Defamation

Yesterday's 2nd Reading Speech for the Defamation Amendment Bill 2023 (NSW) seeks to give effect to the Stage 2 reforms program for Australia's uniform defamation laws. 

It states 

 In summary, there are six key reforms: one, a conditional exemption from defamation liability for conduit, caching and storage services, and for search engines in relation to organic search results; two, updates to the mandatory requirements for an offer to make amends for online publications; three, a requirement for courts to consider balancing factors when making preliminary discovery orders against digital intermediaries; four, a new innocent dissemination defence for digital intermediaries, subject to a simple complaints process; five, a specific power for courts to make non-party orders against digital intermediaries to prevent access to defamatory matter online; and six, expanded electronic means by which notices can be served. 

I now turn to the detail of the proposed digital intermediary amendments. Schedule 1 [1] to the bill adds new defined terms to the existing section 4 definitions of the Defamation Act 2005. The new defined terms are fundamental to the operation of the digital intermediary amendments in the bill. I will explain some of the new defined terms later as I outline the substantive amendment provisions to which they relate. However, some of terms apply broadly across the amendment provisions so I will cover those now, starting with the term ''digital intermediary". First, I note that a lot of policy thinking, consultation and refinement sits behind this definition. Digital intermediary, in the context of the publication of digital matter, is defined to mean: … a person, other than an author, originator or poster of the matter, who provides or administers the online service by means of which the matter is published. 

A note makes clear that there may be more than one digital intermediary in relation to the publication of the same digital matter. ''Online service" essentially means any service provided to a person to enable them to use the internet. This includes using the internet to do a range of things, such as sending or receiving content, searching for content, sharing content and interacting with other people. Some examples of an online service are included in a note to the definition to emphasise the range of services covered by the definition. An ''online service" specifically includes a forum created or administered by a person using a facility provided by an internet‑based social media platform that enables users to share content or interact with other users about a topic. 

The term ''digital intermediary" is intended to apply broadly. It was developed to cover the full spectrum of functions considered by the stage two review of the Model Defamation Provisions. It deliberately includes forum administrators. It is also intended to cover any new or emerging functions, given the pace at which technology in this area evolves. Another important aspect of the definition of 'digital intermediary is the exclusions. The definition specifically excludes the author, originator or poster of the matter because they are not intermediaries. "Poster" is defined to mean a person who uses the online service to communicate the matter to one or more other persons. The terms ''author" and ''originator" are not defined. Both terms are used in the existing innocent dissemination offence at section 32. 

For the purpose of the digital intermediary amendments, firstly, ''author" is intended to cover circumstances such as when a person who writes a defamatory statement is not the person who posts it. Secondly, ''originator" is intended to include anyone who plays a role in creating the content. Often they may also be the poster, but in some circumstances they may not—for example, where a person edits and endorses a statement that is drafted and posted by another person. Finally, the term ''digital matter" is defined to mean "matter published in electronic form by means of an online service". This is not intended to affect or limit the meaning of ''matter" in the Act. It is only intended to cover a subset of matter, being digital matter. ... 

I now turn to parts of the bill relating to exemptions from liability for digital intermediaries. Schedule 1 [3] to the bill inserts new division 2A into the Defamation Act. This includes two conditional statutory exemptions from defamation liability that apply to narrow classes of digital intermediaries. In the development of defamation law it has been argued that certain traditional intermediaries, such as telephone lines and postal services, are so passive in the publication process that they are not publishers; indeed, they are mere conduits. The stage two review considered if there are equal passive digital intermediary functions that should have statutory protection from defamation liability for third‑party content. The stage two review concluded that there is a very small group of digital intermediary functions that meet this criteria. 

As a result, schedule 1 [3] establishes a conditional exemption from defamation liability for three specific digital intermediary functions. Firstly, a caching service that stores content temporarily to make onward transmission more efficient will be exempted. For example, this includes files commonly downloaded from a website temporarily and automatically stored to speed up the download time. Secondly, a conduit service whose principal function is to enable users to connect with the internet, send data or receive data will be exempted. This includes internet service providers and email service providers. Thirdly, a storage service whose principal function is to enable users to store content remotely will be exempted. An example is a cloud service provider that enables users to store photos for later retrieval. Proposed new section 10B defines "caching service", "conduit service" and "storage service" and includes examples to illustrate what each definition is intended to cover. 

The policy rationale for this narrow exemption from liability is to recognise the passive role that these digital intermediaries play in the publication process. This does not substantially change the law. These digital intermediaries are generally not the subject of defamation claims and are unlikely to be considered publishers under the Commonwealth test. The intention is to provide clarity and certainty. The exemption would apply irrespective of whether the digital intermediary knew, or ought reasonably to have known, the digital matter was defamatory. Given the breadth of this protection, the exemption only applies very narrowly, and a set of conditions are included to ensure that if an intermediary plays a more active role in a publication—for example, by editing the content—that would make the intermediary ineligible. 

The conditions that apply to the exemption are listed at proposed new section 10C (1) (c). Even where a digital intermediary meets the definition of caching, conduit or storage service, if it played a more active role in relation to the digital matter in question, such as editing or promoting, the exemption would not apply. The stage two review of the Model Defamation Provisions also included careful considerations of the functions performed by search engine providers. Ultimately, it was concluded that a conditional exemption from defamation liability from search engine providers in relation to organic search results is appropriate. 

The policy rationale behind this conclusion is that, firstly, in performing the standard functions, search engine providers have no interest in the content. They simply use an automated process to provide users with access to third‑party content. Secondly, search engine providers are unable to remove content from the internet and can only block access to identified URLs from their search engine. Thirdly, unlike, for example, a social media platform, a search engine provider does not have any relationship with the original author. Fourthly, search engines provide significant public benefit and operate on a massive scale. The exemption for search engine providers applies regardless of whether the search engine provider knew, or ought reasonably to have known, the digital matter was defamatory. 

Given the strength of the protection, the exemption has been designed to apply very narrowly. Firstly, proposed new section 10D (1) provides that the exemption only applies to the publication of digital matter comprised of search results or the publication of digital matter to which the search results provide a hyperlink. ''Search result" is defined in proposed new section 10B. It means a result generated by a search engine that is limited to identifying a webpage on which content is located by reference to one or more of: the title of the webpage, a hyperlink to the webpage, or an extract or an image from the webpage. 

Secondly, proposed new section 10D (1) confines the exemption to publications where the search engine provider's role was limited to providing an automated process for the user to generate the results. An example of a publication that would not be covered by the exemption due to these limitations is an autocomplete suggestion for search terms. Another example is an answer composed by artificial intelligence, such as Bing Chat, in response to a question input by a user. Thirdly, proposed new section 10D (2) provides that sponsored search results are not covered by the exemption. 

The new court power to make orders against non-party digital intermediaries provides for a safeguard where defamatory matter may have been published, even where digital intermediaries qualify for a statutory exemption from liability. The bill will insert new section 39A into the Defamation Act, providing the court with the power to order a digital intermediary that is not a party to proceedings to remove or disable access to defamatory matter online in certain circumstances. The new court power would apply to all digital intermediaries, including those that qualify for the statutory exemptions, meaning that even if a digital intermediary is exempt from liability it will still be possible for orders to be made that the digital intermediary remove access to defamatory material in some circumstances. I will go into further detail about this amendment as I speak about remedies introduced by the bill. 

The bill provides an early determination process for the digital intermediary exemptions. This is at proposed new section 10E, which provides that the judicial officer in defamation proceedings is to determine whether an exemption is established as soon as practicable before the trial starts, unless the judicial officer is satisfied that there are good reasons to postpone the determination to a later state of the proceedings. New section 10E (2) (a) provides a non-exhaustive list of matters that are relevant to this decision. The purpose of the early determination process is to support the policy intent behind the statutory exemptions—namely, to recognise that the role of these digital intermediaries in the publication process is such that they should not be subject to defamation claims. Ideally, the early determination process will mean that time and costs are not expended unnecessarily. The savings and transitional provisions in relation to the statutory exemptions are the same as those for the new innocent dissemination defence. I will briefly outline the intended operation when I speak about the new defence. 

One of the objects of the Defamation Act 2005 is to promote speedy and non-litigious methods of dispute resolution. Part 3 of the Act establishes a procedure to enable parties to settle disputes without the need for expensive litigation by encouraging a publisher to make a reasonable offer to make amends to the aggrieved person. If the aggrieved person does not accept an offer that was reasonable in all the circumstances, the publisher may rely on their offer to make amends as a defence in any subsequent defamation action against them, in accordance with the terms of the Act. 

Section 15 of the Act sets out a number of elements a reasonable offer to make amends must and may include. I will refer to these requirements as the mandatory and discretionary elements of an offer to make amends. The bill includes two proposed amendments to section 15 of the Act. The first is a minor amendment to one of the discretionary elements of an offer to make amends. Section 15 (1A) (b) currently provides that, if the defamatory matter in question has been "published on a website or any other electronically accessible location", an offer to make amends may include "an offer to remove the matter from the website or location". That was added as part of the stage one amendments to accommodate online publications. 

The bill amendments section 15 (1A) (b) to provide that, if the matter is digital matter, an offer to make amends may include an "offer to take access prevention steps in relation to the matter". This amendment broadens the provision by allowing a publisher to offer to remove, block, disable or otherwise prevent access to a matter, and is consistent with wording used in the bill. A more significant amendment is proposed in relation to two of the mandatory elements of an offer to make amends. 

