Source: https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd1718a/18bd056
Timestamp: 2018-02-20 04:12:43
Document Index: 512854914

Matched Legal Cases: ['art 2', 'art 1', 'art 1', 'art 3', 'art 3', 'art 2', 'art 5', 'art 1', 'art 1', 'art 1', 'art 5', 'art 1', 'art 5', 'art 5', 'art 5', 'art 7', 'art 6', 'art 6', 'arts 2', 'art 2', 'art 1', 'art 2']

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 – Parliament of Australia
Home Parliamentary Business Bills and Legislation Browse Bills Digests Bills Digests alphabetical index 2017–18 Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017
Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017
Bills Digest No. 56, 2017-18
Science, Technology, Environment and Resource Section
Recommendations supported by the Bills
Using assessments of medical devices from overseas regulators
Provisional registration – overseas comparisons
New assessment pathway for listed medicines
New definition of advertising
Modified offence regime
Annual conformity assessment body determination charges
Provisional registration annual charges
The purpose of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (the Bill) is to amend the Therapeutic Goods Act 1989 (the Act) to implement further recommendations from the Expert Panel Review of Medicines and Medical Devices Regulation (Sansom Review).[1] These include, in particular, to:
introduce a scheme for the provisional registration of new prescription medicines
implement reforms to the advertising of therapeutic goods and
revise the enforcement and offence provisions in the Act.
The purpose of the Therapeutic Goods (Charges) Amendment Bill 2017 (the Charges Bill) is to amend the Therapeutic Goods (Charges) Act 1989 to support new charges related to amendments implementing the Sansom Review.[2]
The Bill is divided into nine Schedules:
Schedule 1 establishes the new scheme for the provisional registration of new prescription medicines
Schedule 2 amends provisions relating to indications and ingredients for listed medicines
Schedule 3 establishes an additional pathway for listing intermediate risk medicines
Schedule 4 clarifies provisions relating to the preliminary assessment of applications
Schedule 5 amends provisions relating to conformity assessment procedures and certificates
Schedule 6 contains amendments to advertising-related provisions in the Act to reform and ‘modernise’ the advertising framework for therapeutic goods
Schedule 7 revises the compliance, enforcement and penalty provisions in the Act
Schedule 8 amends record-keeping and reporting requirements for biologicals to ensure consistency with prescription medicines and
Schedule 9 contains a range of miscellaneous amendments.
The Schedules of the Bill have different commencement dates as set out in clause 2:
Schedules 1, 2, 4, 5 and 8 of the Bill commence on the later of 1 January 2018 and the day after Royal Assent and
Part 2 of Schedule 6 commences on the later of 1 July 2018 and the day after Royal Assent.
Schedule 3 commences immediately after the commencement of Schedules 1 and 2
Part 1 of Schedule 6 and Schedule 7 commence immediately after the commencement of Schedules 4 and 5 and
Schedule 9 commences immediately after the commencement of Part 1 of Schedule 6.
The Charges Bill commences at the same time as Schedule 5 of the Bill. However, the provisions of the Charges Bill do not commence at all if that Schedule does not commence.[3]
Therapeutic goods are products that are used in humans in connection with:
preventing, diagnosing or treating an illness or injury
altering a physiological process
testing a person’s susceptibility to an illness
affecting conception
testing for pregnancy or
replacing or modifying part of someone’s anatomy.[4]
In Australia, therapeutic goods are regulated by the Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health (DoH). The TGA regulates the supply, import, export, manufacturing and advertising of therapeutic goods.[5] The TGA administers the Act to ensure that medicines and medical devices are evaluated and regulated before they reach the market, and monitored once they are in use.
Therapeutic goods must be assessed by the TGA and entered in the Australian Register of Therapeutic Goods (the Register) before they can be sold in Australia.[6]
The TGA takes a risk-based approach to regulation, which means that lower risk products will receive less assessment than higher risk products.[7] Higher risk medicines (including all prescription medicines and most over-the-counter medicines) must be assessed by the TGA for quality, safety and effectiveness before they can be registered on the Register. Lower risk medicines such as vitamins, sunscreens and herbal complementary medicines can be listed on the Register if the applicant certifies that claims about the effectiveness of the product are accurate, the medicine contains only approved ingredients, and relevant quality, labelling, packaging and manufacturing standards have been followed.[8]
Similarly to medicines, lower risk medical devices (such as bandages) rely on the applicant's certification of compliance with regulatory requirements for inclusion on the Register, whereas higher risk devices (such as pacemakers) require a direct evaluation of the available evidence by the TGA before they can be included on the Register.[9]
The TGA also has a role in monitoring therapeutic goods after they have been approved and are on the market. Depending on the type of good and the degree of risk involved, post-market monitoring activities may include risk management plans, collecting reports of adverse events and reactions, reviewing worldwide complaints data, auditing manufacturers and environmental scanning for safety issues.[10]
The TGA operates on a cost recovery basis. Fees are charged for services such as product evaluations, and taxes are also imposed on regulated industries.[11]
On 24 October 2014 the Australian Government announced an Expert Panel Review of Medicines and Medical Devices Regulation (Sansom Review).[12] This Review was designed to identify:
Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.[13]
The Sansom Review provided two reports to the Government in 2015. The first report, dealing with the regulation of medicines and medical devices, as well as access to unapproved goods, made 32 recommendations. The first report recommended expanding the pathways for sponsors to seek approval for a medicine or medical device; enhancing post-market monitoring of goods and streamlining post-market requirements; and improving transparency and predictability of processes and decisions.[14]
The second report, dealing with the regulation of complementary medicines and the advertising of therapeutic goods, made a further 26 recommendations. The second report recommended expanding pathways for sponsors to seek approval for a listed complementary medicine or for an ingredient for use in a listed medicine; enhancing the transparency and predictability of processes and evidence for such approvals; improving the interface between market approval of goods and advertising requirements; and enhancing and streamlining the therapeutic goods advertising framework.[15]
In response to the Sansom Review, the Government provided $20.4 million over four years (including $9.5 million in capital funding) from 2016–17 to improve the regulation of therapeutic goods in Australia. The ongoing cost of the measure from 2017–18 is to be met by the TGA’s cost recovery arrangements.[16]
The objectives of the Budget measure are to bring medicines and medical devices onto the Australian market faster, reduce costs and administrative burden for industry, make some product assessments shorter and simpler, consider removing regulation for some low risk products, improve information about complementary medicines, simplify advertising for therapeutic goods and reduce the number of committees advising the TGA.[17]
The formal Australian Government Response to the Review of Medicines and Medical Devices Regulation (the Government Response) was released by Minister Ley on 15 September 2016. The stated aim of the Government Response is to strike a balance between improving access to therapeutic goods for consumers and removing unnecessary red tape for industry, while also maintaining the safety of therapeutic goods in Australia. [18]
The Government accepted 43 of the 58 recommendations made by the Sansom Review. A further six were accepted in principle, the Government supported the intent of another five, and two were deferred. Only two recommendations relating to delegation and committee structures within the TGA were rejected.[19]
additional support for small and medium enterprises who need to interact with the TGA
adding an additional pathway to the Special Access Scheme (SAS) to make it easier for patients to access certain unapproved therapeutic goods
making it easier for companies to make minor variations to medicine listings on the Register
updated catalogue of permissible ingredients for listed complementary medicines
a priority review pathway to allow applications to register important new medicines to be assessed more quickly
better data analytics to assess adverse event reports
a reduced number of advisory committees and
review and appeal rights for applicants seeking assessment of a new ingredient for use in listed medicines.[20]
The above list includes the reforms implemented by the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 (the 2016 Measures Act).[21]
The TGA has conducted both targeted and public consultations regarding the program of reforms. A list of public consultation papers is available on the TGA website.[22]
Recommendations 3, 13, 15, 24, 27, 41, 42 and 47 of the Sansom Review were implemented or partially implemented by the 2016 Measures Act.[23]
According to the Explanatory Memorandum, the current Bill implements or partially implements recommendations 3, 10, 15, 16, 17, 27, 28, 38, 39, 45, 52, 54, 55, 56 and 57 of the Sansom Review.[24] The Charges Bill supports recommendations 3, 10 and 15.[25] These 15 recommendations are briefly described below. All 15 of the recommendations were accepted in the Government Response, unless otherwise noted.
