The MHLW has decided to establish a special exception to allow the use of non-approved drugs for patients suffering from serious illnesses and having no possible alternatives for treatment. Currently, individual import of medical treatments is allowed in certain cases, but this new pathway would allow for importation via drug companies. The MHLW expects to establish this pathway in a few years and hopes to reduce importing hassles on patients.
Japan is using the “compassionate use” designation utilized in the US and the EU as a reference to establish which drugs would fall into this category and determining how expenses are allocated.
According to the MHLW, the new system would take into account the following factors when making their decision:
- If clinical trials are currently being conducted in Japan or have already been completed in Japan;
- If clinical trials are currently being conducted in the US or EU or have already been completed in the US or EU;
- And if the product has been approved in the US or EU.
The MHLW plans to include drugs such as anticancer agents delayed in product approval to drugs whose clinical trials have been postponed due to insufficient funding.
Once a drug is elected for this compassionate use pathway, it can be imported into Japan without being approved.