In reading the Commonwealth Government's response to the reports of the Expert Panel Review of Medicines and Medical Devices Regulation noted
here observers might be forgiven for believing that the Government has once again deferred difficult decisions about the Therapeutic Goods Administration (TGA) and that the Medical Technology Association of Australia (MTAA) has escaped calls for a more coherent registration regime.
The response is described as presenting "a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia [with] ways to improve access to therapeutic goods for consumers and remove unnecessary red tape for industry whilst maintaining the safety of therapeutic goods in Australia".
The response indicates that
The Expert Panel identified several significant trends in the regulation of medicines and medical devices internationally. In particular, the Panel noted international trends towards allowing earlier access to medicines and medical devices through the development of provisional approval pathways.
Additionally, the Panel commented on the benefits of harmonising international regulatory frameworks, noting that there are benefits for consumers and efficiencies for industry from greater harmonisation.
After considering the current regulatory framework for therapeutic goods, the Panel found that the TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators. However, the Panel found that while the TGA performs well there are opportunities for reform and improvement in the regulation of therapeutic goods.
The Panel concluded that allowing for greater flexibility in approval pathways for medicines and medical devices (including greater use of overseas assessment reports and provisional approvals in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices.
The Panel also identified areas of regulation where a more risk-based approach could be adopted to more appropriately align regulation with the risk posed by regulated products. The Panel was also of the view that the use of data was essential in assessments of therapeutic goods, and that better utilising existing data sets could lead to system enhancements and provide greater information for the regulator to base decisions upon.
The Panel’s recommendations considered the following issues: the role of the Australian Government to make sovereign decisions regarding therapeutic goods; the medicines regulatory framework; the medical devices regulatory framework; enhancements to post-market monitoring; the complementary medicines framework; and the framework for advertising therapeutic goods to the public.
In considering the Panel's recommendations the Government’s "plan for reform" is described thus
Of the Review's 58 recommendations, 56 are supported by the Government. The majority of these recommendations are supported in full, while for some, the Government supports the intention of the recommendation but proposes to implement them in a different manner to that suggested by the Review.
Of the 56 supported recommendations, the Government has decided to defer two recommendations namely the:
establishment of registries for all high-risk medical devices (recommendation 22);
review of the Therapeutic Goods Administration's (TGA) funding arrangements (recommendation 32).
The two recommendations that the Government has rejected relate to the decision-making and governance arrangements of the regulator (recommendations 29 and 30). These recommendations were primarily rejected due to widespread stakeholder concerns that they would result in significant approval delays for new medicines and medical devices. In addition, the intention of these recommendations can be achieved through the implementation of the broader suite of reforms recommended by the Review.
The response states
The Government recognises that streamlining access to medicines and medical devices, including access to novel and life-saving therapies, offers significant benefits to consumers, health professionals and industry. The proposed reforms reflect the Government’s plan to boost competitiveness and lessen unnecessary regulatory burden through the Industry, Innovation and Competitiveness Agenda and encourage innovation through the National Innovation and Science Agenda.
The Panel has provided a strong case for the reform of the regulation of therapeutic goods in Australia - one that strikes a balance between supporting consumer choice, the safe and effective use of therapeutic products, creates flexibility for industry and ensures that regulatory settings are appropriately aligned to risk. The proposed programme of reform involves:
• increasing use of overseas assessments with comparable regulators, while maintaining sovereignty of regulatory decisions;
• increasing flexibility in pre-market assessment processes for medicines and medical devices, including expedited and provisional approval and allowing the operation of commercial assessment bodies in Australia for medical device assessments;
• taking a risk-based approach to variations to medicines and medical devices and access to products not listed in the Australian Register of Therapeutic Goods (ARTG);
• enhancing post-market monitoring and improving integration of administrative arrangements relating to pre- and post-market processes for subsidy and other purposes;
• simplifying processes by which advertising of therapeutic products to the public is regulated;
• working across government to consider incentives for innovation to improve the competitiveness of the Australian complementary medicines industry and increasing information available to consumers; and
• conducting further reviews on the Scheduling Policy Framework for substances in consultation with states and territories and on the appropriateness of the application of the therapeutic goods regime to a range of low-risk products.
Moving into
Yes, Minister territory, the response states
In order to progress this important programme of reform, the Government will take a strategic and systems-based approach. This will involve implementation of recommendations in a staged approach over the next three years in order to maintain continuity of business. The Department of Health will collaborate and consult across government and with consumers, health professionals and industry in order to progress these reforms. The TGA, where necessary, will cost recover from industry so as to ensure that it is adequately resourced to implement these reforms and undertake the ongoing work without interrupting business as usual.
