The long awaited Commonwealth Government Response to the Expert Review of Medicines and Medical Devices Regulation was finally published on 15 September. The response received breathless news coverage around TGA only rejecting one recommendation (for final product approvals to be the prerogative of the Chief Medical Officer). On closer reading – it’s clear that a number of the more contentious issues have been deferred or accepted-in-principle, with no clear information on how they will be dealt with, essentially kicking the can down the road.
Third Party Assessment
The recommendations to progress to multiple pathways to registration of medical devices, including potential TGA designation of Australian Conformity Assessment bodies was supported “in principle” with the detail yet to be developed and subject to further rounds of consultation. One of the potential weaknesses of the Australian devices regulation is that it is currently highly reliant on CE certification for most of its regulatory decision making. Although some higher risk devices are subject to desk audit of Technical information and a few are directly assessed by TGA, the truth is that the large majority of devices are registered in Australia based on CE certification alone. TGA simply doesn’t have the resource to do all the assessments itself and the agency is completely dependent on a stable European regulatory framework.
In reality, the same organisations which act as European Notified Bodies achieve accreditation as registrars or assessors in multiple markets (similar arrangements apply in Canada and Japan and to some extent in the USA, as well as many emerging markets). This is leading to an increasingly globalized third party assessment system. The possibility of designation of Australian assessors holds out the prospect for greater independence and less direct reliance on Europe and may provide incentive for European Notified Bodies to set up more substantial Australian operations, providing greater choice to local manufacturers.
Postmarket regulation: not yet for registries
The Expert Panel was enthusiastic about strengthening postmarket regulation of high risk devices, and especially on all Class III implants being recorded in registries. This was always a controversial recommendation, with issues of control and governance of registries, access to data, as well as funding all uncertain. The Commonwealth has deferred consideration of this recommendation citing concerns about funding and data access.
Rewriting the Act?
The Panel was of the view that Therapeutic Goods Act is in need of a serious overhaul and shoud be be completely re-written to reflect contemporary realities. While accepting the principle of this idea, the Commonwealth response is worthy of Yes Minister’s Sir Humphrey, proposing to implement the intent during the course of other legislative changes where possible and then making a later assessment on the need for a more comprehensive review taking into account costs of redrafting against benefits. Don’t hold your breath.
Full Cost Recovery in Doubt?
The Commonwealth also deferred consideration of recommendation 32 – which proposed consideration of allocation of additional funding from government for pubic good purposes. This goes against the current full cost recovery model. The Commonwealth response was again suitably ambiguous, wrapped up in prose about consideration of whole-of-portfolio perspectives. In these cash strapped times for the Commonwealth, don’t expect any major changes to the TGA funding model.
One curiosity was the support of the intent of recommendation 31, to reorganize TGA along functional lines – integrating premarket assessment of medicines and devices, postmarket monitoring for different product groups and the like. TGA has not very long ago abandoned precisely such a model, reverting to a Product based organisation which arguably makes the best use of scarce resources. More importantly, the response hints at continuing to look for ways to combine clinical assessments for product safety with those for reimbursement.
All in all, there’s nothing too controversial in the government response. Many of the recommendations of the Expert Panel were already under active consideration anyway, especially broadening of third party assessment, where TGA has been actively undertaking Confidence Building measures involving observed audits and other reviews of Notified Bodies. These activities are directed towards being able to accept certifications from certain Notified Bodies without further TGA review – even for high risk devices. The Commonwealth has accepted the straightforward and practical, but has neatly avoided any immediate commitments around funding or organisational change. The proposal to rewrite the Act is firmly in the too hard basket.
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