Lemmens, Trudo --- "Why Regulate the New Genetics?" [2003] ALRCRefJl 24; (2003) 83 Australian Law Reform Commission Reform Journal 41

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Reform Issue 83 Spring 2003

This article appeared on pages 41 – 46 of the original journal.

Why regulate the new genetics?

In May 2003, the report, Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96), was tabled in federal Parliament. The report was co-authored by the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC). Trudo Lemmens* reviewed some of the report’s findings and recommendations as they relate to clinical genetic testing and research.

After two years of inquiry, the ALRC and AHEC launched in 2003 their report on the protection of human genetic information in Australia. Not unlike other reports in this area, the title—Essentially Yours—already evokes the idea that genetic information is indeed highly personal and intimate information. The use of the word ‘essentially’ also points, however, also in a clever way to the fact that, even if genetic data falls very much within the domain of privacy, personal rights over this information should not be absolute. A person’s genes are essentially something that ‘belongs’ to her or him, that reveals intimate characteristics of the person, but there are also other aspects that bring it outside of the personal realm. Genetic information is fundamentally shared with family members; it may tell us something about ‘shared’ ethnic or racial background; and there may be circumstances, such as in the criminal law context, where a person’s right to privacy may have to be limited for reasons of public interest.

The balanced and sensible approach conveyed by the title is found throughout the two-volume report and is a reflection of the impressively thorough background work on which it is based. While the October 2001 Issues Paper, Protection of Human Genetic Information (IP 26), provided an in-depth review of the literature, with more extensive references to the literature and foreign jurisdictions, the final report has benefited from an impressive set of interviews, discussions, and submissions by individual scholars, various organisations and interested citizens from all over the world. Members of the team involved in this report have also been travelling extensively and gathered opinions from various experts in the field. The way in which the authors of the report have managed to integrate these contributions is remarkable. It gives the report not only wider public legitimacy, but it also makes it a very useful background document for anyone interested in these issues.

Various commentators have argued that genetic information shares many characteristics with other forms of health information and that increasingly they will be integrated in everyday medical practice.¹ A regulatory and legal response to the new genetics, therefore, has to be solidly integrated in legal and regulatory regimes dealing with the use of and access to more common forms of medical information. Following this approach, the report devotes much attention to how these regimes can handle various specific legal, ethical and social concerns raised by genetics, and whether changes are warranted. But the report also recognises that the fast pace of change in genetic knowledge makes it likely that new issues will emerge and that an on-going review of these developments is warranted. For that reason, the report recommends the establishment of a Human Genetics Commission of Australia, which would have an advisory function as well as a role in the context of policy making. I am inclined to agree with this recommendation, having been involved in the drafting of a similar report as a member of an advisory committee for the Ontario government, which led to the establishment of a similar advisory committee in this Canadian province.² I also agree to some extent with the warning of the report against the introduction of rigid legal structures that would not be amenable to change.

But I would like to emphasise here one of the major reasons why the implementation of a solid regulatory review structure in the context of genetics requires more than the establishment of an advisory commission. A general advisory commission on genetics can play a vital role in promoting debate, in exploring new ethical, social and legal issues, and in making important policy recommendations. A more stringent regulatory structure is needed, however, to ensure appropriate public control over a technology that can contribute to improving health care, but that also has the potential of impacting significantly on societal values and could lead to stigmatisation of, and discrimination against, individual people, their families and their communities.

In an Ontario report that we are currently finalising with some Canadian colleagues, I framed the crucial questions that a regulatory agency should ask as follows:

• Who can conduct genetic testing?

• Who can order it?

• For what purpose can it be done?

• What is the impact of this testing?

• Who has access to the information gained by the test?

• How will the information be kept, and for how long?

These questions should be at the core of the review of any form of genetic testing before approval is given for its use. The first four questions refer to issues of both value and validity. They also relate to genetic testing undertaken in the context of research as well as genetic testing undertaken for clinical or other purposes such as criminal prosecution, employment or immigration. The latter questions deal more with the issue of data protection and privacy.

