Medical manslaughter

'Gross negligence ‘medical’ manslaughter in Ireland: Legal context and clinician concerns' by Mary-Elizabeth Tumelty and Eimear Spain in (2021) Medical Law International comments 

In recent years, the prospect of the criminal prosecution of medical practitioners for patient safety incidents resulting in fatality which occur in the course of clinical practice has caused heightened anxiety among medical practitioners, particularly in England and Wales, where a number of high-profile cases have raised public consciousness of this issue. The full impact of this landscape on individual practitioners and the delivery of healthcare has yet to be ascertained, although research suggests that medical practice has been impacted. Of particular interest is the phenomenon of defensive medicine which occurs where physicians adopt assurance and/or avoidance behaviours in an attempt to minimise the risk of medical negligence litigation and/or to avoid complaints to regulatory bodies. While defensive medicine is traditionally conceived of in a civil context, the possibility of criminal prosecution for patient safety incidents resulting in fatality may also result in alterations to medical practice. Drawing on the findings of an empirical study (a survey), this research sought to explore the impact, if any, of the threat of criminal prosecution on surgical practice in the Republic of Ireland, including a potential rise in defensive practice.

The authors argue 

In Ireland, redress for patient safety incidents resulting in harm is typically achieved through civil law remedies, that is, medical negligence litigation. Regulatory processes, such as complaints made to the Medical Council, are also a feature of the landscape. In contrast, criminal prosecution for patient safety incidents have been rare and prosecutions of medical practitioners for gross negligence manslaughter, relating to their professional roles, have to-date been non-existent. Recent events, such as the CervicalCheck controversy, resulting from a failure to and/or delay in disclosing the results of a retrospective audit to a group of women, who had developed cervical cancer, have increased the appetite for the accountability of the medical profession in Ireland. There has also been a criminal prosecution of a GP, Bernadette Scully, for gross negligence manslaughter in 2016, where it was alleged that the administration of an excessive quantity of sedative given during an epileptic seizure resulted in the death of her daughter . While Dr. Scully was acting in a private capacity when the incident occurred, this prosecution has raised the possibility of prosecution in the consciousness of the public and within the profession. Increases in prosecutions of this nature in England and Wales, are also significant given the close historic and cultural ties between the two jurisdictions and the similarities between the two legal systems. A factor which is poorly understood in this discourse is the lower legal standard which applies in gross negligence manslaughter cases in Ireland and which has the potential to lead to higher rates of conviction than in England and Wales, should the decision be made by prosecuting authorities to bring medical practitioners to trial for gross negligence manslaughter in Ireland. 

The personal and professional impact on individual doctors practicing in an increasingly adversarial, high-risk environment, which includes the possibility of criminal sanction must not be underestimated. As Brazier and Cave note, ‘[t]he increasingly common demand that doctors be punished for tragic mistakes causes anxiety within the profession’. Recent developments in the United Kingdom, such as the high-profile prosecution of Dr Hadiza Bawa-Garba, a junior doctor who had recently returned from maternity leave, for the gross negligence manslaughter of a young boy who tragically died under her care following a misdiagnosis, has led to what has been described as ‘toxic fear’. Despite the systemic failures in this case including issues with the hospital computer system, staff shortages, and long-working hours, she was convicted in 2015, and subsequently erased from the medical register, leading to an outcry by the profession. While the sanction of erasure was subsequently reversed, the case had a far-reaching impact. The implications of operating in this environment are felt by patients, doctors and the healthcare system, leading to defensive practice whereby the decisions of healthcare professionals are coloured by the threat of legal and/or regulatory action. The literature on defensive medicine has to-date been limited in two ways: it has focused on the impact on the patient and the system, to the exclusion of the physician; and has explored the impact of civil legal actions and/or regulatory sanctions, rather than criminal prosecution.  Defensive medicine, the practices which may be adopted by physicians as a means of mitigating against the threat of litigation, complaints, and/or criticism, arguably, could equally apply to measures taken to avoid criminal prosecution. While negligence litigation was traditionally viewed as the sole trigger for defensive practice, Case has described this view as ‘reductionist’ and notes that ‘[r]esearch into defensive practice in medicine has. . . re-contextualised such defensiveness as a multifactorial phenomenon with broader parameters’. The acknowledgement that defensive practice is engaged in for a myriad of factors including ‘for the purpose of protecting the doctor from criticism’  or ‘protection against possible accusations of negligence or under performance’ is welcome, yet acknowledgments of the impact of potential criminal prosecution in this context have been rare. As Quick surmises ‘whether the threat of criminal prosecution impacts on the behaviour of healthcare professionals, and if so in what ways, is not well understood’. However, it appears from anecdotal evidence that prosecutions of this nature are resulting in defensive practice. For example, the independent review on gross negligence manslaughter commissioned by the GMC in 2019 noted: ‘[w]e have heard repeated reference to doctors resorting to defensive medicine’. 

This article seeks to explore the impact of the threat of criminal prosecution on surgical practice in Ireland, drawing on the findings of an empirical study. The literature and case law suggest that there is an international awareness of the impact of the threat of litigation, criticism, and/or complaints on surgical practice, specifically, the area of practice which is the focus in this study. Internationally, surgeons have been identified as a group who may be especially susceptible to defensive practices, due to the high-risk nature of surgery.  Empirical insights into defensive practices both generally and in the context of surgical practice are non-existent in Ireland. In addition, despite the significant body of research that exists in this area, research on the impact of the threat of criminal prosecution on the practice of medicine is limited. 

The first part of this paper critically examines the current legal framework as it relates to gross negligence manslaughter in Ireland, and discusses proposals for reform. The second part of this paper provides an overview of the methodological approach adopted in this study, and presents and explores the findings of this research. In doing so, the paper argues that an increase in prosecutions for gross negligence manslaughter has the potential to intensify defensive practice, and such a punitive approach to patient safety incidents which result in fatality will do little to cultivate a ‘just culture’ and achieve the overall important policy goal of patient safety.

'Death caused by negligent medical care: Reconsidering the role of gross negligence manslaughter in the aftermath of Bawa-Garba' by Ash Samanta and Jo Samanta in the same journal comments -

Gross negligence manslaughter is a well-established common law offence in English jurisdiction. Nevertheless, it remains a troubled area of law. Academic commentators, as well as the Law Commission, have frequently called for reform. We explore this offence through the prism of medical manslaughter and argue that the offence is insufficiently nuanced in certain situations of death caused by gross negligence. This applies particularly to complex professional circumstances where a coalescence of inter-linking factors may converge with disastrous results for the parties concerned. Using the clinical care model as an exemplar, we argue that relentless focus on the offender can result in a disproportionately high level of blame being foisted on an individual. On the basis of decision theory, we suggest that insufficient regard may be given to confounding contextual matters. Failure to address underlying systemic factors may impede wider patient safety initiatives such as professional medical candour and strategies designed for institutional improvements directed at broader societal benefit. We offer an alternative approach based upon principles of fair attribution of blame and transparency. A new statutory offence is suggested for a fault-based standard that is set by law that gives greater prominence to contextual matters. We argue for wider disposal options that include ancillary court orders for rectification of systems failures and more proactive engagement of the coronial process.

