Written Ministerial Statements
Thursday 25 May 2006
Treasury
Civil Registration Reform
The Financial Secretary to the Treasury (John Healey): I announced to the House on 16 November 2005, Official Report, col 51WS the publication of the consultation paper 'Registration Modernisation' containing proposals for giving local authorities greater responsibility and accountability for the delivery of the local registration service in England and Wales. The consultation paper also included other proposals to modernise civil registration.
Around 150 responses were received to the consultation paper from local authorities, registration officers, specific interest groups, national and regional groups, and representative organisations. There was overwhelming agreement from the full range of respondents that a new governance framework is long overdue and almost unanimous support from local authorities and regional local authority groups to the proposed revised framework.
The Government intend to push ahead with the new governance arrangements and other changes which can be taken forward under existing legislation. The General Register Office will work with the Local Authority Coordinators of Regulatory Services and the Society of Registration Officers to agree national standards and over the next two months aim to finalise the guidance to be issued to local authorities. The guidance will also seek to deal with the concerns about the employment position of registration officers raised in response to the consultation. The Government will keep under review the need for legislation on other aspects civil registration.
I have placed a copy of the report on the response to the consultation paper in the Libraries of both Houses.
Constitutional Affairs
City of London Franchise Report
The Parliamentary Under-Secretary of State for Constitutional Affairs (Bridget Prentice): My noble Friend the Secretary of State and Lord Chancellor has made the following written ministerial statement:
“I have today laid before Parliament the City of London corporation report on the City of London (Ward Elections) Act 2002, hereafter referred to as “The Act”. The Act reformed and modernised the business element of the franchise for local elections in the City of London.
The City of London corporation submitted the report on the working of its new franchise arrangements to me pursuant to Section 7(1) of the Act.
I am inclined to think that a further report will be required following the 2009 elections, however I will make a final decision on whether to ask the city to submit one, under section 7(2) of the Act 2002, at the time”.
Defence
Equal Opportunities Commission Action Plan
The Secretary of State for Defence (Des Browne): The action plan forms phase three of an agreement signed by the MOD and the EOC in June 2005 that outlined the MOD’s commitment to tackling sexual harassment.
To inform the action plan, MOD commissioned independent research into the nature and extent of sexual harassment in the Armed Forces, including a survey of all service women. The action plan demonstrates the MOD’s commitment to tackling the serious issues highlighted by this research. It provides a clear undertaking to create an environment, through strong leadership, in which harassment is recognised as inappropriate and preventable.
The full text of the action plan and the survey report is at www.mod.uk/DefenceIntenet/AboutDefence/Issue/DiversityAndEquality/EqualOpportunitiesInTheArmedForces.htm and copies are also available in the Library of the House.
Gurkhas
The Parliamentary Under-Secretary of State for Defence (Mr. Tom Watson): On 11 January 2005, the then Secretary of State for Defence, announced to the House that we were undertaking a comprehensive review of the terms and conditions of service under which Gurkhas serve in the British Army, which would subsume an earlier review on married accompanied service for Gurkhas.
I am pleased to be able to confirm that improved married accompanied service arrangements are being implemented from 1 April this year, and I hope our Gurkha soldiers will benefit from the much better opportunities to have their families with them at their permanent station. We have also been able to introduce national insurance contribution records for Gurkhas, so that they can qualify for the associated benefits, and they now pay food and accommodation charges, and are eligible for refunds, on the same basis as British soldiers.
But the then Secretary of State for Defence warned that the review would be a major piece of work, and it has raised some very substantial and complex issues which I do not intend to press to hasty conclusions. Therefore, although at the time of the last statement it was hoped that the review could be completed by late autumn 2005, it is now unlikely that I will be able to make any further announcement until later this year.
Environment, Food and Rural Affairs
Departmental Report
The Secretary of State for Environment, Food and Rural Affairs (David Miliband): My 2006 Departmental report which contains information on progress against the Department's aims and Public Service Agreement Targets, the challenges ahead and summary expenditure plans for 2005-06 to 2007-08 will be laid before Parliament today.
