On 27 September 2022, the UK’s Association of the British Pharmaceutical Industry (ABPI) published its updated guidance: Working with patients and patient organisations - A Sourcebook for Industry (August 2022) (‘the Sourcebook’). The ABPI’s first Sourcebook was published in 2018 and has now been updated to reflect the 2021 ABPI Code of Practice for the Pharmaceutical Industry (‘the 2021 Code’).
This updated, detailed guidance provides the industry with an essential compliance tool, which will help with successful self-regulation. Although the Sourcebook is provided by way of informal guidance, it is likely to be influential in determining best practice and compliance with the 2021 Code.
The ABPI invites users of the Sourcebook to provide comments and feedback to inform future editions.
In greater detail
The ABPI Code of Practice, first established in 1958, is a self-regulatory code which governs interactions between pharmaceutical companies and healthcare representatives, including promotional activities. It is indented to support members’ commitment to operating in a professional, ethical and transparent manner.
The 2021 Code marked a “substantial overhaul” and the most extensive revision to the Code in over 30 years, and the ABPI’s new Sourcebook reflects this. Broadly, the main aims of the revised Code were to increase transparency, ensure the appropriate marketing of medicines, and place an increased emphasis on the ABPI’s Principles (benefiting patients, acting with integrity, ensuring transparency, and treating everyone with respect).
The updated Sourcebook
The Sourcebook is intended to provide “informal” guidance on working relationships and collaborations between industry members, patient organisations and patients, in line with the standards set out in the revised 2021 Code. It also draws on guidance from national and international organisations, designed to “bring together practical tools and tips” and “help pharmaceutical companies and patient organisations plan how best to engage and work together successfully”.
The Sourcebook provides guidance on six areas encompassing working relationships with patient organisations. It explains how each is covered by the 20212 ABPI Code and provides checklists, guidelines and additional sources. The six areas are:
1. Principles and Agreements
Any collaborative work between industry and patient organisations is to be underpinned by four guiding principles:
- clarity of purpose – each party should be clear about the reason for and planned outcome of the collaboration, and the ultimate benefit for patients;
- integrity – each party should act, and be seen to act, honestly and with integrity at all times;
- independence – each party should maintain their independence; and
- transparency – each party should be open and honest about the purpose of the collaboration and be able to account publicly for the associated activities and any exchange of funding.
The Sourcebook sets out detailed requirements for written agreements for any working relationships (e.g., in respect of donations, grants, sponsorships and collaborative working).
2. Definitions of participants
The Sourcebook highlights the importance of defining roles precisely when pharmaceutical companies and patient organisations work together. It provides guidance on definitions (e.g., “patient organisation”, “individual patient”, “patient experts” and “patient organisation representatives”). This is important as relevant definitions will impact what information can be shared and how pharmaceutical companies and patient organisations can engage and work with one another.
3. Events and meetings
The 2021 Code states that there must be a written agreement in place for sponsorship of patient organisations (including individuals representing patient organisations at events/meetings) and including, where possible, a breakdown of costs. The Sourcebook sets out the guidelines and tests relevant to the rules contained in the Code for acceptable patient/patient organisation participation in such events. This includes requirements for the disclosure of payments, the sharing of information when patients are present (with promotional materials classed as inappropriate for patients), and social media use (ensuring that information does not constitute the advertising of prescription-only medicines to the public, as prohibited by the Code).
4. Research and development
The Code covers responsibilities in relation to the disclosure of clinical trials and non-interventional studies of marketed medicines. Written agreements must be in place and companies must disclose details of patient organisations to which they provide financial or significant non-financial support. The emphasis with any activity must be on transparency.
5. Product launches
The 2021 Code applies to new product launches in the same way and with the same requirements as any other activity (e.g., around promotion, information, agreements and events). Again, in this context, care must be taken to ensure that any information shared is not promotional or for promotional purposes.
6. Payments and disclosure
In the context of patient organisations/patients devoting their time to supporting and participating in activities with the industry, the services they provide are acceptable providing they are for the purposes of supporting healthcare, research or education and do not constitute an inducement to recommend and/or prescribe, supply, sell or administer a specific medicine. Any such services are permitted to be remunerated and any remuneration must be reasonable and not exceed the fair market value of the services provided. Any such payments must also be disclosed and made publicly available. Again, the emphasis is on consistency, transparency and a well-developed rationale regarding patient organisation/patient involvement.
The MHRA has indicated its ongoing support for appropriate self-regulation by the pharmaceutical industry, and it is clear that the MHRA considers adherence to the 2021 Code an important part of that (read more here).