Regulators cite need to involve diverse patient groups in decision making

A recent survey issued by the European Patients’ Academy on Therapeutic Innovation (EUPATI) found that the level of patient input in regulatory decision making varies among EU member states in authorizing new medicines and designing clinical protocols, with some authorities reporting a higher level of patient engagement than others.

Regulators who participated on a 13 March panel at DIA Europe in Brussels applauded the study and said it’s a good first step in understanding the level and extent of patient involvement. However, they said more work is needed to involve more patients in regulatory decision making, and to recruit more diverse patients. They also stressed the necessity of patient training.

The study focused on the level of interaction between patients and European National Competent Authorities (NCAs). The study was also done in collaboration with the European Medicines Agency (EMA) and was conducted from February 2023 to February 2024.

Thirteen of 27 Member States participated in the survey, including Austria, the Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Latvia Malta, the Netherlands, Sweden and Slovenia. Switzerland and the United Kingdom also participated.

David Haerry, co-chair of the European Patients' Academy on Therapeutic Innovation (EUPATI) presented the study. It showed that of the 15 respondents, 11 reported engaging with patients involving regulatory actions, and four said they did not. In terms of the types of regulatory activities, two said they involve patients in disseminating scientific advice, five said they involve patients in designing clinical trial protocols, and five said they involve patients in marketing authorization decisions.

Most of the respondents, eight, do not compensate patients for their engagement with 10 saying they do not pay honorariums.

More work is needed

Regulators signaled their support for the survey, and said it is a good first step in understanding and quantifying patient input in regulatory decision making.

Sinead Curran, director of human products monitoring for Ireland’s Health Products Regulatory Agency (HPRA) said, “HPRA really welcomes the opportunity to participate in a survey like this” She added that “my view of this survey is that this is really important and a developing area.”

Her takeaway from the survey is “there is a broad level and a variety of patient interactions. We will start there. I see that as real progress.” Another takeaway is the varied level of patient interactions. “I think that it is interesting to try to understand what is driving those type of interactions in the national context and why some Members States will be involving patients in different activities.”

Lars Bo Nielson, director general of the Danish Medicines Agency (DKMA), said, “I think it is an extremely interesting survey. It is positive, but I wonder about those who have not participated and whether this means there is no patient involvement.”

He said that in Denmark, there are laws that mandate that patients have a seat at the table and are involved in setting regulatory policy.

Richard Ballerand, a patient advocate for UK’s National Institute for Health and Care Excellence (NICE), said “the results are what you might hope, one can be quite upset, or you may think this is the first step… Things are improving, and my own perspective what I see within the United Kingdom is that within different organizations there are different levels of involvement.”

Ballerand said that “what this paper started is the discussion that patient organizations have to communicate with each other to find out what isn’t done in their countries and what can be done. People are not very well aware.”

He added, however, that it is important to train patients in these engagement activities. “You may bring someone to the table but if they have no background, they can’t necessarily provide us much input.”

Ballerand also added that it is important to pay patients for their involvement, “MHRA is now providing honorariums to people. For some people this may not matter, if you are retired or a middle-class lawyer it may not be as relevant, but for young families, he said “this could be important.”

More diversity needed

Haerry said that two of the learnings from developing patient engagement programs is that it takes a long time to set them up. It took his group four years to set up such a program at Swissmedic. Another learning is that these groups need to be more diverse.

“One of the things that struck me is that the people that I see at some of these meetings are white and middle class and they can afford to go to these meetings. All of the others are missing. I often thought, ‘How can we overcome this barrier?’” Haerry said.

The other panelists said that work is ongoing in their countries to recruit more diverse patient pools.

DIA Europe

Regulators cite need to involve diverse patient groups in decision making

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