EFPIA and PhRMA Release Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients

  EFPIA and PhRMA Release Joint Principles for Responsible Clinical Trial Data
  Sharing to Benefit Patients

   Data Sharing Commitments will Enhance Research and Scientific Knowledge,
                Advance Patient Care and Improve Public Health

Business Wire

WASHINGTON & BRUSSELS -- July 24, 2013

The European Federation of Pharmaceutical Industries and Associations (EFPIA)
and the Pharmaceutical Research and Manufacturers of America (PhRMA) today
strengthened their long-standing commitment to enhancing public health by
endorsing joint “Principles for Responsible Clinical Trial Data Sharing: Our
Commitment to Patients and Researchers.”

“Companies routinely publish their clinical research, collaborate with
academic researchers, and share clinical trial information on public
websites,” said Christopher Viehbacher, President of EFPIA and CEO of Sanofi.
“By endorsing the Principles, biopharmaceutical companies commit to enhance
these efforts by making additional information available to the public,
patients who participate in clinical trials, and to qualified researchers.”

“The data sharing commitments reflect EFPIA member companies’ strong support
for sharing clinical trial data to benefit patients and foster scientific
discovery in a way that maintains patient privacy, the integrity of regulatory
systems, and incentives to invest in biomedical research,” said Richard
Bergström, Director General of EFPIA. “These commitments stand as a
responsible alternative to other proposals being put forth in the European
Union (EU).”

Under the new commitments, biopharmaceutical companies will dramatically
increase the amount of information available to researchers, patients, and
members of the public.

  *Patient-level clinical trial data, study-level clinical trial data, full
    clinical study reports, and protocols from clinical trials in patients for
    medicines approved in the United States and European Union will be shared
    with qualified scientific and medical researchers upon request and subject
    to terms necessary to protect patient privacy and confidential commercial
    information. Researchers who obtain such clinical trial data will be
    encouraged to publish their findings.
  *Companies will work with regulators to provide a factual summary of
    clinical trial results to patients who participate in clinical trials.
  *The synopses of clinical study reports for clinical trials in patients
    submitted to the Food and Drug Administration, European Medicines Agency,
    or national authorities of EU member states will be made publicly
    available upon the approval of a new medicine or new indication.
  *Biopharmaceutical companies have also reaffirmed their commitment to
    publish clinical trial results regardless of the outcome. At a minimum,
    results from all phase 3 clinical trials and clinical trial results of
    significant medical importance should be submitted for publication.

“The commitments recognize the importance of sharing clinical trial data in
the interest of patients, healthcare and the economy. Imperative to the
success of this initiative are safeguards that ensure patient privacy, respect
for integrity of regulatory systems worldwide and greater incentives for more
investment in medical innovation,” said Robert Hugin, Chairman of PhRMA and
Chairman and CEO of Celgene Corporation.

“The Principles demonstrate the long-held commitment of PhRMA member companies
to responsible sharing of clinical trial data,” said PhRMA President and CEO
John Castellani. “They supplement PhRMA’s Principles on Conduct of Clinical
Trials and Communication of Clinical Trial Results which were strengthened in
2004 and again in 2009.”

The Principles are available at:

http://transparency.efpia.eu/responsible-data-sharing and

Implementation of the commitments begins on January 1, 2014.

About EFPIA:

EFPIA represents the pharmaceutical industry operating in Europe. Through its
directmembership of 33 national associations and 40 leading pharmaceutical
companies, EFPIAprovides the voice of 1,900 companies committed to
researching, developing and bringingnew medicines to improve health and
quality of life around the world. The pharmaceutical industry invests 30
billion on research and development per year in Europe and directly employs
700,000 people including 116,000 in R&D units in Europe.

EFPIA members are committed to delivering innovative medicines to address
unmet needs ofpatients and reducing the burden of chronic diseases for
Europe’s ageing population. EFPIAbelieves in close cooperation with its
stakeholders to help create sustainable healthcare systems and to develop
prompt responses to health threats in Europe.

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents
the country’s leading innovative biopharmaceutical research and biotechnology
companies, which are devoted to discovering and developing medicines that
enable patients to live longer, healthier, and more productive lives. Since
2000, PhRMA member companies have invested approximately $550 billion in the
search for new treatments and cures, including an estimated $48.5 billion in
2012 alone.

Find PhRMA Online:

  *Website – http://www.phrma.org
  *Facebook – www.facebook.com/PhRMA
  *Blog – www.phrma.org/catalyst
  *Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress
  *YouTube – www.youtube.com/PhRMApress

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