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Regulation impact statement: Changes to premarket assessment requirements for medical devices
This RIS identifies the problem as concerns around:
- the increased level of pre market scrutiny for higher risk implantable medical devices prior to approval
- transparency in decision making
- third party conformity assessment, particularly for Australian manufacturers.
These concerns have been identified through multiple reports and inquiries, including the HTA review, TGA blueprint reforms, Senate Inquiries and through TGA consultation.
This RIS has considered the merits of the following three options:
- Taking no further action to change premarket assessment requirements for medical devices
- Changing premarket assessment of medical devices through targeted selection of Class IIb implantable and long term surgically invasive medical devices for mandatory audit, introduction of a Level 3 audit, staged publication of all medical device decisions (including negative decisions based on safety/efficacy concerns) and abolition of TGA conformity assessment for all medical devices (except Class 4 IVDs)
- Changing premarket assessment of medical devices to mitigate all foreseen risks through selecting all Class IIb implantable and long term surgically invasive medical devices for mandatory audit, subjecting all AIMD and implantable Class III medical devices for full TGA conformity assessment, and abolishing TGA conformity assessment for all medical devices (except Class 4 IVDs)
In addition, the impact of these options on consumers, the medical device industry, health professionals and government agencies has been analysed, together with the costs and benefits. Extensive consultation with industry and other stakeholders has occurred on the proposed amendments to the regulatory model and will continue to occur throughout the implementation phase.
|Option 1||Option 2||Option 3|
|Key issues (as outlined in the 'Problem' section)|
|Increased level of premarket scrutiny: AIMD and Class III implantable||Not addressed||Level 3 audit||Expanded requirement for TGA conformity assessment|
|Increased level of premarket scrutiny: Class IIb implantable||Not addressed||Expanded mandatory audit requirement54||Expanded mandatory audit requirement54|
|Transparency of decision making||Not addressed||Publication of TGA decisions||Publication of TGA decisions|
|Requirements for TGA conformity assessment for Australian manufacturers||Not addressed||Abolition of requirement||Abolition of requirement|
|Objectives (as outlined in the 'Objective' section)|
|greater assurance that higher risk medical devices approved do not compromise public health and safety||Not addressed||Level 3 audit and expanded mandatory audit requirement||Expanded requirement for TGA conformity assessment|
||No changes to timeframes for availability||Audits will extend times frames for targeted devices (weeks to months)||TGA conformity assessment will extend times frames for targeted devices (months to years)|
||No changes to regulatory burden and no additional costs||Increases regulatory burden and significant additional costs||Greater increase to regulatory burden and very significant additional costs|
||Not addressed||Instrument for additional mandatory audits allows risk management over time||Not addressed - options proposed are static|
||Not addressed||Minimises duplication of regulatory activity||Duplication of conformity assessment for AIMD and Class III implantable devices|
Note: the more ticks in a cell the greater the effect of the option on the key issue or objective. Crosses indicate no effect.
It has been argued that there is no clear evidence that increased premarket scrutiny for medical devices will prevent the failure of higher risk medical devices and that Option 1 and use of post market mechanisms, would be more appropriate. However, this argument fails to recognise that increased premarket assessment of available evidence will allow the TGA to determine whether the risk-benefit conclusion reached by an EU Notified Body is acceptable in the Australian context, therefore reducing the exposure of the Australian public to risks TGA considers to be unacceptable. This will assist TGA to better meet its mandate of protecting public health and safety at all stages of the device regulatory life cycle, from premarket assessment to postmarket surveillance.
Option 2 in this RIS achieves increased scrutiny of medical devices, and allows increased premarket scrutiny of medical devices by consumers and health professionals. This is because under this proposal more information is made available to consumers and health professionals, to better empower them to make decisions about the use of medical devices.
Option 3 has many of the same advantages and similar disadvantages as Option 2. However, under Option 3, fewer higher risk devices are subjected to additional TGA scrutiny at a higher cost to industry than Option 2 (see 'Costs and Benefits' section above). This means that the cost per public health outcome is higher and therefore less cost-effective. Furthermore, Option 3 does not provide flexibility to reduce the levels of regulatory oversight over time (and therefore costs), based on changing risks for particular devices or notified bodies.
Each of the options will have a range of positive and negative consequences for stakeholders. Option 2 provides the most balanced and cost-effective approach to improving public health outcomes in both the short term and the longer term, given that this is the only option that creates a positive feedback loop from the increased level of TGA oversight. Specifically, it is the only option that incentivises the use of notified bodies which have demonstrated their performance through confidence building, thereby increasing assurance about the safety and performance of higher risk devices.
Following a review of the MTAA cost estimate for Proposal 2 that was presented in response to the May 2013 consultations, the TGA is of the view that the TGA model is a more robust and conservative than the model presented by the MTAA. Additionally the TGA cost estimate of $6,129,316 is the absolute maximum costs to industry as a whole. This takes into account adjustments to the TGA cost model in light of MTAA feedback provided.
