Patient experience in European Medicine Agency (EMA) activities. 

Why did I go to the EMA?

For several years, I was involved in several EMA activities as a patient representative of our patient organisation. I learned a lot and I discovered that the regulatory and healthcare environment was an area that fascinated me very much. I also learned how important it is to bring the patient perspective into this strict environment to make sure that health care decisions and strategies meet the needs of the patients.
When a call for volunteers as patient observers for the PhVWP was launched, I applied because I was convinced that patients’ input in pharmacovigilance activities is a must. Pharmacovigilance decisions impact greatly the patients community and the input of patient observers will make connection between regulatory work and the reality of patients life smoother and make sure that the decisions meet the needs of the patients. Patient involvement also increases transparency of
regulatory/pharmacovigilance activities towards the patient community.

What was expected from me?

Patient observers in the PhVWP take fully part at the monthly (3-day meetings). Moreover, there are conference calls and ad-hoc meetings in which the patient representatives participate.

What kind of involvement was expected from the PO:

•To give the patient perspective in discussions, assessments and actions to be taken (this way connecting the discussions with the reality of the patients life)
•Advice on communication strategy (content of communication, channels, target groups)
•Review of product information (PL, EPAR, SmPC)
•Connection with concerned patient groups for specific advice
•Drafting group on transparency and communication (elaboration on guidelines on risk communication)
•Drafting group on new PV-legislation
•Meetings with external stakeholders
•Involvement in external conferences/workshops, bringing again the patients

How much notice did I get and how did I prepare?

The meetings are scientific and very intensive and for a lay-person, thorough preparation ensures efficient participation.

How did I proceed?

•    EMA was very willing to give us additional trainings and background information whenever we asked for that e.g. EPITT training (European Pharmacovigilance Issue Tracking Tool), training on signal management, medDRA (Medical Dictionary for Drug Regulatory Activities)…
•    As soon as the first agenda for the next meeting came out, I reviewed all the topics (usually more than 30 topics are on the agenda per meeting). I made sure that I became familiar with all medicines and disease conditions and the specific pharmacovigilance concern by searching the medical literature, by communication with concerned EMA-persons, by contacting specific patient organizations,…. As the agenda changes a lot before become definite, this “research” was at times quite challenging but very useful.
•    5 days before the start of the monthly-meeting, the patient observers had a conference call with EMA to go through all the topics of the agenda and we could ask questions for better insight and understanding
•    4 days before the meeting, there was a conference call with the other (scientific) participants of the meeting
•    we were always able to contact EMA with specific questions and a lot of effort was done each time in answering our questions. I often had contact with our PhVWP contact persons to ask for explanations or clarifications.

What was it like? Describe the experience. In which language was it?

In the beginning, the meetings seem very impressive: a very heavy agenda, scientific and medical topics, a meeting room full of scientists, doctors and pharmacists, very long working days…
The language used is always English. Of course the language used is also scientific and medical.

But, I was delighted to see how welcome the patient observers were. Everybody was extremely kind and friendly. Personally, I can say that my remarks and input were really taken into account, were discussed thoroughly and were taken very seriously. That was very rewarding and motivating.
I also saw the impact of the input of the patient representatives:  it influenced communication strategies and the contents of communication. Our chairperson transmitted at several occasions patients’ ideas and input to the CHMP to make sure they took the advice into account. That was a great experience.

Moreover, very soon, the scientific colleagues asked for more input in additional topics like in specific working groups and I was asked to participate in ad-hoc meetings and congresses (by e.g. giving a presentation).

It was really remarkable how “human” this hard work was. Additionally, long lasting friendships were established with several of the scientific colleagues, which is heartwarming and this shows that they really considered the patient observers as full part of the team.
When at the end of my term, I was confronted with some health problems, the emotional support I got from the colleagues was really great: mails, telephone calls, cards…!

Was there any difficulties?

The major challenges for me where:

•    as a patient, you have a lot of experience in your own disease area but during the PhVWP meetings, you have to represent patients from different disease areas. For me personally, the only way to do this well was thorough preparation: to contact the specific patient representatives in the disease area in advance and talk with them, familiarize with their specific situation or difficulties these patients are confronted with, to learn about their disease…
•    at times meetings were very intensive and long. As a cancer patient, fatigue makes part of your daily life and this was at times challenging. After the 3-day meeting, I was quite exhausted and needed some time to recover
•    often the nature of the job asked for some extra work immediately after the meetings in order to follow up your involvement in some of the topics. As a consequence, working days in London could be very long!
•    Monthly 3 day-meetings (plus the additional pre and post work) are time consuming and you need a lot of organization to fit this into your life: your work, your family, your treatment schedules.
•    The scientific and medical “level” of the discussions ask for some individual preparation.

Did I get any feedback?

Feedback was great. As said before, input was taken very seriously and was followed-up. 
I always had a return of my work. I got feedback on specific input I gave, on suggestions I made but also on my general way of working.
A lot of effort was done in this matter and that was really motivating.

Any other thoughts:

My experience at the PhVWP was a very intensive but very useful and rewarding one!

It does ask a lot of motivation, preparation and investment to do the job well. The PhVWP colleagues did their utmost to help you with the preparation (they were great!) but the work still asks for an individual effort to further prepare and be familiar with the work and the topics of the meeting in order to be efficient.
As a Patient Observer, you really have a unique position in this scientific group and your input connects the scientific and regulatory decisions with the reality of the patients.
I personally look back at a very intensive but fruitful, useful and rewarding term as Patient Observer in the PhVWP!


                        Greetje Goossens