The patient is one of the most important partners for the Federal Agency for Medicines and Health Products (FAMHP). In response to this, two symposia have already been organized regarding working with and for the patient.
A first symposium was organized by the FAMHP in 2017 on “patient centricity”. There the focus was on the importance of clinical trials with and for the patient, and the various initiatives to involve the patients more in this process. One year later, on September 25, 2018, a follow-up symposium was organized, in which we put the focus more on our new trial projects regarding cooperation with disease-specific patient organizations.
September 25, 2018, a short overview
On September 25, 2018, the administrator-general of the FAMHP provided a short overview of the various initiatives within Europe during the welcome speech, such as patient representation within the EMA (the European Medicines Agency) and ERNs (European reference networks). There were approximately 200 participants from the various sectors involved, with a large representation from patient organizations and ethics committees.
In the main presentation, the Dutch landscape on the level of the involvement of the patient in the development of medicines was presented by Annemiek van Rensen. Ms. van Rensen works in the Netherlands within the independent network organization for patient and client organizations (PGO support) and has been a member of the patient and consumer perspective of the college on drug assessment (CBG) since October 2015. In her presentation, she focused on the importance of the involvement of the patient as a function of the participation ladder in various regulatory procedures and the impact these can have on the patient (representative).
At the symposium the work provided by patient representatives within ERNs was also put forward. These European networks promote the cooperation between academics, doctors and patient representatives within the domain of various rare diseases. 3 witnesses were heard who showed the various aspects and possible realizations of ERNs.
Also the role of the patient within the FAMHP was discussed and the initiatives undertaken to involve the patient more and to give them a voice from their perspective. The experiences within the agency and the commission for drugs for human use were presented. Representation within this organ allows patient organizations to understand more into what is necessary to bring a drug to market and which evaluations are performed within the agency to weigh the benefits and risks for a certain drug from development until it is on the market.
New initiatives within the FAMHP were also highlighted, such as the database for clinical trials, the information campaign on clinical studies and the test project started for the involvement of disease-specific organization in the assessment of requests for scientific advice for clinical studies. The two organizations that already took part in this project shared their experience. The patient is involved in this at a very early age of the development of a drug to have the greatest possible impact.
During the symposium, other involved partners shared their experiences on the subject of “keeping the patient central”. There were presentations by representatives from ethics committees, the pharmaceutical industry and EUPATI. All of this shows that the patient (representative) plays an important role in various processes, and that it is important to hear his/her voice.
The FAMHP is striving to make this symposium an annual event.