HO 30

 

 

Memorandum submitted by the British Association of Homeopathic Manufacturers

 

 

 

 

1. The British Association of Homeopathic Manufacturers (BAHM) welcomes the opportunity to submit evidence to the Science and Technology Select Committee's evidence check for homoeopathy. As the trade association for the manufacturing industry, we act as the focus point for discussions between the Medicines and Healthcare Products Regulatory Agency (MHRA) and industry, ensuring that homoeopathic products are produced to the highest quality and safety standards.

 

2. We provide evidence below on the following issues:

 

Government policy on licensing of homoeopathic products

Government policy on the funding of homoeopathy through the NHS

The evidence base on homoeopathic products and services

 

 

About the British Association of Homoeopathic Manufacturers

 

3. The British Association of Homoeopathic Manufacturers was founded in 1992 to act as a central point for discussions between UK licensed homoeopathic manufacturing industry and the (then) Medicines Control Agency (MCA) in the run-up to the introduction of the EU Homoeopathic Directive in 2001. BAHM's founder members were UK homoeopathic manufacturing companies who held Product Licences of Right for a wide range of medicinal products. Since the adoption of the EU Homoeopathic Directive, two further UK manufacturers have obtained product registrations and have joined the BAHM. Today, BAHM continues to act as the focus point for discussions between the Medicines and Healthcare Products Regulatory Agency (MHRA) and the industry.

 

4. BAHM and its individual company members recognise the need for effective regulation of medicinal products in the UK and throughout the EU. As a responsible industry, BAHM members operate within this regulatory framework to ensure that consumers, patients and practitioners have access to high quality homoeopathic medicinal products as part of an integrated approach to healthcare in the UK

 

5. BAHM member companies are:

Ainsworths Ltd., 36 New Cavendish Street, London W1G 8UF

A. Nelson and Co. Ltd., 83 Parkside, Wimbledon, London SW19 5LP

Helios Homoeopathy Ltd., 89-97 Camden Road, Tunbridge Wells, Kent TN1 2QR

Seven Seas Ltd., Hedon Road, Marfleet, Hull HU9 5NJ

Weleda (UK) Ltd., Heanor Road, Ilkeston, Derbyshire DE7 8DR

 

6. Together, these companies represent 95% of UK homoeopathic production.

 

 

Government policy on licensing of homoeopathic products

 

7. Homoeopathic medicinal products in the UK are authorised or registered in accordance with the legislation for medicinal products. They may have:

 

Product Licences of Right (PLR) granted MHRA, or

Homoeopathic Registration Certificates, granted by MHRA in accordance with the requirements of Directive 92/73/EC, or

Homoeopathic Registration Certificates, granted by MHRA under the National Rules scheme, in accordance with the requirements of Directive 200l/83/EC.

 

8. The primary purpose of the MHRA licensing process is to guarantee patient and consumer safety. As the Department of Health noted in its submission to the committee's broader evidence check in the summer, "only products which are indicated for the relief of minor symptoms and minor conditions in humans are eligible for a homoeopathic marketing authorisation under this scheme. For these purposes, minor symptoms are those which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor."

 

9. Patients themselves can make decisions on Over the Counter product purchase in the full knowledge that the homoeopathic medicines they are purchasing are safe. Health professionals, particularly GPs and pharmacists, are also in a strong position to advise on when complementary products and services can provide a solution, and when conventional medicines are more appropriate and can prescribe homoeopathic medicines accordingly.

 

 

Government policy on the funding of homoeopathy through the NHS

 

10. The Department of Health determines and authorises those homoeopathic medicines that can be obtained via NHS prescription. It is up to Primary Care Trusts to determine the flow of funds in each particular area are available within the National Health Service, and to direct funds accordingly.

 

11. As Department of Health Minister Phil Hope MP said in a written answer on 5 February 2009:

 

"The Government considers that it is the responsibility of the National Health Service to make decisions on what treatments are most appropriate for their patients, including complementary and alternative medicine treatments and referrals to homoeopathic hospitals. In some cases complementary and alternative medicine treatments may be appropriate and a general practitioner would make a decision to refer taking into account safety,, clinical and cost effectiveness as well as the availability of suitably qualified and regulated practitioners." (Official Report, 5 February 2009, column WA 1501)

 

 

12. The situation in other European countries is radically different to the UK. For example, in France, 25% of prescriptions are homoeopathic. The situation in Germany is similar. Whilst

we are aware that the reimbursement system is different in France and Germany, it is nevertheless significant that medical practitioners see a role for homeopathic medicines and are willing to direct prescribing decisions accordingly.

 

 

The evidence base on homoeopathic products and services

 

13. The authorisation/registration legislation for homoeopathic medicinal products primarily relates to assurance of safety and quality as we describe above. Comment on homoeopathic 'services' is outside the scope of activity of the BAHM.

 

14. There is a place for homoeopathic medicine in any system based on patient outcomes and patient demand, and the Faculty of Homoeopathy has separately studied the evidence base in detail.

 

15. As indicated above, patients themselves make decisions on product purchase in the full knowledge that the homoeopathic medicines they are purchasing are safe, often under the guidance of GPs and pharmacists. Such professionals are in a strong place to advise when homoeopathic medicines present a cost-effective, quality solution to specific health conditions.

 

 

November 2009