'Surgical harm, consent, and English criminal law: When should ‘bad-apple’ surgeons be prosecuted?' by Alexandra Mullock in (2021) 21(4) Medical Law International 343–368 comments -

This article examines the legal principles determining when surgical harm becomes a criminal matter. In England and Wales, and other common law jurisdictions, the criminal law has predominantly concerned itself with fatal medical misconduct via the offence of gross negligence manslaughter. The convictions of two surgeons in 2017 (Ian Paterson and Simon Bramhall), for offences against the person, suggests that police and prosecutors have, for the first time, become willing to prosecute surgeons for non-fatal surgical harm. Understanding when non-fatal surgical harm should be treated as a criminal matter is, however, a complex issue. The medical exception to the criminal law legitimizes consensual and reasonable surgical harm. Thus, the question of what is reasonable and what constitutes valid consent is key to determining the parameters of lawful surgery; however, the principles are perplexing and insofar as they may be agreed and understood, they are arguably unsatisfactory. After examining the cases involving serious surgical harm and analysing the doctrines applied, this article argues for a more patient-centred approach. The focus should be on the nature of the harm to the victim, the behaviour of the dangerous surgeon and whether a violation has occurred, rather than on traditional professional assessments, which are unduly deferential to the medical profession. 

Mullock argues -

 This article examines the uncertain principles concerning non-fatal surgical harm and the criminal law. In England and Wales, and other common law jurisdictions, the criminal law has predominantly concerned itself with fatal medical misconduct via the offence of gross negligence manslaughter (GNM). The ‘medical exception’ within criminal law creates a legitimate but uncertain space, allowing doctors to consensually harm patients for ‘reasonable’ surgical purposes. Thus, lawful surgery must be both consensual and reasonable. Without the medical exception, because surgery necessarily involves intentional wounding, it inevitably satisfies the requirements of section 20 of the Offences Against the Person Act 1861 (OAPA) and, if the wound is sufficiently serious to constitute grievous bodily harm (GBH), section 18 OAPA is potentially applicable. The convictions of two surgeons Paterson and Bramhall, in 2017, for offences against the person, suggests that police and prosecutors have become more willing to question the presumption that surgical harm is not a criminal matter. This article examines Paterson, Bramhall, other cases involving surgical malpractice and the legal principles determining when surgical harm might be regarded as a non-fatal offence. 

This research contributes to the debate about the appropriate domain of the criminal law in medicine. While doctors have been convicted of sexual offences, the criminal law has not traditionally been used to capture other non-fatal medical harm-doing. The seminal work of Glanville Williams urged us to trust in the medical profession’s ability to self-regulate and not look to the criminal law when things go wrong, unless serious problems demand the concern of Parliament:

It may be questioned whether the criminal law has any place in controlling operations performed by qualified practitioners upon adults of sound mind with their consent, whether for reasons of therapy, charity or experiment. Controls exercised by the medical profession itself should be accepted as sufficient.

Paterson and Bramhall suggest that the criminal law does have a role to play when surgeons abuse trust and harm patients, but understanding when non-fatal surgical harm should be treated as a criminal matter is a complex issue. The question of what is reasonable and what constitutes consent are key to determining the parameters of lawful surgery; however, the principles are perplexing and insofar as they may be agreed and understood, they are arguably unsatisfactory. By examining these principles, I consider the challenges of determining whether and when harmful surgical injuries should be treated as a criminal rather than a civil matter. Ian Paterson’s crimes – mutilating many patients over more than a decade – provides an extreme example of criminal conduct, usually however, ‘bad-apple’ surgeons who recklessly inflict serious harm are subjected only to the scrutiny and accountability available via civil law and regulatory, disciplinary measures. 

In the first section, I examine the problem of harmful surgery perpetrated by ‘bad-apple’ surgeons (Paterson, Bramhall, and others) and how contextual challenges when applying the criminal law to a medical setting make it difficult to capture surgical crime. The second section explores the principles of consent and the uncertainty over what constitutes reasonable – and thus unlawful – surgery. My analysis reveals that while we can be sure that lying to patients about a procedure is a criminal wrong, the threshold for sufficient information for valid consent is uncertain and seemingly inadequate to protect patient interests. Similarly, it is far from clear what the threshold for ‘reasonable’ and thus lawful surgery is. The next section draws from Feinberg’s work on consent and the relationship between being harmed and being wronged in order to present an argument for requiring more than minimal honesty for lawful consent. Finally, I argue that a clearer, less professionally driven concept of ‘reasonable surgery’ within the criminal law should be established. These arguments point towards the need for a more patient-centred approach, which recognizes the serious harm that can be inflicted under the guise of legitimate surgery as a criminal wrong. The focus should be on the nature of the harm to the victim, the behaviour of the bad-apple surgeon and whether a violation has occurred, rather than on traditional professional standards, which are unduly deferential to the medical profession.

Colanders

A bad but unsurprising day for adherents of the Church of the Flying Spaghetti Monster in a case that alas has been much misreported.

In de Wilde v. the Netherlands (9476/19, Decision 9.11.2021) the ECHR has held that Article 9 of the Human Rights Convention is not applicable and in non-recognition of Pastafarianism as a religion or belief has endorsed rejection by the Netherlands of identity photos of Pastafarians wearing a colander. 

The Court's statement indicates 

Facts – The applicant is a so-called “Pastafarian”, a follower of the “Church of the Flying Spaghetti Monster”. When she tried to renew her identity card and her driving licence, she submitted identity photographs of herself on which, allegedly in line with the prescriptions of her belief, she was wearing a colander. These were rejected, in accordance with the delegated legislation in force, which required the identity photograph on official identity documents to show the bearer bareheaded unless a head covering was prescribed by the bearer’s religion. Her challenges were unsuccessful; the administrative and judicial authorities found that Pastafarianism did not qualify as a “religion”. The applicant complained, inter alia, that the domestic authorities, in particular the Administrative Jurisdiction Division of the Council of State, had misapplied the standards developed by the Court and that no account had been taken of her forum internum. 

