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[EPF Congress 2019] Interview with June Raine: “We have so much to gain from the Congress and to contribute to its outputs”

This month, we asked Dr June Raine – Director of Vigilance and Risk Management of Medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and one of the ambassadors of the event, a few questions on what to expect from the Congress.

  • What made you agree to become Ambassador to our Congress?

I’m very excited and greatly honoured to be invited by the European Patients’ Forum to become an Ambassador to this landmark Congress. Today in 2019, the patient’s role in driving better health in Europe is at a particularly critical timepoint. The journey has clearly begun but there is still a long way to go before the potential for patient involvement to drive better health in Europe is fully realised. This Congress will, I believe, be a key milestone on that journey, and an opportunity to create a roadmap to the future to deliver the change we want to see. 

Let me tell you a bit more about my thinking. I had the privilege of working over six years with EPF President Marco Greco as we strove to optimise patient involvement in decisions on medicines safety in Europe via the new EMA Committee, the Pharmacovigilance Risk Assessment Committee. In learning about EPF, I was hugely impressed not only with the ambition of EPF to make a difference for patient involvement but by its strategic importance. The EPF occupies a unique position as the only European-level cross-disease patient organisation, linking patient communities across the Union with EU developments in policy and practice.

"Becoming an Ambassador to the Congress offers an unprecedented opportunity to influence and to help achieve the aims and objectives of the EPF for meaningful patient involvement"

So for me, becoming an Ambassador to the Congress offers an unprecedented opportunity to influence and to help achieve the aims and objectives of the EPF for meaningful patient involvement. This includes the twin goals, both of patient-centred development of new medicines and technologies throughout their lifecycle, and of transforming health services to truly embody the principle of ‘no decision about me without me’.

  • Why, in your view, is patient involvement in healthcare a necessity (rather than a “nice to have”)?  

Even the need to ask this question at all is proof that there still exists an element of ‘tokenism’ in healthcare when it comes to patient involvement! There are some sound policy, ethical and moral arguments in favour of patient ‘centricity’ in healthcare. I recall hearing of a notice someone had pinned on a hospital wall to remind the healthcare staff of this, saying ‘Patients are the reason for this organisation, not an interruption to it’.

"The best way to address those who question the necessity of patient involvement is with evidence"

I believe that the best way to address those who question the necessity of patient involvement in healthcare is with evidence. The good news is that there is robust evidence that patients who are empowered and ‘expert’ in their own care achieve better health outcomes, which surely must convince all those who need convincing. This is particularly relevant now that we are in an era of long-term medical conditions and planning for the needs of an ageing population.

But we will need to go further, and this is where the EPF Congress has a key role to play in accepting the challenge of demonstrating the value of patient involvement in healthcare. From my experience in medicines regulation, I have been convinced of the added value of patient involvement in interpreting the evidence and shaping decisions on proportionate risk management. Now healthcare needs to do the same.

  • How have you seen patient involvement evolving in medicines regulation, and where are there still gaps?

Great question! There’s a lot to say on this! The evolution of patient involvement in medicines regulation has been a slow process, starting with the realisation that patients contribute vital information to monitoring safety and detecting signals of harm associated with medicines and medical devices in clinical use. The first step came around two decades ago when the first patient reporting schemes were introduced in EU. Now, in the UK at least, patient reports of suspected adverse drug reactions exceed those from GPs.

"We are now in the era of patient involvement in regulatory decision-making"

Then came the focus of regulators on ensuring patient receive full and comprehensible information with their medicines, to support safe use. This has proved to be surprisingly difficult, partly because of the challenge of marrying completeness with comprehensibility. Even though the need has been recognised to involve patients in designing information which meets their needs, we still have a long way to go to fully address the shortcomings of patient information leaflets.

We are now in the era of patient involvement in regulatory decision-making. The constitution of the EU safety committee, the PRAC, has embodied this principle, as a result of the European Commission’s determination to appoint patient representatives who are full voting members of the committee. We now have direct experience of the importance of listening and acting upon the patient voice via the EMA’s public hearings.

Where are the gaps in patient involvement in regulation now? In terms of safety surveillance, there is work still to be done on involving patients more fully in the design of risk management measures and monitoring their effectiveness so that the health protection outcomes are acceptable from the patient perspective. The best example of patient involvement in design and monitoring of risk minimisation measures is valproate risks in pregnancy, where patient groups from the UK, Belgium, France and Ireland have been very active in advancing better health for women and their babies.

"The Congress will be an inspiring opportunity and a unique experience to really drive better healthcare decisions – so all patients benefit"

In terms of development of new medicines and medical devices, despite the growing use of patient reported outcomes, there is still a gap in terms of systematic patient involvement in benefit risk decisions. Let me emphasise here and now that we are determined to close these gaps, and I’m confident that the Congress will be an inspiring opportunity and a unique experience to really drive better healthcare decisions – so all patients benefit.

  • What could other “parts” of the health system learn from these experiences [in regulation]?  

The story of patient involvement in medicines regulation has revealed on the way a fragmented picture across Europe, and I suspect that other ‘parts’ of the health system show a similarly variable picture. The central challenge for all aspects of healthcare is delivering meaningful patient involvement to enhance patient experience and outcomes. What constitutes good practice in patient involvement will be based on mutual learnings and cross-fertilisation of ideas. A common framework for patient involvement and principles for best practice would be a great outcome for the Congress.

"The central challenge is delivering meaningful patient involvement to enhance patient experience and outcomes"

  • Who do you think should attend the event, and why?

Where shall I begin? My list of those who should attend the Congress is a long one since all stakeholders have something to learn on patient involvement, much to gain from attending the Congress, and a contribution to make to its outputs. At the centre of several ‘concentric circles’ are patients and the public - no decision about me without me! Then a circle of all those health professionals responsible for delivery of individual patient care. The next circle relates to those with organisational responsibilities for healthcare delivery and policy, then there is a final circle of regulators and policy makers responsible for population level decision-making. The most important criteria are that all should come with an open mind and all should be willing to contribute to this unique opportunity.

"All stakeholders have something to learn on patient involvement. Patients in the EU deserve nothing less"Why should they attend the Congress? In a nutshell, to create together the standards and best practices for the involvement of patients that realise fully the potential to optimise healthcare at both individual and organisational level. Patients in the EU deserve nothing less.

EPF Congress 2019

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