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Traditional Medicines: Proposed Directive
Lord Colwyn asked Her Majesty's Government:
- Further to the Written Answer by Lord Hunt of Kings Heath on 12 December (WA 15), whether it is their policy, in discussions on the proposed Traditional Use Medicines Directive, to extend its scope to include products which are combinations of herbs with other ingredients which have been on the market for the qualifying period either as part of the combination in question or as separate ingredients; and[HL247]
Further to the Written Answer by Lord Hunt of Kings Heath on 12 December (WA 15), whether it is their policy, in discussions on the proposed Traditional Use Medicines Directive, to reduce the 30-year qualifying period for the demonstration of traditional use to a shorter period which would reflect the conditions of the existing United Kingdom market; and if not, why not; and[HL248]
Further to the Written Answer by Lord Hunt of Kings Heath on 12 December (WA 15), whether in their view the proposed Traditional Use Medicines Directive is likely to provide a secure regulatory home on the market for products which are safe combinations of herbal remedies and food ingredients; and, if not, what steps they intend to take to provide one.[HL249]
The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): Our priority in continuing European discussions on the proposed directive is to achieve a secure regulatory regime for traditional herbal remedies. We are aware that there are also some traditional medicines which consist wholly or partly of non-herbal ingredients. Our current position is that, once the directive goes beyond relatively discrete categories such as traditional herbal remedies, it may become more difficult to contain the wider public health and regulatory consequences. We therefore wish to continue to review the developing shape of the directive and the implications for overall medicines regulation before firmly committing ourselves to supporting the principle that coverage should extend more widely.
We are also considering carefully our detailed position on the definition of traditional use, including the qualifying time period, and on criteria which might apply in the case of combinations. One general consideration is that the normal regulatory requirements for medicines include demonstration of efficacy. While we have advocated in Europe the specific case for lifting the requirement for efficacy in the case of genuinely traditional herbal remedies, we would have concerns about the potential implications if the parameters for traditional use were set so loosely that a very wide range of medicinal products were no longer required to demonstrate efficacy.
At this stage we do not yet know the views of other member states on specific issues relating to combination products. We would expect a clearer picture to emerge over the coming months as European discussions continue. The Medicines
Control Agency (MCA) has submitted our initial response to the European Commission on the preliminary draft of the proposed directive. Copies of the MCA's letter will be placed in the Library. We will continue our current consultative approach with herbal interest groups.Hospital Patients: Use of First Name
Lord Monson asked Her Majesty's Government:
- Whether the current practice of routinely addressing hospital patients only by their first name accords (a) with government policy and (b) with standard practice in other western countries.[HL261]
Lord Hunt of Kings Heath: The current Patient's Charter states that staff should ask patients whether they want to be called by their first or last name and respect their preference. We do not hold information about practices in other western countries.
Reproductive Cloning
Lord Alton of Liverpool asked Her Majesty's Government:
- When they intend to introduce a Bill which they have promised to prohibit reproduction cloning.[HL257]
Lord Hunt of Kings Heath: The Government regard human reproductive cloning as ethically unacceptable.
In their response (Cmnd 4833) to the report of the Chief Medical Officer's Expert Advisory Group, Stem Cell Research: Medical Progress with Responsibility, the Government announced that they would bring forward legislation to set out unequivocally the ban on human reproductive cloning when parliamentary time allows.
Therapeutic Cloning
Lord Alton of Liverpool asked Her Majesty's Government:
- Whether they will set up a House of Lords Select Committee to inquire into the issue of therapeutic cloning to enable conflicting claims about the respective benefits of the use of embryonic stem cells and adult stem cells to be fully considered.[HL258]
Lord Hunt of Kings Heath. These issues were fully considered by the Chief Medical Officer's Expert Advisory Group set up in June 1999 and discussed in its Report: Stem Cell Research: Medical Progress with Responsibility. Since publication of the report in August 2000 members of the expert group have continued to review the research on this issue. They confirm that, while other sources of stem cells are demonstrating possibilities, research using human embryos remains essential to reap the full benefits in terms of treating serious diseases.
This is a view supported by many scientific bodies and individuals at the forefront of research involving both adult and embryonic stem cells. What is important is that research into both adult and human embryonic stem cells is able to take place.
Lord Alton of Liverpool asked Her Majesty's Government:
- Following their decision to permit procedures which could lead to therapeutic cloning, what action they will take if this is contrary to European Union law.[HL259]
Lord Hunt of Kings Heath: On 13 December the European Parliament voted to set up a temporary committee on human genetics and other new technologies in modern medicine and the United Kingdom will be fully involved in the committee's deliberations. However, the European Commission has already stated that there are no plans for harmonisation or Community legislation in this area.
Medical Toxicology Unit and Agrochemical Companies
The Countess of Mar asked Her Majesty's Government:
- Whether they consider that the employment in the outpatients department of the Medical Toxicology Unit (formerly the National Poisons Unit) of a clinical consultant who is also employed by the agrochemical company Syngenta (formerly Zeneca) might lead to a potential conflict of interest in view of the role of the MTU in the collection of data relating to pesticide poisoning incidents.[HL66]
Lord Hunt of Kings Heath: The Medical Toxicology Unit, as part of Guy's and St Thomas' Hospital NHS Trust, requires all consultant staff to adhere to the trust's policies on disclosure of interest and additional earnings. As a general rule this requires staff to register any other paid employment. It is the trust's view that this covers situations where consultants who hold part-time positions within the trust work for other employers during the time when they are not employed by the trust.
The Countess of Mar asked Her Majesty's Government:
- What employment contracts, consultancies (whole or part-time) or liaison arrangements have existed between the agrochemical companies Zeneca and Novartis or their predecessors and the Medical Toxicology Unit (formerly the National Poisons Unit) since 1990; and how many of these arrangements are current.[HL67]
Lord Hunt of Kings Heath: There are no employment contracts or consultancies between the Medical Toxicology Unit and the agrochemical companies Zeneca and Novartis or their predecessors. The Medical Toxicology Unit has received funding from Zeneca to maintain a database on the incidence
of paraquat poisoning in the United Kingdom. This project was originally set up in 1980 at the request of the Ministry of Agriculture, Fisheries and Food. The Medical Toxicology Unit has also received funding from Zeneca in 2000 towards the establishment of a specialist registrar position in medical toxicology with an emphasis on agrochemical toxicology and product safety.
The Countess of Mar asked Her Majesty's Government:
- Whether Ethics Committee approval was necessary for any joint staffing arrangements between the Medical Toxicology Unit (formerly the National Poisons Unit) and agrochemical companies.[HL68]
Lord Hunt of Kings Heath: There are no joint staffing arrangements between the Medical Toxicology Unit and agrochemical companies. All staff are required to adhere to the trust's policies on disclosure of interest and additional earnings.
The Countess of Mar asked Her Majesty's Government:
- Whether any members of staff employed by the Medical Toxicology Unit (formerly the National Poisons Unit) have a formal qualification in crop protection science or have published research in pesticide-related science; and, if so, who they are.[HL91]
Lord Hunt of Kings Heath: The consultant grade scientist who is the manager of the National Poisons Information Service (London centre), which is part of the Medical Toxicology Unit, was awarded a post-graduate diploma in crop protection from Harper Adams Agricultural College.
Publications on organophosphate pesticide related science/disease by the Medical Toxicology Unit staff have appeared in the following journals:
- Human and Experimental Toxicology,
- Human Toxicology,
- New England Journal of Medicine,
- British Journal of Anaesthesia,
- Anaesthesia, and
- Public Health British Medical Journal.
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