The Australian Government has given approval to proceed with the implementation of enhanced transparency measures for prescription medicines, in response to public demand for more information on prescription medicines that are under evaluation.
AusBiotech is seeking member feedback on the two proposed implementation options, including the preferred notification option, predicted impacts (financial and non-financial), and any changes that would minimise the burden on industry.
The Australian Government is proposing to increase transparency for applications under evaluation in a way that balances the availability of information to the public while recognising that this information could have commercial value to the applicant.
Consumers, their carers and families, together with healthcare professionals, have said they are frustrated in not being able to know whether new treatments are likely to be available in Australia as they are not aware that an application has been made to the TGA.
Measure one: Early publication of major innovator medicine applications
Information on the potential availability of new medicines or new uses for medicines is considered to be of the greatest value to consumers and healthcare professionals. This measure will introduce earlier publication of major innovator prescription medicines that have been accepted for evaluation under section 25 of the Act.
This measure could commence from June 2020. No additional actions are required by the applicant for registration of the medicine. The TGA will publish information within one month of the date that an affected application has passed the preliminary assessment.
Measure two: Earlier notification of generic medicine applications to the innovator
It is expected that there would be less public interest in the notifications of generic prescription medicine evaluations as many follow-on from previously-registered generic medicines that are already on the market.
This measure will introduce earlier notification of generic medicine applications to the innovator. Implementation is planned from early 2021. This is intended to address the flaw (whether there is notification prior to registration of the generic is at the sole discretion of the generic) in the existing notification scheme which has caused the significant cost to the generic, the innovator and the community as manifested in the expensive patent dispute litigation.
There are two options for implementing an early notification scheme for new generic medicines:
- Option one requires early notification in addition to the existing scheme, only where a patent has not expired.
The purpose of this option is to remove the assessment of whether the marketing of the generic (should its application for registration be approved) would infringe a valid claim of a patent from being at the sole discretion of the applicant. The obligation on the applicant is reduced to apply only in circumstances in which it has a reasonable belief about the existence of a valid patent. In effect, whether the marketing would so infringe the patent would be for the applicant and the patentee to resolve. - Option two requires early notification regardless of belief of the existence of a patent. This option would, in addition to moving the current certification or notification requirements to the earlier point in the process also require the applicant to provide notification to the innovator where the applicant determines that a valid patent is not infringed.
In February 2019, the TGA released a public consultation paper on Whether the TGA should publish that a prescription medicine is under evaluation. Read previous responses and the implementation’s consultation document here.
AusBiotech asks members email or call (03 9828 1455) Juliana Potulic, Policy and Programmes Manager, AusBiotech, with your views and comments by Tuesday 2 June 2020.