by Gerlind Bode, ICCCPO advisor
For a three-year term Gerlind Bode (Germany) was a patient delegate at the Pediatric Committee (PDCO) of the European Medicine Agency. Here a personal summary of her term:
Shortly after I had started retirement from my job as CEO of the German Childhood Cancer Foundation, the ICCCPO office suggested: “You have time now – why don’t you represent us at the EMA (European Medicines Agency)?” ICCCPO had been invited to apply for a seat of a patient representative in the Paediatric Committee (PDCO) which is responsible for approving all medicines intended for the use in children within Europe.
This was easier said than done, even though there was a very high interest on my part and at that time, I was not yet so heavily involved in other chores (which seem to come automatically when you are retired!). And I could not foresee how much time consuming this job would be: a three-day meeting every month and lots of papers to read (and understand!). I was appointed as an alternate delegate, which means I would only have to attend the monthly meetings, when the member-delegate could not. But as it happened, early on in this three year term, the number one in line had to give up due to professional obligations that did not permit him to get involved more in this voluntary exercise. So, it was my turn.
The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The Paediatric Committee (PDCO) deals only with drugs for children. It is composed of one member and one alternate appointed by each European Union (EU), five members of the EMA-committee for Medicinal Products for Human Use (CHMP) with their alternates. Three members and alternates represent healthcare professionals (from any EU-country) and three members and alternates represent patient associations. Our input is that of a kind of ‘watch dog’ on behalf of the patients. But in order to apply ‘common sense’ one must be able to understand what is presented and discussed in a very scientific medical language with all those unknown administrative terms of this European agency. At least this was hard for me as I seem to have been the only person with a non-medical or pharmacological background. So, I had to learn the meaning of terms within this setting like: mechanism of action, extrapolation, modification, deferral, waiver, class waiver etc., while many of the freely used abbreviations still remain a puzzle.
Over all, it has been a very interesting and stimulating time – and at the same time a bit frustrating (mainly because there is very little demand for patient-input as most of the procedures are well structured and always keep the interest and well-being of children in their different developmental stages in focus). Sometimes we can contribute from our experiences of the patient reality. But only a minority of the drugs developed is meant for the use in paediatric oncology, where my background would have been helpful. What do I know about allergies or viral diseases, let alone vaccinations? Admirable is the so called ‘formulation-group’ within the delegates which keeps a very close eye on child- and (often specifically) age-adapted formulations of the different compounds. And very interesting are the insights into activities of the agency in general which give a glimpse into its full scope of operational duties. In that context specifically memorable was the presentation of a UK-based group which involves children/teenagers as advisers in the design of clinical studies for children.
At the end of these three years, I am grateful for this opportunity to look into the mechanisms of this European agency which after all, has great importance for us all.