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Human Genome Research Project releases final report

Students in the Unicol dining room

Wednesday 4 March 2009 12:05pm

The Human Genome Research Project (HGRP) has released its final report, drawing a line under nearly three-and-a-half years of research, traversing the many legal, ethical, medical and cultural issues surrounding the regulation of human genome-based technologies in New Zealand.

Sponsored by the New Zealand Law Foundation, the University of Otago Law Faculty-led project has drawn on New Zealand and overseas expertise from a range of disciplines to produce a series of reports totalling 1800 pages.

The third and final volume of Genes, Society and the Future covers a range of topics, from pharmacogenetics, or so-called personalised medicine, to the implications surrounding the use of genetic testing for insurance purposes.

Other topics include the impact of the patenting of genetic knowledge on research, accessing stored human tissue samples for genetic research, and issues surrounding intellectual property gained from studies of whole communities. The report examines issues around preimplantation genetic diagnosis (PGD) by building on the recommendations of the project's first report Choosing Genes for Future Children.

Project leader and Law Faculty Dean Professor Mark Henaghan says genetic knowledge is both inspiring and intimidating.

"It taps into our strongest hopes and our deepest fears. This knowledge can be used to choose the genes of future children, test for potential diseases in our genetic make-up, find the relationships between illness, genetic profile and environmental influences in a community, and design drugs which are better suited for our particular human genome," he says.

"It can also be misused to discriminate against those with certain conditions once we know their genetic code."

Professor Henaghan says the objective throughout has been to determine whether regulation is necessary or not.

"Our focus has been to analyse the benefits and harms from a range of perspectives and disciplines. We give each position as fair a hearing as possible. We then take a position which is contestable and will not be accepted by everyone," he says.

"In a democracy, this is the only way we can proceed on issues which both have the potential to divide and unite us."

Professor Henaghan says the project team is hugely indebted to the New Zealand Law Foundation for enabling this research to be carried out.

"One of the strengths of the Human Genome Research Project is that it is independent of Government or any particular interested professional body."

Law Foundation Director Lynda Hagen says they are proud of what has been achieved.

"The Law Foundation-sponsored Project's strength is its multidisciplinary approach, combining legal, scientific, medical, ethical, cultural, and philosophical perspectives. This research will give the people of New Zealand the ability to appreciate and discuss ethical choices and will help inform policy makers in developing appropriate policy and regulatory framework.

"We recognised the need to take the initiative and explore significant areas where it appeared that the development of the law may well be lagging behind developments in biotechnological advancement."

Ms Hagen says the sponsorship of the Law Foundation has meant the HGRP has remained independent, lending significant weight to its findings and recommendations.

"It is pleasing to know that this valuable research will be able to continue with the establishment of the New Zealand Law Foundation Chair in Emerging Technologies and a new Centre for Law and Policy in Emerging Technologies within the Law Faculty at Otago."

The establishment of the new Chair has been boosted by a $1.5m endowment from the Law Foundation, as well as $500,000 from the University of Otago's Leading Thinkers initiative with the Government.

The new centre will focus on projects relating to legal issues, regulations and policies affected by the increasingly rapid rate of technological advancements.

The third and final volume of Genes, Society and the Future will be launched by the Hon Simon Power, Minister of Justice and Minister Responsible for the Law Commission, at a parliamentary function on Wednesday 4 March. The Project will hold an evening of public talks in Auckland, at the Lewis Lecture Theatre, Faculty of Medical and Health Sciences, from 5.15pm to 7.15pm on Friday 6 March.

For further information, contact

Prof Mark Henaghan
Principal Investigator
Dean of the University of Otago Law Faculty
Tel 64 3 479 8856

Richman Wee
Project Manager
Law Foundation-sponsored Human Genome Research Project
Tel 64 3 479 5324

Brad Tattersfield
Communications Advisor
NZ Law Foundation

A brief summary of Vol III main findings:

Using PGD for low penetrance, late onset conditions

The use of PGD for low penetrance (having only a low chance of occurring) and late onset (occurring in later life) conditions is recommended in this report. They include hereditary breast, ovarian or bowel cancer and neurodegenerative disorders such as Alzheimer's Disease.

PGD is already seen as an ethically and legally sound option in screening for diseases that manifest at birth or early childhood or for late onset diseases, such as Huntington's Disease, that the person will inevitably succumb to.

The report concludes that even though PGD uses for low penetrance and late onset conditions were not contemplated when the Human Assisted Reproductive Technology (HART) Act was passed, the current guidelines written by the Advisory Group on Assisted Reproductive Technology (ACART) which use the term 'serious impairment' are wide enough to include low penetrance and late onset conditions.

Using PGD for exclusion testing

PGD offers the ability to test and exclude embryos which may be at risk of Huntington's Disease.

