Transparency interrupted: The curtailment of the european medicines agency's policy on access to documents

JAMA Internal Medicine

Volumn 173, Issue 21, 2013, Pages 2009-2011

  Doshi, Peter ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; PIRFENIDONE;

ACCESS TO INFORMATION; CONFIDENTIALITY; DRUG INDUSTRY; EUROPE; EUROPEAN UNION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HEALTH SERVICE; HUMAN; INFORMATION PROCESSING; LEGAL ASPECT; LETTER; MANAGEMENT; MEDICAL DOCUMENTATION; PRIORITY JOURNAL;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; COMMERCE; DRUG INDUSTRY; EUROPEAN UNION; GOVERNMENT AGENCIES; HUMANS; UNITED STATES;

EID: 84888026156     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2013.9989     Document Type: Letter

References (9)

1. Doshi P, Jefferson T. The first 2 years of the European Medicines Agency's policy on access to documents: secret no longer. JAMA Intern Med. 2013;173(5):380-382.
2. Jaeger M. Interim decision of the president of the general court in case T-44/13, AbbVie v European Medicines Agency (EMA). (General Court of the European Union 2013.) http://curia.europa.eu/juris/document/document.jsf?text= &docid=137241&pageIndex=0&doclang=en&mode=lst&dir=&occ= first& part=1&cid=3667720. Accessed June 8, 2013.
3. Jaeger M. Interim decision of the president of the general court in case T-73/13, InterMune v European Medicines Agency (EMA). (General Court of the European Union 2013.) http://curia.europa.eu/juris/document/document.jsf?text= &docid=137242&pageIndex=0&doclang=en&mode=lst&dir=&occ= first& part=1&cid=937960. Accessed June 8, 2013.
4. Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? a view from regulators. PLoS Med. 2012;9(4):e1001202.
5. Dyer C. European drug agency's attempts to improve transparency stalled by legal action from two US drug companies. BMJ. 2013;346:f3588.
6. European Medicines Agency. European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information. 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and- events/news/2013/04/news-detail-001779.jsp&mid= WC0b01ac058004d5c1. Accessed April 30, 2013.
7. European Medicines Agency. Publication and access to clinical-trial data. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2013/06/ WC500144730.pdf. Accessed June 24, 2013.
8. GlaxoSmithKline. Data transparency. 2013. http://www.gsk.com/explore-gsk/ how-we-do-r-and-d/data-transparency.html. Accessed June 19, 2013.
9. F. Hoffmann-La Roche Ltd. Roche Global Policy on Sharing of Clinical Trials Data. 2013. http://roche-trials.com/dataSharingPolicy.action. Accessed June 19, 2013.