The regulation of pharmaceutical advertising in the UK is primarily governed by Part 14 of the Human Medicines Regulations 2012 (HMR). This legislation incorporates provisions of EU Directive 2001/83/EC as it stood before the Brexit transition period which ended on 31 January 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the advertising of medicinal products as part of its role as the licensing authority. To support compliance, the MHRA has issued guidelines, including The Blue Guide – Advertising and Promotion of Medicines in the UK, along with additional guidance available on the MHRA website.

In addition, the Cancer Act 1939 also imposes strict prohibitions on advertisements that claim to treat cancer, prescribe remedies for it, or offer advice on its treatment. The Act is overseen by the Trading Standards, the Advertising Standards Authority (ASA) and the MHRA.

Beyond medicines-specific laws, general consumer advertising laws are also relevant. These include the Trade Descriptions Act 1968, the Consumer Protection from Unfair Trading Regulations 2008, and the Business Protection from Misleading Marketing Regulations 2008. Advertising practices are also influenced by broadcasting legislation, such as the Broadcasting Acts of 1990 and 1996 and the Communications Act 2003, for broadcast media. The Trading Standards, ASA, the Competition and Markets Authority and the MHRA may play a role in enforcing these Acts.

Yes, a number of self-regulatory codes of practice apply to the advertising of medicines in the UK. These codes complement existing legal frameworks and ensure high standards by providing detailed guidance on how medicines should be promoted.

The Association of the British Pharmaceutical Industry (ABPI) Code of Practice (the ABPI Code) is a key code governing the promotion of prescription-only medicinal products (POMS) in the UK. The Code also applies to a number of areas which are non-promotional, including information made available to the public about POMs. It is administered by the Prescription Medicines Code of Practice Authority (PMCPA), an independent body that ensures compliance.

The Proprietary Association of Great Britain (PAGB) provides two codes of practice for over-the-counter medicines (OTC). The PAGB Consumer Code regulates advertisements directed at the general public and the PAGB Professional Code governs advertising directed at healthcare professionals (HCPs) who are qualified to prescribe or supply medicines. These codes apply to all OTC medicines, irrespective of their regulatory approval route. PAGB codes ensure that advertising is accurate, responsible, and compliant with both legal and ethical standards.

In addition to industry-specific codes, the ASA oversees the UK Code of Non-broadcast Advertising, Sales Promotion, and Direct Marketing (CAP Code) and the UK Code of Broadcast Advertising (BCAP Code). The CAP Code regulates non-broadcast advertisements, including online and social media promotions, while the BCAP Code governs broadcast advertisements such as those on television and radio. Both codes include provisions specific to the advertising of medicinal products, with Section 12 of the CAP Code and Section 11 of the BCAP Code addressing these issues. The ASA ensures compliance by monitoring advertisements across all media and taking enforcement action when necessary.

These self-regulatory codes provide a framework that largely reflects legal requirements but often extends beyond them to address specific ethical concerns.

a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?

Many pharmaceutical companies established or operating in the UK opt to comply with self-regulatory codes, even if they are not official members of the related association.

The ABPI Code applies to all ABPI member companies and any non-member companies that formally agree to adhere to it. The ABPI represents companies which supply more than 80% of branded medicine used by the UK’s National Health Service (NHS).

Similarly, the PAGB Code applies to PAGB members and their authorized associates.

The CAP and BCAP Codes apply to public advertising in non-broadcast and broadcast media, respectively.

b) What is the legal status of the self-regulatory codes?

The various self-regulatory codes are not legally binding, but the organizations managing the codes generally oblige members to comply with the terms of the codes and failure to comply may lead to sanctions by the relevant enforcement bodies.

a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?

Under UK law, ‘advertisement’ for medicinal products is broadly defined in Regulation 7 of the HMR as “anything designed to promote the prescription, supply, sale, or use of a product”. This definition encompasses various activities, such as door-to-door canvassing, visits by sales representatives to persons qualified to prescribe or supply medicinal products, provision of samples, inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind (except those with minimal intrinsic value), and sponsorship of promotional meetings or scientific congresses attended by persons qualified to prescribe or supply medicinal products, including the payment of related travel and accommodation.

Regulation 7 also lists certain items or activities that fall outside of the definition of ‘advertising’. These include, a medicinal product’s package and leaflet, reference material and announcements of a factual and informative nature provided that no product claim is made (e.g. material relating to changes to a medicinal product’s package or package leaflet, adverse reaction warnings, trade catalogues and price lists), and correspondence, which may be accompanied by material of a non-promotional nature, answering a specific question about a medicinal product.

The ABPI Code uses the term ‘promotion’ instead of ‘advertisement’ and defines the term in Clause 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”. Activities covered under this definition are similar to those listed in the HMR and include journal and direct mail advertising, the activities of representatives, including any electronic or printed material used by them, provision of samples, inducements (monetary or otherwise), promotional hospitality, and sponsorship of events, whether promotional or scientific. The ABPI Code also provides a long list of items that are excluded from the definition of advertisement including, among others, certain responses to unsolicited requests from HCPs; factual, accurate, informative announcements and reference material concerning licensed medicines; and certain documentation relating to medicines.

