Pharmaceutical advertising regulation and medical device advertising in the United Kingdom

1.1 Medicinal Products

The key UK statute regulating advertising/promotion of medicines is the Human Medicines Regulations 2012/1916. 

These are supplemented by guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA) setting out its interpretation of the regulations for which it has competence. This guidance is for the most part set out in the “Blue Guide – Advertising and Promotion of Medicines in the UK”.

The general anti-bribery/anti-corruption offences set out in the Bribery Act 2010 are also relevant to the promotion of medicines. 

1.2 Medical devices

At present, the Medicines and Medical Devices Act 2021 and the Medical Devices Regulations 2002 (the “UK Regulations”) do not explicitly regulate the promotion of medical devices other than to prohibit marketing of devices that do not conform to the UK Regulations.

However, the UK medical devices regulatory regime is under review. New regulations are expected (most likely in two tranches in 2023 and 2024). The government has indicated that these regulations are likely to include provisions governing claims made about medical devices similar to those in the EU Medical Devices Regulations 2017/745/EU and 2017/746/EU (the “EU Regulations”) prohibiting misleading claims. 

The EU Regulations do not apply in Great Britain (England, Wales and Scotland). However, they do apply in Northern Ireland, under the terms of the Northern Ireland protocol. This means the rules for placing medical devices on the market vary within the UK. Therefore, any advertising of medical devices in Northern Ireland must comply with the prohibition of misleading claims in the EU Regulations. 

1.3 General advertising law

The promotion of medicines and medical devices is also subject to general advertising law, such as:

• The Consumer Protection from Unfair Trading Regulations 2008/1277 (“CPRs”), which regulate general business-to-consumer advertising including of medicines; and
• The Business Protection from Misleading Marketing Regulations 2008/1276 (“BPRs”), which regulate general business-to-business advertising including of medicines.

2.1 Medicinal Products

In addition to the regulations and guidelines set out above, there exist industry codes of practice which companies either adhere to as members of the relevant trade associations, or voluntarily agree to adhere to.

• The Association of the British Pharmaceutical Industry (ABPI) Code of Practice is applicable to the advertising of proprietary medicines to healthcare professionals and other relevant decision-makers. Members of the ABPI are bound by the ABPI Code and non-members can voluntarily agree to be bound by the ABPI Code;
• The Proprietary Association of Great Britain (PAGB) Professional and Consumer Codes, to which PAGB members agree to adhere, set down rules which relate to advertising of over the counter medicines; and

In each case, the codes reflect but also extend beyond the underlying statutory provisions.

2.2 Medical devices

In addition to the legislation set out above, there are self-regulatory codes of practice:

• The Association of British Healthcare Industries (ABHI) Code of Practice, including the ABHI Guidelines on Advertisements & Promotions addressed solely or primarily to Healthcare Professionals (the “ABHI HCP Advertising Guidelines”) and the ABHI Guidelines on Interactions with Healthcare Professionals, a voluntary code, enforced by the ABHI, which binds its members; and
• The PAGB Medical Devices Consumer Code, which applies to advertising by PAGB members of self-care medical devices that are within the scope of an existing OTC therapeutic category within the PAGB OTC directory. The PAGB will consider inter-member complaints regarding breaches of the code.

There are also other sector-specific medical devices trade associations which operate their own codes of practice which regulate advertising amongst other matters, e.g. the Code of Practice for the Promotion of Wound Care Products to Healthcare Professionals of the Surgical Dressing Manufacturers Association (SDMA), which bind their members.

2.3 General advertising rules

The UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (“CAP Code”) and the UK Code of Broadcast Advertising (“BCAP Code”) are regulatory codes that apply to general non-broadcast (including internet) and broadcast business-to-consumer advertising respectively. 

The general advertising provisions of the codes apply and the codes also contain provisions specifically regulating the advertising of medicines and medical devices. 

Subject to very limited exceptions, it is unlawful to advertise a medicinal product unless the medicine is authorised (generally) via a marketing authorisation (“MA”).  

Promotional materials that are subject to the PAGB Consumer Code are submitted to the PAGB for pre-vetting to review the materials’ compliance with the PAGB Consumer Code. 

Medical devices must bear either the CE mark or UKCA mark to be lawfully advertised in Great Britain.  Although not yet published as either draft or actual legislation, the MHRA has indicated that CE marking under the EU Medical Devices Directives as well as under the EU Regulations is likely to continue to be recognised in Great Britain for a period of up to five years from July 2023, under transitionary arrangements.

UKCA mark is not accepted in Northern Ireland - medical devices supplied there must be CE marked in accordance with applicable EU requirements before they can be promoted. 

