Background As a provision of the UK Human Tissue Act 2004, a government-sponsored body, the Human Tissue Authority (HTA), was established to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes. These Scheduled Purposes included research, transplantation, and education and training. In order to establish a workable system of regulation, the rules that apply to the activities to be regulated had to be clear, but such clarity was not a feature of the Act itself. One of the first responsibilities of the HTA was therefore to draw up specific codes of practice covering the various aspects of the Scheduled Purposes. To date, six such codes have received Parliamentary approval and have been published, these deal with 1. consent, 2. donation of organs, tissue and cells for transplantation, 3. post mortem examination, 4. anatomical examination, 5. removal, storage and disposal, and 6. donation of allogeneic bone marrow and peripheral blood stem cells for transplantation. A seventh code, relating to import and export, is nearing completion. Codes of Practice During the drafting of the Act itself, it became apparent that the issues concerned were complex, and considerable consultation was required from a wide range of experts and other stakeholders, in order to ensure that as far as possible, the Act didn’t end up causing more problems than it solved. Pharmagene made a significant contribution to this stage primarily through the efforts of Dr Brian Clark, the company’s then VP of Ethics & Pathogenesis. A similar situation applied in the HTA’s drafting of the codes of practice, and the HTA actively sought to gain as wide a range of relevant perspectives as possible in drawing up the individual codes. They achieved this initially by recruiting representatives of the relevant stakeholder groups to join specific Working Parties. This was followed by the opening up of the draft versions of the various codes of practice to potential stakeholders generally through the HTA website, and inviting feedback. It was only following extensive input from the membership of those Working Parties, and subsequent public consultation that the final documents were submitted to Parliament for approval. At all stages, Pharmagene/Asterand contributed to this process both through the contributions of Dr Robert Coleman, Pharmagene’s co-founder and Chief Scientific Officer, and subsequently Consultant to Asterand, as a member of one of the working parties, and active attendee at various consultation meetings. The result is that at least for those scheduled uses most relevant to Asterand, ie Removal, storage and disposal, Consent, and Import & export, Asterand has made significant contributions in order to ensure that its views were heard and that as far as possible, the final codes of practice reflected what Asterand and other such companies involved in human tissue research consider practicable and sensible. Management through licensing But of course, the drawing up and acceptance of guidelines to govern what is appropriate, ethical and indeed legal counts for little if there is no means of review and enforcement. In order to provide this most important practical function, the HTA was empowered to institute a system of licensing for those involved. The first decision was of course to decide who and what should be licensed. Again, after extensive consultation, it was decided that licences should be required by all individuals or establishments storing donated human tissues for scheduled purposes, and furthermore, that the HTA should have the power and indeed the duty to inspect all licensed premises. Again, Asterand had a significant input into discussions leading up to the finalisation and parliamentary approval of the licensing scheme. The institution of the licensing scheme was managed in two phases; firstly by requiring the licensing of establishments storing tissues for human application, implemented in April 2006, and then following up with licensing of establishments removing and storing human tissues for other scheduled purposes, implemented in September 2006. Both licensing systems are now in place.
Influence of legislation on Asterand’s business Pharmagene/Asterand have always been advocates of official regulation of the acquisition, use, storage and disposal of donated human tissues, and the legislation and associated regulations put in place by the HTA represent a positive development as far as the company is concerned in the prosecution of its business. Prior to its merger with Asterand, and prior to the publication of the Human Tissue Act and the establishment of the HTA, Pharmagene had had nearly 10 years experience in the acquisition and use of donated human tissues for therapeutically-related research. In the light of this, the HTA was comfortable in drawing upon the company’s experience in the drafting of the codes of practice that relate to these aspects of human tissue work, such as consent and ethical approval. As a result, the direction of the legislation was very much in line with Asterand current practice, and none of the codes relevant to Asterand’s activities presented the company with any challenges that it did not already face. The issue of licensing was a separate question, there having previously been no such requirement to apply for permission to operate in this area of activity, or to formally present the company and its activities for approval by any regulatory authority. Despite this, this development has undoubtedly been positive, providing an official stamp of approval on what, prior to the publication of the Human Tissue Act, was seen as an area of activity for which there was little more than ethical guidance to rely upon, and with which some have thus felt a reluctance to involve themselves. The provision of a licence to a specific establishment to acquire and store human tissue for Scheduled Uses requires a specific structure within that establishment. At the centre of this structure is the Designated Individual (DI), that senior member of staff who takes primary responsibility for observance of the regulations relating to the running of the relevant human tissue related activities. Asterand’s appointed DI is Dr Tony Brown who, as VP Drug Discovery Services and General Manager (UK), with over 8 years service within the company and a long-term responsibility for all of the company’s UK human tissue-related activity, was the ideal appointee. Dr Brown’s first responsibility was to ensure that Asterand secured a licence to operate under the Human Tissue Act (2004), and this he successfully secured, ensuring that the introduction of mandatory licensing caused no disruption in the company’s ability to conduct its core business activities, and to continue as market leader in the human tissue services sector. Conclusion Pharmagene/Asterand’s decade-long experience in conducting service work on donated human tissue to the highest ethical standards, together with its successful application for a licence to operate under the Human Tissue Act, has left the company in the strongest position to continue as the world’s leading provider of human tissue services to the bio-pharmaceutical industry.