I welcome Ms Erica Murray of the Irish Association of Health Stores, Mr. Martin Forde of the Irish Health Trade Association and Dr. Robert Verkerk, scientific adviser to both organisations. I ask Ms Murray to begin the presentation on the proposed EU Supplements Directive (2002/46/EC). Then members will have an opportunity to ask questions. I would draw your attention to the fact that committee members have absolute privilege. That same privilege does not apply to people coming before the committee. The members are reminded of the long-standing practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official by name in such a way as to make him or her identifiable.
Irish Health Trade Association and the Association of Health Stores: Presentations.
Ms Erica Murray
Good morning. I am Erica Murray. I am representing the Irish Association of Health Stores and the Irish Health Trade Association. I came to this industry 25 year ago as a retailer, as a result of successfully weaning myself off steroids using natural means. Although I am a retailer I am, first and foremost, a passionate consumer. My story is replicated countless times throughout our industry. With me are Mr. Martin Forde from the Irish Health Trade Association and Dr. Robert Verkerk, our scientific adviser. The IHS and IHTA together make up the natural products industry in Ireland.
I thank the committee for giving us this opportunity to present our concerns to the foods supplement directive. I know our time is limited, so I will be brief and to the point. You have the full briefing document in front of you, which contains much more information, and I will be referring to it from time to time.
You see from page 5 of this document that a whopping 45% of Irish adults use food supplements - we are talking about vitamins and minerals - and this is spread evenly across all socio-economic groups. We want to stress at the outset that, given this high level of usage, it is entirely reasonable and appropriate to ensure that these products are properly and appropriately regulated. However, as we will discover, this directive will regulate out of existence most of the range which is currently available and which has been consumed safely in Ireland for over 40 years. The directive in fact represents a highly restrictive form of regulation. A brief summary of the main provisions of the directive are given on page 3 of the briefing document.
I will move on to the problems posed by the directive which are listed under four main headings on page 5. The first one of these, detailed on page 6, is the positive list. This is a list of vitamins and minerals permitted to be used in a food supplement. The EU Commission has borrowed another list from a completely different application, the PARNUTS list. It was never designed for food supplements, which is indicated by the fact that it contains such highly toxic substances as sodium hydroxide, better known as drain cleaner or caustic soda, and sodium fluoride, which is used as rat poison. It is ironic that some of the newer and more absorbable forms of nutrients have been omitted completely. Based on even a cursory examination of the ingredients list of the most popular food supplement products stocked by our members' stores, we estimate that these omissions will necessitate the reformulation of approximately 85% of vitamin and mineral supplements.
The second problem, which is detailed on page 7, refers to safety dossiers. It is possible to get a nutrient added to the positive list but only by submitting a full safety dossier, which will be extremely costly and time consuming to produce, so much so that many of the small to medium sized enterprises, which supply most of our products, will not be able to get even one ingredient on the list. I will come to compliance costs in a minute.
The third problem is detailed on page 8, which is the determination of maximum amounts or permitted levels of vitamins and minerals. The EU Scientific Committee on Food, the SCF, will issue an opinion as to the upper safe levels for each of the vitamins and minerals on the positive list. The Commission will then set the maximum permitted level for each nutrient, taking into account the recommended daily allowance, RDA, as well as the average dietary intake. The RDA is the minimum amount of a nutrient necessary to avoid a deficiency. The problem is that a majority of member states mistakenly believe that nutrients over the RDA are dangerous. That a whole industry could be legislated out of existence on the basis of a scientific falsehood is deplorable.
The fourth and final problem we discuss on page 10. It relates to compliance costs which are a major concern. There will be relabelling and reformulation costs. However, the main cost to industry involves the submission of a full safety dossier to the SCF, which is estimated at between €130,000 and €400,000 per ingredient, not per product. Our members rely in the main on products manufactured by smaller innovative companies as opposed to the multinational pharmaceutical companies. These smaller companies will undoubtedly suffer under the directive due to the problems I have detailed. Moreover, the UK Food Standards Agency reports that:
Small specialist retailers, such as health stores, stand to lose significant amounts of business if a wide range of specialist products is no longer available. Thus, it can readily be seen that this directive will undoubtedly have a severe impact on the range of food supplements we carry at present.