The PAGB Consumer Code similarly outlines promotional materials it governs, such as websites, social media, text messages, advertorials, and materials received from third parties where member companies have influenced the content.

b) Does the definition apply equally to all target audiences?

The above rules do not establish distinct definitions according to the target audience of the advertising or promotion. However, the rules governing the advertising and promotion of medicinal products vary depending on the target audience and the type of medicinal products.

In addition, judgments from the Court of Justice of the European Union (CJEU), which are still relevant in the UK, clarify the definition of ‘advertising’ and the persons that may be subject to advertising rules. Accordingly, the CJEU provides that any information on the availability or the properties of a medicinal product which is intended or may, either directly or indirectly, influence the behaviour of patients is considered promotional. Moreover, the dissemination by an independent third party of information about a medical product, may be considered advertising if it is designed to promote the prescription, supply, sale or consumption thereof (Case C-421/07, Damgaard).

However, materials faithfully reproducing the approved summary of product characteristics (SmPC) or package leaflets are typically not advertising unless manipulated to serve a promotional purpose (C-249/09, Novo Nordisk). This approach is also confirmed in the Blue Guide which establishes that, in general, the labelling and packaging leaflet of a medicinal product which comply fully with the requirements of Part 13 of the HMR (on Packaging and leaflets) would not qualify as advertising.

Yes, provided that they are genuinely newsworthy and are not used to promote the medicinal product.

The Blue Guide recognizes the need for pharmaceutical companies to share information about their products with the business and financial press, including for purposes of keeping their shareholders informed of material developments. However, the Blue Guide establishes guidelines for press releases. For example, business press releases should identify the commercial importance of the information and the information in a press release must be factual and non-promotional. To promote balanced media coverage, the context in which the medicinal product will be used, and the intended population should be addressed. It may also be helpful to set the product and relevant results in the context of alternative and standard of care treatments for the relevant disease. In addition, brand names should be limited, the information should be appropriate for the target audience and the terminology used should be understood by most readers.

The ABPI Code provides some additional guidance to its members and establishes that it is good practice to refer to the SmPC for the medicinal product in the press release. The inclusion of other credible sources of information about a condition or medicinal product may also be helpful.

Yes, the ABPI Code requires that the final forms of any promotional material be certified by a nominated person within the company prior to their dissemination. This person must be a registered medical practitioner, or a pharmacist registered in the UK, or a registered dentist for products intended for dental use only. In addition, this person cannot be the one responsible for developing or drawing up the material.

The certificate certifies that the signatory has examined the final form of the promotional material and that, it is their believe that the material complies with advertising laws and the requirements of the ABPI Code, is consistent with the marketing authorization and the SmPC of the product, and fairly and faithfully presents facts about the medicinal product.

Materials that are used continuously must be re-certified every two years at least and the certificates and related promotional materials must be preserved by the Company for at least three years after the final use of the material.

The HMR do not require all promotional materials to be approved by regulatory bodies before their release. However, in accordance with Regulation 304 of the HMR, the MHRA has the power to request copies of certain advertising materials before their publication. In these circumstances, the materials may not be used until they have been approved by the MHRA. The MHRA has the power to make such a request in relation to newly authorized medicinal products, products that have been reclassified (e.g. from a POM to pharmacy sale) and in case of prior infringements.

In accordance with the Blue Guide, the MHRA’s policy is to vet initial advertising for all new active substances. The vetting process may take a maximum of 12 months. In practice, the process generally takes one to three months and up to 6 months. The MHRA will, in any case, inform the company of the duration.

Companies may also seek prior advice from the MHRA and the ABPI on promotional materials.

The PAGB Consumer Code also establishes a pre-publication approval system for advertising of OTC medicines aimed at consumers. As a condition of membership, all advertising aimed at consumers must be submitted to the PAGB for screening and approval prior to the release of the material into the public domain.

The regulation of comparative advertising in the pharmaceutical industry is governed by a range of laws, codes, and guidelines that seek to balance the promotion of medicines with the need to protect consumers and ensure fair competition. These frameworks are particularly stringent due to the sensitive nature of medicinal products.

General Legal Principles

The Business Protection from Misleading Marketing Regulations 2008 and the Consumer Protection from Unfair Trading Regulations 2008 set overarching principles for comparative advertising across all sectors, including medicinal products. These laws generally require that comparisons:

• are not misleading or deceptive;
• are fair and relate to products intended for the same purpose;
• are objective, based on verifiable, relevant features of a product;
• do not discredit or unfairly exploit a competitors’ marks or reputations.

Comparative Advertising of Medicinal Products to the Public

Regulation 287 of the HMR prohibits advertising to the general public that implies a product’s effects are “better than or equivalent to” those of another identifiable treatment or medicinal product. The Blue Guide elaborates that direct comparisons naming specific competitor products (e.g., “works faster than [competitor product]”) are not allowed in public-facing advertisements. However, category-wide claims (e.g., “works faster than standard tablets”) may be acceptable, provided they are supported by robust evidence. In addition, comparative advertising must not mislead consumers. Statements such as “nothing acts faster than [product]” may be permitted only if they are factually accurate and supported by evidence that no competitor in the therapeutic category has demonstrated superior performance. Similarly, claims regarding the purity or quality of a product compared to competitors should avoid misleading implications.

