Senate debates

Wednesday, 3 December 2014

Questions without Notice

Therapeutic Goods Administration

2:50 pm

Photo of Zed SeseljaZed Seselja (ACT, Liberal Party) Share this | | Hansard source

My question is to the Assistant Minister for Health, Senator Nash. Will the minister advise the Senate what the government is doing to give Australian patients access to the latest, most innovative therapeutic treatments in a timely manner?

Photo of Fiona NashFiona Nash (NSW, National Party, Assistant Minister for Health) Share this | | Hansard source

I thank Senator Seselja for his question and for his interest in this matter. I am pleased to inform the Senate that the government has announced an expert review of medicines and medical devices. Emeritus Professor Lloyd Sansom AO will chair the expert review panel. Professor Samson has extensive experience in the pharmaceutical sector. He played a major role in the development of Australia's National Medicines Policy and is a former longstanding chair of the Pharmaceutical Benefits Advisory Committee. He will be joined on the panel by Mr Will Delaat AM and Professor John Horvath AO. The review will examine Australia's regulatory framework for therapeutic goods which is administered by the Therapeutic Goods Administration in order to identify opportunities to modernise regulations, to ensure Australians can access the latest treatments in a timely manner and areas of outdated or irrelevant regulation which have built up over time and need to be streamlined.

This review complements the government's industry innovation and competitiveness agenda. It is a key step in efforts to remove ineffective regulation and encourage greater competition and innovation in the medicines and medical devices sectors.

Medical technology is constantly evolving and Australia needs a modern regulatory framework to ensure consumers can access new technologies without unnecessary delays. This review will in in way jeopardise the safety and quality of medicines and medical devices marketed in Australia. Consumer protections are paramount.

The expert panel recently released a discussion paper to inform the public consultation process, and I encourage all stakeholders to contribute their ideas. The panel will provide recommendations for prescription and over-the-counter medicines as well as medical devices by 31 March 2015, and opportunities in the complementary medicines sector will be reported during the second quarter of 2015.

2:52 pm

Photo of Zed SeseljaZed Seselja (ACT, Liberal Party) Share this | | Hansard source

Mr President, I ask a supplementary question. Thank you, Minister. I note that this expert review complements the government's innovation, competitiveness and deregulation agendas. How will this expert review help the government reduce red tape and strengthen Australia's competitiveness?

Photo of Fiona NashFiona Nash (NSW, National Party, Assistant Minister for Health) Share this | | Hansard source

Before the election, the coalition promised to cut red-tape costs by $1 billion each year, and the government is getting on with the job of cutting unnecessary regulation. Under the former government, almost 21,000 new regulations became part of our national life. Best practice regulation is necessary but it is fair to say that our therapeutic goods regulations are overdue for an upgrade. The terms of reference indicate the panel will consider changes to outdated or irrelevant regulations that have built up over time. If accepted by government, these recommendations will contribute to the annual red-tape reduction target.

Consistent with the coalition's industry, innovation and competitiveness agenda, the panel will benchmark the regulatory arrangements for therapeutic goods against trusted international competitors and explore how international evaluations can be better utilised to ensure timely patient access.

2:53 pm

Photo of Zed SeseljaZed Seselja (ACT, Liberal Party) Share this | | Hansard source

Mr President, I ask a further supplementary question. Can the minister update the Senate on the action the government is taking to promote innovation and competitiveness in the therapeutic goods sector?

2:54 pm

Photo of Fiona NashFiona Nash (NSW, National Party, Assistant Minister for Health) Share this | | Hansard source

This government is committed to building a modern regulatory framework that provides timely access to innovative treatments, supports Australian businesses and maintains the high standards of safety and quality that consumers expect. The coalition recently introduced new regulations to allow Australian manufacturers to obtain market approval for most medical devices, using conformity assessment certification from European notified bodies. With these changes, Australian manufacturers can choose to have conformity assessment conducted by either the TGA or a trusted European body. This will cut red tape and provide more flexibility for local manufacturers.

The new arrangements will also bring Australian manufacturers in line with the regulatory requirements for overseas manufacturers. Mr Chris Roberts, the CEO of Cochlear Australia, recently said, 'This change alone means thousands of Australians will have their hearing restored with the latest technology, sometimes up to a year earlier than otherwise may have been the case. The social and economic benefits of this change are immense.' (Time expired)