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FOREIGN AND COMMONWEALTH AFFAIRS
Iran (Nuclear Programme)
The Minister for Europe (Mr. Denis MacShane): My right hon. Friend the Secretary of State for Foreign and Commonwealth Affairs has today laid before the House Command Paper 6443 "Iran's Nuclear Programme: A Collection of Documents". Cm 6443, which includes a preface by the Foreign Secretary, records the international effort over the past two years to establish with confidence whether Iran's nuclear programme is for peaceful purposes. Copies will be placed in the Library of the House and the Vote Office.
Bosnia and Herzegovina (Export Licence Applications)
The Minister for Europe (Mr. Denis MacShane): In December 2004 the Government issued four licences for the export of armoured jackets to the Ministry of Security in Bosnia and Herzegovina. The Ministry of Security required the vests for the State Information and Protection Agency (SIPA). SIPA is responsible for, inter alia, diplomatic protection, which includes the British Embassy in Sarajevo as well as the missions of EU partners and other allies; tackling organised crime; and investigating war crimes.
An EU arms embargo has been in place against Bosnia and Herzegovina since 1996. The purpose of the embargo was to aid the establishment of peace and stability for the people of the region, taking into account in particular the need to ensure the safety of international troops and civilian personnel deployed. The embargo was amended in 1999 to exclude de-mining equipment and the transfer of small arms to the police.
We fully support the EU embargo. However, we are, in limited circumstances, prepared to make exceptions where denying an export would frustrate the purposes of the embargo. The UK has been active in encouraging Bosnia and Herzegovina to take greater responsibility for maintaining the rule of law and strengthening civilian policing. I am confident that granting this exception is fully consistent with this responsible approach of supporting the development of civilian policing whilst respecting the aims of the embargo.
HEALTH
Medicines for Human Use (Clinical Trials) Regulations
The Minister of State, Department of Health (Ms Rosie Winterton): My noble Friend the Parliamentary Under-Secretary of State, Department of Health (Lord Warner) has made the following written ministerial statement today.
I am today notifying Parliament of the Government's proposals to amend the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004 for consent in emergency situations.
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The clinical trials directive 1 requires that before an incapacitated person is entered into a clinical trial his or her legal representative must give consent. Our implementing regulations include specific provision for establishing who should act as the legal representative. Since the implementing regulations came into force on 1 May 2004, researchers conducting a large international trial in cardiac arrest (the TROICA trial) have concluded that the scheme for establishing the legal representative and obtaining his or her consent is unworkable for clinical trials set in the context of emergency medicine. Thus, it would prove impossible to include UK patients in such trials unless the UK's requirements were amended.
The Medicines and Healthcare Products Regulatory Agency will consult on a proposal to amend the regulations so that an incapacitated person can be entered into a clinical trial involving emergency treatment prior to consent being obtained from his or her legal representative. This exception to the requirement for prior consent would be subject to strict safeguards. The proposed approach would be consistent with the accepted international standards for conducting clinical trials in emergency situations as set out in the international conference on harmonisation guidelines 2 on good clinical practice, and with the approach for research envisaged in the Mental Capacity Bill.
It is the Government's view that the proposed amendment would ensure that the rights, safety and well-being of those participating in clinical trials of medicines are protected whilst also ensuring that new treatments for medical emergencies can be developed in the UK.
1 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121 1.5.2001 p. 34
NHS Foundation Trusts
The Secretary of State for Health (Dr. John Reid): I have today placed in the Library a list of national health service trusts that submitted a preliminary application for NHS foundation trust status in late November 2004, as part of wave two, and that have been successful in the preliminary application phase. All 32 trusts, including for the first time eight mental health trusts, will now enter the preparatory phase of the application process for NHS foundation trust status.
Applicants must satisfy the requirements of the preparatory phase and retain a three star rating this summer in order to receive my support to make an application to Monitor (whose statutory name is the Independent Regulator of NHS foundation trusts) for consideration for authorisation as a NHS foundation trust. The objective of the preparatory phase is to help applicants to develop the arrangements and systems that they will need to have in place to be established as NHS foundation trusts and operate successfully. The preparatory phase will therefore include developing new governance arrangements, a five year business strategy and a human resources strategy. Applicants will also be required to undergo an independent financial review
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and hold a public consultation where they must demonstrate that they have consulted staff, local NHS partners and the public on their proposals and that their proposals fit with the local vision for health services.
I expect to make decisions on preparatory phase applications in autumn 2005 only after I have had the opportunity to consider fully the outcome of the review into the policy by the Healthcare Commission (whose statutory name is the Commission for Healthcare Audit and Inspection). This is due to be published in summer 2005. Applicants will begin their public consultation only after the outcome of the review is known, which will allow them to take into consideration issues arising from the review when finalising their preparatory phase proposals. Once applicants have received my support, decisions on authorisations will strictly be for Monitor after having satisfied itself of an applicant's preparedness and viability for foundation status.
TRADE AND INDUSTRY
British Energy plc
The Secretary of State for Trade and Industry (Ms Patricia Hewitt): British Energy plc announced on 14 January 2005 that it had successfully implemented the restructuring plan it announced on 28 November 2002.
The Government's overriding objectives in supporting British Energy were nuclear safety and security of electricity supplies. The successful completion of the restructuring has secured these objectives whilst safeguarding the interests of the taxpayer.
I would remind the House that, as part of the restructuring and in addition to the significant contribution being made by British Energy's other financial stakeholders, Government are taking financial
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responsibility for the company's historic spent nuclear fuel liabilities. The estimated cost to Government remains as set out in my statement to the House on 28 November 2002, i.e. £150 million to £200 million a year on average for the next 10 years, falling thereafter. British Energy will also be making new and enhanced payments, including 65 per cent. of its annual free cash-flow, to the nuclear liabilities fund (NLF) which will be used to pay for the costs of decommissioning the company's nuclear power stations and certain other nuclear liabilities. The Government are underwriting the NLF to ensure safety and environmental protection. The Government's support for British Energy has been approved by the European Commission, subject to certain conditions.
British Energy has relisted its shares and will continue as a public limited company managed by its board of directors and subject to the normal private sector disciplines and requirements. The company will have the freedom to run its business, in terms of corporate, operational and financial policies, subject both to the measures the Government have taken in the restructuring agreements, including monitoring arrangements, to manage its financial exposure to British Energy's liabilities, and to conditions attached to the European Commission's approval of the restructuring aid. The restructuring agreements strike a balance between protecting taxpayers' interests and ensuring these private sector disciplines maximise the company's contributions to its liabilities.
The Government restructuring agreement signed on 1 October 2003 has now been fulfilled. It committed the Government to entering into certain legally binding agreements on the restructuring effective date (14 January 2005) and these have now come fully into effect. The principal agreements were set out in my statement to the House of 14 October 2003, Official Report, column 11WS. I will be placing copies of the final versions of these agreements on my Department's website and in the Libraries of both Houses shortly.