JOINT COMMITTEE ON HEALTH AND CHILDREN díospóireacht -
Thursday, 13 Apr 2006

Scrutiny of EU Proposals.

Vice Chairman

The purpose of this meeting is scrutiny of EU legislative proposals COM (2005) 681 on the review of the medical devices directive, COM (2005) 567 on advanced medicinal products, and COM (2005) 577 on medicinal products for paediatric use. I welcome to the meeting Mr. Eamon Corcoran, Ms Mary Jackson, Mr. Wilf Higgins, Ms Moira Griffin and Ms Noreen Quinn from the Department of Health and Children, and Ms Ann O'Connell from the Irish Medicines Board. We are here to discuss the three proposals which have been referred to this committee for further scrutiny.

Before asking the representatives to commence their presentation, I draw their attention to the fact that members of the committee have absolute privilege but this same privilege does not apply to witnesses appearing before the committee. Members are reminded of the long-standing parliamentary practice to the effect that members should not comment on, criticise or make charges against a person outside the House or an official by name or in such a way as to make him or her identifiable. I invite Mr. Corcoran to make his presentation following which members may ask questions if they wish.

Mr. Eamon Corcoran

I thank the Vice Chairman. I understand I am to make the three presentations.

In regard to the medical devices proposal, the background is that a review of Directive 93/42/EC was carried out by the medical devices expert group and published in 2002. The review found that the directive required improved implementation by all parties and that the legislative modification was necessary to clarify certain existing requirements and to provide legal certainty.

The report and the subsequent Commission communication, COM (2003) 386, found that although the directive provided an appropriate legal framework, there was room for improvement in the following areas: conformity assessment, the sufficiency and adequacy of clinical data for all classes of devices, post-market surveillance, notified bodies, increased transparency to the general public, and modification of Directive 90/385/EEC relating to active implantable medical devices to align it with the framework directive on medical devices.

An open consultation was conducted by the Commission in 2005. Industry welcomed any initiative that brought clarification and consistency to the implementation and interpretation of the directives. The proposal currently being considered will amend Directive 98/8/EC on biocides to exclude in vitro diagnostic medical devices from its scope to remove the legal ambiguity in certain cases as to which directive should apply. In terms of an assessment of the proposal, because it relates to a regulatory clarification, no significant economic impacts are expected. Similarly, no environmental impacts are identified.

The main features of the proposal are as follows: increasing clarity will continue to support a high level of public health protection, provide more transparency and increase certainty for all market players, especially the public. The improved regulatory framework will continue to support fast technical progress to benefit citizens under better clarified conditions for guaranteeing safety and increased trust.

Advanced therapies are highly innovative medical products based on genes, known as gene therapy, cells, known as cell therapy, or tissues, known as tissue engineering. The advancement of science in the fields of biology, biotechnology and medicine has led to the development of these promising gene and cell-based approaches for the prevention and treatment of diseases or dysfunctions of the human body.

All three advanced therapy products share several key scientific regulatory and economic features. Gene therapy and somatic cell therapy products are, to a large extent, already regulated under existing medicinal products legislation. However, as engineered products are currently outside any EU legislative framework, the main focus of this proposed regulation is to regulate these products. The European Commission is of the view that progress in this sector is hampered by the lack of a harmonised regulatory environment. Accordingly, the proposed regulation aims to establish specific procedures and requirements for their authorisation, supervision and monitoring.

There is already a comprehensive system of European and national legislation governing the authorisation, marketing and post-marketing surveillance of medicinal products, including biotechnology derived medicines. Advanced therapy medicines will be subject to the same over-arching regulatory requirements as other biotechnology derived medicines and the proposed regulation aims to address any regulatory gap in this existing legislative framework. The overall policy objective is to make advanced therapies safely accessible to patients.

The general background to the proposal is that advanced therapies are expected to have a major impact on public health by improving the quality of life of patients and changing medical practice significantly. These therapies are based on complex, highly innovative manufacturing processes aimed at modifying genetic, physiological or structural properties of cells and tissues.