Recommendation 3 proposes three pathways for registering a new medicine on the Register: the existing TGA assessment pathway (but with the possibility of work-sharing with comparable overseas regulators); registration via assessment by the TGA of a submission dossier and evaluation report from a comparable overseas regulator, together with Australian-specific information; and expedited approval of a medicine via either of these two pathways.[26] The Government response noted that expedited approval could involve either an accelerated approval (such as the priority approval process implemented by the 2016 Measures Act), or a provisional (time bound) approval.[27]
Recommendation 10 is that if an accelerated approval is based on more limited evidence than would be required under the existing approval process, then the registration of the medicine in the Register should be: provisional and time-limited, with the sponsor required to submit further evidence to receive full registration; subject to conditions approved by the TGA; and subject to advice to consumers and health professionals that the medicine has received provisional approval.[28]
Recommendation 38 is that the TGA should establish a list of permitted indications (uses for the medicine) from which sponsors must draw when applying to list a medicine.[29]
Option One: A pathway that is similar to the current requirements for listed medicines, but with the requirement that sponsors may only use permitted indications
Option Two: A new pathway for listed medicines, where sponsors wish to make health claims that fall outside the list of permitted indications. The sponsor would be required to provide evidence to the TGA of the safety and efficacy of the product for the proposed indication
Option Three: Retention of the current pathway for registering complementary medicines, for higher risk complementary medicines with higher level health claims.[30]
Recommendation 45 is that sponsors who use Option Two (above) should be allowed to indicate in advertising and on the product label that the efficacy of the product has been independently assessed for the approved indications.[31] This recommendation was accepted-in-principle in the Government Response, with a note that ‘the design and use of the promotional statements will require careful consideration by the TGA and further consultation with stakeholders.’[32]
Conformity assessment refers to ‘[p]rocedures used and evidence generated by the manufacturer to demonstrate that a medical device is designed and produced to be safe, fit for purpose and perform as intended’.[33]
Recommendation 15 relates to the assessment and inclusion of medical devices on the Register. Similarly to recommendation 3 for medicines, it is recommended that there should be three pathways to seek approval for the inclusion of most medical devices on the Register: assessment within Australia by either the TGA or a body designated by the TGA; utilisation of certain overseas conformity assessments or an overseas marketing approval; and expedited approval in certain circumstances.[34] This recommendation was partially implemented by the 2016 Measures Act.
Recommendation 16 is that the Australian Government develop transparent criteria for designating suitably qualified bodies within Australia to undertake conformity assessments of medical devices.[35]
As noted above, recommendation 15 includes a pathway for medical devices to be approved for inclusion on the Register using certain overseas conformity assessments or approval of the device by a comparable overseas regulator.[36]
Recommendation 17 is that the Government should develop (in consultation with stakeholders) criteria for identifying comparable overseas regulators of medical devices, and comparable overseas bodies which designate companies that can undertake conformity assessments.[37] The Government accepted recommendation 17 in principle, noting that the development of the criteria would require further consultation with stakeholders.[38]
Direct-to-consumer advertising is prohibited for prescription medicines and most pharmacist only medicines. Advertising to consumers is permitted for over-the-counter and complementary medicines. The TGA is responsible for legislation, monitoring and compliance; co-regulation by government and stakeholders occurs in some areas, and self-regulation under industry associations’ codes of practice also occurs. The Sansom Review noted that the current framework has been subject to sustained criticism for its complexity.[39]
Recommendation 52 is that advertising of therapeutic goods to consumers should continue to be regulated by the TGA under a legislative framework which includes an advertising code.[40]
Recommendation 54 is that requirements for direct-to-consumer advertising should be made consistent for all medicines and medical devices.[41]
Direct-to-consumer advertising of over-the-counter and complementary medicines via some media channels currently requires pre-approval from delegates of the Secretary located in industry associations. Recommendation 55 is that this vetting and pre-approval process should be replaced with a more self-regulatory regime.[42]
The current system for complaints about advertising of therapeutic goods is also complex, and involves industry complaints panels in each sector, a Complaints Resolution Panel (CRP) with representatives from industry, consumers, health professionals and government, and the TGA. Recommendation 56 is that the current complaints system should be replaced with a best practice system managed by a single agency. This agency could be the TGA, another Commonwealth agency or an external organisation contracted to manage complaints.[43]
Recommendation 57 is that consideration be given to whether the TGA’s current range of investigation and enforcement powers should be broadened. This recommendation is made under the heading of ‘[e]nhancing investigative powers and penalties for breaches of the advertising framework’. The Review notes that acceptance of recommendation 55 (a more self-regulatory advertising regime) could potentially lead to greater non-compliance unless sanctions and powers to take action in response to advertising breaches were enhanced. The Review also noted that recommendation 57 could be considered as part of recommendation 28, which is to undertake a comprehensive review of the legislative framework for therapeutic goods, including the Act. This would address a number of matters including penalties for non-compliance with the Act. This review could possibly be undertaken by the Australian Law Reform Commission.[44] The Government accepted recommendation 28 in principle, noting that it would propose amendments as required to implement particular recommendations, and then consider whether it was worthwhile to redraft the entire Act.[45]
Recommendation 27 proposes that the Government develop a more comprehensive post-market monitoring scheme for medicines and medical devices, including better integration and analysis of information from data sets such as the Medical Benefits Scheme, establishment of registries for all high-risk implantable devices, implementation of an alert scheme for newly registered medicines to encourage reporting of adverse events, allowing electronic reporting of adverse events, and improving collaboration with overseas regulators.[46] The Government accepted recommendation 27, except for the establishment of registries for all high-risk implantable devices.[47] Recommendation 27 was partially implemented by the 2016 Measures Act.
The Selection of Bills Committee considered the Bills at its meeting of 29 November 2017 but was unable to reach agreement.[48] The Senate subsequently agreed to refer the Bills to the Community Affairs Legislation Committee for inquiry and report by 2 February 2018.[49] Details of the inquiry are at the inquiry homepage.[50]
The Senate Scrutiny of Bills Committee commented on two issues in relation to the Bill.[51]
The first issue related to review rights for decisions involving the registration of ‘provisionally registered goods’. As outlined in the ‘key issues and provisions’ section of this Digest, items 14 to 17 of Schedule 1 of the Bill propose to amend section 60 of the Act, which sets out review mechanisms for decisions made by the Secretary or his or her delegate. While these amendments make the review mechanisms available for decisions about provisional registration, the ability to request review is proposed to be limited to ‘the person in relation to whom the medicine is registered’. This is in contrast to other provisions in section 60 of the Act, which allow ‘persons whose interests are affected by an initial decision’ to request a review.[52]
The Committee noted the suggestion in the Explanatory Memorandum that this restriction on review rights is necessary in the case of decisions concerning provisional registration because an 'interested party' could be either another competitor sponsor or 'a consumer with, having regard to the very nature of medicine that may use this pathway, necessarily limited information'.[53] The Committee accepted that ‘preventing commercial competitors from seeking review may be justified in this context’.[54] However, the Committee was concerned that the exclusion of other interested parties, such as consumers, from requesting a review had not been adequately justified in the Explanatory Memorandum.[55] The Committee therefore requested the Minister's detailed justification as to:
...the appropriateness of restricting merits review in relation to decisions about provisional determinations and registrations, or determinations regarding permitted indications, so that consumers who may be affected by a decision (but who are not the applicant) would not have a right to seek review.[56]
The second issue raised by the Scrutiny of Bills Committee related to the amendments to a ‘large number’ of strict liability offences already contained in the Act as well as the introduction of additional strict liability offences.[57] However, the Committee noted that, in this instance, the Explanatory Memorandum ‘gives a detail and comprehensive justification for the imposition of strict liability for these offences’, and therefore made no further comment on the matter.[58]
The Australian Labor Party has indicated that it will support the Bills. Mr Tony Zappia, Shadow Assistant Minister for Medicare, has stated that Labor believes, on balance, that the Bills are in the public interest. He noted the importance of providing patients with earlier access to medicines and medical devices, but argued this should be done cautiously. Labor’s support comes with some provisos, namely:
they will closely scrutinise the Regulations associated with the Bills
they do not wish to see any downsizing of the TGA and
the impact of the reforms should be closely monitored by the TGA and the government.[59]
At the time of writing, there had been little stakeholder comment on the Bills themselves. However, a number of stakeholders had commented on the Government Response to the Sansom Review. Selected comments which are relevant to the Bills are presented below.