As food supplements form more than 50% of most of our retail members' stock at any time, the livelihood of many of our members is at stake. The European and External Relations Committee of the Scottish Parliament has stated that it recognises:
. . . the very real financial impact to the industry, potentially threatening a continued ability to trade. It is for this reason that the committee recommends greater consideration of the regulatory impact of such legislation at Scottish and local level in addition to anything which is done at UK or EU level.
The committee notes with dismay that the Commission's original proposal appears not to have been accompanied by any regulatory impact assessment.
Food supplements have a safety record which surpasses that of food itself; no deaths from food supplements have ever been recorded in Ireland. It may be comforting to know that you have more chance of being struck by lightning that you have of being harmed by a food supplement. That is a statistical fact, as you will see from figure 1 on the last page of our document. One of the extraordinary things about the directive is that the benefits of food supplements are not taken into account when assessing the relative safety of nutrients. The evidence, all to be found in the scientific literature, is now overwhelmingly in support of the benefits of supplements. It far outweighs any evidence of harm.
I refer the committee to the bottom of page 14 to page 16 of our document where many examples may be found of how supplementation can protect health and reduce the risk of chronic diseases. We also set out how supplementation can reduce health care costs - on page 17. It is often stated that as long as we eat a well balanced diet we will get all the nutrients we need. Even if we endeavour to eat the recommended five servings of fruit and vegetable a day, we find that the nutrient value of fruit and vegetables has fallen by 50% over the last 25 years. According to a report in the British Medical Journal last month, the US National Cancer Institute now, amusingly, recommends that men should increase the number of daily servings of fruit and vegetables to nine, women to seven and children to five because of declining nutrients. Is this realistic, I ask.
To sum up, nutrition is a young and emerging science but even at this early stage it is obvious that a good diet, combined with the judicious use of supplements, helps to protect health and reduce the risk of chronic diseases such as cancer, osteoporosis and heart disease.
It is almost impossible for people to eat a well balanced diet in these hectic times. Given these facts, you would think that health departments around the world would at least be investigating the benefits of supplements instead of restricting them. They look at the possibilities of food fortification but totally ignore supplementation. We suspect that this may have more to do with commercial considerations than a genuine concern for the health of the nation.
Basically this directive is using a sledgehammer to crack a nut. Bearing in mind the superb safety record of food supplements over many decades, together with the burgeoning amount of scientific evidence attesting to the benefits of higher dose vitamin and mineral supplements, we put it to you that the measures proposed in the food supplements directive are not proportional to the risks presented by these products.
We ask the committee to give consideration to the following recommendations which are detailed on page 12, under the heading, "What can be done?" First, ensure that the primacy of nutrition in supporting public health, supported by supplementation when necessary, be written into national health policy; second, ensure that a regulatory impact assessment be carried out before this directive is transposed into domestic law, consistent with good regulatory practice; third, ensure that the statutory instrument allows the derogation for substances which are the subject of dossiers; fourth, recommend that the Irish Government request the EU authorities to accept simplified safety dossiers in respect of nutrients which are currently on the market and have a long history of safe use and, fifth, recommend that the Minister take on board the concerns of our industry and instruct his officials to negotiate for upper safe levels on these safe nutrients. Thank you very much.
Mr. Martin Forde
I thank the committee for giving me the opportunity to speak to it about this.
I am a naturopath and a member of the Irish Association of Holistic Medicine and the British Naturopathic Association. I have been a practitioner in the area of nutritional medicine and nutritional health for 22 years. I work with health stores in an advisory capacity, which is what brings me here today.
We believe that people have abundant opportunities to build health by lifestyle choices, inclulding an approach we call optimum nutrition. The optimum levels of vitamins and minerals, which is what our industry is based on, are in many cases much higher than the RDA, particularly for vitamins. By avoiding sub-clinical nutritional deficiency and ensuring an abundance of anti-oxidants and vital nutrients, we can make the most of our potential for health. Put another way, we can influence our gene expression in a positive direction. We do not have to be victims of our genetic make-up. It is like stacking the odds in favour of well-being. This is a matter of good function.
My colleague, Dr. Robert Verkerk, has often referred me to the work of the Institute for Functional Medicine in the US. Their focus is on using nutrition to ensure that function is at a high level rather than on emergency medicine when serious organic problems have arisen. That is not to say that it does not find application in that area also.
