|Previous Section||Index||Home Page|
The functions of NHS walk-in centres, as established in Great Britain, will be provided in Northern Ireland by health and care centres, which bring together a range of primary and community-based care services into a 'one stop shop', and local hospitals, as defined in Developing Better Services". Work is
21 Jun 2005 : Column 965W
currently in progress on the building of three of these centres in Belfast. Plans for a network of similar centres across Northern Ireland are currently being developed by HSS boards and trusts.
Jane Kennedy: Data from the Prescription Pricing Authority indicates that, in 2004, 192,000 prescription items were dispensed in the community in England for antidepressant drugs to children under 16 and young people aged 16 to 18 in full-time education. Data is not collected on the number of people for whom these prescriptions were dispensed, nor the proportion which they represent.
Based on the work of its expert working group on the selective serotonin reuptake inhibitors (SSRIs), the committee on safety of medicines (CSM) issued advice on the use of SSRIs in children and adolescents in June, September and December 2003. That advice was that the balance of risks and benefits for the treatment of depressive illness in under-18s is judged to be unfavourable for paroxetine (Seroxat), venlafaxine (Efexor), sertraline (Lustral), citalopram (Cipramil), escitalopram (Cipralex) and mirtazapine (Zispin). It is not possible to assess the balance of risks and benefits for fluvoxamine (Faverin), due to the absence of paediatric clinical trial data. Only fluoxetine (Prozac) has been shown in clinical trials to be effective in treating depressive illness in children and adolescents, although it is possible that, in common with the other SSRIs, it is associated with a small increased risk of self-harm and suicidal thoughts. Overall, the balance of risks and benefits for fluoxetine in the treatment of depressive illness in under-18s is judged to be favourable. This advice was reiterated in December 2004, when the report of the expert working group was published.
The National Institute for Health and Clinical Excellence is developing a guideline on the identification and management of depression in children and young people in primary, community and secondary care, which is due to be published in September 2005.
21 Jun 2005 : Column 966W
Mr. Dismore: To ask the Secretary of State for Health if she will make a statement on performance against targets for accident and emergency waiting times at Barnet hospital in (a) 200405 and (b) the last month. 
Jane Kennedy: The information is not available in the format requested. Performance figures for Barnet and Chase Farm Hospital National Health Service Trust for 200405, giving the percentage of patients who spend less than fours hours in accident and emergency, are shown in table 1.
These figures include a proportion of accident and emergency services which are provided by its partner primary care trust (PCT). 73 per cent. of Barnet PCTs performance is mapped to Barnet and Chase Farm Hospital NHS Trust.
A capital incentive scheme was launched in January 2004. Under this scheme, each trust that meets the five thresholds identified can access payments of up to £0.5 million. Four of these thresholds were in 200405. The performance requirements for each threshold are shown in table 2.
To ask the Secretary of State for Health what progress the Government have made towards the
21 Jun 2005 : Column 967W
2004 public service agreement target to reduce cancer mortality in people under 75 years by at least 20 per cent. 
Ms Rosie Winterton [holding answer 20 June 2005]: We are on course to meet the target by 2010. The latest information, for the three years from 2001 to 2003, shows a 12.2 per cent. reduction in mortality rates in people under 75 years against the 199597 baseline.
Mr. Brady: To ask the Secretary of State for Health (1) what assessment her Department has made of theeffect that the Clinical Trials Directive has had on the length of time taken for clinical trials to be approved; 
(2) what assessment her Department has made of the effect that the Clinical Trials Directive has had on the volume of paperwork and administrative work which has to be completed and submitted by researchers before a project is approved; 
Jane Kennedy: The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) that implement the European Union Clinical Trials Directive 2001/20/EC in the United Kingdom came into force on 1 May 2004.
The regulations provide a statutory basis for the regulation of the commencement and conduct of clinical trials of medicines. Most of the provisions were part of existing UK clinical trials regulation. The regulations require a positive opinion from an ethics committee and an authorisation issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
To achieve this, the regulations provided for the UK Ethics Committee Authority to recognise ethics committees and oversee the ethics review system. The regulations also provide for a single UK-wide opinion for multi-centre studies and set a defined time period60 daysand restrict previous time-consuming reiteration of correspondence passing between applicant and committee. This has streamlined previous procedures while reinforcing the protection of research subjects. Throughout the first year of these regulations UK ethics committees have operated well within the 60-day target.
The regulations shortened MHRA's statutory response times to 30 days from 35 days and the Government agreed a pharmaceutical industry competitiveness task force performance target for response to applications for phase I trials of a mean of 14 days, with a maximum of 21 days. In the first year following implementation, the MHRA has met its deadline of 14 days for phase I applications and of 30 days for all other applications. The MHRA has no additional application process.
For regulatory approval for pharmaceutical company trials, the documentation required under the new legislation is similar to that required under the previous system. Non commercial researchers have a simplified application procedure requiring an
21 Jun 2005 : Column 968W
application form and protocol and minimal supporting data. This is similar to the procedure before the clinical trials regulations came into force. The new application form is the same for all types of trial and has been designed to avoid unnecessary bureaucracy. It uses check boxes rather than free text and typically takes 20 to 30 minutes to complete.
|Next Section||Index||Home Page|