Other than these overarching requirements, there are no licences or approvals required specifically for advertising of medicines or medical devices to either the general public or healthcare professionals.

4.1 Medicinal products

Yes.  It is unlawful to promote prescription only medicines to the general public.  Promotion to healthcare professionals is permitted (subject to the requirements of the Regulations).

Additionally, as set out above and below different advertising laws / codes apply depending on whether the medicine is authorised as over-the-counter or prescription-only. 

4.2 Medical devices

Not applicable. 

5.1 Medicinal products

Over-the-counter medicines may be advertised to the general public. Prescription only medicines cannot be advertised to the general public except in the context of a campaign, approved by the UK Government, that relates to the use of a medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation or an approved vaccination campaign.  

In all cases, advertisements must:

• comply with the particulars of the Summary of Product Characteristics (“SmPC”); 
• not be misleading; and
• encourage the rational use of the product by presenting it objectively and without exaggerating its properties. 

The advertiser must be able to substantiate all claims made in an advertisement. Advertisements must be obviously recognisable as such. 

Specific restrictions apply and are set out in Regulations 281 to 293 (inclusive) of The Human Medicines Regulations 2012.  For example, an advert must not relate to medicinal products which contain narcotic substances, suggest that the safety or efficacy of a medicinal product is related to the fact that it is “natural”, suggest it is a food or cosmetic, or lead to the use of the product for inducing abortion.

Please see response to question 3 above regarding materials within the scope of the PAGB Consumer Code being submitted for pre-vetting by the PAGB.

5.2 Medical devices

In Northern Ireland, misleading claims for medical devices are prohibited under the EU Regulations.  

The EU Regulations do not apply in Great Britain (see question 1 above).  There is therefore no sector-specific legislation which applies to the promotion of medical devices in Great Britain, although general counsmer advertising rules will apply (see below). 

5.3 General consumer advertising rules

The CPRs are not specific to medicines or medical devices, but apply to all marketing communications made to consumers (i.e., individuals acting outside the course of their business). The CPRs prohibit unfair marketing to consumers, including misleading and aggressive advertising.

Schedule 1 of the CPRs contains a list of commercial practices that are always considered unfair, even if they do not cause the consumer to change their buying decision.

The CAP Code contains a number of restrictions on the advertising of medicines and medical devices, including:

• Objective claims must be backed by evidence;
• Marketers must not discourage essential treatment for conditions for which medical supervision should be sought;
• Marketers must not confuse consumers by using unfamiliar scientific words for common conditions;
• Marketers inviting consumers to diagnose their minor ailments must not make claims that might lead to a mistaken diagnosis; and
• Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.

The BCAP Code contains similar restrictions in the context of broadcast advertising.

6.1 Medicinal products

Advertisements for all medicinal products (including prescription-only products) must:

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

The advertiser must be able to substantiate all claims made in an advertisement. Advertisements must be obviously recognisable as such. 

In addition, the Human Medicines Regulations 2012 contain specific restrictions against the provision of gifts and hospitality to members of the healthcare professions.

6.2 Medical devices

The BPRs (which are generally applicable to all B2B advertising) govern advertisements aimed at traders (i.e., persons acting for purposes relating to their trade, craft, business or profession), including healthcare professionals.

The BPRs prohibit misleading advertising. This includes providing misleading information relating to the characteristics of a product, including the results to be expected from use of the product.

In addition, the ABHI HCP Advertising Guidelines govern marketing communications addressed solely or primarily to healthcare professionals by ABHI members. They contain the following general principles:

• Advertising must be suitable for the intended audience and must conform to generally acceptable standards of good taste; and
• An advertisement should be readily recognisable as such by the intended audience and its commercial intent must be made clear if it is not obvious from the context.

They also set out detailed requirements for the accuracy and substantiation of claims and information.

Please see the response to question 1 above in relation to anticipated new legislation in Great Britain.

As noted in the responses to questions 1 and 5 above, the EU Regulations (and specifically the prohibition of misleading claims) apply in Nothern Ireland but not Great Britain.

7.1 Medicinal products

Advertisements must be consistent with the SmPC and set out details of the MA number and MA holder, the name of the product, its classification and its active ingredients. They must also contain required prescribing information covering the indications for which the medicinal product is authorised, and a succinct summary of the entries in the SmPC on side effects, special warnings, precautions and contra-indications, method of use and dosage. The cost excluding VAT must also be provided.

Short, abbreviated advertisements (such as those in magazines or circulars for prescribers) are permitted subject to certain conditions.  They must contain the information set out above, save that information on adverse reactions, contraindications and methods of use can instead be made accessible online.

