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Food Supplements
Mr. Laurence Robertson: To ask the Secretary of State for Health if he will make a statement about the incorporation of EU directives on food supplements and herbal medicines into UK law; and what assessment he
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has made of the impact on the over the counter availability of food supplements and herbal medicines following the incorporation into UK law of the EU directives. [57973]
Ms Blears [holding answer 22 May 2002]: The food supplements directive must be transposed into UK law by the last day of the month, one year after the date of entry into force of the Directive.
The Directive will not immediately outlaw any products already on the UK market. Lists of permitted vitamin and mineral sources remain open, pending safety assessments for additional substances. The Government welcomes the amendment to Article 4(6)(b) which was recently adopted by the European Parliament and which extends the time for dossier submission from 18 to 36 months after the Directive comes into force. The Directive gives Member States the opportunity to allow continued sale of products containing vitamin and mineral sources not yet on the permitted list for up to seven years after the Directive comes into force, pending safety assessment of these sources. When implementing the Directive, the Government intends to take full advantage of this flexibility.
Incorporation into United Kingdom law of the proposed Directive on Traditional Herbal Medicinal Products will be subject to the outcome of European negotiations. On the basis of the formal proposals published in January 2002 by the European Commission, we anticipate that consumers will have continuing access to a wide range of traditional herbal remedies sold over the counter.
Features of the proposed Directive which might, in principle, inhibit availability are the requirements relating to safety and quality and the definition of traditional use. However, our assessment is that the introduction of the proposed safety and quality standards is necessary for effective public health protection and the maintenance of public confidence in the sector. This in turn will ultimately affect the strength of public demand for herbal remedies. The proposed standards are ones which are already successfully met by many manufacturers in UK and elsewhere of traditional herbal remedies.
As to the definition of traditional use, we take the view that a large number of unlicensed herbal remedies currently on the market, and sold legally under Section 12(2) of the Medicines Act, 1968, have a strong basis in tradition and so should be able to satisfy the requirement to demonstrate traditional usage. This assessment is based, for example, on the extensive herbal literature covering various herbal traditions, on the activities of herbalists over many decades in supplying herbal medicinal products to individual patients following consultation, and on the existence of large numbers of long-standing licensed herbal remedies in the UK and elsewhere.
It will not be possible to predict for some time to come the full extent to which herbal remedies will be sold under this Directive. One important issue is that there are likely to be significant numbers of products with a clear basis in tradition and containing herbal ingredients which, depending on the presentation of the company's specific product, may legally be sold either as medicines or in another regulatory product category such as food, cosmetic or general consumer product. There may
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therefore be options for companies in relation to many such products as to which regulatory route would be most advantageous.
The Medicines Control Agency is holding a public consultation on the proposed Directive including its likely regulatory impact. The consultation document (MLX 283) can be viewed on the Agency's website www.mca.gov.uk. The consultation period closes on 21 June 2002.
Food Standards (Mobile Retailers)
Tim Loughton: To ask the Secretary of State for Health, pursuant to the answer given to the hon. Member for Pendle (Mr. Prentice) on 26 April 2002, Official Report, column 519W, on food standards (mobile retailers), what extra resources the Government are planning to give local authority environmental health inspectors in the enforcement of food hygiene standards of mobile retailers and takeaway establishments. [59547]
Ms Blears [holding answer 24 May 2002]: Local authorities already receive funding, through the revenue support grant, to enable them to undertake food law enforcement inspections to the full range of food premises, of which mobile retailers form a very small part. It is for individual local authorities to decide specific resource allocations for these purposes.
Hepatitis
Tim Loughton: To ask the Secretary of State for Health what studies have been carried out into the anticipated incidence of chronic hepatitis B over the (a) next 5 years and (b) next 10 years. [60520]
Ms Blears [holding answer 10 June 2002]: The public health laboratory service (PHLS) has estimated the current incidence of chronic hepatitis B infection using laboratory reports of acute hepatitis B infection from 1992 to 1996. The estimate is based on reports to the PHLS, the proportion of cases that develop symptoms and the proportion that progress to chronic infection.