Nutritional supplements are already regulated in Ireland. Vitamins A, D, B6, B12, folic acid and vitamin K, which may present hazards, especially at higher doses, are controlled by prescription. The others are widely available without any problems being apparent. I am absolutely certain that the Irish Medicines Board would have acted before now if any of them was not safe.
Our request is that the committee recommend that Ireland support upper safe levels when these are discussed in Europe. This will happen in an implementation directive, based on the current one, which will emerge in the next year or so.
Our thanks to the Irish Medicines Board and the Food Safety Authority of Ireland for establishing communications with our industry over the last couple of years. However, we believe much greater communication is required. We ask you to consider whether an advisory committee in the Department of Health and Children would be appropriate where all the interested agencies and the industry could come together.
Healthcare costs are a serious concern. We suggest that the committee considers examining the establishment of an institute for the study of effective, low-cost, natural health enhancement and treatment measures which are currently being used all over the world. These methods are generally non-toxic and are based on nutritional methods and non-patentable, naturally occurring, substances which can be very widely applied. We would be delighted to make a further presentation to you on that subject at some other time. Thank you.
Dr. Robert Verkerk
My name is Dr. Robert Verkerk. I have been a research fellow at Imperial College, University of London, for ten years. My focus now is as the executive director of the Alliance for Natural Health, which is a pan-European organisation working with complementary health practitioners, health stores and innovative supplement manufacturers to ameliorate the impact of the European directives.
As I have an appointment, if I may, I will ask a couple of questions. I thank you for your very well presented, reasonable and well argued presentation.
In your experiences with the Department of Health and Childdren, have you received a fair hearing from them? If you have not had a good debate with the Department perhaps we should send this presentation to them, on behalf of the Oireachtas Committee, and ask them to consider the points in it.
I do not feel qualified, in terms of professional expertise, to work out the merits or demerits of the case, but I can certainly see, very clearly, that there is merit in trying to ensure that complementary medicine and mainstream medicine are working together, which seems to be what is developing in other European countries. It has not happened here to any great extent, which I think is a pity. Obviously, many people benefit from natural products and complementary medicine. At the same time, safety issues are terribly important. I am not quite clear on the role of the Irish Medicines Board and the Food Safety Authority of Ireland regarding your industry. I remember there was a huge amount of upset over the banning of St. John's wort, and then magically, months or years later, the IMB rolled back on that decision to a great degree without any explanation. That was very unsatisfactory because it did not seem to be assessing fairly and openly what the issue was. It is very confusing for people who are trying to judge if safety standards are being maintained. Does somebody know about these things?
The idea of an institute is a very attractive proposition. As to who sets it up and how it is set up, I do not know. There are many other priorities in the health service which need to be dealt with.
Who is responsible? Is it the Department of Health and Children, the Food Safety Authority or the IMB that will actually drive the issues that you are talking about? Thank you.
Where stands the Irish Medicines Board on this directive? What consultation has there been with the Irish Medicines Board?
Mr. Forde
If I may take that last point first. I am aware that the medicines board was involved in the negotiations on the Food Supplements Directive (2002/46/EC). Most of the material was supplied to it and it made proposals on it.
Are you saying the board is actually party to the European recommendations?
Mr. Forde
The Food Supplements Directive, 2002/46/EC, is in essence a trade measure but it has assurances for public health written into it. The board advises the Food Authority of Ireland and the Department of Health and Children on the issue. The vitamins and minerals to be traded will not be above levels that could cause harm to people. That is where the Irish Medicines Board would come in. The IMB has for many years and reiterated this year maintained the position that all vitamins and minerals above the recommended daily allowance are medicines. We have an entire industry which in their formal eyes is selling unlicensed medicines. We may take a different view and in fact the European Commission eventually took a different view, as a result of which the food supplements directive came about - establishing that food supplements for vitamins and minerals above the recommended daily allowance are indeed foods. That is what will come into Irish law on 1 August this year. The Food Safety Authority of Ireland, therefore, will be responsible for food supplements under the food supplements directive. It is not clear what will happen to food supplements which for the moment fall outside the levels of the food supplements directive. However, the levels have not yet been set, so it the matter is not that urgent. Over the next two years that will happen. The Irish Medicines Board has this view, which I presume will now change because vitamins and minerals are firmly under food law. That does not necessarily protect the other types of ingredients found in food supplements, for instance, fish oils or evening primrose oil or various food extracts. It will not protect such foods from being deemed by the IMB to be medicines. They will be considered by the European Commission at a later stage for inclusion under an extension of the directive. That is the situation. The IMB has deemed - even from the days of the National Drugs Advisory Board - that all vitamins and minerals above the recommended daily allowance are medicines but they have never enforced that in terms of mandating registration because there would be difficulties with registration, not on safety or quality grounds, but on efficacy because there may be difficulty in showing they are efficacious for a particular condition, whereas we would hold that they provide an opportunity for people to have super-nutrition, as it were, and protect themselves. There is one other area mentioned by MsMurray, namely, whether we are getting a fair hearing from the Department of Health and Children. I believe that, in our contacts with the regulatory authorities, there is a great deal of legislation in all sorts of areas that the regulators have to keep up with. Sometimes a smaller area may not receive all the attention that it should. We see a need for more attention on our industry and the regulations that are involved. We have increasingly good communications with the Department of Health and Children but difficulties arise from time to time, particularly as three agencies may be involved - the Department, the Food Safety Authority of Ireland, and the Irish Medicines Board. Many of the questions are quite complex. The issues that arise require specialised attention. That is our situation.
