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BPI seeks strategic input into research approvals

BPI seeks more strategic input arising from fate of transgenic sheep

A failure to consider the strategic value of an approval to create a flock of transgenic sheep in New Zealand means that our scientists are on the verge of losing a significant scientific resource the Chairman of the BioScience Policy Institute, Rt Hon Jim Bolger said today.

"PPL Therapeutics received approval from ERMA in 1998 to breed a flock of up to 5000 transgenic sheep in secure containment which had been modified to express the recombinant version of the alpha 1 antitrypsin protein in their milk. This protein was to be used to produce medications for a number of conditions with a genetic origin, including cystic fibrosis, chronic pulmonary obstructive disease and congenital deficiency.

"Late last year Bayer Biological Products, for whom the project was being carried out, made a strategic decision to terminate the New Zealand project which resulted in the financial collapse of PPL, the parent company of the New Zealand operation.

"At the time over 3500 transgenic sheep had been bred. Most of those sheep have now been put down and only a small number of two-tooth ewes and lambs remain at the present time.
"The original ERMA approval for the establishment of the transgenic flock required that, if the project was terminated, all biological material should be incinerated.
(Ref ERMA GMF 98001 ".7. In the event that operations cease all sheep in the containment facilities shall be destroyed and all biological material derived from transgenic sheep be incinerated...")

"In hindsight, the problem with this decision is that it does not acknowledge the strategic value of having a multi-generation flock of sheep which has been genetically modified and which will therefore be able to provide valuable information on the impact of modification of large animals.

"The BioScience Policy Institute has carefully examined the issues in consultation with a range of interested scientists in New Zealand and overseas. Unfortunately the absence of a control group and lack of funding for retention of the sheep means there is no compelling reason not to let the remainder be disposed of."

"The BPI regrets the opportunities which have been lost through the decision by Bayer to terminate the research," says Trustee Dr Jim Watson. "The sheep flock was an opportunity to study, over a long term, the impacts of genetic transformation on large animals - and in particular an animal which has huge strategic importance for New Zealand.

"The course of events since Bayer announced it was withdrawing from the research highlights the need for the strategic opportunities which are presented by this sort of research to be considered when approvals are given and for strategic science policy considerations to be included in the controls on research.

"The original ERMA decision to approve imposed a requirement to destroy all biological matter at the end of the research project. A literal interpretation of this condition means that none of the tissues, embryos, semen or vital organs can be stored for further or related public good research purposes once the remaining sheep in the flock have been slaughtered. A wealth of potential knowledge is lost to us.

"This is short-sighted and we must make sure it never happens again in future. The BioScience Policy Institute will be entering into discussions with ERMA and other government agencies to ensure a more strategic approach to the science is taken in future."

From the BioScience Policy Institute Team
BioScience Policy Institute

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