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Thursday, September 29, 2016

Most of the Sansom review's recommendations have been accepted but is the Government really prepared to dispense the changes Sansom has prescribed?

By Sarah Matheson, Partner, and Ric Morgan, Special Counsel

In March and July 2015, the Expert Panel Review of Medicine and Medical Devices Regulation – which became known as the Sansom Review – reported its findings and recommendations to the Government. The Sansom Review was tasked with undertaking a systematic examination of how Australia regulates the sale of medicines and medical devices in this country. It offered up a raft of recommendations touching on legislative reform, who should have a say in making these decisions and how the process should work.  Now, more than 15 months later, we have the Government's response. So, does this mean we can expect a healthier regulatory scheme for medicines and medical devices?

Don't get your hopes up – it’s not clear that the Government will be taking the medicine Sansom has prescribed. While only two of the 58 recommendations have been rejected, the remaining responses from the Government cover a spectrum from  deferral to support of intent to  in principle support and also acceptance, with the overriding impression being that there will only be incremental change to the Government regulation of medicines and medical devices.

This may stem from the nature of the recommendations in the Sansom Review, many of which go to the overall approach of the TGA. Even where the Sansom recommendations address specific issues, it might be said they lack changes which can be implemented readily or at all – they lack any real detail of what legislative changes might actually be required.

It may also be a result of the very nature of Australia's current regulatory system. Unlike some other countries (notably the US), Australia's legislative scheme is not prescriptive, particularly in relation to regulatory pathways for new medicines and medical devices. Rather, we have non-binding guidelines and administrative practice. There is no specific direction in the Sansom Review as to which specific guidance materials (such as European Medicines Agency's  Committee for Medicinal Products for Human (CHMP)), should be adopted or followed.

With that in mind, let's look at the Sansom prescription, and what the Government has dispensed.

The TGA's role [recommendations 1 – 2]

In the first two recommendations, Sansom simply prescribed that the TGA maintain its current role and that Australia maintain drug assessment capability. Unsurprisingly, the Government response endorses this given it only requires that the TGA keep doing its current job and remain funded to do so. The latter is medicine easily swallowed in circumstances where the TGA "will recover cost from industry".

Getting a medicine registered [recommendations 3 – 14]

This group of 12 recommendations, if implemented, has the potential to reshape the regulatory approval process for therapeutic goods in Australia. Broadly speaking, the recommendations suggest that new pathways for approval be implemented, with three alternatives for new drugs and two for follow-on products. For new products these are:
  • submission of complete dossier (as now) but with the option of work sharing arrangements for assessments with other regulators;
  • submission of one (previously two) unredacted copy of an assessment of the product elsewhere with additional Australia specific details; and
  • a new expedited pathway for medicines meeting particular criteria (such as urgent need or breakthrough treatments) including transparency around the criteria.
For the follow-on products these are:
  • submission of complete dossier (as now) but with the option of work sharing arrangements for assessments with other regulators;
  • submission of one (previously two) unredacted copy of an assessment of the product elsewhere with additional Australia specific details; and
    • for generics, bioequivalence/interchangeablity data against the Australian product; or
    • for biosimilars, evidence that the overseas reference product and the Australian reference product is the same.
The Sansom Review  also made recommendations intended to reduce overlapping regulatory systems.

Each of these has been accepted.  However, there were important caveats. For example:
  • Changes to the evaluation of new medicines "will only be achievable in the longer term".
  • For the proposals aimed at facilitating biosimilar registration – an area where the new pathway would be a significant reduction in the regulatory burden – "implementation of the multiple pathways will only be viable in the longer-term".
  • The Government has only committed to "consult with stakeholders" in response to Sansom's recommendation that there be transparency around the criteria for access to accelerated pathways for new medicines. There is therefore clearly some way to go before this treatment could result in a cure.
  • In relation to the overlap with other regulatory schemes including drugs and poisons scheduling and excluding products from regulation, again the Government has preferred consultation over surgery aimed at cutting out the overlapping schemes currently in place.

Medical devices [recommendations 15 – 23]

The nine recommendations covered:
  • new pathways for approval of medical devices including greater transparency over which overseas agencies will be acceptable and harmonisation, particularly with European assessment frameworks;
  • introduction of registries for high risk devices; and
  • reclassification of existing devices.
Of these nine recommendations, one is deferred and two are accepted in principle, with the remaining six being accepted fully. It is difficult to understand how these distinctions were drawn, with the deferred and in principle acceptances seemingly requiring no less consultation before implementation than others that are accepted. For those accepted recommendations, there seems to be no clear indication of how these will be implemented. If the Government response is just the beginning of the process, then it gives rise to the question why has it taken so long?

