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Genetics and Justice: Must One Theory Fit All Contexts?

Published online by Cambridge University Press: 06 March 2018

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Abstract:

Appeals to social justice that argue medicine and healthcare should have certain priorities and not others are common. It is an obvious question to ask: What does social justice demand of the new genetic technologies? However, it is important to note that there are many theories and sub-theories of justice. There are utilitarian theories, libertarian theories, and egalitarian theories. There are so-called luck egalitarians, equality-as-fairness thinkers, and capability theorists, with each having his or her own distinctive approach to the distribution of medical goods and technologies, and to healthcare priorities. This article argues that the discussion surrounding this question is potentially hampered by an implicit assumption that if one theory of justice is applicable in one context, then it must also be applicable in others. Instead, it is proposed that one adopt the stance, influenced by Michael Waltzer, that different theories with their opposing principles may be applicable to different questions regarding justice and genetics. The specific view advanced is that to answer questions about what justice requires regarding the therapeutic and enhancement use of genetic techniques, a method of reflective equilibrium can show how intuitions, in context, may support different theories of justice. When particular pre-theoretic ethical judgments are balanced against the theories that might explain or justify them, and are in accord with what seems emotionally acceptable, then it can be seen how different general theories may be applicable in the different contexts in which questions of justice and genetics arise.

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References

1. For example, Colin Farrelly thinks that we should all be “prioritarians.” Farelly C. Justice in the genetically transformed society. Kennedy Institute of Ethics Journal 2005;15(1):91–9.

2. Beauchamp , TL , Childress , JF . Principles of Biomedical Ethics . New York : Oxford University Press ; 1979 .Google Scholar

3. Jinek , M , Chylinski , K , Fonfara , I , Hauer , M , Doudna , JA , Charpentier , E . A programmable dual-RNA–guided DNA endonuclease in adaptive bacterial immunity . Science 2012 ; 337 ( 6096 ): 816 –21.CrossRefGoogle ScholarPubMed

4. Rawls , J . A Theory of Justice , 2nd ed. Cambridge, MA : Harvard University Press ; 1999 , at 79.Google Scholar

Genetics and Justice: Must One Theory Fit All Contexts? – Volume 27 Issue 2

JustResearch no. 11

5. Research in Profile (cont’d)

5.3 Privacy and rights issues related to developments in health genetics: Highlights of recent legal and policy research at the Department of Justice Canada (DOJ).

By Valerie Howe, Senior Research Officer, Research and Statistics Division

The Biotech Century

Many analysts predict that the 21st Century will be distinguished as the “Biotech Century.” They foresee that new developments in biology and genetics facilitate the merging of biological information with advances in informatics, and other areas such as nanotechnology. The results, they suggest, will reach into many sectors of the economy and many facets of life. The merged technological developments have every potential to be “transformative” in the sense that chemical or computer technologies have been – that is, to substantially change the way we produce and live. The first Speech from the Throne under Prime Minister Paul Martin notes: ” We want a Canada that is a world leader in developing and applying the path-breaking technologies of the 21st century – biotechnology, environmental technology, information and communications technologies, health technologies, and nanotechnology. “

The Genetic Information and Privacy Working Group

This update will identify developments related to the ‘genetic’ or human health side of biotechnology and recent research in support of the Department of Justice’s role as Chair of the Genetic Information and Privacy Working Group (GI&P). The Champion is Senior Assistant Deputy Minister of the Policy Sector, Joy Kane. The GI&P was established under the aegis of the Canadian Biotechnology Strategy to identify the challenges that may be posed as this science increasingly enters the marketplace as technology. Stewardship has consistently been a pillar of Canada’s plan for biotechnology and for genetics in particular and the Department of Justice’s lead role in this area reflects the importance attributed to human rights and privacy in the stewardship framework. As well, research in this area is increasingly being recognized as fitting within the rubric of “research on human subjects.” This brings into play ethical principles such as respect for human dignity and autonomy. In its first year the GI&P undertook background research to outline the state of affairs as the science becomes marketable and available as technology. The Department of Justice Canada compiled and analyzed the domestic and international legal framework for the GI&P, which is now in the process of outlining and assessing several policy options.

