Research Tissue Banking and the HTA 2004 Jacki Trafford Procurement Manager

The agenda What ATB does Research support The impact of the HTA 2004

What does Abcellute Tissue Bank do? Supply human tissue for biomedical research within ethical, transparent and legal framework. Offer another choice to donor families/patients. Validate research methods using human tissue Reduce, refine and replace use of animals.

Where does the tissue come from? Living donors: Donation of excess surgical tissues from patients undergoing surgery e.g. hepatic resection for tumour, gut tissue following resection for cancer. *No impact following HTA 2004. Deceased donors: Organs retrieved but found unsuitable e.g. kidneys, heart, pancreas. *We can no longer access tissues retrieved purely for research e.g. lungs, gut, bladder.

Human tissue in research. Prediction of drug absorption, distribution, metabolism and excretion - liver, lung, heart Toxicology - liver, heart, kidney, skin, lung Drug delivery - skin, gut, lung Novel drug development - all e.g. pancreata, blood vessels, skin, lung Diagnosis - liver, diseased tissue, tumours, heart Internal R&D - to maximise usefulness of tissues – e.g. Abcellute media

Human Tissue Act 2004 Limits retrieval of organs/tissue purely for research unless operating theatres are specifically licensed by extending existing Pathology licence with Human Tissue Authority. Satellite licence fees of £2k are enforced if operating theatres are not on same site as address on Pathology Licence – NHS Trusts will therefore NOT extend at distant hospital sites (many Trusts are made up of a number of individual hospitals e.g. Heart of England NHS Trust = Solihull Hospital, Heartlands Hospital and Good Hope Hospital = 3 addresses). Human Tissue Authority keep no central list of extended licences and do not acknowledge requests from hospitals to extend licence unless specifically requested to do so citing lack of resources. Affects NHS, academic and commercial researchers.

The impact of the HTA 2004 British pharma using tissue sources from outside UK

For a short time only, we are making thousands of specimens available at the special price of $250 per tissue specimen and $70 per 1 ml aliquot of serum and plasma. To qualify for this promotion your purchase order must be of $5,000 in value or more and be received in our offices on or by March 30, 2012. If you are interested in purchasing specimens with this special pricing, please let me know and I’ll be delighted to prepare a quotation for you.

British pharma moving outside the UK Research halted Tissue sourced from outside the UK £££ lost to the UK economy?

Conclusions Huge impact on retrieval of organs unsuitable for therapeutic use from deceased donors. Massive impact on commercial research in the UK, with knock on affect to NHS/Academic sectors. Incalculable impact on economy. Solutions difficult to find …… www.abcellutetissuebank.org jacki@abcellutetissuebank.org