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10 July 2007 : Column 1442W—continued
Clinical Trials
Mr. Lansley: To ask the Secretary of State for Health (1) pursuant to the answer of 23 January 2007, Official Report, column 1735W, on clinical trials, on what date the implementation group set up by the Medicines and Healthcare Products Regulatory Agency was established; on how many occasions it has met since; and over what timescale he expects each of the recommendations contained within the report of the Independent Expert Scientific Group on clinical trials to be implemented; [147500]
(2) whether the Medicines and Healthcare Products Regulatory Agency assesses the size of doses to be administered to volunteers in clinical trials on the basis of minimum anticipated biological effect levels; [147537]
(3) pursuant to the answer of 23 January 2007, Official Report, columns 1735-36W, on clinical trials, whether the Medicines and Healthcare Products Regulatory Agency has established an expert advisory group to advise on applications for clinical trials on higher risk substances. [147550]
Dawn Primarolo: The Implementation Group established by the Medicines and Healthcare products Regulatory Agency (MHRA) to take forward the recommendations made by the independent Expert Scientific Group (ESG) held its first meeting on 27 September 2006 and has met a further four times since then.
The MHRA assesses the starting doses to be administered to volunteers in clinical trials based on available toxicology and pharmacology data.
In general, the calculation of the first dose in man is based on the no observed adverse effect level (NOAEL) determined in non-clinical safety studies performed in the most sensitive and relevant animal species. However, a calculation of the minimal anticipated biological effect level (MABEL) is also used and this approach is considered to be more appropriate than the NOAEL when the results of animal studies are thought less likely to predict the effect of the molecule in man.
The MHRA has established an Expert Advisory Group (EAG) of the Commission on Human Medicines (CHM) to advise on applications for clinical trials on higher risk substances, and it held its first meeting on 18 March 2007. Prior to this, and since the ESG formulated its interim advice in July 2006, advice on applications for clinical trials on higher risk substances was obtained from the CHM.
Progress is being made on implementing the ESG report recommendations as follows:
Recommendation one concerns the drug development process itself and the need for those involved in such programmes to be appropriately trained. The former will be addressed in the revised European Union guidance which we expect to be published by the end of July 2007. The MHRA is having discussions with relevant bodies on the latter with a view to developing a training and accreditation scheme for investigators for Phase 1 trials. We do not expect this recommendation to be implemented before 2008.
Recommendation two proposes a regular review of the regulatory process and has already been implemented as one of the responsibilities of the newly formed EAG.
Recommendations three and four propose that clinical and pre-clinical unpublished studies relevant to the safety of human exposure need to be collected in a format that can be shared confidentially between regulators. Discussions on the proposal have taken place with the European Medicines Agency (EMEA) and they will discuss the recommendations with the US Food and Drug Administration (FDA) and with the International Conference for Harmonisation (ICH) to involve the wider regulatory population. The EMEA will also ask the European Commission about raising the issue of data sharing with other countries. The EU databases will need amendment to enable the information to be collected. We do not expect these recommendations to be implemented before 2008.
Recommendations five and eight recommend earlier dialogue between regulator and drug developer, and better communication between regulator and ethics committees. The recommendation on earlier dialogue has been implemented through establishing a procedure that allows for informal discussion and submission of data on higher risk substances in advance of submission of the formal clinical trial application. This will avoid the need to lengthen current formal approval times.
The recommendation on better communication was implemented in October 2006 through adoption of a Memorandum of Understanding between MHRA and ethics committees.
Recommendations six and seven recommend the regulator should have access to additional advice from experts and were implemented by establishment of the EAG of the CHM in March 2007.
Recommendations nine to 17 concern determining and administering the initial doses of a drug in man and are addressed in the guidance being developed by the EU scientific committee, which should be published by the end of July 2007. In the meantime the MHRA is operating interim arrangements that take account of these recommendations.
Recommendation 18 refers to the training of principal investigators and is being progressed with recommendation 1.
Recommendation 19 proposes development of a treatment strategy when drawing up protocols for trials involving higher risk substances and will be addressed in the EU guidance.
Recommendation 20 specifies the facilities that should be available for first in man studies of higher risk substances. The MHRA is developing a voluntary accreditation scheme for Phase 1 units which will provide assurances that they have appropriate facilities available. This scheme will be available from April 2008, although we expect an informal self assessment scheme to be implemented shortly, prior to the scheme being finalised.
Recommendation 21 advocates widening availability of “hands-on” experience in the conduct of clinical trials and has wide-ranging implications for industry and those responsible for the training of medical personnel. Although discussions are under way, it is unlikely that this recommendation will be implemented before 2008.
Recommendation 22 considers the need for specialist Phase 1 centres, and we propose this should be addressed via the proposed accreditation scheme, which should provide assurance in the longer term that trials are conducted only in units with suitable facilities and staff.
Community Care
Jane Kennedy: To ask the Secretary of State for Health (1) what measures are in place to ensure that recipients of domiciliary care commissioned by a local authority have continuity of care protected during a change in care provider; [146599]
(2) what redress is open to clients in receipt of domiciliary care commissioned by a local authority in circumstances where they have had their carer withdrawn by the local authority without provision for alternative support services being made. [146600]
Mr. Ivan Lewis [holding answer 29 June 2007]: Local authorities are responsible for assessing the care needs of their populations and providing or arranging care services to meet those needs. It is for local authorities to ensure that people's assessed needs are met on a day to day basis, regardless of how services are delivered. Local authorities are responsible for setting the criteria that determine people's eligibility for care. They do so based on local need and may also take into account their resources.
