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Clinical Trials

Mr. Godsiff: To ask the Secretary of State for Health what impact the introduction of the Medicines for Human Use (Clinical Trials) Regulations in May 2004 will have on trials of new treatment regimes carried out by researchers in hospitals and universities; and if he will make a statement on how the directive will be implemented in the UK. [126828]

Miss Melanie Johnson: The draft regulations are to transpose into United Kingdom law, Directive 2001/20/EC on approximation of the laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Consultation on the draft regulations closed on 16 May 2003. The Medical Research Council's (MRC) response is available in full on its website. Its assessment reflected the main concerns expressed by the charitable and public sector.

The Department of Health and the MRC have agreed jointly to lead a project to clarify the arrangements for publicly funded clinical trials involving medicines in the UK. It will draw up practical advice to enable publicly funded clinical trials involving medicines to comply with the law while making best use of existing good practice, minimising additional bureaucracy and making maximum use of public resources to avoid unnecessary expense.

The project is about to start, under the chairmanship of Professor Kent Woods, Director of the national health service health technology assessment programme. It will draw extensively on expert advice from trialists and from the charitable and public sector.

Member states are required to implement the Directive fully by 1 May 2004. I announced that the process of developing the regulations should be completed some time after Parliament reconvenes in October, with the aim of an update around that time.

Ministerial Meetings

Joyce Quin: To ask the Secretary of State for Health how often he met his counterparts in the devolved Administrations in the last 12 months; and if he will make a statement. [126518]

Ms Rosie Winterton: Ministers in the Department of Health have regular meetings with Ministers from the devolved Administrations where various issues are discussed.

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MRI Scanning (Worcestershire)

Mr. Luff: To ask the Secretary of State for Health what assessment he has made of existing capacity for MRI scanning for NHS patients in the public and private sectors in Worcestershire; and if he will make a statement. [126961]

Dr. Ladyman: The Department of Health maintains a database to monitor the provision of magnetic resonance imaging (MRI) scanners in the national health service, and the age of the machines installed. Allocation of MRI scanners has been made on the basis of improving access to MRI scanners across the NHS as a whole.

The Department of Health is aware of the majority of private installations in England but this information is not continually monitored.

Mr. Luff: To ask the Secretary of State for Health if he will make a statement on his plans to provide additional MRI scanning capacity in Worcestershire. [126962]

Dr. Ladyman: The magnetic resonance imaging (MRI) scanner at Worcester Royal Infirmary was installed in March 2002 and has been working full-time since 1 July 2003.

Worcestershire Acute Hospitals National Health Service Trust is to install another MRI scanner at Kidderminster hospital as part of the diagnostic and treatment centre development which is due to be up and running before the end of this year. This will be funded as part of the NHS Cancer Plan commitment to provide 50 additional MRI scanners by 2004.

MRSA

Mr. Tony Lloyd: To ask the Secretary of State for Health what research he has commissioned into best practice in preventing MRSA, with particular reference to overseas examples. [116436]

Miss Melanie Johnson: No research has been specifically commissioned with a focus on identifying best practice in preventing methicillin-resistant Staphylococcus aureus (MRSA).

However, a broad strategic programme of research has recently been commissioned aimed at improving our scientific understanding of antimicrobial resistance. Over £2.5 million worth of research has been commissioned during the past six months, following an open competitive call for research proposals, and following rigorous peer review.

A number of these research projects will provide useful information relating to best practice in preventing MRSA. Those that relate most closely include the following:

A project at the University of Leeds and Leeds General Infirmary entitled, 'What is the size and nature of the current

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need for single room isolation in hospital, and how does success or failure to isolate patients affect the control of methicillin-resistant Staphylococcus aureus.'


A project at Thames Valley University, London entitled, 'Collaborative research to reduce the incidence of hospital ward-acquired methicillin-resistant Staphylococcus aureus (MRSA) colonisation/infection, using Statistical Process Control (SPC) feedback and structured diagnosis of the underlying causes of MRSA acquisition.'


A project at the London School of Hygiene and Tropical Medicine entitled, 'Faster testing for MRS—Models to estimate the cost-effectiveness of faster testing of cases admitted for hip and knee replacement.'

National Institute for Clinical Excellence

Mr. Havard: To ask the Secretary of State for Health what discussions are taking place between his Department and the National Institute for Clinical Excellence to create a new fast track process allowing interim guidance between class appraisals to be given for medical treatments that are licensed. [126372]

Miss Melanie Johnson: Officials have held preliminary discussions with the National Institute for Clinical Excellence about the possible development of interim guidance, but no decisions have yet been taken.

Mr. Havard: To ask the Secretary of State for Health if he plans to make more resources available for the National Institute for Clinical Excellence to conduct more appraisals each year. [126373]

Miss Melanie Johnson: Funding for the National Institute for Clinical Excellence has been set for the three financial years, 2003–04 to 2005–06. The funding includes provision for an additional appraisal committee to be established. This will enable more appraisals to be carried out.