Tissue engineering is an emerging field that promises extraordinary advances in medical technology, especially in the field of regenerative medicine. Products on the market include simple tissue products such as skin, cartilage and bone but the technology could lead to the in vitro construction of human organs. A tissue engineered product is defined in the proposal as a product that “contains or consists of engineered cells or tissues and is presented as having properties for, or is administered with a view to, regenerating, repairing or replacing human tissue”, for example, tissue engineered skin, bone or cartilage substitutes. Tissue engineered products may incorporate as an integral part of the product one or more medical devices. In this case the product is referred to as a combined advanced therapy medicinal product. The fact that tissue engineered products are administered with a view to regenerating, repairing or replacing human tissue distinguishes them from other cell therapies.

The main objectives of the proposal are to guarantee a high level of health protection for patients treated with advanced therapy products, to harmonise market access and improve the functioning of the Internal Market by establishing a tailored and comprehensive regulatory framework for the authorisation, supervision and post-authorisation vigilance of advanced therapy products; to foster competitiveness, and to provide legal certainty while allowing for sufficient flexibility at technical level to keep pace with the evolution of science and technology.

In regard to the assessment of the proposal, the EU has conducted an impact assessment carried out by the Commission, which accompanies the proposal. Its overall conclusion was that in the long term, the proposed regulation should be of significant benefit for all interested parties by providing legal clarity and certainty; harmonising quality, safety and efficacy standards for the placing on the Community market of these products; improving the competitiveness of the economic operators concerned; and increasing the confidence of patients and health care practitioners. The assessment notes that the success of the proposal will, however, depend on particular attention being paid to certain categories of stakeholders to avoid imposing an unnecessary regulatory burden with little public health benefit. This especially concerns hospitals in regard to the scope of the regulation and small and medium-sized enterprises in relation to the centralised procedure for assessing products and special financial or administrative incentives that would be offered.

The proposal has been met with a broad welcome from member states but two elements have emerged which require further discussion. They are the border line between advanced therapy medicinal products and medical devices and possible licensing exemptions for hospitals.

Ireland supports the proposal which is aimed at regulating a highly innovative and swiftly evolving area of medicine. The regulation will not interfere with decisions made by Irish policy makers on whether to allow the use of any specific type of human or animal cell. It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medical products containing, consisting of or derived from, these cells. An appendix to the document, from which I have read, clarifies some of the terms used.

In regard to the medical products for paediatric medicines, namely, proposal COM (2005) 577, the overall objective of the proposed regulation is to improve the health of the children of Europe by facilitating research, development and authorisation of medicines for use in children. The background to the proposal is that the paediatric population is a vulnerable group with developmental, physiological and psychological differences from adults which makes age and development related research into medicinal products especially important. In contrast to the position of adults, more than 50% of medicines used to treat children have not been tested for use in children. Under the regulation, the submission of paediatric studies will be obligatory, unless a waiver or deferral is granted, when applying for a marketing authorisation.

The main objectives of the proposal are to increase the development of medicines for use in children, to ensure the medicines used to treat children are subject to high quality research, to ensure that they are appropriately authorised for use in children, to improve the information available and to achieve all these objectives without subjecting children to unnecessary clinical trials in compliance with the EU clinical trials directive. The regulation proposes a system of obligations, rewards and incentives to achieve the above objectives.

A key provision of the proposed regulation is the establishment of a paediatric committee within the EMEA, the European Medicines Agency. Among the functions of this committee will be the approval of paediatric investigation plans, PIPs. These are research and development programmes aimed at ensuring that the necessary data are gathered before the product can be approved as a paediatric medicine. When considering PIPs for approval, the paediatric committee must be satisfied that there is a potential for therapeutic benefit to children, including the avoidance of unnecessary studies, and that the requirement for studies in children does not delay the authorisation of medicines for other populations.