Drought Order Applications
The Minister for Climate Change and the Environment (Ian Pearson): My right hon. Friend the Secretary of State, on the application by the companies concerned, has today granted drought orders that empower Mid Kent Water and Southern Water to limit or prohibit the uses set out in the Drought Direction 1991 (as modified in the Orders). The Mid Kent Water order affects its entire supply area. The two Orders granted to Southern Water apply to the company's Medway, Thanet, Hastings and Sussex Coast/Sussex North supply areas but not to the company's Hampshire and Isle of Wight supply areas. These follow the Order granted last week to Sutton and East Surrey Water.
We have seen 18 months of below average rainfall. In these circumstances, the Government's priority is the protection of consumers and of the environment during this exceptional drought. By reducing non-essential uses, through the sensible implementation of this type of drought order, essential supplies to communities can be better maintained should the drought continue. Taking precautionary action now is the responsible thing to do.
In taking these decisions, we have carefully considered the reports by the independent Inspectors. The reports concluded that there has been an exceptional shortage of rain and that without the proposed non-essential use bans there is a substantial threat to water supplies in the companies' supply areas. In reaching their conclusions the Inspectors examined the companies' performance in terms of leakage, and noted that both are meeting the long-term targets set by the economic regulator, Ofwat. I am persuaded that the restrictions allowed by these Orders are necessary over and above any further improvements on leakage they are able to make in the short term. I have made clear that we expect to see continued efforts from all the companies to improve leakage. But reducing leakage alone does not solve the problems of low rainfall.
We are granting these Orders as a precautionary measure, to allow the companies to take the actions proportionate to the evolving threat to supplies. While the exercise and use of the powers conferred through the Orders is a matter for each company concerned, I expect each company to implement the restrictions in a manner that achieves the most in the way of water savings with as little impact as possible on businesses and in the light of changing circumstances. I have asked each company to keep me informed about the
way that they are implementing those restrictions that prove necessary and their overall position on supplies. In addition to this my right hon. Friend the Secretary of State and I will be meeting next week with both the Regulator, Ofwat, and all of the water companies to discuss the management of water resources.
Many people have reacted positively to the message that in addition to action by the companies, we have collective responsibility for managing water as a shared resource. I hope that today's decisions will help everyone focus on the key message that in the areas affected it is their actions now, and in the months to come, which will help all of us to avoid more extreme sanctions should the drought continue into the summer and beyond.
Recent rainfall will temporarily boost river flows and help to maintain reservoir stocks, but will do little for overall supplies because the region relies heavily on groundwater (water that seeps through the soil into porous rocks, such as chalk) for 70 per cent. of its supply; in the case of Mid Kent Water that rises to85 per cent.
In its report to Ministers last week, the Environment Agency advised that the winter recharge season for groundwater is now over, yet groundwater levels remain critically low. The rain we are seeing now and any we see over the rest of the summer will have little impact on groundwater levels, because at this time of year the effects of evaporation and the uptake of water by growing plants and trees means that most of the rain does not reach the aquifers. In winter we usually get more rain than in other seasons, and a higher proportion gets down to the aquifers. But even though we have passed the recharge season we are still taking hundreds of thousands of tons of water every day from the aquifers in the areas concerned.
There are no further drought orders under consideration. I will keep the House informed of any further decisions, should more applications for drought orders be made.
Health
MHRA
The Minister of State, Department of Health (Andy Burnham): My predecessor my right hon. Friend the Member for Liverpool and Wavertree (Jane Kennedy), informed the House of progress made by the Medicines and Healthcare products Regulatory Agency (MHRA) in investigating the incident that occurred with the phase 1 clinical trial for a drug in development known as TGN1412, 19 April 2006, Official Report, cols 13-14WS. The MHRA is today publishing the final report of its investigations. A copy of the report has been placed in the Library and copies are available for hon. Members in the Vote Office.
The report indicates that the adverse incidents did not involve errors in the manufacture of TGN1412 or in its formulation, dilution or administration to trial participants. The report does reference a number of procedural shortcomings that were brought to light by
the MHRA's inspection. None of these was judged to have led to the adverse incidents suffered by the volunteers in this trial, but they are being followed up in the normal way through regulatory action with the company.