These existing mandatory elements are, firstly, section 15 (1) (d), which provides, relevantly, that an offer to make amends must include "an offer to publish, or join in publishing, a reasonable correction of, or clarification of or additional information about, the matter in question"; and, secondly, section 15 (1) (e), which provides that an offer to make amends must include, "if material containing the matter has been given to someone else by the publisher or with the publisher's knowledge, an offer to take, or join in taking, reasonable steps to tell the other person that the matter is or may be defamatory of the complainant". 

These mandatory elements were not originally designed with digital intermediaries for online publications in mind. They make sense for traditional publications, such hard copy newspapers, that do not remain readily accessible at the click of a button. If the publisher of a newspaper receives a concerns notice about a defamatory statement in a particular edition, they could then offer to publish a correction in a subsequent edition, presumably reaching largely the same audience. However, a digital intermediary may not be able to do these things. For example, a search engine would not be able to publish a reasonable correction for a search result. Also, when defamatory matter is published online, it often stays there. Added to this concern is the ease and speed at which it can be further disseminated to a wider audience. It is understandable then that, for many plaintiffs, their central concern is simply to have the matter removed. 

The bill inserts new section 15 (1B), which updates the operation of these two mandatory elements for digital matter. It provides that, if the matter in question is digital matter, an offer to take access prevention steps may be made instead of or in addition to either or both of the offers mentioned in paragraphs 15 (1) (d) and (e). The purpose of this amendment is to ensure that there is an appropriate avenue for offering to make amends in circumstances where it is not possible or meaningful for online publishers to publish a correction or clarification. It also reflects the kind of remedy that many plaintiffs are seeking in relation to online publications. An important safeguard is that, under the existing section 18, if the defendant seeks to rely on the offer to make amends defence, the court must be satisfied that, in all the circumstances, the offer was reasonable. The offer to make amends changes will apply to offers made after the commencement of the amendments. That is even where the matter is published before the commencement. 

Many originators who post defamatory material online do so using a pseudonym. In order to commence defamation proceedings, the plaintiff must identify and locate the originator. In some recent cases, particularly in the Federal Court, plaintiffs have obtained preliminary discovery orders requiring a digital intermediary to disclose information concerning the originator's identity. Australian courts already can and do consider proportionality, privacy and the risk of abuse of process in exercising the discretion to make preliminary discovery orders. However, there may still be a risk that such orders are abused or have a chilling effect. 

Proposed new section 23A provides that, before making an order for preliminary discovery, the court must take into account the objects of the Act and any privacy, safety or other public interest considerations. This does not provide a new avenue to seek preliminary discovery; it simply applies this requirement over the general rules. While courts already have the discretion to consider these factors, there is value in making consideration of these factors mandatory. This will promote consistency across jurisdictions. It is also in the interests of protecting domestic violence victims and other vulnerable members of society. For example, a person who has published matter online using a pseudonym may fear for their safety. A bad actor could seek a preliminary discovery order on the basis that they want to commence defamation proceedings against the person when the real motive is to find out the person's current location or other contact details. 

Proposed new section 23A would ensure the court takes into account privacy and safety considerations before making a preliminary discovery order requiring a digital intermediary to disclose any identifying information it holds about the person. The savings and transitional provisions for proposed new section 23A are the same as for the power of the court to make non-party orders. I will briefly outline their intended operation when I speak about the power to make non-party orders in a moment.

Medical Devices Regulatory Failure

The UK First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review (Cumberlege Report) is an important point of reference for regulatory failure in Australia regarding pelvic mesh and other implants. It also highlights the salience of listening to patients and their families.

Cumberlege comments that the Review

has been about people who have suffered avoidable harm. Our report is entitled “First Do No Harm”. Having spent two years listening to heart wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought it an appropriate title. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not. ... We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago. The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most. Secretary of State, we are entering a new world, in which innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided.

The Report states

1.1 This Review was announced in the House of Commons on 21st February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care. Its purpose is to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future. 

1.2 Under my chairmanship the Review was asked to investigate what had happened in respect of two medications and one medical device:

• hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages; 

• sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and 

• pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications; and to make recommendations for the future. 

1.3 The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos over decades, drawing active support from their respective All-Party Parliamentary Groups and the media. As the Secretary of State commented: ‘We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. Sometimes the reaction has felt too focussed on defending the status quo, rather than addressing the needs of patients and, as a result, patients and their families have spent too long feeling that they were not being listened to...’ 

1.5 The Review was asked to consider how to strengthen the patient voice in order to help build a ‘system that listens, hears and acts – with speed, compassion and proportionality.’ 

1.6 On the face of it we were being asked to investigate three disparate interventions governed by two different product regulatory frameworks in the one Review. It soon became apparent, however, that far more binds these interventions than separates them:

• they all are taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy; 

• patients affected by each tell similar and compelling stories of their battles to be listened to when things go wrong; 

• patients turning to each other for help and mutual support; 

• patients campaigning for years, if not decades, to achieve acknowledgement, resorting to the media and politicians to take up their cause because the healthcare system did not. 

1.7 The Review looks not just at what happened in the three individual cases but how the healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate. It is in this sense a system-wide review. 

1.8 Finally, as complex and wide-ranging as our Review proved to be, we know that there are many who contacted us during the course of our work and who were disappointed that we could not also consider their concerns about other medications and devices on the market. The list is long – Essure (a contraceptive device), Roaccutane (a treatment for severe acne that can cause birth defects if used in pregnancy), Poly Implant Prostheses (PIP) breast implants, cervical cancer vaccination, in utero exposure to hormones, valproate use in children. We are aware of the similarities between pelvic mesh and mesh used for hernia procedures and we have heard from a number of people adversely affected following hernia mesh procedures. With regards to mesh, the scope of this Review relates only to pelvic mesh, which following insertion resides in the pelvis to support pelvic organs. So, neither hernia mesh nor the other medications and devices listed above were within our remit. Concerns about these taken together, however, point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns. We believe that what we have to say and recommend for the future will have an important read-across to these and other interventions and the manner in which they are approved, delivered, regulated and monitored. 

1.9 What follows is a summary of what we heard, and then a summary of our observations and recommendations and the reasoning behind them. These recommendations cover England only, though we know the devolved administrations are following our work closely. We hope those governments will consider the recommendations we have made for England. 

What we heard 

1.10 Patients were at the heart of our Review. Although our focus was on England, we travelled to the four corners of the UK to listen and learn. We met with hundreds of affected patients and their families and heard by email, phone and letter from many more. It became all too clear that those who have been affected have been dismissed, overlooked, and ignored for far too long. The issue here is not one of a single or a few rogue medical practitioners, or differences in regional practice. It is system-wide. 

1.11 We took evidence from a wide range of stakeholders, from clinicians and the Royal Colleges, from the pharmaceutical industry and manufacturers of devices, from the full range of NHS and private sector providers and arms-length bodies including the regulators, professional and disciplinary bodies and finally from the Department of Health and Social Care. Collectively we refer to this group of stakeholders as the healthcare system. 

1.12 The patients’ stories were harrowing. Our two-year journey took its toll on all of us but that paled into insignificance in the face of so much adversity borne with such resilience and bravery by those we met and heard from. They told their stories with dignity and eloquence, but also with sadness and anger, to highlight common and compelling themes:

• the lack of information to make informed choices; 

• lack of awareness of who to complain to and how to report adverse events; 

• the struggle to be heard; 

• not being believed; 

• dismissive and unhelpful attitudes on the part of some clinicians; 

• a sense of abandonment; 

• life-changing consequences, not only for those directly affected, but for their families and friends too; 

• breakdown of family life; 

• loss of jobs, financial support and sometimes housing; 

• loss of identity and self-worth; 

• a persistent feeling of guilt; 

• children becoming their mothers’ and siblings’ carers; 

• clinicians untutored in the skills they need to make a proper diagnosis; 

• clinicians not knowing how to learn from patients; 

• inaccurate or altered patient records; 

• a lack of interest in, and an inability to deliver, the monitoring of adverse outcomes and long-term follow-up across the healthcare system. 

1.13 These testimonies provided the background to our own diligent inquiry into the roles played by those whose job it is to ‘listen, hear and act with compassion, speed and proportionality’. 

What we learnt 

1.14 What follows will not make comfortable reading for many who have dedicated their lives with the best of intentions to delivering high-quality and compassionate treatment and care. We recognise that most people do excellent work most of the time in the health service. They work hard, they work long hours and they came into the healthcare professions to help sick people get better, never more so than during the Covid-19 pandemic. We recognise too that the constituent parts of the healthcare system do for the most part what each is asked to do. But what they have been asked to do is not the solution to the problem as we see it. 

1.15 Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous. Crucial opportunities are lost to learn about what works well, what does not, what needs special measures put around its use, and what should be withdrawn because the risks over time outweigh the benefits. Without such information it is not possible for doctors and patients to understand the risks, and patients cannot make informed choices. This applies both to medications and to medical devices. 

