GAfPA Blog

The GAfPA Patient Advocacy Blog

Revamped EudraVigilance System Could Improve Drug Safety Reporting

  Preventable drug safety issues caused nearly 200,000 deaths across the European Union in 2017.  Now the European Medicines Agency is working to address that statistic by improving its drug track-and-trace system, known as EudraVigilance.     The EudraVigilance system compiles data about side effects caused by drugs that are either in the marketplace or … Continued

Are Regulators Too Hasty in Approving Cancer Drugs?

The British Medical Journal ignited debate earlier last month when it announced that about half of cancer drugs approved by the European Medicines Agency don’t improve survival or quality of life.  The claim begs several complex question: How can regulators evaluate drugs both quickly and effectively?  And whose values should determine access to drugs for … Continued

“Fast Facts” on Pharmacovigilance Tackles Drug Safety Issues

Drug safety issues have caused more than 200,000 patient deaths in the EU. And one in three U.S. drugs may have safety issues, explains a new “Fast Facts” from the Global Alliance for Patient Access.   The paper explores how countries track and trace prescription drug side effects – and why advanced medicine demands a stronger … Continued

BLOG: GAfPA Examines How Improving Drug Donations Can Boost Patient Access

Reposted from the Institute for Patient Access   International prescription drug donation programs make a difference, explains a new white paper from the Global Alliance for Patient Access.  But they could work even better. In “The Role of Drug Donations in Expanding Access to Medicines,” author Neeraj Mistry, MD, MPH, explains that, “Millions of low-income … Continued

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

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