Vol. 512 No. 7
14 Mr. Howlin asked the Minister for Health and Children if he will ensure that the 1 January 2000 date for the addition of St. John's Wort to the list of prescription only medicines is at least delayed pending the ruling of the European Commissioner for the Internal Market on this decision in view of the fact that, if the decision is seen as a restriction on fair trade, infringement proceedings will be taken against Ireland. [27076/99]
19 Mr. Dukes asked the Minister for Health and Children if he has considered the submission furnished to him by an organisation (details supplied) on its scientific review launched on 2 December 1999 relating to the herb St. John's Wort; and the plans, if any, he has to act on the scientific review of safety data having had an opportunity to consider its contents. [26670/99]
55 Mr. Perry asked the Minister for Health and Children if the Irish Medicines Board has set up a working group to review the regulation of herbal medicinal products; if not, when this group will be established; the range of interests to be represented on this group; and if he will amend S.I. 271/99 as it applies to herbal remedies pending the publication of this group's report. [27147/99]
58 Mr. Dukes asked the Minister for Health and Children the proposals, if any, he has to provide an authorisation or regulatory system for herbal remedies. [27139/99]
136 Mr. Shatter asked the Minister for Health and Children if he has considered the submission furnished to him by an organisation (details supplied) of its scientific review launched on 2 December 1999 relating to the herb St. John's Wort; and the plans, if any, he has to act on the scientific review of safety data having had an opportunity to consider its contents. [27174/99]
142 Mr. Shatter asked the Minister for Health and Children the proposals, if any, he has to provide an authorisation or regulatory system for herbal remedies. [27182/99]
146 Mr. Shatter asked the Minister for Health and Children if the Irish Medicines Board has set up a working group to review the regulation of herbal medicinal products; if not, when this group will be established; the range of interests to be represented on this group; and if he will amend S.I. 271/99 as it applies to herbal remedies pending the publication of this group's report. [27186/99]
151 Mr. O'Shea asked the Minister for Health and Children his views on a review (details supplied) in respect of S.I. 271/99; and if he will make a statement on the matter. [27192/99]
I propose to take questions Nos. 14, 19, 55, 58, 136, 142, 146 and 151 together.
On a point of order, Baineann ceist 21 agus 48 le St. John's Wort freisin.
The Chair has no control over the number of questions that taken together.
An bhfuil botún déanta ag duine éigin?
Tá freagra agatsa.
Freagra difriúil.
Tá an cheist difriúil.
Tá siad cosúil leis na ceisteanna a lua tú.
Tá breis eolais iontu nach bhfuil ag baint leis na ceisteanna seo.
I would prefer it if we proceeded with these questions because time is limited.
The submission concerned has been comprehensively reviewed by the Irish Medicines Board. Following this review and because of the serious concerns about the safety of products containing hypericum perforatum or St. John's Wort, together with the promotion of the use of these products for depression, which is a most serious illness, I have been advised by the Irish Medicines Board, which is the competent expert authority in the matter, that its recommendation in regard to the prescription status of products containing St. John's Wort is unchanged. As Minister for Health and Children, I am obliged to have regard to the Irish Medicines Board's opinion in this area and I, therefore, must advise the Deputies that no case has been made which would enable me to alter the regulatory position regarding products containing St. John's Wort.
In regard to these products and the EU internal market, I am not aware that any complaint has been lodged with the Commission nor am I aware that a ruling regarding this issue is pending.
The Deputies will be aware that the overall situation regarding the control of herbal medicinal products is unsatisfactory in many EU countries and that currently many herbal medicinal products are being unlawfully placed on the market in this country. As these products are unlicensed, their safety, quality and efficacy cannot be satisfactorily assured. The market for these products is increasing and as Minister for Health and Children I have responsibilities in regard to public health concerns about the current situation. As a result of these concerns, and because it is not anticipated that the current discussions at EU level will provide a resolution to these difficulties in the near future, I have asked officials in my Department to investigate the possibility of an interim national system for the licensing of certain herbal or traditionally used medicinal products. This will not alter the prescription-only status of products containing St. John's Wort but it may allow the products concerned to be licensed. I anticipate that the working group which is currently being set up by the Irish Medicines Board to consider the question of regulatory control of herbal medicinal products will be of assistance in this respect and I look forward to receiving the board's recommendations when the group has completed its consideration. I also look forward to the co-operation of the organisations representing the various interested parties and I welcome recent statements which indicate a willingness to progress along these lines.
Deputy McManus rose.
