According to The Japan Times, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will revise the regulations concerning clinical trials beginning early next year. Under the new regulations, patients suffering from certain types of cancer or other incurable diseases will be allowed to participate in the final stages of clinical trials for new, unapproved treatments. The MHLW believes this will improve some patients’ prognosis.
A key feature of the new system will require pharmaceutical companies and participating doctors to post information about clinical trial results on the official PMDA website. Patients can then research information about ongoing trials and alert their doctor if they want to participate in the clinical study. The patient’s personal doctor will then consult with the doctors overseeing the study, and the pharmaceutical company will ultimately decide if the patient can participate.
If a patient is rejected, they can file a complaint with the MHLW. The MHLW will review the patient’s claims and, if they deem it is appropriate, they will ask the drug company to let the patient participate. To help alleviate some of this financial burden, the Japanese government will begin implementation of new insurance laws that will cover conventional and unapproved treatments that are not currently covered by the Japanese healthcare system.