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6 Oct 2008 : Column 425W—continued
Herbal Medicine: EU Law
Sir Nicholas Winterton: To ask the Secretary of State for Health what assessment he has made of the impact upon the (a) Chinese and (b) ayurvedic medicinal traditions of the requirement that 15 years use within the European Union must be demonstrated as being part of the qualifying minimum period of 30 years traditional use required for registration of herbal remedies under the Traditional Herbal Medicinal Products Directive; what representations he has received from the (i) Chinese and (ii) Indian communities on these matters; what assessment he has made of whether these geographic requirements comply with the United Kingdom’s obligations under international human rights and trade treaties; and if he will make a statement. [221880]
Dawn Primarolo: Our understanding from discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and the herbal medicine sector is that much of practice in traditional Chinese and Ayurvedic medicine is based on products prepared to meet individual patient needs. The main regulatory route for such herbal medicines in the United Kingdom would be through the provision of section 12(1) of the Medicines Act 1968 rather than traditional herbal registration scheme set up under European Directive 2004/24/EC.
It is likely that it would be possible in some cases for an applicant seeking a product registration under the traditional herbal registration scheme to demonstrate that a traditional Chinese or Ayurvedic medicinal product had had sufficient usage in the European Union (EU) for at least 15 years. There is also a provision in the directive under which the Herbal Medicinal Products Committee at the European Medicines Agency can lower the 15 years requirement in specific cases where all other requirements of the scheme are met.
We recognise that it is necessary to require demonstration of an adequate period of traditional use, given that this is the basis for lifting or easing a number of the normal requirements in medicines regulation in relation to the demonstration of efficacy and safety. However, we would like to see greater flexibility over the requirement for
evidence of usage specifically within the EU. We have received a variety of representations on this issue over a period from a number of interested parties such as businesses and practitioner representatives. These have generally argued the case that the specific requirement for evidence of 15 years use within the EU is unduly onerous. The UK is not in position to set aside the provisions of a European Directive. The MHRA presented the case for changing the European legislative requirements in responding to the European Commission’s consultation in 2007 on the early operation of the directive and also alerted interested parties to the opportunity to comment. We await the outcome of that review.
Sir Nicholas Winterton: To ask the Secretary of State for Health what steps he plans to take to assist small and medium-sized businesses which are specialist manufacturers and retailers of traditional herbal remedies to meet the costs of compliance with the Traditional Herbal Medicinal Products Directive and related measures. [221882]
Dawn Primarolo: Compliance costs of the traditional herbal registration (THR) scheme fall largely on manufacturers and wholesalers rather than retailers. The Medicines and Healthcare products Regulatory Agency (MHRA) has been running an extensive programme to manage the impact of the THR scheme. This has included well over 100 meetings held free of charge to help companies progress their plans and applications. The MHRA has taken a range of measures to help companies, for example publication of public assessment reports on registration granted, and has also issued a range of pragmatic guidance, for example on how companies can use monographs published by the European Herbal Medicinal Products Committee to mitigate the effects of delay in development of the Community positive list. The MHRA regularly meets the industry’s Herbal Forum to discuss progress of the THR scheme and whether there is further action that either MHRA or industry itself can take to facilitate progress. Recently two specialist small or medium sized businesses achieved their first grants of THR, demonstrating the possibilities for this kind of company.
Ann Winterton: To ask the Secretary of State for Health (1) what estimate the Medicines and Healthcare Products Regulatory Agency has made of the number of herbal remedies marketed in the United Kingdom under the provisions of section 12(2) of the Medicines Act 1968; for how many and what percentage of those products an application has been received by the Agency for registration under the Traditional Herbal Medicinal Products Directive; and what the legal status will be of those products for which applications for registration have not been received by the end of the transition period in 2011; [222349]
(2) what his objective is in relation to the future availability of safe and proper herbal remedies; and what steps he is taking to achieve that objective; [222350]
(3) when Ministers of his Department last visited the facilities of small and medium-sized manufacturers of specialist herbal remedies to discuss the impact upon their business of the Traditional Herbal Medicinal Products Directive; [222351]
(4) what steps he has taken to establish whether chromatographic fingerprinting is an appropriate requirement in the testing of multi-ingredient herbal remedies in relation to registration under the Traditional Herbal Medicinal Products Directive; and what estimate he has made of the cost of commissioning such tests for a single product containing several herbal ingredients. [222352]
Dawn Primarolo: Companies are not required to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of products marketed under section 12(2) of the Medicines Act 1968, therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under Directive 2004/24/EC manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration (THR). As now there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over the counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Chromatographic fingerprinting is an accepted methodology in the analysis of herbal products and has been included in European Guidelines and the European Pharmacopoeia since the early 1990s. With regard to multi-ingredient herbal medicinal products it is recognised that identification and assay of individual herbal ingredients in the herbal product is difficult to perform and sometimes impossible. The European Herbal Medicinal Product Committee has recently developed a guideline, in consultation with industry, which addresses the issue of multi-ingredient herbal products. The guideline states that if testing for identity, assay or to demonstrate stability cannot be performed in the herbal product, alternative strategies may be considered. The guideline refers to appropriate fingerprint chromatograms, appropriate overall methods of assay and physical or other appropriate tests. The applicant is therefore able to select appropriate methods and justify their use.