Access to medicines that don't have Australian marketing authorisation [recommendations 24 – 26]

Three recommendations aimed at simplifying access and increasing transparency have been accepted.  However, it needs to be recognised that these recommendations are essentially aimed at implementing better ways of doing what is currently done. The Government response does nothing to suggest how this goal will be achieved.

Post market monitoring [recommendation 27]

The prescription for more comprehensive post-market monitoring of medicines and devices has been partly accepted, but again, there is no detail about how this will be implemented. It is likely to require some legislative change, so until draft legislation is developed, whether this medicine will be effective remains to be seen.

Legislative reform [recommendation 28]

The Sansom prescription was for a comprehensive review of the Therapeutic Goods Act and its associated regulations to make it more user friendly. This has been met with a polite in principle acceptance but, in essence, the response that this will be done "when implementing agreed changes to legislation" represents no more than agreeing to dispense the medicine when it comes into stock rather than making any effort to bring that new medicine to market.

Changing the decision maker, advisory structures and funding [recommendations 29 – 32]

In a rare rejection, the Government did not accept the Sansom prescription that the Australian Government’s Chief Medical Officer be the decision maker for marketing approval advised by reworked versions of the current committees. The Sansom prescription aimed to facilitate cooperative decision making within the TGA, and better engagement with sponsors. The Government response suggests that the rejection is because the patients (ie industry stakeholders – including both health professionals and consumer groups - who strongly opposed this recommendation) didn't like the medicine. However, this misses the point.  These groups reportedly didn't like "delegating decision-making to a single person [that would] slow approval processes and lead to a significant backlog of applications". Yet this is what happens under the current system, where it is the Secretary who decides what will be given marketing approval. The recommendation was to shift the approval power to a person the Sansom Review considered had the appro
priate skill set.

Changes designed to bring medicines scheduling (which includes drugs within the schedules depending on their characteristics and risks to facilitate different levels of control over access) within the TGA's committee structure were also rejected. Currently, while the TGA is a part of this decision making process, States and Territories also have input and the scheme looks at drugs and poisons together. Any change is likely to require States and Territories to agree. It seems the bitter pill of State and Territory buy-in has simply been too difficult to swallow.

Similarly, the Sansom prescription for improved organisational structures was considered by the Government as having potential benefits, but the Government's response simply keeps up the same treatment regime of "recent organisational changes…to address process alignment and implement collaborative mechanisms" instead of the reorganisation that appears to have been intended.

The Sansom recommendation for dedicated funding to the TGA has been deferred. It seems the Government wants industry to remain the primary payer.

Reworking the complementary medicines regulatory framework [recommendations 33 – 51]

The Samson Review recommended a broad change to the policy approach to complementary medicines which would:
  • allow the refusal of listing of a product on public health policy grounds – not currently an option;
  • set up new pathways and processes for assessment including:
    • assessing efficacy in some circumstances;
    • similar reliance on and cooperation with overseas regulators as was recommended for medicines;
    • new time frames; and
  • a requirement that sponsors publish the evidence that supports the indications they claim for the products.
While the majority of the Sansom prescriptions for the complementary medicines regulatory framework have been accepted, there is no detail about how the medicine required will be dispensed. Those responses that have been accepted appear to either allow the Government to continue with business as usual or are reliant on further steps including legislative change. This may not translate into real change anytime soon.

For some of the recommendations, particularly where implementation would be an impost on industry, the Government supports the intent but apparently wants to rely on industry self regulation and further consultation.

The therapeutic goods advertising and complaints framework [recommendations 52 – 58]

The Sansom prescription for advertising would have the system substantially reworked, removing pre-approval and providing consistency across all therapeutic goods. In relation to complaints, there was also major change recommended, with the TGA to take control from the current industry based review committees and to be given broader investigatory and enforcement powers.

While this has been accepted, the Government's response is unlikely to cure the dissatisfaction of those most critical of the current system in relation to how complaints about advertising are dealt with by industry and the TGA. The continued reliance on self-regulation, and the Government's lack of commitment to greater transparency or consistency across all types of therapeutic goods are likely to remain matters of concern to consumer representatives.

In summary, with the exception of those recommendations that support the status quo, the Government has left itself room to avoid effecting much by way of meaningful change in the near future by:
  • accepting recommendations only in very broad terms; 
  • suggesting that any proposed changes will not apply across the scope of the relevant recommendation – thereby allowing the actual response to be limited and selective; or
  • committing merely to further consultation.
There seems to be little real commitment to address the Sansom recommendations in a substantive fashion that will drive real change, giving rise to the question of whether the relevant political will exists to do so.

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