As noted by the Minister in his second reading speech, the measures in the Bills have been subject to a number of consultation processes, including consultations conducted by the Sansom Review, consultations conducted by the TGA (outlined above) and consultations on the exposure draft Bills.[60] The Minister cited ‘overwhelming stakeholder support for these reforms’, and it does appear that stakeholders generally support the measures in the Bills. However, some stakeholders have expressed concerns regarding the move to a more self-regulatory advertising system, and these are also briefly outlined below.
Industry peak bodies have generally expressed their support for the measures in the Bills. Medicines Australia (representing the patented medicines industry) believes that reforms including a provisional approval pathway using earlier data sets and changes to the regulation of complementary medicines should ‘reduce red-tape and help to lower the costs of bringing a medicine to Australia’, as well as reducing the time lag between medicines coming to market in Australia compared to the United States and Europe.[61]
Complementary Medicines Australia (CMA, representing stakeholders in the complementary healthcare industry) welcomed both the Government Response and the Exposure Draft of the Bills. CMA believes the ‘new approval pathway for listing complementary medicines with higher therapeutic indications and health claims’ will be an ‘incentive to further expand the clinical research base for complementary medicines, enabling Australian companies to expand business opportunities’.[62] CMA also supports the reforms to the advertising and complaints framework and strong compliance measures against misleading advertising, calling them ‘alterations that are long overdue’.[63]
The Australian Self Medication Industry (ASMI, the peak body for the non-prescription medicine industry) supports almost all of the Government Response, but disagrees with the decision to retain advertising restrictions for pharmacist only medicines. ASMI also disagrees with the decision to replace mandatory advertising pre-approvals with a self-regulatory system. According to ASMI, there is ‘clear and compelling evidence that pre-approval of advertisements ensures high levels of compliance and protects consumers from non-compliant advertising’.[64]
The Medical Technology Association of Australia (MTAA, representing medical technology companies) welcomed the Government response, including the greater use of overseas assessment reports for medical devices.[65]
The Consumers Health Forum of Australia (CHF, the peak body for health consumer organisations) welcomed aspects of the Government response but is concerned that the regulation of complementary medicines, including advertising, ‘has not been tightened up sufficiently’. Ms Wells, CEO of the CHF, supports the new pathway for evidence-based complementary medicines, but believes that more public education will be required to ‘convey the difference between “listed products” which do not have evidence of efficacy, the proposed new approval category of products backed by some evidence and “registered” products which are backed by good evidence of efficacy’.[66] Ms Wells is pleased the TGA is considering a note on the product label indicating complementary products that have proven efficacy.[67]
The Australian Medical Association (AMA, representing doctors) is pleased that the TGA reforms include many advocated for by the AMA. The AMA supports the proposed provisional approval pathway ‘on the basis that the benefits to patients from earlier access would need to outweigh the risks, and provisional registration will be time limited and automatically lapse unless sponsors meet conditions imposed by the TGA, including additional post-market safety and efficacy data leading to full registration.’[68] The AMA supports most of the changes to the advertising of over-the-counter medicines, but does not support replacing advertising pre-vetting with a self-regulatory model. The AMA is ‘not confident that a self-regulatory approach would sufficiently protect the public from misleading and fraudulent claims about the therapeutic benefits of (mainly) scientifically unproven products.’[69]
The Society of Hospital Pharmacists of Australia supports the TGA reforms announced in the 2016–17 Budget, including collaboration with international trusted regulators, because ‘drug regulation is a global enterprise’.[70]
The TGA operates on a cost recovery basis and is largely self-funding. The opening balance of the TGA special account at 1 July 2017 was budgeted to be $54.1 million, and the closing balance at 30 June 2018 is budgeted to be $45.3 million.[71]
As noted earlier, the Government provided $20.4 million over four years (including $9.5 million in capital funding) in the 2016–17 Budget to improve the regulation of therapeutic goods in Australia, with the ongoing cost of the measure from 2017–18 to be met by the TGA’s cost recovery arrangements.[72] This is restated in the Explanatory Memorandum to the Bill.[73]
The Explanatory Memorandum to the Charges Bill notes that regulating Australian conformity assessment bodies will create administration costs for the Government, and that these costs will be recovered by an annual charge for Australian conformity assessment bodies.[74]
As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible ‘because it promotes the right to health, and to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate’.[75]
The Parliamentary Joint Committee on Human Rights considers that the Bills do not raise human rights concerns.[76]
Schedule 1 of the Bill implements recommendations 3 and 10 of the Sansom Review by establishing a scheme for registering new medicines via a new ‘provisional approval pathway’.
The Register of Therapeutic Goods (the Register) is established by section 9A of the Act, and currently contains four parts, which cover registered goods, listed goods, biologicals[77] and medical devices. Item 5 of Schedule 1 amends section 9A to provide for a new (fifth) part on the Register for provisionally registered goods, while item 3 creates a new class of therapeutic goods—provisionally registered goods—which can be included on the Register.
Under proposed section 22D, the Secretary may make a provisional determination if satisfied that certain criteria, prescribed by the Regulations, are met. Although the Explanatory Memorandum does not elaborate on the sort of criteria that might be prescribed in the Regulations,[78] the Government has released a summary of proposed Regulations to support the Bill.[79] That summary states that the criteria for provisional determinations ‘will relate to having highly promising early clinical data on efficacy and safety, and addressing an unmet clinical need’.[80]
Proposed section 22E provides for provisional determinations to remain in force for an ‘initial period’ of either six months or another period prescribed by the Regulations. That initial period may be extended for a further period of six months (or another period prescribed by the Regulations) if an applicant requests that extension at least 28 days before the determination expires and pays a prescribed application fee. Only one extension may be given.[81] The Secretary may grant an extension only if satisfied that the relevant criteria (as prescribed by the Regulations under proposed section 22D) are met in relation to the medicine and that the person would make an application for provisional registration of the medicine before the end of the extended period.
the application lapses because the initial period has expired
the applicant notifies the Secretary that they wish the application to be treated as having been refused or
the application for provisional registration is finally determined.[82]
Proposed section 22F enables the Secretary to revoke a provisional determination in certain circumstances. In particular, the Secretary may revoke a provisional determination on his or her own initiative if satisfied that the medicine no longer meets the criteria for obtaining a determination. The Explanatory Memorandum indicates that this is intended to be a ‘measure available to the Secretary where there is evidence that the medicine is not safe’.[83] In addition, under proposed subsection 22F(2), if the holder of the determination requests the Secretary to revoke a provisional determination, the Secretary must revoke the determination.
This ties the application for registration to the specifications of the provisional determination as provided for by subsection 22D(3). The TGA proposes to issue guidance on how it proposes that the specifications of the provisional determination will be relevant to the assessment of a provisional registration application.[84]
based on preliminary clinical data, the safety and efficacy of the medicine for the purpose for which it is to be used have been satisfactorily established
the quality of the medicine for the purposes for which it is to be used has been satisfactorily established and
if the Secretary were to register the medicine, the Secretary is satisfied with the applicant’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine within six years of the commencement of provisional registration.