In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme, which includes the cost of conducting appropriate quality testing, could be several tens of thousand pounds. The impact assessment also recognised that the figure would vary widely according to specific circumstances, not least, depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
I recently met a small manufacturer of herbal medicines. The MHRA has had well over a hundred meetings with companies, including small and medium sized businesses, to discuss the progress of actual or prospective applications under the THR scheme. The MHRA has also undertaken a number of site visits.
HIV Infection
Anne Milton: To ask the Secretary of State for Health whether his Department plans formally to include HIV within the schedule of long-term conditions covered by the recommendations of the NHS Next Stage Review. [221822]
Dawn Primarolo: Long term conditions are currently defined as those that cannot at present be cured, but can be controlled by medication and other therapies. The widespread use of combination anti-retroviral therapies to control HIV, means the infection is now managed largely as a long-term condition. By 2010, all people with a long term condition, including those with HIV will be offered a personalised care plan, as recommended in the NHS Next Stage Review.
HIV Infection: Health Services
Mr. Streeter: To ask the Secretary of State for Health (1) what estimate his Department has made of the number of foreign nationals who have come to the UK for the sole purpose of accessing free HIV treatment on the NHS in the last five years; and if he will make a statement; [222414]
(2) what information his Department gathers on the number of (a) asylum seekers, (b) those of uncertain residency status and (c) other migrants who have accessed NHS HIV testing services in the last five years. [222415]
Dawn Primarolo: It is not possible to provide the information requested. Successive governments have not required the national health service to provide statistics on the number of foreign nationals seen, treated or charged under the provisions of the NHS (Charges to Overseas Visitors) Regulations 1989, as amended, nor any costs involved.
Hospitals: Accidents
Mr. Amess: To ask the Secretary of State for Health (1) how many patients experienced a fall in hospital in each health authority in each of the last five years, broken down by (a) age and (b) sex; and if he will make a statement; [222233]
(2) what steps he has (a) taken and (b) plans to take to prevent patient falls in hospital; what recent representations he has received on the issue; what reply he gave; and if he will make a statement. [222234]
Ann Keen: The following table sets out the incident data in relation to patient falls for each English strategic health authority from the 1 January 2006 to 31 December 2007. The incidents summarised in the table have been drawn from the National Patient Safety Agency's (NPSA) National Reporting and Learning System (NRLS). Age and gender are not mandatory fields in the NRLS. It is, therefore, not possible to determine whether the data reflect the true pattern of those patient characteristics.
The data prior to January 2006 have not been included due to the low number of reports received by the NPSA and issues regarding the quality of data.
Steps taken to prevent falls in hospitals include the following:
The NPSA issued a report ‘Slips, trips and falls in hospital’ in February 2007. This included six recommendations to ensure that efforts by hospitals to prevent patient falls are as effective as possible. The Healthcare Commission is reviewing how well trusts are meeting these recommendations in their current round of random and targeted inspections.
In February 2007 the NPSA also produced a Safer Practice Notice ‘Using bedrails safely and effectively’ to help hospitals prevent falls from bed. This included additional resources such as awareness raising posters, staff education materials, and patient leaflets.
The Department makes available best practice guidance, Health Technical Memorandum 61: ‘Flooring’ (latest edition published in February, 2006). This provides guidance on suitable floor finishes in hospitals and includes information on slip resistance. A copy has been placed in the Library.
In addition, in March 2007, the Health and Safety Executive developed the guidance ‘Assessing the slip resistance of flooring. A technical information sheet’. This is intended to assist organisations including the national health service to assess pedestrian slip risks.
The Department has not received any representations on this issue.
Hospitals: Infectious Diseases
Mr. Hancock: To ask the Secretary of State for Health whether healthcare associated infections (HAIs) are always included on death certificates of those patients who die in NHS hospitals subsequent to contracting a HAI; and if he will make a statement. [221824]
Ann Keen: Healthcare associated infections (HCAI) (such as methicillin-resistant Staphylococcus aureus (MRSA) or Clostridium difficile infection) should, like all other illnesses, injuries, and complications of treatment, be included on a death certificate if the certifying doctor considers they contributed to the death directly or indirectly. Patients who die with a HCAI often have several other serious and potentially fatal underlying medical conditions.
The Chief Medical Officer has previously written to all doctors to remind them of their responsibility to provide appropriate information on HCAIs on death certificates and of guidance issued by the Office for National Statistics on death certification. The latest reminder was sent in October 2007.
Mr. Amess: To ask the Secretary of State for Health what (a) guidance, (b) circulars and (c) statutory instruments were issued between (i) 1979 and 1997 and (ii) 1997 and 2002 on the control of healthcare-acquired infections; what (A) ministerial statements and (B) press notices on the subject were issued between 1997 and 2008; and if he will make a statement. [222238]
Ann Keen: The information requested can be obtained only at disproportionate costs.
Mr. Amess: To ask the Secretary of State for Health what steps he (a) has taken and (b) plans to take during the next 12 months to improve hospital cleanliness in (i) Southend-on-Sea, (ii) Essex and (iii) the Metropolitan Police area of London; and if he will make a statement. [222239]
Dawn Primarolo: The Department has given a strong public commitment to improving hospital cleanliness and has in place a comprehensive programme of work to improve hospital cleanliness.
At the national level steps taken to improve cleanliness include;
a deep-clean of all hospitals during 2007-2008 which will enable trusts' strategic and operational cleaning plans to make provision for ongoing deep cleaning activity, all NHS bodies being subject to the Health Act 2006: Code of Practice for the Prevention and Control of Healthcare Associated Infections, which came into force on 1 October 2006.
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