Thursday, August 31, 2006
On September 1, controversial new organ donor laws, changes to the Human Tissue Act, come in to effect. The radical changes now mean relatives of organ donor card carriers will no longer be able to overturn their wishes. Under the current system 1 in 10 of all possible organ donations are stopped by the families of the deceased.
The new act (proposed in 2004) replaces the original Human Tissue Act 1961 and the Anatomy Act 1984.
Chris Rudge (MD of UK transplant) said, “Many more people could receive a life-saving transplant with the donors’ wishes being given priority.” He indicated that the new legislation could mean 400 extra donors a year translating to 1,200 more transplant operations (an average of 3 organs are used per donor).
The changes, which apply to England, Wales and Northern Ireland, are the result of a series of recent scandals. The Isaacs Report, published 2003, was held after Elaine Issacs discovered (in 2000) her husbands brain was passed on to Manchester University for research after his post-mortem, the report concluded that ethical considerations had been sidelined and that the Human Tissues Act (in its then form) was not followed. A further scandal involved Alder Hey hospital, where it was discovered that children’s organs were removed without permission over a period of 7 years.
The new laws extend beyond Organ donation also covering things like DNA theft (a new offence involving the taking and testing of genetic material without consent) or the illegal storage of human tissue (with the penalty of up to 3 years in jail).
The act will modify the operation of the Human Tissue Authority (HTA); a relatively new body which will regulate these new laws as well as issuing licenses to organisations and facilities who perform post-mortems or who test, store or display human materials. The HTA said they expected to hand out around 500 licenses. Licensing is required from the start of the act (September 1) although storage of human tissue for therapeutic use will not be licensed till April 2007.
The new laws mean consent must be given for any kind of storage or research to be carried out. Adrian McNeil (Chief executive) said, “Consent is the underlying principle on which this act is based. This is an important milestone for the HTA, and for patients, the families and professionals.”
Other organisations welcomed the act, Professor Alex Markham of Cancer Research UK said that “Cancer Research UK is hopeful that this new regulatory framework will give researchers the support they need to carry out their work.”
However some have criticised the changes, saying they are worried that researchers will not be able to cope with the additional administration and that tissue would be even harder to obtain for research.