7.2 Medical devices

There is no prescribed, mandatory content for medical device adverts.

As explained in response to question 3 above, the advertising of medical devices must be within the scope of an appropriate CE mark or UKCA mark, as applicable. Any claims made in advertising should align with the CE/UKCA marked intended purpose of the device as stated in the declaration of conformity; be capable of substantiation by reference to robust, objective evidence (generally this will be contained in the product technical file) and not be misleading.  

8.1 Medicinal products

The advertisement must contain the name of the product, the active ingredient, information necessary for its correct use and an express and clear invitation to read the instructions properly.  It must be clear that it is an advertisement and it must be clear the product is a medicine.

8.2 Medical devices

See the response to question 7 above.  It must also be clear that it is an advertisement.

9.1 Medicinal products

The applicable legislation does not contain express provisions regarding the standard of evidence and data required to substantiate claims in advertisements. However, the self-regulatory codes do and cases/decisions under these codes provide additional interpretation of the evidential requirements. These requirements apply to companies subject to those codes but also provide useful guidance for what standards of evidence are likely to be acceptable to comply with the general statutory requirements. 

For example, the ABPI Code requires that information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. The ABPI Code also provides that when promotional material refers to published studies, clear references must be given. 

In addition, the ABPI Code provides that substantiation requested by healthcare professionals or other relevant decision makers must be provided as soon as possible, and certainly within 10 working days. It is possible to refer to “data on file” in advertisements, but the same rules apply in terms of providing substantiation to healthcare professionals or other relevant decision makers. 

In general, data must be statistically relevant and be presented in a way which is fair and accurate. It must not be used in a way which is misleading.

9.2 Medical devices

In addition to the general legal requirement that the advertising of medical devices must not be misleading, the ABHI HCP Advertising Guidelines provide that all information and claims must be accurate, balanced, fair, objective and unambiguous and must be based on a fair evaluation of appropriate evidence and reflect that evidence clearly.

Clear references must be provided if published studies are referred to and any graphs or tables used must be presented so as to give a clear, fair and balanced view of the matters they deal with.  Material reproduced from a published study should not be altered unnecessarily and must not distort or give a false impression of the evidence published in the study.

The key issues when using scientific data are their quality, relevance and overall credibility when relied on to support the advertiser’s claims.  On their own non-refereed articles are unlikely to be adequate substantiation for science-based claims concerning device safety or performance.

10.1 Medicinal products

An advertisement for a medicinal product directed wholly or mainly at members of the public must not suggest that the effects of taking the medicinal product are better than or equivalent to those of another identifiable treatment or medicinal product. This rule does not apply in relation to advertising of prescription-only medicines to healthcare professionals. 

The BPRs implement the general requirements relating to comparative advertising in the Comparative Advertising Directive 2006/114/EC and these also apply to the advertising of medicinal products. 

The ABPI Code sets out specific requirements for comparative advertising, which include that it must not be misleading; medicines for the same needs or intended purposes must be compared; there must be no confusion created between the advertised medicine and a competitor medicine; and the trade marks/names etc. of a competitor must not be denigrated/discredited or taken unfair advantage of. 

Each of the CAP Code, the BCAP Code and the PAGB Codes also contain provisions specifically regulating comparative advertising. 

10.2 Medical devices

The provisions in the BPRs on comparative advertising also apply to medical devices.

Further, the ABHI HCP Advertising Guidelines contain detailed rules on the use of comparative advertising. A comparison shall only be permitted to be used as part of an advertisement if:

• It is not misleading;
• Devices or services for the same needs or the same intended purpose are compared;
• One or more relevant features are compared;
• No confusion is created between the device or service advertised and that of a competitor or between the advertiser’s trade marks, trade names, other distinguishing marks and those of a competitor;
• The trade marks, trade names and other distinguishing marks, products, services, activities or circumstances of a competitor are not discredited or denigrated;
• No unfair advantage is taken of the reputation of a trade mark, trade name or other distinguishing marks of a competitor; and 
• The advertiser’s devices or services are not presented as imitations or replicas of goods or services bearing a competitor’s trade mark or trade name. 

The CAP Code and the BCAP Code also contain provisions specifically regulating comparative advertising which will apply to non-broadcast / broadcast consumer advertising, respectively.

11.1 Medicinal products

The MHRA considers that prescription only medicines should only be advertised on websites specifically directed to healthcare professionals and clearly marked as such. Use of social media (e.g. twitter) for promotional information concerning prescription medicines is consequently prohibited because of its general availability to non-healthcare professionals.