Comparative Advertising of POMs to HCPs

For professional audiences, the standards for comparative advertising are set out in the ABPI Code and the Blue Guide. The ABPI Code does not preclude the use of a competitor’s brand name when making comparisons. However, the following key principles should be observed:

• Accuracy, balance, fairness, objectivity, unambiguity and substantiation: Comparisons must be accurate, fair, objective, and substantiated by up-to-date evaluations of evidence. Any comparison must be capable of substantiation, including upon request.
• Relevance: Comparisons must relate to authorized and relevant uses of the medicinal products and must not contradict the information in the SmPCs. Medicines or services for the same needs or intended for the same purpose must be compared, and a comparison included of one or more material, relevant, substantiable and representative
• No Misleading Claims: Comparisons must not mislead directly or by implication, distortion, exaggeration or undue emphasis (e.g. claims should compare products with the same indication or patient population, and no confusion should be created between the advertised product and the competitor’s product).
• Respect for Competitors: Comparative advertising must not discredit, denigrate, or take unfair advantage of a competitor’s trade marks, names, or reputation.

The ABPI Code also explicitly prohibits disparagement of other pharmaceutical companies’ products or activities and outlines conditions for permissible comparisons, including the requirement to avoid presenting a product as an imitation of a competitor’s product. The ABPI Code further identifies certain areas where particular care should be taken by companies. For example, claims for superior potency in relation to weight are generally meaningless and best avoided unless they can be linked with some practical advantage; hanging comparisons whereby a medicine is described as being better or stronger or such like without stating with which product it is compared, must not be made.

Comparative Advertising of OTC medicines under the PAGB Codes

The PAGB Professional Code emphasizes similar principles including fairness, balance and substantiation, respect for competitors, no misleading claims, and a prohibition of hanging claims. This code also requires that when using comparisons, the difference that is compared is sufficiently significant to be meaningful. As an illustration, a claim that a product is “the only pain relief tablet that works for up to 6 hours”, where there is a capsule that has a similar duration of action, would not be permitted.

In addition, specific types of claims are addressed. For example, superiority claims are not acceptable unless supported by direct comparative evidence. Top parity claims are only acceptable if they are supported by positive evidence (e.g. comparative studies or meta analysis).

The PAGB Consumer Code mandates similar principles and requirements for claims directed at consumers and requires that caution be exercised in relation to comparative claims.

Regulations 279 and 280 of the HMR prohibit the promotion of a medicinal product prior to authorisation or for indications that are not covered by its authorisation. Infringements constitute a criminal offense, particularly where the promotion poses a significant risk to public health. These prohibitions are reiterated in the ABPI Code and the PAGB Codes.

However, information regarding unauthorised medicinal products or uses may be provided in certain limited circumstances:

• Responding to unsolicited requests from HCPs: the ABPI Code and the Blue Guide permit companies to respond to unsolicited written inquiries from HCPs about unauthorised medicines or off-label uses. These responses must be factual and non-promotional, limited to the scope of the inquiry, accurate, balanced, and not misleading.
• Scientific and medical exchanges: companies can share genuine scientific and medical information about a product during its development, provided it is factual and non-promotional. In addition, in accordance with the Blue Guide, at international conferences, symposia and other meetings of high scientific standing, advertising material relating to products or indications that are not authorised in the UK may be shared if (i) a significant portion of attendees are from countries where the product or indication is authorised; and (ii) the material is relevant, proportional to the purpose of the meeting, and indicates clearly and prominently that the product or indication is not authorised in the UK.
• National Health Services (NHS) planning and budgetary information: in accordance with the ABPI Code, non-promotional advance information about the introduction of new medicines or significant changes to existing ones may be shared with policy decision-makers for budget planning. The provision of this information is limited to specific conditions.
• Price Lists: the ABPI Code and the Blue Guide are aligned on the fact that price lists related to unauthorised medicinal products may be provided to HCPs and relevant decision makers. The lists must be factual, including only essential details like product name, dosage, pack size, and price, clearly state the unauthorized status of the products, and avoid any promotional claims. They may not be used proactively in a manner which could be seen as promotional (e.g. by displaying them on exhibition stands).

In accordance with Regulations 279 and 280 of the HMR, the advertising of medicinal products is only permitted in relation to authorised medicinal products and uses. In addition, the advertisement must comply with the particulars listed in the products SmPC, the advertising must encourage the rational use of the product by presenting it objectively and without exaggeration, and it must not be misleading.

Further specific restrictions regarding the advertising of certain medicinal products to the public are established in Regulations 283 to 292 of the HMR. These include the prohibition of advertising POMs to the general public.

Prohibited information:

The following advertisements relating to a medicinal product are prohibited, advertisements that:

• state, or imply, that a medical consultation or surgical operation is unnecessary;
• offer to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the Communications Act 2003;
• might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
• suggest that the effects of taking the medicinal product are guaranteed, better than or equivalent to those of another identifiable treatment or medicinal product, or are not accompanied by any adverse reaction;
• uses, in terms that are misleading or likely to cause alarm, pictorial representations of changes in the human body caused by disease or injury; or the action of the medicinal product on the human body;
• refers to, in terms that are misleading or likely to cause alarm, claims of recovery;
• suggests that the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or the health of a person could be affected by not taking the medicinal product;
• suggests that the medicinal product is not a medicinal product or that its safety or efficacy is due to the fact that it is natural;
• refers to a recommendation by scientists, HCPs or persons who because of their celebrity could encourage use of the medicinal product;
• contains any material that is directed principally at children.

