Genomics Gateway Net Logo
This website is designed to guide users through the area of international treaties, conventions, standards and guidelines applicable to biotechnology.
Genomics Gateway Home Page

 


Biotechnology Issues in the News

 


Genetic Screening

National GM Debate

US-EU GM Trade Dispute

The Human Genome

Human Cloning

Ricin

 


Genetic Screening and Pre-implantation Genetic Diagnosis

New genetic technologies enable the screening of embryos for certain genetic traits, including freedom from a particular disease and compatibility as a stem cell donor. Rapidly expanding knowledge of the human genome will extend the range of traits that can be screened for. Screening for disease of embryos already in the womb has taken place for a number of years now, through procedures such as amniocentesis and for diseases like Down Syndrome. This has not been without controversy particularly since the tests themselves are invasive and carry risks; they can only indicate likelihood of a disease and not severity; and presently the only alternative available is termination of the pregnancy and not treatment.

Stories of genetic screening which have recently been in the media under headlines about 'designer babies' and 'saviour siblings' involve a different type of screening; a procedure known as pre-implantation genetic diagnosis (PGD). Here sperm and eggs are collected from the parents and fertilisation takes place in vitro. After a few days a cell is removed from each resulting embryo and that cell is tested for the presence of the desired/undesired trait. Some of the embryos with the desired or without the undesired trait (up to three at one time) are implanted into the mother's womb, the others are stored or rejected. This element of selection and rejection is the basis of some of the opposition to this technique, from those who believe that life begins at conception and/or that selection on 'desirable' traits may lead down a slippery slope into eugenic practices.

Two particular stories involving PGD have recently been in the UK media: that of the Hashmi family and that of the Whitaker family. The Hashmis were permitted to undertake the procedure in the UK by the Human and Fertilisation and Embryo Authority (HFEA) to not only provide a donor match for their son (suffering from beta-thalassaemia, a hereditary blood disorder) but also to ensure the new child would be free of the disease. The Whitakers were refused permission in the UK and had to go to the United States for part of the procedure. The HFEA said that the refusal was on the basis that the disease in this case (Diamond Blackfan anaemia) is not hereditary and so the new child would not benefit from the procedure, only the sibling. The HFEA had since decided that PGD should be allowed in such cases and has broadened the range of diseases for which PGD may be used.

The technique is controversial because while it has the potential to save lives it can also be viewed as destroying them (in the form of the rejected embryos) and as a form of genetic selection. There is concern over the psychological impact on the child who has been born to save a sibling, particularly if the genetic match should be unsuccessful. There is also concern because the same technique could also be used to select embryos for a number of other genetic traits some of which have nothing to do with avoiding life-threatening diseases or saving the lives of others. The British Human Genetics Commission in its first annual report recommended that, "…PGD should be limited to specific and serious conditions…", while admitting that, "It has proved impossible to define what 'serious' should mean in this context." (http://www.hgc.gov.uk/business_publications_annualreport_first.pdf).

There is as yet no international regulation specifically governing genetic screening and PGD however it may be useful to look at UNESCO's Declaration on the Human Genome and Human Rights particularly Article 5 which includes in point e) the statement that:

"If according to the law a person does not have the capacity to consent, research affecting his or her genome may only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law. Research which does not have an expected direct health benefit may only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and if the research is intended to contribute to the health benefit of other persons in the same age category or with the same genetic condition, subject to the conditions prescribed by law, and provided such research is compatible with the protection of the individual's human rights." (http://unesdoc.unesco.org/images/0012/001229/122990eo.pdf).

Genetic screening in the news:

(External) "Fighting disease at source" , The Guardian, Online Version, 02/11/04.

"Designer baby rules are relaxed" , BBC News Online, 21/07/04.

(External) "Banned 'designer baby' is born in UK" , Shaoni Bhattacahrya, NewScientist.com News Service , 19/06/03.

(External) "HFEA to allow tissue typing in conjunction with pre-implantation genetic diagnosis" , Human Fertilisation and Embryo Authority, Press Releases, 13/12/01.

