GAfPA Blog

The GAfPA Patient Advocacy Blog

PV Studies

Click any of the links below to read country fact sheets based on Professor Michael Kaeding of the University of Duisburg Essen’s latest study, Pharmacovigilance in the EU: Practical implementation across Member States.   The study examines how well EU pharmacovigilance legislation is being implemented by six member states: the UK, Germany, France, Finland, Poland, and … Continued

Study Released on Pharmacovigilance Systems in Europe

Patients and doctors need to be better informed about the need for high quality monitoring around all biologic medicines, according to a new study published today. An examination of the pharmacovigilance legislation in place across six EU countries has identified that patient reactions to biologic products are underreported in a number of EU countries. These … Continued

Clinical judgement first, value proposition second: drugmakers issue joint global position paper on biosimilar switching

European and global drug bodies have joined forces to send a strong message: when it comes to decisions around biosimilar switching, clinicians and patients must come first.  In a joint statement released this week, three industry trade bodies came together to stress that physicians and patients must be central to the decision-making process. They added … Continued

GAfPA Attends 12th Annual Congress of the European Crohn’s and Colitis Organisation

GAfPA Attends 12th Annual Congress of the European Crohn’s and Colitis Organisation ‘Advancing knowledge, improving care’ – that was the resounding theme of the 12th congress of the European Crohn’s and Colitis Organisation.   Crohn’s Disease and Ulcerative Colitis are the two main forms of inflammatory bowel disease, but also among the least known immune-mediated diseases.  … Continued

EFCCA / GAfPA European Parliament Report Released

On November 15th, 2016, more than 70 patient advocates and physicians from across the European Union attended the Patient Advocacy and Safety conference at the European Parliament in Brussels, Belgium. The patient and physician advocates – who came from almost every country in the EU – represented a variety of autoimmune conditions and the fields … Continued

Copenhagen Biologics and Biosimilars Report Released

A recent workshop hosted by the Global Alliance for Patient Access (GAfPA) allowed patient advocates from across Europe’s Nordic region to consider biosimilar policies and discuss a topic of growing international interest: switching from a biologic to a biosimilar medicine. The workshop, held on October 5-6, 2016 in Copenhagen, drew seven different patient advocacy groups … Continued

GAfPA Releases “Fast Facts” on Non-Medical Switching

While 21st Century medications represent some remarkable breakthroughs, they often come with high costs. As a result, many agencies are exploring ways to minimize drug costs, sometimes without considering the long-term consequences. English Spanish French German

New Biosimilar Switching Paper Prioritizes Physician-Patient Relationship and Robust Pharmacovigilance

By Brian Kennedy, Executive Director, Global Alliance for Patient Access A new position paper from the European Crohn’s and Colitis Organisation has garnered attention from physicians and patient advocates across Europe. The paper supports switching inflammatory bowel disease patients from an infliximab biologic medicine to a biosimilar – a position that some readers have misinterpreted as an endorsement for switching all patients to … Continued