The PHLS estimates that in the United Kingdom, there are an annual average of 311 hepatitis B infections that lead to chronic infection.
Tim Loughton: To ask the Secretary of State for Health if he will list (a) the members of the Steering Group on hepatitis C and (b) the terms of reference of the group. [60406]
Ms Blears [holding answer 10 June 2002]: The membership of the Hepatitis C strategy steering group is as follows:
- Chairman
Professor Howard Thomas, Imperial College School of Medicine, London and Chairman, Advisory Group on Hepatitis
Members
John Bryce, lay member
Jim Camp, Needle Exchange Forum
Hannah Cinamon, Health Promotion England (until November 2001)
Professor Chris Day, Medical School, Newcastle University
Manlio Fahrni, Chair of Re-act and vice-chair of the recently launched national forum, the UK Assembly on Hepatitis (from September 2001)
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Jo Guy, Hepatology Nurse Specialist, Southampton General Hospital
Dr. Paul Hatton, Consultant in Communicable Disease Control, Leeds health authority and member, Advisory Group on Hepatitis
Lorraine Hewitt, Action on Hepatitis C and member, Advisory Council on the Misuse of Drugs
Nigel Hughes, British Liver Trust
Professor Will Irving, Department of Microbiology, University of Nottingham and member, Advisory Group on Hepatitis
Tania Machell, Head of National Hepatitis C Resource Centre, Mainliners (from July 2001)
Grant McNally, National Drug Users Development Agency
Dr. Mary Ramsay, Public Health Laboratory Service Communicable Disease Surveillance Centre
Professor Gerry Stimson, Centre for Research on Drugs and Medicine, Imperial College School of Medicine, London
Professor John Strang, Director of the National Addiction Centre, Maudsley Hospital, London and member of the Advisory Council on the Misuse of Drugs
Monique Tomlinson, Deputy Director, Mainliners (until July 2001)
Dr. Martyn Wake, General Practitioner, south west London.
"To oversee development of the Department's strategic approach to hepatitis C by bringing together issues relating to prevention, control and treatment and to produce a document within the year, for consultation with the national health service, professional bodies and the voluntary sector and community sectors".
Tim Loughton: To ask the Secretary of State for Health what studies have been carried out since 1997 to monitor the changes in the epidemiology of hepatitis C infection in England following the introduction of an effective antiviral treatment with interferon and ribavirin; and if he will make a statement. [60526]
Ms Blears [holding answer 10 June 2002]: We are not aware of any national studies on the effect of the introduction of treatment for hepatitis C infection with interferon and ribavirin on its epidemiology.
Tim Loughton: To ask the Secretary of State for Health, pursuant to his answer of 10 May 2002, Official Report, column 406W, on hepatitis C, what proportion of those cases identified had persistent viraemia. [60404]
Ms Blears [holding answer 10 June 2002]: The information requested is not available. However, several studies have shown that persistent viraemia occurs in about 80 per cent. of cases with antibody positive hepatitis C diagnoses.
Tim Loughton: To ask the Secretary of State for Health, pursuant to his answer of 10 May 2002, Official Report, column 406W, on hepatitis C, if the figures given included testing carried out in virology departments of teaching hospitals and private laboratories. [60403]
Ms Blears [holding answer 10 June 2002]: The information already provided about antibody positive hepatitis C diagnoses does include those reported to the public health laboratory service (PHLS) by laboratories in teaching hospitals and the private sector.
Most national health service microbiology laboratories (including laboratories in teaching hospitals) and some private microbiology laboratories voluntarily report
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diagnoses of hepatitis C to the PHLS. Reports from private laboratories form a very small proportion of all reports received.
