The red tape of bureaucracy is the last thing that patients and patient organisations need when they are working with industry. Constructive partnerships are what the rare disease community needs—not convoluted processes that hinder effective engagement. Sheela Upadhyaya is keeping a watchful eye on developments

By Sheela Upadhyaya, a life sciences consultant specialising in rare disease

In my previous article, I emphasised the importance of collaboration between industry and rare disease patient groups, to improve the overall landscape for rare diseases. I highlighted how the current ABPI Code of Practice has created challenges and hindered effective engagement between these parties. I am pleased to report that the PMCPA has taken steps to improve the situation: it recently organised a series of workshops to find potential solutions.

During March, the ABPI and PMCPA jointly hosted two inaugural “Code Partnership” events. There was one event for the ABPI Patient Organisation Forum and one for the ABPI Compliance Network. The primary objectives of these events were as follows:

• enriching knowledge and confidence about activities that can be done when companies, patient organisations or patients are working together
• exploring common challenges to share examples and insights 

This enabled the PMCPA to hear about the problems that arise during these collaborations from the people who are directly involved. Feedback from the Patient Organisation Forum event fed into the Compliance Network event to help focus further on the challenges faced in collaborative efforts, such as the complex written agreements that are always needed but which may be different for each interaction. The rich and insightful discussions produced feedback that may be considered when the ABPI Code is updated.

I have reliably heard that the ABPI and PMCPA are both fully committed to making the process of collaboration easier for everyone. They have agreed to the following actions:

Development of fact sheets on key topics: The organisations will create concise fact sheets focused on specific subjects, such as “engaging patients to provide services”, “proactive versus reactive provision of information”, and “grants versus sponsorships”. They will develop two or three fact sheets and gather feedback before covering more topics, so patient groups can check that the documents are useful and easy to understand.

Updates to the 2021 ABPI Code of Practice: The organisations intend to continue to gather feedback on the code, which will be considered when it is updated. There will be a comprehensive public consultation so stakeholders can give feedback before the changes are finalised and the new code is published, which is expected to be in early 2024.

Glossary of code terminology in plain English: A glossary of terms will be prepared to support the clarity and consistency of all documents. It will explain key terms in plain English and give examples of grants, donations and sponsorships.

Online video-based training on the code: An online training programme is being developed for stakeholders to use alongside the code. Set to launch in 2024, it aims to promote a comprehensive understanding of the code and its provisions.

Further “Code Partnership” events: The ABPI and PMCPA are committed to continue engaging with the community (at least annually) through the ABPI Patient Organisation Forum.

As a result of  these conversations, the ABPI has produced the Sourcebook, which is a comprehensive guide for industry when it is working with patients and patient organisations. This resource outlines various ways in which the industry can collaborate effectively and provide support to patient groups.

In my article I called for the following actions to cut red tape:

• a standard agreement template to be developed for all to use
• the sharing of example agreements that patient groups are comfortable using
• education of legal and compliance teams so they deliver simpler, more penetrable documents
• clarity on scenarios where sanctions could be applied
• transparency by sharing agreements with the wider stakeholder community, where possible, to enable learning 

I am not sure these have been delivered yet or recognised as things the ABPI and PMCPA are willing to do. Therefore, the question that arises now is whether their new proposals will simplify contracting processes and foster greater engagement between industry and patient groups. Personally, I believe more structured support, tools and guidance would be much better. Only time will tell, but these steps do show a positive movement towards industry, patient organisations and patients being able to work together smoothly and effectively—which is especially valuable in the rare disease space.

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