On September 17, 2008, the Antitrust Division of the Department of Justice (DOJ) announced that it will not oppose a proposal by the CEO Roundtable on Cancer (CRC) to develop and publicize model clauses for use in agreements governing clinical trials of potential new cancer treatments. DOJ stated its opinion in a business review letter to CRC’s outside legal counsel, Hogan & Hartson LLP. Under DOJ’s business review procedure, an organization may receive a statement as to whether DOJ currently intends to challenge the proposed conduct under the antitrust laws. CRC is a 501(c)(3) non-profit organization whose goal is to make continual progress towards the elimination of cancer as a personal disease and public-health problem. CRC believes that cancer research is often unnecessarily delayed by the lengthy negotiation of clinical trial agreements. To lessen this delay, CRC is working in partnership with the National Cancer Institute (NCI) to lead a project to develop model clauses for clinical trial agreements. CRC contends that model clauses will reduce inefficiencies in contract negotiations and reduce transactional costs for all parties involved in clinical research, including (1) the pharmaceutical or medical-device company (the “sponsor”), (2) the hospital, clinic, or university where the research is performed (the “research institution”), and (3) the physician who is in charge of the trial (the “principal investigator”). CRC anticipates that this project ultimately will reduce the time needed to bring medical therapies to cancer patients.
As part of this project, CRC hired the Science and Technology Policy Institute (STPI), an independent, federally-funded research and development center, to collect clinical trial agreements for analysis and identification of model clauses to be included in the project. CRC confirmed that none of these clauses will include price or price-related terms, and the project will not involve the sharing of competitively significant information. STPI, with the assistance of outside legal counsel, will also generate a list of possible language for the model clauses. CRC and NCI will work together to develop a structured approach for achieving consensus on the language for the model clauses. They will then publicize the model clauses to sponsors, research institutions, principal investigators, and other interested parties. Importantly, CRC and NCI will present these model clauses for use on a completely voluntary basis. Interested parties may choose to use them, but they may also choose to negotiate them or reject them entirely.
In explaining its decision not to challenge this project, DOJ emphasized that the model clauses would not contain prices or rates, as well as the fact that use of the clauses would be entirely voluntary. It concluded that the project “is not likely to reduce competition.” Indeed, DOJ stated that the project may potentially benefit competition by reducing costs and shortening the time needed to begin clinical trial research of potential new cancer treatments.