Table 6 New framework for ethical provision of OOS products
Items | Proposition |
|---|---|
Purpose and objective | Compassionate use for patient treatment |
Necessary regulatory compliance | The law needs to be amended to provide exceptions to Article 65–5 of the PMD Act |
Legal handling of OOS products | Commercial products |
Definition and standards of OOS products that can be provided | Autologous regenerative medicine that have no clearly increased risks compared with that of commercially available products and whose benefits outweigh the risks. Although setting uniform standards is difficult, products that do not meet safety standards, such as sterility, will not be provided |
Indications | Patients with serious diseases or conditions for whom alternative treatments are not available and OOS products have been considered to be essential for treatment, with their consent |
HA interaction | The requirements for OOS products that may be exceptionally provided are stipulated in the Ministerial Ordinance. MAHs providing OOS products must notify the HA of the applicability of these requirements and the specification items that can be provided for each product |
Supply flow of OOS products | MAHs will establish an evaluation system for OOS products, conduct a risk assessment, and provide the physician with the risk assessment. Based on the risk assessment provided by the MAHs, physician will conduct a risk–benefit assessment for each patient and determine whether or not to use the OOS product. Physicians will obtain the patient’s consent for using the OOS products and request their provision from MAHs |
Monitoring system for the use of OOS products | The appropriateness of using OOS products on patients must be approved by the Ethics Committee (EC) before their administration to patients. The overall flow of using OOS products is reviewed and approved in advance by the EC. As OOS products are required to be provided promptly, no need for review will be required when using individual OOS products, which should be administered at the physician’s discretion in accordance with the approved flow |
Reports from MAHs | The number of OOS products and doses can be provided as requested by the authorities |
Safety information collection and reporting system | As part of safety monitoring activities for commercially available products, a system will be established for collecting, evaluating, and communicating information on OOS products |
Safety and efficacy data collection | As with commercial products, post-marketing safety monitoring is required, and the details of the implementation are left to the discretion of each MAHs |
Contract between Medical institutions and MAHs | When concluding a contract to adopt commercially products, matters related to OOS products would be also handled |