AGORA | Report on the Patient Advocacy and Safety Conference
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Report on the Patient Advocacy and Safety Conference

15 November 2016, European Parliament – Hotel Silken Berlaymont, Belgium

The Patient Advocacy and Safety Conference was organised by the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA) and the Global Alliance for Patient Access (GAfPA). The main aim of this conference was to support patients’ right to information and knowledge, to ensure their access to drugs and to health care and to include them in the decision-making processes, especially as it pertains to biosimilars and biologic treatments. The Conference gathered over 50 representatives from several immunomodulated disease groups such as Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Hemofilia, Hidradenitis suppurativa as well as general patient associations. Agora was represented by its Chair Ms Souzi Makri while many representatives of its members also attended the conference.

During both sessions of the conference – the morning session took place at the European Parliament and the afternoon session at the Hotel Silken Berlaymont – a constructive and open debate was held among the participants and speakers where the scientific, regulatory and patient point of view were presented respectively.

The morning session began with a welcome speech from Mr Martin Kojinkov, Chairman of EFCCA, on behalf of the organizers and it was followed by the interventions of three Members of the European Parliament, Mr Vladimir Urutchev and Mr Andrey Kovatchev from Bulgaria and Mr Sergio Cofferati from Italy, who mainly highlighted the importance of equal representation and effective cooperation among all the involved partners. Subsequently, Dr Alessandro Armuzio, Head of IBD Unit at the Complesso Intergrato Columbus, Catholic University of Rome, in his presentation under the title “ Scientific Scenario: Innovative Medicines in IBD and latest news”, he made an introduction about biologicals and biosimilars treatments from the perspective of patients’ safety and he referred to the importance of the extrapolation in medicine development as well as of NOR-SWITCH study.

Then, the regulatory point of view on safety and clinical trials was raised with the presentations of Ms Luisa Avedano, Chief Executive Officer of EFCCA (she represented Mr Marco Greco, President of EPF and EFCAA Ambassador) and Mr Fergal O’Regan, Ombudsman’s Head of Inquiry Coordination Unit. Ms Avedano referred to the patients’ and their organizations’ involvement in European Medicine Agency as well as their role in Pharmacovigilance Risk Assessment Committee of the EMA. Mr O’Regan underlined the importance of issues such as patients’ personal data protection as well as patients’ information on safety and efficiency of the taken medicines.

In the final part of the morning session the debate focused on the patients’ perspective with a presentation under the title “Patient Center Focus: Is it a reality?”. Ms Bente Buus Nielsen, President of the Danish Crohn and Colitics Association, took the floor and referred to the problems that came up through a recent switch in patients’ treatment in Denmark, and the importance of taking into account the patients and their associations’ opinion in these kind of decisions. After, Ms Sanna Lonnfors, Scientific Advisor of EFCCA, presented the findings and the lessons drawn from a recent survey on Biologics and Biosimilars. Based on this survey with regard to biosimilars, IBD patients want to be informed and involved in the decision-making process, they ask for transparency and to be aware of what they are taking and they also stressed the need for more information on biosimilars.

The morning session was concluded with a presentation of the main issues which arose through the conversation which took place and with some questions from the participants.

The second session at the Hotel Silken Berlaymont started with the presentation of Dr David Charles, founder of GAFPA, of the NOR-SWITCH study and how the results of this study could affect the policy-making decisions on biosimilars switching treatments. After that, Mr Michael Kaeding, Professor of European Integration and European Union Politics at the Leiden University, took the floor and presented a study on the assessment of the timely transposition and accurate implementation of Article 102 of Directive 2010/84/EU which foresees the reporting of adverse drug reactions (ADRs) within the EU pharmacovigilance framework. The study took showed that the ADR reporting is perceived as insufficient in terms of information quantity and quality in all of the six countries where the study took place.

After the two presentations, the participants were separated in different groups in order to participate in four Small Group Advocacy Workshops. In each of these Workshops it was mainly discussed the main obstacles and burdens that the patients faced on their way to achieve sufficient information and knowledge about their treatments as well as on their effort to take into account their perspectives into decision-making process.

The Conference ended with presentation of the final remarks and conclusions and the organisers thanked all the participants for their presence.


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