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Home > Ministers > The Hon Catherine King MP, Parliamentary Secretary for Health and Ageing > Media Hub > Speech to the AUSBIOTECH CEO FORUM - Parliament House, Canberra - Wednesday 14 March 2012

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PDF printable version of Speech to the AUSBIOTECH CEO FORUM - Parliament House, Canberra - Wednesday 14 March 2012 (PDF 314 KB)

15 March 2012

Check Against Delivery
[Acknowledgements omitted]

Thank you for inviting me to discuss with you the recently announced reforms to the TGA.

It is a time of change at the TGA, and a timely opportunity to update you on the work in this area.

The TGA’s role of safeguarding and enhancing the health of the Australian community through the regulation of therapeutic goods has met significant scrutiny in recent times.

Public concern ranged across the work of the TGA from questions about the advertising of therapeutic products, to the claims made about the health benefits of complementary medicines, to issues surrounding the regulatory settings for high risk medical devices.

As Parliamentary Secretary for Health and Ageing, with executive responsibility for the TGA, I sought to examine the many criticisms facing the regulator, and established a number of reviews to identify opportunities for improvement.

The Auditor-General, as well as the TGA themselves, also commissioned reviews into areas of the TGA’s work.

Recent reviews of the TGA have included:

• A review to improve the TGA’s general transparency
• An Auditor General’s report on the TGA’s regulation of complementary medicines
• An informal working group examining the regulation of complementary medicines and the reason for low compliance rates when applications are made
• Public consultations on the regulatory framework for advertising therapeutic goods
• A working group to look at the promotion of therapeutic products to health professionals
• Public consultations on the medical device regulatory framework and
• The Health Technology Assessment Review

In examining these reviews and their associated recommendations, I formed the view that a comprehensive response, which mapped the path ahead for the TGA, was required.

In December last year, I announced the TGA Blueprint, which touches upon all facets of the TGA’s work and, when complete, will set the TGA on a stronger footing both in regard to its relationship with its stakeholders – the Australian public, as well as yourselves in industry – and will ensure the more effective and efficient regulation of therapeutics.

The implementation of these reforms will take place in phases over time. Some can be actioned quickly, others will take some targeted consultation and will require a little time.

A detailed implementation plan is currently being finalised. This will be made public soon and will set out the concrete plan of action.

The reforms are grouped into the following themes:

• Communication and stakeholder engagement
• Advertising of therapeutic products
• Complementary medicines
• Medical devices and
• Promotion of therapeutic products to health professionals

In response to the concerns about the lack of openness and transparency, the TGA will adopt a strong focus on improving its communication and engagement with the community.

I have asked the TGA to establish the Australian Therapeutic Goods Advisory Council whose membership will be representative of its stakeholder base.

The Council will have a role in the oversight of the implementation and evaluation of all the recommendations resulting from the transparency review.

The Council will also play a role in the development of key performance indicators aimed at providing the best information on the TGA’s organisational effectiveness and operational efficiency.

The TGA will develop and implement a comprehensive communications strategy to inform and educate the community about how the products they may use everyday are regulated, and the process by which the TGA arrives at its decisions.

As an example – and a priority – the differences between registered and listed therapeutic goods, and the way they are evaluated, will be fully explained by the TGA to avoid confusion surrounding the different regulatory arrangements for these different styles of therapeutic product.

Further to this, the TGA will work to improve arrangements for the regulation of therapeutic goods advertising.

A central point for all advertising complaints will be created to streamline the process for resolution.

The TGA will conduct targeted stakeholder consultation on options for broadening the current arrangements for pre-approval of advertisements to include medical devices and advertisements for therapeutic goods on pay TV.

There will also be an opportunity for consultation on the development of a more effective approach to sanctions and penalties for breaches of advertising requirements to bring the current therapeutic goods advertising arrangements into line with other areas of government regulation.

The Blueprint sets out a number of reforms to medical device regulation.

The rigour of pre-market regulatory assessment of higher-risk medical devices will be increased to ensure an appropriate level of evidential review is undertaken before these products reach the market to assure safety, quality and efficacy of these devices.

In order for the TGA to better facilitate recalls of medical devices – an area that has received significant public interest in recent times – the TGA will amend the way in which a group of medical devices are included in the ARTG.

This will mean that when seeking to include a medical device on the register, sponsors will, in future, be required to nominate specific product names under each register entry for each kind of medical device.

These products will then be more rapidly identified by the regulator.

To improve the transparency of information about medical devices for consumers and health professionals, the TGA website will carry greater product information relating to medical devices.

The promotion of therapeutic products (including medical devices) to health professionals is also considered in the Blueprint.

From time to time, we have seen examples of industry inducements being offered to health professionals.

In response to this issue, my predecessor, Mark Butler established an industry Working Group to examine options to ensure that Australians receive the most appropriate therapeutic products for their conditions with no other influences.

I thank you for AusBiotech’s involvement on that Working Group and for your commitment to this work.

The Australian Government supports industry’s initiative to implement consistent and enforceable codes of conduct based on the framework of high-level principles developed by the Working Group on Promotion of Therapeutic Goods.

This is a powerful first step in strengthening the oversight of the relationship between health care professionals and therapeutic goods companies.

The Government is committed to achieving a level playing field in this area.

Our preference is to initially maintain the emphasis on self-regulation of industry codes of conduct and we strongly support these industry initiatives.

While some industry associations have strong codes of conduct in place, other sectors will require more time to achieve alignment with the Working Group’s high-level principles.

I received advice from some Industry bodies that the updating of codes would take some time.

I am committed to progressing this work and will be writing to each of the industry bodies involved seeking a report on the progress of implementing the recommendations in the report.

I look forward to hearing from AusBiotech in this context.

The work on codes of conduct by industry bodies will be scrutinised by the government and future regulatory options for achieving a level playing field will be considered if the necessary progress has not occurred.

Outside of the Blueprint reforms, your industry group has recent experience in regulatory reform at the TGA, with the new arrangements for In Vitro Diagnostic (IVD) devices.

The new regulatory arrangements for these devices came into effect in July 2010 and I understand that the transition of these devices under the new framework is proceeding relatively slowly.

I have asked the TGA to ensure it continues to work with AusBiotech during this transition period to provide any assistance necessary to accommodate this.

I hope that you will continue to encourage your members to work to implement the new arrangements for your industry group.

This quick outline covers just a small number of the reforms in the Blueprint.
In total, over 50 recommendations have been made.

The vast majority of these are either agreed to, or agreed to in principle, subject to some further consultation with yourselves and other key stakeholders.

The Government recognises that the Blueprint encompasses a complex range of interconnected actions which will require careful management, but is committed to the reform package which are fundamental to the open, transparent and appropriate regulation of medicines and medical devices that are to be supplied to the Australian marketplace.

When implemented, these reforms will improve Australians’ understanding of what the TGA does and the decisions it makes, most importantly enhancing the public trust in the safety and quality of the medicines and medical devices it regulates.

Thanks again for the opportunity to talk to you today.

With over 3,000 members in areas as diverse as therapeutics, medical technology (devices and diagnostics), food technology and agricultural, environmental and industrial sectors AusBiotech is an important voice for industry in the life sciences arena and the Government recognises the contribution you make across these diverse areas and values your engagement.

Thank you

Ends