Another function of the committee will be the consideration of requests for waivers and deferrals made by the industry in making applications for marketing authorisations. Waivers may be necessary where a product is never intended for use on children. An example would be a new treatment for Alzheimer's disease. Deferrals may be necessary to ensure that medicines are tested on children only when it is safe to do so. The paediatric committee to be set up will establish an inventory of therapeutic needs, in particular with a view to identifying research priorities, and will support and advise the EMEA in establishing a European network of experts on paediatric studies.

A number of incentives are proposed. As an incentive to encourage the development of medicinal products for the paediatric population, it is proposed that off-patent products developed exclusively for use in children will be eligible for ten years' market exclusivity. A new type of marketing authorisation, the paediatric use marketing authorisation, will be granted for this type of product. For products already protected by patent, the proposed reward is six months' extension effectively of the patent on the whole product, including indications for adults. Orphan drugs, those used for treating very rare diseases, are to receive an additional two years of market exclusivity.

In each case, to qualify for the incentives, studies must be conducted in compliance with an agreed PIP and the medicine must be authorised in all member states. Where a medicinal product is granted a marketing authorisation for a paediatric indication, the label will display a symbol. The Commission will select a symbol following a recommendation of the paediatric committee and the symbol will be publicised.

In terms of progress to date, the Commission submitted its original proposal on 25 October 2004. The European Parliament adopted its First Reading opinion on 7 September 2005 and the Commission adopted its amended proposal on 10 November 2005. The working party on pharmaceuticals and medical devices has examined the proposal under the Netherlands, Luxembourg and United Kingdom presidencies. The Council of Ministers held a policy debate concentrating on the proposed extensions of the patent protection periods for medicines and on transparency issues concerning paediatric trials on 3 June 2005. The outcome of this debate served as guidance for the continued work of the Council preparatory bodies.

COREPER finalised at its meeting of 25 November 2005 a draft text of the regulation and political agreement was secured at the Council meeting of 9 December 2005. A political agreement was reached in a common position document at this meeting. The document was adopted on 10 March. On 13 March, the Commission adopted a communication supporting the common position document.

Senator Henry

On a point of information, what sort of in vitro diagnostic devices are to be excluded in the first directive?

Mr. Wilf Higgins

We are not excluding in vitro diagnostics, IVDs. The medical devices directive, by amending the biocides directive, does not exclude any IVDs but instead puts the IVD directive as a directive on its own stand to monitor the biocides used in IVDs.

Senator Henry

It does not exclude the devices.

Mr. Higgins

It does not exclude; it is the reverse. It excludes the IVD directive from under the biocides directive.

Senator Henry

I understand.

Vice Chairman

I thank Mr. Corcoran for the presentation.

Deputy Neville

I thank the delegation. As a lay person, it is impossible for me to comprehend exactly the implications of the presentation. We are here to scrutinise the proposals but, to be honest, I do not feel competent to do so given what I have heard. The presentation is highly complex and technical. Of necessity, perhaps, it is loaded with jargon with which I am unfamiliar and, therefore, I am not in a position to scrutinise this EU legislation as outlined.

I pose two simple questions, however. What are the implications for Irish legislation? Will changes to current Irish legislation be necessitated to implement fully the presentation that has been made?

Mr. Corcoran

Yes. Changes will be required. However, the bulk of our medicines legislation comes from Europe. It would often be transposed by way of regulations under the European Communities Act. The recently enacted Irish Medicines Board (Miscellaneous Provisions) Act also provides for transpositions. This is not radically different from what is taking place.

I accept the Deputy's comment that the proposals cover very technical areas but I am afraid that there is no way around that. We made a major effort in preparing these documents to attempt to bring lay persons through the issues.

Deputy Neville

Therefore, it is a reflection on me.

Mr. Corcoran

All I can say in my defence is that if members of the committee think these information notes are complex, they should see the parent documents.

Deputy Neville

Will Mr. Corcoran outline the legislative changes required? That would be a test for me as regards the implications of what has been presented to us. Obviously, that is an area we could scrutinise to see the implications of the legal changes.

