The Human Genome and Human Rights recommendations: “aspirational and symbolic”

2 December 2015 by Rosalind English

The International Bioethics Committee, under the auspices of UNESCO, has recently updated its guidance on the human genome and human rights. The Report of the IBC on Updating its Reflection on the Human Genome and Human Rights was published in October 2015, and takes into account the  Universal Declaration on the Human Genome and Human Rights (1997), the International Declaration on Human Genetic Data (2003) and the Universal Declaration on Bioethics and Human Rights (2005). The following summary is based on Alison Hall’s review of the recommendations in the PHG Foundation’s bulletin.

The IBC’s report attempts to review all the relevant ethical challenges for regulating genetic research and clinical care across national boundaries. The area that has received most coverage in the press involves the emerging techniques for editing the human genome, in particular engineering gametes. The other four areas of application the IBC has chosen for review are:

Direct-to-consumer genetic tests and genetic analysis that is not related to health care
Precision/personalised medicine
Biobanks (banks of genetic information)
Non-invasive prenatal testing

Unrealistic

Hall notes that the IBC’s practical recommendations for States, governments, scientists and ‘all actors of civil society’  “confusingly combine statements of principle, challenges and recommendations in one”:

Whilst the ethical / societal principles (respect for autonomy and privacy, justice and solidarity, the complexity of factors associated with understanding illness and health; cultural, social and economic aspects and responsibility towards future generations) seem self-evident – the justifications for the recommendations that emanate from those principles are less so.

The main basis for their recommendations is that the human genome underlies the fundamental unity of the human family and as such, ’the human genome is the heritage of humanity’ (para 115 and Article 1 of the UDHGHR).

As such, it is argued,

this creates a global responsibility which cannot be met simply by States and governments, which falls upon the international community as a whole. As a result, there multiple calls throughout the document for international actions or the creation of international infrastructures. Examples include a call for an international legally binding instrument to ban human cloning for reproductive purposes; a moratorium on genome engineering of the human germline; a willingness to co-operate on establishing shared, global standards relating to engineering the human genome and acceptance of a shared global standard; and the acceptance of non-controversial rules, procedures and solutions for modifying the human genome and producing and destroying human embryos.

It is obvious to anyone following the news of China’s progress in this field that this is an unachievable goal.  The plethora of national approaches will make it near-impossible to achieve any such international consensus.

Medical versus non-medical applications – an unworkable distinction?

The author also criticises the IBC’s distinction between medical and non-medical applications to inform the ethical acceptability of the proposed action. The recommendation is that interventions  may only be permitted ‘for preventative, diagnostic and therapeutic reasons’, and these should not enact modifications to descendants (that is, no interference with germ line DNA).  The alternative, says the IBC, would be to jeopardize the inherent and therefore equal dignity of all human beings and renew eugenics disguised as the fulfilment of the wish for a better improved life.  Hall observes that

our burgeoning knowledge about genetic variations and their interplay with other risk factors such as the environment or lifestyle suggests that this distinction is not straightforward and is often somewhat arbitrary, as is the definition of the interventions that are ‘preventative, diagnostic or therapeutic’.

One example she points to is the promotion of genetic tests that are only for health purposes.

If this was imposed it would limit the development of functional genetic tests in basic science where the potential health benefits of testing might only become clear at a comparatively late stage.

With better scientific expertise the IBC might have developed recommendations that were “more scientifically robust”.

The harmonisation of biobanks

At best these recommendations are “unashamedly aspirational” and “symbolic”. Hall cuts as an example the recommendation applying to biobanks, which the IBC suggests should be contained in an international registry with clear rules for access and sharing, in particular for cross-border and industrial access, because there are too many of them and have statuses that are too diverse. However this type of registry should be implemented‘. It adds as an afterthought – ’the rules governing data confidentiality and ethical review should also be harmonized‘ (para. 80).

How, the review asks, are these enormous barriers to be overcome? The IBC has not suggested any practical way of doing so, and their advocacy of such actions are therefore “implicitly unattainable”.

There are aspects of the Report that are welcome, such as the recommendation that genetic services should be developed in line with ethical principles and in compliance with agreed standards. Similarly the move towards greater personalisation will be facilitated if there are sustained efforts to improve genetic literacy.

But the Report is hobbled by a fundamental difficulty – how to square the circle of scientific advance and resource inequities within and between countries. The IBC argues that

Scientific progress should not deepen inequalities within and among countries nor be used for discriminating against individuals or groups’ (para. 122), and that

Considering that scientific advancements in this field are likely to offer unprecedented tools against diseases, it is crucial to acknowledge that these opportunities should never become the privilege of few (para.128).

One solution Hall suggests is to ensure that access to genetic and genomic technologies is offered fairly in ways that are “transparent and accountable”.

In an era of ever tightening resources in higher income countries as well as low and middle-income countries, these obligations seem to be increasingly important and deserve more attention both in ethical guidance and elsewhere.

Time will tell whether any of these recommendations gain traction in real life.