Needle Stick Injuries

Mr. Baron: To ask the Secretary of State for Health how many hours were spent by NHS staff in 2002–03 (a) investigating accidents and (b) completing accident reports concerning needle stick injuries suffered by nurses and other health care staff. [127002]

Mr. Hutton: The Department of Health does not collect this data centrally but has advised all national health service trusts that all accidents including needle sticks should be reported and recorded.

Health and Safety legislation and good management practice requires the causes of accidents to be properly investigated to inform risk assessments and reduce the possibility of such accidents happening again.

Mr. Baron: To ask the Secretary of State for Health what the cost to the NHS was in 2002–03 of occupational sick pay, statutory sick pay and NHS injury benefits given to nurses and other health care staff who have suffered needle stick injury. [127003]

Mr. Hutton: The Department of Health does not collect information on sick pay or injury benefits centrally as these are matters for individual national health service employers. Information for individual NHS trusts should be available locally.

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The NHS Pensions Agency does collect data on Temporary Injury Benefit payable to staff injured during employment in the NHS. For injuries sustained before 1997 the annual costs of Personal Injury Benefit (PIB), funded centrally, are currently £38.7 million. Since 1997, PIB costs are re-charged to the NHS employer and these figures are not held centrally.

Mr. Baron: To ask the Secretary of State for Health what the cost to the NHS was in 2002–03 of (a) counselling services and (b) loss of earnings litigation for nurses and other health care staff who suffered needle stick injury. [127004]

Mr. Hutton: All staff in the national health service have access to confidential counselling services and best practice is that staff are offered counselling after accidents and injuries. Referring employees to occupational health or infection control staff, who will carry out the necessary tests to ascertain whether there has been any transmission of a blood borne virus, is usually done during working hours, as is counselling. There is no centrally held data available on the exact cost of counselling services provided by NHS employing organisations.

The Department of Health does not collect data on individual litigation cases. "The National Audit Office Report A Safer Place to Work—Improving the Management of Health and Safety Risks to Staff in NHS Trusts", estimated that compensation payments cost the NHS £1.5 million in 2001–02. The average compensation payment negotiated by UNISON with NHS employers for needlesticks injuries that do not result in the transmission of blood borne viruses is currently £2,000.

Mr. Baron: To ask the Secretary of State for Health what the cost to the NHS was in 2002–03 of providing cover for nurses and other health care staff who have been forced to take time off for investigation, treatment and counselling as a result of blood-borne viruses contracted through needle stick injury. [127005]

Mr. Hutton: Information on the cost of providing staff to cover for health care workers absent due to injury is not collected centrally by the Department of Health.

In the majority of cases where there has been no transmission of a blood borne virus, the investigation, treatment and counselling associated with a needle stick injury will take place in working hours.

Mr. Baron: To ask the Secretary of State for Health what emotional and psychological support is provided to nurses and other health care staff who are concerned about having been infected with a blood-borne virus contracted through needle stick injury. [127006]

Mr. Hutton: National health service staff who experience a needle stick injury which they believe may result in their being infected with a blood borne virus are referred to infection control staff who carry out the necessary tests and provide advice and counselling. If the health care worker concerned requests it, they will also be referred to a counselling service.

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NHS unions also provide advice and support to their members to assist them in coping with workplace injuries.

Mr. Baron: To ask the Secretary of State for Health how many nurses and other health care staff who have become infected with a blood-borne virus as a result of needle stick injury have been forced to leave their employment as a result of this infection in the last five years. [127007]

Mr. Hutton: Information on health care workers who have become infected with a blood borne virus is not collected centrally by the Department of Health, but should be available from individual national health service employers.

Many health care workers infected with hepatitis B and health care workers infected with hepatitis C or HIV should not perform exposure prone procedures, those procedures in which injury to the health care worker could result in the worker's blood contaminating a patient's open tissue. However, being HIV or hepatitis C positive or carrying hepatitis B is not a bar to working in the NHS. Where modification of working practice is necessary, suitable alternative work or retraining opportunities are made available, in accordance with good general principles of occupational health and general management practice.

Mr. Baron: To ask the Secretary of State for Health how many nurses and other health care staff have contracted (a) hepatitis B, (b) hepatitis C and (c) HIV as a result of needle stick injuries in each of the last five years. [127008]

Mr. Hutton: No complete data are available centrally on the number of health care workers who have contracted blood borne viruses as a result of needle stick injuries. However, the Health Protection Agency, formerly the Public Health Laboratory Service, runs enhanced surveillance whereby occupational health departments can report such incidents on a voluntary basis. The results in the last five years are shown in the table.

	1998	1999	2000	2001	2002
Hepatitis B	0	0	0	0	0
Hepatitis C	0	0	1	1	0
HIV	0	1	0	0	0

Mr. Baron: To ask the Secretary of State for Health how many nurses and other health care staff have sustained needle stick injuries in each of the last five years. [127009]

Mr. Hutton: The Department of Health does not collect this data centrally but has advised all national health service trusts that it should be collected locally to enable them to assess the risks to staff and patients. Figures for needle stick injuries should be available from NHS trusts locally.

The National Audit Office report 'A Safer Place to Work, improving the management of health and safety risks to staff in NHS Trusts' estimated that there were 23,000 needle stick injuries in England each year.

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