1.16 The lack of such vigilant, long-term monitoring has been a predominant thread throughout our work. Its absence means that the system does not know the scale of the problems we were asked to investigate:

i. The system does not know, so neither do we, just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh. The system does not know, so neither do we, how many women have been cured of their incontinence, or been successfully treated for their prolapse – only then to experience a long list of life-changing conditions that include loss of sex life, chronic pain, infection, difficulty voiding, recurrent urinary incontinence, permanent nerve damage or damage to surrounding organs, haemorrhage, autoimmune disease and psychiatric injury. We met so many women with limited mobility having to rely on a wheelchair or crutches to move around, unable to sit for periods at a time, unable to play with their children or carry their grandchildren. Living daily with the consequences of the operations and procedures they thought would cure them. The effects of these procedures have caused fractured relationships for some and placed some women and their families in dire financial straits. In short, the system does not know the true long-term complication rate for pelvic mesh procedures. In the absence of such information, it is impossible to know how many women would have chosen a different form of treatment – a different care pathway – if only they had been given the information they needed to make a fully-informed choice; 

ii. The system does not know, so neither do we, just how many women over four decades took sodium valproate, a highly effective treatment for managing epilepsy but a known teratogenic medication, who then went on to become pregnant because they had not been properly informed as to the risk they were taking and the options open to them. The system does not know, so neither do we, how many of those children were subsequently born with either significant malformations, developmental delay or autism (now termed Foetal Valproate Spectrum Disorder or FVSD). The research tells us that 10% of unborn children exposed to the medication are likely to suffer physical birth defects such as spina bifida, hare lip and cleft palate, heart problems and limb defects, and 40% will have a developmental delay or autism. The system still does not know where all these valproate-affected children, now adults in many cases, are, or how to contact them to secure the proper diagnosis and assessment of their care needs. The system does not know how to ensure every woman of childbearing age on sodium valproate is continuously monitored, advised of the risks and aware of the Pregnancy Prevention Programme. How then can the system minimise the risk of future babies being damaged by valproate taken in pregnancy? 

iii. The system does not know, so neither do we, just how many women took a Hormone Pregnancy Test, such as Primodos, between the 1950s and 1978 when it was withdrawn. The system does not know, so neither do we, how many miscarriages may have occurred after taking this medication, how many of the children born to mothers who took Primodos may have suffered physical malformations or died before reaching adulthood, or how many of those children, now adults, may still be alive and in need of extensive care and support. 

1.17 The healthcare system collects a huge amount of information. But it cannot answer these fundamental questions. How then can it spot trends and complications and act swiftly and coherently to protect patients and prevent harm? How then can it design and provide the services that those affected need to lead as full a life as possible? How then can the healthcare system be considered a system for all? 

1.18 We heard about the failure of the system to acknowledge when things go wrong for fear of blame and litigation. There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension – the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’. 

1.19 We heard about a system that does not work in a joined-up fashion, and that lacks the leadership to deliver coherent and fully integrated patient safety policy directives and standards. Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability. This culture has to change, starting at ground level while being encouraged and supported from the top. Witness Professor Ted Baker, the Care Quality Commission’s (CQC) Chief Inspector of Hospitals, speaking at a recent Patient Safety Learning Conference at The King’s Fund, referring to an ‘insidious culture of defensiveness and blame.’ 

1.20 We heard about a system that cannot be relied upon to identify promptly significant adverse outcomes arising from a medication or device because it lacks the means to do so. For decades there has been something known as the ‘Yellow Card’ system through which clinicians, and indeed patients, can report suspected adverse reactions to treatment. But it is clear that there is gross under-reporting, and our complaints systems are both too complex and too diffuse to allow early signal detection. 

1.21 We heard much said about manufacturers being motivated by sales, speed to market and returns to shareholders; manufacturers who contest their liability to contribute towards help for these patient groups. Those suffering from mesh complications around the world have had to resort to litigation to have the wrongs done to them acknowledged. Valproate-affected families have also failed in their group litigation attempt in the UK. In France it is a government-backed scheme that will pay compensation to those who have suffered one or more complications attributable to Fetal Valproate Spectrum Disorder. HPT-affected families in the UK have one failed litigation behind them although we understand that solicitors are now preparing to file a second group action in the UK in relation to HPTs. 

1.22 We heard about the gaps in knowledge and evidence gathering that have already been identified by the National Institute for Health and Care Excellence (NICE), and by others who set the standards for best clinical practice. Crucial research evidence that should help shine a light on what are safe and effective interventions is neither prioritised nor funded. And we heard about research that is funded by manufacturers that never sees the light of day because it is negative or inconclusive for the product in question, or is less than transparent in its declaration of conflicts of interest when positive findings are reported. 

1.23 All that we have heard leads us to conclude the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques. Patients are being exposed to a risk of harm when they do not need to be. And, while we have looked in detail at only three interventions, we have heard nothing that would lead us to believe that things are different for other surgical procedures and devices or other medications. 

1.24 It has taken this Review to shine a light on systemic failings. That the healthcare system itself failed to do so suggests that it has either lost sight of the interests of all those it was set up to serve or does not know how best to do this. The NHS is funded by the taxpayer for the benefit of all of society – current and future. Patients have been affected adversely by poor or indifferent care, have suffered at the hands of clinicians who do not, or who chose not to listen, and have been abandoned by a system that fails to recognise and then correct its mistakes at the earliest opportunity. At times patients have been denied their fundamental right to have the information they need to make fully informed choices. These patients should not have to campaign for years or even decades for their voices to be heard. Patients should not have to find the evidence to say whether the treatments they are being offered are safe and will leave them better off than before. They should not have to join the dots of patient safety. But when they do just that, they deserve to be listened to with respect. 

1.25 Medicine has made great strides in what it has been able to do to prolong life and treat the previously untreatable. But along that journey of scientific progress it has also become complex and potentially too dangerous to be left solely in the hands of clinicians. The influence of patients within the NHS and the overall delivery of healthcare needs to be increased to balance the authority both directly and indirectly of those we call stakeholders in the healthcare system – the professionals certainly, but others too, including big pharma. Patients are unable to make decisions that concern what happens to them because of a widespread lack of truly informed consent and a reluctance or inability by those charged with patient care and treatment to listen and, having listened, to act and where necessary remedy mistakes or misjudgements made. We have much more to say about this throughout our report. 

1.26 In the following chapters we catalogue a list of missed opportunities. These are moments when something could or should have been done to minimise continuing patient harm in respect of each of the three interventions. We also set out our recommendations below and the justification for them. 

1.27 Many will have benefited from pelvic mesh implants. Likewise, sodium valproate will have been an effective treatment for many. But this cannot justify the damage done to those who have suffered without prior knowledge of the dangers they faced – which could take years to present. While the title of our report may not be original, it was chosen with care. ‘FIRST DO NO HARM’ is a fundamental maxim of medical practice – and that has not been the case here. After ‘first do no harm’ comes, of course, ‘NEXT DO SOME GOOD’. We do not want to stifle the medical progress which has enabled many of us to live longer and in better health over the last fifty years. The task for the healthcare system is to get the balance right. It can and must do both. 

Our Recommendations 

1.28 Our Terms of Reference required us to investigate whether the response of the healthcare system was sufficiently robust, speedy and appropriate. In the following chapters we will show that it was not, resulting in avoidable harm. The passage of time between the concerns being raised and the effectiveness of actions taken to address those concerns and then to investigate and learn the lessons – decades in the case of sodium valproate and Primodos – demonstrably added to the suffering and pain of those affected. The system, and those that oversee it, need to acknowledge what has gone so badly wrong. 

Recommendation 1: 

The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh. 

1.29 The patient voice and influence within the NHS and the overall delivery of health care needs to be strengthened. The failure of the healthcare system to respond to patient concerns is a recurrent theme, most recently raised by the Paterson Inquiry. Patients often know when something has gone wrong with their treatment. All too often they are the first to know. Their experience must no longer be considered anecdotal and weighted least in the hierarchy of evidence-based medicine. 

1.30 We do not need another re-organisation of the NHS to get this right; we do not need another regulatory body in an already crowded field. But we do need a new voice, with statutory powers, to talk and act from the perspective of the patient, to encourage the system to do what needs to be done and hold it to account. We need a person of standing who sits outside the healthcare system and who is accountable to Parliament through the Health and Social Care Select Committee. This new voice, which we are calling the Patient Safety Commissioner, would continue the work this Review has started, in pressing the system to take timely action where action is called for to minimise harm. 

1.31 This new Commissioner would champion the patient voice and from this unique perspective would support and encourage the efforts of the healthcare system to improve patient safety around the use of medicines and medical devices. The Commissioner would lead, with full patient group engagement and involvement, on developing a set of principles of Better Patient Safety that would govern the way the Commissioner fulfilled her or his remit. 

1.32 Where there are areas of concern related to the use of medicines and devices, the healthcare system will need to satisfy the Patient Safety Commissioner on the outcomes required for change, who is responsible for delivery and who will take the lead on co-ordination. The Patient Safety Commissioner will wish to monitor the effectiveness of the outcomes. 

Recommendation 2: 

The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices. 

1.33 Litigation has, so far, not served our patient groups well. We would not wish to remove the option to litigate, but for the future we propose a Redress Agency. This agency would supplement the current systems for resolution of disputes between patients and the healthcare system. This Redress Agency is not about addressing the needs of those already affected by the three interventions considered by this Review - these are addressed by Recommendation 4. It is about creating a new way of delivering redress in the future. There are precedents for this both in the UK and abroad, see Appendix 3. 

