Memorandum 5
Submission from Merial Animal Health
1. MERIAL ANIMAL
HEALTH
1.1 Merial is a global, innovation-driven
animal health company. It provides a comprehensive range of products
to enhance the health and well-being of a wide range of companion
and production animals. Merial researches, manufactures and markets
veterinary pharmaceuticals and vaccines; many of its products
are considered the gold standard in their categories. Jointly
owned by the two major human pharmaceutical companies, sanofi-aventis
and Merck, Merial is the largest animal health company solely
dedicated to veterinary products.
1.2 In the United Kingdom, Merial employs
some 200 people. Commercial activities are headquartered at Harlow,
Essex, which also has responsibility for business in the Republic
of Ireland.
1.3 For the past 15 years, Merial's Industrial
Operations function has operated a foot-and-mouth disease (FMD)
and, more recently, a bluetongue (BTV) vaccines centre at Pirbright,
Surrey. [The Pirbright site has been the centre of UK foot and
mouth disease vaccine production since 1963.] This is one of the
company's 15 manufacturing plants around the world. Pirbright
has two units producing active ingredients for FMD and bluetongue
virus vaccines and employs over 80 people.
1.4 Merial Pirbright has three main roles:
— the manufacture of FMD viral
vaccines for use in Europe, North Africa, Middle East, and Asia;
— the manufacture of viral antigens
of BTV which are made into finished vaccines at manufacturing
plants in Lyon; and
— running the world's largest
FMD (vaccine) antigen bank, which enables Merial to provide a
rapid and effective response when members of the bank (typically
international governments) request emergency vaccines against
FMD.
1.5 Throughout its tenure of the site, Merial
has rebuilt, extended and modernised the facilities it acquired.
The most recent major investment was £10 million in 2005
to add the second production unit, which supports the company's
commitment to BTV vaccine manufacture.
The following points are made in response to
the issues posed in the announcement of the Committee's inquiry:
2. 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
2.1 In the main, Merial Pirbright manufactures
FMD and BTV active ingredients (or antigens) for use in the production
of vaccines against these devastating animal diseases. In the
case of BTV, once the active ingredients are produced they are
sent to Merial's European headquarters in Lyon for the final stage
of the vaccine production process.
2.2 Whilst most of Merial's work at the
Pirbright site is predominantly focused on virus and vaccine production,
a small amount of research has been carried out. This work is
occasionally done to monitor and improve different aspects of
the manufacturing processes and is thus more in the nature of
development.
3. The state of biological containment facilities
in the UK
3.1 Merial meets, and in many areas, exceeds
the biosecurity requirements of the regulations and guidelines
that govern its activities. The manufacturing stages that involve
live virus are contained within closed steel vessels that are
themselves located within biosecure rooms protected by high efficiency
particulate air (HEPA) inlet and outlet filters, and pressures
negative to ambient. Access to these rooms is strictly controlled
and monitored. Apart from specially-packaged small samples of
virus sent to other approved laboratories from time to time, nothing
leaves this area without decontamination or treatment. Where small
amounts of virus need to be handled, eg for procedures such as
quality control (QC), this occurs within Class II safety cabinets
within the biosecure areas of virus production and QC.
3.2 A multi-layered approach is adopted
for the safe handling of live virus so that a single equipment
failure or other mishap does not lead to an environmental threat.
In addition, improvements are always sought. Despite Merial's
existing biosecurity arrangements satisfying all appropriate authorities,
we have recently installed facilities to heat treat waste that
might contain live virus as this method is considered by some
authorities to have advantages compared with chemical treatment
alone.
3.3 The two thorough investigations (carried
out by the Health and Safety Executive—HSE—and Professor
Brian Spratt) into the 2007 FMD outbreak recognised the importance
of Merial's biosecurity processes, which were not found to have
been breached. Merial viewed this as an endorsement of the high
standards it both aspires to and seeks to improve. [Section 6.3
of the Spratt report (Independent Review of the safety of UK facilities
handling foot-and-mouth disease virus, 31 August 2007) provides
an overview of biosecurity procedures at the Merial Centre.]
4. Laboratory inspection regimes and the
rationale and practicalities of the licensing system
4.1 Merial's activities are inspected routinely
by the Veterinary Medicines Directorate with regard to Good Manufacturing
Practice (GMP) and by Defra with regard to its Specified Animal
Pathogens (SAPO) licences for FMD and BTV. The HSE conducted an
exhaustive inspection in connection with the 2007 FMD outbreak.
