Dáil Éireann debate -
Wednesday, 10 Nov 1999

Vol. 510 No. 4

Adjournment Debate. - Herbal Products.

Mr. Sheehan

I thank the Leas-Cheann Comhairle for allowing me to raise this important matter and ask him to facilitate Deputy Gormley after I conclude as he is interested in contributing to this debate. I express my concern at a recent statutory instrument signed by the Minister for Health and Children which confines the sale of the herb St. John's Wort to prescription use from 1 January. St. John's Wort is named after St. John the Baptist and has been in common use since before his time to help with mood swings and other minor conditions. From 1 January the individuals concerned will have to obtain a prescription to get the product. It is most likely, since few doctors are familiar with the herb, that they will be given prescriptions for much stronger drugs with known side effects and addictive patterns.

St. John's Wort now joins Gingko Biloba as a herb restricted to prescription in Ireland but freely available in every other country in the European Union. Gingko Biloba is another popular herb in Europe which is used to improve circulation. This comes on top of the publication by the Irish Medicines Board last June of a highly controversial document, Guide to the Definition of a Medicinal Product, which implies that vitamins, minerals and natural herbs will be classed as medicines. The guidelines are largely based on EU Directive 65/65 EEC which, as its name implies, was written in 1965, a time when we were all basking in the comfort and safety of miracle antibiotics and drugs which promised a healthy future for all. Times have changed since then and there is a massive interest in complementary medicines such as homeopathy, nutritional supplements and herbalism. There are health food shops in almost every medium sized town in Ireland – there are two in my maternal town of Bantry.

The changing times have been recognised by EU regulators and at least 13 of the 15 member states are in breach of several aspects of EU Directive 65/65 EEC. At the 48th meeting of the pharmaceutical committee at DG III in Brussels last month it was unanimously agreed that there was a need to study the possibility of introducing a traditional medicines directive. Less than one week after Ireland voted in favour of considering such a directive the Minister for Health and Children made a pre-emptive strike and signed away our rights to have free access to a popular herb. While the European Union accepts that there needs to be a regulatory framework in which to deal with vitamins, minerals, herbs etc., the IMB has suddenly decided to overzealously address itself to the task of regulating these products within a framework which is entirely inappropriate.

The product Bioforce Echinaforce is known to help the immune system. Other products such as propolis, produced in the beehive, and garlic often prove effective alternatives to antibiotics. The medical profession recognises that such alternatives are urgently needed if we are to limit the current gross overprescribing of antibiotics. Sales of Bioforce products alone amount to about £1.5 million per annum at retail prices.

The Minister referred to the herb as being an MAO inihibitor. There is no need to explain what this is, but current literature indicates that this is not the manner in which the herb works and this information is grossly out of date. Food supplements, including vitamins and minerals and a wide range of herbal products, have been available on free sale in Ireland for well over 20 years. Traditional herbal remedies, including St. John's Wort, have also been available for this period though their use in Ireland dates back to the beginning of our civilisation. Attempts to regulate these products by means of conventional medicinal licensing have proved totally unworkable in Ireland and throughout the rest of Europe. This is because medicinal licensing procedures were designed to assess powerful pharmaceutical drugs and are inappropriate for food supplements and gentle acting herbal products.

Hundreds of thousands of consumers in Ireland and throughout the rest of Europe and the world are demanding their rights to choose safe and effective natural health products. Any restriction of this freedom to choose legitimate safe products is an infringement of the democratic rights of the consumer. It is also contrary to the EU Single Market which attempts to dismantle barriers to trade because they will continue to be available in other member states.

I call on the Minister for Health and Children to immediately withdraw St. John's Wort and gingko biloba from the prescription list and to require the Irish Medicines Board and the Department to consult in future with industry and independent professional experts on any further regulation.

An Leas-Cheann Comhairle

If the House is agreeable, we will allow Deputy Gormley two minutes.

Mr. Gormley

I will be brief. I thank Deputy Sheehan for sharing his time.

The Minister's decision to make the popular herbal supplement, St. John's Wort, available only by prescription is bizarre and inexplicable, both in its content and in its timing. There are no recorded instances of any adverse effects or interactions from St. John's Wort. It is sold freely throughout the rest of Europe and in the United States and has been sold freely over the counter in this country for many years. Yet, following a report in May by the Irish Medicines Board, the Minister last month issued a Statutory Instrument, SI 271, making St. John's Wort available only by prescription in the new year. What is the reason for that? Why is Ireland taking such an anti-consumer stance and why is it at such variance with the rest of Europe? Why was this decision taken only a few weeks after we had agreed in the EU to seek a joint approach on the regulation of herbal medicines?

At the 48th pharmaceutical committee meeting in Brussels on 27 September, all 15 EU states took the unanimous decision to explore the possibility of a traditional medicines directive. This would include herbal medicines. The Commission is now preparing proposals for next spring. This is regarded as a reasonable approach by the European Herbal Practitioners Association which sees it as both protecting the public while enabling access to plant medicines which have been in use to great benefit for thousands of years.

Products such as evening primrose oil, garlic and fish oils are in danger of being outlawed by the Minister and placed under arrest by the pharmaceutical industry. Such constraint is, in reality, bad medicine. Rather than promoting healthy, preventative medicine through the free availability of health supplements and herbal products and promoting the individual's right to control his or her health, and to better understand the ingredients of good health, this decision by the Irish Medicines Board and the Minister, Deputy Cowen, will ensure a pharmaceutical monopoly on natural products. Only the pharmaceutical companies can benefit from the Minister's decisions, certainly not the 75,000 people who bought St. John's Wort in the past year or the 150 health shops and 2,000 jobs now under threat.