1.34 The Redress Agency will provide a standing structure which is easy for patients to access and use. Rather than blaming individuals, decisions will be based on avoidable harm looking at systemic failings. This will encourage reporting by clinicians and so provide faster resolution for claimants. The Redress Agency will administer decisions using a non-adversarial process. The support or redress offered could be both financial and non-monetary. 

1.35 To enable flexibility to adapt and respond to situations as they arise, different injury types would have separate schemes. Each scheme would have its own eligibility criteria and its own funding. A levy for pharmaceuticals could be paid into a pharmaceuticals scheme and separately a levy for medical devices could be paid into a medical devices scheme. Placing such products on the UK market should be made conditional upon contributing to a scheme. The Redress Agency would administer these schemes. 

1.36 The costs of running the Redress Agency could be met by contributions from manufacturers and the state, but it must be situated outside the current organisations and the exercise of its functions must be entirely independent. 

1.37 Those responsible for the Redress Agency will have an important role to play in harm prevention as adverse event reports would be centralised, so enabling data to be provided that will help regulators detect signals earlier. 

Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals. 

1.38 In our view all three of the interventions have caused avoidable psychological harm in some patients. It is clear that mesh has caused significant physical harm and valproate has caused physical and neurodevelopmental harm. We believe that the state and manufacturers have an ethical responsibility to provide ex gratia payments  to those who have experienced avoidable damage from the interventions we have reviewed. We recommend these schemes provide discretionary payments. Each of the three interventions should have its own scheme with tailored eligibility criteria. These payments are not intended to cover the costs of services which are available free of charge, such as health care and social security payments, but rather for other needs that could, for example, include travel to medical appointments, respite breaks or emergency payments where a parent has had to stop working to cover care. Patients have waited far too long for redress. Any scheme must be set up promptly. However, each should be structured so that it can be incorporated into the wider Redress Agency for the future as set out in Recommendation 3. 

1.39 Individuals who obtain compensation from litigation or from out of court settlements (like J&J’s Scottish pelvic mesh settlement) will not need recourse to these schemes. 

Recommendation 4: 

Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.  

1.40 We believe that those harmed are due not only an apology but better care and support through specialist centres: specialist centres for mesh, and separately specialist centres for those affected by medications taken during pregnancy. As well as meeting clinical needs, these centres should act as a one stop shop, able to signpost and refer patients to other services including educational, social and welfare. NHS England as the commissioner should collaborate with other government bodies which provide these services. As centres of excellence, such centres should have the responsibility to research better treatments and to audit outcomes. We have been in discussions with NHS England about commissioning these centres. At the time of writing, the commissioning process for specialist mesh centres is ongoing and we have been actively engaged in this process, see Chapter 5, paragraphs 5.12 – 5.13. 

Recommendation 5: 

Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy. 

1.41 Post Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) will have to change, as indeed it recognises. This provides an opportunity to bring much needed cultural and legislative reform and to become more public-facing. The MHRA does not have the public profile of some other international regulators, such as the US Food and Drugs Administration (FDA). If they have concerns patients need to know what the MHRA does and how to contact it. The MHRA must work both for patients and with them. Reform, underpinned by legislation, is needed so that the views of patients are systematically listened to and their experiences of medications and devices are used to inform licensing and regulatory decisions. These strategic themes are further explored in Chapter 2 Theme 11.

1.42 For both medicines and medical devices there is a need for more robust, publicly accessible post-marketing surveillance. This should include mandatory requirements on healthcare organisations to report adverse events within a designated time period. The MHRA should provide assessments of the risks of individual medicines or devices and of classes of medicines or device where one or more members of the class carries an elevated risk. 

1.43 The spontaneous reporting platform for medicines and devices, the Yellow Card system, needs reform. It needs to provide a user-friendly, accessible, transparent repository of adverse event reports. We recognise that the MHRA has previously tried to persuade other EU member states to be more open over adverse device reports. In our view openness and transparency should be a statutory requirement for adverse event reporting in the UK. The MHRA should be required to invite representatives of those who report adverse events (both patients and healthcare professionals) to be involved in evaluating and making decisions on specific safety concerns. 

1.44 Medicines have to pass tests of quality, safety and efficacy before reaching the market. Medical devices are less rigorously examined before they are first marketed. This is because devices continually evolve, so by the time a clinical trial was complete the device may be onto a new iteration. Unlike medicines many implantable medical devices are intended to be permanent. 

1.45 At present the MHRA has no involvement in the pre-market phase of medical device development. It should develop a proactive regulatory role for devices that is more akin to the licensing of medicines; this must be clinically focussed and at least as stringent as the new EU Medical Devices Regulations (MDR). The MHRA should keep a register of all devices approved for the UK market. Manufacturers should be required to apply to the MHRA before marketing their device. The MHRA should assess the application in a way that is proportionate to the risks posed taking into account relevant factors such as, the evidence base supplied, approvals in other jurisdictions, and the post-marketing surveillance plans. If approved a device will be added to the register. Marketing approval for devices should be a staged process, progressing to wider use and dissemination of the device as more information becomes available. In the event of an issue with a device the MHRA must have the power to remove a device from the register. Given there are an estimated 600,000 or more devices on the market we recognise that initially this will almost certainly involve some ‘grandfathering’ of currently marketed devices. 

Recommendation 6: 

The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work. 

1.46 Post-market surveillance for devices and medicines needs to be high-quality and comprehensive, and it can be greatly facilitated by digital technology and big data. It became apparent to us that there were problems with obtaining comprehensive data and creating registries. We know that mature registries can deliver good- quality long-term outcome data using measures that matter to patients. They are, however, few and far between and all too often prompted by catastrophe. 

1.47 We propose a two-stage process for data gathering. Firstly, the setting up of a mesh database with comprehensive coverage. In November 2019 the Secretary of State accepted what we had to say and mandated the requisite data collection by NHS Digital. The second stage will consist of establishing a mesh registry or registries to investigate specific issues in depth. Contact information can be extracted from a database into the registry to enable this research to take place. 

1.48 Ultimately the goal must be to establish a database for all implantable medical devices, which can feed into registries as required. 

1.49 While this recommendation focuses on medical devices, consideration should be given to the creation of comparable databases for specific medications, for example the use of medications during pregnancy.  

Recommendation 7: 

A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures. 

1.50 We have been concerned by conflicts of interest, both potential and real, in the provision of care or treatment, particularly where doctors have financial and other links with the pharmaceutical and medical device companies. Currently there is no central register of clinicians’ financial and non-financial interests. 

1.51 Other regulators should consider similar requirements as necessary, and the Professional Standards Authority should evaluate whether conflicts of interests have been adequately declared. 

1.52 There is also no easily accessible means of identifying the accredited competencies of individual clinicians. The General Medical Council (GMC) has introduced registration for GPs and for specialists who want to practise as consultants. We recommend that this should be expanded to include all doctors’ particular clinical interests (and any supporting accreditation). 

1.53 We believe that responsibility for transparency of interests should not lie only with the medical profession. Medicines and medical device manufacturers should also ensure that they publish details of payments and payments in kind that they make to teaching hospitals, research institutions and individuals. This should be a statutory requirement similar to the Physician Payments Sunshine Act 2010 in the US. Consideration should be given as to where these disclosures should be published, including potentially expanding Disclosure UK and making it mandatory. 

Recommendation 8: 

Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. 

1.54 Our recommendations are designed to reduce the risk of similar cases of avoidable harm in future and to pave the way for a healthcare system that looks and feels very different from the past. It should not take years of campaigning by patients and yet another series of reviews or inquiries to achieve this. 

1.55 We hope this Government, and all those bodies that comprise the healthcare system, will take heed of what we have to say, and that our recommendations, if accepted in full as we believe they should be, will be implemented with real determination and a sense of urgency. Our final recommendation shifts the focus to implementation. 

Recommendation 9: 

The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.

Saying Sorry

'Should Public Figures Apologize? Preliminary Evidence and Speculations' by Cass R. Sunstein comments

In the modern era, the statements and actions of public figures are scrutinized with great care, and it often emerges that they have said or done things that many people consider objectionable, hurtful, offensive, or despicable. A persistent question is whether public figures should apologize for those statements or actions. Suppose that an apology has a purely strategic motivation: helping a politician to be elected or reelected, helping an executive to keep his job, helping a nominee to be confirmed by the U.S. Senate. Empirical work presented here suggests that an apology might well turn out to be futile or even counterproductive. One reason is Bayesian; an apology produces updating that can be unfavorable to the apologizer (by, for example, resolving doubts about whether the apologizer actually said or did the objectionable thing, and about whether what the apologizer did was actually objectionable). Another reason is behavioral; an apology triggers the public’s attention, makes the public figure’s wrongdoing more salient, and can help define him or her. But many open questions remain about the reasons why apologies by public figures fail, and about the circumstances in which they might turn out to be effective.

Spooks and secrets

'The Liberty to Spy' by Asaf Lubin in (2019) 61(1) Harvard International Law Journal comments

Many, if not most, international legal scholars share the ominous contention that espionage, as a legal field, is devoid of meaning. For them, any attempt to extrapolate the lex lata corpus of the International Law of Intelligence (ILI), let alone its lex scripta, would inevitably prove to be a failed attempt, as there is simply nothing to extrapolate. The notion that international law is moot as to the question of if, when, and how intelligence is to be collected, analyzed, and promulgated, has been repeated so many times that it has attained the status of a dogma. 