Tim Loughton: To ask the Secretary of State for Health what proportion of patients have chronic liver diseases in the UK owing to chronic infection with hepatitis C virus. [60522]
Ms Blears [holding answer 10 June 2002]: The data requested are not available. However, in 2000–01, there were 27,827 finished consultant episodes in national health service hospitals in England with a primary diagnosis of liver disease. Of these, 524 finished consultant episodes had a secondary diagnosis of chronic viral hepatitis C.
- Notes:
- 1. A finished consultant episode is defined as a period of patient care under one consultant in one health care provider. The figures do not represent the number of patients, as one person may have several episodes within the year.
- 2. Occasionally there may be missing records or missing diagnosis/operation codes in the HES records so a scaling factor is applied to allow for this. However these grossing factors have not yet been applied to the 2000–01 data.
- Source:
- Hospital Episode Statistics (HES), Department of Health.
Tim Loughton: To ask the Secretary of State for Health how many people have been diagnosed with acute hepatitis (a) A, (b) B, (c) C, (d) D, (e) E and (f) G in each year since 1990; and if he will make a statement. [60521]
Ms Blears [holding answer 10 June 2002]: The information available is given in the tables.
| Number of people diagnosed | |
|---|---|
| Hepatitis A infection | |
| 1990 | 7,545 |
| 1991 | 7,202 |
| 1992 | 6,762 |
| 1993 | 3,957 |
| 1994 | 2,413 |
| 1995 | 1,750 |
| 1996 | 1,086 |
| 1997 | 1,310 |
| 1998 | 1,104 |
| 1999 | 1,389 |
| 2000 | 1,047 |
| 2001 | 772 |
| Acute hepatitis B infection | |
| 1990 | 618 |
| 1991 | 572 |
| 1992 | 531 |
| 1993 | 629 |
| 1994 | 631 |
| 1995 | 614 |
| 1996 | 569 |
| 1997 | 652 |
| 1998 | 843 |
| 1999 | 725 |
| 2000 | 661 |
| 2001 | 534 |
(22) 2001 data are provisional.
Source:
Public Health Laboratory Service
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| Number of people diagnosed | |
|---|---|
| Hepatitis E infection | |
| 1994 | 12 |
| 1995 | 33 |
| 1996 | 52 |
| 1997 | 21 |
| 1998 | 56 |
| 1999 | 30 |
| 2000 | 34 |
| 2001 | 25 |
(23) 2001 data are provisional
Source:
Public Health Laboratory Service
The majority of cases of acute hepatitis C infection do not result in symptoms. Laboratory reports of antibody to hepatitis C do not distinguish between new and previous infections. Hepatitis D can only occur in people infected with hepatitis B and separate data on hepatitis D infections are not collected routinely. Hepatitis G is not known to cause hepatitis.
Tim Loughton: To ask the Secretary of State for Health when he will publish the consultation paper on a strategy for hepatitis C. [60405]
Ms Blears [holding answer 10 June 2002]: I refer the hon. Member to the answer given to him by my hon. Friend the Member for Pontefract and Castleford (Yvette Cooper) on 14 May 2002, Official Report, column 630W.
Tim Loughton: To ask the Secretary of State for Health (1) what (a) percentage and (b) sums of the budgets of each health authority and primary health trust in England are allocated for the treatment of hepatitis C; [60525]
- (2) if additional funding will be made available to primary health trusts for the use of pegylated interferon for the antiviral treatment of chronic hepatitis C, and if he will make a statement. [60523]
Ms Blears [holding answer 10 June 2002]: Health authority allocations for 2002–03 increased by £3,704 million, or 9.9 per cent.
It is for health authorities in partnership with primary care trusts and other local stakeholders to determine how best to use their funds to meet national and local priorities for improving health, tackling health inequalities and modernising services.
A key priority for the use of additional funding is the implementation of guidance from the National Institute for Clinical Excellence (NICE). We have referred pegylated interferons for the treatment of hepatitis C to NICE for inclusion in its work programme.
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