Health, trade, intellectual property and investment laws and norms interact in multiple ways, both to the benefit of health and to its detriment. This subject explores both the harmonies and the tensions across these critical areas of policy and governance at legal, normative, operational and institutional levels. It draws out some of the major themes by examining a number of high-profile areas of controversy in detail, in particular the World Trade Organization and investment treaty challenges to Australia’s tobacco plain packaging laws; the tensions between intellectual property protection and access to affordable medicines, medical technologies and devices; the development of antimicrobial resistance and efforts to combat it; and contests over the negotiation of new trade and investment agreements, particularly their implications for governments’ regulatory space to protect and promote health.

This subject is taught by two leading global health law practitioners who bring both academic expertise and practical experience.

Principal topics include:

• Global health law and governance
• International trade, intellectual property and investment law and governance
• International trade and investment challenges to tobacco control
• Trade, intellectual property and investment law issues in pharmaceutical innovation and access to affordable medicines, medical technologies and devices
• Trade, intellectual property and investment law issues in the development of antimicrobial resistance and in efforts to combat it
• Trade and investment law issues in the regulation of alcohol and unhealthy food
• The protection of health in the negotiation and implementation of trade and investment agreements
• The role of evidence in health-trade-investment policy development and litigation
• The opportunities and challenges for achieving multi-sectoral health-trade-investment collaboration and understanding

Data relating to an individual’s physical and mental health and condition can reveal extremely sensitive information. Valuable health data also underpins improvements in health care and can be useful for other government and commercial purposes. How can the law protect the principle of medical confidentiality and enable the data flows necessary for a modern learning healthcare system, public health, and other public interest purposes?

Health privacy and data protection expert Mark Taylor considers the relevant law and governance in Australia and comparable jurisdictions. This subject will provide students with an advanced and specialised knowledge of health data governance, including relevant privacy and data protection law. It will invite critical consideration of relevant law benchmarked against the European Union General Data Protection Regulation and other international standards, such as the Recommendation of the Organisation for Economic Co-operation and Development (OECD) Council on Health Data Governance.

Principal topics include:

• Legal concepts of ‘personal health data’, ‘identifiability’, and ‘public interest’
• Transparency, informed consent, and respect for individual objection
• Confidentiality and third-party access, including family members, researcher, public health and government
• Feedback of incidental findings and the ‘right not to know’
• Oversight and approval mechanisms, with consideration of issues raised by increasing use of new techniques of machine learning and analysis of big data
• International and cross-border transfer

This subject will address a range of human rights in the health law area, including bioethical origins of contemporary views of health rights; Article 12 of the International Covenant on Economic, Social and Cultural Rights and the role of the Special Rapporteur; rights to engage in health tourism; rights to life and death; rights to health information; rights to civil remedy and compensation for malpractice; rights to coronial investigation of deaths; rights to complain about registered practitioners; and public health law rights.

Principal topics include:

• Bioethical and human rights to health
• Rights to health
• Rights to obtain health services overseas
• Rights to health information
• Rights to compensation for malpractice
• Rights to death
• Rights to death investigation
• Rights to complaint and notification.

This subject will examine patients’ expectations and legal rights when receiving health care, their avenues for complaint and compensation, and accountability mechanisms (including professional discipline) for protecting the public in the event of health, performance or conduct problems involving a health practitioner. The focus will be on patients and health practitioners in Australia and New Zealand.

Principal topics include:

• Patient safety
• Patients’ needs and rights following an adverse event
• Open disclosure
• Defensive medicine
• Health practitioner regulation (including the Australian Health Practitioner Regulatory Scheme)
• Health complaint systems in Australia and New Zealand.

Medical practitioners, policy-makers, the courts, patients and families are dealing with ongoing debates in medical ethics ranging from euthanasia, abortion, resource allocation and managing the risks of research, to issues thrown up at the cutting-edge of science where we can now edit the germline, or create new life via so-called 'synthetic biology'. While we have existing legal frameworks in place for some of these issues, enormous moral disagreements remain. How should we think about these issues?