Minister of State at the Department of Health and Children (Mr. Fahey)

I thank Deputy Sheehan for raising this issue. I often wondered what put the pep in the Deputy's step. It is obvious now that he has a remedy that most of us did not know about.

Mr. Sheehan

The Minister of State's leader has a gingko tree growing in his back garden.

Mr. Gormley

He takes two litres every day.

Mr. Fahey

There has been much public interest and debate about the recent decision by the Irish Medicines Board to recommend to my Department that products containing hypericum perforatum, or St. John's Wort, should only be available on medical prescription. I am pleased to have this opportunity to clarify matters. I would first like to outline the background to this decision.

As Deputies will be aware, the Irish Medicines Board is the competent authority for the various EU directives on prescribed medicines. It is an independent body established under the Irish Medicines Board Act, 1995, and is the licensing authority responsible for the grant of product authorisations for medicinal products. Following the thalidomide tragedy in the 1960s, most countries around the world introduced controls on placing medicinal products on the market. European Council Directive 65/65/EEC defines a medicinal product as "any substance or combination of substances for treating or preventing disease in humans or animals or which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions".

Earlier this year, the Irish Medicines Board published a guide to the definition of a medicinal product. This was necessary because of the significant confusion that appeared to exist in regard to what was understood by the term "medicinal product" in this country. This guide set out the current EU definition of a medicinal product and went on to explain the various features of the definition, drawing to some extent from the case law of the European Court of Justice. It then went on to give guidance on the basis of examples, particularly in regard to various claims that, if made, would compel classification as a medicinal product.

The various categories of potential borderline products referred to in the guide included cosmetic products, foods, products with vitamins and minerals, products with selected amino acids, products with herbal ingredients, slimming products, homeopathic products, disinfectants, biocides and medical devices.

The guide concerned was an updated version of a guidance note that had been published in the Department of Health and Children in 1988 and which had been widely circulated on a number of occasions. In effect, there was little new in the guide. It merely consisted of a re-statement of the position under Community law. The policy in regard to the controls in force in respect of medicinal products has not been changed by the publication of this guide by the Irish Medicines Board.

As part of its normal day to day functions, the Irish Medicines Board recently carried out an evaluation in respect of a medicinal product which contained the herbal ingredient hypericum perforatum, otherwise known as St. John's Wort. In view of the claims made in respect of products containing St. John's Wort, such products are considered to be medicinal and therefore require product authorisations if they are to be lawfully placed on the market. Following the medical assessment, and in the interest of public health, the Irish Medicines Board recommended to my Department that products containing hypericum perforatum should be subject to 'prescription only' control. The reasons given by the board for its recommendation include the following: the products appear to act as monoamine oxidase inhibitors, MAOIs, and as such must be used with particular care because of risks of interactions not just with other medicines, but also with certain foods. Patients, therefore, may be at risk from hypertension or increased blood pressure if these products were taken with certain other anti-depressants, over the counter cough mixtures and with foods rich in tyramine such as cheese, yeast extract and red wine; the product may interfere with the metabolism of commonly prescribed medicines; side effects such as photosensitivity, gastrointestinal disturbances, fatigue and nervousness have been reported; the board was concerned about the attempted treatment of mild to moderate depression by use of an over the counter medicine. The board considers that the treatment of such a condition should be under medical supervision and advice and that self-diagnosis and self-medication are inappropriate for such a condition; and the board was also concerned at the misleading information being conveyed in the advertising and promotion of these products. Claims have been made that these products can be taken with no side effects and supported by the description "The Sunshine Supplement". These descriptions are not consistent with the published scientific literature on these products.

The Deputies should be aware that the decision to place a product under 'prescription only' control is carried out in the interest of protecting public health and safety and where it is considered appropriate that such products should be used only under medical supervision and advice.

Some interests in the health food industry have expressed opposition to the Irish Medicines Board's attempt to complete the implementation of the various EU directives here. There is a perception that the board's guide to the definition of a medicinal product could become a threat to their involvement in the health care sector where the supply of various unlicensed "borderline" medicinal products is now commonplace. The impression is being created that all food supplements are under threat, and there are references to products such as garlic, ginger and fish oils, to name just a few. The suggestion is also being made that evaluation and authorisation by the Irish Medicines Board will lead to the imposition of prescription control for these products. This suggestion is false and is creating unnecessary worry in the general public, many of whom have written to me and to the Department with their concerns.

The situation is quite clear. If a product placed on the market includes a medicinal claim, the product concerned becomes a medicinal product and requires a product authorisation from the Irish Medicines Board. Before the board may grant an authorisation, it is required to be satisfied as to the safety, quality and efficacy of the product concerned. Obviously, in the case of unlicensed products that may be available on the market, neither the safety, quality nor efficacy of such products would have been established by the board. I say to the manufacturers and retailers of these products that the answer lies in their own hands. They should stop making medical claims for products because once these medical claims are applied to the products, they become, under the law, medicinal products for which product authorisations are required in order that they may lawfully be placed on the market.

I assure the Deputies that it is not my intention, nor that of the Minister, to in any way interfere with the rights of individuals to avail of appropriate medicines which they may wish to use. However, it is generally accepted that in the interest of consumer health and protection, some form of regulation of alternative medicines is desirable. The European Commission is currently considering what controls, if any, should be applied in this area.