The Government understands that consumer, professional, and industry groups are looking for immediate action. Accordingly, the Department of Health will commence work on designing implementation of the recommendations, with a view to implementing early opportunities in 2016-2017. Implementation of this important programme of reform will deliver significant benefits for the Australian public and to the Australian medicine and medical device industries. ...
The reforms outlined in this response will improve access to therapeutic goods for Australian consumers, including the potential for expedited access to innovative and life-saving products, without compromising the integrity and safety of medicines and medical devices available in Australia. These benefits include:
• access to life-saving and innovative medicines and medical devices will be improved through the introduction of new, expedited pathways for approval. This will lead to earlier access to vital, life-saving therapies for patients with serious conditions;
• faster access for Australian consumers to certain medicines and medical devices that are approved based on assessments from comparable overseas regulators. This will reduce duplication of effort, leading to efficiencies, while ensuring Australian consumer protection is maintained through retention of oversight by the TGA as the final decision-making authority;
• consumer protection will be enhanced through the development of a more comprehensive system of post-market monitoring which will provide the TGA with better information about emerging safety issues. This will ensure that therapeutic goods in Australia continue to be safe for use, efficacious and of a good quality;
• access to products under the Special Access Scheme and the Authorised Prescriber Scheme will be streamlined, reducing burden for healthcare professionals and enabling ease of access to products not on the ARTG for individual patients who meet the relevant criteria;
• the process for managing complaints relating to advertisements of therapeutic goods directed at consumers will be simplified and streamlined, but with stronger compliance powers against misleading advertising;
• the regulation of complementary medicines will be reformed to provide new pathways where evidence of efficacy will be reviewed by the TGA prior to market and compliance powers strengthened, whilst recognising the low-risk nature of complementary medicines.
As Recommendation 22 the Panel recommended that:
1. All high-risk implantable devices are included in a registry that is compliant with the requirements for registries established by the Australian Commission on Safety and Quality in Health Care (ACSQHC).
2. Responsibility for ensuring that registries are operated consistent with the ACSQHC requirements should rest with the NRA [ie the TGA as Australian
National Regulatory Authority].
3. Data collected by device registries should be made available to the NRA in a timely manner to inform post-market monitoring.
4. The NRA should implement an active programme of analysis and reporting on adverse events, and associated data, collected through registries or by other means.
5. The NRA should continue collaborative activities with overseas medical device regulators to actively share registry and other monitoring data, with a view to facilitating timely identification of emerging safety concerns and to inform better clinical practice.
The Government's response is
The Commonwealth defers consideration of Recommendation Twenty-Two, as establishing and maintaining registries requires careful consideration of the range of registries managed by a variety of organisations and how they could be sustainably managed and funded in the future.
Further consultation with stakeholders is required to adequately assess the risks and benefits of establishing registries, and to determine appropriate mechanisms to enable access to data.
As Recommendation 32 the Panel recommended
that the Australian Government review and enhance the NRA’s funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and operation are achieved.
The Government's response is
The Commonwealth defers consideration of Recommendation Thirty-Two. The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 2017/18. A review of the regulator’s funding arrangements should not be conducted in isolation. Deferring consideration under the Portfolio Charging Review will ensure funding arrangements are fully considered and aligned within a whole-of-portfolio perspective.
As recommendation 29 the Panel recommended that:
1. The decision making process for the inclusion of medicines and medical devices in the ARTG be changed to provide for:
A. The Australian Government’s Chief Medical Officer to be the delegate for decisions.
B. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about registration of a medicine in the ARTG (Advisory Committee on Medicines).
C. The establishment of a statutory committee to make recommendations to the Chief Medical Officer about inclusion of a medical device in the ARTG (Advisory Committee on Medical Devices).
2. Both Committees be composed of experts across relevant fields and consumer representation and have the authority to:
A. Consider information submitted by the product sponsor.
B. Consider evaluation reports prepared by or for the Australian NRA and comparable overseas NRAs.
C. Take evidence from sponsors, the Australian NRA, and any other parties which the committees consider may have a reasonable interest in the registration of the medication or medical device.
D. Take into account any other information that the committees consider may be material in their deliberations.
The Government's response is that
The Commonwealth rejects Recommendation Twenty-Nine. In consultation on the review recommendations, all stakeholders (industry, health professionals and consumer groups) strongly opposed this recommendation, as there was a consensus that delegating decision-making to a single person would slow approval processes and lead to a significant backlog of applications, thus potentially undermining efficiencies gained by implementing other recommendations in the Review. The Commonwealth notes that the stated purpose of the recommendation (which is to increase dialogue between the TGA and sponsors), will be achieved through implementation of the broad range of reforms the Commonwealth proposes to adopt, such as improving transparency of decision-making, developing an SME support function to provide regulatory advice and facilitating increased engagement between sponsors and the regulator.