Some countries already have approval pathways that provide for assessment of a medicine based on less, or different clinical data than is generally required for marketing approval.[85] For example, the U.S. Food & Drug Administration (FDA) has an Accelerated Approval Program for medicines that fill an unmet medical need and treat a serious condition. Medicines may be approved based on a surrogate endpoint (a marker that is thought to predict clinical benefit, but does not actually measure clinical benefit), allowing for earlier approval. Pharmaceutical companies are required to conduct clinical trials to confirm the clinical benefit. If clinical benefit cannot be shown, the medicine could be removed from the market.[86]
The European Medicines Agency (EMA) may grant conditional marketing authorisation for medicines treating serious conditions or emergency medicines, provided that a number of requirements are met, including the requirement that ‘the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data’. Conditional marketing authorisations are valid for one year and can be renewed annually. Pharmaceutical companies are required to provide comprehensive data confirming the positive benefit-risk balance of the medicine, at which point the authorisation can be converted into a standard marketing authorisation.[87]
The EMA granted conditional marketing authorisation for 30 medicines between July 2006 and June 2016, and none had to be revoked or suspended.[88] However, provisional approval pathways are not without risks. The medicine bevacizumab received accelerated approval from the FDA in 2008, but the approval as a treatment for metastatic breast cancer was later rescinded after post-marketing trials showed no improvement in survival and increased toxicity.[89]
Questions have also been raised in the scientific literature about the quality and timeliness of the confirmatory clinical trials conducted to convert a provisional approval into a standard authorisation. One study found that post approval clinical trials conducted after accelerated approval from the FDA suffered from similar design issues as the pre-approval trials and were slow to be completed. While most confirmatory studies that were completed showed positive results, ‘all completed confirmatory studies demonstrating drug benefit evaluated surrogate measures of disease activity rather than clinical outcomes’. Further, for the two indications where confirmatory studies failed to demonstrate clinical benefit, the FDA had not withdrawn the approval.[90]
The EMA emphasises that conditional approval has brought forward authorisation of medicines by an average of four years. Any suggestion that early access to medicines without comprehensive data benefits patients should be supported by evidence. Even when manufacturers do eventually provide comprehensive clinical data, it can hardly be considered as ethically and clinically appropriate that patients and their doctors have been unaware of the benefit-risk profile of medicines they have been using for a long time-over seven years in some cases.[91]
Section 29 of the Act currently provides that goods stay on the Register until their registration or listing is cancelled. However, a key feature of provisional registration is that it is time-limited.[92] Items 11 and 12 therefore amend section 29 to provide that provisionally registered medicines remain on the Register for two years (starting on the day the registration commences).[93] However, under proposed subsection 29(4), provisional registration may be extended for up to two years further, provided an application is made at least six months before the provisional registration is period is due to expire. In deciding whether to grant (or refuse to grant) an extension of the provisional registration period, the Secretary must have regard to:
whether the Secretary is satisfied with the applicant’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine within six years (starting on the day of the medicine’s provisional registration) and
any other matters he or she considers relevant.[94]
However, under proposed subsection 29(9), if an applicant applies, during the term of the provisional registration, for registration of the medicine under section 23, the Secretary may end or extend the provisional registration ‘as the Secretary considers appropriate’. In doing so, the Secretary must have regard to ‘any matters prescribed by the Regulations’.[95] In particular, under proposed paragraph 29(10)(b), the Secretary is required to ensure that the provisional registration period continues while an application for full registration is being considered. Provisional registration is limited to a maximum term of six years, unless it is extended during the Secretary’s consideration of an application for full registration.[96]
Section 60 of the Act provides for requests for reconsideration by the Minister of certain decisions made under the Act. This includes decisions made under Part 3‑2 of the Act, which relate to registration and listing of therapeutic goods.[97] Under subsection 60(8), that reconsideration decision may then be reviewed by the Administrative Appeals Tribunal.
This is because an ‘interested party’ could be either another competitor sponsor or a consumer with, having regard to the very nature of medicine that may use this pathway, necessarily limited information. Providing an opportunity for one sponsor to appeal a decision made in relation to the medicine of another sponsor is antithetical to the purpose of the ‘Provisional Approval’ Pathway of encouraging promising new medicines for a limited time to be brought to the market sooner. In this context, there is a public interest in having certainty and finality about rights of review for those about whom a regulatory decision is made.[98]
Schedule 2 of the Bill implements recommendation 38 of the Sansom Review, which suggested that the TGA should establish a list of permitted indications (uses for the medicine) from which sponsors must draw when applying to list a medicine.[99] As noted earlier, lower risk medicines such as vitamins, sunscreens and herbal complementary medicines can be listed on the Register, provided the applicant certifies that the medicine in the application meets all of the legislative requirements of section 26A of the Act. The requirements under section 26A currently include that claims about the effectiveness of the product are accurate, the medicine contains only approved ingredients, and relevant quality, labelling, packaging and manufacturing standards have been followed.
Sponsors will be required, when applying to list their medicines in the Register, to certify that each indication for their medicine is permitted under the new instrument, and it will be a ground for cancellation from the Register if such a certification was, or is no longer, correct.[100]
Item 15 inserts several new subsections into the Act relating to the proposed list of permitted indications. In particular, proposed section 26BF allows the Minister (by a disallowable legislative instrument) to make a determination to specify permitted indications for use with listed medicines.[101] The Explanatory Memorandum states that it is appropriate to authorise the use of indications by legislative instruments, rather than in the principal legislation, as this provides for a ‘timely and flexible mechanism to add new indications’ and to ‘allow timely amendments ... where a potential safety concern with a particular ingredient arises’.[102] At the same time, according to the Explanatory Memorandum, the existing ‘“fast to market” approval process for sponsors to list medicines in the Register’ is retained.[103] The TGA has published a draft list of permitted indications for public consultation.[104]
An indication may require inclusion on the non-permitted list where, in the interest of consumer safety or for consistency with the Government’s public health messages, it is appropriate that such a medicine is assessed through a pre-market assessment pathway, which could include the registration pathway or the new pathway for assessed listed medicines (Schedule 3 refers). For example, indications and claims relating to smoking cessation or obesity.[105]
Under proposed section 26BH, the determination containing the list of permitted indications will be able to be varied by the Minister (on his or her own initiative). Under proposed section 26BJ, any person may apply to the Secretary for a recommendation that the Minister vary the permitted indications determination.[106] However, there are limits on these applications. For example, the applicant cannot apply for an indication, that is specified in a non-permitted indication determination (under proposed section 26BG) or an indication that refers to preventing, curing or alleviating a disease, ailment, defect or injury (other than prevention of a dietary deficiency or prevention of skin cancer or sun damage for listed therapeutic sunscreen products).[107] The Explanatory Memorandum states these indications ‘are not considered to be low risk and as such are unsuitable for medicines that are not assessed pre-market’.[108]
Other amendments in Schedule 2 include:
Section 26BB of the Act currently provides for the Minister to establish a list of permissible ingredients for medicines, and requirements relating to those ingredients. Item 6 inserts a proposed subsection 26BB(2A) which is designed to enable the Minister to permit a successful applicant for a new permitted ingredient to have exclusive use of that ingredient (as a ‘protected ingredient’) for a specified period of time.[109]
Items 9 to 14 and 20, which primarily amend section 26BE of the Act to allow timeframes to be specified in Regulations for assessments of applications for new ingredients proposed for use in listed medicines.
Schedule 3 implements recommendations 39 and 45 of the Sansom Review. As noted earlier, recommendation 39 proposed three pathways for sponsors to include complementary medicines on the Register. Schedule 3 implements this recommendation by establishing an additional pathway for intermediate risk medicines.