This subject aims to provide a basic toolkit and skills to engage in deeper ethical reflection about the major debates in medical ethics and about advances in the biological and neurosciences. Professor Julian Savulescu is Director of the Centre for Practical Ethics, the Oxford Centre for Neuroethics and the Institute for Science and Ethics, University of Oxford. He is Editor of the Journal of Medical Ethics and is a recognised world leader in medical ethics. The goal of this subject is not to provide answers to these medical dilemmas, but to enable students to think more deeply for themselves about what their position is and to be able to justify that position to others. A variety of perspectives will be covered through the use of guest lecturers.

Principal topics include:

• The current revolution in bioethical reasoning and methods in bioethics
• Making good medical/moral judgments for self and others
• Basic ethical theories and concepts
• Abortion
• Euthanasia
• Regulation of research, including:
  • Gene editing
  • Stem cell research and cloning
  • Transgenesis and human-non-human chimeras
  • Synthetic biology
  • Sale of biological material and body parts
  • Regulation of doping in sport
  • Reproductive cloning
  • Human enhancement
  • Genetic selection
  • Coercion in reproduction
  • Neuroethics.

As we rapidly approach the 30th anniversary of the landmark Australian medical law decision Rogers v Whitaker in 2022, medical litigation remains a vibrant and challenging field, given the rapid pace of scientific and social developments that generate new challenges for the law. Many are at the core of personal importance - birth, reproduction and personal autonomy. The legal issues are wide-ranging, covering the existence of duties, what should be considered negligent, the challenges of legal causation and appropriate compensation- all against a background of insurance affordability, medical treatment innovations and dispute resolution process changes.

This subject examines the framework of medical litigation, current challenges and issues on the horizon. The subject coordinator Bill Madden is a lawyer specialising in medical litigation, a co-author of two health law texts and a regular writer and presenter on medical law topics.

Principal topics include:

• History and incidence of medical litigation
• The impact of recent legal and court-based reforms
• Duty, breach of duty and statutory defences / protections
• Consent, informed consent and treatment errors
• Factual and normative causation and loss of chance
• The changing framework of expert evidence
• Privacy and confidentiality issues
• Mandatory reporting impacts
• Coroners’ investigations and hearings.

This subject will analyse the relationship between psychiatry, psychology and law in contemporary Australia. It will address criteria and policy relating to involuntary status and the use of coercion in relation to those with mental illnesses and intellectual disabilities, focusing on the Mental Health Act 2014 (Vic) and the Disability Act 2006 (Vic); the role of the 2013 DSM-5; fitness to stand trial; mental impairment; sentencing of offenders with disabilities; expert evidence by mental health practitioners; mental harm litigation; the role of post-traumatic stress disorder (PTSD) in civil litigation; prediction of risk in criminal law; syndrome evidence in litigation; profiling evidence; and therapeutic jurisprudence.

Principal topics include:

• Involuntary status in contemporary Australia
• The role of the Chief Psychiatrist, the Mental Health Commissioner and the Mental Health Tribunal
• The role of DSM-5 and ICD-10
• Therapeutic jurisprudence
• Mental impairment
• Expert evidence by psychiatrists and psychologists
• Sentencing of offenders with mental illnesses, brain injuries and intellectual disabilities
• Fitness to stand trial under international criminal law
• Civil litigation and complaints against mental health practitioners
• Mental harm litigation
• PTSD in the law
• Prediction of risk evidence
• Syndrome evidence.

Pharmaceuticals provide fundamentally important medical treatments, saving lives and alleviating suffering, but they are also mired in controversy. Patients and governments struggle to meet rising costs, and have to deal with medical conditions for which there are still no effective drugs. Companies complain about heavy regulatory burdens and sagging profits. What is the role of law in mediating these tensions? Does it do so successfully?

The subject will not be limited to a single jurisdiction, but focusses on Australian and European law and draws widely on world events. It will be taught by Dr Kathleen Liddell, Director of the Centre for Law, Medicine and Life Sciences (Cambridge) who has more than 20 years’ experience in academia, legal practice, law reform, policy advice and ethical analysis. Significantly, the subject is not solely for practicing lawyers in health and medical law. It is also suitable for doctors, research scientists, policymakers, industry executives, patent attorneys, and pharmacists.