Form and content of advertisement:

Regulation 291(2) of the HMR and Annex 3 to the Blue Guide state that an advertisement relating to a medicinal product may not be published unless it is presented so that it:

• clearly presents that it is an advertisement;
• clearly identifies the product as a medicinal product;
• includes:
  • the name of the medicinal product;
  • if the medicinal product contains only one active ingredient, the common name of the active ingredient;
  • the information necessary for the correct use of the medicinal product; and
  • an express and clear invitation to read carefully the instructions on the package or in the package leaflet (as the case may be).

The PAGB Consumer Code largely reflects the requirements of the HMR.

Patient organizations (POs) often collaborate with pharmaceutical companies, but strict rules govern these interactions to ensure transparency, independence, and compliance with advertising regulations.  Restrictions on interactions with patients or POs are extensively addressed and detailed in the ABPI Code.

The ABPI Code, notably addresses relationships between companies and POs (including individuals representing the PO) in relation to the provision of sponsorship, donations or grants, and the contracting of patient organisations for certain services. Key principles that govern these relationships require that:

• the independence of patient organizations is respected and that any support does not compromise the organization’s autonomy or result in undue influence;
• there is no promotion or request to promote a particular POM (POs are expected to maintain editorial control of their materials and encouraging patients to request specific POMs from HCPs is prohibited);
• a written certified agreement is in place setting out what has been agreed and a breakdown of costs in relation to any transfers of values between a pharmaceutical company and a PO (among other specific requirements established in Clause 27.2 of the ABPI Code);
• information regarding certain transfers of value be disclosed by the pharmaceutical company on an annual basis (as set out in Clause 29 of the ABPI Code).

General content requirements

Advertising medicinal products to HCPs in the UK is subject to specific regulations outlined in Regulation 294 and Schedule 30 of the HMR, as well as supplementary guidance from the ABPI Code. These requirements ensure transparency, compliance with marketing authorizations, and alignment with the SmPC.

Advertisements to healthcare professionals, excluding abbreviated advertisements, oral representations made by medical sales representatives, and reminder-only advertisements, must generally include the following key elements in a clear and legible manner:

1. The number of the marketing authorization;
2. The name and address of the marketing authorization holder or the business name and address of the part of the holder’s business that is responsible for sale and supply;
3. The classification of the product (e.g., Prescription Only Medicine (POM), Pharmacy Medicine (P), or General Sales List (GSL));
4. The name of the medicinal product
5. The list of the active ingredients of the medicinal product that uses their common names and is placed immediately adjacent to the most prominent display of the name of the product;
6. The indications for use consistent with the marketing authorization;
7. A succinct statement of entries in the SmPC relating to:
   • Adverse reactions, precautions and relevant contra-indications;
   • dosage and method of use so far as relevant to the indications shown in the advertisement; and
   • where this is not obvious, the method of administration, so far as relevant to those indications,
8. The cost of the product (excluding VAT).

As an exception to the above, advertising that related to a Pharmacy Medicine (P), or a medicinal product on the General Sales List (GSL), the advertisement must contain the particulars listed from 1 to 6 above, and the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: XXX”; accompanied by a website address that corresponds to that statement. The website must make available all the information listed in 1 to 8 above, or a copy of the SmPC.

If the advertisement is not a written advertisement, the particulars may alternatively be made available in written form to all persons to whom the advertisement is made available.

Clause 12 of the ABPI Code requires the same particulars to be listed in all promotional materials (except for abbreviated advertisements) as well as:

• Any warning issued by the Medicines Commission, the Commission on Human Medicines, the Committee on Safety of Medicines or the MHRA which is required to be included in advertisements; and
• The date the prescribing information was drawn up or last revised.

This ‘prescribing information’ must be provided in a clear and legible manner, and form part of the promotional material. Depending on the type of material, this information may be provided by inclusion as text, through a QR code or a direct, single click link.

In addition, the ABPI Code requires that promotional materials include:

• where not immediately apparent, a clear prominent statement as to where the prescribing information can be found;
• the International Nonproprietary Name (INN), a list of the active ingredients using approved names where such exist 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 INN or list of active ingredients occupies a total area no less than that taken up by the brand name;
• the date on which the promotional material was created or last revised (except for advertisements in professional publications);
• 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]”;
• an inverted black triangle, if required to indicated that the medicine is being closely monitored by regulatory authorities which must be located adjacent to the most prominent display of the name of the product (or the first mention of the product for digital materials).

Abbreviated advertisements

Abbreviated advertisements are those no larger than 420 square centimeters, appearing in publications directed predominantly at healthcare professionals authorized to prescribe or supply medicinal products. Such advertisements must include the particulars listed from 2 to 6 above, and the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: XXX ”; accompanied by a website address that corresponds to that statement. The website must make available all the information listed in 1 to 8 above, or include a copy of the SmPC.

Clause 13 of the ABPI Code specifically addresses these types of advertisements. Moreover, the Blue Guide refers to these advertisements as “short form” advertisements and establishes specific requirements including a list of particular items that must be included as set out in Annex 5 to the Blue Guide.