Further Resources:

(External) Human Fertilisation and Embryology Authority

(External) Human Genetics Commission

(External) "Preimplantation Genetic Diagnosis (PGD) - Guiding Principles for Commissioners of NHS services" , Department of Health, 03/10/02.

(External) "Debating the Ethical Future of Human Genetics, The First Annual Report of the Human Genetics Commission" , 2001.

(External) Universal Declaration on the Human Genome and Human Rights ,UNESCO, 1997.

top of page

Originally published June 2003, last updated June 2006

 


UK National GM Debate

The UK Government ran a national debate on genetically modified foods during 2003, prior to making a decision on the commercial introduction of genetically modified crops. Genetically modified crops have not yet been commercially grown in the UK but field trials (open air) have been conducted over the past few years. At the launch meetings of the GM Debate (which took place in six locations) many participants expressed doubts about whether the process and their views would have any impact on government policy. However, the government has insisted that it does want to listen to the public's views.

The GM Debate had three strands: an economic review, a scientific review and a public debate. Reports have now been published for each of the three strands. The results of the farm-scale field trials have also been published. These can be accessed through the following links:

(External) The economic review: Field Work: weighing up the costs and benefits of GM Crops , July 2003, Strategy Unit
(External) The science review: GM Science Review: First Report , 20th July 2003, GM Science Review Panel
(External) The public debate: The Findings of the Public Debate - Executive Summary , September 2003, Steering Board of the Public Debate on GM
(External) Crops and Farm Scale Evaluations , Department of the Environment, Food and Rural Affairs

The 1998 Aarhus Convention on Access to Information, Public Participation and Access to Justice in Environmental Matters, specifically outlines the rights of the public to participate in decision-making about the deliberate release of genetically modified organisms, and the state parties to the Convention at their first meeting in 2002 adopted guidelines specifically related to public participation in this area. The UK is a signatory to the Convention but has not yet ratified it.

The UK Government was expected to announce its approval of the commercial release of a genetically modified maize (T25/Chardon LL) in Spring 2004. It now appears that this decision will be delayed for a further year, possibly pending further public consultation. A Genetically Modified Organisms Bill was to receive its second reading in parliament on the 26th March 2004, but debate on the Bill was blocked by some MPs.

The GM debate in the news:

(External) "Government Ministers Kill GM Debate" , Press Release from the office of Gregory Barker, MP, 26/03/04.
"GM tests show wildlife dangers" , BBC News Online, 16/10/03
(External) "GM crops to get go-ahead - Leaked papers reveal decision" , Paul Brown, The Guardian , Online Edition, 18/02/04.
(External) "GM crops delayed at least a year after cabinet leak" , Paul Brown, The Guardian , Online Edition, 26/02/04.

Further resources:

the Aarhus Convention

(External) the National GM Debate Website

(External) Genewatch UK, GM Public Debate Briefings

(External) Genetically Modified Organisms (Contamination and Liability) Bill

top of page

Originally published June 2003, last updated June 2006.

 


United States - European Union GM Trade Dispute

The United States (US), Canada and Argentina brought a case against the European Union (EU) to the World Trade Organisation (WTO) in 2003 claiming that EU actions on the import and marketing of genetically modified (GM) products are discriminatory and unfair, costing their farmers millions of dollars each year and contrary to the rules of free trade. The US also claims that the EU's policy is damaging to farmers in developing countries.

The EU has approved more than 30 GM products for marketing, however, there was a de facto moratorium in place between 1999 and 2004, based on concerns about the safety of such products for the environment and human and animal health. The moratorium ended when new EU legislation was enacted to deal with these issues. The current legislation is intended to ensure that GM products are assessed in terms of safety before release, and monitored afterwards. The legislation has provisions on labelling and traceability of GM products to assist the monitoring process and to allow consumers to make informed choices.

