From plague columns to Global Health Security

By Dr. Karen Sliter, Regional Manager for Europe, Africa and the Middle East, USDA Animal and Plant Health Inspection Services’ International Services, and U.S. Mission to the European Union, Brussels, Belgium One needs look no further than the plague columns scattered throughout European city squares to realize the impact infectious disease has had on the trajectory of human history.  Prior to the discovery of the … Continue reading From plague columns to Global Health Security

U.S. and EU Act Together on Global Medical Safety

This is the fourth post in our weeklong blog series, Talking Trade: Stories of the Transatlantic Exchange.

By Donald Prater, Director, FDA Europe at the U.S. Mission to the EU

U.S. demand for medical products grew substantially between the late 1990s and 2010, spurred in large part by the emergence of new medical technologies and services.  Increasingly, this demand has been met by imported products. Since 2002, for example, imports of pharmaceutical products and biologics have more than doubled, and medical device imports have quadrupled. Foreign-sourced pharmaceuticals now account for some 40% of medicines and an astonishing 80% of active ingredients in U.S.-consumed drugs.

pharmaceutical image 1Similarly, medical products in Europe are increasingly reliant on foreign-sourced materials and face the same challenges of longer and more complex supply chains. Additional shared challenges include an increasing number of clinical trials conducted across the world and risks from substandard/counterfeit/falsified products finding their way to consumers. Continue reading “U.S. and EU Act Together on Global Medical Safety”

Using IPR Tools to Promote Safe Online Pharmacies

Commercial Attaché Michael Rogers on a panel during the Global Forum on Access to Safe Medicines
Commercial Attaché Michael Rogers on a panel during the Global Forum on Access to Safe Medicines

Earlier this month, I had the opportunity to speak at the Global Forum on Access to Safe Medicines in London. The event brought together pharmaceutical companies, companies that provide anti-counterfeiting technology, law enforcement, regulatory agencies from around the world, NGOs, patient groups, and academics to discuss how to protect people from substandard or counterfeit medicines. I spoke briefly about the efforts underway in the Transatlantic IPR Working Group to contribute to this effort. Continue reading “Using IPR Tools to Promote Safe Online Pharmacies”