Author: Reena Patel
Several years ago, the Australian Therapeutic Goods Administration (TGA) embarked on a journey to increase the transparency of the Australian prescription medicine evaluation process as part of the Business Process Reforms Initiative.
This commenced with the publication of Australian Public Assessment Reports (AusPARs) in November 2009. Each publicly available report provides an overview of the scientific reasoning upon which the TGA’s decision to approve or refuse a prescription medicine application was made. Although the TGA’s AusPARs were modelled on the European Public Assessment Reports (EPARs), unlike their European counterparts the TGA’s preferred approach was to publish an AusPARs per evaluation instead of medicine. Additionally, Australian assessment reports were only published for major applications where advice from the Advisory Committee for Medicines had been sought as part of the regulatory review. Consistent with the principles of continuous improvement the TGA have refined the content of the AusPAR over time, and a streamlined version of the document was implemented in September 2019.The latest reiteration now simply includes an introduction, registration timeline, Delegates action and Advisory Committee resolution. The resulting assessment report is a substantially smaller document than that published at inception, and as a result is now typically available in much closer proximity to the regulatory decision than in previous years.
Whilst not all new prescription medicine evaluations result in the publication of an AusPAR, the TGA did embark on another transparency initiative for new prescription medicine decisions effective 1 September 2019. The publication of an Australian Prescription Medicine Decision Summary was intended to provide information in a more consumer friendly format and is available for new chemical or biological medicine registrations. The TGA aims to publish this summary within 10 days of inclusion of the new medicine on the Australian Register to Therapeutic Goods (ARTG).
The TGA also routinely publishes abbreviated information on new prescription medicines and biologicals as they are approved. This includes new medicines, extended uses (‘extensions of indications’) or new combinations of already registered medicines, and new generic or biosimilar medicines. Typically, this will include tradename/active ingredient, sponsor, indications, type of application and registration timeline (as applicable).
Collectively these measures demonstrate the TGA’s continued commitment to transparency as it relates to prescription medicine evaluation. It is however acknowledged that the focus to-date has been on publication of information at the end of the evaluation process, and as yet there is much less visibility as to prescription medicine applications which are under review. Disclosure of applications which are actually under evaluation is considered to be a much more commercially sensitive matter and in addressing this, requires the management of competing needs of different stakeholders.
In February 2019, the TGA sought comments from interested parties on whether the TGA should publish that a prescription medicine is under evaluation. The impetus for the consultation was multi-factorial and included increasing demands from the general public for knowledge of marketing applications, an awareness that due to parallel review processes and shared evaluations, information is often available in the public domain (eg. scheduling, reimbursement applications, overseas regulators) whilst acknowledging the potential commercial sensitivity of its release.
The consultation proposed four options for stakeholders:
- Maintain the status quo ie. no publication of information for new medicines under review.
- Publication of information for all new medicines at the same time (acceptance into evaluation), this would apply for new chemical entities (including biological prescription medicines), extensions of indications, all generic and biosimilar medicines.
- Publication of all applications at two different time points depending on whether the medicine is a new medicine or a generic medicine or biosimilar.
- Publication of applications for innovator medicines of highest public interest, but not generic or biosimilar medicines.
Thirty-nine submissions were received from industry, health professionals, consumer representative groups, regulatory consultants and government. Companies with novel medicines tended to strongly advocate for an equitable approach to transparency, supporting Option 2, which proposed the publication of all new medicines at the same time. In contrast suppliers of generic medicines noted that the disclosure of information for generics and biosimilars would be commercially disadvantageous, and preferred retention of the current model.
On 8 April 2020, the TGA announced that the Australian Government had given approval to proceed with implementation of enhanced transparency measures for prescription medicines, and advised an intention to implement the following measures:
- Early publication of major innovator medicine applications
Introduce earlier publication of major innovator prescription medicines that have been accepted for evaluation under section 25 of the Act. The measure will provide information on potential availability of new medicines, or new uses for medicines and new combinations (where one active ingredient is a new medicine). Publication will occur from June 2020.
- Earlier notification of generic medicine applications to the innovator
This measure will introduce earlier notification of generic medicine applications to the innovator. Implementation is planned for early 2021.
In relation to the generic application notification, a second round of consultation (which concludes on 9 June 2020) has been initiated that outlines TGA’s attempts to navigate a pathway between balancing the need for public disclosure and commercial sensitivity. In particular, the TGA is now seeking feedback on two options for implementing an early notification scheme for new generic medicines, specifically:
- Option 1 – Early notification only where a patent has not expired Where an applicant has a reasonable belief that a patent has not expired, it would be required to provide a confidential notification to the patentee that the application has passed preliminary assessment. The purpose of this option is to remove the assessment of whether the marketing of the generic would infringe a valid claim of a patent from being at the sole discretion of the applicant.
- Option 2 – Early notification regardless of belief of the existence of a patent
This option would apply to all applicants where it is proposed that the application rely on information of another to support that application. All applicants would be required to provide a notification to the innovator, and a copy of the notification to TGA. This option, 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.
Whilst the TGA’s framework for increasing transparency continues to evolve, the current consultation demonstrates the TGA’s commitment in pursuing a balanced approach to transparency.
TGA Consultation on Prescription medicines transparency measures: Implementation of generic medicines early notification to innovators of an application and publication of innovator applications here.