Staff Opinion--Foundation for the Accreditation of Hematopoietic Cell Therapy

A proposal to establish a program of standards, inspection, and accreditation of entities involved in medical or laboratory practice related to hematopoietic progenitor cell therapy does not appear to raise inherent antitrust concerns, staff of the Federal Trade Commission have advised the Foundation for the Accreditation of Hematopoietic Cell Therapy ("FAHCT"). Hematopoietic progenitor cell therapy refers generally to the infusion into a patient of blood- forming stem cells for the treatment of leukemia, certain other kinds of cancers, and some non- cancerous blood disorders. The blood-forming stem cells are derived from bone marrow, peripheral blood, or cord blood.

FAHCT’s members are the International Society of Hematotherapy and Graft Engineering ("ISHAGE") and the American Society of Blood and Marrow Transplantation ("ASBMT"). The members of ISHAGE and ASBMT primarily are individuals associated with academic and research centers engaged in hematopoietic progenitor cell therapy. FAHCT has developed standards for facilities and individuals performing hematopoietic progenitor cell transplantation and therapy or providing support services for such procedures. In addition, FAHCT will implement an accreditation program incorporating on-site inspection by FAHCT inspectors and accreditation decisions by a committee of FAHCT. Accreditation is voluntary, and can be sought by any medical or laboratory facility engaged in any aspect of hematopoietic progenitor cell therapy, including clinical transplant programs, stem cell collection facilities, and processing laboratories.

According to the staff’s advisory opinion, signed by Robert F. Leibenluft, Assistant Director for Healthcare at the FTC, private standard-setting and accreditation programs, in general, have the potential to promote competition by providing useful information to consumers. Accordingly, standard-setting programs usually are evaluated under the rule of reason.

The letter noted however, that the actions of standard-setting bodies controlled by entities with horizontal business relationships are subject to scrutiny under the antitrust laws. In some circumstances, according to the staff letter, standard-setting programs can have anticompetitive effects that require an analysis of the reasonableness of the underlying standards. For example, some aspects of an accreditation or certification program may directly impose an unreasonable restraint on competition among the participants in the program, or competitors may abuse or distort the standard-setting process for the purpose of reducing competition. Further, a standard may have a direct exclusionary effect when market participants agree not to deal with uncertified entities. "Concerted efforts to enforce product standards can warrant more rigorous antitrust scrutiny than does the establishment of standards," staff said.

Based on the information provided, it does not appear that FAHCT standards, on their face, unduly restrict competition among accredited entities in ways not reasonably related to the legitimate purposes of the standard-setting program, or that FAHCT is attempting, or has the power, to impose its standards on the market, staff advised. FAHCT has no power to require buyer adherence to its determinations. Moreover, there is no agreement by certified entities not to deal with uncertified facilities. Accredited collection facilities and processing labs may deal with unaccredited transplant programs. In those instances where the standards require accredited entities to deal with other entities that meet FAHCT standards, compliance can be demonstrated by means other than FAHCT accreditation, including accreditation by organizations with substantially similar standards. "The requirements that accredited transplant programs use stem cells acquired from processing and collection facilities that meet FAHCT standards, and that accredited processing laboratories use blood collected in accordance with FAHCT standards, appear to be reasonably related to FAHCT’s purpose to have standards that govern all phases of handling of stem cells used in accredited transplant programs," the staff letter said.

The staff letter also noted that a number of procedural protections are built into FAHCT’s accreditation process. "This is not determinative of the antitrust analysis; the antitrust laws do not require standard-setting bodies to adhere to any particular due process standards," the letter said. Nonetheless, the use of procedures designed to prevent abuse of the process for anticompetitive purposes, and to promote informed decision-making, should reduce the risk that the program in practice will reduce competition unreasonably.

"Of course, we cannot in this context, and do not purport to, evaluate the substantive reasonableness of FAHCT’s standards," staff advised. "Moreover, we cannot predict the actual marketplace impact of the proposed standards and accreditation process, or anticipate future developments in technology or medical practice that may affect the future impact of the process. Based on the proposed program as described above, however, it does not appear that the proposed standard-setting and certification program is intended, or is likely, to restrain competition unreasonably."

NOTE: This letter sets out the views of the staff of the FTC's Bureau of Competition, as authorized by the Commission's Rules of Practice. It has not been reviewed or approved by the Commission. As the Commission's rules explain, the staff's advice is rendered "without prejudice to the right of the Commission later to rescind the advice and, where appropriate, to commence an enforcement proceeding."

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