Pharma giants pledge greater drug transparency

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have strengthened their 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.

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

For example, 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 US and the EU 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.

“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 are available here. The commitments will come into force from January 2014.

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