Mr. Corcoran

If it would be helpful, we could circulate to committee members, through the secretariat, an example of a previous regulation and of the transposing statutory instrument. That might clarify the procedure and set the context.

Vice Chairman

I would appreciate that.

Ms Mary Jackson

Maybe some clarity can be provided concerning the tissues directive. While we are not discussing it today, I appeared before the joint committee on that directive. It put a number of quality and safety standards in place concerning any aspect of procurement, testing, storage and distribution of tissues and cells. That directive did not interfere with whatever member states had in their own national laws. In other words, whatever practices are under way in various member states can continue, but the quality and safety standards set in that directive must be adhered to.

That directive provided a framework for quality and safety but the problem in Ireland is that there is no national legislation on tissues and cells. That point was made clearly when Dr. Madden's report on post mortem practice and procedures was published. There is a need for national legislation on tissues, a tissue Bill, that would be the grounding legislation for practice in Ireland. In the meantime, however, whatever practice is under way must adhere to the quality and safety standards being set in these directives to safeguard public health. There is a lacuna in Irish legislation.

Deputy McManus

I share Deputy Neville's difficulty in this. It is a bit testing for those of us outside the medical world but I appreciate that the witnesses are making their best efforts. I understood that we were going to seek our own independent scrutineer to examine this proposal. When we embarked on this process I thought we were going to get some expert advice. That is not to say the Department of Health and Children is not independent, but there is an issue for the joint committee and I think we should pursue that.

My second point relates to the human tissues Bill. As there is a lacuna, I asked on the Order of Business within the past ten days when the human tissues Bill would be introduced. The Taoiseach, however, was completely bewildered and had no answer. It is obvious to me that there is no policy to introduce this Bill. It is not on the programme of forthcoming legislation and no answer was forthcoming from the Taoiseach. It is a matter of some concern because the Madden report covered a major issue that affected a large number of people. The clear signal was that we needed human tissues legislation. The fact that there is no political will to deal with it, as far as I can see, is a matter of concern.

It is important for us to understand more about technological advances. I suggest that we should have a meeting dedicated to medical advances, which are so important. In the meantime, perhaps the witnesses could advise the joint committee on what oversight exists on clinical trials. I have sought information by way of parliamentary questions on how many patients are engaged in clinical trials. That information is not forthcoming, although I would have thought it is basic data. Somebody must know who has embarked on a clinical trial and who else is involved in it. Recent events in Britain, where serious side effects arose from a clinical trial, alerted people to the need for better management of such trials. I strongly support clinical trials and I do not wish to be cautious about them. I advocate them but we need to have hard information in that regard.

Perhaps the witnesses can bring the committee up to date on an issue that arose concerning children in residential institutions in the 1960s who were used in clinical trials. That matter was not fully investigated and I recall that there were legal issues involved. I cannot remember whether there were any outstanding issues on that which we should be concerned about now.

The religious ethos of a particular hospital stopped women temporarily having access to clinical trials whereby they would have been able to get access to modern cancer treatments. That matter was dealt with but I seek a reassurance that it will never happen again.

Mr. Corcoran

I have some information on clinical trials with me but it relates to the numbers of such trials rather than to participants. I would prefer to see if I can assemble that information and reply in writing to the joint committee.

With regard to the vaccine trials, my area includes the medicines unit of the Department. The 1950s and 1960s vaccine trials issue is being dealt with by the child care section of the Department and we fed into that process at an earlier stage. I have a little information but would need to check it. If it is acceptable, we can reply in writing.

On the issue that arose before Christmas, it is part of the bedding in of the new 2004 clinical trials regulations. Previously, clinical trials were regulated under the Control of Clinical Trials Act 1987, which provided for an ethics committee in each centre in which a clinical trial took place. The new system provides for a single ethics committee authorisation, with other centres having the option of saying "yes" or "no" to the clinical trial. Centres can say "no" to participating in a clinical trial for a number of reasons, including resource implications because conducting such a trial is resource intensive. Hospital management takes account of other clinical trials being conducted. It should not attempt to reopen the ethics issue if the ethics committee of the centre has given approval. We clarified the issue but I cannot give a guarantee that this will not occur in the future because it is out of my hands. The issues that arose at the time have been adequately clarified with the hospital concerned.

