Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?

Acorn Regulatory assists companies in maintaining compliance with a variety of codes of conduct.  In this article, we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK and Ireland.  The respective IPHA and ABPI codes cover the promotion of medicines for prescribing to both health professionals and other relevant decision-makers.

Overview of the Code of Practice

The Irish pharmaceutical industry is governed by the IPHA (Irish Pharmaceutical Healthcare Association) code.  The UK is governed by the ABPI (Association of the British Pharmaceutical Industry) code. The organisations and their attendant codes have been in force and existence for many years, and year on year, they both publish updates and addendum’s to the existing code and further clarify and expand on what is the expected behaviour and standard for all companies (member or not) to follow.

Treatment of Competitors

One of the first recommendations to the code was to ‘not disparage your competitors’ and Clause 5.5 of the IPHA code (2017) clearly sets out the parameters ‘ in presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis and by omission or in any other way’. The ABPI code (2017) has a similar brief in clause 8.2 ‘the health professionals and the clinical and scientific opinions of health professionals must not be disparaged’.

A case in the UK (2016) found a company promoting an antipsychotic in breach of the ABPI code for clause 8.2 and also for Clause 9.1 (high standards had not been maintained). The company organised a series of high-quality educational meetings for clinical psychiatrists and related professionals- known as the ‘HOPE’ programme. These meetings had been held since 2014. The overall aim was to inform, educate and encourage discussion among an audience of peers. The meeting content was highly scientific and included efficacy and safety data presentations on their own treatment, as well as competitor treatments. One speaker in a panel of seven speakers presented on the various treatments prescribed currently for schizophrenia, including the company’s product. The presenter (who was not an employee of the company) made a remark when presenting competitors’ data that was construed to be disparaging to the company’s competitors and in breach of the code. The company apologised on behalf of their speaker and for any unintended consequences. The presentation had been developed by a speaker who had attended a rehearsal and briefing with all other speakers prior to the meeting. The company stated that this was a one-off comment, at a single meeting in a series of high-quality educational events that had been well received by clinicians. All content and material had been reviewed and certified and none contained or advocated anything which disparaged another product or competitor.

The ABPI panel noted that this was clearly a promotional meeting. They considered the comments made by the presented and found that they did disparage those health professionals and their clinical and scientific opinions. They ruled a breach of 8.2 and 9.1.

Adhering to the Code

Companies strive to do what is right and compliant under the IPHA or ABPI code. There is a continuous effort and cost to streamline their processes and resources to make sure they are in line with the code and its complexities. The company referenced above were found in breach for something they tried to control to the best of their abilities, from an internal perspective. All presentations had been approved from an internal approval process, as well as a rehearsal and briefing with speakers prior to the event.

The incident above brings up many questions:

  • What controls can be put in place to manage the actions and utterances of a third party speaker?
  • Should responsibility for comments be the responsibility of the company, or individual responsibility, and a claim made before a meeting commences?
  • Should this become mandatory under the code to avoid a ‘slip of the tongue’ in the future?

This was a difficult lesson for the aforementioned company to learn, but one in which other companies should also take leave from, and start to think about what processes and controls can be put in place to avoid this breach for them.

We Can Help

Acorn Regulatory can advise your company on compliance issues and ensure that your company avoids unnecessary breaches of the relevant codes of practice.  Contact us today if you would like to discuss this further.  Call us on 00353 52 61 76 706 or complete your details below and we will get back to you.

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About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
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