Many EU consumers either don't want to eat GM food at all or want a clear choice through labelling, and are thought unlikely to accept the products even if the US forces them through, and probably even less so because of that action. It is probably true that farmers in developing countries are eager for a decision to be made in this area, so that they can decide on their own policies on growing and marketing GM products and that a delay on this decision is damaging, however it is unclear that a final decision either way would carry any particular benefits for them.

International trade rules like the Technical Barriers to Trade Agreement of the WTO would seem to support the US case, allowing discrimination only on the basis of scientific certainty of harm. Other international agreements take a different approach to genetic modification issues, the Cartagena Protocol on Biosafety allows countries to refuse to import genetically modified organisms where there are legitimate safety concerns even where there is a lack of scientific evidence (a use of the precautionary principle). Guidelines for food safety assessments of foods derived from genetically modified plants or produced from genetically modified microorganisms have been produced by the Codex Alimentarius Commission (an international food safety organisation) and these recommend rigorous assessment of the effects on human health of certain genetically modified foods. The European Commission is also a signatory of the UNECE Aarhus Convention and this obliges states to take account of public views on the release of genetically modified organisms into the environment.

The WTO's Dispute Settlement Panel for the case issued a preliminary report on 7th February 2006 (not available to the public), a final report will be published later in the year. Although the report is not publicly available, reports in the press appear to indicate that the Panel ruled in favour of the complainants.

US-EU trade dispute in the news:

(External) "Supermarkets tell Blair: we won't stock GM" , Mark Townshend, The Observer , Online Edition, 08/06/03.

(External) "Bush attack on Europe's GM barrier" , Suzanne Goldberg, The Guardian , Online Edition, 24/06/03.

"US launches GM trade war" , Steve Schifferes, BBC News Online , 13/05/03.

Responses to the preliminary report:

(External) "Europe's rules on GMOs and the WTO" , European Commission press release, 07/02/06.

(External) "The WTO GMO dispute: the interim report of the dispute panel" , GeneWatch UK, 31/03/06.

(External) "GM food must be allowed into Europe, WTO rules" , Stephen Castle, The Independent , Online Edition, 08/02/06.

Further resources:

(External) European Union Fact Sheet, Biotech - Genetically Modified Organisms , published on the occasion of the EU-US summit, 25/06/03.

(External) European Regulation (EC) No. 1829/2003 on Genetically Modified Food and Feed

(External) Genewatch UK, The US challenge on GM foods at the World Trade Organisation (WTO)

Q&A: Trade battle over GM food , BBC News Online , 07/02/06.

Official information about the dispute can be found through the WTO's website at (External) http://www.wto.org/english/tratop_e/dispu_e/dispu_status_e.htm . The dispute was initiated in 2003 and is listed under numbers DS291, 292 and 293. Information on disputes can now also be searched by subject area at (External) http://www.wto.org/english/tratop_e/dispu_e/dispu_subjects_index_e.htm . The subject of this dispute is listed as 'GMOs - biotech products'.

top of page

Originally published June 2003, last updated June 2006

 


The Human Genome

Genome is the collective name given to all the genes in the DNA of a particular lifeform; its entire genetic code. Work began on sequencing the human genome in 1990 (that is working out the entire sequence of the DNA bases adenine (A), cytosine (C), guanine (G) and thymine (T)). Work on sequencing the human genome has been done by an international, public project - the Human Genome Project and also by a private company, Celera. Both groups published rough drafts in February 2001. The completion of the final draft of the human genome was announced in April 2003.

(External) The Human Genome Project Website

The Human Genome in the News

(External) "Final Human Genome Sequence Released" , Andy Coghlan, New Scientist.com News Service , 14/04/03 .

(External) "The Finished Human Genome - Wellcome to the Genomic Age" , Sanger Institute Press Releases, 14/04/03.

(External) "Human Code Finally Cracked" , Tim Radford, The Guardian , Online Edition, 14/04/03.

Further Resources

The Genome News Network's (External) List of Sequenced Genomes .

top of page

Originally published April 2003, last updated June 2006.