Listed complementary medicines are currently included in the Register on the basis of self‑certification by the applicant, while the registration of complementary medicines requires evaluation by the TGA.[110]
The proposed new pathway established by item 4 of Schedule 3 consists of a new application and evaluation process to allow medicines to be included in the Register following certification by the sponsor about their safety and quality, and an evaluation by the Secretary of whether the efficacy of the medicine has been satisfactorily established.[111]
The Explanatory Memorandum states that the ‘applicant certification provisions reflect the policy intention that sponsors of medicines listed in the Register under section 26AE will self-assess the quality and safety of the product against established criteria’.[112] For example, under proposed subsections 26AB(4) and (5), the applicant must supply evidence that each overseas manufacturer involved in the manufacture of the product has acceptable manufacturing and quality control procedures in place. Under proposed subsection 26AB(6), if the medicine includes any ingredient of animal origin, then prior to the application, the Secretary must have certified that he or she is satisfied of the safety of the ingredient. According to the Explanatory Memorandum, this is to ‘ensure that medicines containing such ingredients do not present an unacceptable safety risk to consumers’.[113]
Proposed subsection 26AE(1) requires the Secretary to evaluate that medicine, having regard to whether the efficacy of the medicine has been satisfactorily established, and any other matters that the Secretary considers relevant. An evaluation fee must be paid under proposed section 26AC, with the amount of the fee to be specified in Regulations.[114] After that evaluation, the Secretary must decide whether or not to list the medicine under proposed subsection 26AE(3).[115]
Recommendation 45 of the Sansom Review also proposed that sponsors using this new assessment pathway should be allowed to indicate in advertising and on the product label that the efficacy of the product has been independently assessed for the approved indications.[116] The Explanatory Memorandum states that the Bill ‘supports the implementation of this recommendation for listed complementary medicines that have been evaluated by the TGA through this process’.[117] However, the Explanatory Memorandum does not identify the specific provisions that support this recommendation.
Schedule 6 of the Bill implements recommendations 52 and 54–57 of the Sansom review in relation to the current advertising framework for over-the-counter and complementary medicines. As noted earlier in this Digest, recommendation 52 proposed that advertising of therapeutic goods should continue to be regulated by the TGA under a legislative framework which includes an advertising code. Recommendation 54 suggested that requirements for direct‑to‑consumer advertising should be made consistent for all medicines and medical devices and recommendation 55 proposed that the pre-approval process for the advertising of over-the-counter and complementary medicines via some media channels should be replaced with a more self-regulatory regime.
Part 2 of Schedule 6 implements recommendations 54 and 55. The pre-approval process is currently contained in Division 2 of Part 5-1 of the Act. That Division currently requires advertisements in ‘specified media’ for designated therapeutic goods[118] to be approved by the Secretary (or his or her delegate). In particular, section 42C contains offences relating to the publication or broadcast of unapproved advertisements in ‘specified media’. ‘Specified media’ is defined in section 42B to include a range of media, including television, radio, magazines and newspapers. However, as a result of section 5BA of the Therapeutic Goods Regulations 1990, advertising on the internet, e-mail or SMS is exempted.
For example, medical device advertisements are not subject to pre-approval. However, complementary and certain Over-the-Counter (OTC) medicine advertisements for television, radio, magazines and newspapers require pre‑approval, while internet advertisements of these goods do not.[119]
In addition, as a result of delegations of the Secretary’s approval power in section 5Q of the Therapeutic Goods Regulations 1990 ‘advertisers wishing to advertise complementary and certain OTC medicines in a multi‑media campaign require approval from two separate bodies’.[120]
Advertising pre-approval, however, does not protect advertisers from being found non-compliant with the advertising requirements. The involvement of multiple parties in pre-approvals and complaints handling has resulted in inconsistent decisions about advertisements. These issues could result in increased regulatory burden for industry and limit the effectiveness of advertising compliance which has been detrimental for consumers.[121]
The Explanatory Memorandum states that, although the advertising pre-approval mechanism will be removed as outlined above, ‘other consumer protections will be implemented prior to this occurring, such as an improved complaints handling system and enhanced sanctions and penalties’.[122] Many of the ‘enhanced sanctions and penalties’ in relation to advertising are contained in Part 1 of Schedule 6.
Part 1 of Schedule 6 (in conjunction with Schedule 7, as outlined below) also implements recommendation 57 of the Sansom Review by amending the advertising enforcement provisions in the Act including to ‘broaden sanctions and penalties to more effectively deter inappropriate and misleading advertising of therapeutic goods’.[123] The Explanatory Memorandum notes that, if these changes proceed, an education program will be implemented to ‘assist industry, sponsors and advertisers in understanding their obligations under the new regulatory framework’.[124]
Various items in Part 1 of Schedule 6 amend the advertising–related civil penalty and offence provisions. In particular, the Part introduces a tiered regime of criminal offences which aim to ‘tailor penalties to criminal conduct so that more serious offences resulting in or likely to cause harm or injury will attract sanctions that appropriately reflect that severity’.[125] In short, this tiered regime provides for various levels of offences consisting of:
a high level ‘aggravated’ offence with aggravating elements (‘aggravated offences’), whereby contravening the relevant offence has resulted in, will result in, or is likely to result in harm or injury to a person. The penalties for these aggravated offences are significantly higher than existing offences without the aggravating element, to ‘reflect the fact that breaches of these provisions have resulted in, or will pose, a serious and direct threat to public health and safety’[126]
an ordinary offence, which attract a maximum penalty of 12 months imprisonment or 1,000 penalty units and
a strictly liability version of the offence, with a maximum penalty of 100 penalty units.[127] The maximum penalty for the proposed new strict liability offences introduced by Schedule 6 will be 100 penalty units ($21,000 for an individual or $105,000 for a body corporate).[128] The Explanatory Memorandum states that although this is ‘higher than the usual maximum for strict liability offences, this is justified because of the potential risk to public health arising from the misuse of therapeutic goods’.[129]
insert proposed subsection 21B(4), to provide a new civil penalty provision for advertising of indications that are not an accepted indication in relation to that particular therapeutic good, with a maximum penalty of 5,000 penalty units ($1,050,000) for an individual or 50,000 penalty units ($10,500,000) for a body corporate (item 4)
insert proposed subsection 22(2) to provide a high level offence for that conduct, including an aggravated element requiring that the use of the goods has resulted in, or will result in, or is likely to result in harm or injury to any person, or the use of the goods, if the goods were used, would result, or would be likely to result, in harm or injury to a person. It also requires a link between the harm or injury and the contravention. The maximum penalty is imprisonment for 5 years or 4,000 penalty units or both (item 5)
insert proposed subsection 22(3), which provides a standard offence for advertising of an indication, where the advertised indication is not an accepted indication in relation to that particular therapeutic good. The maximum penalty for this standard is 12 months imprisonment or 1,000 penalty units, or both (item 5) and
amend the existing subsection 22(5) and insert proposed subsection 22(5A), which would convert the existing offence into a strict liability offence with maximum penalty of 100 penalty units (items 6 and 7).
Section 30 of the Act currently enables the Secretary to cancel the registration or listing of therapeutic goods in certain circumstances. Under paragraph 30(1)(f), this includes situations where a person has not complied with a direction or requirement given by ‘an authority constituted by or under the Regulations’ in relation to an advertisement of the goods to ensure that advertising complies with the Therapeutic Goods Advertising Code. The Complaints Resolution Panel (established by section 42R of the Therapeutic Goods Regulations) currently has the power to give a direction or make a requirement of a person in relation to the advertising of therapeutic goods.[130] However, the Explanatory Memorandum indicates that the Complaints Resolution Panel will be abolished, and the Secretary of the Department of Health will instead be the ‘single body responsible for the handling of all complaints about the advertising of therapeutic goods to the public in the future’.[131]
So, for example, item 38 of Schedule 6 inserts a proposed section 42DV which will authorise the Secretary to issue directions about advertisements, such as correcting or ceasing the advertisement, if the Secretary is satisfied that there has been a contravention of the Act or the Regulations. Item 9 of Schedule 6 also replaces paragraph 30(1)(f) to enable the Secretary to cancel the registration or the listing of the therapeutic goods where a person or body corporate has failed to comply with a direction given by the Secretary under proposed subsection 32DV in relation to an advertisement about the goods.[132] Item 9 also enables the Secretary to cancel a registration or listing of therapeutic goods where there is a breach of the Therapeutic Goods Advertising Code or any other advertising requirement under Part 5-1 of the Act or Regulations. However, the Secretary must be satisfied that the breach is significant and that the presentation of the goods is misleading to a significant extent as a result of the breach.[133]
Item 1 of Schedule 6 also inserts a new definition of ‘advertise’ in section 3 of the Act, while item 2 repeals the existing definition of ‘advertisement’. The new definition of ‘advertise’ is broadly defined and clarifies that it covers any statement, picture or design intended to promote the goods, including those on the label, in the package or on material included in the package, of the therapeutic goods. Redundant references to ‘publish’ or ‘broadcast’ are also removed from the Act, as a result of items 33, 35, 37 and 60 of Schedule 6.[134]
Schedule 7 (in conjunction with Part 1 of Schedule 6, as outlined above) implements recommendation 57 of the Sansom Review by amending the enforcement and offence provisions in the Act as outlined below. The Explanatory Memorandum states that the amendments in Schedule 7 will bring the powers of the Secretary under the TGA regime into line with those of comparable Commonwealth regulators, such as the Australian Sports Anti-Doping Authority, the Office of Drug Control and the National Industrial Chemicals Notification and Assessment Scheme.[135]
Schedule 7 revises the current tiered structure of many offences in the Act to strengthen the aggravated elements in the criminal offence provisions, standardise the existing strict liability offences and add some strict liability offences to correspond with existing fault-based offences.