Ms Murray
May I ask Dr. Verkerk to comment on the safety aspects?
Dr. Verkerk
Worldwide there have been many efforts to assess the safety of nutritional supplements. There is no doubt that the most complete dataset comes from the United States. If we look at it in sum total, we see in general terms that the average nutritional supplement is in fact the safest group of products we put into our mouths. They are tens or hundreds of times safer than the average food and tens of thousands time safer than the average medicine. Of course, the difficulty is that there is a shift to move supplements away from being regulated as foods that are anyway more toxic and regulating them more like medicines and, in the process, having a distinct impact commercially on particular sectors of the industry that sell more efficacious supplements.
Thank you all for the presentation, which is interesting, as ever. Like the previous speaker, I do not profess to be an expert in this area but I would describe myself as being broadly well disposed towards the case you are making because I favour preventative medicine and the notion of keeping people healthy rather than treating them when they become sick. I favour choice for the consumer too and I believe this is an important aspect of the services provided. I am not against traditional medicine by any means, but I do think it is important that consumers are given choice in the kind of health care they choose for themselves. It is important that people are actively involved in their own health care. I also favour regulation and safety standards. I am more than aware, however, that regulation can be abused to prevent competition. Indeed, the EU is a hotbed for using regulation to prevent competition. Countries do it; I am sure pharmaceutical companies are not beyond using it as well. I am always suspicious when I see, as you put it, a sledgehammer being used to crack a nut. I think that is what is happening here.
When we spoke before, you talked in particular about what we could do. As you said, this is a complex area, a very specialised area and requires a great deal of scientific medicine. Somebody like myself can only judge the truth of the situation by our instincts, by what we feel is right. As to what can be done, you have given us a list numbered one to five. The last time we met, No. 5 was the one we concentrated on, that is, the upper safety limits versus the RDA. Is that still the one you want us to concentrate on, or if there is one thing we can do for whatever is coming down the road for this industry, what is it?
May members ask a few questions first?
Sure.
Thank you for this very good presentation. I am interested that we just look at the US standards and take them as being all right. Let me make two specific points.
Because of our genetic predisposition towards having children with neural tube defects, it has been hugely important that Irish women take folic acid. This has been very important in the decrease in the incidence of spina bifida in particular. We also have a problem with homocystinuria - this is a genetic predisposition we have in Ireland. Cardiologists constantly ask why we do not do more. Some of them want bread supplemented with folic acid because they believe it would greatly reduce the incidence here of cardiac disease. At the same time, while that is a genetic predisposition which would be helped by food supplements, on the other hand we have a genetic predisposition to haemochromatosis, and the carrier rate in this country is about 20%, whereas in the United States it is only about10%. I am concerned at the number of people who appear to be taking food supplements. How many of them are taking iron,and is this important in the increase in the incidence of haemochromatosis in this country, with of course liver damage and pancreatic damage leading to diabetes and cardiac damage? We did not have immigration until very recently, so we have a very limited genetic pool. Haemochromatosis has been described as "the Celtic curse" because one gets it from both one's father and one's mother,but with 20% of the population carriers, that is not too difficult. We have to take this very seriously. With a high genetic predisposition towards haemochromatosis we have to be very careful about supporting safety limits which are above the recommended daily intake.
