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Tuesday, December 20, 2016

Legislation to implement the Sansom review recommendations clarifies the Government response. We now have an interesting framework for implementation but the details are still to come.

By Ric Morgan, Special Counsel

A little over two months ago we wrote that the Government response to the Sansom review provided no clear indication 'the Government will be taking the medicine Sansom has prescribed'. The ongoing release of information and active consultation by the TGA is much more encouraging than our original prognosis.

One reason we thought might explain the ambivalent Government response was the nature of the Sansom recommendations themselves. They did not include any real detail of what legislative changes might actually be required.

The introduction of the Therapeutic Goods Amendment (2016 Measures No 1) Bill to parliament on the last sitting day for 2016 provides a framework for the changes required to implement some of the Sansom recommendations. It is anticipated that the Bill will have bipartisan support and will become law early in the new year. However, the detail remains unclear—much is left for new or amended regulations. The fact there are no draft regulations yet is unsurprising as many of the details are matters on which the TGA is still consulting with stakeholders.

On the Sansom recommendations as detailed in our previous post, we look at what is achieved by the proposed legislation. We identified "groups" of recommendations.  The Bill seems to address some (but not all) of these including:
Summary of Sansom recommendation Comment
Recommendation 3
Three pathways to obtain registration of a new chemical entities:
Pathway One: Submission of a complete dossier for de novo assessment including using assessment by comparable overseas NRAs. Not addressed
Pathway Two: Reliance on assessment by a comparable overseas NRA with minimal Australia specific assessment. Not addressed
Pathway Three: An expedited approval pathway in certain circumstances. Schedule 6 provide a framework to facilitate this aspect of the recommendations with details to be provided in the regulations.
Recommendation 13
1. Notification of variations to the Australian NRA in circumstances where the variation does not impact the quality, safety or efficacy of the medicine; to be harmonised with the European approach. Schedule 1 provides a framework to facilitate this with details of what will be permitted to be will be addressed in the regulations
2. Abridged assessment of the variation by the Australian NRA in circumstances where the variation has the potential to impact the safety, quality or efficacy of the medicine. Not addressed
3. Reduced legislative timeframes for abridged assessments. Not addressed
4. Fees for abridged assessments that reflect cost recovery principles. Not addressed
5. Electronic submission of data. Not addressed
Recommendation 15
1. Class I, non-sterile and non-measuring devices, continue to be included in the ARTG on the basis of a self-assessment by the device manufacturer. Not addressed
2. Timely access to devices that are safe, high quality and fit for purpose, using here be multiple pathways:
Pathway One: Conformity Assessment to occur within Australia by the Australian NRA or accredited private operators.
Pathway Two: Reliance on marketing approval for the device in an overseas market
Schedule 2 only provides a framework to facilitate the use of private operators accredited by the NRA with the details to be provided in the regulations.
Pathway Three: Expedited approval of medical devices in certain circumstances. Schedule 6 provides a framework to facilitate this aspect of the recommendations with details to be provided in the regulations.
Recommendation 24
1. The current criteria and processes for Category A Special Access Scheme patients remain unchanged.
2. The Australian NRA to develop and apply transparent criteria for identifying Category B applications that could be subject to automatic approval.
3. The Australian NRA to continue to require individual assessment and approval for the remaining Category B products.
Schedule 3 is said to address this recommendation but in fact provides an alternative scheme.  The proposed framework will allow supply by health practitioners  of certain types of therapeutic goods without those goods being on the ARTG subject to the health practitioner notifying the TGA of the supply. This is quite a different access scheme than was contemplated by the recommendation which proposed automatic approval in certain circumstance.  The practical difference will not be clear until the regulations are made.
Not all health practitioners will be permitted to supply using these exceptions.  Notable exclusions are chiropractors, Chinese medicine practitioners, osteopaths and a subset of dental practitioners.
Interestingly, the scheme set up for medical devices may make it more straightforward for customised medical devices as 3D printing now facilitates to be more readily accommodated by Australia's regulatory scheme.
Recommendation 27
Development of a more comprehensive post-market monitoring scheme for medicines and medical devices including:
1. Better integration and timely analysis of available datasets, including analysis of matched  data from a range of Government, hospital and insurer databases.
2. Registries for all high-risk implantable devices;
3. Alerts to practitioners and consumers for new drugs encouraging reporting of any adverse events;
4. Electronic reporting of adverse events; and
5. Enhanced collaboration with overseas NRAs.
Schedule 8 implements new requirements that:
  1. require particular types of records to be kept;
  2. allow further record-keeping requirements to be imposed by regulation; and
  3. permit the TGA to investigate and monitor record-keeping required.
While it is said these changes support recommendation 27, they appear simply to provide an incremental increase in the record-keeping requirements and powers of entry that the TGA can already exercise.
Recommendation 41
Development of legislative timeframes for the:
A. assessment of new ingredients for use in listed medicinal products;
B. publication of finalised compositional guidelines for newly approved ingredients for use in listed medicinal products;
C. assessment of medicinal products listed under Option Two; and
D. registration of medicinal products under Option Three.
Schedule 7 adds regulation making powers that will permit regulations associated with the time requirements in recommendation 41. However, they will expand the regulation making power generally instead of addressing the particular concerns raised by the Sansom review. 
The actual time requirements, if any, will be part of the new regulations.
Recommendation 42
Consistent with recommendation 13, the NRA should  adopt a risk-based approach to the management of variations to complementary medicines listed in the ARTG providing for:
A. variations by notification if the variation does not impact the quality, safety or efficacy of the product; The amendments schedule 1 provide a framework to facilitate this aspect of the recommendations, with detail to be provided in regulation.
B. abridged  assessment of the variation by the NRA which only considers aspects that require evaluation in order to establish the continued safety, quality and efficacy. Not addressed
Recommendation 47
Implementing review and appeal rights for sponsors who have lodged an application for a new ingredient for complementary medicines Schedule 5 provides the relevant appeal rights to the applicant  on refusal.  It also appears to allow any person with a relevant interest to seek to have a positive recommendation reviewed or appealed.

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