United States: Pharmaceutical Advertising 2018

Originally published in The International Comparative Legal Guide to: Pharmaceutical Advertising, 2018 (15th edition)

1 GENERAL – MEDICINAL PRODUCTS

1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?

The advertising of medicinal products in the UK is controlled by a combination of legislation and codes of practice. The main regulations are found in Part 14 of the Human Medicines Regulations 2012/1916 (the Regulations). The Medicines and Healthcare products Regulatory Agency (MHRA) supervises the advertising of medicinal products on behalf of the licensing authority. The Regulations are supplemented by guidelines published by the MHRA; mainly the Blue Guide – Advertising and Promotion of Medicines in the UK, September 2014 and general guidance published on the MHRA website.

In addition to control by the MHRA, most pharmaceutical companies operating in the UK agree to abide by industry Codes of Practice, which provide the most detailed and immediate control over the advertising of medicines. The Association of the British Pharmaceutical Industry Code of Practice (the ABPI Code), administered by the Prescription Medicines Code of Practice Authority (PMCPA), governs the advertising of prescriptiononly medicines (POM); the latest version came into operation on 1 January 2016. A new version is announced for 2018. The Proprietary Association of Great Britain (PAGB) Consumer Code governs the advertising of over-the-counter medicines to the general public and the PAGB Professional Code governs the advertising of over-the-counter medicines to persons qualified to prescribe or supply. The Codes of Practice repeat the law, but in several respects, go beyond it. Companies who have not agreed to abide by the relevant Codes of Practice and the associated self-regulatory mechanisms are supervised directly by the MHRA.

In addition to the controls which specifically relate to medicines, in principle, other general legislation may be relevant including, for example, the Trade Descriptions Act 1968. Commercial practices (including advertising) relating to consumer goods are subject to a series of laws on trading of consumer goods, including the Consumer Protection from Unfair Trading Regulations 2008/1277 (businessto- consumer practices) and the Business Protection from Misleading Marketing Regulations 2008/1276 (business-to-business practices). The MHRA works with the Advertising Standards Authority (ASA), the UK's independent regulator for general advertising across all media, and the Committee of Advertising Practice (CAP), the body responsible for writing and maintaining the UK Advertising Codes and providing authoritative advice on the rules, to maintain high and consistent standards.

1.2 How is "advertising" defined?

"Advertisement" is defined in section 7 of the Regulations, as including "anything designed to promote the prescription, supply, sale or use" of a medicinal product. This is stated to include: door-todoor canvassing; visits by medical sales representatives to persons qualified to prescribe or supply medicinal products; the supply of samples; the provision of 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 where the intrinsic value is minimal); the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products, including payment of expenses.

The Regulations state that the definition of "advertisement" does not include: packaging; correspondence answering specific questions about a medicinal product (which may be accompanied by material of a non-promotional nature); and reference material and announcements of a factual and informative nature (including: (i) material relating to changes to a medicinal product's package or package leaflet; (ii) adverse reaction warnings; (iii) trade catalogues; and (iv) price lists), provided that no product claim is made. The ABPI Code does not define "advertising", but uses the term "promotion", which is similar. Promotion under the ABPI Code therefore covers "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" (Clause 1.2).

The Court of Justice of the European Union (CJEU) has clarified the definition of advertising and the persons subject to EU advertising rules. In particular, Article 86(1) of Directive 2001/83/EC (the Directive) provides a definition of advertising that focuses on the purpose of the message and the objective pursued, i.e. if the intention is to promote the prescription, supply, sale or consumption of medicinal products, it is advertising (C-316/09 MSD). It is not necessary for the message to be disseminated by a person linked to the manufacturer and/or seller of the medicinal product or to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising (C-421/07 Damgaard). However, the prohibitions, for example, in relation to the provision of financial inducements, do not apply to national authorities pursuing public health policy, including any policy on the public expenditure on pharmaceuticals (C-62/09 ABPI).

The dissemination of information that is a faithful reproduction of the approved package leaflet or summary of product characteristics (SmPC) of a medicinal product is unlikely to be considered advertising, although the selection, manipulation or rewriting of any such information can likely only be explained by a promotional purpose (C-249/09 Novo Nordisk).

1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?

