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Regulation impact statement: Changes to premarket assessment requirements for medical devices
Implementation of the current regulatory framework for medical devices in Australia commenced in 2002, with the framework fully operational since 2007. The current framework takes into account the inherent differences between medical devices and medicines. This allows a more appropriate risk-based framework able to accommodate the rapid and ongoing changes in medical device technology while reducing costs and supporting timely access.
Consistent concerns have arisen over time about certain elements of the regulatory framework. In recent years these concerns have been reflected in several reports and inquiries - primarily the HTA Review and two Senate Inquiries (on ASR hip joint and PIP breast implants). These concerns relate to:
- the need for an increased level of premarket scrutiny for higher risk implantable medical devices prior to approval
- transparency of decision making
- third party conformity assessment, particularly for Australian manufacturers.
Recent issues with the performance of European notified bodies and the reliance of Australia on their assessments have strengthened the level of concern amongst consumers, healthcare professionals, the medical devices industry and Government around these key issues.
No medical device is completely safe, or immune from failure, irrespective of the level of premarket scrutiny it has undergone. It is also generally recognised that medical devices are inherently different from medicines and the medical devices industry has argued for a long time that it is not possible to accumulate a similar body of clinical trial data at the premarket stage without delaying timely access to market.
As explained earlier, the small size of the Australian medical devices market has meant that Australia's medical device regulatory system is largely dependent on a premarket assessment of a medical device conducted by a European notified body which determines whether the device can be supplied in the EU. Over a number of years, TGA has been strengthening its postmarket activities, particularly in relation to devices. However, while this makes postmarket surveillance critically important to the effective regulation of medical devices, relying purely on postmarket mechanisms alone is subject to a number of difficulties:
- By the time an adverse event with a higher risk medical device has occurred (particularly an implantable device), a patient has already been adversely affected or harmed physically and/or mentally through the failure of the device. This is unacceptable if that adverse event could have been prevented from happening in the first instance through a more rigorous evaluation of premarket data and a determination of whether the benefits outweigh the risks. For example, the British Medical Journal article on 21 May 201120 states that problems with the ASR hip had emerged in some patients two years after implantation and that therefore clinical tests with relatively short follow-up may have detected the problem with the ASR hip.
- Stakeholder expectation is that the TGA's role is to 'protect Australian consumers from health technologies which cause harm'21. Protecting the Australian public from unacceptable harm includes not only dealing with safety issues when they arise, but also from preventing them in the first place. Failure to protect consumers from harm is perceived as a failure of Government and the regulated industry. A large number of such failures could reduce public confidence in the regulatory system so significantly that the device industry will be adversely impacted through reduced revenue or demands to move to more stringent regulatory model. Government would be adversely impacted as there would significantly greater costs associated with amending the regulatory framework.
- The key driver for relying on postmarket mechanisms rather than collection of better premarket data is faster access to market. This argument is flawed as the international fiscal environment is resulting in more HTA reimbursement authorities demanding better premarket data before making decisions about the subsidy of medical devices. As noted above, while market access for higher risk medical devices may be faster in the EU, reimbursement for these devices can be significantly delayed. Therefore, any real commercial benefits gained from early approval are offset by the delays in reimbursement decisions.
It is therefore important that the regulatory lifecycle of a device comprises stringent pre and postmarket mechanisms to ensure that products where the benefits outweigh the risks are approved for marketing and that the benefit continues to outweigh the risks over the market life of the device. While Australia has significantly bolstered its postmarket activities, until confidence building activities in notified bodies has occurred or significant changes to the notified body governance and performance in Europe occurs, Australia needs to increase its rigour of premarket assessment.
Increased review of information produced by a European notified body at the premarket stage, particularly clinical information, will enable identification of whether the device is acceptable for marketing in Australia. Specifically at issue is whether the TGA reaches the same risk benefit conclusion as the notified body based on the same clinical evidence and design dossier i.e that the notified body's decision that the benefits of the device outweigh the risks are supported by sufficient evidence. For example, through increased TGA premarket scrutiny, TGA can prevent devices from being approved in Australia in the following circumstances, irrespective of whether the device has gained approval in the EU:
- where the clinical evidence indicates that the revision surgery rates associated with the use of a particular implantable medical device may have been acceptable in the European context, but not in the Australian context
- where there is insufficient evidence that a new material used in a device is safe and does not damage the structural integrity of other components of the device as this could lead to premature device failure
- where there is insufficient clinical evidence that a medical device intended to be used to seal lung incisions following surgery to prevent lung collapse performs as intended.
It is worth noting that adequate clinical evidence is also a key additional requirement for public and private reimbursement arrangements in both Australian and the EU. Market entry and reimbursement arrangements are regulated separately and to different standards, with market entry focused on the safety, performance or quality of medical devices, while reimbursement systems are also concerned with the cost effectiveness of the device. However these arrangements do need to be coordinated, and for those devices affected by both systems, reimbursement requirements are also an effective, if not prescribed, prerequisite to marketing the medical device.22
Increased premarket scrutiny ensures that every best effort has been undertaken to detect issues relating to the safety, performance or quality with a medical device before the product has been implanted into a patient and needs to be removed. Government’s recognition that there is a need for preventive action rather than corrective action in relation to higher risk medical devices is clear through its response to the HTA review and the first Senate Inquiry into medical devices.