 

Law – Article 9: Given the applicant’s complaints, the core question was whether Pastafarianism could be regarded as a “religion” or “belief” to be protected by Article 9. The Court replied in the negative. In particular, it found no reason to deviate from the findings of the Administrative Jurisdiction Division, whose decision appeared carefully measured and did not seem in any way arbitrary or illogical. That court had duly applied the standards set out in the Court’s case-law and noted a lack of the required conditions of seriousness and cohesion. While accepting that the applicant had been consistent in wearing her colander out of doors, it found that she had not shown that she belonged to a Pastafarian denomination that met the above preconditions. In this context, the Court noted that the original aim for which the Pastafarian movement had been founded had been to protest against the introduction into the school curriculum of the state of Kansas of the doctrine of “intelligent design” alongside the theory of evolution; this had inspired a movement critical of the influence and privileged position afforded to established religions in some contemporary societies. That movement had sought to express this criticism by parodying aspects of those religions and by claiming the same privileges for itself with a view to propagating its message. This understanding was supported not only by the form and content of Pastafarian teaching but also by the appearance in one of its “canonical” texts of the outright statement to that effect. 

 

In these circumstances, and in particular given the very aims for which the Pastafarian movement had been founded, the Court did not consider Pastafarianism to be a “religion” or “belief” within the meaning of Article 9. Consequently, the wearing of a colander by followers of Pastafarianism could not be considered a manifestation of a “religion” or “belief”, even if the person concerned submitted that he or she chose to do so out of a conviction that was genuine and sincerely held. 

 

It followed that Article 9 could not apply either to the “Church of the Flying Spaghetti Monster” or to those who claimed to profess its doctrines.

Water Registration

The Productivity Commission's Register of Foreign owned Water Entitlements report today notes

In response to community concerns and a perception of rapidly rising foreign control of water assets, the Australian Government introduced the Register of Foreign Ownership of Water Entitlements (the Register) in 2017 to provide transparency about the level of foreign ownership of water. Under the Register, foreign persons are required to notify the ATO if they acquire a specified water asset or if there are changes to their foreign status or water entitlement holdings .... 

In addition to some personal details, registrants furnish information on:

• the type and terms of the water right held 

• when and by whom the right was issued 

• the State or Territory and water system the right relates to 

• the characteristics of the water resource 

• the percentage of foreign ownership of the resource 

• the sector in which it is used.

The ATO holds this information in the ‘basic part’ of the Register, which is not publicly available but can be shared with some authorised users for specific purposes. The ATO also prepares a statistical summary of Register data — termed the ‘statistical part’ — which provides an overview of the level of foreign ownership of water nationally, by State and Territory, by type of water resource and by sector at 30 June each year. This report is published on the Foreign Investment Review Board (FIRB) website.

The key points in the report are 

• There is no compelling case for major changes to the Register of Foreign Ownership of Water Entitlements. It plays a small, yet useful, role and apart from a few tweaks should continue for now, provided its costs remain low. 
• Foreign investment provides capital for businesses to grow, introduces new technologies, practices and technical expertise, and enables Australians to enjoy higher standards of living than they otherwise would. 
• There is support for foreign investment within the agricultural and mining industries, but a sizeable share of the broader community has some unease with foreign investment. Foreign investment can also be conflated with other water market concerns, such as water market manipulation. 
•  The Register requires foreign persons to notify the ATO if they acquire a specified water asset or if there are changes to their foreign status or water entitlement holdings. 
• It shows that of the share of Australian water issued as entitlements, about 11 per cent is foreign owned. 
• The transparency provided by the Register helps maintain community confidence in Australia’s approach to foreign investment. It gives ministers, government agencies and other interested parties an authoritative source of information on foreign ownership of water entitlements in Australia. There is no other source for this information. 
• The information provided by the Register is sufficient for its limited purpose.
• The high level summary of Register data contained in the statistical reports published by the ATO provides the necessary transparency. These reports are generally clear and easy to use. 
• Compliance and enforcement activities are proportionate to the minimal risks associated with non compliance. 
• There is not a compelling case to provide more granular information on foreign ownership, such as at the water source or catchment level. Such information could risk being used to identify registrants, violating confidentiality provisions. 
• There is no alternative approach to the current Register that would provide the appropriate transparency at a lower cost. 
• There is scope for some tweaks to the current Register. 
• The statistical reports should include data on the proportion of foreign owners of water entitlements that also hold agricultural land. This would be of low cost and improve the effectiveness of the Register. 
• The statistical reports should clarify several misperceptions, including by clearly stating that registration is compulsory, and that foreign ownership need not entail foreign control. 
• The States and Territories should link to the Register from their water information portals.

The Commission's Findings and Recommendations are - 

Rationales for the Register 

F 3.1 A TRANSPARENCY RATIONALE 

There is a prima facie rationale for a transparency mechanism, such as a Register, to maintain community confidence in foreign ownership of water entitlements. In the absence of a transparency mechanism, the Government may be more likely to be pressured to make (small) adverse changes to the foreign investment regime and water policy settings. 

F 3.2 THE REGISTER CANNOT ADDRESS COMPETITION ISSUES IN WATER MARKETS 

The Register cannot — and nor is it intended to — respond to problems with the efficient and fair operation of water markets. Anti competitive conduct, where it exists, should be dealt with through competition or water market policy. 

F 3.3 THE REGISTER DOES NOT SUPPORT POLICY DEVELOPMENT OR ADMINISTRATION 

Information from the Register is intended to support policy development and administration. However, the Commission has not been able to identify a tangible use of Register information for these purposes. 

How is the Register performing? 

F 4.1 THE REGISTER PROVIDES TRANSPARENCY BUT IS LITTLE KNOWN 

The information contained in the Register and published in the statistical reports prepared by the ATO is appropriate for its narrow function. It provides clarity on the level of foreign ownership of water entitlements. However, there is a low level of awareness of the Register in the community and its information is sometimes negatively portrayed. 

F 4.2 PRIVACY RESTRICTIONS ON ACCESS TO DATA ARE APPROPRIATE 

Privacy restrictions on access to Register data help to preserve its integrity by maintaining registrants’ trust in the ATO and the foreign investment regime more broadly. 

F 4.3 THE STATISTICAL REPORTS ARE ACCESSIBLE AND USER FRIENDLY 

The statistical reports are accessible and user friendly. However, some terminology requires prior knowledge of water market concepts. Current explanatory materials risk not being understood by those unfamiliar with water markets. There have been delays in the release of the statistical reports due to the ATO’s quality assurance processes. However, Register information is not time sensitive. 

F 4.4 ADMINISTRATION IS LOW COST AND SUPPORTS DATA INTEGRITY 

Administrative costs of the Register are low, estimated at no more than $0.5 million a year. Included in this cost are activities necessary to support the integrity of Register data. 

