Sussan Ley (Farrer, Liberal Party, Minister for Sport) Share this | Hansard source

I move:

That this bill be now read a second time.

I am pleased to introduce the Therapeutic Goods Amendment (2016 Measures No.1) Bill 2016, which amends the Therapeutic Goods Act 1989.

A number of the measures in this bill support the recommendations made by the Expert Panel Review of Medicines and Medical Devices Regulation about improving key aspects of the regulatory scheme for therapeutic goods.

The reforms reflect extensive consultation undertaken by an expert panel led by Emeritus Professor Lloyd Sansom AO, a distinguished educator, researcher and policy adviser in the health and pharmaceutical sectors. Professor Sansom was assisted by Mr Will Delaat AM and Professor John Horvath AO.

The review found that the Therapeutic Goods Administration is well respected internationally and benchmarks well against overseas regulators. However, it also identified areas for improvement, particularly in relation to providing industry with more flexible and timely pathways to market; enabling patients to access new medicines and medical devices faster; increasing collaboration with overseas counterparts to minimise regulatory burden; and enhancing post-market monitoring of the safety of products.

The purpose of this bill is to make a number of such changes that will enable members of the public to have access to medicines and medical devices more quickly, while continuing to maintain high standards of safety and efficacy which the public expects, as well as decrease the regulatory burden on industry and on medical practitioners.

The bill includes measures which support the introduction of new expedited pathways for the marketing approval of certain medicines and medical devices, by providing a regulation-making power to set out the details of the new pathways for priority review. The detail will be set out in the regulations and will include, for example, the criteria for goods to utilise these pathways, how to apply, what fees may apply et cetera. Such details will be the subject of extensive consultation with industry and other relevant stakeholders before any such regulations are made.

Expedited pathways for the registration of certain new medicines are intended to facilitate earlier access for patients with serious and life-threatening conditions who have unmet clinical need. Expedited review processes will also be available for certain medical devices that are identified as novel, such as a device which represents a use of a breakthrough technology and also meets the criteria of addressing an unmet clinical need. The criteria for these pathways are currently being developed in close consultation with consumers, health professionals and industry.

Recognising that some important new medicines will be available to patients at an earlier stage, the medicines and medical devices review recommended that the current post-market monitoring framework in Australia be enhanced through a more comprehensive monitoring scheme for medicines and medical devices. The bill supports the implementation of this measure by enhancing compliance requirements for medicines sponsors.

The bill supports another review recommendation to allow certain kinds of variations that do not impact the quality, safety or efficacy of medicines to be made through notification. This approach is similar to practices adopted overseas. The bill provides for regulations to identify what are likely to be low-risk, straightforward changes to product details.

The bill also contains measures to support the review recommendation to allow easier access to certain unapproved therapeutic goods by health practitioners through notifying the TGA rather than by requiring pre-approval.

The bill provides for regulations to be made to allow Australian companies to undertake conformity assessments of the manufacture of medical devices in Australia, rather than the TGA or overseas-based assessment bodies being the only ones able to do such assessments. The precise nature of these details will be the subject of extensive stakeholder consultation before any regulations are made.

The bill also provides for regulations to prescribe time periods within which decisions in relation to listed complementary medicines must be made.

These timeframes would be the subject of industry consultation before being implemented in regulations. This change removes a barrier to bringing innovative products to market—statutory timeframes provide a degree of certainty and allow sponsors to plan for the rollout of a new listed product containing the new ingredient.

The bill provides review and appeal rights for sponsors seeking approval for the use of a new ingredient in listed medicines.

The bill includes measures to support the intent of other review recommendations in relation to consolidating TGA advisory committees. A number of minor amendments in the bill aim principally to achieve greater consistency between the regulation of different types of therapeutic goods and to reduce health risks to the public.

I commend the bill to the House.

Debate adjourned.

See this speech in context