Saturday, July 27, 2013

Open Drug Data

Pharmaceutical firms possess two major methods for shielding their products from competition.  The first is patent protection, although it expires 20 years - slightly longer with patent term extension - after the priority application is first filed.  The second method is the secrecy of much research and clinical trial data.  Even after a patent claiming a particular drug has expired, how precisely to manufacture that drug may remain opaque to aspiring competitors.  Competition tends to lower prices and raise quality.  Thwarting competition is thought to harm social welfare.

On July 18, 2013, the two largest trade groups representing drug companies, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") and the Pharmaceutical Research and Manufacturers of America ("PhRMA"), announced their strengthened commitment to data openness.  According to the joint press release issued by EFPIA and PhRMA,
[u]nder 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.
This kinder, more open strategy may be designed to soften current antipathy towards drug companies.  An anagram of the two organizations' acronyms may be prophetic of the industry's hopes:  "Ah, IF PAMPER."