F 4.5 CURRENT COMPLIANCE AND ENFORCEMENT ACTIVITIES ARE SUFFICIENT 

The ATO’s approach to compliance and enforcement has been targeted towards raising awareness of the Register. Enforcement activities have been limited but sufficient, in part reflecting the low risks associated with non compliance. 

F 4.6 LOW COMPLIANCE COSTS, BUT THE REGISTER ADDS TO COMPLEXITY 

The direct compliance costs created by the Register are low. However, it contributes to a complex set of regulatory requirements in both agriculture and foreign investment, imposing indirect costs on foreign water entitlement holders. 

Reconsidering the Register 

F 5.1 THE REGISTER SHOULD CONTINUE 

There remains a small, yet useful, role for the Register in reducing pressures for adverse changes to foreign investment and water policies. Although the benefits are difficult to measure, they plausibly exceed the Register’s administration and compliance costs. 

F 5.2 ADAPTING STATE WATER REGISTERS WOULD NOT BE COST EFFECTIVE 

State and Territory water registers should not be adapted and used in place of the Register of Foreign Ownership of Water Entitlements. The registers vary significantly in coverage, terminology and frameworks used to record ownership information. Simply adding foreign ownership information to the existing, separate registration systems would entail moderate costs and be less effective than retaining the Register. It would be prohibitively expensive to recalibrate and align the different systems to enable them to provide nationally consistent estimates. 

F 5.3 SURVEYS WOULD NOT PROVIDE A COMPLETE PICTURE 

The Agricultural Land and Water Ownership Survey, last conducted by the ABS in 2016, provided information on the level of foreign ownership of water assets, but at a lower level of detail than the current Register. It was relatively expensive to run, and would not meet the Government’s objective at a lower cost than the Register. Other existing government information sources, such as ABS agricultural and foreign investment data sources and ABARES farm surveys, are not suitable for adaptation and use in place of the Register. 

F 5.4 THE REGISTER’S MEASURE OF FOREIGN OWNERSHIP IS REASONABLE 

The Register uses a reasonable method for measuring foreign ownership, which is based on the definition specified in the Foreign Acquisitions and Takeovers Act 1975 (Cth). 

F 5.5 MINING WATER ENTITLEMENTS SHOULD NOT BE EXCLUDED FROM SCOPE 

Although some water entitlements used in mining have different characteristics and purposes than other water entitlements, they should not be excluded from the Register’s scope. Retaining a comprehensive scope adds to the Register’s credibility. 

F 5.6 GEOGRAPHIC INFORMATION IN THE STATISTICAL REPORTS 

The geographic breakdown of information in the statistical reports provides sufficient transparency to support confidence in the maintenance of Australia’s foreign investment and water policy settings. There could be scope for the ATO to provide further geographic information on foreign ownership in the southern Murray-Darling Basin. The ATO, in consultation with relevant federal and state government agencies, could conduct further work to explore the feasibility, cost and merit of this proposal as part of the development of the forthcoming Register of Foreign-Owned Assets. 

F 5.7 THE CASE FOR PROVIDING ADDITIONAL DATA 

Most proposals to include additional information — such as on the size and structure of entitlement owners — in the statistical report would not further the Register’s objective and would entail additional cost. 

F 5.8 NO CASE TO MOVE TO ‘REAL TIME’ PUBLICATION 

Updating the statistical report online in real time would provide few benefits to users but would create material costs and difficulties for the ATO and registrants. 

R 5.1 LINKING TO THE REGISTER FROM STATE WATER REGISTERS 

All State and Territory governments should ensure that their online water registers and related portals provide a link to the Register of Foreign Ownership of Water Entitlements. They should also ensure that their water licence application processes inform applicants of the requirement for entitlement holders who are foreign persons to register with the ATO. 

R 5.2 THE SHARE OF REGISTRANTS THAT HOLD LAND 

In future statistical reports, the ATO should specify the share of water registrants that also hold agricultural land. 

R 5.3 CLARIFYING CONCEPTS AND AVOIDING MISUNDERSTANDINGS 

The ATO should revise the statistical reports or develop release materials to highlight or explain: 

• that registering is mandatory 

• the concepts of foreign ‘owned’ and foreign ‘controlled’ entitlements 

• the distinctions between water market concepts, such as entitlements and allocations, and total available water resources 

• the distinct characteristics of the use of water entitlements in the mining sector.

Medical Devices

The TGA consultation (somewhat inhibited by the difficulty of finding its discussion paper) regarding the potential for mandatory reporting of medical device adverse events by healthcare facilities involves people answering the following questions - 

1. Potential introduction of mandatory reporting 

• Should Australia introduce mandatory reporting for medical device-related adverse events by healthcare facilities?

– Why should Australia introduce mandatory reporting for medical device- related adverse events by healthcare facilities? 

– Why should Australia not introduce mandatory reporting for medical device-related adverse events by healthcare facilities? 

• Can you identify any unintended consequences of introducing mandatory reporting of adverse events by healthcare facilities? 

2. Healthcare facilities that could be included or excluded 

• Are there any healthcare facilities licensed/accredited through national schemes (listed in the discussion paper) that should not be included in any proposed mandatory reporting of medical device adverse event reports? – If so, why? 

• Are there any other frequent users of medical devices that could potentially be included? Please select from the provided list or provide examples of other:

 – Public and private ambulance services 

– Dental and orthodontic practices 

– Chiropractic practices (who conduct diagnostic imaging) 

– Pharmacy practices (who supply medical devices) 

– Non-medical specialist cosmetic procedure centres 

– Other residential care providers 

– General practices 

– Specialist medical practices 

– Allied health practices 

– Community-based health services (e.g., district nursing services) 

– Other (Please provide) 

• Are you aware of a reporting, accreditation or licencing body that would be able to mandate potential mandatory reporting of medical device- related adverse events? 

• Are you aware of any specific state and territory legislation, health service licencing or other requirements that would prevent potential mandatory reporting?

 3. Types of medical device incidents to report

• What type of medical device-related incidents or events do you consider should be reported through to the TGA?

– Incidents resulting in death 

 

– Incidents resulting in serious injury 

 

– Near misses that could have resulted in death or serious injury 

 

– Issues identified during routine maintenance where the device is fixed or replaced prior to use 

 

– Incidents that occur outside of a hospital setting e.g. malfunction of an implant and the patient presents to a healthcare facility 

 

– Other (please specify and provide reason) 

• If you work in a healthcare facility, will the harm metrics that your healthcare facility utilises allow for identification of reportable incidents (including the types mentioned in the preceding question)? 

• When an adverse event occurs, what medical device related information is collected by facilities through incident or other information management systems?

