Chalmers, Don --- "Globalisation & medical law" [2000] ALRCRefJl 8; (2000) 76 Australian Law Reform Commission Reform Journal 40

---

Reform Issue 76 Autumn 2000

This article appeared on pages 40 - 43 & 100 of the original journal.

Globalisation & medical law

By Professor Don Chalmers*

Globalisation has had its most obvious impact in driving changes in international trade and trade laws. Some professions have responded to globalisation, most notably the accountants by facilitating trans-national practice. Arguably, medical research and many aspects of medical practice in this country were already directly and richly influenced by international trends before the neologism of globalisation. Importantly, Australian governments on both sides are committed to maintaining a high quality health care system. Effective regulation of medical practice, consistent with global best practice, is a not insignificant element in achieving this agreed social goal.

In the coming decades, traditional legal and ethical complexities of the doctor/patient relationship such as consent, confidentiality, medical record keeping, maintenance of professional standards, medical registration and discipline, are likely to remain within national jurisdictional boundaries. However, medical practice is no longer confined within a single set of borders; it is increasingly common for medical practitioners to practise in different countries. A continuing trend of convergence of national medical education and professional standards is facilitating trans-national registration. National competition policies and professional reciprocal recognition rules also are facilitating this trend. The increasing use of telemedicine, the delivery of advice or direction in diagnosis, treatment and surgery via real-time computers is a recent reason for the increasing portability of medical qualifications. Telemedicine is prompting discussion about issues of conflicts of laws, for example, what is the liability attaching to the on-line advice-giver or the creator of the accessed program data.

Formal & informal medical law

Many aspects of medical law, both formal and informal, are increasingly converging into one stream, though retaining distinctive national currents, to adopt Ashburner’s famous fluvial metaphor.

In the formal sense, national courts regularly examine overseas jurisprudence. For example, recent leading High Court decisions in Rogers v Whitaker in 1992¹ and Breen v Williams in 1996² both examined the leading Canadian, US and American thinking in relation, respectively, to doctors’ duties to warn their patients of material risks and patients’ rights to access their doctors’ records.

Informal law is a useful term to cover the plethora of professional practice guidelines and codes which apply from the broadest to the narrowest aspects of medical care, treatment and administration. These guidelines and codes of practice are developed by a range of bodies from the Australian Medical Council, specialist colleges, government-appointed Health Complaints Commissioners to the National Health and Medical Research Council and other government agencies. These guidelines and codes of practice may be described as informal in their making, but are inaccurately described as ‘informal’ in their application. The guidelines and codes are consulted by the courts to establish standards of professional conduct in actions for medical negligence. In fact, many of these guidelines take on a quasi-legislative flavour by being placed before parliament. For example, Australian Health Ethics Committee ethical research guidelines are laid before the Commonwealth Parliament.

Loosely, globalisation has influenced the development of these guidelines and codes of practice, which are invariably informed by reference to overseas rules and standards. The recently completed revision of the National Statement on Ethical Conduct in Research Involving Humans³ – presented to the Commonwealth Parliament in July 1999 – was informed not only by extensive public consultation but by reference to British, American, Canadian and World Health Organisation (WHO) codes.

Human tissue

Globalisation has had more obvious impacts on other areas of medical law. The collection, use and transplantation of human tissue is an area in which the Australian Law Reform Commission (ALRC) made a profound and distinguished international contribution to the consideration of the complex moral, medical and legal problems involved. The seminal Human tissue transplants report (ALRC 7), released in 1977, made recommendations about the collection and use of tissues and organs from cadaveric and living donors.

Importantly, the ALRC recommended establishing standards prohibiting commerce in human tissue. The decline in the availability of suitable organs for transplantation has, sadly, created a seedy, black market international trade in live organs. These black market, living donors are invariably from appallingly poor third-world countries. International medical law has an evident moral role to pursue.

The decline in available human organs for transplant has been a significant reason for moving into exotic areas of research, such as xenotransplantation. Xenotransplantation involves the transfer of human genes to animals (principally pigs) with a view to developing compatible organs, body parts or medicines suitable for use in humans. However, there are genuine risks of introducing virulent viruses from these genetically modified animal parts. The writ of the scientific precautionary principle, which demands that procedures should not be undertaken until risks are determined and estimated, does not have currency in all countries. While most countries have introduced stringent regulation of related research work, there are real dangers of lower regulation ‘xeno-havens’ arising. The National Health and Medical Research Council (NHMRC) is examining xenotransplantation from both the scientific and ethical perspective.

Cloning

A maelstrom of media reaction met the announcement of the cloning of Dolly the sheep at the Roslyn Institute in Edinburgh, Scotland. Shortly afterwards, there followed reports of cloned calves at the Ishikawa Research Centre in Japan. These events excited an international frenzy of reports about eternal copying of geriatric millionaires. The biological impossibility of copying all the genetic characteristics of a whole person, by the Dolly technique, with their memories and personality did not spoil the stories.

More probably, scientists are suggesting that it may prove feasible to culture and develop stem cells that will later differentiate into replacement parts or even whole human organs. The UK Human Genetics Advisory Commission extended the lexicon in its report by referring euphemistically to cloning parts as ‘therapeutic cloning’. Where these stem cells are harvested from human embryos, strict legal restrictions apply in most countries. But, it is possible to find non-regulated areas. For example, some Australian scientists are conducting stem cell research in Singapore, which is currently banned in most Australian states and territories.