Reminder-only advertisements

Advertisements intended solely to remind healthcare professionals of a product’s name, its international non-proprietary name, trademark, or the scientific name for registered homeopathic products are exempt from the general requirements for advertisements.

Restrictions on advertising

The HMR sets out general principles regarding the advertising of medicinal products which establish restrictions on the content of advertisements. In accordance with Regulations 280, all information within advertisements must be consistent with the terms of the marketing authorization and the SmPC. While not all content needs to be verbatim, claims must remain consistent with SmPC details (Case C-249/09, Novo Nordisk).

In addition, advertisements must encourage the rational use of the medicinal product by presenting it objectively, without exaggerating its properties and may not be misleading or inaccurate.  This is further elaborated in the ABPI Code which establishes that all information, claims and comparisons be:

• accurate;
• balanced;
• fair;
• objective;
• unambiguous;
• based on an up-to-date evaluation of all the evidence and reflect that evidence clearly;
• not mislead either directly or by implication, by distortion, exaggeration or undue emphasis;
• sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine; and
• capable of substantiation.

The Blue Guide prohibits advertising which states or implies that a product is “safe”.

Accompanying materials

Regulation 297 of the HMR permits the supply of certain written materials as part of the promotion of medicinal products provided that the materials:

• contain all the general requirement particulars listed above;
• state the date on which it was drawn up or last revised;
• only include information that is accurate, up-to-date, can be verified and is sufficiently complete to enable the recipient to form an opinion on the therapeutic value of the product to which it relates; and
• any illustrative materials (e.g. quotation, table or other illustrative material from a medical journal or other scientific work) that is included must be accurately reproduced and the related source.

The ABPI Code permits promotional materials to refer to published studies if clear references are given. In addition, references may be made to “data on file” provided that the data is not contrary to the SmPC, and the relevant part of the data is provided as soon as possible (and within ten working days) upon request from an HCP or other relevant decision maker. Reprints of articles in journals must not be provided proactively unless the articles have been peer reviewed, and they must be accompanied by prescribing information and adverse event reporting information.

In accordance with Regulations 300 of the HMR, gifts, pecuniary advantages or benefits may not be provided to HCPs in connection with the promotion of medicinal products unless they are ‘inexpensive’ and ‘relevant to the practice of medicine or pharmacy’.

The Blue Guide reiterates that both of these requirements must be fulfilled and provides guidance on the meaning of these terms. Accordingly, ‘inexpensive’ means items which do not cost a company more than £6 (excluding VAT) and represent a similar value to the recipient. The criterion of ‘relevance’ is only met if the items have a clear business use (e.g. pens, notepads, calculators, computer accessories, diaries, calendars, surgical gloves, tissues and coffee mugs).

The ABPI Code is more restrictive and prohibits all gifts for personal benefit (e.g. sporting or entertainment tickets, social courtesy gifts) given directly or indirectly to any individual HPC. It also prohibits the supply of any gift, pecuniary advantage or benefit offered or promised to HCPs in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. As a result, almost all promotional aids (i.e. a non-monetary item given for a promotional purpose) are prohibited with only very limited exceptions. Accordingly, items for use in the home or car (e.g. coffee mugs, stationery, computer accessories, diaries, calendars and the like), items for use with patients in the clinic, surgery or treatment room, etc., (e.g. surgical gloves, nail brushes, tongue depressors, tissues and the like) or items intended for children to play with while waiting (e.g. toys and puzzles) are not acceptable.

The ABPI Code does, however, permit the provision of inexpensive pens, pencils and notepads to attendees when required for use at company organized events or meetings provided that they do not bear the name of any medicine or any information about medicines, one item is provided per attendee, and the total cost of all items provided to each recipient does not exceed £6 (excluding VAT) and represent a similar value to the recipient. Pens, pencils and notepads can also be provided in conference bags at independently organised meetings under similar conditions. However, in these circumstances the items must also not include the name of the company.

The ABPI Code also allows companies to provide inexpensive materials and items that are intended to and directly benefit patient support to be passed on to patients (e.g. leaflets and booklets about medicines and their uses). These materials may not bear the name of a medicinal product (unless it is essential for the correct use of the item by the patient). The items may not be given out at exhibition stands nor to administrative staff unless they are to be passed on to the HCP. An ‘inexpensive’ item for patient support means one that costs no more than £15 (excluding VAT) with a similar perceived value to the HCP and patient.

Moreover, HCPs may be provided with inexpensive data storage devices (e.g. memory sticks and the like) which bear educational or promotional material provided that the materials comply with the ABPI Code and their storage capacity is commensurate with the amount of data to be provided.

Regulations 298 of the HMR establish that samples of a medicinal product may only be provided free of charge to HCPs that are qualified to prescribe the product and provided that:

• the HCP receives the sample for the purpose of acquiring experience in dealing with the product;
• the samples are provided on an exceptional basis;
• the samples are provided in response to a request from, and signed and dated by the recipient HCP;
• only a limited number of samples are provided to an HCP per year (in accordance with the ABPI Code, this means 4 samples per HCP per year);
• the sample is no larger than the smallest presentation of the product that is available for sale;
• the sample is marked “free medical sample – not for resale” or bears a similar description;
• the sample is accompanied by a copy of the SmPC;
• the sample does not contain a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention) or a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention)); and
• the supply of samples is subject to an adequate system of control and accountability.

