Medical Kit Shortage Highlights Japan's Medical Crisis Management

Tokyo, Feb. 4 (Jiji Press)--A serious shortage of a key medical kit
has made it nearly impossible to perform bone marrow transplants on patients
with leukemia and other diseases in Japan, raising questions over the
country's medical crisis management.

The situation surrounding a bone marrow collection kit,
indispensable to transplant surgeries, has become critical since a
reorganization of supplier Baxter International Inc.
The U.S. medical products giant last December told the Japan
Society for Hematopoietic Cell Transplantation that supply of the kit to
Japan would be suspended for a while.
Baxter sold some of its manufacturing operations, including those
making the kit, in 2007. The operations, now named Fenwal Inc., planned to
start a new plant to make the kit, used to filter bone marrow, in Janaury
this year, but the project has been delayed.
As Baxter's kit is the only one approved for use in Japan, its
domestic stocks were initially forecast to run out by March. The news has
caused intense anxiety among patients and their families, sources said.
The medical society moved swiftly to secure a substitute. It
examined a similar kit, made by U.S. firm BioAccess Inc. and approved by the
U.S. Food and Drug Administration, and confirmed its safety and
effectiveness.
After negotiating with BioAccess, the Japan Marrow Donor Program
secured 600 units, enough to cover four months' demand in Japan.
At a news conference in late January, Minister of Health, Labor and
Welfare Yoichi Masuzoe said, "We can now avoid a situation in which products
necessary for bone marrow transplantation will run out in the immediate
future."
The BioAccess kit, however, raises a different problem. As it has
not received official regulatory approval in Japan, the costs related to its
use are not covered by the country's public medical insurance program.
The program does not provide any benefits for medical treatment if
it involves the use of any apparatus, medicine or technique outside its
coverage.
This means that if patients want the BioAccess kit to be used
during their bone marrow transplant, they have to put up the entire cost of
the operation, which is nearly 10 million yen.
The Japan Marrow Donor Registry Promotion Conference has started a
campaign, including a petition, against the huge financial burden on
patients.
Masuzoe has promised to do everything he can to ensure speedy
regulatory approval of the BioAccess kit.
The near crisis in Japan was triggered by Baxter's restructuring as
part of the company's moves to withdraw from businesses with low
profitability.
"Similar problems are expected to occur if the economic crisis
intensifies further and pharmaceutical firms wind up more of their
unprofitable operations," said Masahiro Kami, associate professor at the
University of Tokyo's Institute of Medical Science.
Noting that the government stockpiles oil and influenza drug
Tamiflu, Kami said, "The government should establish a crisis management
division so that it can take such measures as emergency imports of
pharmaceutical products from around the world if supply shortages are likely
to happen."