Why we need regulations, where they come from and how they are interpreted

Regulatory frameworks governing interactions between pharmaceutical companies and HCPs were developed in response to past conflicts of interest and have played a critical role in protecting patients, maintaining public trust and safeguarding scientific integrity. These protections remain essential and were designed to accommodate existing bilateral relationships between industry, academia and HCPs. Critically, current frameworks may not accommodate PWLE involvement in discussions. The challenge is to ensure that regulation continues to serve the public interest while also enabling early-stage, non-promotional collaboration focused on unmet need and responsible innovation. These are conversations that PWLE are well placed to shape, support and guide.

In the UK, interactions between pharmaceutical companies and HCPs are governed by Association of the British Pharmaceutical Industry guidance. For international meetings, additional national guidance applies, with organisations typically defaulting to the most conservative interpretation where requirements differ. In the case of our proposed meeting, two country frameworks applied. Ambiguities in guidance, combined with differing internal interpretations, led to increased risk perception and delays despite the absence of promotional intent. The regulatory complexity posed a particular challenge for meaningful involvement of PWLE, especially if they had no organisational affiliation and lacked institutional support to engage with contractual requirements.

In practice, regulatory complexity does not arise solely from differences between national codes. Companies must also interpret how those rules apply to specific situations, and internal compliance teams may reasonably reach different conclusions about the same guidance. This variability can create uncertainty even when all parties are acting in good faith and attempting to remain within established ethical boundaries.

Problems arising by design and in operationalisation of existing regulations

Specific constraints included limits on meeting size and requirements that company staff be fewer in number than external participants. Although defensible from a compliance perspective, these constraints restrict inclusive, multidisciplinary discussion. Such restrictions are particularly challenging in mental health research where effective dialogue often requires participation from clinicians, PWLE, methodologists and social scientists. Practical requirements may include explicit justification of every participant, clear documentation of the unique contribution that each attendee is expected to make and alignment of those roles with a pre-approved agenda. In some cases, industry representatives cannot outnumber external participants, and any additional company attendees must be formally justified or remain passive observers who are unable to participate in discussion. Although these safeguards support transparency, they can make inclusive, multidisciplinary dialogue harder to organise.

Current compliance frameworks appear to be optimised for advisory board-style engagement, where industry seeks defined expert input that is not already available internally. By contrast, early-stage scientific exchange that is characterised by exploratory, ‘blue-sky’ thinking may not fit easily into existing models.

In some circumstances, financial support cannot be provided unless a project has clearly defined deliverables, milestones and contractual expectations. As a result, exploratory in-person meetings may become difficult to support, even when these are explicitly non-promotional and focused on unmet patient need. When participants include HCPs who prescribe medications, additional safeguards apply to prevent perceived influence on prescribing behaviour. This can narrow discussions to tightly defined, transactional engagements.

Paradoxically, explicit consultancy on named compounds may be permitted while broader, pre-competitive discussions about unmet need or the desired characteristics of future treatments may be discouraged, despite being patient-centred and non-promotional. In our experience the co-presence of PWLE and prescribers was treated as a potential risk, based on concerns about indirect pressure on prescribing. This approach does not fully reflect contemporary mental health research practice, where PWLE involvement is widely regarded as an ethical and scientific necessity rather than a source of undue influence.

Within companies, PWLE and HCP engagements are frequently managed through separate contractual and compliance processes, requiring extensive internal review; this increases administrative burden and slows collaboration. Additional complexity arises because different engagement models (sponsorship of educational events, independent research funding and formal collaborative agreements) each carry distinct governance requirements and differing levels of permissible industry involvement. This can make it challenging for academic partners to understand which route is most appropriate at the early stages of idea development. Relocating meetings to a single country does not necessarily resolve these issues, because similar approval processes and timelines often apply.

These challenges may be particularly significant for PWLE who participate independently rather than through an institution. Unlike academic and clinical participants, PWLE may lack organisational support for contracting, indemnity and payment. Requirements for predefined roles may also sit uneasily with meaningful co-production. Accessibility needs, meeting logistics and involvement after key decisions have been taken may further limit effective participation.

Online meetings hosted by academic institutions may sometimes represent the only feasible and compliant route for early-stage dialogue, particularly where regulations prevent financial support for exploratory in-person interactions. This approach allows dialogue and scientific exchange to continue, but it does not fully substitute for the trust, nuance and creative collaboration that often emerge during face-to-face meetings and may limit inclusivity. Reliance on these compromises highlights the need for clearer, proportionate frameworks rather than procedural circumvention.

Towards proportionate frameworks for collaboration

Although the underlying regulatory principles remain essential, our experience suggests that existing frameworks may prioritise risk avoidance over facilitation of early-stage, non-promotional collaboration. This may disproportionately affect mental health research, where multidisciplinary exchange and PWLE involvement are central, and may reduce opportunities for companies to address patient need. Importantly, many of these constraints arise from compliance systems designed to prevent inappropriate influence on clinical decision-making. This objective remains essential. The challenge is not the existence of regulation itself but ensuring that frameworks are proportionate to the different types of collaboration now required in modern, multidisciplinary mental health research.

Robust regulation is indispensable to protect patients, maintain public trust and prevent conflicts of interest. However, regulation must also evolve to reflect contemporary research practice and the urgent need for more effective and better-tolerated mental health treatments.

This is a timely opportunity to develop a flexible framework for industry, people with lived experience, HCPs and academia to work together towards common goals that deliver tangible benefits to people with severe mental illness. Refining existing frameworks to enable responsible, transparent collaboration without compromising public safety or trust will be critical to translating scientific advances into meaningful benefits for people living with mental illness.

Despite these many challenges, the meeting was finally able to proceed with all parties represented. The event was valuable both to the company and the participating PWLE, who have subsequently engaged in follow-up meetings. The company’s interest in further meetings focused specifically on lived experience illustrates the value that can be placed on PWLE perspectives in the development of future therapies. PWLE representatives within the Mental Health Platform are keen to work with industry in pursuit of more effective and better-tolerated treatments. We should therefore seek to enable the ethical involvement of PWLE in industry collaborations and develop proportionate approaches that are fit for purpose.