a fault-based offence with an aggravating element (for conduct that results in, or will result in harm or injury) generally attracting a maximum penalty of 4,000 penalty units ($840,000 for an individual or $4,200,000 for a body corporate) and/or 5 years imprisonment
a strict liability offence with an aggravating element (conduct likely to result in harm or injury), generally attracting a maximum penalty of 2,000 penalty units ($420,000 for an individual or $2,100,000 for a body corporate) with no term of imprisonment and
a fault-based offence (with no aggravating element), generally attracting a maximum penalty of 1,000 penalty units ($210,000 for an individual or $1,050,000 for a body corporate) and/or 12 months imprisonment.[136]
The Bill proposes to amend the Act to provide a consistent regime throughout the Act ‘with sanctions that better match the degree of seriousness of the consequences of conduct that currently constitutes an offence’.[137] The new tiered offences regime structure will amend the existing regime as follows:
fault-based offences with an aggravating element (for conduct that results in, or will result in harm or injury) will be modified to include cases where the conduct is likely to result in harm or injury with the same current maximum penalty (as outlined above)
existing fault-based offences (with no aggravating element) will be retained with the same current maximum penalty (as outlined above) and
strict liability offences will be modified to remove the current aggravating element (conduct likely to result in harm or injury) as this will now be included in the higher fault-based offence. The maximum penalty for strict liability offences will be reduced from 2,000 penalty units to 100 penalty units ($21,000 for an individual or $105,000 for a body corporate) with no term of imprisonment. As such, the proposed modified strict liability offences will now form the bottom tier of each three-tiered offence regime.[138]
So, for example, items 4 to 7 of Schedule 7 amend section 9G of the Act to apply this modified regime to the offences for making a false or misleading statement in connection with a request to vary an entry on the Register.[139] The Explanatory Memorandum contains several tables identifying the relevant offences in various sections of the Act that the Bill proposes to amend to implement this new regime.[140]
Item 291 of Schedule 7 replaces the current infringement notice regime in Part 5A-2 of Chapter 5A of the Act. The Explanatory Memorandum states that the new infringement notice provisions are based on Part 5 of the Regulatory Powers (Standard Provisions) Act 2014 and will ‘provide a simpler and faster remedy to a suspected contravention of a provision than formal civil or criminal proceedings’.[141] Under the new provisions, the Secretary can give a person an infringement notice if the Secretary reasonably believes the person has contravened a provision of the Act or the Regulations that is an offence of strict liability or for a contravention of a civil penalty provision.[142] Infringement notices provide a person with the option of paying a fine as an alternative to court proceedings for the contravention. If the person chooses not to pay the fine, proceedings can be brought against the person in relation to the contravention.[143]
one-fifth of the maximum penalty that could be imposed by a court and
12 penalty units ($2,520) for an individual, or 60 penalty units ($12,600) for an incorporated body.[144]
Item 292 of Schedule 7 inserts a new Part 5A-4 into Chapter 5A of the Act to provide for the Secretary to seek injunctions (or interim injunctions)[145] from the Federal Court or Federal Circuit Court to restrain a person from contravening the Act or the Regulations, or to compel compliance with the Act or the Regulations. The Explanatory Memorandum states that the new injunction provisions are based on Part 7 of the Regulatory Powers Act and:
... will allow the Secretary to rapidly address serious noncompliance with regulatory requirements that might lead to poor public health outcomes, such as advertising unapproved therapeutic goods to the public with false claims as to the medicine’s relevant indications, such as its capacity to treat serious diseases including cancer.[146]
Part 6-2 in Chapter 6 of the Act currently contains a number of monitoring and investigation powers, including provisions relating to entry, searches and warrants. Schedule 7 amends Part 6-2 with the intention of aligning these monitoring and investigation powers with Parts 2 and 3 of the Regulatory Powers Act. For example, item 300 inserts proposed section 48AB into the Act to confer powers on authorised persons[147] to use electronic equipment for monitoring compliance with the Act or Regulations. The Explanatory Memorandum states that this proposed section is based on the monitoring powers in sections 20 and 21 of the Regulatory Powers Act.
Schedule 5 of the Bill implements recommendations 15 to 17 of the Sansom Review, which relate to conformity assessment of medical devices, to determine whether they meet minimum safety and performance standards.
In particular, Schedule 5 enables the Secretary to make greater use of assessments of therapeutic goods from comparable overseas regulators when assessing medical devices.[148] Under proposed section 41BIB (inserted by item 5) comparable overseas regulators will be specified in a notifiable instrument made by the Secretary. The Secretary must be satisfied that the overseas body is empowered to issue certificates or other documents to the effect that the body is satisfied that requirements, comparable to the Australian conformity assessment procedures,[149] have been applied to medical devices by the manufacturers of the devices.
As noted earlier in this Digest, the 2016 Measures Act partially implemented recommendation 15 of the Sansom Review by enabling the Secretary to designate Australian corporations as Australian conformity assessment bodies, authorised to undertake conformity assessments.[150] Schedule 5 further implements recommendations 15 and 16 of the Sansom Review by amending the Act to further refine that scheme. This includes amendments which propose to:
require conformity assessment bodies to maintain records (proposed section 41EWD inserted by item 18)
enable the Secretary to publish information in relation to Australian conformity assessment bodies (see item 13)
provide for conformity assessment certificates for medical devices to specify the duration of certificate, which must not be longer than five years (see items 8 and 18)[151] and
ensure the Secretary has the same powers in relation to conformity assessment certificates issued by Australian conformity assessment bodies as for conformity assessment certificates issued by the Secretary him or herself (see for example proposed section 41GFA, inserted by item 30, which extends the Secretary’s powers to suspend medical devices in certain circumstances).
Schedules 4, 8 and 9 of the Bill contain amendments which primarily clarify the operation of the Act or provide for greater consistency in the regulation of different types of therapeutic goods. They are dealt with adequately in the Explanatory Memorandum to the Bill, and readers are referred to the Explanatory Memorandum for a summary of the amendments in these Schedules.
Section 4 of the Charges Act allows various charges to be prescribed in Regulations for the purposes of the TGA. Section 5 contains the regulation-making power, enabling the Governor‑General to make Regulations prescribing the amounts of charges. As the Explanatory Memorandum states, annual charges are designed to ensure that the TGA is able to recover the costs of its post-market monitoring activities (in accordance with the Australian Government Cost Recovery Guidelines).[152]
As noted earlier in this Digest, the 2016 Measures Act implemented recommendation 15 of the Sansom Review by allowing Australian corporations to be designated as Australian conformity assessment bodies.[153] Once designated, these bodies are able to undertake conformity assessments of manufacturers of medical devices.
