E-DRUG: Sparring Begins Over a European Policy for Disclosing Clinical Trial
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
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
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
"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
EMA policy, however, has been greeted with skepticism lately. The European
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
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) -
With kind regards,
BUKO Pharma-Kampagne / Gesundheit und Dritte Welt e.V.
Tel.: +49 (0)521 60550
Fax.: +49 (0)521 63789
Hedwig Diekwisch <firstname.lastname@example.org>