Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth).
The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”. This new class provides an opportunity for sponsors to release new medicines more quickly before complete clinical data is available.
Background to the changes
The reforms form part of a process that began with the Expert Panel Review of Medicines and Medical Devices Regulation, which reported in March and July 2015. After the Government’s response to the panel’s work last year, some regulatory changes were passed on 14 June 2017.
The current exposure drafts were released for consultation on 31 August 2017, with final bills expected to be introduced to parliament on 13 September 2017.
Introduction of class of provisionally registered goods
A major change proposed in the exposure drafts is the creation of a new class of “provisionally registered goods” on the Australian Register of Therapeutic Goods, which will accelerate the path to market for new medicines.
The proposed new approval process would allow prescription medicines to be marketed on the basis of early favourable clinical data on efficacy and safety, as opposed to a full dossier of data, in circumstances where there is the potential for a “substantial benefit” to Australian patients. The proposed change follows the recommendations of the Expert Panel Review.
It is proposed that obtaining provisional approval will be a two-step process. First, sponsors will submit a “determination application” and, if a “provisional determination” is granted, a further application for Provisional Approval can be made.
The provisional registration period is two years, which may be extended by one or two years by an application to the Secretary (up to a maximum of two extensions).
It is proposed that post-marketing conditions will require sponsors to provide information relating to efficacy and safety. Sponsors will also be required to communicate with health professionals and patients about the potential risks associated with particular products.
Changes to regulation of complementary medicine
The exposure drafts also propose significant changes to the regulation of complementary medicines. These changes include:
- Introducing a list of “permitted indications” for listed complementary medicines, to be issued by the Minister as a legislative instrument. This is to “ensure that listed medicines may only make pre-approved, low level claims for the conditions that the medicine can treat”. This is said to be appropriate in circumstances where these medicines are not assessed prior to being released. This reflects recommendation 38 of the Expert Panel Review.
- An additional assessment pathway for listed complementary medicines for indications that are not included on the “permitted indications” list. These can be included following assessment by the Secretary of information provided by the sponsor about safety and efficacy. This reflects recommendation 39 of the Expert Panel Review.
- Allowing sponsors to make claims about the efficacy of complementary medicines to treat certain conditions where the TGA has evaluated the claim. This reflects recommendation 45 of the Expert Panel Review.
Strengthening of investigation and enforcement powers
The Bill proposes to make a number of changes to the regulator’s investigation and enforcement powers, following recommendation 57 of the Expert Panel Review. These changes include:
- Granting the Secretary new powers in relation to “monitoring, investigation, infringement notices and injunctions” to be consistent with the powers of other Commonwealth regulators such as the Australian Sports Anti-Doping Authority, the Office of Drug Control, and the National Industrial Chemicals Notification and Assessment Scheme.
- Eliminating the requirement to prove harm or likelihood of harm from strict liability offences in the Act and reducing the maximum penalty for these offences.
- Amending provisions relating to aggravated criminal offences so as to require a likelihood of harm or injury.
- Strengthening offences in relation to the advertising of therapeutic goods.
Other proposed amendments include:
- Allowing the TGA to rely on assessments of specified foreign regulators when assessing medical devices (this is already the position so far as the evaluation of medicines is concerned). An applicant must “certify that an appropriate conformity assessment procedure, or an equivalent procedure carried out by a comparable overseas regulator, has been carried out in relation to medical devices of that kind”.
- Strengthening monitoring in relation to biologicals and record keeping requirements in particular.
These proposed changes represent a significant opportunity for sponsors of new products to obtain regulatory approval more quickly as well as sponsors of complimentary medicines who will be able to make certain permitted therapeutic claims as well as apply to the TGA in relation to the making of broader therapeutic claims.