• Governance I Risk I Compliance Management

MHRA’s The Blue Guide: Advertising and Promotion of Medicines in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA)  The Blue Guide -Third Edition Second revision  July 2019 – is a UK legislation sets out the rules for medicines advertising in general and the specific requirements and restrictions for advertising directed at the public and for advertising directed at healthcare professionals.

The Blue Guide provides directions on how UK medicines can be promoted or advertised legally. The guide aims to help pharmaceutical companies better understand existing medicine advertising and promotion laws applicable in the UK. Although first published in 1999, this paper will overview the guide’s latest edition, the Third Edition published in August 2012. The current guide is organised into ten chapters. It begins by justifying the need for the Blue Guide, explaining that all medicines should be safe and promoted in a way that is in the best interests of consumers. It emphasises two major advertising legislations, “the Community Code relating to medicinal products for human use” from European legislation and the UK Human Medicines Regulations 2012.

The guide then outlines general rules: for example, medicine advertisements must maintain quality standards, and public advertisements cannot be misleading. However, Chapter 6 is the most relevant section for this paper: it outlines anti-bribery standards. It identifies HCPs and HCOs as a part of a larger group called “persons qualified to prescribe or supply” (PQPS).

According to Regulation 300(1) of the Human Medicines Regulations 2012, it is prohibited for those who promote medicines to offer “any gift, pecuniary advantage or benefit” to a PQPS with only one exception: the offer is inexpensive and relevant to the practice of medicine or pharmacy (Medicines and Healthcare products Regulatory Agency, 2014, p. 39). Inexpensive items are specifically defined as those equal to or less than £6 (excluding VAT).

Relevant item examples are given: pens, notepads, calculators, computer accessories, diaries, calendars, surgical gloves, tissues and coffee mugs. The ‘inexpensive rule’ additionally applies to any point scheme. Hospitality is allowed only when in conjunction with a professional event, but any offer of hospitality must still be “reasonable in level” (2014, p. 40).

Any offer by a pharmaceutical company to sponsor research is only allowable if there is absolutely no sponsorship of a company product or product. In these ways, the Blue Guide is more detailed than general ABAC laws: it aims to eliminate any confusion or distortion of ABAC laws by pharmaceutical companies.

In contrast to the ABHI and ABPI, the MHRA is a statutory power to act on behalf of government Health Ministers. It has the right to mandate and carry out a review of any advertisement by a pharmaceutical company and order that an advertisement is refrained from being published. However, formal procedures are only undertaken by the MHRA if there is a public health justification; in most instances, companies will cooperate with the MHRA to publish fair and legal advertisements. Should a company disagree with the MHRA, it can then approach an Independent Review Panel (IRP), which will determine if the advertisement in question is in breach of the law. However, it remains the prerogative of the MHRA to act or not act on the advice of the IRP.

The MHRA’s decision is final and can only be contested in a court of law. If the MHRA finds a breach in advertising regulations, which is a criminal offence, it can choose whether or not to pursue an enforcement action, i.e. prosecution (2014, p. 54). As stated previously, these formal procedures are usually only undertaken in extreme circumstances. In most instances, the MHRA encourages pharmaceutical companies to cooperate and self-regulate. The latter can be achieved through various independent regulatory bodies; one example given is the PMCPA’s ABPI Code.

Codes such as the Blue Guide, ABHI Code, ABPI Code, and MedTech Europe are regional and industry-specific. While they have helped the life sciences collaborate in mitigating risk, they do not address ABAC problems specific to one company. This is where internal ABAC policies become necessary. 

Yet there remains an important problem: no matter how much a life sciences company promises that its internal ABAC policies are effective, there is a degree of concern on the part of consumers and potential clients that such policies are not enough. How does one know that a company is committed to mitigating risk and risk mitigation steps are in place? This is our final question of this article: could there be an additional way for companies to ensure to the outside world and their internal staff that their ABAC policies are adequate, appropriate, and dependable? Could this final risk mitigation method be IS37001 Certification? The answer is yes.

Could ISO 37001:2016 have prevented bribery and corruption in the case studies reviewed?

If a life sciences company had appropriately and fully followed all of the ISO 37001:2016 requirements, bribery risk should have been greatly mitigated. The benefit of ISO 37001 is that it is an internationally accepted standard, and whereas an individual company may try to replicate its tenants in its own ABAC code, any such replication lacks the impartial nature and widely accepted reputation of ISO 37001 certification. To be sure, ISO 37001:2016 does not prevent all bribery from ever happening. Furthermore, it remains impossible to definitively say that had a company from the case studies above earned ISO 37001 certification; it would have never faced government enforcement action. That being said, if a company earns ISO 37001:2016 certification following appropriate training, tailors the ISO 37001 requirements to its business operations, and adheres to all other ABAC laws, conventions, and codes, then this Certification should prove a strong and effective deterrent against bribery in future.

 ISO 37001 Anti-Bribery Management System (ABMS) certification 

ISO 37001 Anti-bribery Management Systems (ABMS): corruption and bribery affect any organisation, large or small, public or not-for-profit. It has the potential to cause severe harm to your business, including financial loss, dire legal consequences, damage to your brand, company’s reputation and sustainable development. Therefore, anti-bribery needs to be managed correctly and effectively.

ISO has developed a standard – ISO 37001:2016 ABMS – to help organisations promote an ethical business culture. “Designed to help your organisation implement an anti-bribery management system (ABMS) and/or enhance the controls you currently have. It helps to reduce the risk of bribery [and corruption] occurring and can demonstrate to your stakeholders that you have put in place internationally recognised good-practice anti-bribery [and anti-corruption] controls”.

This new standard mirrors numerous steps contained in the U.S. Foreign Corrupt Practices Act (DOJ and SEC) and Good Practice Guidance on Internal Controls, Ethics and Compliance (OECD), Anti-Corruption Ethics and Compliance Handbook for Business (OECD), U.K. Bribery Act 2010 and the British Ministry of Justice’s Adequate Procedures document. ISO 37001 ABMS Standard is flexible and can be adapted to manage many types of bribery in addition to suiting any type of business locally or worldwide.

ISO 37001 certifies that your organisation has implemented reasonable and proportionate measures to prevent bribery. These measures involve top-level leadership, training, bribery risk assessment, due diligence adequacy, financial and commercial controls, reporting, audit, and investigation.

Why do you need our ABAC® program?

The ABAC® offers a complete suite of services and solutions designed to help organisations against bribery and corruption even when operating in multi-jurisdiction and multi-cultural environments. ABAC© offers Introductory, Internal Auditor and Lead Auditor training (online and in-class training) to all personnel who are involved in the development, implementation and evaluation of their organisation’s ABMS and in coordinating anti-bribery compliance activities within the organisation. Whilst our Certification is a mitigating piece of evidence to regulators, prosecutors, or even courts that your company has taken meaningful steps in its efforts to prevent bribery and corruption.

ABAC® program helps ensure that your business has implemented a management system that prevents, detects and responds to bribery and complies with anti-bribery laws, internally and externally (i.e. agents, consultants, suppliers, distributors and other third parties). ABAC© works with clients of all industries, sizes and organisation types to develop robust programs using the latest techniques and best practices that help foster an ethical business culture.

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  • Our professionals are acutely trained in international business compliance, including the Foreign Corrupt Practices Act (FCPA), U.K. Bribery Act, OECD Anti-Bribery Convention, Money Laundering Regulations and their associated developments. Business intelligence is gathered from regulators, industry observers, suppliers, competitors, distributors and even current/former customers.

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 Anti-Bribery Anti-Corruption (ABAC®) Center of Excellence is an independent certification body that provides education and certification services for individuals and organisations on a wide range of disciplines and ISO standards, including:

ABAC® offers a complete suite of solutions designed to help organisations mitigate the internal and external risks associated with operating in multi-jurisdiction and multi-cultural environments while assisting in the development of frameworks for strategic compliance programs.

ABAC® is accredited by the United Kingdom Accreditation Service (UKAS CB number: 10613) against ISO/IEC 17021-1:2015 Conformity assessment — Requirements for bodies providing audit and Certification of the scheme’s management systems of ISO 37001:2016 Anti-Bribery Management Systems (ABMS). This makes ABAC® Certification the leading accreditated certification body specialising in global anti-bribery and anti-corruption, risk and compliance management system standards. ABAC® experts audit any existing compliance and anti-bribery anti-corruption management systems to assess effectiveness and vulnerabilities while ensuring your organisation complies with Internal Standards, FCPA, U.K. Bribery Act, Anti-Money Laundering regulations, and all