Memorandum 32
Submission from the Association of the
British Pharmaceutical Industry (ABPI)
1. The UK pharmaceutical industry is actively
engaged in research programmes to develop prophylactic and therapeutic
pharmaceuticals to prevent and treat infectious disease. The Association
of the British Pharmaceutical Industry (ABPI) is the leading organisation
that represents pharmaceutical and biopharmaceutical companies,
including contract research organisations, who develop and manufacture
innovative medicines.
2. Research in this area requires work with
relevant biological agents including naturally occurring human
and animal pathogens, genetically-modified micro-organisms and
a number of toxins of biological origin. Companies are committed
to ensuring high standards of biosafety and biosecurity apply
to all relevant activities in the UK and elsewhere.
3. It is recognised that successful management
of risks associated with such work must address both biosafety
and biosecurity issues.[44]
4. On the specific issues raised by the
Committee we offer the following comments.
The current capacity for research on dangerous pathogenic
material in the UK
5. Infectious diseases continue to cause
high numbers of cases of morbidity and mortality around the world.
Among these are relatively new diseases such as HIV AIDS and Severe
Acute Respiratory Syndrome (SARS) and more recently, limited cases
of human infection with highly pathogenic avian influenza strains.
6. Recent years have also seen a resurgence
of some infectious diseases including Tuberculosis where there
is particular concern about the emergence of multi- and extensively
drug-resistant strains of the causative organism.
7. Resistance to existing antibiotic therapies
is also a serious concern in other diseases including infections
caused by MRSA which in the UK and elsewhere continues to be major
problem in hospital-acquired infections.
8. Against this background there is a clear
and demonstrable need for continuing basic research to better
understand the mechanisms of pathogenicity and drug resistance
and for application of this understanding in research to discover
and develop new therapies.
The capability to conduct research on the causative
agents of disease that may emerge at a future time
9. The emergence of new infectious diseases
is likely to be a continuing problem. While appropriate prescribing
by physicians and encouragement of better patient compliance will
help to mitigate the spread of drug resistance, the underlying
phenomenon is an inherent feature of microbial evolution.
The state of biological containment facilities in
the UK
10. We note that UK law[45],
[46]
and associated guidance provides standards for the design and
operation of microbiological containment laboratories. These standards
have been developed to ensure that appropriate safeguards can
be provided according to the hazards posed by pathogens and the
associated risk attached to relevant work activities. While there
are restrictions on access even at Containment Level 2, these
have traditionally been prescribed to afford an adequate standard
of safety for those working in the facility and to guard against
accidental escape into the wider community rather than the risks
of deliberate misappropriation, theft, subversion and misuse.
11. We also note that the Anti-terrorism,
Crime and Security Act 2001 provides for notification to the Home
Office of possession of relevant materials and also for the establishment
of appropriate physical, procedural and personnel screening measures.
The Act also provides for inspection by the relevant authority
that may also require implementation of specified measures to
improve existing arrangements where this is deemed to be necessary.
We support the need to ensure that proportionate biosecurity measures
are taken with respect to work with relevant materials.
12. Laboratories where pathogens are handled
in the UK should be and are designed, constructed, operated and
maintained to comply with the relevant standards of containment
provided for in UK legislation and account taken of associated
guidance.
Laboratory inspection regimes and the rationale
and practicalities of the licensing system
13. We believe that it is important for
organisations to implement appropriate self-inspection and auditing
regimes as part of their biosafety and biosecurity management
procedures.
14. We recognise the additional assurance
provided for through inspections and/or audits by regulators and
we support a proportionate, scientific and risk-based approach
to the regulation of work activities involving the use of hazardous
biological materials.
15. We support the recommendations made
in the Callaghan Review[47]
to merge the regulatory regimes governing work with human and
animal pathogens and for enforcement to be the responsibility
of the Health and Safety Executive.