This subject follows a medicine’s journey from a scientific idea through to the marketplace, clinic and (occasionally) courtroom. Along the way, we investigate the major legal and ethical issues affecting pharmaceuticals, including:

• criteria for market approval
• regulation of clinical trials
• intellectual property incentives
• controversies with pricing and competition in high income and low income countries
• safety monitoring
• compensation for injuries
• experimental therapies
• off-label prescribing
• direct to consumer advertising
• counterfeit medicines
• the looming crisis of antibiotic resistance
• future challenges such as genomic and ‘precision’ medicine.

Civil litigation is experiencing unprecedented levels of reform. Legislative changes, court decisions, changes to court rules and economic pressures are changing the way litigation is practised across the common law world. The proper roles of parties, lawyers, judges and courts are under scrutiny and discussion. The focus of this subject is current and significant issues in civil litigation, with an emphasis on new and emerging developments.

Andrew Higgins is an Associate Professor in Civil Procedure at the Faculty of Law, University of Oxford, and a Fellow in Law at Mansfield College. He is also a practising barrister specialising in mass tort litigation and General Editor of Civil Justice Quarterly.

Bernie Quinn is a Queens Counsel at the Victorian Bar who practices in a wide range of areas including commercial law, public law and product liability law. He speaks Bahasa Indonesian and was an Associate to Justice Michael Kirby. The subject will include guest lecturers drawn from the judiciary and the profession.

Principal topics include:

• Significant procedural reforms in Australia and overseas
• Law reform proposals
• The role of the judge, including case management trends
• Principles of apprehended bias
• ‘Overarching’ obligations of participants in the civil justice system
• Summary and interim relief
• Discovery
• Client legal privilege
• Expert evidence
• Procedural issues in conflict of laws
• Procedural issues in collective redress
• Costs and funding rules
• Appeal processes
• Enforcement
• Alternative dispute resolution
• Online dispute resolution and its impact on civil procedure.

This subject will be delivered online in 2020 over the scheduled dates.

Negligence is one of the most heavily litigated causes of action in common law jurisdictions. It is of enormous practical importance in a very wide range of fact situations. It is also a dynamic area of law: the relevant principles are constantly being applied to new fact situations, and the courts are regularly forced to grapple with difficult questions about the scope of negligence liability. This subject examines key current issues and controversies in the law of negligence in the light of theoretical and comparative perspectives. The lecturers have both published widely on private law topics, including a range of issues in the law of negligence.

Principal topics include:

• An overview of the law of negligence, including theoretical and historical perspectives and the place of negligence in tort law and private law
• The duty of care requirement in general terms, including the distinction between duty in law and duty in fact, the approach to the duty question in novel situations and the role of public policy in duty decisions
• Liability for psychiatric injury
• Liability for pure economic loss
• Liability for omissions
• Liability of public authorities
• Current issues in the standard of care and its application, with particular reference to professional negligence cases
• The requirement of damage
• Factual causation, including recovery for loss of a chance
• Scope of liability (legal causation and remoteness)
• Defences (both common law and statutory).

Expert evidence continues to play a major role in civil litigation and criminal prosecution, as well as in administrative regulation. Moreover, the field of expertise in law has become the site of numerous contemporary controversies over judicial standards for admissibility of expertise, how to evaluate the reliability of expert testimony and the ethics of experts and attorneys who present expert testimony. This subject is primarily a detailed examination of the law and policy of the regulation of expert evidence in Australia, as well as comparative reform movements of likely significance to Australia in the future, notably developments in the United States. The materials for the subject, most of which are from court files of actual cases, will emphasise the practical uses of expert evidence inside and outside the courtroom.

Principal topics include:

• The legal framework for regulating expert evidence
• Debate and controversies about expertise
• The admissibility of expert testimony
• Restrictions on the conduct of experts
• Use of expert evidence inside and outside courtrooms.

The above topics will be illuminated through the study of specific instances of expert evidence, conduct and regulation that have prompted change and reform or controversy in Australia or other countries, especially the United States.

This is a foundational subject in the Melbourne Law Masters (MLM), which is compulsory for graduates in disciplines other than law and for law graduates from countries with a non-common law system. It provides students with an opportunity to acquire the foundational legal skills necessary for studying and working in a common law system, such as that in Australia.

The common law forms one of the two principal systems of Western law that, through colonisation, have spread throughout the world. Common law systems have a distinctive approach to understanding the sources of law, the role of law-making institutions, and processes for resolving disputes. These characteristics of the common law system have had a profound effect on the development not only of the societies in the countries in which it applied, but also on international law and practice.