Issues in Genetic Science

Genes are a small proportion of the DNA in our chromosomes (about 2%) but they are key to life because they “code for protein” which means that they carry the instructions for making all the protein-based structures and activities the body needs to function. Genes direct the formation of proteins and proteins do the work of the cells.

The double chains of DNA in the human genome are made up of over 3,000,000,000 complimentary base pairs surrounded by sugars and phosphates. The bulk of the work, though, is done by the 30,000 genes that produce about 200,000 proteins.

Now that the human genome has been mapped, two key areas of focus for the science are gene sequencing and gene expression. Scientists need to understand the differences in the sequence of the four base pairs – pairs of Adenine, Thymine, Cytosine and Guanine – in each chromosome in different people. While the order of the DNA chain is very similar for all humans, the small differences mean that each individual has his or her own unique sequence. The sequence encodes the structure of an enzyme or other protein specified by that gene, which in turn determines its function within cells of the organism. Various changes in the sequence or order of any specific base, including a dropped base or inverted order, can mean a mutation, some of which lead to increased likelihood of disease. Attention is also focused on the role of non-gene DNA in gene “expression” – regulation or activity. People may have a problematic gene sequence or mutation but the gene may be ‘turned off’ or not ‘expressed’. Scientists have much to learn about the cellular and intercellular events that signal the nucleus to express genesm (Howe, in press).

Impacts of the Science on Society

At this time, there are not many genetic therapies available [4] . Two important areas where science and society are interacting are research and genetic testing. In order to better understand how genes actually work in humans in the real world, researchers need genetic samples from a wide range of populations – family lines; members of small isolated communities with strong hereditary tendencies; comparative populations; [5] and, representative national samples. For population health benefits and some other types of research, there is a need to combine genetic information about a specific individual with their life-style, environment and other health factors. Even though the interest is in aggregate statistics, the researchers may not wish to remove all identifying information, according to the Canadian Institute for Health Research (CIHR), because of “the need to consider the effect of important individual characteristics or to link data about individuals so as to construct histories over time” (CIHR, 2002, p.8). The genetic research undertaken by universities, governments, and the private sector depend upon the willingness of Canadians to agree to the use of their genetic information. And that consent requires assurances about the confidentiality and security of that information.

Genetic Research and Data-bases

Research undertaken under the aegis of the GI&P indicated that only a few Canadian firms are gathering genetic information (Howe, in press); that much of the research is linked to Health Canada or a university and guided by Ethical Review Boards and the Tri-Council Policy Statement; and that protections are in place to ensure the security of the information. As well, typically, the information is ‘anonymized’ so that the personal identifier is not kept with the genetic information but is kept separately and the genetic information is coded. While no immediate problems were identified, the GI&P recommends greater education and development of best practices in regard to the collection and conditions of storage of genetic information and other sensitive personal health information. Efforts in this regard, as well as projects to enhance the awareness of standards for research on human subjects have been proposed.

Guidelines and standards are also being developed or enhanced in regard to clinical or diagnostic genetic testing at many levels from associations of doctors to the international level. In general, informed consent is considered essential. For that reason, and because there can be substantial health benefits, genetic screening of newborns is of particular interest for policy research and development. In its report entitled “Promoting Safe and Effective Genetic Testing in United States – Final Report of the Task Force on Genetic Testing”, the National Human Genome Research Institute recommends that: “If informed consent is waived for a newborn screening test, the analytical and clinical validity and utility of the test must be established, and parents must be provided with sufficient information to understand the reasons for screening.” This is an example of the broad range of policies and guidelines currently under development.

Genetic Tests

Doctors in medical practice now have an ever-increasing range of genetic tests available that provide some additional information to family history information and need to decide whether to recommend genetic testing. A test may reveal that a person has a particular mutation on a particular gene – and this may raise the probability that they may develop a particular disease, condition or characteristic. Only in rare cases will having that gene or mutation indicate the exact fate of that person in regard to that condition since most conditions result from the interaction of several genes in particular situations – such as health conditions, environmental conditions, etc. Tests at the genetic level add to what can be known about a person’s heredity from family history but rarely provide certainty. A report commissioned by Health Canada for the GI&P indicates the following developments in testing are anticipated:

  • the ability to test for complex and multi-factorial disorders will increase;
  • pharmacogenetic testing, the ability to test for gene-based reactions to specific drugs, will begin to emerge; and,
  • there will be a significant (5-10% a year) growth in the numbers of tests for single gene disorders.