Deputy McManus

Is Mr. Corcoran working on the human tissues legislation?

Ms Jackson

Last Friday we transposed the directive on human tissue and cells. We have the first tranche of legislation, under which no tissue or cell can be procured or tested without the tissue establishments being authorised to carry out procurement, testing, storage or distribution of tissues and cells.

Deputy McManus

Has that been done without Dáil scrutiny?

Ms Jackson

No, it was scrutinised by the committee——

Deputy McManus

Where stands the human tissues legislation?

Ms Jackson

A directive is transposed by regulations under the European Communities Act.

Deputy McManus

I know that; I referred to the human tissues Bill.

Ms Jackson

The regulations transposed into law a Commission directive on the quality and safety of tissues and did not require scrutiny in the Houses of the Oireachtas. That is the first tranche of legislation on tissues and cells. It is important because all tissue establishments such as hospitals, which procure bone and bone marrow, and fertility clinics must be authorised to procure, test and store tissues and cells. Under the regulations, imports and exports of tissues and cells must be authorised by the competent authority, the Irish Medicines Board. Our main priority in 2006 was to transpose the directive into Irish law. It is the first building block for the tissues legislation which will address other areas such as anatomy, the removal and retention of tissues and cells by pathologists during a post mortem.

Deputy McManus

When is the second tranche of legislation expected?

Ms Jackson

It is my job to work on it and identify the timeframe for the Tánaiste and Minister for Health and Children for putting it in place. Advances will be made this year. The main objective was to get transposition of the European directive out of the way and that has happened. The next step is to bring forward the tissues legislation.

Senator Henry

I thank the officials for their comprehensive presentation. I referred to in vitro devices. Are test kits sold to the public covered by the directive? Many test kits, including those for pregnancy and HIV, are marketed. Is there post-market surveillance? Do these kits come under this heading?

I am glad Ms Jackson has got the tissues directive through and I am sure she will glad to see the back of me in this regard. Will fertility clinics be covered by regulations because in the United Kingdom such clinics have sought a derogation? When I visited Brussels, I asked who could apply for a derogation and I was told Ireland would have to have legislation in place before a derogation could be sought. Given that the regulations are in place, should Ireland seek such a derogation? Would it cause a problem for fertility clinics?

The paediatrics legislation is important but difficult to deal with. Deputy Fitzpatrick will recall the time aspirin was given to children and Reye's syndrome became a problem. Both Deputies Twomey and Devins are too young to recall this. However, aspirin which was widely prescribed for children was subsequently found to be unsuitable for those aged under 12 years. This is an important issue which is difficult to address but I am glad the legislation is on the way.

Clinical trials were conducted in the good old days by those of us who worked in the research departments of hospitals and were employees of the hospital but nowadays a considerable number of such trials are conducted by private companies in public hospitals. It is big business. In the Northwich Park case the trial was conducted by a private company. Are all the officials happy that there is sufficient surveillance of the companies involved? I have no reason to question any of them but, at the same time, I do not know all of them. The advent of private companies conducting clinical trials represents a change in emphasis from the time people were employed by the health service to conduct them.

Deputy Connolly

With the best will in the world, we could not have read all the documentation circulated to us prior to the meeting because it comprises only part of our preparations for such a meeting. This is typical of EU legislation. Officials can bury, hide and try to get anything through in such legislation by presenting us with documentation like this because there is no way we can read it all. I compliment Mr. Corcoran on the synopsis he provided of the documentation. It is readable, understandable and useful. Perhaps the brief will be circulated prior to the next meeting and if we need to conduct in-depth analysis, we can consult the reference book. If legislation or regulations receive the stamp of approval of the committee, we are endorsing them without having properly analysed the documentation, which is a matter of concern. Paediatric research is important in the development of child medicine and so on. As children are a vulnerable group, we need to examine such legislation closely. More than 50% of medicines used to treat children have not been tested for use on them. Senator Henry asked about clinical trials. Are they carried out on vulnerable children in Third World countries? How are medicines tested for use in children?

