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

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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