But if genetic information should not be fundamentally distinguished from other health information, one might ask, why recommend a regulatory review and approval structure in the context of genetics? Why not simply rely on existing legal and regulatory regimes? Three immediate reasons can be pointed out, which are largely also recognised in the report. First of all, the protection of personal health information is still the focus of considerable debate, and various countries are still working on how to improve the protection of sensitive health information and the control over its use through privacy and human rights legislation and through an amelioration of research governance systems. If there are overall weaknesses in the system, they also have to be pointed out in the context of genetics, as the Australian report very aptly does.

Secondly, in some areas, genetic testing or the use of genetic technology escapes the governance mechanisms that have been put in place for other medical technologies. For example, in several countries, including Australia and Canada, some forms of genetic research in the private sector do not fit the categories of research that are covered by existing forms of research governance. Genetic research in the private sector is not covered by research regulations related to clinical trials for drugs or medical devices, and it is not subject to the research ethics guidelines of the funding agencies, in Australia the National Statement issued by the NHMRC. Here again, the Australian report puts its fingers on many of the problems. The report contains one of the most detailed discussions of the research review system in Australia, and how it relates to genetic research. It points out how certain forms of genetic research fall outside of the scope of the National Statement and it highlights the need to look into an all-encompassing more rigorous review system.

Thirdly, although genetic information shares many characteristics with other forms of health information, I believe that there are reasons for increased concern about potential abuse of genetic testing and genetic information. While individual characteristics of genetics (such as its familial character, its potential links to ethnic groups, and its predictive nature) can also be found in other forms of health information, genetic samples combine all of these characteristics and contain a truly staggering amount of intimate information. Moreover, the technological advances that accompany its development are a source of concern: computer technology is one of the cornerstones of the genomics revolution, but this technology can also be used to easily transfer, trace, analyse and interconnect sensitive health information.³ And finally, genetic testing and the use of genetic information have to be placed in a larger social, cultural and historical context. The concerns we may have about the unregulated use of such technologies are intimately connected to the particular societal and cultural context in which they are applied. These technologies are being developed in a way that may escape detailed societal debate and they may, at the same time, have a profound impact on societal values.

The history of eugenics, in particular, functions as a reminder of how medical knowledge and technology can develop within a given societal and cultural context and not only reaffirm, but also become a powerful force in the promotion of values which, in retrospect, seem highly questionable. Although much effort has gone into distinguishing the new genetics from its ‘eugenic’ counterpart, the difference between the two, as Allen Buchanan, Dan W Brock, Norman Daniels and Daniel Wikler have pointed out, is mainly one of degree and context.⁴ Genetic testing and potential discriminatory use of genetic information do convey and reaffirm values about what constitutes normalcy and about what traits ought to be avoided. An in-depth discussion of these values exceeds the scope of this article, but it is important to emphasise that new biomedical technologies are not just the result of neutral scientific advances. They are the result of a specific desire for control and they re-emphasise values. Members of the disability community have argued, for example, that offering pre-natal genetic testing expresses the idea that certain ‘disabled’ lives are to be avoided and that this devalues their own lives. Our culturally determined drive for control over our health and the health of our offspring may thus clash with the interests of others and impact on important social values. It may increase the pressure towards genetic testing. In a recent article, Deborah Hellman explores why there are calls for genetic-specific regulations. She stresses that it is important to look at what genetic discrimination ‘expresses’ in a particular social and cultural context in order to determine whether a specific genetic-focussed protective regime is needed; she also invokes the history of eugenics.⁵

While the social and cultural context is now very different from the time of the eugenic movement, other contextual factors are a reason to support strict regulation. I am thinking here, in particular, of the commercial context in which genetic technologies are being developed and promoted. The commercialisation of genetics plays out at different levels: it affects genetic research, genetic databases, the development and promotion of genetic testing, whether pre-natal testing, clinical testing, or testing for employment or insurance purposes. This is not to say that the private interests of biotechnology companies cannot contribute to the public good. Private interests can stimulate research and contribute positively to improving health care, but they frequently also conflict with public interests. Commercial interests currently push private companies to bank genetic material of individuals, which raises issues about adequate compensation, ownership of genetic material, and potential financial impediments on access to genetic technologies developed for private gain. Private interests can help to stimulate certain forms of research, but generally only such research that leads to marketable products. Diseases affecting developing countries and the poor will receive little attention, and research will focus on treatment, rather than prevention of disease, or on technology-based health care, rather than on public health measures based on, say, nutrition and hygiene.

