Why does EUPATI matter? The panel was formed by Róisín Adams from Ireland’s National Centre for Pharmacoeconomics, Simon Denegri, chair of the United Kingdom’s INVOLVE project, Cordula Landgraf from Swissmedic, and Birka Lehmann from BfArM, Germany’s Medicines Agency. Chairing was shared between representatives of patients and industry, Anders Olausen from the European Patients’ Forum, Belgium, and Kay Warner from GlaxoSmithKline, United Kingdom.
The representatives of government agencies were looking forward to greater involvement from patients. “It’s really good that we will have a little army of 100 people who are really informed,” said Adams from the health technology assessment side. “We want to involve patients, so they need to know what the whole R&D and registration process is all about,” said Landgraf – and she, too, is eager to see the EUPATI Toolbox. From Germany, Lehmann said it was “brilliant” to have patients in all areas, and she hoped the EUPATI students would become “multipliers” in the other Member States.
“The more people who are involved in research, the healthier all of our nations will be,” said Denegri. “EUPATI is a very good start and a potentially very important vision.” But he then borrowed the language of marketing to say that EUPATI needs to crystallise three areas: the learning and development agenda; working across nations; and the linkage with industry. “[Industry] is where we really need to build bridges,” he said. “I absolutely accept the difficulties in some nations, but we cannot stand on opposite sides of the river and point fingers at each other.”
Over to you
Davies then put the panel on the spot, asking what steps they would take to make patient involvement a reality in their own country. “We are moving as quickly as we can,” said Adams. It’s not easy fitting patients into a process that wasn’t patient-centric to begin with, but she pointed to the need for a broader acknowledgement of the core values patients want in every decision – that would make it easier to measure how well patient involvement is working. She also called for support for patients wishing to initiate research themselves. Another important step would be implementing the idea of patient key opinion leaders. (Later in the discussion, she added that she saw an important role for expert patients in research, “so if patients do want to collect data they know what to collect and how to collect it.”)
Denegri seemed less enthusiastic about the key leaders idea. “Leadership is very important, but it’s a heavily loaded term – as is ‘expert’,” he said. Even in the UK, with government funding and established ways of involving patients and the public, there is still much to learn and to do. “We need to make patient involvement more visible and help patients see how they can contribute to healthcare as part of their [own] care pathway,” he said. “I am all in favour of spreading expertise, but I want contributions from many people at all levels.” He added that we need to move from seeing public involvement as enabling individuals to contribute to enabling communities and regions to contribute. “That won’t happen through a few highly specialised individuals.”
That elicited a response from expert student Russell Wheeler. He pronounced himself a little confused: “There seems almost a suggestion that the EUPATI project is training people who aren’t needed.” Along the same lines, he had heard much talk in regulatory circles of the importance of the “naïve” patient. On the other hand, “It seems EUPATI is trying to remove the naïve patient, which I applaud,” he said, adding that in wanting “naïve” patients, the European Medicines Agency (EMA)is looking for patients “who don’t ask difficult questions”.
Denegri came straight back. “We get ourselves into unnecessary tangles when we talk about professional patients and naïve patients,” he said. And he clarified his comments about “a few highly specialised individuals” by saying: “I applaud what EUPATI has done in building up a broad cadre of people like you, but for sustainability it’s about how it can support you to spread the message among others.”
Adams also responded, seeing an important role for expert patients in research, “so if patients do want to collect data they know what to collect and how to collect it.”
From Switzerland, Landgraf said the most important challenge at the moment is raising awareness of EUPATI. The team there are working on a “concept paper” to establish “a clear vision of what we want to do with the EUPATI National Network”. Once it is written, they want to take the concept paper out to the general public and use it to get involvement and funding.
Lehmann’s institute already involves patients in two of its national committees, and has reached out to several patient organisations in a move to increase transparency and improve communications. But things are clearly at an early stage. “We don’t know how patients want to contribute to our ideas – we will see how it works,” she said. “We have to think about how we can work with EUPATI, from the point of view of a federal institute.” She noted that patient involvement in marketing authorisation is already established at the level of the EMA. Rather than duplicate that, she talked about having “a bridge to the national level”.
What about the professionals?
Olauson then threw the discussion out to the workshop as a whole. First in was Pedro Montellano, one of the expert students. Patients want to be involved, he said, but what about the professionals? What has to be done to convince them?