Professor Henaghan says normal genetic testing approaches would also reveal the prospective parent's susceptibility to developing the disease when it is something they don't want to know.

"If one of your grandparents had Huntington's Disease, you've probably got a one in two chance of developing it. Many would prefer to leave it at that because knowing for sure that they are going to develop what is an awful, debilitating disease would be too much for them to bear," he says.

"Exclusion testing means they can avoid exposing their prospective child to the disease without learning what their own future holds."

The report recommends that this procedure should be allowed in New Zealand.

Using patents to charge for genetic knowledge

In New Zealand, an Australian biotechnology company called GTG (Genetic Technologies Ltd) enforced its patents against research and clinical genetic testing services. After protracted negotiation and mediation, GTG settled the case.

Research carried out by the Law Foundation-sponsored Project has found existing patents on genes and experimental techniques are not preventing New Zealand researchers and genetic services from accessing what they need to do. But the project recommends that legislative changes would provide a welcome safety net.

Professor Henaghan says there is always a danger that patents over genetic knowledge, be it tests or experimental technology, could make it too expensive for New Zealand researchers to use or adapt.

"Fortunately overseas patent holders are not insisting on high premiums for patented techniques and knowledge but I think we still need to provide some sort of protection for local researchers.

"One option would be to have a research exemption in the Patents Act so researchers can use the knowledge from overseas research to develop tools here."

Genetic studies of whole communities for genetic knowledge necessary to make major breakthroughs into diseases such as cancer, heart disease and kidney failure

Important discoveries have been made using genetic material from individual communities and Iwi.

The Rakaipaaka Health and Ancestry Study (RHAS), a longitudinal population genetics study led by Te Iwi o Rakaipaaka (TIORI) in collaboration with the Environmental Science Research Institute (ESR), is examined as a case study. Internationally, this is a unique study where 3,000 people have agreed to submit their genetic material to determine the relationship between genes and environmental factors that lead to health problems.

The report provides a model for how such studies can be conducted in partnership with indigenous communities that include negotiating with Iwi about control over any intellectual property benefits that may accrue and control over how results are disseminated.

Accessing stored human tissue samples for genetic research

Headlines in 2006, claiming a "Warrior Gene" had been identified, highlighted issues about the use of genetic material without permission, particularly where it led to an ethnic group ended up being stigmatised.

Hospitals, labs, universities, DNA banks, private researchers and fertility clinics all have archived tissue collections which are a potentially valuable resource for research.

Rather than prohibiting their use, the report recommends imposing tighter controls over what research is conducted and greater obligations on researchers to explain findings in a way that is not likely to be misinterpreted by both the media and public.

Registration and licensing of collections is recommended as a way of imposing stricter control and regulation.

Scientific responsibility for genetic discovery

Without the splitting of the atom, the nuclear bomb would not have been created. But that raises questions around whether scientists can claim their job is to focus on the science, leaving it for society to determine how it is to be used.

The report recommends that scientists do have a wider scientific responsibility and puts forward a model that highlights researchers' obligations to consider the effects of their actions on others, both harmful and beneficial.

Internal obligations include truthfulness and carefulness, particularly in interpreting and reporting results, and in showing respect for research subjects. External obligations relate to the effect of scientific knowledge when put in the public domain or applied in society as technology.

Among its recommendations the report says researchers should avoid actions that are harmful and promote those that are beneficial.

Using genetic knowledge for insurance purposes

If insurance companies have knowledge of our genetic makeup, would that mean that some of us become uninsurable?

At present the practice is that if individuals have had a genetic test they are required to hand over the results of that test for insurance purposes.

This report looks at whether genetic information is different from other health information and whether it creates higher risks for both consumers of insurance and insurance companies.

The report recommends the creation of an independent, non-statutory body, the focus of which would be on protecting consumers. Its role would be three-fold: to establish criteria to assess the suitability of particular tests, to evaluate tests and make recommendations, and to monitor and assess the use of genetic tests by the insurance industry.

It also recommends an insurer should be required to disclose the reasons for a non-standard underwriting decision.

Using genetic knowledge to personalise medicine

Pharmacogenetics offers the hope of tailoring drugs to meet an individual's genetic make-up.

Professor Henaghan says while the concept sounds exciting it is still a long way off and the hype may be outpacing the evidence.

"Yes it does open the way to safer and more effective use of medicines through more effective prescribing and avoiding situations where an individual's genetic make-up could render a given dose ineffective or even toxic.

"It is important to also be aware of downsides, such as a situation where drug companies are happy to tailor drugs for more common genetic conditions, leaving smaller groups on the periphery because the economics of producing drugs for them don't add up."

The report identifies several issues to be addressed including establishing an approval process for validating new genetic tests before they are introduced and a need for greater medical education so that doctors become more familiar with interpreting pharmacogenetic tests, discussing them with patients and prescribing accordingly.

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