The aim of this subject is to acquire basic foundational legal skills that will assist you with other subjects in the MLM program. The subject teaches students how to read, use and interpret reported cases and legislation. The subject explains the sources of law, what influences them, and how they influence the development of the common law. These aims are given in context of some contemporary debates on common law reasoning by assessing the role of the High Court of Australia. The subject focuses on developing skills in analysis and legal writing, the tools of the common lawyer

Principal topics include:

• How to read and analyse a case
• The concept and use of precedent
• Evolution of a common law principle
• Common law issues: judicial activism, separation of powers
• The role of the High Court and an overview of the Constitution
• The relationship between the Constitution, case law and statute law
• Influences of other sources of law on the common law
• How to read and analyse statutes
• Approaches to statutory interpretation
• Legal writing skills and expectations in the MLM program.

International Legal Internship allows students to gain credit for undertaking advanced legal research and analysis on an approved international internship of at least eight weeks of full-time work in an approved international institution or organisation. This subject is focused on providing students with an opportunity to engage with legal and policy issues in contemporary society through work experience and further develop oral and written communication skills. Students are required to secure and fund their internships personally.

Students are encouraged to discuss their internship proposals with the subject coordinators. Students who successfully enrol in International Legal Internship must arrange a meeting with at least one of the subject coordinators both prior to their internship and upon completion, to develop a better understanding of research and the role of international institutions in international law and relations.

Privacy has been valued for centuries but now there is a resurgent interest in its protection as a result of new technologies, changing social norms and a rise of markets focused on the commodity value of information. Overlapping with the resurgent interest in privacy is a related concern about the management of data flows, especially on the part of government agencies and business organisations. The legal frameworks that deal with privacy and data protection have a long history but are coming under pressure to adapt to a more complex modern environment.

Privacy and data protection experts Professor Megan Richardson and Karin Clark explore these issues. They pay particular attention to the scope and nature of privacy protection as well as appropriate limits and exceptions, the ongoing pressures for law reform, and the practical operation of privacy and data protection laws in Australia and comparable jurisdictions.

Principal topics include:

• What is privacy?
• Conceptual and legal definitional issues
• International and comparative privacy and data protection regimes
• Protection of privacy in general law in Australia and comparable jurisdictions
• The Privacy Act 1988 (Cth): regulation of personal information held by the private and public sectors
• State/territory (especially Victorian) legislative regimes for the regulation of personal information
• Current topics in privacy law such as privacy and the media, privacy and health information, online privacy, telecommunications and surveillance privacy
• Current reform inquiries and proposals and likely reforms.

Regulation has become a permanent feature of the way in which contemporary democratic economies, including Australia, are governed. There are few spheres of economic activity that are not subject to some form of regulatory oversight and control. Daily news programs rarely pass without some mention of a significant regulatory decision, proposed regulatory reform or allegations of some regulatory failure or scandal. For lawyers, dealings with regulators and regulatory regimes have become part of the staple diet of their work. Yet the practice of regulation is far from straightforward. Regulatory policy and practice has evolved considerably from its traditional origins in the form of ‘command and control’, accompanied by the growth of specific terminology and concepts that are likely to be unfamiliar to those other than regulatory technocrats. This subject provides an opportunity for students to develop an understanding of, and critically to evaluate, the basic tools, techniques and decision-making methodologies that are employed in regulatory design and practice. It will be of interest to both private and public sector lawyers who practise in regulated sectors of the economy, enhancing their understanding of how regulators go about the business of regulatory decision-making.

Principal topics include:

• Introduction: What is ‘regulation’ and ‘governance’?; the regulatory agency: institutional features, strengths and shortcomings; the rise of the ‘regulatory state’; regulatory regimes and the role of non-state actors
• Tools, techniques and instruments of regulation: command—traditional legal prohibitions backed by sanctions; competition—market based approaches; communication—information disclosure and publicity-based approaches; consensus (including self-regulation); code architecture and the use of ‘nudge’ techniques
• ‘New governance’ approaches to regulation: choice of Instrument; ‘hybrid’ approaches to regulation; responsive regulation, ‘smart regulation’ and its variants (including meta-regulation); algorithmic regulation, cost-benefit analysis and regulatory impact assessment and ‘better regulation’
• Enforcement and compliance: problems with rules; principles-based regulation; the role of the criminal and civil law; punitive civil sanctions (the Macrory Review); regulatory enforcement styles; national styles of regulation; private enforcement, third party monitoring and certification systems and the role of technological instruments for monitoring and control.
• Appraising Regulation: regulatory accountability; regulatory legitimacy: between democracy and expertise.

