the product and its benefit risk profile.

The ABPI Code applies to websites of:

• a UK company or with a UK company’s authority; or
• an affiliate of a UK company, or with the authority of such a company, and where 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

The PAGB Code (1.5.12, Rule 53) considers that the following fall within the remit of its Consumer Code and an offline 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, where they will be considered as such 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
• encouragements to the user to read further information such as “Find out more about Brand X”.

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

See 7.1 The Advertisement of Medicinal Products on the Internet.

There are no specific permissions or prohibitions on posting disease awareness information and/or materials online, so 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.

See 7.1 The Advertisement of Medicinal Products on the Internet. Social media is a broad term, and the following rules cover any digital platform for communicating information.

The PMCPA published social media guidance in 2023. This applies where there is a UK nexus, which is social media activity by a UK company or its affiliate which makes specific reference to the use or availability of the medicine in the UK. The code can apply to activities outsourced to third parties or those carried out by an employee in a supposed personal capacity. Any social media content posted by a pharma company must clearly and prominently state its involvement.

Company Policies

As a result of the complexity of rules around advertising medicinal products, pharmaceutical companies must have social media policies and guidelines for employees and contractors, and must implement training on them. Procedures should be implemented to:

• monitor all social media activities under the company’s purview or direction;
• meet its pharmacovigilance responsibilities arising from social media, including steps for reporting adverse events; and
• indicate how employees may interact with the company’s disease awareness posts.

Companies would be wise to limit the use of social media by employees to specifically authorised individuals and/or specifically authorised activities. For all other activities and employees, there should be a warning not to mention their company or its products in their personal social media activities. Companies have been found to be in breach of the ABPI Code when employees have discussed their employer’s products in their personal activities on social media.

Policies should extend to the management of third parties creating and posting on behalf of the company and for which the company can be considered responsible, even after the end of the contract.

Audience Targeting

The major issue with social media is the potentially public nature of it. A further issue is that through likes, shares and other interventions an individual set of content can spiral out of the control of the originator. Material should only be provided or made available by pharma companies to individuals or groups who can reasonably be assumed to have a need for or interest in it. Pharma companies therefore need to exert control over readership and over reuse or additions to their content.

The PMCPA social media guidance suggests “signposting” to exert control on readership. Signposting means stating the intended audience and then requiring an individual user’s positive confirmation that they are within the intended audience before being granted access. Self-validation by the individual is acceptable to the PMCPA. This is useful for information intended only for HCPs or for providing information to patients who have already been prescribed a licensed product. Sufficient and clear information should be given in the signpost for the individual to determine whether the information is relevant to them, but not constitute the promotion of a POM to the public or a promotion of an unlicensed medicine. The PMCPA social media guidance suggests that more formal validation might be required if the post leads to an event for in-person or virtual attendance to ensure that only appropriate individuals attend.

Managing Content

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).

Links shared in posts will be considered part of the post and for which the company will be responsible, even if the link is not to content they have generated. Pharma companies must ensure that links are appropriate for the audience, state the source and whether the company is involved, and should redirect anyone who is not the intended audience.

Companies should be cautious in tagging and sharing content. The tagged or shared content will be treated as if their own, so that the same rules will apply, and therefore the content should be vetted in the same way as company-generated material. A similar approach should be taken to hashtags.

The PMCPA social media guidelines are somewhat equivocal on whether companies must correct misinformation or inaccuracies. It suggests that correcting some misinformation rather than all misinformation might lead to questions about corporate motivation behind the posts which are not corrected. It suggests companies should have a policy on corrections. If that policy were to state that no misstatements are to be corrected, or that misstatements only on certain websites are to be corrected, it is possible that the question on motivation might not then be called into question if the policy is followed.

The same cautious approach should be taken to corrections. If the inaccuracy relates to a product, then the PMCPA suggests that it will be less problematic to link to reference documents such as SPCs and package leaflets already publicly available online than to point to any individual section of those documents.

Content Awareness

Companies should avoid referring to POMs or unlicensed medicines, for example, in job titles or descriptions of roles.

Disease awareness campaigns are permitted but should not refer to the name of any medicine. As with any other type of media, disease awareness campaigns are likely to be considered promotion where the company behind the campaign has the sole medicine available to treat the disease.

Clinical trial recruitment should also be carefully targeted to those who can reasonably be assumed to fulfil the demographics or criteria and should avoid reference to any specific products but rather refer to where further information might be obtained.

Influencers

Influencers are permitted, but it is critical to ensure transparency of their relationship with the company, which can be held responsible for the influencer’s content even if the influencer acts outside their brief.

Pharmacovigilance

The PMCPA social media guidance requires that companies be responsible for pharmacovigilance on social media under their control and that they signpost users to the MHRA Yellow Card site as well as the company contact for adverse event reporting. Material relating to a medicine must include the wording on side effects found in the ABPI Code, Clause 26.4.

There is EFPIA guidance on pharmacovigilance in digital channels which suggests that member companies consider developing specific guidance for digital channels and contact their pharmacovigilance experts for specific projects to meet their pharmacovigilance responsibilities.