There is also increasing concern about the impact of commercialisation on the integrity of the scientific process itself. Scientific research provides the basis for weighing the validity and value of new technologies and therapies, and for determining whether they should be funded through the health care system. It is therefore crucial that the research process be independent, transparent and reliable and not biased by a commercialisation agenda. Furthermore, genetic research creates ‘informational risks’ and a solid evaluation of the balance between these risks and the potential benefits of this research is necessary to protect and respect research subjects and their families. As already pointed out, the report joins the chorus of those who have pointed to serious deficiencies in the existing review system based on research ethics review boards (referred to as Human Research Ethics Committees (HREC) in Australia, and Research Ethics Boards (REB) in Canada). As in other countries, there is little or no regulatory oversight over these boards, there are no clear professional standards and there is a lack of expertise and training among the members of many of the committees. In the context of growing commercialisation, it can be questioned if these boards will be able to provide solid and independent review. The report makes important recommendations with respect to improved training (which is particularly important in new areas such as genetics), accreditation, and the inclusion of private research under the existing governance system. It is somewhat surprising that it does not discuss in more detail growing problems of conflict of interests of these ethics committees. This is, certainly in North America, one of the major challenges of the research review system.⁶ In an increasingly commercial environment, research review boards have become more vulnerable than ever to conflict of interest situations.⁷ Within academic institutions, members of the review boards need to evaluate conflicts of colleagues and hierarchical superiors, but they also have to make decisions that may impact significantly on the financial interests of their academic institutions. Moreover, commercial review boards have taken a large share of the ‘research review market’, while they do not fulfil, in my view, basic requirements of administrative independence. Since medical research has become a business, it needs an adequate regulatory system and solidly independent review boards to counterbalance the commercial interests.

Once genetic technologies are developed, regulatory review is needed to determine their use. Some forms of genetic testing may be valuable in the context of clinical care, while marketing these tests for other purposes could be unacceptable. Without regulation, commercial interests could create markets for predictive genetic tests that are stigmatising and discriminatory, or simply invade human dignity. This is already a concern. Some US-based companies currently invite parents through worldwide web advertisements to submit clothing samples of their adolescent children to detect whether they engage in premarital sex. If markets for such tests can be created, surely we will see commercial campaigns trying to sell future parents the idea of prenatal testing for various behavioural conditions, even in the absence of solid scientific data supporting the tests. Do we really want to see a commercial promotion of prenatal testing for Down syndrome, for short stature, or in the future perhaps even ‘gay genes’? And should we allow biotech companies to develop an aggressive campaign pushing employers and insurers to use highly stigmatising genetic tests? A regulatory regime should at least enable an independent analysis of the implications of allowing certain forms of genetic testing. Most countries currently have some form of regulatory control over drugs and medical devices in place. Although many of these review systems are being criticised, they evaluate to some extent the efficacy and safety of products to determine whether they should be allowed into the market. A regulatory review system should allow us to evaluate the risks involved with new genetic technologies.

It has to be recognised, however, that regulating genetic technologies will also create important social and moral responsibilities. While I strongly believe that it would be unwise to leave the development of genetic technologies and its use up to market forces, I also realise that there is something uncomfortable about the idea of governmental review and ‘approval’ of genetic testing. When discussing the need for regulating the use of genetic testing and genetic information with a journalist, she asked what the difference was between such a governmental review committee and the advisory committees that were part of eugenic governmental policies in the previous century. This penetrating question indicates how important it will be to have a review system that remains critical of the values expressed through approval or disapproval of genetic testing and that integrates solid human rights standards in the evaluation process.