In addition, the ABPI Code requires that:

• samples of a particular medicine may be provided to an HCP for no longer than two years after that HCP first requested the samples;
• medicines which are sent by post must be packed so as to be reasonably secure against being opened by young children;
• The provision of « starter packs » (small packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a call out in the night) are not permitted;
• Samples distributed by representatives must be handed directly to the HCP requesting them or persons authorised to receive them on their behalf and the provision of medicines and samples in hospitals must comply with individual hospital requirements; and
• samples must not be provided simply as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine, and must not be given for the sole purpose of treating patients.

In accordance with Regulation 300 of the HMR ���hospitality’ (i.e. sponsorship of a person’s attendance at a meeting or event, and the payment of travelling or accommodation expenses) offered at a meeting or event may only be provided to an HCP and must be strictly limited to the main purpose of the meeting or event. The Blue Guide requires that ‘hospitality’ be provided at a “reasonable in level”.

The ABPI Code reiterates similar requirements and further elaborates on the above by specifying that such hospitality may include drinks and meals, accommodation and registration fees. In addition, hospitality costs involved in events or meetings must not exceed that level which the recipients would normally adopt when paying for themselves.

Meals and food should not exceed £75 (excluding VAT and gratuities) per person. However, this maximum amount is only appropriate in exceptional circumstances (e.g. dinner at a residential meeting for senior consultants or a dinner at a learned society conference with substantial educational content). In principle, the costs of subsistence should be well below this figure.

Companies may sponsor UK HCPs to attend events or meetings outside the UK. However, there must be a valid and cogent reason for the choice of location (e.g. that most invitees are from outside the UK and it makes more logistical sense to hold the event or meeting in another location given the invitee’s country of origin). The ABPI Code may still apply but the maximum amount for subsistence will not apply when the event or meeting is held outside the UK in a European country where the national association is an EFPIA member covered by the EFPIA Code. In these circumstances, the national limits of the country where the event or meeting is held would apply.

Under the Regulations (Article 300(2)) Hospitality is only allowed within a scientific event if it is:

• strictly limited to the main scientific objective of the event; and
• offered to health care professionals.

It is difficult to argue that cultural, sports, and non-scientific events fulfil such requirements and accordingly such events are very likely to be regarded as being unacceptable under Article 300(3) of the Regulations.

Article 300(1) of the Regulations also provides that a person may not in connection with the promotion of medicinal products supply, offer, or promise any gift, pecuniary advantage or benefit to any person qualified to prescribe or supply medicinal products unless such gift, advantage, or benefit is both inexpensive and relevant to the practice of medicine or pharmacy.  Such requirements are highly unlikely to be met by any cultural, sporting, or non-scientific event.

Paragraph 1.16 of the Blue Guide confirms that hospitality can also “be offered to healthcare professionals at meetings or events held to promote medicines, provided it is strictly limited to the main purpose of the meeting or event” and that hospitality should be reasonable in level.

Clause 10.1 of the ABPI Code makes clear that “companies must not sponsor, support or organise entertainment (such as sporting or leisure activities, etc.)”.

Yes, but as set out in Paragraph 6.14 of Blue Guide, particular care must be taken to ensure that there is no element of promotion and ‘advisory boards, market research and the like should be clearly designed to answer legitimate business questions and the number of participants should be kept to the minimum needed for this purpose’.

If there is an element of promotion then the restrictions set out above in the answers to questions 14 and 15 will apply.

Clause 24 of the ABPI Code sets out the requirements that must be met when engaging health care professionals as consultants or advisors, including:

• All contracts must be set out in writing before services commence;
• Contracts must clearly set out the services being provided and the basis for payment;
• There must be a clear and documented need for the services before requesting them;
• Selection criteria must directly relate to the identified need;
• Individuals responsible for selection must possess the expertise to evaluate potential contractors;
• Selection criteria must directly relate to the identified need;
• Individuals responsible for selection must possess the expertise to evaluate potential contractors;
• The number of contractors and the extent of services must be limited to what is reasonably necessary to fulfill the identified need;
• Companies must maintain records of services provided and ensure appropriate use of those services;
• Contracting should not influence medical decisions or serve as a means to provide unjustified compensation;
• Compensation for services must be reasonable and reflect fair market value and ‘token’ consulting agreements should not be used to justify paying the relevant consultant or advisor;
• Contracted individuals must disclose their affiliations when speaking or writing publicly on relevant topics; and
• Companies employing part-time health professionals must ensure these individuals disclose their employment when speaking or writing publicly on relevant topics.

The Regulations do not provide any exemptions for monetary grants or donations and so the general rules on any amounts supplied in connection with promotion must meet the general requirements (i.e. they must be both inexpensive and relevant to the practice of medicine or pharmacy).

Clause 23 of the ABPI Code makes clear that donations and grants to health care organisations, patient organisations or other organisations (but not individuals) are permitted, and only 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; and
• do not bear the name of any medicine (although they can bear the name of the company supplying such donation or grant).