The main proposals in the legislation are welcome in the development of high quality medicines for children. The establishment of the paediatric investigation plans, PIP, is necessary in terms of ensuring safeguards for children.

I am concerned about the incentives and the proposed patent protection period, which in one case is ten years. While this is a way of rewarding pharmaceutical companies that have produced good medicines, the patent protection in some cases is too long and results in prices being kept artificially high for a long period. I would like the patent protection period shortened in some cases. Once a drug is developed the company has the exclusive right to it for a long period which can have the effect of making a medicine extremely expensive and unreachable for many parents who do not deserve to be faced with such a situation. There is a case in England where health authorities cannot afford to buy a particular drug for breast cancer for the treatment of patients.

Senator Henry

It is called Herceptin.

Deputy Connolly

A similar situation could arise here, because what happens there is often replicated here, where prices are kept artificially high and beyond the reach of most persons who need the drugs.

Senator Browne

I am delighted to hear I am not the most stupid person on the committee as other members do not understand what has been said either. We are here to scrutinise these proposals. Are we to accept, reject or amend them, or what is the purpose of the meeting? I am not fully au fait with it. Deputy Neville asked a question about——

Vice Chairman

These are proposals and we either accept or reject them.

Senator Browne

I will ask the opposite question to Deputy Neville. If we were to reject them, what would happen? The organ retention scandal emerged some years ago and families are still coming to terms with it. Are there implications on that front, in terms of the proposals before us, about organ retention by hospitals, especially of dead children?

Among the witnesses is a lady from the Irish Medicines Board. The Irish Medicines Board (Miscellaneous Provisions) Bill was recently before the Seanad. It is well and good having regulations but the reality is that there is a major problem in terms of the sale of drugs on the Internet. People can buy whatever they want on the Internet. The Irish Examiner has devoted a two-day feature to this matter. Apropos of this, I heard a reference on the radio to drugs being made in cement mixers in India and then being sold on the Internet. People buy them in good faith but they are buying drugs that at the very least could be ineffective or, at worst, harmful. How do we counteract this serious problem? Are we completely missing the point in having these well intentioned regulations and proposals but not addressing the issue of Internet sales of medicines?

I was skiing recently and was amazed to see the number of dogs in pubs, restaurants and hotels. In a particular restaurant one night there were five or six dogs. That would not happen in Ireland. We are very good at implementing EU policy but our EU colleagues do not appear to be as good. The minimum wage comes to mind as an example. How effective will this regulation be unless all 25 member states fully implement and enforce it? I suspect it will not be fully implemented elsewhere, as is the case with other aspects of EU legislation. How do we counteract that?

Senator Hanafin

Looking at the summaries, the proposals and objectives are laudable in terms of ensuring a high standard throughout Europe. I have a particular interest in gene therapy. I note the different proposals and the recognition of the advances in this area. It is important to note that the advances are currently taking place in adult stem cell tissues. The original difficulties continue to be encountered with embryonic stem cells in regard to their pluripotency and the inability of the scientific community to switch off the multiple growth that takes place within embryonic stem cells. In particular, I note the false dawn of Dr. Hwang in South Korea. We should note it is adult stem cells that continue to give success.

Deputy Twomey

Is there a statutory body within the EU that has the same power and authority as the FDA?

Mr. Corcoran

The FDA is the Food and Drugs Administration in the United States. In Europe there are two separate agencies; the European medicines agency and the European Food Safety Authority, EFSA. The two areas do not come together in the same way in Europe. The two bodies would have some but not all of the powers of the FDA because of the different structure of government in the United States. It is a different method of organising this area but it is broadly similar. There are probably some differences. I have not done much research in this area in terms of comparing and contrasting in any great detail but I am aware of the issue in a general sense.