I am a little concerned about looking at things from a US point of view, where they have a much bigger genetic pool and therefore have not got these concentrated problems. Maybe we have to ask the Department to look at these sorts of things too.
I thank the Chairman. Also thanks again for the presentation which was very interesting. Well done.
I have a worry. To use the old saying, "one man's meat is another man's poison". These substances can mean different things to different people. My worry is that there has been a big proliferation of health supplement outlets and as the witnesses are representing the industry, they would have a vested interest. The industry is profit-driven.
I was interested in what was said, that there was as little chance of dying from a food supplement as being hit by lightning, but if you happen to be the person who was hit by lightning it is very personal to you, as well as being terminal. I know a man who was hit by lightning, so it is not that unusual. Lightning cannot be controlled. There is no telling when lightning will strike. However, we can certainly control food supplements, which is what we are doing.
While agreeing with the free market, my worry is the proliferation of outlets. When we were studying medicine we were always told about mothers buying vitamins for children when they could ill afford to buy food. We were told it was more important to give a child a balanced diet. People are concentrating on supplements to the exclusion of nutrition, balanced diet and exercise. The point is being made about the effects of modern living and smoking, but is it not more important to stop people smoking than encouraging them to take vitamins while they are smoking? I am sure the witnesses would agree that it might be better to lead a less stressful life than taking vitamins to alleviate stress. There is a lot of fringe medicine here. I am afraid that, when someone goes to one of these outlets complaining of tiredness, the person they meet there has a vested interest in showing them a shelf with items for depression, to improve their sex life and so on. Really the Irish health trade association and the Irish association of health stores control this. I am all for preventative medicine, but we have our obligations as well. There is an emphasis on vitamins when perhaps a lot of our focus should be on a better diet and better living.
All the Deputy has to do is go down to Ringaskiddy and have a whiff of the air there and he will be fine.
Thank you for coming in and making such a precise presentation. It appears you are falling between two or three different regulatory authorities. On one level it is food and on the other level it is branded as medicine. Have you had any formal discussions with the Irish Medicines Board and the Food Safety Authority and the Department of Health and Children or is this the first time you have made a presentation like this?
Speaking as a former GP, the health shops I have dealt with in my area have been of the highest standard in professionalism. I certainly think that, as a committee, if there is any way that we can help in the continuation of what they are doing, provided the consumer is protected, it must be done.
I would also like to welcome you here and thank you for a very precise briefing.
I take vitamins and believe in it as a practice. I am not an expert, but I am worried that there may be a vested interest. It presents difficulties for me that you have to come before this committee. It seems, along the way, various groups have not listened to you. Is there some vested interest that will benefit from this directive - chemists or doctors? If I am not feeling well, the cost of going to a doctor can be prohibitive. I feel there may be something driving this, although I am not sure. Maybe you can answer this.
Touché.
Ms Murray
Senator Henry's questions about folic acid, iron and haemochromatosis will be answered by Dr. Verkerk.
Dr. Verkerk
There is an absolute need to develop policies that are specific to given localities. It is one of the reasons that, as much as the Institute for Functional Medicine is doing some wonderful work in the US, I would like to support the recommendation that Martin Forde has made, that Ireland looks very seriously at an integrated healthcare institute that looks at the best possible way of taking the bits that make sense from complementary healthcare and seeing how they interact with all the good bits in conventional, or allopathic, healthcare, so that we can really move forward with a paradigm that is specific to this region.
I agree that one has to take into account the specific genetic pool that one is dealing with, but the real issue with this European directive is that they are trying to create a one size fits all regime that may impact negatively in certain regions, which is why it makes sense to develop something specific for Ireland.
Mr. Forde
It is fascinating that genetic issues bring about a requirement for greater levels of vitamins and, possibly, minerals. There was research some time ago which indicated that in Ireland there is also a genetic difficulty with the conversion of vitamin B6 into its active form. Could this be related to difficulties people have with B6-responsive conditions?
We are delighted to have these matters pointed out. As an industry we are delighted to provide the vitamins and minerals which may help. We are quite willing to accept regulation. Our difficulty is that the regulation that is being proposed possibly favours a vested interest. Perhaps Dr. Verkerk will describe the way the food supplements directive favours one sector of the food supplements industry over another.
