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Seanad Éireann debate -
Thursday, 10 Oct 1996

Vol. 148 No. 15

Adjournment Matters. - AIDS Treatment.

I welcome the Minister whom I regard as a very vigorous and decent person. I am glad to provide him with the opportunity of dealing with the subject of the availability of new combinations of drugs which have been very successful in fighting AIDS. I do so having read an article in the newspapers which raised certain concerns. The matter is not so urgent in this country. I know that Irish patients have access to almost all of these drugs on a named patient basis by agreement with the board. There are 250 patients with full-blown AIDS who receive this combination of drugs when required.

The Department of Health gives a grant to hospitals for the treatment of AIDS patients. At the end of the year the hospitals will begin to pay for some of these drugs. Could the Minister clarify whether the amount of money given to the hospitals will increase to cover this additional cost? I do not expect the Minister to answer this off the top of his head. If he does, it would be very much appreciated but perhaps he would make inquiries.

I raise this matter because a number of countries apart from Ireland, Portugal and Greece, for example, have more vulnerable populations with no access to these drugs on a named patient basis. It is important to curtail the amount of time made available for the testing of AIDS drugs. There is also the question of the timescale from the patient's point of view. Timely intervention is one of the critical factors in treatment. Currently there are two requirements for testing. The European Commission has to approve an existing approval from the European Medicines Evaluation Agency. The agency takes 210 days and the Commission gets another 90 days. That adds up to 300 days. This may not seem such a huge time lag.

Consider the situation for an AIDS patient whose health is declining: their T-cell count is diminishing and this cocktail of drugs could assist substantially. The prospect of a 300-day wait is intimidating. I reiterate that we do not have this problem in Ireland but in Europe. Will the Minister try to influence his colleagues during Ireland's Presidency of the European Union? It is important that strong representations are made at Commission level to ensure equality of treatment and equality of opportunity for life for people living with AIDS throughout Europe and that we do not have a fast track system in our good and responsive health service while people in more marginalised communities are disadvantaged by not having access and must wait the full 300 days during which their situation may deteriorate rapidly.

I know a number of people who have been seriously affected by this virus and of some who have been placed on this treatment. The change is remarkable. From being obviously seriously ill and deteriorating, they are now virtually back to full health. I know we are waiting for tests to see if this is just a question of inhibiting the viral reproduction in the system and whether it will start to replicate again if the drugs are removed. It is beginning to look as if it is not impossible to conceive of a full cure for AIDS. In those circumstances, it is humane to make this available as rapidly as possible. Where health deteriorates so rapidly, as it does with AIDS, 90 plus 210 days can make a difference between life and death. It is not just a question of a short space of time; it is a critical life and death issue for many people.

The Minister represented Ireland at the recent Vancouver conference. A public appeal was issued at the conference by the European AIDS Treatment Group, a Europe-wide network connecting the major European AIDS organisations. It said: "We need these drugs now, not in three months. We want Mr. O'Shea to force the European Commission in Brussels to treat these drug approvals as a public health emergency, and demand that they be moved through the system immediately, not in three months' time." That is the language of a lobbying group, which the Minister understands. He certainly understands that because one is in the driving seat in the European Union for six months does not mean one can change the world. I am aware of the Minister's skills in persuasion and diplomacy and I hope he will use his position, which is an important one, although he is not the dictator of the health services in Europe, to exert a considerable degree of influence. I expect he may be doing this already; I certainly hope he is and that raising the issue will encourage, reinforce and strengthen his hand.

The Minister is quoted in a journal as saying: "We don't need to rush matters here: 210 plus 90 days is no exorbitant time." I am not sure if that is an accurate quote and of the circumstances in which it was obtained. Whatever about the period when this question was asked, I have no doubt the Minister now realises — perhaps he did at the time — that 300 days is critical for a number of people. This quotation was been made available to charities in Europe with whom I have been in contact and which I know well; I respect their work and I am sure the Minister does. The Terrence Higgins Trust, for example, said the delays imposed by the European Union bloc are ludicrous and a waste of human life. That is very strong language. It accepts that these drugs are available in Britain and Ireland on a named patient basis. Spain, Portugal, Italy and Greece are listed as being particularly vulnerable areas.

Last year I was at a conference of European parliamentarians against AIDS in Barcelona. Spain has an enormous AIDS problem largely in relation to intravenous drug use. I imagine many people there will be dead within six to eight months if this treatment is not made available to them. Many of the marvellous, intelligent and talented people I knew over the past ten to 15 years died because of the absence of this drug. I wish it had been available to them. If it had been available and they were denied it because of delays in testing and so on, I would have been furious and would have been out at the barricades.

