What’s happening in regulation?

John SkerrittDeputy Secretary for Health Products RegulationCommonwealth Department of HealthCMA Annual Conference – September 2016

Health Products Regulation Group Structure

Medicines Regulation

Medical Devices and Compliance

Prescription Medicines Authorisation

Complementary and OTC Medicines

Pharmacovigilance and Special Access

Medical Devices

Laboratories

Manufacturing Quality

Regulatory Engagement and Planning

Regulatory Services and Improvement

Regulatory Practice, Education and

Compliance

Office of Drug Control

Medicinal Cannabis

Drug Control

Scientific Evaluation

Health Products Regulation Group

Deputy Secretary

Principal Medical Adviser

Principal Legal and Policy Adviser

Department of HealthSecretary

Regulatory Reforms

Regulatory Practice and

Support

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TGA stakeholder survey 2016• A requirement for the Government’s Regulator Performance Framework • 2810 responses: 449 health professionals, 65 consumers, 1628 from industry

• Results remarkably positive in terms of trust and confidence in the regulator– 79 % of industry have high/very high confidence in TGA safeguards – 61 % of community/ consumer groups with 27 % ambivalent/ unsure

• Users satisfied or very satisfied with TGA consultations (63%), exhibitions (75%) and information sessions (82%) respectively.

• Main area for work is to TGA to engage more actively with consumers – They are aware of, and have a generally favourable perception of the TGA, but many unsure – Consumers also felt least engaged in TGA policy consultations

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The review process• Two reports on medicines and devices and complementary

medicines and advertising released during 2015

• Review process included discussion papers, submissions and interviews with key stakeholders. Followed by stakeholder workshops and other meetings to get feedback

• Department considered stakeholder feedback and advised Minister took her preferred position to Cabinet

• Government intent released in May 2016 budget, and full response released in September 2016

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Overarching principles for regulation as endorsed by Government • The Australian Government retain responsibility for

approving the inclusion of therapeutic goods in the ARTG– Rather than automatically accepting international approvals– However need to make much greater use of overseas evaluations

• Need to introduce greater flexibility in approval pathways • TGA could more appropriately align level regulation with the

actual risk posed by the products in certain areas7

Seven bundles of work agreed and costed1. Increasing Flexibility for Registration and Post-Market Processes for

Medicines2. Increasing Flexibility for Approval and Enhanced Post-Market

Monitoring of Medical Devices3. Increasing Flexibility for Pre-Market Approval and Increased Evidence

of Efficacy of Complementary Medicines for Consumers4. Simplified and More Effective Regulation of Advertising 5. Streamlined Regulation of Patient Access to Therapeutic Products6. Further Reviews7. Rationalisation of TGA Statutory Advisory Committees

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Complementary Medicines changes1. Streamline transparency and predictability of regulation:

– Better regulatory guidance materials– Catalogue of approved ingredients– Introduce permitted indications for Complementary Medicines– Adopt/ develop evidence monographs– Right of review for applicant of TGA decisions on ingredients – Establish ingredient assessment timeframes– Continue stakeholder input through an advisory committee

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2. Increasing the transparency of evidence of efficacy for particular indications

– Sponsors encouraged but not mandated to publish efficacy evidence– Greater education on what AUST-L means, but sponsors not required

to publish a label disclaimer– A new class of complementary medicines with efficacy assessed by

TGA prior to market authorisation. Sponsors would be allowed to make higher-level claims than listed CMs.

– Closer linkage to advertising claims

3. More use of overseas assessments for new ingredients10

4. Increased postmarket monitoring and compliance • More products to be subject to random and targeted post-market

review• Timely information on products subject to post-market review• Intent of R 34 (TGA being able to refuse to list particular products) is

able to be achieved through current mechanisms (allowing CMs to contain only permitted ingredients and targeted reviews by TGA of products immediately post-listing)

5. Improving the competitiveness of the complementary medicines industry by providing incentives for innovation• Could include consideration of data protection; use of “listed-plus”

pathway; and advice service for SMEs 11

Increase use of risk-based approaches to manage medicine variations• Notification of variations to TGA where the variation does not

impact quality, safety or efficacy of the product– Harmonise with the EMA approach

• Assessment of the variation by TGA if the variation could impact safety, quality or efficacy – Focus specifically on the impacts of the variation

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Strengthening of post market monitoring: recommendations accepted

• Better integration and timely analysis of available datasets (including matched de-identified data from PBS and MBS)

• Electronic reporting of adverse events

• Issue of potential Complementary Medicine interactions with prescription medicines highlighted

• Enhanced information-sharing with overseas regulators

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Further reviews to be undertaken• Medicines Scheduling Policy Framework

• Schedule 3 medicine advertising Guidelines

• Review regulation of lower-risk medicines– Should low-risk products such as homeopathic

and aromatherapy products be regulated as general consumer goods?

– What about vitamins and mineral supplements?

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SME regulatory assistance and clearer regulatory guidance• Aim is to help small business navigate

the “regulatory maze” through advice, guidance documents and workshops

• Builds on work by TGA Regulatory Assistance Team

• Would not replace detailed product-specific advice provided by regulatory consultants

Source: Freeimages.com (Steven Goodwin) 15

Other Recommendations

• Comprehensive review of the Therapeutic Goods Act and Regs - deferred

• The Government review and enhance TGA’s funding model – deferred

• CMO to become decision maker (rather than TGA delegate) for all medicines and devices decisions – not accepted

• Complementary medicines advisory committee - maintained16

Advertising of therapeutic goods• Advertising of therapeutic goods to the public continues to be regulated

by TGA under a framework which includes an advertising code

• Abolish mandatory pre-approvals of advertising, and move to a self-regulatory regime

• New mechanism for managing complaints managed in a streamlined process through a single agency

• Investigation and enforcement powers around advertising to be broadened

• TGA to run sponsor education programs to assist in achieving compliance17

How will we pay for the reforms?• Government agreed that we could use TGA

reserves (and 2015/16 surplus) to pay for cost of design of reforms and implementation of new systems

• Separately a systematic evaluation of appropriate fees and charges will be needed:– For new (e.g. enhanced comp meds

compliance) and existing activities – So fees and charges may change

Source: Freeimages.com (Adrian van Leen) 18

A great opportunity to implement some important reforms… but with some big challenges for TGA

Source: Freeimages.com (Schalk Bergh) 19

Having a wider variety of medicines and devices approval pathways available will add to complexity

Source: Freeimages.com (Jeff Prieb) Source: Freeimages.com (78thelem)

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We are required to utilise international assessments much more widely… but what if other regulators are less driven to share?

Source: Freeimages.com (Ned Horton) Source: Freeimages.com (Joe Zlomek)21

Yet… Stakeholder expectations are very high after years of waiting for reform

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Implementation and Governance• A broad plan for implementation over the next 2 years has been

agreed by Government

• We will also consult closely with stakeholders in developing the finer detail on implementation, including assessment of regulatory impacts and fees and charges

• TGA has been empowered to work out much of the detail on how specific changes could be implemented – But we will need to go back to government for approval, in particular

where changes to the TGA Act or Regulations are needed 23