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 maravirocthe first in a new class of therapies
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
have ever been misplaced or lost at Sandwich. Physical and procedural
controls, risk assessments, staff training and awarenesstogether
with physical inspections and active follow upare 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
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
We make limited use (by quantity) of Schedule
5 toxins. Our total stored quantity is typically 510mgs
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
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.
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 sitelike
all major pharmaceutical research centresis 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
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
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.
10 Anti-Terrorism, Crime and Security Act 2001. Back