– The suspected involvement of a medical device 

 

– The brand/trade name of the medical device 

 

– Where the medical device came from (e.g. facility/health professional) 

 

– The current location of the medical device – Other (please specify) 

4. Recognising and reporting events that might cause (or be causing) harm 

• Do current reporting systems need to be improved to incorporate patient symptoms that might have been caused by a medical device? – If so, what needs to be improved? What level of patient symptoms should be flagged by healthcare facilities? – symptoms causing pain or discomfort – symptoms that cause impairment of function – symptoms that require additional medical care 

• Do healthcare facilities routinely collect the following information relating to potential or actual device malfunctions? a. Issues identified during routine maintenance where the device is fixed or replaced prior to use: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who or where is this information reported to? b. Issues successfully managed by clinical staff e.g. near misses: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who is this information reported to? c. Incidents that occur outside of a hospital setting e.g. malfunction of an implant and the patient presents to a healthcare facility: ▪ Is this information recorded? If so, Where is this information recorded? ▪ Is this information reported? If so, Who is this information reported to? 

5. Reducing duplication of data entry 

• What platform/s does your organisation currently use (or provide, if you are a software vendor) to record medical device-related incidents, adverse events, potential incidents, or device failures (examples below)? o Patient medical records (for symptom related data) o Incident management systems (for events that impact upon patients) o Workplace health and safety systems (for incidents that impact upon staff) o Equipment maintenance records or databases o Hospital purchasing records (e.g. for returned products) o Patient/staff complaints data o Other (please specify) 

• Does the platform include the capability to generate or send reports or summaries of the incidents in standards and formats such as FHIR, XML or JSON? 

• If a healthcare facility, do you already submit data to the TGA for COVID-19 vaccine reaction reporting? I 

• f you have more than one platform that records device incidents, are there issues with integrating current information systems? 

• Is it feasible for an adverse event module to be added to your current platform/s to facilitate data transfer to the TGA? – If so, please outline how this integration could occur, the potential costs and timeframes, and any potential blockers. – If not, could a system adaptor be utilised? If so, please outline which information systems would benefit from an adaptor, the potential costs and timeframes, and any potential blockers. If not, why? 

6. Quality assurance of the incident information 

• Is there a current minimum data set that is collected for adverse event/incident reporting? – If so, what does this data set consist of? – 

• Does this currently undergo quality assurance checks? – If so, who is responsible for undertaking this check? 

• Within healthcare facilities, which health professionals are responsible for reporting adverse events as part of their accreditation requirements? – Nurse manager – Quality and safety consultant – Clinical nurse specialist – Bio-medical engineer – Clinician – Other (please specify) 

7. Accountability for mandatory reporting

• What existing legislative, accreditation or other mechanisms should be explored in relation to potential mandatory reporting and why? 

• What type of compliance schemes could be implemented to reinforce potential mandatory reporting? – Modification to current accreditation schemes – Organisational recognition and reward schemes – Risk-adjusted funding arrangements

Funeral Services and consumer protection

Today's Funeral services sector report from the Australian Competition & Consumer Commission states 

The death of a friend or family member is a time of considerable distress. For those arranging a funeral, these circumstances can impact their usual decision-making abilities. Funeral providers have an important role in guiding consumers through this process. 

Following the ACCC’s recent prioritisation of competition and consumer issues in the funeral services sector we have reviewed reports received from consumers and conducted a survey of consumers and businesses, identifying six key issues of concern: ƒ

• Pricing often lacks transparency and clarity and may mislead consumers, for example where providers do not advise consumers of all the costs associated with their services or label some charges in a way that suggests they are mandatory, when that is not the case.  

• ƒ Some standard form consumer contracts contain potentially unfair contract terms, including excessive interest rates or late fees for overdue accounts (an interest rate or fee may be considered excessive if it is not referable to the cost of recovering late payments). ƒ 

• Claims about being ‘local’ funeral businesses may mislead consumers (where businesses are in fact subsidiaries of larger corporations). ƒ 

• Failing to fulfil prior commitments regarding prepaid funeral products and services harms consumers, who may struggle to enforce their contractual rights and may even be asked to make unexpected additional payments to the funeral business. ƒ 

• Non-disclosure of payments in return for third-party endorsements from comparison websites or health service providers can mislead consumers and may have a detrimental impact on the broader competitive process. ƒ 

• Bundling or tying that limits consumers’ access to funeral products or services and may restrict competing businesses’ access to customers.

The ACCC has already taken enforcement action in relation to some of these issues, including: ƒ

• In March 2021, WT Howard Funeral Services and Coventry Funeral Homes, trading as Fitzgerald’s Funerals, each paid a penalty of $12,600 after the ACCC issued both businesses with infringement notices for allegedly making a false or misleading representation about their ownership. ƒ 

• In September 2021, Alex Gow Funerals paid a penalty of $13,320 after the ACCC issued an infringement notice for an alleged false or misleading representation about the price of its funeral services and the fees that consumers are required to pay. Alex Gow Funerals has also amended its invoices to ensure they accurately describe relevant fees. ƒ 

• In November 2021, Bare Funeral Group, trading as Bare Cremation, paid a penalty of $13,320 after the ACCC issued an infringement notice for allegedly making a false or misleading representation on its website about the ‘minimum price’ for cremation only and memorial services, in circumstances where these prices were not available in the majority of geographic regions where the company operated, or for the vast majority of consumers.

The ACCC continues to investigate other funeral businesses and will take additional enforcement action where appropriate. 

To avoid contravening the Competition and Consumer Act 2010 (CCA) and the Australian Consumer Law (ACL), the ACCC strongly encourages businesses in the sector to consider these issues and review their: ƒ

• promotional material ƒ internal processes such as staff training manuals and salespersons’ scripts ƒ 

• template documents such as quotes, contracts and invoices.

Repair Right

Today's Right To Repair report from the Productivity Commission states 

 • This report finds that there are significant and unnecessary barriers to repair for some products. It proposes a suite of measures that aim to enhance consumers’ right to repair while providing net benefits to the community. 

• A ‘right to repair’ is the ability of consumers to have their products repaired at a competitive price using a repairer of their choice. Realising this aspiration in a practical way involves a range of policies, including consumer and competition law, intellectual property protections, product labelling, and environmental and resource management. 

• Consumers already have rights to have their products repaired, replaced or refunded, and to access spare parts and repair facilities, under consumer guarantees in the Australian Consumer Law. These guarantees are reasonably comprehensive and generally work well, but they should be improved by: – introducing a new guarantee for manufacturers to provide software updates for a reasonable time period after the product has been purchased, to reflect the increasing dependence of consumer products on embedded software – expanding options for ensuring compliance with, and enforcement of, the guarantees to assist individual consumers to resolve their claims and for the Australian Competition and Consumer Commission to address systemic breaches of consumer guarantees – requiring manufacturer warranties to include text stating that entitlements to a remedy under the consumer guarantees do not require consumers to have previously used authorised repair services or spare parts, so that consumers are more aware of their rights. 

