By NextLevel Life Sciences - June 19, 2018

Leading up to NextLevel Life Science’s 10th Edition MedAffairs Leaders Forum Europe (Autumn) 2018, we are conducting interviews with selected members of our prestigious speaker panel to learn more about their thoughts on this vital issue.

*Opinions below are those only of the individual and do not reflect upon corporate strategy or positioning.

For more information regarding NextLevel Life Science’s 10th Edition MedAffairs Leaders Forum Europe (Autumn) 2018 click here!

David Haerry, Patient Advocate, European AIDS Treatment Group (EATG)

NextLevel: How would you describe the work that you do at the EATG?

DH: I am part of the European AIDS Treatment Group (EATG) where I have worked in the past few years on the “European Patients’ Academy on Therapeutic Innovation - Innovative Medicines Initiative” (EUPATI-IMI) project. The EUPATI-IMI project is concerned with training patients for being engaged effectively in drug development related processes. I was co-chairing the “Futures and Sustainability Work Package” there. The project continues under the umbrella of the European Patients’ Forum (EPF). I am currently co-chairing the “EUPATI Futures Group” of the project which is again looking at sustainability issues.

NextLevel: Is the EUPATI-IMI project still running?

DH: The IMI project has been over since February 2017 and we are now in a transitional phase. We expect additional funding coming from IMI soon in September 2018. We will have another two years to complete certain work that is not done yet, especially in terms of sustainability in the future to continue the project. Currently, it is unclear how the project can be sustained in the long-term, but that’s what the “Futures Group” I am involved in is working on now.

NextLevel: What is the role of the “EUPATI Futures Group”?

DH: The “Futures Group” is an advisory group to the EUPATI Consortium as it is now. The EUPATI Consortium now consists of most of the partners who were involved in EUPATI-IMI. That brings us to the topic I am going to talk about at the Medical Affairs meeting in Zürich, because what my work package produced in the IMI project was a set of guidances about how stakeholders should interact with patients and on patient-centricity. That was a major output of our group.

NextLevel: Can you briefly describe what the “EUPATI-IMI Guidances” are about?

DH: The guidances are published on the internet ( A publication in a journal is coming along soon as well. The guidances basically set the framework. What is crucial, however, beyond the guidances is their implementation. Everyone is aware that this is an issue and the EUPATI Consortium gives the framework where people can start working to begin a successful implementation.

There are four sets of guidances: first, for patient organizations and regulatory bodies; second, for patient organizations and HTA bodies; third, for patient organizations and ethics; and fourth, for patient organizations and industry on drug development. In the guidance we inform people about the drug lifecycle from basic research to approval and post-approval and about the areas where interaction with patients is possible or should happen. The guidance is about telling people what they should work on because that is what is needed.

We have a lot of experience from the HIV movement going into this guidance and that is where I am coming from. We have already established this type of interaction with patients in HIV since the 1990s, so almost 30 years ago. Such interactions have also started in other indications. I would like to mention at least some rare disease and cancer organizations which are very good and have initiated this type of interaction. Others will surely follow.

NextLevel: What is the main takeaway that pharma can learn from these successful interactions with patients?

DH: The main takeaway is that you need top management endorsement. If you don’t have top management endorsement then one department will start doing something, but another department will do something else and that means they are not following the same protocols. This is often the case when the companies are very large.

I can give one example. We saw a good relationship where a big pharma company was interacting with our HIV group for many years. When the current Hepatitic C drugs came along we wanted to have the same kind of exchange with their Hepatitis C team. We realized, however, that this was not possible because the company’s hepatitis C team did not have the experience about how to interact with us. The quick fix was that the HIV team from the company was guiding the hepatitis C team on how the interaction should be done.

The real solution is that there should be a policy in companies guiding people about what to do and how, which is endorsed by top management. If you don’t have top management endorsement, you run into all kinds of problems and the interaction won’t necessarily go well. When you run into troubles you need somebody in the company to talk to. Without top management endorsement, everybody involved is on a bumpy road. This puts the interaction at risk and finding solutions will not be easy.

Another issue is interacting with the legal and compliance departments. Legal and compliance teams need to know what is done in patient engagement and why it is done. My experience is that legal and compliance has a huge issue when they don’t understand what is going on. They really need to get to the table with the patients and with the medical team on the company side and understand what they do and why. Without this understanding, they will come up with poorly made rules turning a constructive interaction into a nightmare. This is why you need top management endorsement. Otherwise, you don’t get far.

NextLevel: How do you find the interaction with medical affairs teams, is that part of the “EUPATI-IMI Guidances”?

DH: The interaction with medical affairs is part of the framework. Medical affairs are not difficult to convince. When we started EUPATI-IMI there was a mixed interest from the medical affairs departments in different companies. The interest ranged from a lot of excitement, to curiosity, and even some hesitation about how this could work.

Due to the consortium we had the opportunity to meet with people and have meetings during the project with all the companies involved, the medical people, the patient organizations, and the regulators. This has proven to be very helpful, because people could talk to each other and learn from each other. There needs to be a place where they can exchange information about practices, about models which are not working, and about the good and bad experiences. The bad experiences are as important as the good ones.  People are reluctant to talk about the bad experiences in public and so they need a safe space where this can be done. We have this safe space within the consortium which was extremely helpful.

People need to understand what the challenges are on the industry side and also on the patient organization side. Some patient organizations think that they have a right to be at the table. That’s where their entire motivation is coming from, but I think that while they have a right, this comes with a responsibility. They have to be very clear on what their priorities in drug development are from their perspective. The same kind of preparedness has to exist on the industry side also, meaning that industry needs to know what their priorities are. Once they know about that they should meet with the patient organization they want to work with and see where the common interests are.

There will always be a divergence and they won’t always have the same priorities. There is some overlapping, maybe around 15-25%. If you have that overlap, then you should start working on it. So, know what the interests of the other are and respect that there are differences. I think that’s key before you start working. As you collaborate you need to assess your collaboration every year and exchange your assessment results with the other party. Of course, patients need to have the appropriate training otherwise the interaction is not possible, which is what the entire EUPATI-IMI consortium was about - producing the training material that is necessary for people to engage in these discussions.

NextLevel: What are you looking forward to most about our event in Zürich?

DH: I am looking forward to seeing a lot of people who have questions about patient engagement and hopefully be able to respond to these questions. Everybody talks about patient-centricity, but I have seen few organizations and companies really having it properly implemented and having an established good practice over a couple of years. We are still at an early stage.

For more information about this MedAffairs Leaders Forum Europe (Autumn) please click here!