I understand testing is necessary in traditional terms. We have had many scares, Thalidomide and so on, and we would be rightly angered if medical authorities and the Department of Health did not strictly control and examine drugs which might have side effects downstream. However, for somebody who has the AIDS virus and who may be terminally ill, the question of consequential side effects is not an overriding factor. They would prefer to use these drugs to see if they could give them some relief from the infection.

This is the beginning of a very difficult situation. I have no doubt these drugs are working and that they will work rapidly in providing an amelioration for people. I have no doubt that the problem will begin when large numbers of people within the European Union have access to these drugs because millions in the rest of the world will not be able to afford them. I hope the European Union will have a compassionate view and will do something for not only the privileged few in Europe. I have spoken about how privileged we are in Ireland, but there are people in the European Union whose hope of life is put at risk because of discrimination in different areas. However, this is much worse on a global scale. I hope the Minister will be able to initiate a process where people suffering from this disease throughout the world will be given access to the material which will save their lives.

I thank Senator Norris for raising this important issue and for the balanced, fair and sympathetic way he introduced the subject. What he said at the end of his contribution about the problem in Africa and Asia had the biggest impact on me having returned from the Vancouver conference. I came away from the conference very heartened and optimistic about the medicinal side. I found the background to the problem in Africa and Asia, where infrastructure, the communication network, including education, transport, etc., is at a low level of efficacy, quite disconcerting. It is a huge problem in those areas. As regards the article from which Senator Norris quoted, people who write such articles would benefit from being present at the conferences where comments are made.

I will give the background to this area. I am sympathetic to the needs of AIDS patients as regards having rapid accessibility to the latest drug. However, mandatory evaluations and controls which are now in place at an EU level are necessary if the quality, safety and efficacy of any new discovery are to be established before the product is authorised for use. The harmonisation of the procedures for the evaluation of medicinal products and, in particular, the establishment of the centralised licensing system for high technology drugs, including those which are intended for use in AIDS treatment, has brought about a situation where these drugs can now be made available more rapidly than heretofore.

The centralised procedure for the evaluation of medicines is laid down in Council Regulation EEC 2309/93 which was adopted by the European Council following consultation with the Parliament and the Economic and Social Committee. This regulation was arrived at from experience acquired as a result of Council Directive 87/22/EEC which showed that it was necessary to establish a centralised community authorisation procedure. Amendment to the regulation would involve the co-decision procedures under the Maastricht Treaty which is a lengthy process and the power of initiative in these matters lies with the Commission. However, in the interest of public health it is necessary that the drugs available to AIDS patients should be authorised on the basis of objective scientific criteria.

In the EU central system the authorisation authority is the European Commission, acting on the recommendations of the European Medicines Evaluation Agency. The objective of the EU system is the grant of a central authorisation within 300 days from the date of receipt of a valid application. These days are broken down as follows: 210 days for the EMEA and 90 days for the Commission. Two-hundred and ten days is specified in Article 6 of the Regulation as being the time by which the opinion of the committee should be given.

The scientific opinion of the EMEA is provided by the Committee on Proprietary Medicinal Products. The EMEA has one month within which to finalise the documentation and to forward its recommendations to the European Commission. During this period all relevant documentation must be translated into the nine official languages of the community, which is a major task bearing in mind the technical and scientific nature of the material.

In general and within reason, these limits are being complied with and, in so far as the European Commission is concerned, the full 90 days are not always required. It should be noted that an AIDS drug which has been authorised by the EU Commission under the central procedure was authorised within 52 days of receipt of the recommendation from the EMEA. Indeed, the Commission itself has recently taken an administrative initiative whereby member states are requested to respond to the opinions of the Committee on Proprietary Medicinal Products within 15 days rather than the 30 days provided for in the Regulation. Ireland is cooperating with the Commission in this initiative.

It should also be noted that in a number of EU countries, including Ireland, a named patient arrangement exists, as the Senator has already said, whereby a drug awaiting approval can be prescribed by the patient's medical consultant. This arrangement can allow for the rapid accessibility of the latest drug for the treatment of AIDS.

I was at a Commission press conference in Vancouver, Canada, where the report arose. There will be a follow up to that press conference and there will be an initiative in the global area, Africa in particular, towards the end of this year.

On the Senator's specific question regarding the funding for drugs under the named patient system, I am not aware of a problem but I will investigate the matter and respond quickly to him.

I thank the Minister for his clear comprehensive reply. Would it be possible to make the good aspects of the Irish experience, of the named patient arrangement, available and to point them out to the representatives of countries, such as Spain, Greece and Portugal, where, apparently, this does not exist, so that they might be encouraged to adopt that approach?

I take that point on board and I thank the Senator for making it.

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