Global Intellectual Property Center

Tag Archives: medicines

Getting the Facts Straight: Access to Medicines and the TPP

Getting the Facts Straight: Access to Medicines and the TPP

It’s ironic that today’s life-saving medicines often resemble modern miracles while the biopharmaceutical companies that create them draw the ire of activist groups. This drama is playing out again in the context of the Trans-Pacific Partnership (TPP).

Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices

Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices

EMA study cover graphicThe purpose of this report is twofold. First, provide an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data. Second, review the wider policy implications and interface of these central EU-level policies with current data disclosure policies at the EU member state level, looking at five EU countries: Germany, Italy, Spain, Sweden, and the U.K.

Literally, a Life Saver

Literally, a Life Saver

© erhui1979/iStock

“The treatment for HIV that kept me alive would not have been possible without innovation.”

-Phill Wilson, Founder, President, and CEO of the Black AIDS Institute

Heading in a Different Direction? The European Medicine Agency’s Policy on the Public Release of Clinical Trials Data

Heading in a Different Direction? The European Medicine Agency’s Policy on the Public Release of Clinical Trials Data

EMA study cover graphicThe purpose of this briefing paper is to examine and compare the draft guidelines issued in 2013 by the European Medicines Agency (EMA), titled “Publication and Access to Clinical-Trial Data,” with existing practices in the European Union (EU) and internationally regarding regulatory data protection and data transparency initiatives.