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

Memorandum 5

Submission from 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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