Skip to main content
Normal View

Dáil Éireann debate -
Thursday, 13 Nov 1997

Vol. 482 No. 7

Adjournment Debate. - Complementary Healthcare.

Tá mé fíor-bhuíoch as ucht cead a bheith tugtha dom an cheist seo a ardú. I am disturbed by the lack of provision in the Estimates for preventative healthcare. The incidence of asthma and other medical complaints as well as medical admissions to hospitals such as Beaumont are increasing annually. Therefore, it was a shock to read recently in the Big Issues magazine about the effect of the Irish Medicines Board Act and the background and motivation for its enactment.

Statutory Instrument No. 43 of 1996, the medical preparations regulation, classifies over 40 commonly found herbs, including plants such as ginger, garlic and dandelion, as medicines which now require prescriptions. They will now come under the category of prescribed medicines if their vitamin or mineral contents exceed the World Health Organisation's recommended daily amount guidelines. This draconian legislation also requires simple customer information about alternative health supplements, such as informing a buyer that vitamin C is helpful in preventing 'flu, to be provided and leaves retailers and suppliers open to fines of over £100,000 and/or ten years in prison if convicted of non-compliance.

The World Health Organisation also plans to curtail the availability of food supplements. It will implement a worldwide control and regulation programme for herbs and vitamins before December 1998. The WHO's plan provoked a huge storm of controversy in America when it was revealed that the organisation's so-called independent advisory body comprised exclusively of giant drug companies. The legislation is being challenged by alternative health practitioners and consumer rights groups in America who view the laws as anti-consumer and believe they are motivated by vested interests in the global pharmaceutical industry.

To obtain a licence for herbal remedies requires a £3,000 application fee. In reality, so much laboratory evidence is required that the entire licensing procedure could cost up to £1 million. Many doctors may now be loath to recommend simple remedies, such as evening primrose oil which is effective in the treatment of menopausal hot flushes, for fear of litigation. This also applies to calcium tablets for the treatment of osteoporosis and a huge variety of other supplements.

The Government ideally needs to instigate a debate on community and preventative healthcare. Such care needs to be resourced to ensure the pharmaceutical companies are not needed so much. Fewer sick people should be our objective as a Parliament and a people. In the short-term, the Irish Association of Health Stores should be represented on the Irish Medicines Board. Before sending out such needlessly threatening letters, the board should meet with the association or the producers of complementary health products. Otherwise, we will find ourselves in the ridiculous position of a teenager buying as much paracetamol as they like in a supermarket for the purposes of committing suicide, but needing a doctor's prescription to get vitamin C for a cold. We have sold out to the pharmaceutical companies on this legislation to the extent that a public outcry is needed. The Government must realise it has gone overboard and we need to think about preventive healthcare so that people will not have to spend money. We need to start talking about a Department of Health rather than what we currently have, a Department of Sickness and Pharmaceutical Interests.

Whilst I am aware of reports and rumours circulating along the lines set out in the Deputy's question, I wish to advise the Deputy and the House that there is no truth or substance whatsoever in the suggestion that the Irish Medicine Board has sent out more than 40 threatening letters to complementary health practitioners over the past six months. Furthermore, some magazine articles recently published along these lines are inaccurate and misleading and do not properly reflect the regulatory position.

The Irish Medicines Board was established by an Act of the Oireachtas and I cannot accept that any of the powers given to the board by the Oireachtas could, in any way, be described as draconian. The Act simply gave the board the same powers which had previously been vested in the Minister for Health as the licensing authority for human medicines, including powers of enforcement.

Furthermore, the Deputy will be aware that there has been no new legislation, as is suggested, proscribing vitamins, minerals or herbs as legal medicines, nor are there any plans to introduce such legislation at this time. The current regulatory controls governing the sale and supply of medicinal products are set out in the Medical Preparations (Licensing and Sale) Regulations, 1996, which replaced earlier regulations dating back to 1975. These regulations reflect European Union requirements on the control of medicines and require that all medicinal products placed on the market in Ireland must be the subject of a product authorisation granted by the Irish Medicines Board. However, before the board will grant such an authorisation, it must first be satisfied that the product meets criteria laid down by the European Union to establish the safety, quality and efficacy of the product.

The regulations are directed towards ensuring the health and safety of consumers and do not make any distinction between conventional pharmaceutical products and medicines based on herbs, vitamin or mineral supplements. There are, of course, certain products, including herbal products, which may be classified as either food supplements or medicinal products. Such products are commonly referred to as "borderline" products. As far back as 1988, my Department issued guidelines on the classification of such borderline products.

In relation to herbal products, these are classified as medicines when their labelling or associated literature makes preventive, curative or remedial claim or any of the ingredients presented is recognised as having medicinal properties. In the case of vitamin or mineral supplements these would likewise only be classified as medicinal products if their labelling or associated literature makes any preventive, curative or remedial claim or if they are presented in a dosage form which exceeds the recommended dietary allowances. At the same time, I must stress that if and when the board becomes aware of any medicinal product being sold or marketed without a product authorisation, it is obligated to seek the withdrawal of such products until they have been properly authorised in accordance with the regulatory requirements. The primary objective is to ensure that all medicinal products which are made available to the public are demonstrably safe and of good quality.

Top
Share