In 2010 all Australian governments publicly committed to implementing nationally-uniform laws about work health and safety. This development is bringing to fruition a process that began 30 years ago. However, Victoria is one of two states that have not implemented the agreed national laws. Therefore, this subject examines in detail the content of Victorian law, as well as the new national laws.

By referring to the existing state, territory and Commonwealth body of law, this subject considers the operation of Victorian work health and safety law in its historical and industrial setting, as well as the likely practical operation of the new regulatory regime. The lecturer is a researcher and teacher with over 30 years’ experience in researching and teaching work health and safety regulation.

Principal topics include:

• The problem of work-related injury and disease
• The history of the legal regulation of health and safety at work
• Nationally-uniform workplace health and safety laws
• Standard-setting under the Australian work health and safety statutes
• Worker representation and participation under the Australian work health and safety legislation
• State enforcement of the work health and safety legislation
• The anti-bullying jurisdiction of the Fair Work Commission
• Workers’ compensation schemes in Australia
• The rehabilitation of injured workers
• The role and impact of the common law duty to provide work that is safe and without risks to health.

This subject provides a critical examination of the development and current scope of sports bodies’ duty of care to participants, as relevant to athlete welfare, wellbeing and safety. It will focus on the federal and Victorian jurisdictions but will also be informed by international and comparative perspectives.

This subject is taught by former Olympian Tal Karp and Australian Institute of Sport's Richard Redman (Manager, Conduct & Professionalism). Both are highly qualified and experienced lawyers.

Principal topics will include:

• A working definition of the meaning and scope of duty of care and athlete welfare in sport;
• An analysis of the framework and key features of federal and state legislative provisions relevant to sports bodies within a duty of care context, including the Equal Opportunity Act 2010 (Vic), the Racial Discrimination Act 1975 (Cth), the Sex Discrimination Act 1984 (Cth), the Disability Discrimination Act 1992 (Cth) and the Age Discrimination Act 2004 (Cth);
• Debates regarding the meaning of equality, discrimination and other contested concepts such as “athlete wellbeing”, especially as it relates to high performance athletes;
• An examination of the general member protection provisions in federal and state law pertinent to sports bodies and particularly as relating to children;
• The application of occupational health and safety law to sport;
• An examination of human rights law compliance within the sports sector in Australia both at state and federal level;
• Conciliation, dispute resolution and alternative remedies for athlete grievances with a sporting body;
• The potential for future developments in the field.

This is a foundational subject in the Melbourne Law Masters (MLM), which is compulsory for graduates in disciplines other than law and for law graduates from countries with a non-common law system. It provides students with an opportunity to acquire the foundational legal skills necessary for studying and working in a common law system, such as that in Australia.

The common law forms one of the two principal systems of Western law that, through colonisation, have spread throughout the world. Common law systems have a distinctive approach to understanding the sources of law, the role of law-making institutions, and processes for resolving disputes. These characteristics of the common law system have had a profound effect on the development not only of the societies in the countries in which it applied, but also on international law and practice.

The aim of this subject is to acquire basic foundational legal skills that will assist you with other subjects in the MLM program. The subject teaches students how to read, use and interpret reported cases and legislation. The subject explains the sources of law, what influences them, and how they influence the development of the common law. These aims are given in context of some contemporary debates on common law reasoning by assessing the role of the High Court of Australia. The subject focuses on developing skills in analysis and legal writing, the tools of the common lawyer

Principal topics include:

• How to read and analyse a case
• The concept and use of precedent
• Evolution of a common law principle
• Common law issues: judicial activism, separation of powers
• The role of the High Court and an overview of the Constitution
• The relationship between the Constitution, case law and statute law
• Influences of other sources of law on the common law
• How to read and analyse statutes
• Approaches to statutory interpretation
• Legal writing skills and expectations in the MLM program.