Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 12

Submission from Pfizer Ltd

  The information in this response has been collated following discussions with a range of key colleagues at Pfizer's Global Research and Development (PGRD) facility in Sandwich, Kent. The information provided focuses primarily on issues relating to the relatively limited use of ACDP group 3 pathogens, and of schedule 5 toxins, the biosecurity arrangements for which are anticipated to be of most interest to your study.

  Pfizer is the world's leading pharmaceutical company and the world's largest investor in R&D, and our Sandwich site is a key part of our company's efforts to discover and develop new medicines. Excellent scientists and world class facilities to support biochemical and clinical research are critical to our organisation, and we take very seriously our responsibilities to operate safely and securely. Sandwich has an enviable record of productivity and a long history of generating important new treatments for a range of conditions from cardiovascular to infectious disease. The most recent medicine to be discovered and developed at Sandwich is maraviroc—the first in a new class of therapies for HIV.

  To summarise our response, PGRD biology facilities and operations are designed and operated with biosecurity as a key factor alongside traditional Environmental Health and Safety (EHS) considerations. We operate to very high standards. Arrangements on site and the commitment of our staff have ensured that no ACDP group 3 pathogens or any schedule 5 toxins[10] have ever been misplaced or lost at Sandwich. Physical and procedural controls, risk assessments, staff training and awareness—together with physical inspections and active follow up—are all in place to ensure that activities relating to biosecurity are rigorously controlled and any risks minimised.

The current capacity for research on dangerous pathogenic material in the UK and the capability to conduct research on the causative agents of disease that may emerge at a future time

Reference the use of ACDP Group 3 pathogens

  Within the Pfizer Ltd UK Research and Development Laboratories based in Sandwich, Kent there are two facilities which routinely operate at Containment Level 3 (CL3).

  Both facilities operate at small volume, "research" scale only. Thus at any one time the maximum quantity by volume will be approx. 40 litres.

  The larger of the 2 CL3 facilities has four laboratories housing four class 1/3 (hybrid) microbiological safety cabinets (MSC). All are routinely operated as class 1. A robotic facility for high throughput screening is also operated, under containment conditions, within this facility.

  The second CL3 facility comprises two laboratories each with two class 1 MSCs, four in total. The group 3 pathogens handled to date have been HIV and Hepatitis-C virus. Approximately 75% in practice being HIV.

  An in-vivo CL3 unit has been designed and constructed within our Comparative Medicine Department. Tested at commissioning (yr 2000) to ensure it meets the standards required for CL3 animal research the unit has in practice only been used for level 2 work. There currently no plans to conduce CL3 animal research in the unit.

  We make limited use (by quantity) of Schedule 5 toxins. Our total stored quantity is typically 5—10mgs of these materials. We are therefore registered with and regularly inspected by the Home Office. We have two storage locations (-20 deg. c and +4deg. c). Security of these toxins is maintained by procedural and physical containment measures in accordance with Home Office requirements. There are currently no plans to significantly increase our usage.

The state of biological containment facilities in the UK

  Our CL3 facilities are designed, built and operated to very high standards. Our facilities are highly technically engineered, and maintaining them to such high standards requires a significant commitment in terms of time, money and expertise.

Laboratory inspection regimes and the rationale and practicalities of the licensing system

Internal Inspections

   Local inspections are performed by trained users on a monthly basis and are made and recorded by reference to agreed checklists. Management led inspections are performed on a six monthly basis. EHS Audits are undertaken periodically by the EHS Department. In all cases actions are derived to address any issues raised during the inspections and tracked to completion.

  Inspections consider physical conditions; procedural compliance and staff knowledge.

External Inspections

  In 2007 a Health and Safety Executive Specialist Biosafety inspection team undertook an inspection of our biologics areas (CL2, CL3 and Genetic Modification activities). The inspectors were clearly knowledgeable their interactions with our scientists and EHS professionals were constructive.

  In recent years we have had annual inspections by the Home Office with regard to the security of Schedule 5 toxins. In all cases we have met and in some areas exceeded the expectations as well as the requirements.

  During 2007 Pfizer's Global EHS Audit Team and an external/independent EHS Management Systems audit team have also audited our Biosafety programmes.

  In our experience the licensing of our facilities and, where appropriate, of the activities undertaken therein have been conducted professionally and in a constructive manner. The Home Office inspections in relation to our Schedule 5 toxins are not in themselves problematic. However, as a general observation the frequency and time taken over these inspections (our time and that of the inspectors) is arguably disproportionate to the risk posed by our very limited use. We have notified the Home Office on the basis that we exceed the 5mg maximum quantity that we could hold without notifying. In practice we hold approx 5-10 mg. This has prompted annual inspections for the last three years. Our security standards are very high when considered from the perspective of general security (the Sandwich site—like all major pharmaceutical research centres—is a highly secure location) and also when reviewed specifically by reference to security of any toxins.

  In order to maximise the overall benefit of these inspections, further consideration of details relating to the actual quantity of toxin(s) held/used and past inspection reports for a notified location should be taken account of when scheduling future inspections.

Biosafety training provision for staff working in containment facilities

  Research biologists are trained internally on the EHS aspects of their jobs. Some of this training is "generic" whilst some focuses specifically on a given activity. Staff who are not scientists but whose job requires that they access biology laboratories (eg cleaners, engineers) also receive awareness training focussed on their EHS considerations whilst they undertake their activities. Engineers, cleaners etc. do not have access to CL3 units except during routine closures (post fumigation) or in exceptional circumstances based on a specific risk assessment and under close supervision.

  For staff working in our CL3 facilities a purpose written Code of Practice (COP) is maintained. Familiarisation with the COP is a core part of the training for all colleagues who work in the CL3 facilities. The COP also details specific training requirements for all CL3 users. The training requirements include practical supervisory oversight and are only signed off by a supervisor once appropriate experience is gained and skills demonstrated.

  Colleagues who handle Schedule 5 toxins are experienced biologists with the general training referred to above. They are additionally trained in the exacting security arrangements in place for the storage and use of Schedule 5 toxins and in the risk assessments that are maintained for their tasks.

The maintenance and recording practices surrounding the storage and transportation of dangerous pathogens

  Pfizer has an in-house Dangerous Goods Safety Adviser (DGSA) at Sandwich and make use of this expertise to ensure that we import, export, package and generally transport biologics in accordance with regulatory requirements both with regards to the sender and recipient locations.

Measures implemented when pathogenic material cannot be accounted for

  We have not encountered this problem with either CL3 or Schedule 5 toxins. However, internal investigation processes are in place and would be actioned in the event that any pathogenic material could not be accounted for. These processes are designed to identify both direct and indirect causes of any incidents that result in unaccounted material.

The role of universities in overseeing security clearance for research students working with dangerous pathogens.

  Security clearances are included in our own screening programmes and thus we do not rely on University or Contractor screening programmes.

January 2008

10   Anti-Terrorism, Crime and Security Act 2001. Back

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