Dr. Verkerk
It is important to recognise that about 70% to 80% of the supply of ingredients to the vitamins and minerals market originates from the pharmaceutical industry. These major players are on the whole the players who have dictated the direction that the food supplements directive has moved in. As Martin Forde pointed out, the original reason the food supplements directive came about was specifically to ensure that all nutrients were medicalised. It has only become apparent recently that the impact of it is going to be far wider-reaching than was originally thought. We have talked about certain vitamins and minerals and if we look at some of the most bio available forms of antioxidants - selenium might be a good example - we find that a particular form of selenium, selenium methianine, is one of the key ingredients not on the positive list.
Companies are currently working to produce a dossier on selenium methianine but they are really struggling simply because of the way it behaves within the scientific regime which is required. They are having great difficulty producing scientific data on it despite the fact that there is increasing evidence that people taking selenium methianine as a form of selenium are benefiting greatly, particularly in the treatment of serious diseases such as cancer.
Returning to the idea of an integrated healthcare institute, we have to acknowledge that there are problems regarding delivery of information on nutrition in the allopathic system also. With the development of the overall literature base on the importance of nutrition, it is now widely accepted in certain sectors that cancer and heart disease, the two most important killer diseases in the west, have a nutritional base. We need to support a system which encourages education on nutrition right across the healthcare sphere so that it is not just seen as part of the alternative complementary field but is fully involved in the conventional field as well.
Ms Murray
In reply to Deputy Cowley's question on what he described as the proliferation of health stores, I wish to outline the training required under the code of practice of the Irish Association of Health Stores. At least one member in each store is required to have the diploma in health food retailing, which includes a considerable module on nutrition. Day in and day out, staff in health stores are giving out free advice on lifestyles and diet. I am not aware of any other facility where people can just pop in, on the high street or in a shopping mall, with queries such as: "What am I doing wrong? My children are picky eaters - what should I give them? How do I concoct a meal that is both appealing and nutritious?" We spend hours every day providing this service to the community, backed up by sound training. Perhaps it is appropriate for Mr. Forde to reply about the relative risks to which the Deputy referred regarding appropriate regulation. The Deputy mentioned lightning strikes; we could regulate in that regard by legislating that every house should have a lightning conductor, but we do not do that. Why not?
Mr. Forde
Having worked for years on the other side of the fence, I really appreciate the situation in which doctors may find themselves. It is not an easy job. One is constantly faced with people with all kinds of problems and conditions. I sometimes wish more doctors had the types of nutritional resources of which we are aware. I believe that would make their jobs much easier, without affecting their capacity or position in regard to any form of drug therapy or surgery which might be recommended - that would not be an issue. I believe there is a very strong potential for prevention and for the regulation of function, primarily by nutritional methods. That is my experience.
My point was really——
We will take the delegation's responses to the remaining questions first.
Mr. Forde
In relation to relative risk, nothing in this world can be risk-free. The food supplements directive, as far as possible, brings the situation down to an amazingly risk-free level. In fact, we would dispute some of the risk assessments which have been made. For instance, with regard to Senator Henry's point concerning iron, the type of iron allowed in the food supplements directive would not normally find its way into food supplements at all. Because of its pro-oxidant profile, iron of any kind is not normally included in food supplements, but there may be specialised forms, aside from that. We are quite happy to accept a regulation that would be appropriate and which would be a good fit with what is done already.
I wish to refer to issues which will soon arise in relation the regulation and registration of complementary practitioners. There is a big area of education there. I would like to see improvement in complementary practice and integration also.
Ms Murray
If I may deal with Senator Feighan's question, we will come back to Deputy Devin's question on vested interests driving this directive and who stands to benefit. Perhaps Dr. Verkerk will comment on that.
Dr. Verkerk
There are many different pressures influencing this directive. Obviously the primary one is that of trying to create a single market environment which will undoubtedly bring benefits. There are regional dietary variations within the European population. As we know, the diet of southern Europeans includes a much higher proportion of fresh fruit and vegetables, they use a great deal of olive oil and their homocysteine levels are lower. It is difficult to come up with a "one size fits" all regime. In the case of a population which is relatively healthy regarding heart disease without taking supplements, it is not surprising that there are pressures to maintain that regime and regard supplements as an optional extra not necessarily required.