The Bill amends the Act to make it clear that an annual conformity assessment body determination charge is payable by the Australian corporation that is the subject of such a determination, and to set out related arrangements such as when such charges become payable.[154]
In addition, item 3 inserts a proposed subsection 3(3) into the Charges Act to provide that where the Secretary suspends a conformity assessment body determination,[155] the obligation for the conformity assessment body to pay an annual charge will continue during that period. The Minister’s second reading speech states that ‘this is because a suspension is temporary and during the suspension period the usual regulatory work in relation to the determination continues’.[156]
Item 6 contains a consequential amendment to support the proposed provisional approval pathway for new prescription medicines established by the Schedule 1 of the main Bill (and in turn, recommendations 3 and 10 of the Sansom review). The Explanatory Memorandum states that it is expected annual charges for these products will be prescribed under the existing subsection 4(1) of the Charges Act. However, item 6 proposes to insert a proposed subsection 4(3A) to provide that any annual charges that are prescribed in relation to provisionally registered goods under the existing subsection 4(1) of the Charges Act will also apply to any provisionally registered goods entered in the Register by Commonwealth officers in accordance with a corresponding state law.[157]
The Bill and the Charges Bill are the second tranche of legislation implementing the recommendations of the Sansom Review into the regulation of therapeutic goods (including medicines and medical devices). Key reforms implemented by the Bills include introducing a provisional registration scheme for medicines with promising early evidence of efficacy, moving to a simpler and more self-regulatory system for therapeutic goods advertising, revising enforcement and offence provisions in the Act, and introducing a new approval pathway for intermediate risk complementary medicines. These reforms are the result of extensive consultation, and appear to be generally well supported by stakeholders. However, some stakeholders have raised concerns about replacing advertising pre-approvals with a more self-regulatory system. The ongoing cost of the reforms will be met by the TGA’s cost recovery arrangements.
[1]. Department of Health (DoH), ‘Expert review of medicines and medical devices regulation’, DoH website, 16 March 2017.
[2]. Note that the Charges Bill is a separate Bill due to the constitutional requirement in section 55 of the Australian Constitution that laws imposing taxation must deal only with one subject of taxation and must not deal with any other matter.
[3]. Charges Bill, clause 2.
[4]. DoH, ‘What are “therapeutic goods”?’, Therapeutic Goods Administration (TGA) website; Therapeutic Goods Act 1989, section 3.
[5]. DoH, ‘Who we are and what we do’, TGA website.
[6]. DoH, ‘TGA basics’, TGA website.
[7]. DoH, ‘TGA regulatory framework’, TGA website, 31 May 2012.
[8]. DoH, ‘Product regulation according to risk’, TGA website.
[11]. DoH, ‘Fees and payments’, TGA website.
[12]. DoH, ‘Expert review of medicines and medical devices regulation’, DoH website, 16 March 2017.
[13]. P Dutton (Minister for Health) and F Nash (Assistant Minister for Health), Expert Panel to review medicines and medical devices regulation, media release, 24 October 2014.
[14]. DoH, ‘Expert review of medicines and medical devices regulation’, op. cit.
[16]. Australian Government, ‘Part 2: expense measures’ Budget measures: budget paper no. 2: 2016–17, p. 106.
[17]. DoH, Improving the regulation of therapeutic goods in Australia, Budget 2016–17 fact sheet, DoH, 2016.
[18]. DoH, Australian Government response to the Review of Medicines and Medical Devices Regulation, DoH, Canberra, 2016; S Ley (Minister for Health and Aged Care), Reform of regulation of medicines and medical devices , media release, 15 September 2016.
[19]. DoH, Australian Government response to the Review of Medicines and Medical Devices Regulation, op. cit.
[20]. DoH, ‘Medicines and medical devices regulation review’, TGA website, 28 August 2017.
[21]. Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017. For an overview of the changes made by this Act, see J Mills and A Grove, Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, Bills digest, 67, 2016–17, Parliamentary Library, Canberra, 2017.
[22]. DoH, ‘Implementation of reforms – public consultation forecast’, TGA website, 18 October 2017.
[23]. Explanatory Memorandum, Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, p.1.
[24]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, pp. 1–5.
[25]. Explanatory Memorandum, Therapeutic Goods (Charges) Amendment Bill 2017, pp. 1–2.
[26]. L Sansom, W Delaat and J Hovarth, Review of Medicines and Medical Devices Regulation: report on the regulatory framework for medicines and medical devices, (Sansom Review [Stage One]), Commonwealth of Australia, March 2015, p. ix.
[27]. DoH, Australian Government response to the Review of Medicines and Medical Devices Regulation, op. cit., p. 8.
[28]. Sansom Review [Stage One], op. cit., p. xiv.
[29]. L Sansom, W Delaat and J Hovarth, Review of Medicines and Medical Devices Regulation—stage two: report on the regulatory frameworks for complementary medicines and advertising of therapeutic goods, (Sansom Review [Stage Two]), Commonwealth of Australia, July 2015, p. 26.
[30]. Ibid., pp. 27–29.
[32]. DoH, Australian Government response to the Review of Medicines and Medical Devices Regulation, op. cit., p. 34.
[33]. O Reeves, S Swami, S Tham, and S Jennings, ‘Understanding the TGA's regulatory framework’, presentation to the Device Sponsor Information Day, 15 October 2015.
[34]. Sansom Review [Stage One], op. cit., p. xvi.
[35]. Ibid., p. xvi.
[37]. Ibid., p. xvii.
[38]. DoH, Australian Government response to the review of medicines and medical devices regulation, op. cit., p. 19.
[39]. Sansom Review [Stage Two], op. cit., pp.51–56.
[40]. Ibid., p. 54. The current code is the Therapeutic Goods Advertising Code 2015.
[41]. Sansom Review [Stage Two], op. cit., p. 58.
[42]. Ibid., pp. 53,60.
[43]. Ibid., pp. 53,64.
[44]. Ibid., pp. 64-66; Sansom Review [Stage One], op. cit., p. 163.
[45]. DoH, Australian Government response to the review of medicines and medical devices regulation, op. cit., pp. 25–26.
[46]. Sansom Review [Stage One], op. cit., p. xxii.
[47]. DoH, Australian Government response to the Review of Medicines and Medical Devices Regulation, op. cit., p. 25.
[48]. Senate Selection of Bills Committee, Report, 14, 2017, The Senate, 30 November 2017, p. 4.
[49]. Australia, Senate, ‘Referral to committee’, Journals (proof), 75, 2016–17, 30 November 2017, p. 2402.
[50]. Parliament of Australia, ‘Senate Community Affairs Legislation Committee: Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and related bill’, Parliament of Australia website.
[51]. Senate Scrutiny of Bills Committee, Scrutiny Digest, 12, 2017, The Senate, Canberra, 18 October 2017, pp. 50–53.
[52]. Ibid., p. 50.
[53]. Ibid., p. 51.
[58]. Ibid., p. 52–53.
[59]. T Zappia, ‘Second reading speech: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, Therapeutic Goods (Charges) Amendment Bill 2017’, House of Representatives, Debates, 25 October 2017, pp. 11924–11926.
[60]. G Hunt, ‘Second reading speech: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017’, House of Representatives, Debates, 14 September 2017, pp. 10426–10429; DoH, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017: Exposure Draft, TGA website, 31 August 2017 ; DoH, Therapeutic Goods (Charges) Amendment Bill 2017: Exposure Draft, TGA website, 31 August 2017.
[61]. Medicines Australia, Streamlined approvals means faster access to medicines for patients, media release, 15 September 2016.
[62]. Complementary Medicines Australia (CMA), CMA welcomes draft legislation that will deliver a world class regulatory regime, media release, 31 August 2017.
[63]. CMA, CMA welcomes Government response to the Sansom Review of medicines regulation, media release, 15 September 2016.
[64]. Australian Self Medication Industry, ASMI welcomes the majority of the Federal Government’s decisions on the regulation of medicines, media release, 15 September 2016.
[65]. Medical Technology Association of Australia, Fast-tracking innovation welcomed by medical technology industry, media release, 16 September 2016.
[66]. Consumers Health Forum of Australia (CHF), Fast track for new drugs will need faster subsidy decisions, media release, 15 September 2016.
[67]. CHF, Time for complementary medicines to show proof, media release, 14 February 2017.
