Trial data not 'trade secret', withholding it jeopardises EMA database - German HTA body

Country : Denmark, Germany

Keywords :
BERLIN, Feb 24 (APM) - Officials from Germany's health technology assessment body (HTA) IQWiG have said that neither trial results nor methodology are "trade secrets," and withholding those from a future EMA database is "inconsistent with ethical principles" and "contrary" to the EU initiative and its commitment to "transparency".
In a Monday statement following the close of the database's consultation period on Friday, officials from Germany's lower HTA body argued any exceptions to full disclosure of trial data must be "well-founded" as the redaction or even non-publication of whole documents may affect overriding public interests - such as the health of patients.
Officials also complained that "the decision to keep the data secret is, the more or less left to those who carry out these studies", said Beate Wieseler, head of IQWiG's drug assessment department, in Monday's statement.
In April the EMA was charged to build a database housing comprehensive data from clinical trials to be made available to interested parties.

Some pharmas accept lower rating to keep data confidential

In Germany, some pharmas have opted for lower ratings in order to keep their trial data private. In August 2014, Denmark's Novo Nordisk refused to hand over certain data from the Tresiba (insulin degludec) trials to the higher German health technology assessment (HTA) body, the G-BA, for confidentiality reasons. (APMHE 40125)
The G-BA ruled in line with an earlier decision by IQWiG which said the Danish company had insisted on confidentiality regarding trial data which might have allowed a more positive outcome for their diabetes drug (APMHE 39307).
Under the German system, Novo would be unable to request a higher price for Tresiba in negotiations with the payer, since it has failed to show superiority over comparators.



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