From time to time, the regulatory authorities of governments for
whom Merial maintains antigen banks also inspect the manufacturing
facilities. Merial therefore works hard to ensure that it meets
not only all UK regulatory requirements, but also those of a number
of governments around the world.
4.2 Regulation is the life blood of the
veterinary health business; Merial welcomes the reassurance and
opportunity for improvement that the UK inspection regime offers.
5. Biosafety training provision for staff
working in containment facilities
5.1 The training Merial provides employees
is driven by the joint needs of biosafety, GMP and general HSE
guidelines/requirements. Standard Operating Procedures (SOPs)
are the bedrock of how antigen and vaccine manufacturing activities
at the site are conducted. Before staff begin working with pathogenic
materials it is necessary for them to complete a personalised
induction and training process which involves:
(a) Formal induction on all biosecurity and
HSE requirements for both the Merial site and any areas of the
Institute for Animal Health site that may be applicable,
(b) Formal briefing by the onsite HSE officer,
and
(c) A declaration must be signed to confirm
all staff have understood and agree to comply with all regulations.
5.2 Following this introductory training,
employees receive bespoke training required for their specific
function or departmental responsibility. This process is under
the responsibility of the departmental supervisor, and operatives
do not work independently until all levels of competence required
have been demonstrated. Depending on the technical aspect of their
work this process can take anywhere between three and nine months.
5.3 While all this is suitable for day-to-day
needs, Merial also seeks to broaden the experience and knowledge
of its employees in more specialist areas by the use of ad hoc
training sessions. A range of training courses has been organised
in recent years including use of fire extinguishers, manual handling,
principles of liquid filtration, principles of sterilisation,
air filter testing, basic microbiology, and process valve maintenance.
Some of these courses have been organised by companies that provide
equipment used at the site.
5.4 Merial is proud of its culture of continuous
improvement and is investigating with a local college the provision
of additional, non-vocational qualifications in management techniques
and risk assessment, to further add to its staff training. Merial
would welcome the availability of some form of tertiary education
that would further help staff put their activities into the wider
microbiological context with regard to the exotic pathogens handled.
6. The maintenance and recording practices
surrounding the storage and transportation of dangerous pathogens
6.1 Maintenance and record keeping with
regard to FMD and BTV vaccines/virus are covered by the regulations
relevant to Merial's vaccine manufacturing activities. These are:
the Specified Animal Pathogens Order 1998 (Defra Containment Level
4) and the Veterinary Medicines Regulations 2006. Records are
under the final responsibility of the Quality Operation function,
the head of which is the Site Biosafety Officer. Access to records
is limited by a range of controls, partly physical (eg swipe card
access to restricted areas) and partly operational (eg SOPs and
record sheets monitored and checked by Quality Operations, key
documents protected by passwords and access rights to PCs).
7. Measures implemented when pathogenic material
cannot be accounted for
7.1 The creation, movement and storage of
live virus is closely monitored and recorded; the situation that
such material could not be accounted for has never arisen in Merial's
experience. In the unlikely event that a known loss occurs, there
are a number of SOPs in place for any given situation. These range
from protocols to deal with the spillage of pathogenic materials
to defined processes for closing down the factory in the event
that air pressure in the restricted areas drops, for example as
a result of a power failure. All such incidents must be reported
to the Site Biosecurity Officer who, as a matter of course, would
inform all senior personnel and relevant officials at Defra. If
theft were suspected, then the police would also be informed.
7.2 The only incident that might be considered
in this regard—though Merial wishes to stress that pathogenic
material was not unaccounted—was the recent failure of a
valve within the restricted area. Last November, Merial voluntarily
shut down its vaccine production centre at Pirbright due to the
discovery of a leaking valve inside the restricted area. This
situation was handled by the biosecure waste treatment facilities
on site and as a result no live virus was released into the environment
or was unaccounted. The extensive biosecurity measures that Merial
has in place meant that the virus was contained within the closed
drainage system before passing to the chemical treatment facility
for deactivation.
7.3 In the immediate days following this
incident, Merial replaced and tested the valve in question and
put in place two additional layers of biosecurity, including a
second ("policeman") valve and additional containment
systems. While clearly undesirable, this unprecedented incident
underlines the need to have robust biosecurity measures in place
to ensure several layers of environmental protection.
January 2008
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