Although genetics creates very different risks than other medical technologies, some of which clearly touch on societal values, it seems inappropriate to have the values expressed in genetic technologies reinforced and promoted through marketing strategies. A regulatory review of these new technologies should thus not only involve a control of the validity of the scientific data and of the quality standards of the laboratories conducting the testing, but also a detailed review of their impact on societal values. As with drugs and medical devices, this review should also lead to a determination of the parameters of their use.

The value of the Australian report lies in the detailed discussion of the various concerns I have discussed here, as well as many others concerns, and in the detailed analysis of how the Australian regulatory system is currently apt to deal with them. It does discuss these issues in much detail and deals with them separately. In addition, the report makes important and balanced recommendations to improve, for example, the research review system and privacy protection in the context of genetics. It also, at times, makes strong recommendations that go in the direction of a strict regulatory approach. When discussing genetic testing, it recommends, for example, that a criminal law provision be introduced that would make it a criminal offence to conduct genetic testing without consent. The report also contains a strong argument in favour of a new Human Genetics Commission of Australia. This report points to various important policy roles for this type of committee.

While, in my view, a more stringent regulatory structure is needed, the strength of an official report often lies in its realistic character and balance. While it is easy to write a critical academic commentary in isolation, it may be more realistic, however, in the Australian political context, to introduce a strong advisory system. It certainly will provide flexibility and allow a further exploration of the benefits of new genetic research. As in Canada, constitutional divisions of power may hamper attempts to introduce a federal legislative scheme to regulate research. But I believe it is crucial that research review is removed from those with a vested interest in the—increasingly profitable— research. Combining the mandate of promoting research, and often also the mandate of promoting economic development, with that of protecting subjects seems unwise in the context of the growing commercialisation of research.

The future will tell us whether the development of a Human Genetics Commission will be sufficient to control some of the risks created by the same technology. The report should be taken as a basis by regulatory authorities, both at the federal and state level, to reflect further on what can be done to improve the regulatory oversight. The fact that the report’s very critical analysis of particular issues is often not followed by a strong argument for stringent regulatory control should not be used as an excuse by various governments to rely on self-regulation and regulation by professional organisations. As I have tried to indicate briefly here, the potential impact of new genetic technologies should be analysed in its social, cultural and historical context. The commercial interest in genetic research and genetic technologies, and the values raised by its applications, are a sufficient reason to do more. The Australian report is a very good first step. It is not an end-point.

*Trudo Lemmens,

Lic Jur, LLM, DCL

Assistant Professor,

Faculty of Law, University of Toronto.

Member (2003–2004), School of Social Science, Institute for Advanced Studies, Princeton.

Endnotes

1. For example, TH Murray, ‘Genetic Exceptionalism and ‘Future Diaries’: Is Genetic Information Different from Other Medical Information?’ in MA Rothstein, ed, Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (1997), Yale University Press, New Haven, 60; LO Gostin & JG Hodge (Jr), ‘Genetic Privacy and the Law: An End to Genetics Exceptionalism’ (1999) 40 Jurimetrics, 21–58; T Lemmens, ‘Selective Justice, Genetic Discrimination and Insurance: Should we single out our genes in our laws?’ (2000) 45 McGill Law Journal 347–412.

2. Genetic Services in Ontario: Mapping the Future. (Report of the Provincial Advisory Committee on New Predictive Genetic Technologies), 30 November 2001 (2002) Queen’s Printer for Ontario, Toronto.

3. T Lemmens & L Austin, ‘The Challenges of Regulating the Use of Genetic Information’ (2001) 2(3) ISUMA, Canadian Journal of Policy Research, 26–37

4. A Buchanan et al, From Chance to Choice: Genetics and Justice (2000) Cambridge University Press, Cambridge.

5. D. Hellman, ‘What makes genetic discrimination exceptional?’ (2003) 29 Am J L & Med 77–116.

6. See, for example, the attention paid to this issue in: Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants, (2003) National Academics Press, Washington DC.

7. T Lemmens & B Freedman, ‘Ethics review for sale? Conflicts of interest and Commercial Research Ethics Review Boards’, (2000) 78(4) Milbank Quarterly 547–584.