Biosimilar medicines still a pressing issue for patients worldwide
Contributed by Isabella Haaf, Communication and International Relationships Manager, and Luisa Avedano, CEO of The European Federation of Crohn's and Ulcerative Colitis Associations.
From 4-6 February 2016, EFCCA (the European Crohn´s and Ulcerative Colitis Associations) together with GAfPA (Global Alliance for Patient Access), organised an advocacy workshop on patient safety in Barcelona that gathered over 60 patient representatives from a wide range of immune modulate disease groups and other organizations.
The main objectives of the workshop were twofold: firstly, to create greater awareness amongst patient communities regarding the issues impacting access to biologic and biosimilar treatments, and therefore to provide or improve basic understanding of the science and issues associated with these drugs. Secondly, to provide training on how to employ effective advocacy and communication strategies with the goal of raising awareness and understanding amongst key policy makers.
Presentations concerning biosimilars and biologics, the role of patient representatives at the EMA's Pharmacovigilance Risk Assessment Committee and the first results of the BAB survey (Biologics and Biosimilars – an open door towards a better knowledge), carried out by EFCCA, set the general framework of the seminar. Results will be announced at the ECCO Congress in March 2016.
Representatives from Poland, Spain and Norway talked about the issues involving biosimilars and biologics in their own countries, while Souzi Makri from AGORA (a platform of organisations for people with rheumatic diseases in southern Europe) gave an overview of the above topic among its members.
Focusing on advocacy
The second part of the programme focused on strategies and case studies for advocacy, in particular with EU decision/policymakers. After the presentation of a toolkit on advocacy, participants were invited to form into small working groups to develop a basic advocacy strategy.
EFCCA was very pleased with the level of engagement and interactions between representatives from the various disease groups. What became evident during the discussions and questions following each presentation is that the subject of biosimilars and biologics is a burning issue for all patient representatives and requires an urgent need for unbiased and accurate information. Participants felt that there is at times contradictory information available from the scientific, regulatory and industry community on this topic.
Areas of particular concerns are the issue of switching from biologics to biosimilars, the tracking of a particular drug, and the extrapolation and access to the drug (in many countries due to economic reasons patients do not have access to costly treatment options).
Participants agreed that it was important to work towards a common position in the patient community that would best protect patients´ safety. Several representatives voiced their concern that their lack of resources and time didn’t allow them to successfully lobby their respective policymakers. These comments showed the importance of uniting efforts across disease groups in order to raise a unified voice to ensure that patients concerns were heard.
EFCCA would like to thank all participants for their lively contributions, interactions and for sharing their experiences. The organization remains committed to driving this process forward and hopes to continue working with all interested stakeholders on this important issue.