The MHRA has stated in the Blue Guide that, in principle, the information referred to in the response to question 7 above (mandatory information for healthcare professional advertising) could instead be provided by way of a link to the full SmPC from an internet advertisement instead of including this information in the advert itself.

11.2 General comments

In general, the same rules apply to online advertising of medicines and medical devices as would apply to other forms of advertising.  

However, online advertising brings its own challenges.  For example:

• MA holders and medical device manufacturers have legal surveillance and reporting obligations to systematically collect, evaluate and to report adverse safety information to the MHRA.  If users are permitted to submit comments via online channels (as part of marketing campaigns), this would open up a new channel through which MA holders / manufacturers could potentially receive information on product adverse safety or quality events, which would have to be monitored and evaluated for possible reporting to the MHRA.
• Publicly accessible user comments may constitute off-label promotion, which is a criminal offence.

12.1 Medicinal products

The Human Medicines Regulations are enforced by the MHRA via the criminal law. Penalties can be as severe as an unlimited fine and, in the case of natural persons, up to two years in prison.  There is also scope for personal criminal law liability for company officers and senior management if an offence is committed with their consent or connivance or due to their neglect.

However, according to memoranda of understanding between the Prescription Medicines Code of Practice Authority (PMCPA) and the ABPI on the one hand, and each of the MHRA and the Serious Fraud Office (SFO) on the other, the PMCPA has jurisdiction in respect of matters covered by the ABPI Code though each of MHRA and the SFO have jurisdiction to intervene to enforce the law. 

Companies subject to the jurisdiction of the PMCPA who breach the ABPI Code are liable for administrative costs, public censure and, in the case of particularly serious breaches by ABPI members, suspension of membership or even expulsion from the ABPI, at which point they become subject to the direct scrutiny of the MHRA. All adjudications are made public.   

12.2 Medical devices

The UK Regulations are enforced by the MHRA. The legislation provides for various penalties, ranging from a compliance notice to an unlimited fine and, in the case of individuals, six months’ imprisonment and/or unlimited fine.  There is also scope for personal criminal law liability for company officers and senior management if an offence is committed with their consent or connivance or due to their neglect. 

The Medicines and Medical Devices Act 2021 will substitute new enforcement provisions and powers for medical devices. These are likely to be relevant for enforcement of anticipated new regulations governing the advertising of medical devices (see response to question 1 above). The new enforcement powers will come into effect on a date still to be appointed by the Secretary of State under regulations. Enforcement under the 2021 Act will be by the MHRA but also additionally by local authorities’ Trading Standards Offices for devices which are ordinarily intended for private use or consumption (i.e. consumer devices).

Complaints about breaches of the ABHI Code may be made to the ABHI Panel, which, if the complaint is upheld, can require the advertiser to cease using the advertising complained of and to pay an administrative charge.  Various further sanctions are available to the ABHI Panel, including recommending expulsion of the advertiser from the ABHI and requiring the payment of the Panel’s costs.  Case reports are published on the ABHI’s website and are publicly available.

12.3 General advertising enforcement

Local Trading Standards Authorities and the Competition and Markets Authority (CMA) have competence for enforcing the CPRs and the BPRs. Certain provisions of these regulations can be enforced by way of criminal sanctions. Trading Standards and the CMA may also prohibit the publication of infringing advertising.

Further, consumers may bring a civil law claim under the CPRs to enforce against misleading or aggressive advertising, although traders may be able to rely on a due diligence defence.

Allegations of breaches of the CAP Code and the BCAP Code are directed to the ASA. The ASA may also make challenges to advertisements of its own volition and adjudicate upon them. The ASA has a range of enforcement options available to it. Where complaints cannot be resolved informally and are upheld at adjudication, the usual sanction is simply to direct that the advertisement not appear again in the same form.  However, in particularly serious cases, the ASA has a sliding scale of further enforcement options, which can include alerting media channels not to accept advertising, asking search engines to remove paid-for advertising linking to non-compliant advertising, requiring pre-vetting of advertising or, in the most extreme cases, referring an advertiser to Trading Standards for enforcement under the CPRs.

13.1 Medicinal products

Under the terms of the Withdrawal Agreement, Northern Ireland remains subject to EU law governing the advertising of medicines until at least 1 January 2027. 

GB regulation of advertising of medicines could in principle now diverge from the existing EU legislation at any time. However, it is not currently expected that there will be any significant changes in the short term. 

13.2 Medical devices

A substantial reform of the medical devices regulatory regime is expected in the near future.  New regulations are likely to be published in two tranches in Spring 2023 and later, possibly in early 2024.

According to the government’s consultation response published in June 2022, these regulations are likely to include provisions regulating marketing claims for medical devices.