A person receiving domiciliary care services arranged by a local authority will receive such services, following the process of assessment of their need for such a service carried out by the authority, under section 47 of the National Health Service and Community Care Act 1990, taking into account relevant directions and guidance from the Secretary of State.
Changes may be made by the local authority to the services received following a reassessment under section 47 and an authority may temporarily provide urgently needed services without an assessment, pending the completion of an assessment.
People who have services withdrawn (or their representatives) are entitled to make use of the local authority social services complaints procedure. Procedures for handling complaints about the provision of domiciliary care services are set out in the Local Authority Social Services Complaints (England)
Regulations (S.I.2006/1681). Information on how to make a complaint is available from local authority offices.
Contraceptives: Abortion
Mr. Amess: To ask the Secretary of State for Health (1) what recent assessment he has made of the impact of the morning-after pill on the overall abortion rate in England; and if he will make a statement; [148067]
(2) what research his Department (a) has undertaken and (b) plans to undertake into the reasons for trends in the abortion rate in England between 2005 and 2006; and if he will make a statement; [148106]
(3) what the most recent abortion rate was per 1,000 women aged (a) 19, (b) 18, (c) 17, (d) 16, (e) 15, (f) 14 and (g) under 14 years in the UK; and what forecast he has made of the rate in each of the next 20 years. [148107]
Dawn Primarolo: No research has been commissioned or is planned in this specific area and no future forecast of abortion rates has been made.
The reasons women seek an abortion are complex and may be subject to a number of different factors. It is difficult to attribute any changes to one intervention or event such as the increased availability of emergency contraception.
Information on abortion rates for residents of England and Wales can be found in Table 4a of “Statistical Bulletin: Abortion Statistics, England and Wales: 2006”, copies of which are available in the Library and on the Department’s website at:
Dental Services
Sandra Gidley: To ask the Secretary of State for Health how many units of dental activity (UDAs) are available to dentists in each primary care trust in England; and how many UDAs this equates to per person within each primary care trust area. [148482]
Ann Keen: Information is not available in the form requested. Information is available on the level of service commissioned.
Primary care trusts (PCTs) commission dental services from local dental providers. Information is collected centrally on the number of contracts each PCT holds and the units of dental activity (UDAs) these represent. UDAs are a way of measuring and giving relative weight to the courses of treatment given to patients. The latest information showing the total number of UDAs commissioned as at 31 March 2007 by PCT and the same data expressed per head of population are set out in tables which have been placed in the Library. The latest available population data are as at 2005.
Departments: Consultants
Mr. Meacher:
To ask the Secretary of State for Health how much her Department spent on (a) management consultants and (b) other external consultants and advisers in each year since 2000; and
which of these consultants undertook work for the Department with a total contractual value in excess of £10 million over this period. [146342]
Dawn Primarolo: The Department does not collect information on consultant spend in the format requested.
Total departmental spend on consultants was:
| Consultancy expenditure | |
| £ million | |
The following consultants undertook work for the Department with a total contractual value in excess of £10 million:
| Total annual consultancy expenditure accounted for by supplier for 2004-05 and 2005-06 | ||
| Consultancy supplier name | £ million | |
It should be noted that these figures exclude VAT.
Departments: Management
Mr. Lansley: To ask the Secretary of State for Health what the role is of his Department’s departmental management board. [147563]
Dawn Primarolo: The role of the departmental management board (DMB) is to provide strategic leadership to the Department, support Ministers in developing and policy and strategy for the health and care system and oversee its implementation.
A review of the role of the DMB will be undertaken as part of the Department’s response to its recent capability review.
Mr. Lansley: To ask the Secretary of State for Health which members of his Department are included in his Department’s senior leadership team; and if he will make a statement. [147564]
Dawn Primarolo: The senior leadership team brings together directors general and directors in the Department (senior civil service paybands two and three). Its purpose is to develop a shared approach to corporate leadership of the Department.
Departments: Pay
David Simpson: To ask the Secretary of State for Health how many non-pensionable bonuses were awarded to members of staff in his Department in the last three years; and at what total cost. [146986]
Dawn Primarolo: The number of staff who received bonus payments in the last three years and the total amount of bonus paid is as follows:
| Normal | £ | |
A significant proportion of bonuses paid were to staff who are senior civil servants, where the Department’s policy is determined by the Cabinet Office guidance on civil service bonuses.
Departments: Performance Appraisal
David Simpson: To ask the Secretary of State for Health how many staff in his Department did not achieve an acceptable mark in their annual report in 2006-07. [146920]
Dawn Primarolo: The annual report process for 2006-07 is not yet completed, therefore data are not available.
Departments: Public Expenditure
Mr. Hoban: To ask the Secretary of State for Health what her Department’s budget was for each year (a) before and (b) after reprofiling, broken down into capital, near-cash and non-cash. [146534]
Dawn Primarolo: The Department’s near-cash, non-cash and capital budget is set out in the 2007 Department Report. Previous controls are set out in HM Treasury’s Public Expenditure Statistical Analyses publications. Budget 2006 set out information regarding the reprofiling of departmental resources along with other routine and technical changes.
Departments: Sick Leave
David Simpson: To ask the Secretary of State for Health how many staff in his Department have taken (a) five or more, (b) four, (c) three and (d) two periods of sick leave of less than five days in the last 12 months. [147049]
Dawn Primarolo: Our records show:
81 staff have taken five or more periods of sick leave of less than five days in the last 12 months;
60 staff have taken four periods of sick leave of less than five days in the last 12 months;
153 staff have taken three periods of sick leave of less than five days in the last 12 months;
261 have taken two periods of sick leave of less than five days in the last 12 months.
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