This paper offers a new and innovative legal framework for articulating the law and practice of interstate peacetime espionage operations, relying on a body of moral philosophy and intelligence ethics thus far ignored by legal thinkers. This framework adopts a diagnosis of the legality of covert intelligence, at three distinct temporal stages – before, during, and after. In doing so it follows the traditional paradigms of international law and the use of force, which themselves are grounded in the rich history of Just War Theory. Adopting the Jus Ad, Jus In, Jus Post model makes for an appropriate choice, given the unique symbiosis that exists between espionage and fundamental U.N. Charter principles. 

This paper, focuses on the first of these three paradigms, the Jus Ad Explorationem (JAE), a sovereign’s prerogative to engage in peacetime espionage and the right’s core limitations. Examining a plethora of international legal sources the paper exemplifies the myriad ways by which peacetime intelligence gathering has been already recognized as a necessary pre-requisite for the functioning of our global legal order. The paper then proceeds to discuss the nature of the JAE. It argues that that the right to spy is best understood as a privilege in Hohfeldian terms. It shows how understanding interstate intelligence operations as a weaker “liberty-right” that imposes no obligations on third parties to tolerate such behavior, helps capture the essence of the customary norms that form part of the practice. 

Recognizing the liberty right to spy opens the door for the doctrine of “abuse of rights” to play a role in constraining the practice. By identifying two sole justifications for peacetime espionage – advancing the national security interests of States and promoting an increase in international stability and cooperation – we are able to delimit what may constitute abusive spying (exploiting one’s right to spy not for the purposes for which it was intended). 

The paper thus concludes by introducing five categories of unlawful espionage: (1) spying as a means to advance personal interests; (2) spying as a means to commit internationally wrongful acts; (3) spying as a means to advance corporate interests; (4) spying as a means to facilitate a dictatorship; and (5) spying as a means to exploit post-colonial relationship.

The Law Council of Australia has condemned the Federal Government’s processes in appointing members to the Administrative Appeals Tribunal (AAT) as secretive with the potential to undermine public confidence.

The Council comments

At least 14 former state and federal MPs and staffers were among 86 appointments to the AAT, announced Thursday. Law Council President Arthur Moses SC said the legal profession is concerned and troubled by these developments. “The lack of transparency compromises community confidence in the independence of the tribunal and the quality of its decision making,” Mr Moses said. 

“The independence and integrity of the AAT depends on an apolitical, open and merit-based appointment system. 

“The Federal Government’s announcement of 34 new appointments to the AAT made without community consultation and 52 reappointments for existing members is concerning, as a number of members have been re-appointed before the expiration of their current terms. 

“There is a concern that reappointment of members well before the expiry of their current terms, in the context of an upcoming Federal election, may give rise to a reasonable apprehension that decisions are affected by political considerations and therefore compromises the reputation of the Tribunal. 

“The appearance of a conflict of interest can be just as damaging to the AAT’s integrity as an actual conflict. “Appointments should be made transparently and in consultation with the community, including the legal profession, to safeguard their quality and improve their diversity. 

“The AAT deals with a significant number of cases that directly impact on the lives of Australians. It is important those appointed have the necessary skills to discharge its functions according to law and community expectations. 

“An AAT that reflects the community it serves better enhances public confidence in the administration of justice, including respect for the rule of law,” Mr Moses said. 

The Law Council calls on the Federal Government to implement a transparent appointment process based on merit, similar to that recently announced by the Federal Opposition. Any lack of transparency impacts on the reputations of all members of the AAT, which is unfair.

Tort

'Apologies as ‘Canaries’ — Tortious Liability in Negligence and Insurance in the Twenty-First Century' by Prue Vines in Kit Barker, Karen Fairweather and Ross Grantham (eds), Private Law in the 21st Century (Hart, 2017) comments

The relationship between tort liability in negligence and insurance is significant, although for most of the twentieth century insurance was ignored in determining liability, despite the massive rise in insurance. Although the determination of liability in negligence typically ignores the existence of insurance, it is there in the background (sometimes driving tort reform) and, if it fails it can be catastrophic for the defendant. The extent to which insurance should be taken into account in considering liability is controversial; this chapter argues that it should only be permissible where the insurance is compulsory or universal, but that it is vital to consider the socio-legal or external power of insurance in relation to tort law because of its importance for access to justice. Insurance contracts typically regulate the relationship between the insured and tortious liability. In most jurisdictions liability insurance contracts contain a provision which makes the contract void if the insured makes an admission against interest. This is traditionally taken to include an apology, hence the commonly repeated advice not to apologise after an accident. The question of whether an apology is an admission is not necessarily clear in the absence of apology-protective legislation. Cases have decided this differently both across and within jurisdictions, although the better view in Australia and the UK is that an apology is not an admission of liability in negligence. This paper attempts to map out the law on apologies and insurance and argues that what is vital is that the liability regime and the insurance regime have some congruence in terms of access to justice and that the apology may serve as a ‘canary’ in the mine of liability – to show whether there is proper congruence or not.

In the US a Californian jury has awarded damages of US$105 million to a cancer patient in a dispute with celebrity naturopath Robert Oldham Young, author of nonsensical but alas bestselling 'pH Miracle' books such as The pH Miracle: Balance Your Diet, Reclaim Your Health.

Dawn Kali sued Young in San Diego County Superior Court, alleging negligence and fraud. She reportedly claimed he had held himself out as a doctor and counseled her to forgo conventional medical treatment, forgoing chemotherapy and accordingly relying on ' alkaline theories' (ie acidity is the cause of all disease and can be addressed through alkaline injections, a 'miracle' diet and so forth). Young spent time in a state prison in 2014 after conviction for practicing medicine without a license, following an investigation by the state medical board and by the District Attorney. At that time he reportedly stated

“I swear to God, from my mouth to God’s ears, that’s the last thing I would do is practice medicine, The reason why is because number one, I don’t believe in it, and number two, the reason I don’t believe in it is because it’s a treatment protocol to deal with symptoms rather than underlying causes.

In his 2014 trial the prosecutor claimed that Young’s degrees came from a correspondence-based diploma mill, with Young progressing from a bachelor’s degree to award of doctorate in about eight months. In 2016, the Osteopathic Medical Board of California charged Johnson with gross negligence, repeated negligence, and general unprofessional conduct in connection with his treatment of four patients at the pH Miracle Center, with his license being revoked the following year alongside an assessment of US$20,000 for the cost of the board's enforcement action.

I am bleakly amused by Young's reported comment that the award is “totally outrageous”, "appalling” and “It’s one-tenth of a billion”. His theories and treatments - at least one of which apparently involved intravenous injections of baking soda and fluid cocktail at US$500 per infusion - might be junk but he can count.

Difference

'Buggery and Parliament, 1533-2017' by Paul Johnson comments 

Over nearly five centuries the UK Parliament, and its earlier incarnations, frequently legislated to ensure the regulation and punishment of buggery, a form of sexual conduct once generally accepted to constitute one of the most serious criminal offences known to law. In the early twenty-first century, Parliament abolished the offence of buggery and, subsequently, granted pardons to certain individuals previously convicted of it. Whilst some aspects of the history of Parliament’s approach to buggery are well known – particularly in respect of homosexual law reform – much of this history remains obscure. This article provides an in-depth consideration of the making of statute law in Parliament relating to buggery that reveals the dramatically changing attitudes of legislators towards this aspect of sexual conduct and highlights the significance and importance of the pardons granted to those convicted of the offence.

Johnson provides a cogent discussion of disregards and pardons, before going on to conclude that

Whilst the criminal offence of buggery has been abolished in English and Northern Irish law references to buggery continue to endure in a range of statutes which, for example, make provision for granting anonymity to people who allege they are victims of the offence, ensure the continuity of sexual offences law in respect of criminal justice proceedings, and regulate what information a person must provide when making an application for a licence to provide gambling facilities. Buggery also forms one of the offences for which a person can become subject to the notification requirements of the ‘sex offenders register’. In due course, when those who were victims of buggery and those who committed the offence are deceased, all of these statutory provisions will become superfluous and, along with the legislation making provision for the disregarding of offences, will likely be repealed. At such time, the only references to buggery that will endure in UK statute law will be in the legislation that provides pardons for past offences (which, as discussed above, will hopefully be expanded in the future in respect of armed forces personnel). Buggery will not, however, disappear from parliamentary debate but will continue to be discussed in relation to those jurisdictions to which Britain ‘exported’ the offence and where it, or some version of it, continues to endure in criminal law. A concern with buggery will remain an inherent aspect of the ‘common enterprise’ that has recently developed amongst legislators committed to challenging and abolishing ‘oppressive discriminatory laws’ affecting LGBT people around the world in Commonwealth nations, as well as in the Crown Dependencies and British Overseas Territories.

Apology

'The Failure of ‘Sorry’: An Empirical Evaluation of Apology Laws, Health Care, and Medical Malpractice' by Benjamin Michael comments

As part of the effort to contain the size and frequency of medical malpractice claims, many states have adopted apology laws. These laws make apologies from physicians to patients inadmissible in any subsequent court proceedings. The basic rationale behind apology laws is that meritless malpractice claims are less likely to be filed when a physician can apologize to his or her patient without risking those statements being used in court. Through the use of a unique dataset, this article corrects several misunderstandings concerning this new generation of tort reform. 

First, it shows that while apology laws may reduce the frequency and size of malpractice claims as intended, they may also have a perverse effect on patients’ propensity to litigate. If a physician knows more about whether a patient’s injury was caused by malpractice than the patient, an apology could alert the patient to that malpractice and encourage the filing of a claim. 