 


Human Cloning

There are two main types of cloning that could, potentially, be applied to humans. The more well known and controversial of the two is reproductive cloning. Reproductive human cloning would aim to create a new human being with identical genes to an existing human donor. There are considerable doubts at present about both the technical feasibility and the safety of reproductive human cloning, which also raises many ethical issues. Human cloning has been back in the news again recently due to the claims of a private company, Clonaid, that at least two babies, produced through cloning techniques, have been born. These claims have yet to be independently verified, and many experts belief them to be false.

The second type of human cloning (referred to as therapeutic cloning) does not aim to produce new human beings but instead small clusters of embryonic stem cells for use in medical research. While this type of human cloning is viewed by some as less problematic technically and ethically, others believe that it should be prohibited. A South Korean team annouced that it had produced 30 cloned human embryos for therapeutic research purposes in February 2004, and in August 2004 the first UK licence was issued for such cloning.

The United Nations began work on creating a prohibition on human cloning in 2001. Difficulties in reconciling the positions of two groups of states - one which wants to see all human cloning (including therapeutic) banned, and the other that wants to ban only reproductive human cloning - have meant that the intended legally-binding prohibition on reproductive human cloning has not been achieved. Instead a political declaration was adopted by the UN General Assembly in March 2005.

Human Cloning in the News

"UK scientists clone human embryo" , BBC News Online , 20/05/05.

(External) "UN abandons legal ban on human cloning" , Celeste Biever, NewScientist.com News Service , 09/03/05.

(External) "Britain to defy UN vote on cloning" , Ian Sample, The Guardian , Online Edition, 09/03/05.

(External) "HFEA grants the first therapeutic cloning licence for research" , Press Release issued by the Human Fertilisation and Embryology Authority, 11/08/04.

(External) "First cloned baby 'born on 26th December'" , Emma Young, NewScientist.com News Service , 27/12/02.

(External) "Fertility experts pour scorn on cloned baby claims" , Robin McKie, and (External) "All about Eve, Human cloning must be controlled" , Leader, The Observer , Online Edition, 29/12/02.

"Q & A: Therapeutic Cloning" , BBC News Online , 08/02/05.

(External) "Therapeutic versus reproductive cloning" Robin Mckie, The Observer , Online Edition, 20/03/05.

Further Resources

For information on the UN Convention see the website of the (External) Ad Hoc Committee on an International Convention against the Reproductive Cloning of Human Beings

top of page

Originally published January 2003, last updated August 2005.

 


Ricin

Ricin is a toxic chemical derived from the beans of the castor oil plant. Ricin has been in the news recently following the discovery of traces of the chemical, and the means for its production, in a London flat. Ricin can be fatal to humans in very small amounts when inhaled or ingested. It is relatively easy to produce small amounts of ricin with little specialist knowledge or equipment. It would be difficult, however, to use ricin as a weapon of mass destruction, because such large amounts of the poison would be needed.

The production, stockpiling and use of ricin is prohibited under the Chemical Weapons Convention, where it is listed in Schedule 1 of Annex I. As a plant toxin, ricin is similarly prohibted by the Biological and Toxin Weapons Convention . Both these conventions apply to the activities of states. The Harvard Sussex Program's Draft Convention on the Criminalisation of Chemical and Biological Weapons would also cover the actions of individuals and sub-state groups.

Ricin in the News

(External) "Police search for missing terror toxin", Damian Carrington, NewScientist.com News Service , 08/01/03.

(External) "Poison find sparks terror alert" , Nick Hopkins and Tania Branigan, and (External) "Terror weapon from a humble bean" , Tim Radford, The Guardian, Online Edition, 08/01/03.

"Terror police find deadly poison", BBC News Online , 07/01/03.

top of page

Originally published January 2003, last updated January 2005


 

Page last updated 26th June 2006.

Comments/enquiries to catherine.rhodes-2 'at' manchester.ac.uk

Change Text Only Settings

Graphic version of this page