Companies who supply POMs and have agreed to abide by the ABPI Code, should make sure that all relevant personnel involved in promotion are appropriately trained on Code requirements. Although companies may have different internal procedures and guidelines for reviewing material, promotional material must not be issued unless its final form has been certified by a person on behalf of the company. This person must be different from the person responsible for developing the material.

Materials that will be printed can be certified in electronic form by a company signatory in the usual way; however, such material must not be used until the company signatory has checked and signed the item in its final printed form (in those circumstances, the material will have two certificates and both must be preserved). The signatory should be a registered medical practitioner or a pharmacist registered in the UK. UK-registered dentists may also certify promotional material if the product is for dental use only.

All promotional materials must be certified, regardless of format (e.g. printed or electronic, audio and audio-visual). The following materials must be certified in a similar manner: (i) educational material for the public or patients issued by companies that relates to disease or medicines, but is not intended as promotion for those medicines; (ii) material relating to working with patient organisations; (iii) material prepared in relation to joint working between the NHS and the pharmaceutical industry (only the final documents need to be certified); (iv) material relating to patient support programmes involving the provision to healthcare professionals of items to be passed on to patients; and (v) non-promotional material for patients or healthcare professionals relating to the provision of medical and educational goods and services issued by companies. Material that is still in use must be recertified at intervals of no more than two years. Certificates and accompanying material must be retained for at least three years after the final use of the material. There is no need to certify or examine meetings which involve travel outside the UK if the only involvement is sponsoring a speaker to present at a meeting and the pharmaceutical company has not participated in the arrangements for the meeting in any way.

Companies must have a scientific service to compile and collate all information (whether received from medical representatives or from any other source) about the medicines they market.

1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?

There are no legal requirements for companies to have specific SOPs. The ABPI Code includes a section on "Guidelines on company procedures relating to the code of practice". These guidelines provide that in order to assist with compliance, companies should have a comprehensive set of SOPs covering all aspects of the ABPI Code. SOPs should establish high standards, and companies are expected to ensure that relevant staff are trained and validated on

their content. The guidelines require pharmaceutical companies to have written documents setting out the representatives' instructions on the application of the ABPI Code to their work, and a written document that sets out their policies on meetings and hospitality and the associated allowable expenditure. The ABPI Code provides that each company should have a senior employee who is responsible for ensuring that this document meets the requirements of the Code. There is an assumption that this responsible person is the managing director or chief executive or equivalent unless other formal arrangements have been made within the company. In addition, and in line with the requirements of Directive 2001/83/EC, the Regulations require marketing authorisation holders to establish a scientific service to compile and collate all information relating to the product. This legal requirement is mirrored by the ABPI Code.

1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?

The Regulations do not require the advance approval of advertising. However, the MHRA has the power under section 304 of the Regulations to issue a notice requiring any person concerned with the publication of advertisements relating to medicinal products to supply copies of advertisements prior to publication and not to use those advertisements until they have been approved. It is a criminal offence to fail to comply with such a notice. Circumstances in which pre-use vetting may be required include: (i) where a newly licensed product subject to intensive monitoring is placed on the market; (ii) where a product is a reclassified product, for example, from prescription-only to pharmacy; or (iii) where previous advertising for a product has breached the Regulations. Pre-use vetting may also be requested as a result of a major new indication for use or where there are safety concerns. In addition, the MHRA has committed to vet initial advertising for all new active substances.

The duration of the vetting is commonly two to three months, and does not normally extend for longer than six months. This period can be reduced or extended depending on the quality of the initial advertising material submitted and other relevant factors. It is also open to companies to seek guidance from the MHRA on proposed advertisements or to request a meeting to discuss issues that arise during the vetting procedure.

The ABPI Code does not require any prior approval for the advertising of POMs, but again, guidance can be sought prior to publication. MHRA vetting does not guarantee compliance with the ABPI Code.

In the case of over-the-counter medicines, the PAGB Consumer Code requires prior approval. However, this requirement does not apply to advertisements aimed at persons qualified to prescribe or supply medicines, or their employers (caught by the PAGB Professional Code). The PAGB reviews all of their members' advertising to the public against their code of practice.

1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/ or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?