I will call Deputy Shatter first, Deputy McManus, because one of the questions is submitted in his name. The precedent is that the Members in the House in whose name questions have been tabled are called first when a number of questions are taken together.
Has the Minister made inquiries with the Irish Medicines Board regarding why it believes that St. John's Wort should become a prescription only medicine when prescriptions for it are not needed in most other European Union countries? Would he agree that it might be better that the issue of herbal remedies be dealt with globally and that two or three types of remedies, one of which is St. John's Wort, should not be dealt with separately? Would it not be more satisfactory if a uniform approach to herbal remedies be taken across the European Union? To make St. John's Wort a prescription only remedy may create difficulties for people who wish to gain access to it. However, a person living in Dundalk can simply drive across the Border and purchase it in Newry without the need for a prescription. Does the Minister agree that the board's approach is an illogical way to deal with this issue?
The Irish Medicines Board is the relevant statutory authority in respect of this matter and I do not believe it is appropriate for the Minister for Health and Children to interfere with the board in the discharge of its remit in relation to medicinal products, howsoever these products may be described. It is important that the terminology employed is not interchangeable. If the board becomes aware in the course of its work that there are issues of concern in respect of public health which need to be addressed, it is the board's responsibility and duty to take whatever action is necessary to protect the health of our citizens. I do not believe that the position is negotiable.
It is important to point out that the basis upon which this issue arose was that the Irish Medicines Board 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. The medical evaluation of that application revealed major deficiencies in the submitted information and the concerns of the board were conveyed to the applicants in the usual manner. The applicants involved decided to withdraw the application rather than respond to those concerns in the normal way.
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 interests of public health. That is the basis upon which it applied a prescription only status to it. What occurs in Germany and Northern Ireland on this issue does not come under the remit of the IMB. It is the statutory authority to deal with the issue, as established by the Oireachtas.
Every medicinal product must be authorised and it must meet the criteria of health, safety and efficacy. This product failed on the basis of public health. It is available on prescription as an over the counter product. I must take the board's advice seriously. An interim registration system has been established for other medicines which had traditional uses. It is more simplified in terms of meeting the criteria of health and safety because there is a difficulty in some instances where other products which do not relate to this issue are efficacious in that they do what they claim. There is an absence of clinical trials in regard to them.
These products are unlicensed. People in the industry want regulation and licensing. I am providing an interim licensing arrangement for all those products and a working group will work with the IMB and other interests, which are knowledgable in this area, to deal with that specific issue, which is historical. The board made a decision based on medical and scientific grounds and public health considerations given the interaction that takes place between St. John's Wort and other medicines. It is not appropriate for me to interfere with the independence of that authority.
Does the Minister accept there can also be a common sense approach to this issue and that the IMB has taken a sledgehammer to crack a nut? Does he feel he had responsibility to ensure the full range of research was assessed by the IMB before this decision was made? I am sure, like the rest of us, he has received a great deal of correspondence on this issue. Does he agree it is difficult to explain to the public that paracetamol, for example, is on sale over the counter and is more likely to have a serious medical impact if it is inappropriately used than products, such as St. John's Wort? Does he accept that generally there is evidence to prove this is a safe product and the IMB decision was based on flimsy evidence? Does he further accept that he has a responsibility to apply common sense? Does he agree the concept of general practitioners prescribing this product is not a good use of their time and that it would be more appropriate for him to establish a separate regulatory body, including representatives of the industry and consumers, to examine these products?
Nobody is arguing against regulation, particularly those involved in the industry. They have asked the Department for this for many years. Does the Minister accept that would be a more appropriate response than the inappropriate over the top reaction by the IMB based on flimsy evidence? Will he ensure further evidence, arising from a full assessment which was carried out by the Health Products Alliance and made available to the Department, will be taken on board by the IMB?
An assessment has been carried out. It does not behove any Member to undermine the authority of the IMB. It is the relevant statutory authority, which has been given powers by the Oireachtas to deal with these matters on an objective, scientific and medical basis, quite apart from any commercial or other considerations that exist. On the question of this being an over the top response, the board has recently provided the scientific basis for this decision in journals such as Lancet, and other evidence is emerging. Scientific interactions are involved, about which I do not claim to have full knowledge.
I take the advice of the board seriously and it does not behove any of us to trivialise, for example, the seriousness of depression as an illness. It requires treatment with medical supervision. The IMB is deciding this issue as it is not a political issue, on which I decide. The decision was taken on the basis of objective, scientific criteria and in the interests of public health, which is within the IMB's remit. I do not underestimate the importance of its responsibility.