Deputy Twomey

Much of what we are discussing is pending legislation and in this case the transposition of EU legislation. In recent weeks a practitioner in Cork brought in gene cell therapy that was used on a patient. Will the regulation that came in last week prevent a recurrence of what happened in this case, where a person brought in something like that for use as a medicinal product?

Ms Jackson

Under the tissue regulations, the Irish Medicines Board is the competent authority that will have to check out the practice of this practitioner and decide whether he can be authorised to do whatever he is doing. The matter is being investigated. This set of regulations provides the statutory instrument that will allow persons engaged in stem cell work to be inspected and authorised, or not as the case may be, depending on what their practice entails.

Vice Chairman

Does that mean persons can start giving treatments without prior approval and that they would then be investigated retrospectively, or do they have to conform with regulations before they commence?

Ms Jackson

No regulations covered the area of tissue procurement etc., and the stem cell work in which the person concerned was involved. This work is now covered under the regulations that transpose the tissue directive.

Deputy Twomey

Were the regulations just introduced last week?

Ms Jackson

As far as I know the practitioner has been operating for some time. This was highlighted in the media in recent weeks.

Deputy Twomey

Are the regulations covering the individual concerned in operation for some time?

Ms Jackson

No, the regulations that were in place covered medicines but not human cells.

Deputy Twomey

Are the regulations now in place?

Ms Jackson

Yes.

Deputy Twomey

This committee is setting up a sub-committee to investigate side effects and adverse events in administering drugs. I was particularly interested in what Ms Jackson said about children because in the process of setting up the sub-committee I have received a significant amount of correspondence from people, most of it extremely negative towards the drugs industry, about adverse events in administering drugs to children. Some of the accusations made against pharmaceutical companies are that they basically hoodwink the FDA or that the FDA does not have the expertise to deal with the issues. Is the Irish Medicines Board, IMB, strong enough to counterpoint these kinds of issues? I hope to invite the IMB to appear before the sub-committee.

I am interested to find out if there is a European equivalent of the FDA because it is not really possible for a national body in each individual country to carry out the background research into clinical trials and how they are put together and the background work that needs to be done by a pharmaceutical company before a drug comes on the market. We are discussing proposed legislation but although legislation is in place for medicinal products we are running into difficulties. We have seen four drugs withdrawn from human consumption in the past four years. This suggests the legislation is not good enough. Should we really be looking at something stronger than this? Should we ask the EU to establish a more powerful body to examine what is happening in medicinal products and devices? Do we go far enough to protect patients?

Senator Henry

Many clinical trials are now multi-centred with the results sent back to the drug company, which are then interpreted by a doctor in that company. This is what concerns me — the drug companies have huge control over the interpretation of the clinical trials. Looking at Vioxx, the clotting problems were evident from early on but the product was marketed for a considerable time until post-market surveillance showed there were many problems.

Mr. Corcoran

Senator Henry referred to the importance of the proposed paediatric regulation. It is very important. The European Parliament had its Second Reading of the legislation and a number of amendments have been tabled. It is likely, however, that the proposal will be adopted without having to go through the conciliation procedure and it could be in place by the end of the summer.

The issue of private companies carrying out clinical trials was raised. The Control of Clinical Trials Act 1987 and the EU clinical trials directive, which was transposed in 2004, take account of the fact that private companies are involved and the system is designed to be robust enough to cover that contingency.

Mr. Higgins

The IVD directive is not being changed under the proposals before the European Council and Parliament. Clarifying the position on the directive, it has been in place since December 2003 and is fully applicable under the statutory instrument transposing it. It is an open market situation and any kits and products on the market will be CE marked and must qualify for the essential requirements in the directive.

There is co-operation at national and European level on the market surveillance operations group. Information is passed between all member states on issues that have arisen in clinical trials. Ireland is well positioned to get the information and co-ordinate with Europe on the removal or suspension of any kits which are not performing in accordance with their defined requirements.