Second, the article provides the first empirical analysis of the effect of apology laws on clinical outcomes, investigating their ability to reduce the practice of defensive medicine. Examining over 1.6 million hospital stays for heart attack patients, the article finds no evidence that apology laws reduce defensive medicine. Apology laws do not decrease the intensity of treatment received by patients. In fact, they increase the medical resources used to treat heart attack patients, consistent with an increase in defensive medicine. Based on these empirical findings, the article concludes that apology laws are not effective tort reforms and that states should look to other policies if they wish to achieve the goals of apology laws.

'Promoting and Protecting Apologetic Discourse Through Law: A Global Survey and Critique of Apology Legislation and Case Law' (2017, 7(3) Oñati Socio-Legal Series) by John C. Kleefeld comments

The year 2016 was a milestone for the law-and-apology field, marking the thirtieth anniversary of the first general law aimed at enabling apologies for civil wrongs, introduced in Massachusetts in 1986, as well as the tenth anniversary of the Apology Act, enacted in British Columbia in 2006. The Apology Act seeks to promote apologies and apologetic discourse as an important form of out-of-court dispute resolution, chiefly by making apologetic statements inadmissible for proving liability in civil wrongs. It has served as a benchmark from which subsequent law reform efforts in Canada and abroad have been measured. In 2017, that benchmark was passed with the enactment in Hong Kong of the most ambitious apology law yet, which privileges not only statements of remorse, but also statements of facts embedded in apologies. This article summarises global apology legislation and court decisions to date. Part I considers each major jurisdiction, starting with the USA and concluding with Hong Kong. Part II draws some conclusions about where we have been and where we are going in our efforts to promote or protect apologetic discourse, including recommendations on interpreting existing laws and on drafting or redrafting apology legislation.

Eugenics and Reparation

'California’s Sterilization Survivors: An Estimate and Call for Redress' by Alexandra Minna Stern, Nicole Novak, Natalie Lira, Kate O’Connor, Siobán Harlow and Sharon Kardia in (2017) 107(1) American Journal of Public Health 50-54 comments

From 1919 to 1952, approximately 20 000 individuals were sterilized in California’s state institutions on the basis of eugenic laws that sought to control the reproductive capacity of people labeled unfit and defective. 

Using data from more than 19 000 sterilization recommendations processed by state institutions over this 33-year period, we provide the most accurate estimate of living sterilization survivors. As of 2016, we estimate that as many as 831 individuals, with an average age of 87.9 years, are alive. 

We suggest that California emulate North Carolina and Virginia, states that maintained similar sterilization programs and recently have approved monetary compensation for victims. We discuss the societal obligation for redress of this historical injustice and recommend that California seriously consider reparations and full accountability.

They state

In 1926, Marsha (all names are pseudonyms) was admitted to the Sonoma State Home in California and recommended for sterilization because of her IQ score of 56, which placed her in the category of “low moron [sic]”. Given this diagnosis and because she was “sly, profane, [and] obstinate,” the medical superintendent determined that Marsha was “dangerous to public health” and, therefore, should be sterilized. Marsha was but one of approximately 20 000 people affected by a law passed in 1909 that authorized such reproductive surgery on patients committed to state homes or hospitals and judged to be suffering from a “mental disease which may have been inherited” and was “likely to be transmitted to descendants.” 

On the books until 1979, this statute provided the legal framework for the most active sterilization program in the United States. California’s sterilization law authorized medical superintendents to perform the operation without consent. Nevertheless, institutional authorities did seek written consent from a family member or legal guardian when possible, probably as a result of liability concerns. Yet, the prison-like environment of state institutions during this era raises serious questions about the validity of the consent process. Notably, sterilization was a prerequisite for release from some institutions. 

Confirming genuine consent is complicated because signatures, dates, and names on consent forms are often inconsistent with information in patient records. The documents themselves do not always record when or whether the operation was actually performed. In addition, we identified multiple efforts by families and patients themselves to prevent sterilization. Although some sterilizations may have been performed with the signed consent of a parent or guardian, these procedures did not meet the standards of voluntary consent, and in many cases people were sterilized against their will. Although California was the most aggressive sterilizer, information about the likely number of living victims is scant because of the paucity of large-scale data sources and the silence of the victims themselves. 

As of 2016, we estimate that as many as 831 patients sterilized in California institutions are alive today. Producing this estimate is one facet of a larger interdisciplinary project devoted to demographic and historical reconstructions of eugenics and sterilization in California. Given public health’s commitments to social and reproductive justice, we believe that public health offers a useful lens for coming to terms with this past injustice. By providing the most rigorous estimate of sterilization survivors in California to date, we hope to spark a conversation about potential opportunities for recognition and redress.

They go on to note that

Human rights and legal scholars have debated instances of injustice that merit more than a simple apology, such as slavery, internment, and genocide. The ethical principles that one legal scholar provides for determining when society is obliged to provide redress to a group of people include that “a human injustice must have been committed” and that said injustice “must be well documented.” In 2003, California officials publicly apologized for the state-run sterilization program, acknowledging the thousands of surgeries as a human injustice. In addition to state counts of the number of sterilizations, our data and archive include official records and requests that fully document the sterilizations and the biased eugenic logic used to justify them. Given the principles outlined by legal scholars guiding “meritorious redress claims,” the state’s own admission of injustice, and the documented impact of sterilization on people with disabilities and from poor backgrounds, it is reasonable to conclude that what happened in California warrants more than a public apology, especially given the state’s high sterilization numbers. Guided by our estimate of the number of living sterilization survivors, we suggest that California emulate its sister states, North Carolina and Virginia, and launch monetary compensation programs for victims. Both North Carolina and Virginia have created agencies (the North Carolina Office of Justice for Sterilization Victims and the Virginia Eugenical Sterilization Act Compensation Program) to process and adjudicate claims for compensation, which were set at $20 000 and $25 000, respectively. Recent efforts in these two states underscore the merit of compensating individuals who have experienced state-sanctioned reproductive injustice. In 2013, after years of organizing by sterilization survivors and supportive legislative officials, North Carolina, which sterilized approximately 8000 people in the 20th century, passed a law to compensate victims. North Carolina’s State Center for Health Statistics used life table methods similar to our own to estimate that there were as many as 2944 living survivors of the North Carolina Eugenics Board’s sterilization program in 2010 (although adjustment for lower life expectancy among groups targeted for sterilization reduced the final estimate of survivors to 1500–2000). Although North Carolina performed fewer total sterilizations than California, its estimate of living survivors is higher because eugenic sterilizations occurred more recently, well into the 1960s.

A $10 million fund was appropriated to correspond to the number of victims deemed eligible for compensation. The state’s Office of Justice for Sterilization Victims required that victims be alive on June 30, 2013, and it accepted claims through June 30, 2014. The state approved 220 of 768 claims and sent out $20 000 checks to verified claimants. The legislation required proof that the procedure was approved by the North Carolina Eugenics Board, and thus some individuals sterilized by private physicians, even those with eugenic intent, were ineligible for compensation. A bill proposed in the state legislature earlier this year would make additional reparations available to some of these victims. In Virginia, where about 7600 people were sterilized in state institutions during the 20th century, the Christian Law Institute pushed for legislation, established the Justice for Sterilization Victims Project, and lobbied the legislature for monetary compensation following the example of North Carolina. The number of survivors in Virginia was estimated to be approximately 1500 on the basis of North Carolina’s calculation that approximately 20% of initial victims had survived to the present day. In 2015, the state set aside $400 000 to compensate survivors with awards of approximately $25 000 each. The Virginia Eugenical Sterilization Act Compensation Program required that victims be alive on February 1, 2015, and the program continues to accept claims.

One concern in both states has been whether receipt of reparations would count toward individuals’ income and make them ineligible for federal programs such as Medicaid or the Supplemental Nutrition Assistance Program. A bill recently passed in the US House of Representatives would ensure that state-level eugenics reparations do not interfere with the benefit eligibility of this aging and vulnerable population. While North Carolina and Virginia were organizing compensation programs, a new episode of sterilization abuse emerged in California, this time among women incarcerated in state prisons. A 2013 Center for Investigative Reporting article revealed that, between 2006 and 2010, close to 150 unauthorized sterilizations were performed in California prisons. In response, Senator Hannah-Beth Jackson requested an investigation by the California state auditor that corroborated and expanded the article’s findings, showing that 144 women were sterilized without adherence to required protocols.

Prejudices expressed by Dr. James Heinrich, the physician who performed many of the tubal ligations, were particularly revealing. He told a reporter that the money spent sterilizing inmates was negligible “compared to what you save in welfare paying for these unwanted children — as they procreated more.” This callous attitude toward the reproductive lives of institutionalized women, the majority low-income women and women of color, echoed earlier eugenic attitudes. In the 1930s, at the height of eugenic sterilization, California’s health officials repeatedly asserted that, in addition to its therapeutic value, sterilization would relieve the state of the economic burden of “defectives” and their progeny.

Senator Jackson connected the prison sterilizations to California’s past when she stated that “pressuring a vulnerable population—including at least one instance of a patient under sedation[—]to undergo these extreme procedures erodes the ban on eugenics.” This recent news and Senator Jackson’s comments point to the importance of recognizing the long history of sterilization abuse involving vulnerable individuals in California.

