Committee Reports::Report No. 09 - Medical Preparations Regulations::02 July, 1991::Report

Medical Preparations Regulations

A. Introduction


1.In recent years because of the increase in the range and variety of health foods containing or comprising vitamins and minerals which have come onto the market the distinction between medicines and food has become more difficult to identify with potential risk to the wellbeing of the consumer. Such products are commonly referred to as “borderline products”.

The Joint Committee in this Report has confined itself mainly to foods.

The Joint Committee (in accordance with paragraph 1 (a) (iv) of its Orders of Reference) has examined the following Regulations which implement, inter alia, EC Directives on the licensing of proprietary medicinal products and feels it would be of benefit to report to the Houses of the Oireachtas on them:

(i)Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984): and

(ii)Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989 (S.I. No. 347 of 1989).

2.In view of the role of the National Drugs Advisory Board in advising the Minister for Health in relation to the grant of a product authorisation, the Joint Committee also considered the National Drugs Advisory Board (Establishment) Order, 1966, (SI No. 163 of 1966) as amended.

3.An examination of the Medical Preparations Regulations, 1984 and 1989 was carried out for the Joint Committee by its Sub-Committee on Statutory Instruments and Legal Affairs under the Chairmanship of Senator Tom Hussey. It considered memoranda submitted by the Department of Health and the Irish Association of Holistic Medicine.

The Joint Committee is indebted to Senator Hussey and his colleagues for the work carried out by them on its behalf.


4.The Joint Committee wishes to express its appreciation of the considerable assistance received from the Department of Health. A special word of thanks is due to Mr. John Gillen of the Department and Mr. Tom McGuinn its Chief Pharmacist, both of whom attended a meeting of the Sub-Committee.

The Joint Committee also wishes to record its thanks to Mr. Martin Forde, President of the Irish Association of Holistic Medicine and Mr. Pat Henry who also appeared before the Sub-Committee.

Medical Preparations Regulations, 1984 and 1989

5.The Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S. I. No. 210 of 1984) provide for a common statutory licensing system for all medicines, both proprietary and non-proprietary, i.e. generics, and at the same time take into account the provisions of EEC Council Directive 65/65/EEC relating to proprietary medicinal products (as amended). In general the position under the Regulations is that a product authorisation is required to be held in order that a medical preparation may be imported or placed on the market in Ireland.

6.The purpose of the 1989 Regulations is to amend the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 in order principally to overcome the problem of the availability of a wide range of unlicensed medical preparations by:-

(i)requiring that application for licences for the products in question - i.e. those listed by category in the Schedule to the Regulations - be made to the Minister by 1st April, 1990, and

(ii)facilitating enforcement by extending the authority to enforce the statutory requirements to health boards and their officers.

In addition, the Regulations also amend the Medical Preparations (Advertisement and Sale) Regulations, 1958 for the purpose of prohibiting the advertisement of medical preparations in respect of certain conditions i.e. alopecia and impotency.

7.A product authorisation is now necessary from the Minister for Health before a human medicine is placed on the market.

The Minister for Health grants authorisations for human medicines, on the advice of the National Drugs Advisory Board. (The Board authorises veterinary medicines).

B. Views of the Department of Health

Medical Preparations

8.The expression “Medical Preparation” is defined in section 65 (1) of the Health Act, 1947 as being -

(a)a substance which is sold under a proprietary designation and which may be used for the prevention or treatment of any human ailment, infirmity, injury or defect, or

(b)any other prophylactic, diagnostic or therapeutic substance which may be used for the prevention or treatment of any human ailment, infirmity, injury or defect.

The regime of alternative medicine and health food products has blurred the distinction between medical preparations and health food products, such as food supplements, vitamins, minerals etc.

9.The question now arises in respect of such “foods” containing or comprising of vitamins, minerals, herbal or amino acid ingredients and slimming products as to whether or not they are medical preparations in the context of the Regulations and thereby required to be the subject of product authorisations granted by the Minister for Health.

The Department of Health has published guidelines as to the criteria it has to establish whether such “borderline products” are medical preparations within the meaning of the Regulations.