The board has made proposals concerning the need to introduce controls on the sale of paracetamol. They are with the Department and will come into force in the coming months. The controls will relate to package size and the number of packets an individual can purchase. Paracetamol is used to treat pain. It is claimed that St. John's Wort is effective in the treatment of depression.
Mild depression.
It is a false claim.
I am just answering the questions. Paracetamol is a licensed and regulated product while St. John's Wort is not. Information leaflets are available to the consumer regarding paracetamol while similar information is not available regarding St. John's Wort.
There is plenty of information.
Whether the Deputy agrees, all medicinal products according to our law require authorisation. There are many unlicensed products in the marketplace. When the specifics of this issue came before the IMB, it was concerned about the interaction of this herbal ingredient generally and it came to a decision not to make it available but it felt, particularly in regard to the treatment of depression, it should be available on prescription only. It should be recalled that product authorisation was withdrawn and it was open to the IMB to decide on over the counter, prescription or prescription only status with repeatable authorisation. The IMB, not us, decides on this.
With regard to the wider policy issue which this matter raises – it does not change the status of St. John's Wort, as designated by the IMB, having examined all the evidence – an interim licensing arrangement will be established to deal with health and safety aspects on the basis that efficacy is difficult to provide for such products. We need to be careful and recognise that these are not interchangeable terms. These are medicinal products which require authorisation.
An aontaíonn an tAire nach bhfuil éinne ag rá sa Teach seo nó in aon áit eile gur leigheas é St. John's Wort ar depression? Níl siad ach ag rá gur chabhair é do dhaoine áirithe atá in ísle brí agus is mór an difríocht é sin.
Depression is an extremely serious condition, as pointed out by the Minister. It is not claimed that this product is a cure for it and any such claims are not stood over.
An aontaíonn an tAire go mbeadh deireadh le St. John's Wort má tá sé fágtha ag dochtúirí é a thabhairt amach? Ní thuigeann na dochtúirí féin St. John's Wort agus níl sain-eolas acu air. Mar an gcéanna le Tribulus Terrestris agus Blue Cohosh, ar an gcéad lá de mhí Eanáir atá le buaileadh ag an Aire.
An aontaíonn an tAire go mbeidh deireadh leo siúd mar úsáideann herbalists an dá rud sin? Níl siad ar fáil thar an cúntar agus beidh deireadh leo mar ní féidir le herbalists iad a thabhairt amach má bhuaileann an tAire iad. Iarraim ar an Aire gan é seo a dhéanamh ar an gcéad lé de mhí Eanáir mar beidh go leor daoine buailte. Beidh siad tinn agus beidh siad níos measa as dá bharr. Iarraim ar an Aire é seo a chur ar athló
Ceist, mas é do thoil é.
Tá téarmaí teicniúla anseo agus níl mé in ann an freagra iomlán a thabhairt as Gaeilge.
As Bearla.
It is not correct to say that I can suspend this initiative. I do not have authority in deciding what is or is not a medicinal product. The Irish Medicines Board makes that decision.
(Interuptions).
The Deputy should allow the Minister to reply. Three Deputies have not yet contributed and I wish to facilitate them.
If the Deputy intends to pursue an argument on the basis that expert advice is not available to the Irish Medicines Board, he is on a weak wicket. The board is charged with dealing with the authorisation of every medicinal product in the State. It is incorrect to suggest that it is not expert in this area. As the Deputy is aware, the directive does not distinguish between pharmaceutical and any other type of product. Before the directive, Ireland did not have a licensing system for traditional use medicines unlike other countries. The idea that there is harmonisation around the corner at EU level is not a fair assessment of the situation. However, in acknowledging the unlicensed position which has developed and the need to put some interim regulations in place, I am providing a policy initiative to deal with the issue generally.
The issue regarding St. John's Wort arose as a result of a product authorisation application. The IMB decided that it had concerns about its herbal ingredients generally and how it interacts. There is medical evidence in that regard. The board will make the decision, not me as the Minister for Health and Children, based on objective and scientific advice. That is the basis on which such decisions are taken. The board is acting on the basis of its concern for public health. Some emerging issues are of concern to other member states also but I deal with the IMB in relation to this jurisdiction.
Does the Minister agree that, after 1 January, Ireland will be the only country in Europe where St. John Wort's will be available on prescription only? Over the counter sales are allowed in the United States, Canada, South Africa, Australia, New Zealand and all the Far Eastern countries. I am amazed that the Minister is introducing the regulation.