To put the increased costs in perspective, the increased level of reassurance about the quality, safety and performance of higher risk medical devices through a more thorough review of the conformity assessment evidence available is achieved at a cost that is less than 0.06% of the $10 billion revenue of the medical device industry in Australia. Coupled with the additional staffing required to administer this enhanced process and other business review processes currently undertaken within the TGA, it is not expected that there would be any significant increases in assessment times arising from the reforms. A Level 3 audit, depending on the evidence being reviewed, will require more than 60 TGA working days but much less than the 255 TGA working days which is required for TGA to undertake a full conformity assessment.
The TGA considers that the increase in application costs reflects an appropriate level of regulatory scrutiny given the risk of the devices targeted by Option 2, and addresses international concerns over the performance of EU notified bodies, evidence quality and transparency around the basis for regulatory decisions. Recent experience has demonstrated that patients need to be better protected from harm where the device is of high risk, particularly where it is implanted, because of the significant impact adverse events identified at the postmarket stage have on them.
It does need to be acknowledged that this cost will be borne disproportionately, primarily by those supplying implantable medical devices. Additionally, it should be noted that the cost estimated in this RIS are conservative and overstate the eventual cost, in that they do not take into account some additional opportunities to reduce costs which are already underway, as outlined in the 'Cost and benefits' section above.
It should be noted also that Government accepted recommendation 3 of the HTA review, and noted that the TGA's regulatory framework should be underpinned by the principles it outlined for all HTA processes. Option 2 in this RIS meets those principles. The HTA principles, together with an assessment of the reforms proposed under Option 2 in this RIS against that framework, are listed below:
- Sustainable: The scope and cost of changes proposed are very modest in scheme of medical devices industry (representing less than 0.06 per cent of industry revenue). On this basis they are a sustainable cost to the industry, with the potential to reduce over time.
- Level 3 audits (particularly given the operation context of current confidence building in EU notified bodies) underpin the sustainability of TGA in its ongoing role as a regulator in an international environment.
- Removing the requirement for Australian manufacturers to seek TGA conformity assessment is also focused on the sustainability of the local devices industry, providing a level playing field for these manufacturers with international competitors.
- Transparent, accountable and independent: Proposal B, in publishing explanations of TGA's premarket regulatory decisions on medical devices, including negative decisions, is clearly linked to the need for transparency. However all these changes contribute to accountable and independent decision making by the TGA.
- Consultative and reflective of Australian community values: There has been extensive consultation on the changes proposed in this RIS, and community views and values on concerns regarding implantable devices underpin the proposed changes. This has been balanced against the views of the industry, to ensure a balanced and sustainable regulatory approach.
- Administratively efficient: The proposed changes build on existing regulatory processes. They have been designed to reduce duplication, such as reviewing EU notified body conformity assessments, rather than requiring TGA conformity assessments for higher risk devices as previously proposed. This has been balanced with the need to ensure decisions on higher risk medical devices are appropriate to the Australian context, requiring review of the EU notified body conformity assessments rather than simply accepting these at face value.
- The removal of the requirement for TGA conformity assessment also promoted administrative efficiency, particularly given the ANZTPA is planned to commence from 2016, with Australian regulatory requirements intended to apply to New Zealand manufacturers from that time.
- Flexible and fit for purpose: The proposed shift to a legislative instrument to identify medical devices subject to mandatory audits provides flexibility for addressing emerging risks, and also provides a mechanism for removing items from mandatory audit requirements as technology settles over time.
- Flexibility is also promoted through the continued discretion on the audit level to apply, allowing the TGA to address issues such as reductions in risk through confidence building, emerging risk through technological change, and responding to changing risks such as with particular notified bodies. The Australian manufacturer change also recognises that being local manufacturer is not a risk factor in itself, and this change provides Australian device manufacturers with flexibility and choice.
- Informed by robust and relevant evidence: A number of industry submissions argue that the changes to audit requirements proposed under Option 2 are not based on evidence. Post market surveillance such as adverse event reporting has not indicated systematic issues for implantable medical devices. There are a few notable exceptions (the ASR hip, PIP breast implants, and recently issues with vaginal meshes) which industry argue would not generally be identified through additional premarket checks. However those examples are evidence of the very serious consequences and difficulties when post market issues arise for implanted devices, and support the need for premarket vigilance.
- Further, the expanded Class IIb audits and Level 3 audits proposed are very focused TGA undertaking a review of the premarket evidence which is available prior to marketing approval being granted, to ensure there are adequate data to allow the TGA to make an informed assessment of whether the benefits outweigh the risks.
It is recommended that Option 2 is the appropriate response to address the wide ranging and complex problems outlined in this RIS.
Option 2 is a risk based approach to increasing premarket scrutiny of high risk medical devices and addresses the concerns raised in the key local and international issues and objectives included in the table above.
Overall, Option 2 provides for increased scrutiny of high risk medical devices through a risk based and transparent approach, which imposes acceptable additional costs and regulatory burden on the medical device industry.
- Note that the achievement of increased premarket scrutiny of Class IIb implantable is rated more highly for Option 2 than Option 3. This is because Option 2 provides for tighter targeting and flexibility to respond to emerging issues given the proposal to develop an instrument to identify affected medical devices. Option 3 provides for the expansion of mandatory auditing to all Class IIb implantable devices through amendment of Regulation 5.3 to capture all implantable and long term surgically invasive devices captured by classification rule 3.4.