“Borderline Products” - Foods

10.In general most foods are clearly not medical preparations. There are however certain manufactured preparations presented in a form, such as capsules or tablets, usually associated with medicines to which have been added vitamin, mineral, amino acid and/or herbal ingredients. Such preparations may be classed as medical preparations even in circumstances where they may be described by the manufacturers concerned as “foods” or “food supplements”. The following is an outline of the position in regard to such products -

(i) Products containing vitamins and/or mineral ingredients

These preparations are considered to be medical preparations under the Regulations when -

(a)their labelling or accompanying or associated literature makes any preventative, curative or remedial claim; or

(b)the recommended daily intake calculated with respect to any of the added vitamin or mineral constituents exceeds the maximum recommended daily dietary allowance for such constituent as is published from time to time by the Minister for Health.

(ii) Products containing herbal ingredients

These preparations are considered to be medical preparations under the Regulations when -

(a)the labelling or accompanying or associated literature makes any preventative, curative or remedial claim, or

(b)any of the herbal ingredients present is recognised as having medicinal properties.

Preparations consisting of dried, crushed or cominuted herb (s) labelled in a manner which specifies the herb (s) and the process of production are excluded from the scope of the Regulations provided no other name is given to the preparation and no recommendation as to use as a medical preparation is made. Examples of such exempted products would include Senna Leaves, Senna Pods and Carrageen Moss.

(iii) Products containing amino acids

These preparations are considered to be medical preparations under the Regulations when -

(a)the labelling or accompanying or associated literature makes any preventative, curative or remedial claim, or

(b)any of the amino acid constituents are presented at a level greater than is ordinarily encountered in the course of a normal daily diet.

11.Amino acids are the constituent units of dietary protein on break down during digestion. For the most efficient use to be made of amino acids in the diet a complete range must be supplied to the body at the same time. The taking of individual amino acids at levels greater than is ordinarily encountered in the course of a normal diet cannot therefore be considered as being of dietary or nutritive value alone. The use of amino acids in these circumstances is considered medicinal and accordingly such preparations are considered to be medical preparations for which product authorisations must be held under the Regulations.

Certain amino acids if used in non-dietary proportions are hazardous to health. This, according to the Department, has been recognised in the case of non-dietary preparations of L-Tryptophan which under the Medical Preparations (Control of Sale) Regulations, 1987 may only be sold on presentation of a medical prescription.

12.The Department of Health is primarily concerned with the protection of public health and safety. The Medical Preparations Regulations are essential to this. Many health food supplements, which often claim to prevent or treat illness or disease, contain substances, including vitamins and minerals which, if taken in excessive doses, could have serious effects. For this reason it is necessary that the controls of the Regulations should be applied to such products so that their safety, quality and efficacy may be established.

The Medicial Preparations Regulations are primarily instruments for consumer protection.

C. Views of the Irish Association of Holistic Medicine

13.The Irish Association of Holistic Medicine and its affiliate the Tony Quinn Organisation employ about 30 people full-time and a large number part-time as health instructors, holistic therapists currently members of the Irish Health Culture Association and about 200 students of holistic therapy. Its newspaper “Blueprint for Living”, devoted to health and nutrition education, circulates 1.5 million copies in three issues yearly. The Association’s two-year course in holistic nutrition was stated to be the only non-degree opportunity in Ireland for detailed study of nutrition.

On the basis of wide experience the Association accepts that food supplements are of value to many individuals in conjunction with a good diet, as evidenced by recent research linking nutritional supplements to increased intelligence in children, and furthermore constitute a very valuable aid to people affected by poor dietary culture, stressful or irregular living, addiction to alcohol, tobacco, or caffeine etc., for whom they may well prevent illness and obviate the eventual use of drugs.

14.The Association’s position is that the classification of food supplements as drugs is wrong in principle, restricts competition in the health field by biasing trade in favour of pharmacies and patent drugs, is damaging to the health store business and holistic therapy professions, and infringes the rights of the large and growing cohort of consumers who are nutritionally aware, using food supplements in conjunction with a good diet.