• There are several opportunities to give independent repairers greater access to repair supplies, and increase competition for repair services, without compromising public safety or discouraging innovation. To this end, the Australian Government should: – require suppliers of agricultural machinery to provide access to certain repair supplies to reduce the harm of the pervasive barriers to accessing these inputs – undertake more detailed investigations into specific product markets (including mobile phones and tablets, and medical devices) to better understand the extent of harm and examine whether additional regulation would yield net benefits. – amend copyright laws to facilitate the accessing and sharing of repair information (such repair manuals, and repair data hidden behind digital locks). 

• A lack of consumer information about a product’s repairability or durability is likely to make it difficult for some consumers to select more repairable and durable products based on their preferences, while reducing manufacturers’ incentives to develop such products. To address this issue: – the Australian Government (in consultation with consumer, environmental, and industry groups) should introduce a product labelling scheme that provides repairability and/or durability information for consumers. A pilot scheme should target a limited number of white goods and consumer electronics products. 

• There is also scope to improve the way products are managed over their life, to reduce e waste ending up in landfill. In particular, the Government should amend product stewardship schemes to allow for reused e waste to be counted in scheme targets. Further, the use of electronic trackers within product stewardship schemes should increase, to improve awareness of the end of life location of e waste and ensure it is being sent to environmentally sound facilities.

The Commission's Findings and Recommendations are -

The Australian repair sector 

F 2.1 THE AUSTRALIAN REPAIR SECTOR 

A consumer’s decision to repair or replace a broken product is primarily driven by price. The inconvenience of repair and consumer preferences for up-to-date products are also likely to make repair less appealing. The repair sector accounts for about one per cent of all business revenue in Australia and has grown modestly over the past decade. • Most repair activity (revenue, number of businesses and workers) comes from industries with more expensive products, such as motor vehicles and machinery, that require regular maintenance and where repair is often more cost-effective than replacement. • There was less activity in repair industries for relatively less expensive products, such as electronics and appliances, where replacement tends to be more attractive. This is likely due to the relatively low and falling prices of these products over time, rapid technological development, and consumer preferences for new and up-to-date products.

 Existing consumer rights under consumer law 

F 3.1 CONSUMERS SOMETIMES LACK THE ABILITY TO EXERCISE EXISTING RIGHTS 

The Australian Consumer Law provides consumers with rights to obtain a remedy (repair, replacement or refund) for defective products through consumer guarantees. These guarantees are reasonably comprehensive but consumers’ ability to access their rights could be enhanced by: • clarifying existing rights by explicitly requiring manufacturers to provide software updates for a reasonable period • enabling a super complaints process to complement the existing Australian Consumer and Competition Commission’s (ACCC) practices for identifying and dealing with potential systemic breaches of guarantees • enhancing relevant State and Territory regulators’ alternative dispute resolution options for individual cases, through options that can result in enforceable outcomes • empowering the ACCC to seek pecuniary penalties on suppliers and manufacturers that fail to provide a remedy when required to do so, in addition to obtaining redress for affected consumers. 

R 3.1 REQUIRE SOFTWARE UPDATES FOR A REASONABLE PERIOD 

The Australian Government should amend the Australian Consumer Law to include a new consumer guarantee for manufacturers to provide reasonable software updates for a reasonable time period after the product has been purchased, with no option to limit or exclude that guarantee. 

R 3.2 ENABLE A SUPER COMPLAINTS PROCESS 

The Australian Government should enable designated consumer groups to lodge ‘super complaints’ on systemic issues associated with access to consumer guarantees, with the complaints to be fast tracked and responded to by the Australian Competition and Consumer Commission (ACCC). The Australian Government should design the super complaints system in consultation with the ACCC, relevant State and Territory regulators, and consumer and industry groups. The system should be underpinned by operational principles — including criteria for the assignment (or removal) of designated consumer bodies, evidentiary requirements to support a complaint, and the process and time period by which the ACCC should respond. 

R 3.3 ENHANCE ALTERNATIVE DISPUTE RESOLUTION POWERS 

The State and Territory Governments should work together to identify opportunities to enhance alternative dispute resolution options in each jurisdiction to better resolve complaints about the consumer guarantees. In examining such opportunities, governments should consider: • the extent to which consumers in some jurisdictions face less comprehensive access to alternative dispute resolution and whether this is consistent with a national consumer framework • funding options to adequately resource enhanced alternative dispute resolutions • the net benefit of options that enable regulators to make enforceable decisions or facilitate enforceable outcomes • as an alternative, the net benefit of certain product markets (such as motor vehicles) having an ombudsman to make enforceable decisions or facilitate enforceable outcomes. The outcomes of this activity should be published. 

R 3.4 ENHANCE REGULATOR POWERS TO ENFORCE GUARANTEES 

The Australian Government should, in consultation with State and Territory Governments, amend the Australian Consumer Law to make it a contravention for suppliers and manufacturers to fail to provide a remedy to consumers when legally obliged to do so under the consumer guarantees. This would empower the Australian Consumer and Competition Commission to seek pecuniary penalties, in addition to redress for affected consumers.

 Competition in repair markets 

F 4.2 SOME LIMITS ON ACCESS TO REPAIR SUPPLIES LACK SOUND JUSTIFICATION 

There is no evidence of a systemic competition problem across all repair markets. For some products, however, manufacturers are limiting third party access to repair supplies (such as information, tools and parts). While manufacturers often justify these limits as a way to safeguard against risks from poor quality repair (particularly for safety and security), these risks can be overstated for many products and types of repair. Where manufacturers have genuine reasons to restrict access to third-party repair, they should show clear and verifiable evidence of the associated risks. 

F 4.3 LIMITS ON REPAIR SUPPLIES FOR AGRICULTURAL MACHINERY ARE CAUSING HARM 

Manufacturer and dealer restrictions on repair supplies for agricultural machinery (including repair manuals, diagnostic software tools and spare parts) are causing material harm to farmers and other machinery owners through higher repair prices, reduced access and choice, and greater financial risks from repair delays. There is a strong case for additional measures to increase third party access to repair supplies (recommendation 8.2). 

F 4.4 EXTENT OF HARM IN MOBILE PHONE AND TABLET REPAIR MARKETS IS UNCERTAIN 

Manufacturer restrictions on repair supplies for mobile phones and tablets are likely to be resulting in some consumer harm (through higher repair prices and reduced choice of repairer), which could be material in aggregate, given the ubiquitous nature of such goods and the concentrated market for new devices. However, data limitations and some countervailing market characteristics (such as high product turnover) mean that the evidence base is insufficient to justify specific policy interventions at this time. 

