Wednesday, 4 March 2020
Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020; Second Reading
That this bill be now read a second time.
I'm pleased to introduce the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, which amends the Therapeutic Goods Act.
This bill supports the delivery of the highest quality health care for Australians by:
There are also a number of minor, unrelated measures outlined in the bill to reduce regulatory burden or make other improvements to regulation.
This bill implements three main measures.
First, the bill amends a number of foundational medical device definitions to support the closer alignment of the regulation of medical devices in Australia with the EU framework and more broadly the global regulation of medical devices.
In particular, the bill ensures that the definition of 'medical device' expressly covers software, implants and reagents. This reduces uncertainty around the definition of medical devices as those intended to be used for the prediction or prognosis of disease; the investigation, replacement or modification of a pathological process or state; the support of conception and the in-vitro examination of specimens derived from the human body for a specific medical purpose. The bill also brings the 'accessory' and 'system or procedure pack' definitions more into line with the EU terms.
These changes are designed to assist efforts to improve access for Australian consumers to new medical devices by identifying Australia as a market that is closely aligned with the EU and for which access may be sought by device manufacturers and sponsors without delay, following EU approvals of their products. They also support recommendation 20 of the Expert review of medicines and medical devices regulation, agreed to by the Australian government in its response to the review in September 2016, in relation to aligning the regulation of medical devices in Australia with the EU wherever possible. These changes improve the clarity of these definitions which, in turn, supports better regulatory compliance for industry sponsors and manufacturers of medical devices.
Secondly, the bill enables the secretary to provide scientific advice to an applicant about prescription and over-the-counter medicines before they submit a formal application to the TGA for marketing approval.
In some instances, it can be difficult for sponsors of medicines to determine the nature of information needed to support an application for registration, particularly in relation to whether a bioequivalence study is needed for a generic prescription medicine or what is required to justify not submitting a bioequivalence study. This uncertainty may risk sponsors investing considerable time and resources on evidence that is not needed or providing insufficient evidence, resulting in applications being rejected. Both instances may delay consumer access to new medicines and savings to the public through availability of generic brands.
To better support the timely availability of medicines for Australians, the bill allows the applicant to request nonbinding, scientific advice on prescribed aspects of the safety, quality or efficacy of a registrable medicine. While it is anticipated that initially this will focus on bioequivalence issues, the new power would allow a range of matters relevant to safety, quality or efficacy to be prescribed in the regulations.
The advice will be non-binding in that an applicant who requests such advice may apply for registration of a medicine regardless of the advice given in relation to the medicine. However, the TGA will be required to have regard to such advice when evaluating a medicine for registration. This will ensure that, in addition to helping medicine sponsors have greater confidence about the requirements for an application, the advice will also directly support and streamline any subsequent application for registration.
Thirdly, the bill introduces a data protection regime for assessed listed medicines—these are lower risk complementary medicines that are assessed in relation to their efficacy claims before they are given marketing approval.
This regime is based on the existing data protection regime in the Therapeutic Goods Act for innovator prescription medicines, and provides five years' protection for clinical trial information that a sponsor submits in support of an indication (that is, a health condition) for an assessed listed medicine. This will be in cases where the information is not currently publicly available and no other medicine has that indication at the time the application for listing is made. This will mean that a sponsor of another assessed listed medicine will not be able to utilise the same information in the evaluation of its own medicine during that five-year period.
This measure is designed to provide an incentive for sponsors of assessed listed medicines to invest in clinical trials research and innovation and, in so doing, to improve the competitiveness of the Australian complementary medicines industry.
Other, minor matters
The bill also contains a number of other, minor measures, to reduce regulatory burden, improve the consistency of regulatory requirements or make other minor changes to remove spent and redundant provisions, correct headings and codify a longstanding condition of marketing approval for registered and listed therapeutic goods.
These include changes to: