[Ip-health] Politico (Europe): EU health agencies to get knuckles rapped

Thiru Balasubramaniam thiru at keionline.org
Tue Apr 28 07:00:31 PDT 2015


*EU health agencies to get knuckles rapped*

MEPs may apply sanctions to €2.5 billion pharmaceutical partnership, and
critique medicines agency.

By PETER O’DONNELL <http://www.politico.eu/author/peter-odonnell/>
28/4/15, 10:32 AM CET

The European Parliament is on the brink of applying sanctions to the EU’s
multibillion public-private partnership for pharmaceutical research and
rapping the knuckles of the European Medicines Agency (EMA).
On Tuesday MEPs will debate reports taking to task the Innovative Medicines
Initiative (IMI) over its accounting, and the drugs agency over potential
conflicts of interest with companies it regulates. Parliament routinely
clears the budgets of semi-autonomous agencies and partnerships, but
occasionally uses its powers to demand improvements.

The resolution before MEPs recommends holding back funds for the IMI,
citing a lax accounting system. The draft calls on IMI “to address this
issue as a matter of urgency” — using the postponement of funds to force
action. It demands a follow-up report on Parliament’s gripes expressed in
three years of audits and an action plan to fix the deficiencies. IMI
brings together the European Commission and the drug industry in a €2.5
billion program to speed up new drug development.

Recruitment of a new head last December was bungled when none of the
short-listed candidates were appointed, leading to re-advertisement of the
post and a minimum six-month delay. MEPs also want clearer information on
exactly what the drug industry is contributing to the partnership —
“especially on the type of the in-kind contributions and their respective

IMI’s interim executive director, Irene Norstedt, who has been drafted from
the Commission’s research department to fill the leadership gap, said on
Monday she was “surprised” by the Parliament’s move to halt funding.

She said she’s been working with the parliament’s budgetary control
committee almost since she stepped in at the end of 2014.

“The European Court of Auditors gave us a clean bill of health regarding
the legality and regularity of the transactions underlying our accounts,”
she said. Accounting discrepancies occurred in only 2.3 percent of
transactions, she pointed out, which she said was in line with other
research programs.

MEPs are also unhappy with the record of the medicines agency — although
the draft resolution on its accounts stops short of calling for funds to be
postponed. But EMA policies to prevent conflicts of interest are still
insufficient, the report says.

‘It “regrets” that the agency lets doctors act as impartial experts within
as little as three years after ceasing professional activity on related
topics.  And it calls for publication of the patients’ organizations the
agency is working with, with a link to the groups’ funding sources.

EMA officials were not available for comment. MEPs preparing for the debate
have also criticized the agency’s policies on publication of clinical trial
data — particularly letting companies redact data where commercial
interests are potentially jeopardized.
“The agency’s understanding of what constitutes commercial confidential
information is far too broad,” says the report.

Concerns raised last week by health campaigners over close links between
companies and the agency when providing early scientific advice on drug
development also feature in the report that MEPs will debate.
The agency should “publish on its website detailed reports of the
scientific advice provided by the agency to pharmaceutical companies during
the drug development and pre-registration process at the time of trial
authorization and in any case not later than 12 months after the end of the
trial,” it says.


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