Innovative Prescription Medicines Accepted for Evaluation to be Published Earlier
Following the Therapeutic Goods Administration’s (TGA) February 2019 consultation on whether to publish that a prescription medicine is under evaluation they have now released an implementation options paper with the objective of increasing public transparency around whether treatment options are likely to be available...
Currently the TGA will neither confirm nor deny the acceptance for evaluation of any prescription medicine application so as to respect the confidentiality of that information and to allow applicants to disclose it when they consider it is commercially prudent. However, the TGA notes that there are various other factors that can effectively force publication and that other influential jurisdictions publish that a prescription medicine has been accepted for evaluation. It also notes that there is public pressure to increase transparency around what treatments may be available in the near term so that more informed decisions can be made around what treatment option to select.
In resetting the balance between public availability of the information and respecting confidentiality the TGA proposes that publication of acceptance for evaluation will only apply to innovative medicines and that generic medicines will only be published by the TGA when they achieve registration. However, innovator companies will be provided with confidential earlier notification of a generic application that has passed preliminary assessment so that they can evaluate whether to commence litigation.
The TGA proposed to implement the earlier publication of innovative prescription medicines from June 2020 and the confidential notification of generic prescription medicines to innovator companies in early 2021, however the COVID-19 pandemic may affect this timing. The TGA is seeking feedback on two possible options for implementing the confidential notification of generic prescription medicines to innovator companies. In particular, where the generic application relies upon the innovator’s information, whether to:
(1) only require generic companies to notify that its application has passed preliminary assessment to the relevant innovator company if the patent has not expired; or
(2) require generic companies to notify that its application has passed preliminary assessment to the relevant innovator company whether or not the patent has expired.