Eroding Trust in the Entrusted Patients
Repeatedly we are told that it is essential to involve patients in all aspects of decision-making related to their healthcare: from research on new medicines and devices in the laboratory, to clinical trials, to the registration of medicines and devices, to pricing and reimbursement, to bedside care. Everywhere we read and discuss ‘patient-centric medicine’. However, while our societies have developed formal structures for funding hospitals, health professionals, pharmacies, researchers, research enterprises, and health authorities, we have failed to provide a structured and funded place for patients and their representations. Even ethics committees today are given a defined and funded role in healthcare decision-making. Patients and their organisations are largely left at the door begging for charity.
If we are serious about realising our rhetoric, we will have to revise our structures and practices regarding involving patient representation in health-related decision-making. Patient representation will need to be professional, responsible, and accountable. Its value, which is indeed enormous and necessary, needs to be reflected in a ‘fee for service’ that is budgeted into the cost of developing a research proposal, preparing an HTA costing, or consulting on treatment protocols. Society finds it justified and right that scientists, doctors, and regulatory employees are reimbursed for the real value of their participation in health-related decision-making. This should be no different for patients and their organisations.
Europe should develop Patient Advisory Councils (PACs) that provide an intermediary point between patients and their organisations, on the one hand, and those seeking advice from patients: researchers (academic or industry), competent (regulatory) authorities, HTA authorities, and ethics committees. These PACs should have the role of receiving requests for advice and distributing those requests to the appropriate recognised patient organisation(s). The patient organisation(s) may then provide a non-binding advise to the PAC which is then communicated back to the instance requesting the advice. A fee is paid by the one requesting the advice to the PAC and the PAC pays the patient organisation a fee for providing the advice.
PACs should also be involved with assisting in the establishment and development of patient organisations where needed, in informing and educating patient organisations, and ensuring efficient, cost effective systems for providing advice to those requesting it.
It is all too easy to blame the pharmaceutical and medical device industry for providing funding to patient organisations or to blame patient organisations for accepting such support and/or not disclosing it. However, industry would be wrong to develop medicines without the advice of patients and their organisations, as would academia. And similarly, industry or academia would be wrong to request such advice without financial payment. The fact that an advice was sincerely requested and carefully prepared and provided in exchange for financial support does not necessarily mean that the advice is not the best it could be, that it is not what is required by researchers, competent authorities, and healthcare providers.
Mandeville, et al. have investigated the result of society’s failure to properly join patients at the decision-making table when questions of their health are raised. Their conclusion, however, misses the point: 'Yet if patient perspectives are truly given weight by decision makers, any potential bias must also be taken into account. Although greater involvement of patients in HTA is an encouraging trend, a sign of effective patient involvement would be for patient organisations to be held to disclosure standards as robust as those for committee members.' ‘Potential bias’ is not the major concern. This in potentia somehow suggests patients might be biased against their own best health interests. The real challenge is to give patients a structured, defined, responsible, and, yes, paid seat at the table of decision-making. Patient Advisory Councils are the future.
Competing interests: Francis P. Crawley has been instrumental in founding patient organisations; building consortia of patient organisations; developing both research and treatment protocols in cooperation with patients and their doctors as well as at times with industry; developing patient integration into ethics committees, health research, and health policy-making in Europe and globally. This response is partially based on a presentation first provided by the GCPA & SIDCER to an EMA Meeting on Paediatric Patient Advisory Groups and Ethics Committees, London, 11 October 2017.