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The department, in collaboration with the Manchester Heart Centre, has set up a National Heart Rhythm Management Devices Taskforce to consider how it might support and encourage local services to increase their implantation rates. The taskforce also hopes to investigate why there are such large discrepancies between PCT performances in this area. The taskforce issued a guide for commissioners on the use of pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices in 2007.
In 2006, backed by the department and industry funding, the Network Device Survey Group made public the first systematic survey of the National Health Service in England and Wales in respect of its level and equity of heart rhythm management device provision compared to local relative need. The information is provided by primary care trust area. Information has now been collected, and shared with cardiac networks, for 2003 to 2006.
In 2006, compared with 2005, there was a 9.9 per cent increase in the overall provision of heart rhythm
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2007 data are currently being collected.
The national information can be found on the Network Device Survey Group’s website at: www.devicesurvey.com.
Lord Colwyn asked Her Majesty’s Government:
How many people diagnosed with cardiac arrhythmia have been treated with (a) cardiac resynchronisation therapy devices, and (b) internal cardioverter defibrillators in each year since the respective National Institute for Health and Clinical Excellence guidance was published (1) in total; (2) in each strategic health authority; and (3) in each NHS trust; and [HL5087]
What the implantation rate for (a) cardiac resynchronisation therapy devices, and (b) implantable cardioverter defibrillators per million population has been in each of the past five years (1) in total; (2) in each strategic health authority; and (3) in each NHS trust. [HL5088]
Lord Darzi of Denham: Centrally available data based on a primary diagnosis of arrhythmia and then the implantation of a heart rhythm device would not pick up all devices implanted. However, a comprehensive survey of the number of devices implanted and implantation rates for each year from 2003 to 2006 has been conducted by the Network Device Survey Group, an organisation funded by the department.
Its latest report can be found at: www.devicesurvey.com
Health: Herbal Products
Lord Pearson of Rannoch asked Her Majesty's Government:
When the statutory registration of herbal medicine practitioners will take effect; and how this will affect the sale of Chinese herbal patent remedies. [HL5034]
The Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham): A decision on whether statutorily to regulate herbal medicine practitioners has not yet been made. The health departments intend to consult publicly later this summer on the recommendations made in Professor Pittilo’s report: Report to Ministers from the Department of Health Steering Group on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK, a copy of which has been placed in the Library.
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Ministers, together with the devolved Administrations, will consider the report and its recommendations in the light of the responses to the consultation and will respond in due course. If a decision is made statutorily to regulate these practitioners, an assessment will be made on the impact of this legislation on the sale of Chinese herbal patent remedies.
Lord Clement-Jones asked Her Majesty's Government:
How many applications for product registrations under the traditional herbal medicinal products directive (2004/24/EC) have been received to date by the Medicines and Healthcare products Regulatory Agency; and in how many of those cases have approvals been given; and [HL5100]
What assessment they have both made of the regulatory impact of the traditional herbal medicinal products directive (2004/24/EC), in particular on (a) small and medium-sized specialist manufacturers of herbal remedies, (b) specialist retailers, and (c) consumer choice; and [HL5101]
What assessment they have made of the numbers of herbal products that have historically been marketed under Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence; how many and what percentage of those products they anticipate will need to secure registrations under the traditional herbal medicinal products directive (2004/24/EC); and what steps they are taking to assist manufacturers with this process; and [HL5102]
By what date herbal products that have historically been marketed under Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence will need to secure registration under the traditional herbal medicinal products directive (2004/24/EC); and whether they plan to ask the European Union to extend that deadline; and [HL5103]
What charges are levied by the Medicines and Healthcare products Regulatory Agency for processing applications for product registrations under the traditional herbal medicinal products directive (2004/24/EC) for (a) single ingredient products, and (b) more complex products. [HL5104]
Lord Darzi of Denham: The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousand pounds but 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. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over-the-counter herbal medicines made to assured standards of safety, quality and product information.
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Companies are not required to notify the 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 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 MHRA continues to provide a range of help to companies aimed at assisting them to progress plans to register products, including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website.
From 30 April 2011 no herbal medicine within the scope of directive 2004/24/EC may be placed on the UK market or distributed by way of wholesale dealing without a traditional herbal registration. 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. We have no plans to ask the European Commission to propose legislation extending the deadline in directive 2004/24/EC.
The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for a single existing ingredient to £7,480 for complex new products. The fees charged by the MHRA are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with Treasury guidance.
MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.
Earl Howe asked Her Majesty's Government:
How many applications under the traditional herbal medicinal products directive (2004/24/EC) the Medicines and Healthcare products Regulatory Agency expects to receive for (a) single ingredient products, and (b) more complex products; and [HL5127]
What are the principal quality and efficacy tests which must be met by manufacturers submitting products for registration under the traditional herbal
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What are the requirements under the traditional herbal medicinal products directive (2004/24/EC) for a qualified person to be employed to authorise the release of herbal products to the market; what purpose is served by those requirements; and what assessment they have made of the costs associated with the requirements for a small manufacturer of specialist herbal remedies; and [HL5129]
What are the requirements under the traditional herbal medicinal products directive (2004/24/EC) for the certification of manufacturing premises; what charges are levied by the Medicines and Healthcare products Regulatory Agency for inspections associated with such certification; and how many facilities to date have been (a) inspected, and (b) appropriately certified as meeting the necessary standards; and [HL5130]
What was the outcome of the recent review of the operation of the traditional herbal medicinal products directive (2004/24/EC) undertaken by the European Commission; what period was covered by the review; and whether they intend to press for the review to be repeated now that the directive is in force. [HL5131]
Lord Darzi of Denham: It is a commercial decision for individual companies whether to apply for a traditional herbal registration (THR) under the provisions flowing from directive 2004/24/EC. The Medicines and Healthcare products Regulatory Agency (MHRA) is not in a position to estimate how many applications will be submitted. So far the MHRA has received 38 THR applications, of which 33 are for products containing a single active ingredient and five are for combination products. The MHRA expects that a high proportion of early applications will be for relatively simple products while companies become accustomed to meeting the regulatory requirements of the scheme.