At the same time, we have to recognise that the pharmaceutical industry has been fairly involved in this directive. Our view is that we need to concentrate on the science and the fact that we need to ensure that a regulatory environment is not so restrictive that it actually prevents research and development in the field. The research base in Europe, in terms of providing high quality control studies, is limited partially because the companies which produce the ingredients and formulate the products have a disincentive to carry out research, becausethey are worried about medicinal claims being made.
As the committee will be aware, there is a whole series of directives in the pipeline, including a herbals directive, amendments to the medicines for human use directive and also a health claims regulation. All of those pose further problems and we are working with the European Parliament on ways of modifying their impact, so that we can have a regime in place which allows nutritional medicine to flourish.
That brings us to the final question.
Mr. Forde
In relation to Deputy Devins's question, we have sat before Oireachtas committees previously and have had lots of communications on various matters - normally on emergency issues, such as the discovery of an irradiated herb in a food supplement or something of that nature. That is not, in itself, a health issue but a legal issue. There was also a situation involving examination of oils for PAHs and benzophyrene. We live in a world where everything will be examined more closely. We are quite happy with that and we comply when issues arise. We wish to move to a different level and go forward in the terms we have discussed today with regard to nutrition and health.
I thank you for the compliment you paid to health stores. I believe what you said was accurate. Health store operators, such as Ms Erica Murray, are very professional in their approach and do an excellent job.
I apologise for interrupting, but my point was really that some of the products seem to fall within the remit of the Irish Medicines Board while others are the responsibility of the Food Safey Authority. Is there any forum in which all interested parties have sat down together in an effort to iron out matters?
Mr. Forde
Essentially there has not been a forum and this is something we would very much like to see.
Finally, on the question of what our pick of the list would be, for the moment, I feel it would be most harmful for the health food industry were Ireland to be swayed towards the adoption of levels lower than the maximum safe levels that will be recommended in time. If the level is safe, then there is no reason to cut down on it. I am sure there will be political moves possibly to cut down on some of the levels but we hope Ireland will not support that.
I will take a final question from Deputy Cowley. We have another meeting later, so I am keen to wrap this up.
I am most interested in training in this area and the fact that nutrition forms part of it. How much time is spent on this aspect of the training?
One can control what happens with supplements but one cannot control where lightning strikes. Putting something inside a building will not make any difference to lightning because the damage occurs outside, as was the case with my patient. I am a GP and spend a great deal of time talking to people about diet, lifestyle and so on. Lest anyone says that I charge for that, virtually all of my patients are on the GMS scheme, so that is not an issue. If one goes to a health food store there is a vested interest to sell health food products whereas an independent person such as a general practitioner has nothing to gain by recommending such products.
More emphasis should be placed on diet and a proper lifestyle rather than people believing supplements are a panacea for all their ills and that they cannot get on in life without them. I do not think this is the case. It is not that I am against the profession, but there is a limit to what it can do.
I have a final question for Mr. Forde before we decide where we will go from here. Do you feel it would be appropriate at this time for your industry to have representation on the Irish Medicines Board, and the board of the Food Safety Authority of Ireland, given the impact it makes on the marketplace?
Mr. Forde
We feel very strongly that this should be the case in both areas..
Is there currently a feeling that the industry is on a hiding to nothing when an issue comes before the Irish Medicines Board because it will, by and large, be made up of eminent, qualified physicians?
Or Deputies.
Mr. Forde
No. I believe we have extremely well qualified people. I am qualified as a naturopath and osteopath. I went to collegefor four years full-time in the UK; that istypical of the type of training offered there. While there are many other courses whichare of a different standard, I am sure things can be regulated in time. There are very good people, such as Dr. Verkerk, who have a huge interest and are qualified in the area of agriculture and nutrition and they have a great deal to offer.
I propose that we send a transcript of proceedings and the documentation we received this morning to the Department of Health and Children seeking a response fromit.
We will also make the transcript available to the Irish Medicines Board and to the Food Safety Authority of Ireland and look for a response from them on this issue. Is that agreed? Agreed.
I thank the delegates for appearing before the committee and outlining to it the impact and implications of the directive on their businesses. It has been a useful exercise and when we get the response, we can make them available to you. It is to be hoped that will have been a good morning's work.
The joint committee adjourned at 10.55 a.m. until 9.30 a.m. on Thursday, 26 June 2003.