R 4.1 UNDERTAKE MOBILE PHONE AND TABLET MARKET STUDY 

The Australian Competition and Consumer Commission should undertake a market study of the mobile phone and tablet market, to further examine the nature of the market, the magnitude of harm from repair barriers, and the merits of different policy responses (such as a repair supplies obligation on manufacturers). 

F 4.5 MEDICAL DEVICE REGULATIONS DO NOT CONSIDER REPAIR ACCESS 

Current regulations of medical devices — such as the ‘essential principles’ in the Therapeutic Goods (Medical Devices) Regulations 2002 —– aim to minimise safety risks to patients and device users, which has the effect of encouraging manufacturers to restrict access to repair. The regulations do not appear to account for the potential harm from reduced access to repair services (such as medical delays and additional costs), or that risks are likely to be low for some devices or for repairs completed by highly qualified independent repairers. 

R 4.2 REVIEW THE MEDICAL DEVICE MARKET AND REGULATIONS  

The Australian Government should conduct an independent public review of existing medical device regulations to assess whether they strike a balance between repair access and device safety that maximises community wellbeing. The review should consider whether current regulations create incentives for manufacturers to restrict repair, and examine potential ways to improve repair access for low-risk medical devices or for highly qualified independent repair technicians. 

F 4.6 HARM FROM RESTRICTIONS ON WATCH REPAIR SUPPLIES IS SMALL 

The high degree of market concentration and consumer lock-in in the prestige watch market in Australia suggests manufacturer restrictions on the supply of watch repair equipment and components to small independent repairers are resulting in consumer harm. In aggregate, this harm is likely to be limited due to the small size of the prestige watch repair market in Australia. Nonetheless, there are credible arguments that these restrictions may constitute a misuse of market power under Australian competition law (s. 46 of the Competition and Consumer Act 2010) that substantially lessens competition in the watch repair market by affecting the viability of local watch repairers. Such arguments have never been tested in an Australian court. 

F 4.7 ACCC ACTION COULD ADDRESS CONCERNS ABOUT ENFORCEMENT 

There are considerable costs and a high evidentiary threshold for bringing cases under the existing competition provisions in Part IV of the Competition and Consumer Act 2010 — such as the misuse of market power, exclusive dealing and anti-competitive agreement provisions. This is likely to discourage third-party repairers (particularly smaller businesses, such as watch repairers) from taking action against manufacturers and authorised dealers. However, the Australian Competition and Consumer Commission already has powers to investigate credible cases of anti competitive conduct in repair markets and, if warranted, institute court proceedings. New cases could test the impact of recent legislative changes and other global repair market developments, as well as provide an educative or deterrent effect for broader repair market conduct. 

R 4.3 FURTHER INVESTIGATE CONDUCT IN WATCH REPAIR MARKETS 

The Australian Competition and Consumer Commission (ACCC) should investigate whether manufacturer conduct in repair markets is contravening the restrictive trade practices provisions of the Competition and Consumer Act 2010, with a view to commencing proceedings. The ACCC’s investigation should initially focus on whether the alleged conduct of watch manufacturers is breaching the misuse of market power (s. 46) provisions. 

F 4.1 MANUFACTURER WARRANTIES CAN DISCOURAGE INDEPENDENT REPAIR 

Some manufacturer warranties include terms that automatically void the warranty if repairs are undertaken by a non-authorised repairer or use non authorised parts. Other warranties often contain dense and difficult to understand language, which can lead consumers to mistakenly believe that such terms exist. These voiding clauses can deter consumers from using third party repairs during the warranty period, limiting their choice of repairer and reducing competition in repair markets. Many consumers are also not aware that consumer guarantees under the Australian Consumer Law cannot be displaced by terms in warranties, and the guarantees are not extinguished if consumers have previously used non-authorised repair services or spare parts (as long as those services have not caused any damage to the product). 

R 4.4 ADD NEW MANDATORY WARRANTY TEXT 

The Australian Government should amend r. 90 of the Competition and Consumer Regulations 2010, to require manufacturer warranties (‘warranties against defect’) on goods to include text (located in a prominent position in the warranty) stating that entitlements to a remedy under the consumer guarantees do not require consumers to have previously used authorised repair services or spare parts. The final wording of the text should be subject to consultation with industry and consumer groups. 

F 4.8 A PROHIBITION ON WARRANTY VOIDING CLAUSES IS NOT JUSTIFIED AT THIS TIME 

Improvements to awareness of the consumer guarantees (through mandatory warranty text — recommendation 4.4) and the enforcement of those guarantees (through the introduction of pecuniary penalties — recommendation 3.4) will go some way towards reducing the deterrent effect of manufacturer warranty terms that void the warranty if any non-authorised repairs occur. Although a prohibition on such terms may have some additional benefits — through simplifying differences between warranties and the guarantees, clarifying ambiguous warranty language and covering non-consumer purchases — it may also increase costs for manufacturers and consumers, so is not justified at this time.

 Intellectual property protections and repair 

F 5.1 COPYRIGHT LAWS ARE AN IMPEDIMENT TO ACCESSING REPAIR INFORMATION 

Copyright laws that prevent third-party repairers from accessing repair information (such as repair manuals and diagnostic data) are the most significant unnecessary intellectual property-related barrier to repair in Australia. 

R 5.1 AMEND THE TECHNOLOGICAL PROTECTION MEASURES REGIME 

The Australian Government should amend the technological protection measures (TPM) regime in the Copyright Act 1968 and Copyright Regulations 2017 to better facilitate repairers’ access to embedded information protected by TPMs necessary for issue diagnosis and repair. To do this, the Government should: • amend the existing TPM circumvention exception for repair in regulation 40(2)(d) of the Copyright Regulations 2017, to clarify its scope and application to permit circumvention in order to access information necessary to perform repairs to the product in which the TPM is installed • amend section 116AO of the Copyright Act 1968, to permit the distribution of TPM circumvention devices for the purpose of facilitating a permitted act of circumvention (such as circumvention for the purpose of repairing a product in regulation 40(2)(d) of the Copyright Regulations 2017). 

R 5.2 INTRODUCE A NEW ‘USE’ EXCEPTION IN THE COPYRIGHT ACT 

The Australian Government should amend the Copyright Act 1968 to include an exception that allows for the reproduction and sharing of repair information. In the immediate term, this exception should be included through the existing fair dealing framework in the Copyright Act. In the medium to long term, the Australian Government should pursue a more flexible copyright exception regime, including a principles-based ‘fair use’ exception. 

R 5.3 PROHIBIT CONTRACTING OUT OF COPYRIGHT EXCEPTIONS 

To give full effect to copyright exceptions, including those relating to repair, the Australian Government should amend the Copyright Act 1968 to make unenforceable any part of an agreement restricting or preventing a use of copyright material permitted by copyright exceptions.