Clause 23 further provides that a written agreement should be in place, information and records of such donation or grant should be kept by the company, and donations and grants should be publicly disclosed annually.

The Regulations do not provide for such disclosures. Rather, such disclosures are subject to the self-regulatory system set out in the ABPI Code (and so only apply to those companies that are members of the ABPI or who have otherwise agreed to abide by the ABPI Code).

Clause 28 of the ABPI Code (which reflects the corresponding requirements of the European Federation of Pharmaceutical Industries (EFPIA) Disclosure Code.  The transfers of value that must be disclosed are as follows:

• Collaborative/joint working;
• Donations and grants to organisations or institutions;
• Fees paid for contracted services with healthcare professionals, healthcare organisations, institutions and other organisations
• Support of attendance at meetings and events whether paid directly, indirectly, or via another party; and
• Sponsorship, including costs related to meetings/events paid to healthcare organisations or to organisations managing events on their behalf.

The ABPI Code does not distinguish between products on the market and those that are not on the market.

It is illegal to advertise POMs to the general public (Article 284 of the Regulations), there is no exception for advertising via social media and the supplementary information to Clause 26.2 of the ABPI Code states that “particular care” must be taken when using social media and that no statements should encourage patients to push health care professionals to prescribe specific medicines. The supplementary information to Clause 26.2 clarifies that it is permitted to provide non-promotional information to the public regarding POMs but only when in response to a direct enquiry or by dissemination of such information via press conferences, press announcements, television and radio reports, public relations activities, or made available by companies on their websites or otherwise as a resource for members of the public.  Annex 6 of the Blue Guide provides that ‘any claims relating to prescription only medicines made by service providers in tweets or other social media may encourage consumers to seek treatment with the medicine from that particular provider’ and would likely be deemed to be an advertisement, and therefore prohibited

Advertising POMs to health care professionals via social media is not prohibited but must comply with the Regulations. As set out in more detail below in the answer to question 20, advertising POMs on the internet is subject to various regulations. Most notably, the Blue Guide (paragraph 6.3) makes clear that advertisements for POMs are acceptable only on websites ‘whose nature and content are directed at healthcare professionals’. Access to the relevant sections should ‘ideally be ….. restricted’.  It is difficult, if not impossible, to fulfil these requirements (and the other requirements set out in the answer to question 20 in an advert posted on social media. The PMCPA publishes Guidance on Social Media that provides that use of social media to promote medicines is likely to be problematic unless such access restrictions are possible.

Medicines that are not POMs (i.e. over-the-counter, general sales list, and pharmacy medicines) can be advertised to the general public (including on social media) but such advertisements must comply with the general rules for such advertisements set out elsewhere in this Q&A.  The PAGB has clarified that any social media posts related to OTC medicines must make clear whether they constitute advertising.

The Blue Guide confirms that the rules that apply to advertising on the internet are the same as those that apply to other forms of advertising.  The ABPI Code applies to both promotional material on the internet and in other forms.

The Blue Guide (paragraph 6.3) provides that advertisements for POMs are acceptable only on websites ‘whose nature and content are directed at healthcare professionals’. The relevant sections should ‘ideally be access restricted’.  If this is not possible then the sections for consumers and healthcare professionals should be ‘clearly separated and clearly marked for the target audience’.  In order to demonstrate that material on a website without access-controls is ‘wholly or mainly’ directed at persons qualified to prescribe or supply medicinal products, non-promotional information should be included in such a way that individuals do not need to access sections for healthcare professionals to be able to access the sections intended for the general public.

The Blue Guide provides that the following information may appear on a website aimed at the public:

• patient information leaflets, summaries of product characteristics, and public assessment reports for the company’s products;
• information related to disease awareness and health education; and
• other non-promotional reference information about the product that fairly reflects the current body of evidence about the product and its risk-benefit profile.

The MHRA provides specific guidance regarding websites for providers of medicinal treatment services, which clarifies that, whilst such providers may make information available on a certain condition and its management, they should include a ‘balanced overview of the range of therapeutic options’ rather than drawing attention to specific POMs.

The Bribery Act 2010, the UK’s main piece of anti-bribery legislation, applies to the interactions between pharmaceutical companies and healthcare professionals or healthcare organisations.

The main offences are bribing a person, receiving a bribe, bribing a foreign public official, and failing to prevent bribery. There is also an offence that applies to directors and other senior officers of a company of consenting to or conniving in bribery offences committed by such company.   The offence of failing to prevent bribery is a strict liability offence and companies may be liable if they cannot show that they had adequate procedures in place to prevent bribery. For this reason, codes of conduct and ethics that companies put in place and maintain can serve two (connected) purposes of reducing the likelihood of a bribery offence being committed and contributing towards the adequate procedures that may help to establish a defence.

The Bribery Act 2010 applies to companies incorporated in, or conducting business in, the UK and, notably, captures activities of such companies both inside and outside of the UK.

There is a Memorandum of Understanding between the ABPI, the PMCPA and the Serious Fraud Office (SFO) that sets out how the different bodies intend to deal with matters subject to the ABPI Code.  The Memorandum of Understanding states that whilst the SFO will retain discretion at all times over which cases it will pursue, it will take into account action taken by the PCMPA whilst taking a ‘vigorous approach to those corporates which believe that corruption gives a business advantage over ethical competitors’ and taking action in relation to cases that meet its criteria of serious fraud.

