I thank the House for the opportunity to raise what might appear to many people to be a small matter but what has emerged as a substantial issue of major concern to a number of people. The Minister for Health and Children has decided to sign SI 271/99 which will have the affect of making a number of herbal remedies available only on prescription. These remedies are largely available in health food centres, supermarkets and chemists. From 1 January next they will be available only on prescription from a chemist and will be less accessible to people and far more expensive.
Many Members who had not heard of St. John's wort will by now be very well aware of the issue. The proprietors of health food centres and users of these herbal remedies are very concerned about this particular development. I appeal to the Minister for Health and Children to change his mind on this issue and to revoke SI 271/99. I also wish to state that should he choose not to do so it is our intention to place a motion before the House in the very near future seeking the revocation of that statutory instrument. Such a motion was placed before the House earlier in the summer and under Standing Orders we have 21 days in which to move a motion seeking its revocation. I hope the Minister will respond to the genuine concerns which have been raised on this issue.
St. John's wort is a herbal remedy used by many people in the treatment of mild anxiety, mood swings, ear infections and minor wounds. It is extraordinary that the Department of Health and Children is determined to make this herb available only on prescription when paracetemol, which has been linked to death and is well known to be dangerous if abused or misused is widely available without prescription. There are no recorded instances of adverse affects from the use of St. John's wort. The same could not be said of paracetemol or other painkillers available in grocery shops, filling stations and chemists. St. John's wort has been available over the counter for a number of years and has been used quite safely by many thousands of people. It makes no sense to make it an expensive drug available only on prescription.
I ask that the Minister consider this matter carefully and respond to the genuine concerns raised. It appears that this is an example of bureaucracy gone mad. I understand from brief ing made available to me by the Health Products Alliance that the Minister is responding to an outdated 1965 directive and that a traditional medicines directive is being prepared. It would make more sense to wait until that directive is passed before making an order such as this. In the meantime, the Minister should examine the matter and seek professional advice. The Minister should use his power to revoke SI 271/99. Should he choose not to do so I put the House on notice that it is our intention – and I have discussed this with other parties on this side of the House – to place a motion before the House seeking its revocation. I hope that will not be necessary and that the Minister will respond favourably.
Minister of State at the Department of Health and Children (Dr. Moffatt): I thank Senator O'Meara for raising this issue. There has been a great deal of public interest and debate about the recent decision by the Irish Medicines Board to recommend to my Department that the medicinal products containing hypericum perforatum or St. John's wort should be subject to prescription only control. This decision was taken following a medical evaluation by the Irish Medicines Board and in the interest of public health.
It may be useful to set out the context in which decisions such as those are made. The Irish Medicines Board is the competent authority in this country for the various EU directives on medicinal products. It is an independent body established under the Irish Medicines Board Act, 1995, and is the licensing authority responsible for the grant of product authorisation for medical products. Following the thalidomide tragedy in the 1960s, most countries introduced controls over the placing of medicinal products on the market. In the then European Economic Community of six member states, this resulted in the adoption of Council Directive 65/65/EEC which had as its purpose (a) the definition of medicinal products for the purpose of control; (b) the requirement that all new medicinal products in the member states should be the subject of prior marketing authorisations and (c) to secure that these marketing authorisations would only be granted when the national competent authorities were satisfied in regard to the quality, safety and efficacy of the products concerned.
In 1975, the controls provided for under the 1965 directive were extended to all medicinal products, except for products such as vaccines which were the subject of a separate form of control. This extension required the review of all existing medicinal products over a period of 15 years ending in May 1990. The deadline for completion of this review was met in regard to virtually all prescription medicines. There remained, however, a significant range of mainly over-the-counter products for which the review had not been completed. These included almost all of those products which are currently the subject of debate following the issue of guidelines by the Irish Medicines Board on the definition of what constitutes a medicinal product. This guide was considered necessary in the context of significant confusion that appeared to exist in regard to what was understood by the term "medicinal product" in this country. This guide, therefore, set out the current EU definition for 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 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 restatement of the position under Community law. The policy in regard to the controls in force in respect of medicinal products has not been changed in any way by the publication of this guide by the Irish Medicines Board.
The EU Council Directive 65/65/EEC defines a medicinal product as any substance or combination of substances presented for treating or preventing disease in humans or animals, or any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals. The directive does not make any distinction between conventional medicines and those medicinal products that are based on ingredients which are now being described as "natural", "herbal", "traditional", etc.