'Following in North Carolina's Footsteps: California's Challenge in Compensating its Victims of Compulsory Sterilization' by Katherine A. West (2013) 53 Santa Clara Law Review 301 notes

In the 1940s, physicians at the Sonoma State Hospital sterilized Charlie Follett, a fourteen-year-old boy placed in the institution because his parents were alcoholics and unable to care for him. Neither hospital officials nor physicians informed Follett of the procedure he was to undergo. Even worse, Follett did not consent to the operation. According to a CNN interview with Follett, a hospital official brought Follett into the hospital, told him to lie down on an operating table, and gave him a shot to “deaden [his] nerves.” Follett next remembered hearing a “snip, snip”—the sound of him being sterilized. In May 2012, Follett passed away, sixty-seven years after his sterilization operation; he had no remaining family. 

Follett was but one of an estimated 20,108 Californians involuntarily sterilized by the state of California under its eugenic sterilization law. To this date, California has not provided health care services or compensation to its victims of sterilization. State representatives simply issued apologies in 2003 expressing the state’s “profound regret.” 

California is not alone in its history of eugenic sterilization. Beginning in 1907, the United States sterilized roughly 60,000 individuals without their consent. Thirty-two states in total passed eugenic sterilization laws in an attempt to rid the nation of defectives unfit to reproduce and to promote “human betterment.” These state sterilization programs authorized the involuntary sterilization of individuals labeled feebleminded, promiscuous and insane, and targeted those with epilepsy, alcoholism, and syphilis. Proponents of sterilization argued that sterilizing these individuals would cure America’s social ills. State-run sterilization programs continued into the 1970s, with some states maintaining their sterilization laws on the books into the 1980s. Currently, few states have taken action to redress the harm their sterilization victims suffered. Only seven states, including California, have issued apologies recognizing the wrong suffered by their sterilization victims. The remainder of the nation’s victims remain unrecognized.  

North Carolina and its eugenics program recently entered the national spotlight with talks of compensating its estimated 1500 to 2000 living victims. In January 2012, the North Carolina Governor’s Eugenic Compensation Task Force proposed that the North Carolina legislature compensate each living victim with a $50,000 lump sum. In addition, the Task Force recommended that the state offer mental health services for living victims and fund a traveling North Carolina Eugenics Exhibit. In June 2012, the North Carolina state legislature considered the Task Force’s recommendations. The North Carolina House of Representatives approved the legislation; however, the state senate rejected the Task Force’s compensation plan. Had North Carolina adopted these measures, it would have been the first state to compensate its victims of forcible sterilization. While North Carolina contemplated compensating its sterilization victims, eyes turned toward California, the most egregious offender in the nation’s shameful eugenic past. California performed one-third of the total sterilization operations in the nation, more than twice as many sterilizations as its “nearest rivals.” Will California follow North Carolina’s example and consider compensating its living victims? In this Comment, I discuss the challenges California faces in compensating its sterilization victims. Unlike North Carolina whose numbers of sterilizations rose after 1950, California’s sterilization program died down after 1952, meaning a large number of California’s victims are most likely no longer living. In addition, the state will face challenges locating victims and encouraging them to come forward in spite of the shame they may feel. 

Part I of this Comment explores the background of the nation’s eugenics history, focusing particularly on California’s sterilization program. Part II discusses the end of the state eugenic programs and outlines state measures taken to redress victims. Part III analyzes the case for compensation, exploring why states should consider compensating victims of involuntary sterilization. In addition, Part III discusses North Carolina’s approach to the issue. Part IV analyzes California’s challenges in compensating its victims, looking specifically at the number of possible living victims and the difficulties the state will face in locating them. Lastly, Part V examines California’s options and moral obligations, proposing that California should compensate its sterilization victims regardless of how few may be alive and the difficulties the state faces locating victims. I further propose that California should commission a task force to determine the amount of money and type of services it should provide survivors.

Hospital Quality Assurance and Safety

The 309 page report of the 'Duckett Inquiry', ie Targeting zero: Supporting the Victorian hospital system to eliminate avoidable harm and strengthen quality of care - Report of the Review of Hospital Safety and Quality Assurance in Victoria states 

This review’s terms of reference were expansive. The review was charged with examining whether the department has adequate systems for safety and quality assurance in place and (where systems were found to be inadequate) recommending how they might be improved to achieve contemporary best practice, as seen within other jurisdictions and internationally.

We were to assess the department’s systems for all in-hospital care, including mental healthcare, in both the public and private sectors.

In particular, we were asked to consider governance issues pertaining to the following issues:

• how the department should ensure that all boards of public health services and public hospitals are capable of providing appropriate local governance of safety and quality

• what systems the department should have in place to ensure robust monitoring of safety and quality at the hospital and health service levels including its approach to monitoring clinical governance at health services and its performance management framework to monitor clinical safety and quality in local health services

• what information about safety and quality should be reported to the department, and how the department should use that information including through public reporting

• whether the scope of the reporting to the department should be differently configured in public health services as compared with public hospitals, and what the scope of reporting for private hospitals should be.

We considered these along with information flow issues pertaining to:

• the role of the department in monitoring safety and quality in Victoria’s public hospital sector

• the type of information that should be available to boards and chief executive officers to assist in local monitoring of quality and safety

• the implementation of the Victorian Health Incident Management System (VHIMS) improvement project

• the relationships and information flows between the department and various other bodies with responsibility for the quality of care

• the relationship and information flows between the department and private hospitals regarding quality and safety.

 We also examined clinical engagement and leadership issues pertaining to:

• the best approach for providing clinical leadership, advice and support to the new Chief Medical Officer that will strengthen the department’s oversight of quality and safety systems

• strategies to optimise the department’s response capacity and engagement in promoting an improvement culture among management and clinicians

• how the department should participate in and provide leadership to the safety and quality agenda, particularly in improvement, including through enhanced clinical engagement.

Our terms of reference note that some public hospitals are too small to have dedicated comprehensive safety and quality teams or clinical expertise in board members; many only have limited access to medical administration expertise. This is in some respects an anomalous feature of the Victorian system, which has a very large number of unremunerated independent boards for very small public hospitals in rural areas. We have not commented on the optimality of this model but rather have focused on recommending ways to strengthen it so the community can be assured of the same safety and quality of care in small rural services as in larger regional and metropolitan services.

A patient’s experience of care critically depends on the quality of their interaction with the clinical team. So too more broadly, does the overall safety and quality of the Victorian health system depend on clinicians, managers, boards and the oversight of the department. This report’s focus was governance of safety and quality of care in Victoria by the latter. We did not assess the governance of safety and quality within hospitals, except as it was affected by the overall system governance issues. Similarly, our recommendations focus on what the department can do to strengthen care. As we show, it can do a lot. Ultimately, however, it is those at the front lines of care that are best positioned to drive a system-wide transformation. Change of this kind needs to engage clinicians and be embraced by them.

The report's summary of findings is

1. Across all modern health systems, and despite concerted efforts, avoidable patient harm and variability in care occurs that no one should be prepared to accept. Avoidable patient harm means that patients suffered not through their illness or a lack of knowledge about treatment, but because of ineffective systems to keep them safe while receiving care. Variability of care indicates that valuable knowledge is not being shared and implemented widely, so that many patients are receiving care that diverges from best practice.

2. Australian research suggests that around one in every 10 patients suffers a complication of care during their hospital stay, with half of those complications avoidable. Most complications only have a minor impact on patients, but a significant minority end in permanent disability and death.

3. These complications are devastating for patients and families and significantly increase the cost of care across the system. All hospitals should be reducing them as a matter of priority. But doing so is not straightforward. For any health service, the challenge of achieving best practice in safety and quality is immense and requires grappling with clinical autonomy and patient variability. Decision making is all the more difficult because many of the costs of poor care don’t fall on the decision-maker (the hospital) but on patients, their families, other hospitals and the taxpayer more broadly. They can also be hidden, both within hospitals and from patients.

4. Further, complications are rarely the result of individual incompetence or malice. Rather, they arise within complex, high-pressure environments where mistakes easily occur and patients are often already frail and at risk of deteriorating. This inherent risk and complexity is why all hospitals need strong processes to minimise the risk and consequences of human error – and to ensure that when things do go wrong, problems are reported, reviewed and addressed. It is also why hospitals need strong oversight and support by system managers like the department. System managers can protect patients from serious failures in local safety and quality systems by monitoring hospital outcomes for signs of unsafe or low-quality care and by ensuring that hospitals take swift and appropriate action to address deficiencies. System managers can also support hospitals to strengthen the safety and quality of their care by using their vantage point and economies of scale to coordinate, encourage and facilitate improvement efforts across the system.

5. The review panel evaluated the way that the department, firstly, oversees the Victorian hospital system to ensure that it provides consistently safe, high quality care; and secondly, the way it supports hospitals to efficiently and effectively strengthen care. It found that the department is not adequately performing either role.

6. The panel found that the department’s oversight of hospitals is inadequate. It does not have the information it needs to assure the Minister and the public that all hospitals are providing consistently safe and high-quality care. For example, it does not have a functional incident management system for hospital staff to report patient harm. It has over-relied on accreditation when the evidence suggests that is not justifiable. It makes far too little use of the routine data at its disposal to monitor patient outcomes and investigate red flags suggesting poor care. Its expert committees are fragmented and many are not resourced to detect problems in a timely manner or to follow up to stop them happening again.