With the proliferation of new tests, accompanied by public belief in their efficacy, one may expect policy issues to arise with respect to the need for regulation in such areas as:

  • evaluation of tests;
  • costs of testing and the extent to which these may limit access; and,
  • patents and direct-to-consumer marketing of tests.
The Legal and Policy Research

In its first year the GI&P conducted a range of research including the following:

  • Documentation/analysis of major legislative and policy initiatives internationally (DOJ);
  • Cataloguing and analysis of provincial and federal legislation relevant to genetic information and privacy including human rights, privacy, and health legislation with commentary (DOJ);
  • Analysis of recent Supreme Court decisions on human rights, privacy and disability that provide a context for how the court might view issues that could be raised as genetic testing technology becomes readily available (DOJ);
  • Expert discussion of possible futures as the scientific and technological possibilities grow (Genetic Futures Forum hosted by DOJ);
  • Expert discussion of patent law and policy as it has been applied in the human genetics and possible implications – a human rights interpretation (DOJ);
  • Interviews with Genetic Counsellors on the public’s responses to the possibility of having tests that tell them about possible future health outcomes and a review of relevant literature (Health Canada);
  • Surveys of holders of data-banks in the private and public sectors about their holdings and their privacy and security practices (Statistics Canada, Health Canada, Industry Canada);
  • Analysis of how genetic information might impact employment law and practices (Human Resources and Development Canada); and,
  • Discussion with businesses about how they might use genetic information (Industry Canada).
Analysis and Recommendations

The compilation and analysis of existing legal frameworks at the institutional, national, provincial, and international level reveal a web of protections for privacy, autonomy, human dignity, and against discrimination. While few of these protections specifically refer to genetic information, interpretation of the terms used (personal information, sensitive information, health information, recorded information, etc.) provides support for the view that genetic information would likely be protected under a range of regulatory, privacy, and rights legislation – if and when cases of abuse arise. Chief among these protections are those in the Charter of Rights and Freedoms and a review of jurisprudence suggests that discrimination on the basis of a ‘perceived’ disability is unlikely to be tolerated by Canadian courts (Nola, in press). Bartha Maria Knopper’s analysis of the legal framework (DOJ, 2003) has noted that the ‘patchwork’ of protections creates a lack of clarity and certainty. However, other analysis by Eugene Oscapella (2003) in the context of a discussion of instruments of choice, notes that a patchwork is not necessarily a bad thing and may be entirely adequate.

Next Steps

In law, policy, and practice, the policy research undertaken by the GI&P revealed no significant problems that warrant priority attention. Still, the pace of scientific and technological change is so fast, the potential applications so broad, and the issue sufficiently sensitive that an active monitoring of the developments in the global market and in Canadian clinics and institutions is warranted.

Two specific legal reforms are under consideration. [6] One idea is an amendment to the Privacy Act definition of ‘personal information record’ to clarify that genetic samples and information are included. Another is a possible amendment to the Canadian Human Rights Act definition of ‘disability’ to clarify that discrimination is forbidden also on the basis of a perceived disability or a predisposition to a disability. It is anticipated that such reforms might arise when next there are amendments to either of these Acts.

As well, more attention should probably be devoted to increasing public awareness and confidence through communication of the various governance frameworks and activities. It would be desirable to have greater mutual awareness of activities at each level (institution, province, nation, and international) by those at the other levels. Ongoing development and enhancement of standards and guidelines should be promoted and made more evident to Canadians in all walks of life. Governments need to understand how Canadians view these issues, the expectations they have for health benefits, their values in regard to issues such as sharing family information or the need for genetic counselling, their desire to know, or not know, genetic information when there is not a valid treatment, and so on. Current research will explore these questions about Canadian values.

JustResearch no. 11