The MHRA has the power, under sections 304, 305 and 306 of the Regulations, to issue notices prohibiting the publication of specified advertisements. Where the MHRA notifies a company that it is minded to consider an advertisement to be in breach of the Regulations, the company has the right to make written representations to the Review Panel. The findings of the Review Panel have to be taken into consideration by the MHRA before a final decision on how the company promotes its product can be made. If the MHRA issues a final notice determining that an advertisement is in breach, the company has no further right of appeal and will commit a criminal offence if it proceeds to publish the advertisement. The company may also be required to publish a corrective statement.

While there is no appeal mechanism, it is open to the company to challenge the legality of a notice issued under Section 306 of the Regulations by means of judicial review. In practice, this is unlikely to be successful unless the MHRA's procedure was demonstrably unfair.

1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? If there have not been such cases please confirm. To what extent may competitors take direct action through the courts in relation to advertising infringements?

Enforcement is by the Enforcement Group of the MHRA. In most cases, a person (including a company) who contravenes the legislation faces an unlimited fine. In addition (or alternatively), where individuals are involved in the publication or use of unlawful advertising, a period of up to two years' imprisonment may be imposed.

Prosecutions for advertising offences are extremely rare. A prosecution for illegal advertising relating to activities addressed to healthcare professionals has not occurred for many years. More recently, prosecutions have concerned products that are claimed to have medicinal properties, but that are not authorised as medicines, or advertising to the general public of POMs via the internet or otherwise. The MHRA prefers to resolve complaints quickly and informally, with companies agreeing to take voluntary action to amend their advertising and, in some cases, to issue a corrective statement. Details of cases resolved informally are posted on the MHRA's website.

The ABPI Code is administered by the PMCPA, and complaints made under the Code are considered by the PCMPA's Code of Practice Panel. The parties to a complaint have no right to appear or be represented before the Panel, but may appeal decisions made by it to the Code of Practice Appeal Board, which includes representatives of industry and the medical professions, chaired by an independent lawyer. Administrative charges are payable when a company is found in breach of the ABPI Code (£3,500 per matter for ABPI member companies, or £12,000 if the matter is unsuccessfully appealed). The Panel and/or Appeal Board also have the power in serious cases to require an audit of a company's promotional procedures or to refer the matter to the ABPI Board of Management, who may suspend or expel the company from the ABPI or direct that the company should no longer be included in the list of companies who have agreed to be subject to the ABPI Code of Practice (with the result that the company becomes subject to direct supervision by the MHRA).

The PAGB does not impose any financial sanctions, but a company may be expelled from the PAGB if it has failed to comply with the PAGB Code.

Generally, it is unusual for competitors to take direct action through the courts, although they can make complaints to the MHRA, PMCPA and PAGB. Legal proceedings by companies are only possible in the case of an action based on defamation, slander of goods or an infringement of trademark rights (see question 1.9).

1.8 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?

The relationship between the self-regulatory process, administered by the PMCPA, and the supervisory and enforcement function of the competent authority, the MHRA, is set out in a Memorandum of Understanding between the two bodies and the ABPI. The two systems are regarded as "complementary and synergistic", but the self-regulatory system does not oust the jurisdiction of the MHRA. Both bodies can hear complaints from whatever source, save that the MHRA would normally refer inter-company complaints to the PMCPA, and may refer other complaints to the PMCPA with the consent of the complainant. The MHRA will routinely decline to investigate cases where it is aware that these are under investigation by a self-regulatory body, but reserves the right to take action if serious public health concerns are raised or if self-regulation fails (e.g., if the sanctions imposed by a self-regulatory body do not seem to deter a company from committing further material breaches of the rules). It is possible that material pre-vetted and approved by the MHRA might subsequently be ruled by the PMCPA as in breach of the ABPI Code. The MHRA regularly reviews information on the PMCPA website about the consideration of current cases and may investigate the case further when the PMCPA proceedings are completed.

1.9 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?

UK legislation does not create a separate offence of unfair competition. Setting aside breach of the advertising rules, there is the option of taking action based on trademark law, passing off, trade libel or malicious falsehood. A trademark infringement action may be brought by the owner of the trademark that has been infringed. A passing-off action may be brought by a party whose goods are being misrepresented to the public as being the goods of another party, provided the party in question can show sufficient goodwill or reputation in the product and that such actions have caused damage to the claimant. A trade libel or (if malice can be demonstrated in relation to a statement) malicious falsehood action may be brought by a trading corporation or company whose reputation is damaged.

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