E-DRUG: Sparring Begins Over a European Policy for Disclosing Clinical Trial Data
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Article by Ed Silverman - Copied from: The Wall Street Journal
Once again, there is a clash in Europe over disclosing clinical trial data. The latest flare up is over proposed rules
<http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/01/WC500180618.pdf>
for managing a European Union database of clinical study information, which will be overseen by the European Medicines Agency.
The database will not launch until next year, but already there is substantial disagreement about the extent to which commercial information should remain confidential, according to comments submitted to the EMA by pharmaceutical industry trade groups, consumer advocates and one government panel.
Data disclosure is a contentious topic following scandals over safety or effectiveness data that was not publicly shared. Drug makers argue that disclosing certain data may compromise trade secrets or patient privacy. Consumer groups counter that such information is kept out of reach at the expense of patients.
The differing views over the EU database are so pointed that dueling press releases are being issued in hopes of swaying opinion. One missive was released by the German Institute for Quality and Efficiency in Health Care, which makes recommendations about drug effectiveness to German regulators.
In a brief statement, the organization, also known as IQWIG, takes the EMA to task for reinterpreting the proposed EU regulations and, specifically, for crafting a "very broad" definition of confidential commercial information.
Due to the way the EMA defined the term "the decision on which data remain confidential is, thus, more or less left up to the study sponsors," says Beate Wiesler, who heads the IQWIG assessment department, in a statement
"This contradicts the spirit of the EU regulation and the aim of achieving transparency in clinical research."
As far as IQWIG is concerned, clinical study methods and results should not be considered commercially confidential. The "interests of specific groups must be subordinate to the public interest in the swift and complete publication of study data and documents," IQWIG said.
Separately, the BEUC, or European Bureau of Consumer Unions, which is a coalition, released a statement
<http://www.beuc.org/publications/beuc-x-2015-017_ipa_beuc_response_to_the_public_consultation.pdf>
along with comments filed to the EMA that argue "transparency should be the default option. It is up to the sponsors [of a clinical trial] to prove that the disclosure of certain information could damage their economic interests."
Meanwhile, the U.K. Bioindustry Association, along with EuropaBio and the European Association for Bioindustries, released a statement to argue that there should be "a deferral" for disclosing information and summary results from Phase I trial, "noting the commercial sensitivity" of the information.
The trade groups also want the rules aligned with existing EMA policies toward disclosure.
"The BIA has supported the need for a balanced approach to be taken that respects both the rights of patients and the public to be able to access information held on the EU database... as well as the needs of developers and researchers to protect their investments and cutting-edge R&D of new innovative medicines," says Christiane Abouzied, who heads BIA regulatory affairs, in a statement
EMA policy, however, has been greeted with skepticism lately. The European Ombudsman has questioned<http://blogs.wsj.com/pharmalot/2014/10/03/ema-remains-under-fire-for-its-policy-on-disclosing-clinical-trial-data/> whether the EMA watered down its newly adopted disclosure policy after reaching a settlement with AbbVie that went to court to halt the release of trial data. In reaching agreement, the EMA redacted some AbbVie data, but the agency recently maintained some redactions were justified to respect confidential information.
As for the recent comments, the EMA notes these will be reviewed as the agency works toward developing a final version of the database rules. "The outcome will need to balance the public interest and value of immediate transparency with the need to ensure Europe re-establishes itself as the leading location for innovation and research on medicines, which is itself in the public interest," an EMA spokeswoman writes us.
This document could be of further interest for you
EU Clinical Trials Regulation: EMA steers away from transparency by misinterpreting exception provisions -
Joint press release by The Association Internationale de la Mutualité (AIM), Health Action International (HAI), International Society of Drug Bulletins (ISDB) and Medicines in Europe Forum (MiEF) -
http://www.isdbweb.org/publications/download/208
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