A question please, Deputy.
Why is the Minister introducing the regulation when other European countries are not doing anything about it because they do not consider it necessary? Is the Minister aware that the authors of a 1997 article in the European journal of clinical research concluded that, based on the fact that such preparations are extremely well tolerated and free from the risk of dependence or addiction, St. John's Wort can be successfully used—
It is not appropriate to quote during Question Time.
—as a self-medication for temporary mood disorders without requiring treatment by a doctor?
The Minister should take some.
The Minister does not appear to be aware of the concerns of many people about the proposed restriction on the sale of St. John's Wort. Will he explain why Ireland is the only EU country which is proposing to add St. John's Wort to the list of prescription only medicines? The Minister made great play of it being a health issue. Why do issues of public health not arise in other EU countries? Do other EU member states have corresponding bodies to the Irish Medicines Board? Why is Ireland unique in this matter?
There are different national authorisation measures for the control of medicinal products on a traditional use basis. Some countries had a licensing system prior to the issuing of the EU directive but others, including Ireland, did not have such a system. There is not necessarily uniformity of treatment in this matter. For example, in Germany certain medicinal products containing St. John's Wort require a prescription. However, no country, with the exception of Ireland, has yet placed those products on prescription. In some countries, including Belgium, France, Greece, Italy, Luxembourg, Portugal and Spain, medicinal products, including herbal medicinal products, may only be sold in pharmacies. Different approaches are applied in different countries.
When the IMB deliberates on this issue, which arose following the submission of a product authorisation application, it will make a scientific assessment on the basis of public health concerns. I will not overrule public health concerns of the Irish Medicines Board regardless of how long Deputy Sheehan has been interested in this issue.
This product has been around since John the Baptist's time.
The Minister without interruption.
There will not be a restriction with regard to access. People will be able to get this product on prescription only as decided by the Irish Medicine Board. Thousands of products are only available on prescription while others are available over the counter. The Irish Medicines Board makes the decision in that regard, not us.
Three Deputies are offering. We will take their questions and a final reply from the Minister. We have exceeded the time for Question Time but I will allow them, given the season.
The Minister's news is depressing for the people who use this product. Is he aware that 66,000 people have signed a petition on this matter?
They will have their say at the next election.
Is that the Deputy's motivation?
Who funds the Irish Medicines Board? Does the Minister's Department fund it or is it the people who have applied for a product licence? Does the Minister think there is a conflict?
A suggestion has been made in the national debate on this issue that there is an unholy alliance between the Irish Medicines Board and the pharmaceutical industry and possibly a conflict of interest. Will the Minister clarify the situation regarding the independence of the Irish Medicines Board and the funding provided by the State for it?
If we accept the Minister's point that the IMB will make this decision on public health grounds, does he agree that the evidence the IMB used was flimsy and inconsequential? Is he not surprised that the IMB indicated when it made this decision that it did not refer to practice in the EU? It did not check what other countries were doing. The Minister must have an interest in terms of EU harmonisation and ensure that the IMB at least considers the position in other countries which have proper research and back up facilities.
The IMB is not responsible for EU harmonisation. That is a matter for member states and the Commission. I assure the Deputy—
It is a matter for the Minister.
Exactly, and it will not be resolved before 1 January or immediately thereafter because different approaches have been taken by different states depending on their history in relation to this matter, the level of authorisation and the place traditional use medicine has in their medical culture. Completely different situations apply.
Deputies must respond to representations but it does not behove anybody to undermine the independence of the Irish Medicines Board. It holds no brief for anybody in relation to this matter other than for the public as it sees fit. It does not hold a brief for me or any industry or pharmaceutical company.
Answer the question. Who funds it?
I am answering the question. It ill behoves any Member of the House—
Who funds it?
The Irish Medicines Board is an agency of my Department. If the Deputy is questioning for one moment—
I asked the Minister a question. Who funds it?
I will give the Deputy full details on that this evening.
The Minister is not answering the question. Who funds it?
I will not accept from the Deputy or any other Member of the House—
Who funds it?
It ill behoves any Member of the House to undermine the integrity of the people—
Please allow the Minister to conclude.
I am entitled to ask a question.
Yes, the Deputy is entitled to ask questions.
Who is funding them?
I will not be interrupted by the Deputy. That might work in Mayo County Council but it does not work here with me. I will explain, with respect, that the Irish Medicines Board know much more about this issue than the Deputy.
Answer the question.
Written Answers follow Adjournment Debate.