The Irish Medicines Board recently received a product authorisation application in respect of a medicinal product which contained the herbal ingredient Hypericum perforatum, otherwise known as St. John's wort. Medical evaluation of this application revealed major deficiencies in the submitted information and the concerns of the board were conveyed to the applicant in the usual manner. The applicant concerned, rather than responding to these concerns in the normal way, decided to withdraw the application. As some of the board's concerns related to the active herbal ingredient generally, it took the view that products containing St. John's wort should be recommended for prescription control in the interest of public health. The board is clearly of the opinion that products containing the herb Hypericum perforatum– St. John's wort – are medicinal products and, as such, must be the subject of product authorisations from the Irish Medicines Board if they are to be lawfully placed on the market in this country.
A number of reasons have been given by the board in support of its recommendation for prescription control. These 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 – increased blood pressure – if these products were to be taken with certain other antidepressants, over-the-counter cough mixtures – sympathomimetics – 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 also been reported; concern at the attempted treatment of mild to moderate depression by use of over-the-counter medicines. The board considers that the treatment of such conditions should be under medical supervision and advice and self-diagnosis and self-medication are inappropriate for such a condition and is concerned at the misleading information that is 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.
I assure the House that decisions to recommend the placing of any medicinal product under prescription only control is carried out in the interest of protecting public health and, where it is considered appropriate, that such products should be used only under medical supervision and advice.
I would like to briefly refer to the campaign being carried out by interests in the health food sector which has given the impression that all food supplements are under threat and references have been made 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. These propositions are false and are causing unnecessary public concern.
I would also like to correct another false statement which has been circulated concerning the timing of these regulations. References have been made to the involvement of the European Commission in the area of "traditional" medicinal products and to a decision taken at the recent 48th meeting of the EU pharmaceutical committee. This meeting took place on 27 and 28 September 1999. It should be noted that the regulations concerned were signed by the Minister for Health and Children at the end of August 1999, which was one month before the 48th meeting of the EU pharmaceutical committee and not the other way round as has been suggested.
At the 48th meeting of the pharmaceutical committee it was agreed to set up a small expert group which would consider the need and usefulness of specific EU legislation for traditional medicinal products. After an intensive debate the committee agreed on the following conclusions – the regulation of traditional medicinal products clearly deserves attention; there may be a case for sorting out existing problems through specific Community legislation; any future legislation in this sector had to take account of the fact that there is a very strong national component in this issue and that the possibilities for full harmonisation maybe limited and the scope of products concerned should be clearly defined and a possible future regulation should not serve as a safe haven for all sorts of non-effective products. It is clear from this that any Community proposals that may attempt to address the issue of traditional medicinal products, including any eligible herbal medicinal products, are a long way off. While it is recognised that there is little harmony between member states and that there is little prospect of agreement being reached if an attempt to introduce a directive were made, at the same time it is recognised that public health must be protected and that while some form of "traditional use" claims might be acceptable in certain circumstances, there can be no compromise where safety and quality are concerned. The question, therefore, continues under examination at EU level.
I would also like to address the question of consultation with interested parties and the allegations being made that the Irish Medicines Board did not consult the health food industry before making its recommendation. I have been advised that the Irish Medicines Board has consistently informed the alternative/complementary health industry that it is open to dialogue and proposals for different approaches provided these approaches ensured that public health was protected and were consistent with legal obligations and requirements. In this context, the Irish Medicines Board has already set up a working group to review vitamins and minerals and the levels at which they may need to be considered as medicines. This working group will look at appropriate levels for transition from a food supplement to a medicine and appropriate systems for regulation of registration of licensing of vitamin/mineral products containing amounts above this transitional level. The group contains representatives of the main industry bodies, the universities and other statutory bodies in this area. The first meeting is to be held next week.
The IMB has also approved the concept of setting up another group to review herbal medicinal products which will include representatives of a similar range of interested parties and I understand that the board has recently contacted potential participants to determine the level of interest.
The situation with regard to products containing St. John's wort in other EU member states is complicated by the fact that in many of these countries the regulation of medicinal products, including herbal and other traditional medicines, had already existed before Community measures were introduced. While the products concerned are generally considered as medicinal products, not all countries, including Ireland, have been in a position to grant marketing authorisations. Some countries have maintained or introduced national authorisation measures for the control of these medicinal products on a traditional use basis, but these controls are purely national and there is no harmonisation possible for any of these products within the European Union. These latter countries include Austria, Belgium, Denmark, Finland, France, Germany, Spain and Sweden. While it is understood that in Germany certain medicinal products containing St. John's wort require a prescription, no country except Ireland has yet placed these products on general prescription. In some of these countries – Belgium, France, Greece, Italy, Luxembourg, Portugal and Spain – medicinal products, including herbal medicinal products, may only be sold in pharmacies. It is also suggested that in the case of Austria, a full marketing authorisation has been granted in respect of medicinal products containing St. John's wort. This would suggest that full scientific evidence is available for this product should the interests concerned be willing to pursue this route. I hope this goes some way to clarifying an important and complex issue for the House and I will be awaiting with interest the results of the two working groups' deliberations in this area.