The Daily Item, Sunbury, PA

February 22, 2013

Legal rules proposed for cell therapies

The Yomiuri Shimbun.

TOKYO — The Health, Labor and Welfare Ministry has decided to promote the use of induced pluripotent stem cells by proposing new legislation for regenerative medicine, The Yomiuri Shimbun learned Friday.

Provisions to enable the iPS cells extracted from patients by medical institutions to be processed by outside businesses will be incorporated into a new bill to be submitted to the current Diet session.

The ministry also aims to revise the Pharmaceutical Affairs Law so that such products as cells for transplant can be approved within a short period.

The new legislation and legal revision are part of the ministry’s efforts to achieve early practical application of regenerative medicine.

Regenerative medicine refers to treatment methods to regenerate cells and tissue damaged by disease or injury. Doctors extract healthy cells from patients to process them into iPS and other cells. Processed cells will be used to produce transplant cells and tissue for areas such as nerves and skin.

While regenerative medicine using iPS cells has neared practical application due to rapid advances in research, no clear legal provisions exist among current laws and ordinances that would allow doctors to commission the processing of cells extracted for regenerative medicine to outside private firms.

The new law envisioned by the ministry for regenerative medicine would call for setting safety standards for the management of cells by firms that will subcontract cell processing from medical institutions.

Specifically, the law would make it mandatory for such firms to hire engineers who have expertise in cell-processing technology, take all possible measures to prevent infection and formulate internal regulations on process management.

The firms would be permitted to subcontract the cell processing pending ministry approval of their facilities.

By commissioning the cell processing to outside entities, doctors would be able to concentrate on the treatment of patients. Thus the planned legislation is aimed at speeding up clinical research on regenerative medicine and fostering a new cell-processing industry.

Under the revised Pharmaceutical Affairs Law, products for regenerative medicine would be approved conditionally after their safety is established in clinical trials requiring fewer trial participants than needed under the current approval system.

The new system would also call for follow-up inspections of the safety and effectiveness of regenerative medicine products.

Medical institutions would be obliged to give patients explanations, obtain their approval and keep records on regenerative medicine. A formal approval to undertake treatment would be given after safety and effectiveness are confirmed.

A study panel of the industry ministry said Friday the domestic market for regenerative medicine will grow to 1.6 trillion yen by 2030.

According to the study group of the Economy, Trade and Industry Ministry, the demand for medical products in regenerative medicine, such as organ cells grown from iPS cells, will be about 1 trillion yen, including medical treatments using the products.

Related businesses such as devices and containers to culture iPScells will also grow to about 550 billion yen, the group said in its report.

The Study Group on Commercialization and Industrialization of Regenerative Medicine is headed by Prof. Mitsuo Okano of Tokyo Women’s Medical University.

In a breakdown of the market, the group said businesses involved in transplanting eye cells into eyes of age-related macular degeneration (AMD) patients are slated to grow to the 100 billion yen level and those involved in neural cells used in the treatment of Parkinson’s disease are expected to grow to 110 billion yen.

The study group also came up with a forecast of the extent to which treatments using regenerative techniques will be commercialized.

The market is expected to further grow to the 3.8 trillion yen level by 2050, the group added.