[68]. C Moy, ‘AMA fully engaged in review of medicines regulation’, Australian Medicine, 29(2), 20 February 2017, p. 22.
[70]. Society of Hospital Pharmacists of Australia, SHPA supports Budget measure to fast-track medicine approvals, media release, 4 May 2016.
[71]. Australian Government, ‘Part 1: special Accounts table: Agency resourcing’, Budget measures: budget paper no. 4: 2017–18, p. 115.
[72]. Australian Government, ‘Part 2: expense measures’, Budget measures: budget paper no. 2: 2016–17, p. 106.
[73]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 6.
[74]. Explanatory Memorandum, Therapeutic Goods (Charges) Amendment Bill 2017, p. 2.
[75]. The Statements of Compatibility with Human Rights can be found at pages 7–17 of the Explanatory Memorandum to the Bill, and at pages 3–4 of the Explanatory Memorandum to the Charges Bill.
[76]. Parliamentary Joint Committee on Human Rights, Human rights scrutiny report, 11, 2017, 17 October 2017, p. 60.
[77]. Biologicals are defined in section 32A of the Act as a thing made from, or that contains, human cells or human tissues, or live animal cells, tissues or organs and that is used to: treat or prevent a disease, ailment, defect or injury; diagnose a condition of a person; alter the physiological processes of a person; test the susceptibility of a person to disease or ailment; or replace or modify a person’s body parts. See further: TGA, ‘Products regulated as biologicals’, TGA website, 3 July 2017.
[78]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 21.
[79]. TGA, Summary of Regulations to support the 2017 changes to the Therapeutic Goods Act (enacted and proposed), Canberra, 31 August 2017.
[81]. Proposed subsection 22E(8).
[82]. Subsection 22E(10) provides that an application is finally determined when the application, and any reviews or appeals arising from the application have been concluded.
[83]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 22.
[85]. Sansom Review [Stage One], op. cit., p. 69.
[86]. U.S. Food & Drug Administration (FDA), ‘Accelerated approval program’, FDA website, last updated 10 March 2016.
[87]. European Medicines Agency (EMA), ‘Conditional marketing authorisation’, EMA website.
[89]. H Naci, K Smalley and A Kesselheim, ‘Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration’, Journal of the American Medical Association, 318(7), 15 August 2017, pp. 626–636.
[91]. R Banzi, C Gerardi, V Bertele and S Garattini, ‘Conditional approval of medicines by the EMA’, British Medical Journal (online), 357, 2 May 2017. For a more detailed analysis of the ethics of accelerated access to medicines, see J Pace, N Ghinea, I Kerridge and W Lipworth, ‘Accelerated access to medicines: an ethical analysis’, Therapeutic Innovation & Regulatory Science, 51(2), March 2017, pp. 157–163, ProQuest database.
[92]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 23.
[93]. Proposed subsections 29(2) and (3).
[94]. Proposed subsection 29 (6).
[95]. Proposed subsection 29(10).
[96]. Proposed paragraph 29(10)(c). See also Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 24.
[97]. See paragraph 60(1)(c) and subsections 60(2) and (3).
[98]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 24.
[99]. Sansom, Delaat and Hovarth, Review of medicines and medical devices regulation—stage two: report on the regulatory frameworks for complementary medicines and advertising of therapeutic goods, (Sansom Review [Stage Two]), op. cit., p. 26.
[100]. Explanatory Memorandum, op. cit., p. 2. The provisions relating to cancellation of listing are in section 30 of the Act, as amended by items 17 and 18 of Schedule 2.
[101]. In making the determination, the Minister may have regard to a number of matters listed in proposed subsection 26BF(2), but is not limited to those criteria. The Explanatory Memorandum gives examples at pages 30–31.
[102]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 30.
[104]. TGA, ‘Draft list of permitted indications’, TGA website, 1 November 2017.
[105]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 32.
[106]. Decisions by the Secretary (or his or her delegate) in relation to applications to vary the permitted indications determination will be subject to reconsideration and review under section 60 of the Act. However, under proposed subsection 60(2C), inserted by item 19 of Schedule 2, only the application can request the reconsideration of a decision by the Secretary to refuse the application.
[107]. Proposed subsections 26BJ(3) and 26BJ(5).
[108]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 33.
[109]. Ibid., p. 28.
[110]. Ibid., p. 3.
[111]. Ibid. See especially proposed subsections 26AB and 26AE.
[112]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 39.
[113]. Ibid., p. 39.
[114]. Proposed subsection 26AC(2) and see also proposed subsection 26AD which provides that the application will lapse if the fee is not paid.
[115]. A decision to refuse to list a medicine under this section is a reviewable decision under section 60 of the Act.
[116]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 39.
[118]. See the definition of ‘designated therapeutic goods’ in section 2 of the Therapeutic Goods Regulations 1990.
[119]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 98.
[120]. Explanatory Memorandum, op. cit., p. 98. Section 5G of the Therapeutic Goods Regulations 1990 provides for the Secretary to be satisfied of certain matters for approving the advertisement. The Secretary’s power under section 5G may be delegated to either the Complementary Healthcare Council of Australia or to the Australian Self‑Medication Industry (depending on the mode of publication) in accordance with section 5Q.
[121]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 98.
[122]. Ibid., p. 98.
[123]. Ibid., p. 71.
[126]. Ibid., p. 71–72.
[127]. See further Chapter 2 of the Criminal Code Act 1995 (Criminal Code), which sets out the general principles of criminal responsibility that apply to Commonwealth offences.
[128]. Under section 4AA of the Crimes Act 1914, a penalty unit is currently equivalent to $210. Subsection 4B(3) of the Crimes Act also provides that the maximum penalty applicable to a corporation convicted of a Commonwealth offence is five times the maximum penalty that could be imposed on an individual.
[129]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 72.
[130]. Ibid., p. 74. See also TGA, ‘Making a complaint about the advertising of a therapeutic product’, TGA website, 19 March 2015.
[131]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 74 and see also pp. 77 and 93.
[132]. Proposed paragraphs 30(1)(f) and (fa). Similar amendments are made in relation to biologicals by items 20-21 of Schedule 6 of the Bill.
[133]. Proposed paragraph 30(1)(fb).
[134]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 72.
[135]. Ibid., p. 4.
[136]. Ibid., p. 100.
[137]. Ibid., p. 101.
[139]. See further Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 101.
[140]. Ibid., pp. 117–134.
[141]. Ibid., p. 108.
[142]. See proposed sections 42YJ and 42YK.
[143]. Proposed section 42YJ; see also Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 108.
[144]. Proposed subsection 42YKA(2). As noted earlier, under section 4AA of the Crimes Act 1914, a penalty unit is currently equivalent to $210.
[145]. For interim injunctions, see proposed section 42YO.
[146]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, p. 110.
[147]. Authorised persons are defined in section 7A of the Act.
[148]. Explanatory Memorandum, Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017, pp. 4–5.
[149]. See section 41DA of the Act, which provides that the Regulations may set out requirements relating to the obligations of manufacturers of medical devices, which are known as the ‘conformity assessment procedures’.
[150]. See TGA Act, section 41EWA.
[151]. Although note that a single 12 month extension may be granted by the Secretary: item 10 of Schedule 5.
[152]. Explanatory Memorandum, Charges Bill, p. 1; see also Department of Finance, Australian Government cost recovery guidelines, Resource Management Guide, 304, 3rd edn, The Department, Canberra, July 2014.
[153]. See TGA Act, section 41EWA.
[154]. See especially items 54–55 of Schedule 5 of the Bill.
[155]. Such suspensions will be enabled by item 16 of Schedule 5 of the Bill, which amends section 41EWA of the Act.
[156]. G Hunt, ‘Second reading speech: Therapeutic Goods (Charges) Amendment Bill 2017’, House of Representatives, Debates, 14 September 2017, p. 10430.
[157]. Explanatory Memorandum, Charges Bill, p. 7. Note that section 6AAE of the Act enables Commonwealth officers or authorities to enter goods on the Register under a corresponding state law.