The government's regulatory reform panel has recently proposed improvements in the screening process for new medicinal products. Currently, most new drugs, even those with approval overseas, can take up to four years to be approved in Japan. Under the new proposal, that screening time will be reduced to 500 days, roughly the same as in the United States. This is a welcome change that will benefit many patients.
The proposal also calls for deregulation of the drug payment system by public health insurance, permitting greater choice of original and generic drugs. This will allow overall savings and offer doctors and patients more appropriate choices of prescriptions. The significant increase in availability of medicine is an issue of special importance in a society that is quickly aging. Small as these changes may be, they are at least a positive step in a health system that needs continuing reform.
These proposals signal a break with past policies. Previous excuses that Japanese physiology is unique and therefore needs special testing, review and screening no longer carry the cultural force they once did. At the same time, the world market for medical products has greatly internationalized. Many Japanese find it easier to buy drugs overseas and carry them back home in their suitcase than to fight through the health bureaucracy here.
The government proposal also recommends better staffing. Currently, only 200 staff handle drug-screening issues, compared to 10 times that number in the U.S. The issue is serious and urgent enough to warrant a greatly increased budget for more staff.
Caution, care and strict oversight are needed to ensure that newly approved drugs are safe, yet duplicating tests and over-caution does not benefit patients, either. Ridding the health system of bureaucratic constraints and institutional delays will help those who need it most. Better late than never.