The Public Contracts Regulations 2015 are also of relevance and provide that companies convicted of certain offences, including bribery offences, are excluded from public procurement procedures.

In addition to the Bribery Act 2010 (as further discussed above), the Regulations and ABPI Code are the main rules that apply to the offering of benefits or inducements to health care professionals.

Part 14 of the Regulations applies to ‘advertisements’, which are broadly defined to include ‘anything designed to promote the prescription, supply, sale or use of that product’ (Article (7)(1)).

Article 300(1) of the Regulations provides that a person may not in connection with the promotion of medicinal products supply, offer, or promise any gift, pecuniary advantage or benefit to any person qualified to prescribe or supply unless such gift, advantage, or benefit is both inexpensive and relevant to the practice of medicine or pharmacy. The Blue Guide expands on the restriction, explaining that it applies in two stages, first by setting the ‘broad outer limits’ for its application (i.e. any type of promotion of medicines to persons qualified to prescribe or supply including advertising, price promotions, loyalty schemes, bonus schemes, linked share offers, public relations exercises and merchandising offers) and second by setting out the particular type of promotion that is prohibited, namely the supply, offer or promise of pecuniary advantage or benefit to persons qualified to prescribe or supply medicinal products.

The ABPI Code governs transfers of value to a person qualified to prescribe or supply medicinal products, any relevant decision maker, or any company located in the UK.

The MHRA (specifically the MHRA’s Enforcement Group) enforces the Regulations in so far as they relate to advertising.

The PCMPA enforces the ABPI Code and complaints are considered by the PCMPA’s Code of Practice Panel.

The ASA can investigate complaints about misleading advertisements and require companies to either amend or withdraw non-compliant adverts.

The SFO will investigate potential breaches of the Bribery Act 2010 that meet its criteria of serious fraud.

Companies generally cannot take action in the English courts against a competitor for advertising infringements as loss would be required to take such action. The only exceptions to this are where the action is based on defamation, slander of the complainant’s products, or in cases of trade mark infringement. Companies that want to make a complaint can do so under the self-regulatory procedure or to the MHRA.

The penalties, sanctions, or measures that are available depend on whether the relevant violation is of the Regulations, advertising regulations, or the ABPI Code.

The Enforcement Group of the MHRA enforces the Regulations in so far as they relate to advertising.  Persons (including companies) that breach the Regulations can face an unlimited fine.  In certain limited circumstances, a breach of Article 300 of the Regulations (i.e. provisions related to the provision of gifts, inducements, and other benefits to HCPs) could lead to a prison sentence of up to two years.  As a general comment, the MHRA’s approach to complaints is to resolve them quickly and informally.  Prosecutions in relation to breaches of the advertising provisions of the Regulations are extremely rare and generally the outcome of a MHRA investigation is that the MHRA will provide a warning and advice to the person in breach of the regulations and asking them to amend the offending advertising. The outcome of such an investigation is published on the MHRA’s website.  A Memorandum of Understanding between the ABPI, PCMPA, and MHRA provides that the MHRA will, in some cases, refer cases to the PCMPA as the appropriate forum.

The PCMPA enforces the ABPI Code and complaints are considered by the PCMPA’s Code of Practice Panel.  The company subject to the relevant complaint does not appear before the panel but can appeal any decision to the Code of Practice Appeal Board which is chaired by an independent lawyer.  Companies that are unsuccessful (i.e. a company that accepts that it is in breach of the Code or makes an allegation regarding another company that the panel rejects) pay an ‘administrative charge’ which is expressly stated by the PMCPA to not be a fine.  The administrative charges are £5,000 and £13,000 for ABPI members and £6,000 and £14,000 for non-member companies who abide by the ABPI Code. In addition companies that are in breach of Clause 2 of the ABPI Code (activities or materials that bring discredit upon, or reduce confidence in, the pharmaceutical industry) or that are the subject of a public reprimand or required to issue a corrective statement, can be required to pay £4,000 towards the cost of advertising such breach, reprimand, or corrective statement in the medical, pharmaceutical and nursing press.

The ASA can investigate complaints about misleading advertisements and require companies to either amend or withdraw non-compliant adverts.

The procedures before or measures taken by the self-regulatory authorities and those taken by courts/government are not closely related.

The MHRA, PMCPA, and ABPI have entered into a Memorandum of Understanding setting out the working relationship between the self-regulatory procedure by means of the ABPI Code as administered by the PMCPA and UK law administered by the MHRA on behalf of the UK Health Ministers.

However, the self-regulatory system does not overrule the MHRA’s jurisdiction to take action if it wishes to do so.  Similarly, the MHRA pre-vetting and approving advertising material does not prevent the PMCPA from finding such material to breach the ABPI Code.

The MHRA has conducted a number of investigations into companies promoting prescription only medicines for weight-loss medication (primarily GLP-1 agonists) and hayfever medication to the general public.

There was also a well-reported investigation by the MHRA in relation to a LinkedIn post regarding the grant of a marketing authorisation for a product in Great Britain which highlights the need to consider the application of regulations prohibiting advertising of prescription-only medicines to consumers to posts that are globally accessible.