The facility at Peterborough has expanded within the NHS to reach a stage where now the only practical way forward is with private investment: as a public-private partnership. Medical Solutions plc is investing in infrastructure and capability to support Peterborough Hospitals with the intention of expanding tissue acquisition and increasing the range of biomaterials processing technology through a network supported by PathLore specialist surgical pathologists, who are based in NHS and University Departments.

Systems are in place to collect surgically resected tissue that is surplus to diagnostic requirements and cadaveric tissues obtained at post-mortem examination. All procedures are conducted by professional medical intermediaries who protect the rights of the donor.

The need for changes in the way in which patients are asked to give their consent to treatment, care or research was identified in the NHS Plan (2000) with the aim of ensuring that the process of obtaining consent is properly focused on the rights of individual patients and their relatives. The importance of patient-focused consent procedures also emerged as a key theme in Bristol Royal Infirmary Inquiry Report. Pathlore Ltd will make available suitable human biomaterials only with the express permission of the donor or the donor's next of kin through explicit informed consent.

Tissue acquisition procedures fulfil all legal requirements specifically in relation to the Nuffield Council on Bioethics, the UK Medical Research Council and, most recently, the Royal College of Pathologists in addition to the European Directive on protection of biotechnological inventions [2000]. There is as yet, no statute or case law in the UK relating to research tissue banks.

Tissue supply to research organisations is covered by a standard Biomaterials transfer Agreement. A separate tissue supply agreement is held between Pathlore and the NHS host Trust which amongst other things limits the liability of the Trust. The ethics around tissue acquisition and commercial use focus on adequate [preferred terminology] consent for which purpose trained research nurses are employed and consent forms have been written. Pathlore Ltd will record and divulge certain supporting information relevant to the supply of tissues. However, under no circumstance will the identity of the donor be made known to the receiving partner.

Safety issues related to handling of all human tissue are addressed by SOPs. Finance is administered by the host Trust monitored by NHS Internal Audit.

Following the enquiries into paediatric post mortems at Alder Hey Hospital, Liverpool and paediatric cardiac surgery at Bristol Royal Infirmary, the law on use of human tissue is under fundamental review by the Departments of health in England and Wales. Similar review is underway in Scotland. As well as a new legal framework, we also anticipate national ethical guidelines. In the meantime, PathLore is aware of and adheres to current English and European law as well as published ethical and good practice guidelines [such as the Nuffield Council on Bioethics, Medical Research Council, Royal College of Pathologists, Department of Health and Peterborough Hospitals Research Tissue Bank].

PathLore will only supply human biomaterials derived from tissue that is surplus to diagnostic and therapeutic requirements and through an official written agreement with a hospital through authorised persons. Such tissue will have been supplied with demographic and clinical data required by PathLore or clients but PathLore will not accept tissue if the accompanying information is able to identify an individual patient. Arrangements ensure that PathLore are satisfied that patients [and/or families as appropriate] have given consent to use of tissue in commercial research and that the patient and hospital authorities understand the tissue is given as a gift. This means that patient and hospital have no claim to subsequent intellectual property or profits that may result from work on unprocessed or processed tissue once it has passed to PathLore. PathLore recognises and respects that no intrinsic monetary value is attached to donated tissue. Collection of post mortem material must conform to modern day interpretation of the Human Tissue Act 1961 and legislation relating to the activity of HM Coroners.

In order to meet these requirements, tissue acquisition is monitored by the Ethical Committee of the parent company, Medical Solutions plc, which is chaired by non-executive director Professor Karol Sikora. PathLore agrees to pay cost of tissue collection at hospitals. For hospitals that already have a tissue acquisition facility, PathLore will follow the ethical guidelines of the hospital provide its own standards are met. For other hospital suppliers, the Medical Solutions Ethical Committee has produced a supply agreement to facilitate the process. The Ethical Committee monitors developments related to use of human tissue.

The use of biological samples (tissue, blood etc.) removed at examination or treatment and associated (de-identified) clinical/outcome information is covered by the following documents

• Reference Guide to consent for examination and treatment (March 2001) and 12 key points on consent: the law in England (March 2001) summarise the current law on consent to treatment and provides advice on consent to the service

• Health Service Circular 2001/023 (November 2001) focuses on the action necessary to ensure that the principles set out in the Reference Guide are reflected in day-to-day NHS practice by announcing the publication of the Good practice in consent implementation guide: consent to examination or treatment, containing new model consent forms and a new model consent policy.