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(3) if he will make a statement on the circumstances to be taken into account by the MCA in monitoring the licensing of a medicine, with particular reference to the licensing of a new medicine with a lower incidence of side effects. 
Ms Blears [holding answer 22 November 2001]: The primary objective of the Medicines Control Agency (MCA) is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. A marketing authorisation is granted when the balance of risks and benefits is considered to be favourable in the proposed indication.
The MCA continually monitors the safety of all medicines using a number of data sources with expert advice from the independent scientific advisory committee, the Committee on Safety of Medicines. If there is evidence that the balance of risks and benefits is no longer favourable, regulatory action may be taken to minimise risk. This may include strengthening warnings, restricting the terms of the marketing authorisation, or in appropriate circumstances its revocation. Such regulatory action is pursued with the Medicines for Human Use (Marketing Authorisations Etc.) Regulation, SI 1994 No. 3144 and relevant European Community obligations.
Spontaneous reporting data, which are collated by the MCA/CSM through the yellow card scheme, can be used to compare the safety profiles of medicines within a drug class. However, these comparisons must be evaluated with care, as levels of reporting of adverse reactions for particular drugs are dependent on a number of factors including the usage of the drug and the length of time it has been on the market.
If the medicine is administered via a novel route or drug delivery system
If the medicine is going to be used in a new population of patients.
Mr. Heald: To ask the Secretary of State for Health (1) what assessment he has made of the changes in administrative work resulting from the implementation of Clauses 1 to 4 of the National Health Service Reform and Health Care Professions Bill; 
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Mr. Hutton [holding answer 22 November 2001]: Clauses 1 to 4 of the Bill prepare for the structural changes to the national health service. The 95 health authorities will be replaced by about 28 strategic health authorities; the eight regional offices of the Department will be abolished; and primary care trusts will be the key organisations undertaking an increased range of functions. £100 million is to be saved resulting from these changes: a combination not just of savings in management, but from a reduction in infrastructure and increases in shared services.
Mr. Heald: To ask the Secretary of State for Health if he will list the (a) existing and (b) proposed NHS (i) national directors posts, (ii) commissions, (iii) offices, (iv) types of trust, (v) types of authority, (vi) groups, (vii) boards, (viii) committees, (ix) forums, (x) councils and (ix) bodies. 
Ms Blears [holding answer 22 November 2001]: The Department of Health public appointments annual report 2000, copies of which were sent to all hon. Members, contains details of all national health service trusts, primary care trusts, health authorities, special health authorities and non-departmental public bodies, including their chairs and non-executive members, as at 1 April 2000.
The 2001 public appointments annual report will be published, covering local and national bodies and appointments as at 1 April 2001. As in previous years, copies of the report will be sent to all hon. Members.
25 primary care trusts and 14 NHS trusts have been established since 1 April 2001. 28 new health authorities are to be established from April 2002 to replace the 95 currently established. An anticipated 15 care trusts are likely to be established during the course of 200203. About 120 PCTs are likely to be established over the course of the next two years. Other national bodies established since 1 April 2001 and those planned for the future are as follows.
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Directors and chief executives of special health authorities and departmental non-departmental public bodies are listed in "Public Bodies 2000", a copy of which is in the Library. The 2001 edition of "Public Bodies" will be published in January 2002.
Mr. Heald: To ask the Secretary of State for Health what increase in public expenditure the creation of patients forums would require, after taking account of current funding allocations to community health councils and PALS. 
Ms Blears [holding answer 22 November 2001]: People are the most important resource and we will be working to ensure that we make the best use of time offered by lay volunteers in the health service. Patients forums will, of course, require support in terms of human and financial resources for their work, which will be provided by the Commission for Patient and Public Involvement in Health through its local networks. Funding is therefore tied into the overall resource requirements for the commission and the new arrangements collectively, which we are discussing with Her Majesty's Treasury as part of the spending review process.
Barbara Follett: To ask the Chancellor of the Exchequer what steps he has taken to reduce the levels of irrecoverable VAT incurred by the British Tourist Authority in the current financial year; and if he will make a statement. 
Mr. Boateng: The BTA was awarded £14.2 million of additional funding this year to take forward its recovery plan to boost inbound tourism in the wake of the foot and mouth outbreak. Concern was raised in July that this would lead to the BTA incurring irrecoverable VAT on purchases relating to this programme.
The BTA estimated the irrecoverable VAT would be around £600,000. However, HM Customs and Excise has now reached an agreement with the BTA to allow an increase in VAT recovery to achieve a fair and reasonable result within the existing rules. The agreement addresses the impact of foot and mouth disease upon all of BTA's work, not just the elements funded by extra grant in aid. As a result of this agreement, the BTA estimates that the level of irrecoverable VAT incurred on goods and services purchased as part of its tourism recovery programme has now been reduced by between £300,000 and £500,000.
This agreement ensures that as much as possible of the BTA's grant-in-aid and extra funding will go directly towards helping inbound tourism to recover from a particularly difficult year, while complying with the tax laws which apply to all organisations buying goods and services.
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Mr. Howard: To ask the Chancellor of the Exchequer what in real terms was the tax burden in (a) 199798 and (b) the most recent year for which information is available on the lowest quintile of equivalised disposable income. 
Mr. Andrew Smith: As a result of personal tax and benefit measures introduced since 1997, families with children in the poorest fifth of the population are on average £1,700 a year better off in real terms.
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