Delaying the proposal to change premarket assessment requirements for medical devices until changes are implemented in the EU is also not appropriate given the significance of the problems faced by patients, health professionals and Governments when higher risk implantable devices fail. Delaying dealing with these issues would be compounded by the absence of certainty of what the changes to be pursued in Europe will be.
Options outlined in this RIS seek to balance timely access to market for medical devices (allowing continued use of EU certification) while addressing the concerns which underpin the reforms proposed in Europe (given reform of the European system is some time away).
Unlike other leading regulators such as the FDA or Health Canada, TGA does not currently formally publish particulars about its medical device decisions or provide any information about, or access to, its assessments. The outcome is known if and when the device appears in the ARTG. No direct information is published on:
- Conformity assessment: the approval or rejections of an application for conformity assessment;
- Approval for inclusion in the ARTG: the basis for the decision to include a medical device in the ARTG, such as whether the medical device was subject to application audit and if so what information was considered, and the conformity assessment certification (whether issued by a specific EU notified body or the TGA) used to support the application; or
- Rejection for inclusion in the ARTG: for medical device applications for inclusion in the ARTG that are rejected. There is no public record that the application was made, its rejection or the rationale for the rejection.
It became apparent during the Senate Inquiries that there is a misunderstanding of how medical devices are regulated in Australia in relation to the level of assessment TGA undertakes and that consumers and health professionals would welcome visibility of what was assessed in order to inform their decision making in relation to the use of medical devices.
The above issues emerging from the Senate Inquiry about TGA decision making are consistent with the findings of a 2010 transparency review. This review noted the community perception that the TGA does not provide the public with sufficient information about its regulatory activities and in particular about therapeutic goods.
review recommended that the TGA should provide explanation of its various regulatory processes, and adopt publication principles on the outcomes of application assessments. The exemplar of the Australian Public Assessment Reports (AusPAR) has been cited. An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. More general information about particular prescription or pharmacist-only medicines is also available for consumers (in the form of Consumer Medicine Information) and health professionals (Product Information).
This transparency theme is repeated as part of the medical device reforms proposals identified in the TGA Blueprint for Reform relating to improving the level of information published about medical devices to better inform consumers and health professionals.
Medical devices made by Australian manufacturers (other than the lowest risk Class I devices) require conformity assessment by the TGA in order to receive marketing approval as TGA is the only conformity assessment body located in Australia that can issue conformity assessment certificates to the requirements of Australian legislation. In contrast, conformity assessment could be conducted by a European notified body for the same device if it was being manufactured by a company outside Australia.
This requirement can result in higher regulatory costs for Australian manufacturers as they may require a conformity assessment from the TGA if they want to supply in Australia (for one fee) and another from a European notified body if they want to supply in Europe (for a second fee). In contrast an overseas manufacturer can supply in Australia based on a European notified body certificate for the cost of only a single assessment fee.
As the large number of private organisations designated as European notified bodies (around 78 at present) operate in a competitive environment, some industry stakeholders have indicated that there can be significant timing and cost differences in seeking conformity assessment from European notified bodies compared to the TGA. The TGA's exclusive role in issuing certificates to Australian manufacturers has been questioned for a number of years by the medical devices sector, as an unreasonable constraint on Australian manufacturers not shared by their overseas competitors. The options in this paper are intended to address each of the above issues. As noted above, consultation on changes to premarket assessment requirements for medical devices was undertaken between January and March 2013 and May and June 2013. Summaries of the submissions made on the previous papers are included at Attachment F: Summary of consultation on changes to premarket assessment requirements for medical devices and Attachment G: Summary of consultation on Regulation Impact Statement exposure draft. The proposals outlined in this RIS also build on previous consultation, inquiries and reports as outlined in Attachment D: Previous reports and consultations.
- Deborah Cohen, Out of Joint, 21 May 2011, BMJ 2011;342:d2905
- Review of Health Technology Assessment in Australia (December 2009), p 15
- Conditions for public or private reimbursement in both Australia and in the EU are often much more rigorous than those required for accessing the market (through ARTG inclusion in Australia or CE marking in the EU). The HTA Review points out that market entry and reimbursement arrangements are separate, given 90 per cent of devices are not affected by reimbursement, but the two processes should inform each other. For further information see Prosthesis List Advisory Committee paper, Evidence Requirements for Clinical Effectiveness Assessment of Applications for the Prostheses List, which suggests a minimum of two years clinical follow-up data for high risk devices such as joint replacement prostheses (available at : <http://www.privatehealthcareaustralia.org.au/prostheses/august%202012/53_12a.pdf> or <http://www.medicaldevice-network.com/features/feature48597/> for further information on reimbursement in the EU.