The MHRA therefore confirms its conclusion set out in its interim report of 5 April that an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions in the trial participants. Monoclonal antibodies are a relatively new type of biological drug, although there are a number of them already licensed and in use. However, TGN1412 is a new class of monoclonal antibody which has a stimulatory mode of action affecting certain types of cell in the immune system. In this case the resulting activity seen in humans was not predicted from apparently adequate pre-clinical testing. This is a complex scientific issue which raises important scientific and medical questions about the potential risks associated with this type of drug and how to make the transition from pre-clinical testing to trials in humans.
In the earlier written ministerial statement it was also announced that my right hon. Friend the Secretary of State had agreed to the establishment of an expert working group to consider what this incident reveals about the underlying science, and how clinical trials involving these types of products should be managed and authorised in the future. My right hon. Friend has appointed Professor Gordon Duff to chair the expert group. Professor Duff has now identified, and appointed on behalf of the Secretary of State, the members of his group which have today been announced.
The terms of reference of the expert group are to consider what may be necessary in the transition from pre-clinical to first-in-man phase 1 studies, and in the design of these trials, with specific reference to:
biological molecules with novel mechanisms of action;
new agents with a highly species-specific action; and
new drugs directed towards immune system targets.
To provide advice in the form of a report to the Secretary of State for Health for the future authorisation of such trials with an interim report to be provided within three months.
We will then provide a further report to the House when the expert group provides its interim report.
The members of the group are as follows;
Professor Gordon W Duff MA BM BCh PhD FRCP, FRCPE, FMedSci, Professor of Molecular Medicine & Director of Division of Genomic Medicine, Sheffield University: CHAIRMAN
Professor John I Bell MA DM FRCP FMedSci, Regius Professor of Medicine, Oxford University
Professor Dame Carol M Black CBE MD FRCP FMedSci, President of the Royal College of Physicians of London and Professor of Rheumatology, Royal Free Hospital, London
Professor Sir Leszek K Borysiewicz MB BCh FRCP F Med Sci Deputy Rector, Imperial College London
Professor Janet H Darbyshire OBE MB ChB FMedSci FRCP FFPH, Director of the MRC Clinical Trials Unit, Co-Director of UK Clinical Research Network and Professor of Epidemiology, Royal Free and University College London Medical School.
Professor Neva E Haites OBE MB ChB PhD MRCPath FRCPE, Professor of Clinical Genetics & Head of College and Vice-Principal, College of Life Sciences and Medicine, University of Aberdeen
Sir Bob Hepple QC FBA, Cambridge University and Chair of the Nuffield Council of Bioethics
Ms Amanda Hoey, Director, ConsumerHealth Consulting Ltd - Lay representative
Dr Stephen C Inglis BSc PhD, Director, National Institute for Biological Standards and Control (NIBSC)
Professor Lars Klareskog, Professor of Rheumatology, Karolinsha University, Stockholm
Professor Robert Lechler MB, ChB, PhD, FRCP, FRCPath, FMedSci Vice-Principal (Health), King College London
Professor Dr Johannes Löwer MSc, MD President of the Paul Ehrhlich Institute, Langen, Germany*.
Professor Andrew J McMichael MB BChir PhD CNAA FRCP FRS Professor of Immunology, Oxford University
Professor Alexander F Markham BScPhD MB BS DSc FRCP FRCPath Chief Executive Cancer Research UK and Professor of Medicine, St James University Hospital, Leeds
Professor B Kevin Park BSc PhD Hon MRCP FMedSci, Professor of Pharmacology & Head of Department of Pharmacology and Therapeutics, Liverpool University.
Mrs Vivienne Parry - Lay representative
Professor Munir Pirmohaimed MC ChB PhD FRCP Professor of Clinical Pharmacology, Liverpool University
Professor Mark J Walpoft MB BChir MA FRCP FRCPath F Med Sci Director of the Welcome Trust & Professor of Rheumatology/Immunology, Imperial School of Medicine, Hammersmith
Professor Herman Waldrnann PhD, FRS FRCPath F Med Sci Professor of Pathology, Sir William Dunn School of Pathology, Oxford
There will be a number of observers to the expert group from:
The European Medicines Agency
Department of Health
Department of Trade and Industry - Biosciences Unit
US Food and Drug Administration
Pharmaceutical and Medical Devices Agency, Japan
MHRA
*Agency of the German Government responsible for the regulation of biological medicinal products for humans and animals.
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