There is normally no requirement for applicants to submit information on the efficacy of the product under the THR scheme. The quality requirements for herbal medicinal products and traditional herbal medicinal products are set out in detailed guidance documents following consultation with industry. The European Pharmacopoeia also sets out legally binding standards for herbal ingredients as well as excipients used in herbal medicinal products. The purpose of the quality tests is to ensure that the herbal medicinal product is safe for use and has a reproducible quality over its proposed shelf-life. Tests are required to ensure that the correct plant materials are used, free from potentially hazardous contaminants such as pesticide residues, fumigant residues, heavy metals/other toxic elements, mycotoxins, bacteria/fungi. Where herbal extracts are employed tests are required on all materials used, including solvents and reagents used for extraction, to ensure that they are as intended and of acceptable quality. The herbal extract undergoes tests to ensure it is of reproducible quality and that it is free from hazardous levels of, for example, residual solvents,
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In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but 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.
European and United Kingdom medicines legislation requires manufacturers and/or importers of registered traditional herbal medicines for human use to hold a manufacturer's licence. It is a condition of such a licence that the holder must have a qualified person (QP). The QP must either meet existing specific educational and vocational requirements or attain status through transitional arrangements. The QP has a personal responsibility for certifying that each batch of registered traditional herbal medicine has undergone the appropriate tests, complies with its registered specification and has been manufactured in accordance with good manufacturing practice. The purpose of these requirements is to ensure that a safe quality traditional herbal medicine is placed on the market.
The directive on traditional herbal medicinal products requires manufacturers of registered herbal medicines to be authorised by the national competent authority. In the UK, the MHRA authorises and inspects manufacturers. The inspection fee is currently £1,496 for a full day and £920 for half a day. Manufacturers must meet certain conditions and employ a QP in order to be authorised. A number of manufacturers were already authorised to manufacture herbal medicines before the directive came into force. Since the implementation of the directive all of the small number of manufacturers who have applied specifically to manufacture registered herbal medicines have been authorised.
The European Commission launched a public consultation in May 2007 on the review of the operation of directive 2004/24/EC. The consultation included data up to March 2007. It is the European Commission's responsibility to report on the findings of that review and, pending that outcome, we have no present plans to press for an early second review.
Baroness Gardner of Parkes asked Her Majesty's Government:
Which herbal products are currently available on the market under Section 12(2) of the Medicines Act 1968; and for which of those products an application has been received by the Medicines and Healthcare products Regulatory Agency for registration under the traditional herbal medicinal products directive (2004/24/EC); and [HL5020]
Lord Colwyn asked Her Majesty’s Government:
How many applications have been made to date for registration of herbal products under the provisions of the traditional herbal medicinal products directive; and[HL5056]
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What estimate the Medicines and Healthcare products Regulatory Agency has made of the number of herbal remedies currently marketed in the United Kingdom under 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 will be the legal status of those products for which applications for registration have not been received by the end of the transition period in 2011; and [HL5057]
What their objectives are in relation to the future availability of popular herbal remedies; and what specific steps they are taking to achieve that objective; and [HL5058]
When Ministers last visited the facilities of small and medium-sized manufacturers of specialist herbal remedies to discuss the impact on their business of the traditional herbal medicinal products directive. [HL5059]
Lord Darzi of Denham: The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily.
Companies are not required to notify the 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. 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.
Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies,
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Baroness Howe of Idlicote asked Her Majesty's Government:
Whether they will ensure that botanical food supplements containing ingredients for which claims are approved under the provisions of the Nutrition and Health Claims Regulations can continue to be marketed under food law; and [HL5060]
What steps they are taking to ensure that the European Food Safety Authority does not introduce disproportionately difficult thresholds for evidence to support health claims submitted for approval under the provisions of the Nutrition and Health Claims Regulations for botanical ingredients. [HL5061]
Lord Darzi of Denham: The Nutrition and Health Claims Regulations require that the substances for which a claim is made are shown to have a beneficial nutritional or physiological effect and that this is substantiated by generally accepted scientific evidence, taking into account the totality of the available scientific data and by weighing the evidence. The Food Standards Agency for the United Kingdom has ensured that the request to the European Food Safety Authority from the European Commission for independent scientific advice conforms to the requirements of the regulations.
Baroness Howe of Idlicote asked Her Majesty's Government:
What statistics they have collected about the number of specialist manufacturers and distributors of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and [HL5062]
What statistics they have collected about the number of specialist retailers of herbal remedies who have ceased trading or intend to cease trading as a result of the impact of the traditional herbal medicinal products directive; and [HL5063]
What estimate they have made of the costs per product of conducting tests to demonstrate compliance with the key provisions of the European Medicines Agency guidance on applications for registration under the traditional herbal medicinal products directive. [HL5064]
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