The UK Bribery Act 2012 (the “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 both to people in public service and to private businesses, and both individuals and entities can be subject to sanctions under the Bribery Act.

The Bribery Act has extraterritorial 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 by 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 for 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 gift, 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 as including sponsorship of attendance and payment of travelling or accommodation expenses. Breach of these provisions is a criminal offence.

The ABPI Code

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

The 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, notepads, calculators, diaries, calendars and coffee mugs.

The 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, and may include the company name 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 the requirements of the ABPI Code.

Promotional aids may 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. Equally, items for use with patients (which are not for direct patient care), such as surgical gloves are not permitted, nor must toys for waiting children be provided. Thus, only literature intended for patients may be provided in relation to prescription medicines. Memory sticks may be provided with saved promotional material if the volume of memory capacity is compatible with that material. It is also not permitted to provide HCPs with textbooks, 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 their acquiring experience in dealing with the product in question. The following additional conditions apply to the giving of samples:

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

The ABPI Code

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

• no more than four samples of a particular medicine may 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, where that may be “new” (eg, in 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 Controls on the Provision by Pharmaceutical Companies of Benefits and/or Inducements to Healthcare Professionals for the relevant legal provisions, which are restated in the Blue Guide at paragraph 6.16. Note that the Blue Guide defines “advertising” as including sponsorship of meetings.

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

The ABPI Code

The ABPI Code permits companies to hold, sponsor or support delegates to attend events and meetings that meet the Code’s 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 a 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).

The 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 these must be disclosed annually (see 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value).

The 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 constitute a breach.

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

The 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 (Clause 19.1 guidance).

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:

• there must be a prior written agreement 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 defined 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 while continuing to practise medicine.

The NHS conflicts of interest codes (see 8.2 Controls on the Provision by Pharmaceutical Companies of Benefits and/or Inducements to Healthcare Professionals) 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, other relevant decision-makers and healthcare organisations, such as:

• UK individuals, organisations, etc for contracted services, such as HCPs and individuals contracted to patient organisations (Clause 24.4);
• patient organisations (Clause 4.4);
• individual members of the public, including patients and journalists (Clause 4.5);
• support of UK health professionals and other relevant decision-makers in relation to attendance at events/meetings (Clause 10.10);
• 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) (Clause 10.11), and individuals representing patient organisations (including donations, grants and collaborative working (Clause 20.5)); and
• payments made to contracted individuals in relation to market research (Clause 25.4).

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. Companies should be aware, however, that the transparency requirements reach back over the prior calendar year and that, therefore, if they will be placing products on the UK market in the next 12 months, their activities in the previous calendar year will be subject to the transparency requirements if they are ABPI members.

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 be 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 with respect to advertising content.

The Bribery Act is also applicable to inducements and hospitality, and 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 following:

• 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, or, in the case of consumer advertising, the ASA, 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.

There are four categories of veterinary medicines:

• Prescription-Only Medicine – Veterinarian (POM-V);
• Prescription-Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS);
• Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS); and
• Authorised Veterinary Medicine – General Sales List (AVM-GSL).

Regulation 10 of the Veterinary Medicines Regulations 2013 (VMR) prohibits the advertisement of human medicines for administration to animals, save that the holder of a wholesale dealer’s authorisation may supply a list of authorised human medicinal products together with prices to a vet who has requested it if the list clearly states that the product is not authorised as a veterinary medicinal product and may only be prescribed and administered under the cascade. The cascade is a list of products that vets may administer to animals in a descending order if the higher-level product is not available, and is set out in paragraph 1 of Schedule 4 to the VMR.

Regulation 11 VMR requires that:

• the advertising of veterinary medicinal products not be misleading or contain claims not in the SmPC; and
• products requiring a veterinary prescription or containing psychotropic drugs or narcotics are not advertised to the public.

Advertising of:

• POM-V is permitted to vets, veterinary nurses, pharmacists and professional animal keepers;
• POM-VPS is permitted to vets, pharmacists, suitably qualified persons and professional animal keepers; and
• NFA-VPS and AVM-GSL is permitted if the advertising is not misleading, and the claims are accurately taken from the SmPC, and in each case if this is within the SmPC.

It is not permitted in such advertising to give company or product-specific recommendations or endorsements, and any presentations must be unbiased and factual. It is considered by the MHRA to be good practice for vets to declare affiliations when presenting treatment options at conferences or training events.

Anti-microbials must not be advertised to professional animal keepers.

It is prohibited to advertise anything containing a veterinary medicinal product as suitable for top dressing (sprinkling on feed) unless the SmPC specifically permits this.

Enforcement of the VMR is by the Veterinary Medicines Directorate (VMD). In its enforcement guidelines the VMD states that it aims to work with the industry to assist with compliance. Where necessary and proportionate, it will take steps to achieve enforcement, including all or any of the following:

• advisory and warning letters and improvement notices;
• enforcement notices;
• removing non-compliant social media posts from online marketplaces and websites;
• varying, suspending or revoking authorisations;
• destroying products; and
• criminal prosecution.