7. The department’s overarching governance of hospitals is also inadequate. In the public sector, the department expects hospital boards to ensure care is safe and continuously improving. However, it does too little to ensure that all boards are equipped to exercise this function effectively in the first place. In the private sector, where the department’s responsibilities for assuring safety and quality is roughly equivalent, the department relies to an even greater extent on local governance, and conducts no routine monitoring of patient outcomes or serious incidents. In both sectors, the department could and should be doing much more to ensure that hospitals do not provide care when it is outside their capability to do so safely.

8. Finally, the department’s support of hospitals to discharge their responsibilities with respect to safety and quality improvement has been inadequate. There have been fragmented efforts to support improvement but no continuous approach or sustained investment. Hospitals are often left to create their own approach to safety and quality improvement, leading to duplication of work and variation in quality. The department could be doing much more to encourage and facilitate hospitals to learn from each other and to ensure that ideas and innovations from one hospital spread to others.

9. Our review is not the first to identify these problems. Since 2005 the Victorian Auditor-General’s Office has conducted three performance audits on patient safety. The most recent found that the department is not effectively providing leadership or oversight of patient safety, is failing to adequately perform important statewide functions and is not prioritising patient safety. Some of the systematic failures noted in its 2016 audit were first identified over a decade ago in the 2005 audit.

10. The department has suffered a significant loss of capacity in recent years, in some cases creating or exacerbating these problems. Many dedicated departmental staff have called for change but lacked the authority or resources to achieve it. Budget cuts and staffing caps have gutted many departmental functions. The department has become increasingly reliant on external consultancies when the work would have been done better, and more cost-effectively, had the department retained capacity to deliver it in-house. A recent capability review noted the department has struggled to retain talent, so that capable leaders are thinly spread. It found a lack of long-term strategic planning and widespread stakeholder concerns that complacency has caused Victoria’s position as Australia’s leading health system to come into question.

11. The recommendations we have made are designed to change all this. Victoria should be seen as a leader in safety and quality. Our recommendations are broad, across the 10 major themes outlined below. We are confident that all are achievable and affordable. They will help to ensure all Victorians get the best of care. Many aspects of the report can be implemented quickly (within 12 months), some others may take up to three years.

In summary its recommendations are

1. Safety and quality improvement must be a core goal of the department and health system. To achieve this, we have recommended that:

• the Secretary and Minister each make clear public statements about the very high value they place on safety and quality

• the Minister seeks to amend the Health Services Act 1988 to ensure the Act’s objectives reflect this ambition and expectation

• the Secretary makes a clear public statement about the role of the department in the oversight of the health system and her statutory functions

• the Secretary establishes a specialist Office for Safety and Quality Improvement (OSQI) with responsibility for coordinating the efforts of clinical networks and relevant consultative councils and programs to drive system-wide improvement in safety and quality

• the department’s clinical networks set clear and measurable statewide safety and quality improvement goals, with the department publicly reporting on the system’s progress against them

• the department sets clear expectations for boards of all hospitals to have safety and quality as a core focus, with all boards setting and reporting on their progress against local improvement goals

• the department adopts national pricing reforms to strengthen executive focus on reducing hospital-acquired complications

• the department develops a detailed plan and timeline for implementing this report’s recommendations, and reports on progress against it to the Minister on a quarterly basis, with the Victorian Auditor-General’s Office conducting an audit of implementation by 2020.

2. All boards must be highly skilled, independent and effective. To achieve this, we have recommended that:

• the Minister pursues legislative change to extend public health service term-limit requirements and other appointment processes to public hospital boards

• the Minister establishes a Board Appointments Advisory Commission with responsibility for ensuring there is an adequate mix of skills (including substantive clinical governance and consumer representation) on every public hospital and health service board

• the Board Appointments Advisory Commission ensures board skill adequacy by evaluating applicants against an objective and transparent skills assessment framework, by requiring clinical governance training and ongoing development for board directors, by recommending that the Minister supply short-term delegates to boards where the skill mix is inadequate, and by recommending board amalgamation where long-term adequacy of skills cannot be achieved.

3. All hospitals should be held to account for improving safety and quality of care, regardless of their size or sector. To achieve this, we have recommended that:

• the Minister pursues legislative change to extend the statutory obligations for safety and quality in public health services to public hospitals

• the department monitors sentinel events and a common set of broader safety and quality performance indicators across public and private hospitals

• the Minister pursues legislative change to ensure an appropriate level of regulation for private services that are currently unregistered but provide care that carries a risk to patient safety.

4. The flow of information in the health system must ensure deficiencies in care are identified and focus attention on opportunities for improvement. To achieve this, we have recommended that:

• the government establishes the Victorian Health Performance Authority – an independent specialist safety and quality reporting body with responsibility for managing the department’s health data collections, developing the quality of clinical performance indicators, and improving access to clinical data by clinicians, boards, departmental staff and academic researchers

• the department develops a next-generation incident reporting policy and incident management system that significantly reduces the reporting burden for health workers while facilitating improved identification, follow-up and learning from serious patient safety incidents

• the department makes better use of routine data, registries and complaints data to facilitate and expedite identification and investigation of potential deficiencies in care

• the department streamlines its safety committees to improve information flows between hospitals, committees and the department, reduce duplication of functions, and ensure effective and improvement-focused follow-up of identified deficiencies in care

• the department invests in modern data management systems by expediting the development of a statewide patient identifier and the transition to electronic patient record systems in hospitals

• the Minister establishes a statutory Duty of Candour requiring any person harmed while receiving care to be informed and apologised to

• the department strengthens requirements for boards to report on harm, improvement plans and progress against them in annual quality reports

• the department works to improve voluntary reporting, including by monitoring hospital culture surveys to ensure that staff do not face barriers to reporting, discussing and addressing patient safety risks

• there be stronger obligations for clinical registries to report serious deficiencies in care once they are detected.

5. All hospitals should have access to independent clinical expertise to help identify deficiencies in care and focus attention on opportunities for improvement. To achieve this, we have recommended that:

• the department reinstates Limited Adverse Occurrence Screening so that all smaller hospitals have access to reliable and independent information on safety and quality performance

• all small hospitals develop ongoing partnerships with larger health services to ensure they receive adequate expert support for case audit and other clinical governance activities in all their major clinical streams

• larger health services consider initiating a cycle of regular external reviews of all their clinical units to maintain a focus on continuously improving performance

• all health services be required to recruit an independent expert to sit on their root cause analysis panel when investigating a sentinel event.

6. Risk should be managed across the system so that hospitals only offer care that is within their capabilities, with high-risk care concentrated in the centres where it is safest. To achieve this, we have recommended that:

• for all major areas of hospital clinical practice, the department develops and monitors compliance against capability frameworks delineating, for each hospital, which patients and treatments it has the capability to safely care for

• the clinical networks identify those procedures or treatments for which there is evidence of a material volume–outcome relationship, and the department acts to concentrate delivery of these public and private hospitals’ ‘minimum volume’ procedures and treatments within a designated set of ‘high-volume’ centres.

7. There must be robust assessment of clinical governance and hospital safety and quality performance in the department. To achieve this, we have recommended that:

• the department reduces reliance on hospital accreditation while working through national processes to evolve the accreditation process to a more rigorous one

• the department overhauls its performance assessment framework to ensure there is robust monitoring of safety and quality of care, incorporating risk assessment of hospital governance, as well as culture and patient outcomes

• the department pursues legislative change to make strong performance in safety and quality a standalone requirement of health services rather than something that can be traded off against performance under access and financial dimensions of performance

• the department establishes a formal panel of clinical reviewers who can be called on to undertake clinical reviews where indicated in the revised safety and quality monitoring framework.

8. Mental health services must be adequately funded to allow delivery of timely, safe and high-quality care. To achieve this, we have recommended that:

• the department ensures there is robust reporting and public discussion regarding indicators pertaining to safety, quality and pressure on mental health services

• the department develops a forensic mental health infrastructure sub-plan with a clear timeline to expand medium-security forensic bed capacity and to address other needs including those of adolescent and high-security patients.

9. Clinical leaders must be engaged to strengthen, direct and lead efforts to improve safety and quality of care. To achieve this, we have recommended that:

• the department establishes a Victorian Clinical Council to obtain the collective advice of clinicians on strategic issues

• the department rebuilds the clinical networks to lead safety and quality improvement work, with the network activities and priorities coordinated by the newly formed OSQI and each network accountable for improve statewide safety and quality outcomes on relevant dimensions of hospital care

• the department invests in system-wide clinical leadership by establishing, in partnership with Better Care Victoria, a clinician leadership training strategy that incorporates training in contemporary quality improvement methods for all leaders of significant clinical departments

• the clinical networks work to reduce clinical practice variation in all hospitals, including by developing or sharing best practice protocols for common use

• the CEO of OSQI should have authority to issue best-practice guidelines and protocols on the advice of the clinical networks and the clinical council, and clinicians should be held accountable locally for their appropriate application.

10. The system must have a stronger focus on improving patients’ experience of care. To achieve this, we have recommended that:

• the department holds hospitals accountable for managing care transitions, providing professional interpreter services when required and monitoring progress against goals set by the hospital for continuous improvement of the patient experience

• the department works with the Health Services Commissioner to identify hospitals that are underperforming on dimensions of patient experience including management of complaints

• the OSQI adopts improvement of patient engagement and patient experience as a priority improvement goal for the hospital system.