Patient involvement in regulation: an unvalued imperative
There is now an imperative for medical regulators to involve patients and the public across the range of their work, in the same way as it has become accepted practice to involve patients in decisions about their medical care, as part of mainstream existentialist philosophy.
However, patient involvement remains largely unvalued for its influence on decision making about approval of medicines and medical devices, or their withdrawal from use because of safety signals. Regulatory agencies worldwide are grappling with the range and complexity of ways in which patients and the public might be involved in regulation, but they also need to evaluate the outcomes of their efforts.
In the UK, a government-level report about the health-care system’s response to safety concerns emphasised the need to engage with patients throughout the regulatory lifecycle of medicinal products.
In the USA, the Food and Drugs Administration has made patient engagement a priority. Such engagement includes patient input to guide clinical trial design during product development, decisions about market approval, provision of information about the effects of products (especially adverse events), and decisions about whether safety signals justify restrictive action.
Engagement of patients can be in advisory or decision making groups, which enables them both to relate their experiences and to proffer their opinions.
The COVID-19 pandemic has transformed the ways committee meetings, focus groups, and other discussion forums typically take place: video links make it much easier for people to become involved. Training and support remain essential to help lay people join groups of professionals in discussion on an equal footing.
In a wider context, patients’ experiences can contribute to regulation through their reporting of adverse events and especially through patient reported outcomes.
Rapid advances in mobile technologies are facilitating this reporting to an extent that could not have been imagined a few years ago.
It could be argued that involving patients and the public in regulatory decision making is a valid endpoint or outcome in itself, and that, without further examination, it is a good and proper thing to do. However, such involvement will be influential in deciding which health-care interventions society receives, so it ought to be subject to evidence-based evaluation of its benefits (and possible harms). This is a challenge because it means evaluating what specific contributions of patients sway decisions, and how.
Different regulators are at different stages in developing strategies and methods of patient engagement, which are more advanced in some areas (eg, anticancer medicines) than in others.
Embedding patients’ chosen methods of engagement into the regulatory process for philosophical and political reasons without assessing their effect (and, importantly, whether it could be done better) would leave their patient engagement unvalued. Regulators publishing their experiences in well described reports will help establish best possible practice for the good of both patients and society in general. It will also guide other regulators globally and will enhance the reputations of regulators with regard to thoughtful engagement with patients and the public.
Source: Lancet