Yesterday, the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 received Royal Assent.
As a result, the second tranche of reforms to the Therapeutic Goods Act 1989 (Cth) (Act) which implement recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation are now in effect.
This includes the following changes:
- a new regulatory pathway for provisional marketing approval of prescription medicines based on preliminary data, with a view to allowing patients with significant unmet clinical needs to obtain earlier access to new medicines;
- changed processes for listing intermediate risk medicines whose indications fall outside the lower-risk Permitted Indications List - such medicines will be included in the ARTG after sponsor self-assessment and certification regarding the safety and quality of the product, and evaluation efficacy data supporting the proposed indications; and
- enhancement of the TGA’s enforcement powers including conferring powers on the Secretary to seek injunctions (including interim injunctions) from the Australian Federal Court or the Federal Circuit Court to compel a person to engage in particular conduct or to prevent them from engaging in particular conduct.
In addition, after some debate and negotiation during the passage of the reforms through the Australian Federal Parliament, implementation of changes to the direct-to-consumer advertising regulatory framework have been delayed. These advertising amendments will now take effect on 1 July 2020, including as follows:
- abolishing the Complaints Resolution Panel, at which point the Department of Health will be the authority responsible for handling advertising complaints;
- removing the requirement for pre-approval of advertisements in relation to certain therapeutic goods in particular forums; and
- significantly increasing the penalties and sanctions available in respect of advertising offences.
If you have any questions regarding these reforms and how the amendments to the Act may affect your business, please do not hesitate to contact us.