 Product obsolescence 

F 6.1 EVIDENCE ON PREMATURE OBSOLESCENCE IS MIXED 

There is growing community concern in Australia and overseas that product lifespans are becoming unnecessarily short (‘premature obsolescence’), with detrimental impacts on consumers and the environment. However, the evidence is mixed on whether premature obsolescence is a significant problem. • While it is not possible to exclude that some manufacturers engage in strategies to intentionally reduce product lifespans, such practices are unlikely to be widespread. • The lifespans of some products are becoming shorter, but this is often driven by consumers choosing to replace their products with newer ones rather than the products breaking; indeed, some products are becoming more durable. • For certain types of products (such as white goods and consumer electronics), some consumers find it difficult to access relevant information about product repairability and durability when making purchasing decisions. Such information gaps could contribute to premature obsolescence by preventing consumers from selecting more repairable and durable products based on their preferences, and reducing manufacturers’ incentives to develop these products. 

F 6.2 INTERVENTIONIST RESPONSES TO PREMATURE OBSOLESCENCE ARE NOT NEEDED 

Additional policies to prevent premature product obsolescence — in the form of mandatory product design standards, tax incentives and subsidies, or expanded consumer protection laws — are unlikely to have net benefits for the community. The Commission does not support such proposals. Mandatory product design standards, as well as tax incentives and subsidies for repair, are costly and unlikely to be an effective way of addressing concerns about the environmental costs associated with premature obsolescence. Existing consumer protection laws, combined with this inquiry’s recommendations — to increase the ability for consumers to access their rights and a new product labelling scheme (recommendation 6.1) — are likely to address some of the behaviours associated with premature obsolescence. 

F 6.3 BETTER CONSUMER INFORMATION COULD LEAD TO LONGER-LIVED PRODUCTS 

Product labelling is likely to help address information gaps in product repairability and durability for certain products, such as white goods and consumer electronics (finding 6.1). This can assist consumers to purchase more repairable and durable products that align with their preferences and encourage manufacturers to develop these types of products. 

R 6.1 DEVELOP AND INTRODUCE A PRODUCT LABELLING SCHEME   

The Australian Government should develop a product labelling scheme that provides consumer information about product repairability and/or durability. It should develop the scheme in three key stages. 1. Commit to introducing a product labelling scheme within five years and establish a working group (comprising relevant government agencies) to steer its development in consultation with consumer, industry and environmental groups. 2. Design and implement a pilot scheme for products where it is likely to have the most benefits (such as white goods and consumer electronics). 3. Review the pilot scheme within two years of commencement to assess its effectiveness and whether it should be modified or expanded to include additional products in the formal scheme.

 Managing e-waste 

F 7.1 E-WASTE IS A SMALL BUT GROWING WASTE STREAM 

Annual e-waste generation is growing relatively quickly compared to other waste streams (more than doubling by weight between 2009-10 and 2018-19), but is a small share (less than one per cent by weight) of total waste generated in Australia. Information on e-waste is limited, but available data suggest that: • the main sources of e-waste (by weight) over the past decade were tools, washing machines, air conditioners, small domestic appliances (such as adapters, irons and clocks), cooking appliances (such as food processors and grills), and cathode ray tube televisions • solar panels and lithium-ion batteries are expected to generate growing quantities of e-waste over the coming decade. 

F 7.2 RISKS FROM E-WASTE IN LANDFILL ARE RELATIVELY LOW 

Australia’s landfills are generally well-regulated and well-managed, such that risks to the environment and human health from hazardous materials in e-waste are relatively low. That said, landfill quality varies, particularly among smaller and older landfill sites in regional and remote areas, generating increased risks from e-waste in some sites. 

R 7.1 INCLUDE REUSE WITHIN NTCRS ANNUAL RECYCLING TARGETS 

The Australian Government should amend the Recycling and Waste Reduction (Product Stewardship — Televisions and Computers) Rules 2021 to count e waste products that have been repaired and reused towards the annual targets of the National Television and Computer Recycling Scheme (NTCRS) co regulatory bodies. The exact design features that need to be incorporated into the NTCRS to enable reuse options should be determined in consultation with the scheme’s liable parties and co regulatory bodies. The changes should be designed in a way that minimise any adverse incentives, including risks from: • manipulating (or ‘gaming’ of) scheme targets, when the same products cycle through the scheme without legitimately being reused • unlawful exports for reuse that result in more products in the informal recycling sector, generating worse health and environmental outcomes • consumer concerns about data security for repaired and reused products. Any future product stewardship schemes should also include repair and reuse as options within their targets, where practical. 

R 7.2 USE TRACKING DEVICES TO MONITOR E-WASTE EXPORTS 

The Australian Government should make greater use of electronic tracking devices to determine the end-of-life outcomes of Australian e-waste collected for recycling. • At a minimum, the Government should increase the National Television and Computer Recycling Scheme’s use of tracking devices, to better monitor co regulatory bodies and their downstream recyclers and logistic providers. • The Department of Agriculture, Water and the Environment should also examine different ways to use tracking devices in e-waste products outside the scope of product stewardship schemes, taking into account constraints on the use of surveillance devices in some states and territories. Where possible, tracking should be conducted by independent third party auditors, using risk based sampling that focuses on the types of products and supply chains that present the highest risk of unlawful export or disposal of e waste.

 Are broader right to repair laws needed? 

R 8.1 EVALUATE THE MOTOR VEHICLE INFORMATION SHARING SCHEME 

The Australian Government should establish an independent evaluation of the Motor Vehicle Service and Repair Information Sharing Scheme, once it has been in operation for three years. The report of the evaluation should be made public. The evaluation should assess whether the scheme is effectively meeting its objectives to improve competition and choice, whether the benefits outweigh the costs, and whether any changes are required. 

R 8.2 INTRODUCE A REPAIR SUPPLIES OBLIGATION ON AGRICULTURAL MACHINERY 

The Australian Government should introduce a repair supplies obligation on agricultural machinery that requires manufacturers to provide access to repair information and diagnostic software tools to machinery owners and independent repairers on fair and reasonable commercial terms. Design of the scheme should commence by the end of 2022. To inform scheme design and implementation, the Australian Government should: • monitor developments in the Motor Vehicle Service and Repair Information Sharing Scheme, as well as voluntary information sharing within the agricultural machinery industry, to determine the scope of the information to be included • consider whether this obligation should be implemented through an extension of the Motor Vehicle Scheme or through a separate scheme. The scheme should be evaluated after it has been in operation for three years, to assess its effectiveness and determine whether any changes are required, including extending the scheme to cover spare parts.