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Mr. Paterson: To ask the Secretary of State for Health how many drugs have been approved by the European Medicines Evaluation Agency for formal marketing approval in each of the last five years. 
Jane Kennedy: The European Commission, which approves products through European Medicines Agency procedures, publishes a community register of medicinal products for human use, which lists the following numbers of marketing authorisation approvals:
Mr. Burns: To ask the Secretary of State for Health (1) what assessment she has made of whether the consultation process undertaken by the Food Standards Agency on proposed changes in the regulation of tryptophan in food supplements was consistent (a) with the principles set out in Cabinet Office code of practice on consultation and (b) with the code of good practice in consultations and policy appraisal; and if she will make a statement; 
(3) what steps the Food Standards Agency took to communicate with stakeholders about its proposals for new regulations on the use of tryptophan in food supplements after the closure of its formal consultation exercise and prior to the laying of statutory instruments; 
(4) why the Food Standards Agency proposed lower limits for the use of tryptophan in food supplements than the levels established by the agency's Ad Hoc Expert Advisory Committee on Vitamins and Minerals. 
Caroline Flint [holding answer 27 October 2005]: The consultation process carried out by the Food Standards Agency (FSA) included preparing a regulatory impact assessment (RIA) to determine the impact on industry and consumers, which was followed by a 12-week consultation period with stakeholders on the proposed regulations and the draft RIA. The impact on industry, on allowing the re-introduction of L-tryptophan into supplements, was considered and on balance was considered to be positive given that supplements containing tryptophan have been prohibited for sale since 1990. Consumer choice will also be increased without presenting an appreciable risk to health. This approach is consistent with the Cabinet Office code of practice on consultation and the code of good practice in consultations and policy appraisal.
The use of advisory statements was not considered appropriate due to the severity of the symptoms of eosinophilia-myalgia syndrome in people taking dietary supplements containing tryptophan pre-1990, and the uncertainty relating to gaps in the scientific evidence.
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The United Kingdom Government's committee on toxicity (COT) decided to recommend a daily dose level of 220 milligrammes (mg) on a precautionary basis that would not present an appreciable risk to health.
Following the closure of the formal consultation exercise on the regulations for the use of tryptophan in foods, the COT secretariat has reviewed the data submitted by respondents. They found that there was no new evidence to that already reviewed by COT in 2004, when it reached its conclusions on the safety of tryptophan that would support a higher level of tryptophan being used in food supplements. The FSA therefore adopted the level and purity criteria recommended by COT, and this has therefore been adopted into UK legislation to reintroduce the sale of tryptophan supplements in the UK, in the interests of consumer choice and safety. We have asked COT to review its recommendation and any new information on tryptophan since June 2004, and this will be considered at the COT meeting in December. Depending on COTs advice the legislation may be amended. A summary of consultation responses and full RIA will be sent to all respondents, and made available on the FSA website.
Tryptophan was not considered by the expert group on vitamins and minerals (EVM) as it is not a vitamin or mineral. The EVM proposed safe upper levels (SULs) for vitamins and minerals using the well-established paradigm for setting acceptable and tolerable intake levels for chemicals in food. Where the data were not adequate to set a SUL, the EVM gave guidance on levels that would not be expected to result in adverse effects.
The COT uses the same paradigm in its consideration of the safety of tryptophan as a supplement. In its evaluation the COT noted significant uncertainties and decided that an uncertainty factor of 10 should be applied to derive a dose that would not be expected to be a risk to health in the general population. The limit proposed by the COT was 220 mg of tryptophan per day.
The independent sector treatment programme is an efficient and cost effective use of the private sector capacity to reduce waiting times and offer choice across the NHS. The programme is targeted at independent sector providers who are able to make available additional capacity to NHS commissioners. We are following strict procurement regulations, and have not restricted any organisation from expressing an interest and then participating in the procurement.
There is no legal restriction preventing a national health service foundation trust (NHSFT) advertising its services abroad to attract non-United
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Kingdom patients. However, NHSFTs are bound by a duty to provide NHS services to NHS patients according to NHS values and principles and cannot increase their income from private patients at the expense of NHS patients. Section 15 of the Health Care Act 2003 provided for a private patient cap on such income for NHSFTs.
Mr. Lansley: To ask the Secretary of State for Health pursuant to the answer of 14 October 2005, Official Report, column 626W, on GP practices, how many general practitioners, excluding retrainers and registrars are projected to leave the national health service work force at age 55 or above in total between 2005 and 2015, broken down by (a) strategic health authority area and (b) primary care trust area; and how many general practitioners excluding retrainers and registrars have left the national health service work force at age 55 or above in each year since 1990. 
Mr. Byrne: Information relating to the number of general practitioners, excluding retainers and registrars projected to leave the national health service at age 55 or above in total between 2005 and 2015 broken down by strategic health authority and primary care trust could be provided only at disproportionate cost.
|Leavers from||GPs of 55 and over leavers (headcount)|
Helen Goodman: To ask the Secretary of State for Health what assessment she has made of whether overcapacity will emerge in the NHS under the Government's policy of promoting a choice of healthcare provider for NHS patients. 
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