The possible application of cloning techniques to humans prompted the establishment of the National Bioethics Advisory Commission in the United States in 1997. At the end of 1997, the United Nations Educational, Scientific and Cultural Organisation (UNESCO) published the Universal Declaration of the Human Genome and Human Rights. In the following year a cascade of international pronouncements, all censorial, appeared. Included in this cascade has been a Ministerial Report by the Australian Health Ethics Committee, which will be considered by the House of Representatives Committee on Constitutional and Legal Affairs. Cloning and xenotransplantation are at the exotic frontiers of medical research.

Medical research

Protection of research participants, proper compensation in cases of injury and maintenance of high standards of integrity and safety in medical research are increasingly subjects for international attention by law reformers and legislators alike. There have been undeniable benefits to medical research from results generated in international clinical trials. The need to develop international best practices and international consistency in the conduct, safety and reporting from international multi-centre clinical trials has been recognised by the move for standardisation by the International Conference on Harmonisation, which has published Guidelines for Good Clinical Practice.⁴ Increasing internationalisation of medical research has prompted revision of a number of recognised international codes of practice, such as the World Medical Association Declaration of Helsinki, the joint WHO/ Council for International Organisations of Medical Sciences (CIOMS) Ethical Guidelines on Research as well as the Council of Europe Bioethics Convention.

One specific aspect of international multi-centre clinical trials is looming. Very high costs are involved with Phase 3 Clinical Trials. As an illustration, the Australian developed influenza treatment Relenza will require an estimated $300 million for Phase 3; the drug will be trialed overseas in collaboration with a major multi-national drug company. These high costs have encouraged some companies to conduct trials in developing countries with weaker ethical review, lower insurance rates and less costly legal systems. This process has been called ‘ethical export’. The World Medical Association is currently revising the Declaration of Helsinki, which includes a draft clause addressing this difficult subject. The current wording of article 18 may allow researchers, in testing an unproven treatment, to recruit their research subjects solely on the basis that they do not have access to the best existing treatment for the disease for which the new treatment is being tested. This could involve exploitation in the selection of research subjects. Is it ethical for subjects to be included in a research project that will offer superior treatment than is otherwise available, but only for the duration of the research, after which they will return to a lower standard? Equally, is it ethical to run a trial for a drug that the developing country may never be able to purchase and make available to its citizens?

Privacy

Privacy of medical records and information is already a public concern – one that is likely to become more aggravated in future years. The linking of computers has facilitated the trans-border flow of information and this was recognised in the early 1980s by the Organisation for Economic Cooperation and Development (OECD) Working Group. The recommendations of this group were considered by the ALRC and resulted in the publication in 1983 of the seminal report on Privacy (ALRC 22), which was followed by Commonwealth legislation, applicable to federal government agencies. A balance must be reached between individual privacy and legitimate public access. Medical records are created principally for the patient’s benefit; that patient, when on overseas travel may find it highly desirable for an overseas hospital to be able to access Australian medical records in an emergency.

Similarly, the conflict between personal interest in privacy and the public benefit in medical research was recognised in the Privacy Act 1988 (Cth). Section 95 of this Act allows the NHMRC to publish, with the approval of the Commonwealth Privacy Commissioner, guidelines which permit breach of the Information Privacy Principles provided a duly constituted ethics committee considers that the public benefit from the research outweighs the personal interest in privacy. These guidelines are currently under review and have proved challenging to ethics committees in their technicality. However, it is the privatisation of hospitals, the growing multi-nationalism of health care provision and the ease of access to computer data that marks privacy as a continuing problem.

Medical management

The great managerialist revolution of the past two decades has left its claw-print on the health system. That the health care system should be run effectively, efficiently, economically and expertly is undeniable. New funding models of purchaser-provider and managed health care arrangements between insurers and providers aim to provide these efficiencies and value for money. The health lawyer and law reformer are being called on to advise on new styles of legislation and contractual arrangements which establish the architecture for this differently regulated health system. In spite of new management systems and funding procedures, the law has not abrogated its responsibilities to ensure that the health system is delivered justly and without discrimination. The current commitment to a mixed public and private health care delivery system will require careful scrutiny of the health care delivery legislation to ensure that it operates in a just and non-discriminatory fashion.

Conclusion

The move to international business and trade led to the development of international conventions, rules and institutions of, particularly, the World Trade Organisation. There are similar developments in the international medical-legal field. International norms are developing and finding expression in increasing numbers of international statements. The classical Declaration of Helsinki in 1965 has now many accompanying partners. The World Health Organisation and the recently convened Summit of National Bioethics Commissions are trying to spell out an agenda for addressing guidelines in areas of medical research and practice. The considerable international agreement for the unacceptability of human cloning which was reflected in international, European, WHO, United Nations and National Statements should not mislead in misconceiving the magnitude of the task. Legal systems reflect profound cultural differences between nations. Similarly, the delivery of medical services mirrors the gulf between the First and Third Worlds. The luxurious surgical hospital and medical services of North America and Europe rank shamefully against the failure of most developing countries to provide clean water, basic food, antibiotics and aspirin, which are taken as common place in the developed world. The international movement to regulate aspects of medical care cannot deny the stark ethical dilemmas that represent the widening gulf between the First and Third Worlds.

* Professor Don Chalmers is the Head of the School of Law at the University of Tasmania. He is the Chairman of the Australian Health Ethics Committee of the National Health and Medical Research Council and was the Law Reform Commissioner of Tasmania from 1991 - 1998.

Endnotes

1. [1992] HCA 58; (1992) 175 CLR 479.

2. (1996) 138 ALR 259.

3. National Health and Medical Research Council National Statement on Ethical Conduct in Research involving Humans Canberra NH&MRC 1999.

4. CPMP/ICH – 135/95.