Biosafety training provision for staff working
in containment facilities
16. Staff working in containment facilities
must have demonstrable competence not only to work to high scientific
standards but also to work safely. Identification of biosafety
training needs and providing for these to be met is critical in
ensuring this, and this issue should be addressed in any biosafety
and/or biosecurity management programme. A range of training processes
may be used but hands-on training, under an appropriate level
of supervision is an essential element in any training programme.
17. We encourage academic institutions to
ensure that relevant programmes in relevant disciplines include
appropriate provision for the development of an understanding
of microbiological risk assessment, associated safety control
measures and their application.
The maintenance and recording practices surrounding
the storage and transportation of dangerous pathogens
18. National and international regulations
are in force governing the transport of dangerous substance including
hazardous biological materials. These include provisions for appropriate
packaging and labelling and there are also specific requirements
for security plans in connection with the transport of high consequence
agents. We believe that strict adherence to the requirements of
the current regulations provides an appropriate level of safeguard
in terms of safety and security.
19. Inventories should be maintained for
all relevant materials. Safe and secure storage should be provided
and used with specific measures being determined and applied in
accordance with risk assessment and the requirements of national
legislation.
Measures implemented when pathogenic material
cannot be accounted for
20. RIDDOR[48]
specifies requirements to report accidental releases of biological
agents likely to cause severe human illness and the COSHH regulations
require employees to report to their employee or the employer's
nominated representative any accident or incident which has or
may have resulted in the release of a biological agent which could
cause severe human disease. It is not clear from this wording
whether or not this requires reporting where inventories indicate
that relevant material is unaccounted for and we believe that
guidance from the authorities would be helpful. Depending on the
interpretation placed on the existing law, the authorities may
also wish to consider the need for amending legislation.
21. We believe that irrespective of any
legal requirements, failure to account for pathogenic material
should as a minimum, be reported through the management line.
Appropriate emergency procedures taking account of this type of
incident should be in place and should be implemented if an incident
occurs. Depending on the specific circumstances, those measures
should involve reporting to the relevant authorities.
22. Irrespective of any reporting to and
investigation by those authorities, organisations should carry
out their own investigation and act on any findings and recommendations
that arise out of the investigation.
The role of universities in overseeing security
clearance for research students working with dangerous pathogens
23. We believe that it is essential for
continued progress in this area for there to be a strong UK academic
base in the areas of microbiology, virology and molecular biology.
24. Research students typically are involved
in research studies on projects of one to three years duration.
The relatively short duration of projects, the associated high
turnover, the significant numbers engaged in such studies, and
the costs of carrying out security clearance checks mean that
there are particular difficulties for universities in ensuring
that all students are suitably screened in this respect.
25. It is essential that highly competent
and suitably trained individuals are available to carry out relevant
work activities in countries where there are relatively high levels
of endemic and newly emerging infectious diseases. These conditions
are often associated with developing nations. Attracting research
students to UK academic institutions for part or all of their
formal training is not only an important issue for those institutions
but also serves to help ensure that students who subsequently
return to their home countries or other developing nations will
be able to draw on their experience in the UK to the benefit of
their homeland. While we recognise and accept the need for appropriate
screening we also believe that it is important that unnecessary
obstacles are not put in the way of international academic interchange.
January 2008
44 "Biosafety" is used here to describe
the containment principles, technologies and practices that are
implemented to prevent the unintentional exposure to biological
agents and toxins, or their accidental release while "Biosecurity"
is used to describe measures for access control and accountability
for use of biological agents and toxins within laboratories, in
order to prevent their loss, theft, misuse, diversion of, unauthorized
access or intentional unauthorized release. Back
45
The Control of Substances Hazardous to Health Regulations 2002. Back
46
Specified Animal Pathogens Order 1998. Back
47
A Review Of The Regulatory Framework For Handling Animal Pathogens
Chaired by Sir Bill Callaghan. Presented to the Secretary of State
for Environment, Food and Rural Affairs 13 December 2007. Back
48
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
1995. Back
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