15.It is the view of the Association that it is wrong in principle to classify nutritional items as drugs. It was observed that food supplements are entirely different in nature to drugs, being essentially probiotic, i.e. enhancing the normal biological function of the body, as opposed to drugs, which are essentially xenobiotic in action, i.e. supplanting or interfering with the body’s normal function.

It was stated moreover that supplements available in health stores are extremely safe, and that the Association’s discussions with the National Drugs Advisory Board gave them to understand that safety was not the major issue, but quality. A small number of nutritional items are currently restricted by law as to the strength that may be sold, and this approach together with the application of food quality laws offers excellent consumer protection.

16.The cost factor of the complex licensing procedure was stated to be extremely burdensome and would certainly force health stores including numerous small independents to consider severely reducing the number of lines carried, hence the overall size of the business; that while progressive health stores endeavour to identify and import new food supplements of superior quality and utility, this would become impossible due to the extremely high licensing fee for new products, bringing development of the industry to a standstill.

17.It was pointed out that food supplements (vitamins, minerals and amino acids) are generic and non-patentable and inexpensive in comparison to drugs. The application of licensing distorts trade in favour of new patent drugs and the existing pharmaceutical profession. The Association urged that nothing be done to limit the individual’s freedom to choose safe alternatives in the health field.

18.It was stated that licensing of nutritional supplements as drugs goes well beyond any EC requirements, and is a shift in the direction of the civil law pharmaceutical monopolies obtaining in France and Belgium and that, in contrast, supplements are freely available in the UK, Netherlands, and Greece, as well as in the United States. It was feared that an EC move could be made at some future date which would restrict licensed products to pharmacies only.

19.The Association stated that it believed food supplements to be already subject to the normal law relating to food quality and consumer protection and that it had no objection to the full application of these provisions.

D. Views of the Joint Committee

20.A function of the Joint Committee is to act as a conduit for vocational bodies and interested groups to make their views known to the Houses of the Oireachtas on Community issues. In pursuance of this objective, the Joint Committee was pleased to receive representatives of the Irish Association of Holistic Medicine.

21.The Joint Committee is aware that there are other bodies in Ireland concerned with health culture. However, from its preliminary consideration of “borderline products” and EC law governing them, it has an appreciation of the complex technical issues involved. In order for the Joint Committee to make substantive recommendations it would have to broaden its field of consultation and engage scientific expertise. Even then, the Joint Committee feels, it may not contribute significantly, at this stage, to the resolution of the diversity of opinion on food supplements.

22.The Department of Health have a legitimate interest in the field of “borderline products” and a weighty responsibility to guard the interest of public health and safety.

Under Community law, as it stands, it is the responsibility of the national authorities to determine, on a case by case basis, subject to supervision by the courts, whether a product falls within one or other branch of the Community definition of medicinal product.

23.The European Court of Justice recently considered the borderline between Community legislation relating to cosmetics and medicinal products. (1) The Court ruled that any product which satisfies one or other of the criteria mentioned in Article 1, paragraph 2 of Directive 65/65/EEC is to be considered a medicinal product and, if it satisfies the definition of a proprietary medicinal product, must be subject to the legal regime applicable to medicinal products, to the exclusion of that applicable to cosmetics.

E. Conclusion

24.The Joint Committee feels that by reporting to the Houses of the Oireachtas on the Medical Preparations Regulations it will have served a useful purpose by highlighting the issues involved. The fact that there is a controversy about the designation of health foods is evidence that there is a growing awareness among the public about nutrition. The Joint Committee welcomes this focus on nutrition and hopes that through the medium of an early debate in the Dáil and Seanad on its Report the issues involved will be further elucidated.

25.The Joint Committee feels, at this stage, that its most effective recommendation would be that the public should adopt a questioning approach to “borderline products” such as food supplements, vitamins, minerals etc, in the context of the statutory regime governing consumer protection.


John O’Leary, TD.

Vice-Chairman of the Joint Committee

02 July, 1991.

(1) Case C - 112/89, the Upjohn Company V. Farzoo (16 April, 1991).