It was an interesting question, and received quite varied answers. Adams was on the positive side. A recent workshop her organisation had run had on how to make decisions in healthcare had found that those of patients and patient representatives were “spot on”, and probably more sensible than those of the professionals. “I don’t need to be convinced. I am, and most people in my organisation are convinced,” she said. Lehmann has seen more and more involvement from patients in the advice given to companies and researchers. “I get the impression that researchers are taking more notice of patient input – especially in rare diseases,” she said.
A different view came from Landgraf: “In Swissmedic we have a lot of professional personnel. From experience I can say it is not always easy to convince them that there are other stakeholders who have a stake.” Change can happen, she said, but it takes time.
Professional boundaries and systems are indeed hard to shift, said Denegri, but they are having to shift – because they can’t meet the health challenges without involving patients. “There is a recognition that it has to be done,” he said. He talked about the “classic carrot and stick” approach, where younger people thinking about a research career know they have to embrace public involvement.
How can EUPATI help?
Warner turned the discussion to what EUPATI could do to support government institutions in their goal of patient involvement. Once again, the responses from the panel were varied.
Adams took a top-down approach: “It’s about mobilising and supporting a pan-European project that would look at core values and then drill down into individual countries,” she said.
Denegri stressed first how important it was for EUPATI to publish the educational material it is preparing, in particular the EUPATI Toolbox: “Get them out there. People need to see the product. Get it out as soon as possible.” He also called on EUPATI to help the UK build links with other countries (“we have a lot to learn”). And he asked EUPATI to support people in building bridges with industry. “Frankly, I’m a little tired of beating up industry. We all know [negative] things that have happened, but for the sake of patients and families we have to get things to a better place.”
In the short term, said Landgraf, EUPATI should support national teams to exchange information and expertise, as well as act as a coordinator for media enquiries received at a national level. “EUPATI should speak as one voice, with consistent answers,” she said. In the long term, she looked to “a smooth transition” after 2017, when IMI funding ends, with “people like Jan Geissler and Ingrid Klingmann still around.”
Germany is less far down the National Network road than Switzerland, and Lehmann wanted to see the EUPATI concept distributed to all Member States so that patients could begin to speak the same language about medicines development and clinical trials.
Conflict of interest?
Irmi Gallmeier of F. Hoffmann-La Roche, Switzerland, was impressed by the spirit of the expert students and looking forward to having “all these wonderful people” and – like many – to having the toolbox. But then she raised a problem for industry: if we involve patients in trials, those patients will not be able to take part in advisory boards in the authorities, due to conflicts of interest.
It seems as though different countries, and the EMA as a whole, have different ways of coping with such conflicts. Lehmann said such declarations were “a very important tool for scientific bodies” at the EU level. “The only option at the moment is to have more people trained, so some can go to industry and some to the EMA.” But, she added, that would take time.
With a typical UK view, Denegri took a practical approach. “There are conflicts all the time. The important thing is that they are declared, known and can be managed both inside and outside the committee room.”
“We have the same problem with healthcare professionals,” said Landgraf, noting that in rare diseases it is very hard to find experts who don’t have an interest in some form. “The solution is a ‘smart’ declaration of interest,” she said.
Go forth and multiply
EUPATI’s aim is to educate people in medicines development – not just to have experts in committees but also an educated broader population. “We hope some of our students will take up this role,” said Ingrid Klingmann. Would that make the panel’s work easier? Absolutely, said Denegri. But he added a note of caution: it’s one thing to do the training, quite another to perform in the outside world. “You need to support people really well, give them a defined area to work in. We have a few patient ambassadors who work within a hospital, not across a whole nation.” Make the task more manageable and achievable, he said.
“We do need the trained experts to be involved at the high level,” said Landgraf, “but there are so many demands for patients to be involved at all levels.” And, she added, perhaps a more naïve patient would be better when it comes to looking at the patient information leaflet. But she had a problem with the word “patient”. “We are all patients – we have to talk about people.” Anybody, of any age or ethnicity, with or without a condition, should be able to participate in research right across the world, she said. “We need the experts to feed [their knowledge] down in bite-sized pieces.”
Olausen concluded the session on a note of optimism. “We have been knocking on the door for years…Now the door is open – and it’s very complex,” he said. “What I have learned is very good. The regulators are changing, saying they want to change, to play with us, to build bridges. I think this is great!”