Ms Jackson

Fertility clinics in Ireland did not get a derogation and EU Regulation 158/2006, the quality and safety of tissues and cells regulation, applied to them from Friday, 7 April 2006. The British clinics were allowed a derogation because they are already covered by national legislation. Member states that had legislation in place were allowed a derogation to work through what was needed. As there is nothing in place in Ireland, there is no derogation. The regulations and quality standards must be applied from 7 April.

We have a national committee which works with representatives of the fertility clinics, making them aware of the quality standards they must apply in their clinics. The Irish Medicines Board will authorise and inspect each of them to ensure they meet those standards.

Questions were asked about the implications of organ retention and the Madden report. Dr. Madden recommended that there should be an audit of retained organs in all hospitals to ensure anything that remains in hospital is returned or the parents or next of kin are notified. That is under way through the National Hospitals Office. The timeframe for it was a year from the publication of the report. By the end of this year it will be complete.

Mr. Corcoran

Deputy Connolly asked about the complexity of the legislation. It is complex. It is my job to deal with it and I find it complex, it is not user-friendly, but we must play the hand we are dealt. We are constrained by the EU drafting style and I see no way around the problem.

Deputy Connolly also asked about vulnerable children. The paediatric investigation plans provided for in the draft regulation will address that to a great extent. He asked about patent protection, an issue that has arisen before. There is a balance to be struck in giving incentives to drug companies to do work they would not otherwise do. The usual strategy is to extend the period of patent protection. It is a finely balanced decision and the ten years was set on balancing the pros and cons. It would not be possible at this stage of the proposal to reopen the issue. It was considered at length in the process.

Senator Browne asked about organ retention — none of these proposals will have any impact in this area — and the Internet sale of drugs. We recently funded the Irish Patients Association to conduct a study into such sales and we received the report before Christmas. The Department and the Irish Medicines Board are considering it. I will meet the Irish Medicines Board soon for the quarterly meeting and that will be on the agenda. Internet sales are not such a major problem in Ireland because of the drug reimbursement schemes. There is no advantage to a consumer in buying on the Internet because he or she would forfeit the refund he or she would get under the drug payments scheme. It does, however, leave open the door to self-prescribing.

Counterfeit drugs coming into the legitimate supply chain in Ireland are a greater concern. That happened previously with condoms and we are conscious of the issue. A number of Departments are involved, as are the Garda Síochána and Customs and Excise.

Senator Browne also mentioned full implementation in other member states. As the European Commission is fastidious in following up on implementation of directives, I am not concerned about this area.

Senator Hanafin raised an issue about embryonic stem cells, with which Ms Jackson will deal.

Ms Jackson

The Senator said that the major advances are in the adult stem cell area, which includes developments in treatment of certain cancers such as bone marrow cancer. We await Irish legislation on this research. The adult stem cell work is legitimate and proving efficacious.

Mr. Corcoran

Through my regular dealings with the Irish Medicines Board, receiving and reviewing its business plan, and holding quarterly meetings with the chief executive officer of the board and senior management, I have formed the impression that the board is adequately empowered and resourced to perform its functions.

Senator Browne

We have no idea how bad the problem of Internet sales is but it is sure to be much worse than we think. Customs interceptions are the only means to assess it. Substantial cost savings can be made through Internet sales. We do not really know what is happening.

Deputy Twomey

Are embryonic stem cells covered by last Friday's regulations?

Ms Jackson

Yes.

Vice Chairman

I thank the officials for attending the meeting today, and for a comprehensive presentation of the issue. That concludes our scrutiny of COM (2005) 681 regarding the review of the medical devices directive; COM (2005) 567 on advanced medicinal products; and COM (2005) 577 on medicinal products for paediatric use. The clerk to the committee will prepare a formal report on our discussions today. Is that agreed? Agreed.

The agenda for our next meeting will include an item on how to deal with the complex language used in the Commission reports. At that meeting the Irish Hospital Consultants Association and a working group from the Health Service Executive will attend to discuss the new paediatric hospital.

The joint committee adjourned at 11.35 a.m. until 9.30 a.m. on Thursday, 27 April 2006.