GAfPA Blog

The GAfPA Patient Advocacy Blog

Munich 2017

The Global Alliance for Patient Access (GAfPA) and the European Federation of Crohn’s and Colitis Associations (EFCCA) came together to hold a Biologics and Biosimilars Patient Access and Advocacy Workshop in Munich, Germany on May 4-5, 2017. The 17 attendees from 13 different countries represented specialities from across rheumatology, gastroenterology and neurology, including several members … Continued

Advocates Strategize on Pain Care Policy at GAfPA’s Malta Workshop

Advocates Strategize on Pain Care Policy at GAfPA’s Malta Workshop   Young King David beat the biblical giant Goliath, as advocates at a Global Alliance for Patient Access workshop in Malta were recently reminded.  In the same way, a small group of committed advocates can rival much larger, more powerful interest groups – impacting policy … Continued

EU Group Calls for Greater Transparency in Labelling Biosimilars

  EU regulators who want to encourage understanding and acceptance of biosimilar medicines might consider improving the drugs’ labels.  So says the stakeholders group EuropaBio, which has issued recommendations for enhancing transparency in the literature that accompanies a biosimilar. Known as the summary of product characteristics, this documentation is required by the European Commission to … Continued

Access Issues Loom Large at Munich Workshop on Biologics and Biosimilars

When should patients switch from one medicine to another for non-medical reasons? How can pharmacovigilance processes successfully monitor patients’ reactions to a medicine? And, perhaps most importantly, how do we ensure that patients are informed participants in decisions about their medication?   These questions and others framed a May 4-5 advocacy workshop in Munich, hosted … Continued

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