An overview of recommendation fifty from the Review of Medicines and Medical Devices Regulation relating to incentives for innovation for the complementary medicines sector.

1. Complementary medicines MMDR reforms
Innovation for the Complementary
Medicines Sector
Lyndall Soper
Assistant Secretary, Complementary and OTC Medicines Branch
Medicines Regulation Division, TGA
Regulatory Obligations Seminar – Panel Discussion
11 April 2017

2. Incentives for Innovation
Recommendation 50
The Panel recommends that the Australian Government gives
consideration to improving the competitiveness of the
Australian complementary medicines industry by providing
incentives for innovation.
Government response
The Commonwealth accepts-in-principle Recommendation
Fifty, noting the cross government responsibility for innovation
policy.
Complementary Medicines: Regulatory Obligations Seminar – 11 April 2017 1

3. Incentives for Innovation
• 2 options to incentivise innovation were proposed in consultation paper;
– Market exclusivity – prevents others from entering the market
 Available for new ingredients
– Data protection – protection of clinical trial data from use by others
 Available for the new pathway
• Incentives aim to encourage generation of evidence based research – not
available for marginal innovations
• The TGA will not undertake compliance monitoring to enforce data
protection or market exclusivity periods.
Complementary Medicines: Regulatory Obligations Seminar – 11 April 2017 2

4. Proposed protection for new ingredients
2 years market exclusivity to successful applicants for new
ingredients approved for use in listed medicines
Market exclusivity will prevents others from using the ingredient during the exclusivity
period
• e.g. the ingredient would be included in the permitted ingredients list, but other
sponsors could not use that ingredient to enter a product in the ARTG during the
period of exclusivity
Additional considerations
Allowing other applicants to apply to use the ingredient during the exclusivity period
using their own data
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5. Proposed protection for efficacy data
3 years data protection for applicants of medicines containing new
ingredients approved via the new pathway
• Applicants will need to provide clinical data on the finished product (i.e.
Method 1)
• Subsequent sponsors cannot use this data during the protection period to
support efficacy claims for a similar product – they must supply their own
clinical data
Additional considerations for expanding the protection
• published clinical studies that refer to a specific brand named product or
• new uses for existing products
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6. Timeframes
The timeframes proposed aim to support returns on
investment and encourage innovation:
• 2 years market exclusivity period for new ingredients
• 3 years data protection for efficacy data.
Rationale
Timeframes are less than the existing 5 year protection period for registered
medicines which reflect:
• Lower levels of effort, cost and time involved in preparing applications for
evaluation.
• Lower level of research needed to meet the evidence requirements.
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7. Outcomes of Consultation
Market exclusivity for new ingredients
• Broad support for market exclusivity for new ingredients from industry, academic and
consumer stakeholders
• Concerns that the incentives unfairly advantage large sponsors over SME’s
• Proposed timeframes were generally well supported.
Data protection for the finished product (efficacy data)
• The views of industry stakeholders are mixed:
– Some industry stakeholders suggested that protection should only be available
provided the “use” is not already in the public domain.
– Some industry stakeholders suggested the ‘claimer’ is sufficient reward for investment
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8. Questions?
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