Minister's casual line on AIDS exposed on world stage

I WAS in Scotland last week, and there can be no better place from which to appreciate the significance of Ireland holding the President of the European Union. To see how the Scots would love to occupy even the place on the international stage that Ireland at the moment is almost enough to offset the arrogant blare of the motorcades or the cringe making sight of Eurocrats sipping Guinness for the television cameras while pretending that they wouldn't prefer Bollinger.

There is, nevertheless, a price to be paid for high visibility. With the prestige of the EU presidency comes the awful prospect of some of our journeyman politicians finding themselves out of their depth.

Take the case of Brian O'Shea, the Minister of State at the Department of Health. Anonymous enough at home, he is, nevertheless, the current chair of the EU's Council of Health Ministers, and as such responsible for public health policy in the Union as a whole. In this capacity, he recently found himself at the international AIDS conference in Vancouver, representing not Just Ireland but Europe before 15,000 delegates. He was a big player on the world stage, in a life and death drama.

This is probably the most critical time in the history of the epidemic since the HIV virus itself was first discovered. There is now, for the first time, a very real possibility that the virus can be beaten. No single cure has been discovered, but there is strong evidence that different combinations of drugs can keep infected people alive, stop the breakdown of the immune system, and even eradicate the virus from the body entirely. By next year, if current trials remain on course, it is entirely possible that the first HIV positive people may be declared cured.

The genuine possibility of a cure, and the high probability that new treatments can at least extend the lives of millions of people, pose a rather stark challenge for public health policy. There are very large numbers of people all over the world for whom timing is everything. New treatments can save their lives, but those treatments have not yet been through the long, tedious and painstaking process of full clinical evaluation and certification that must happen before new drugs can go on the market.

Given a choice between waiting for full certification of new drugs and possibly dying in the meantime, or taking the new drugs and being around to benefit from new medical developments, the vast majority of HIV positive people would prefer to take their chances on life.

ONE of the leading Irish medical experts in the field put it to me like this: "There is a conscious risk involved. Under normal circumstances, it is right that the procedures for approval should be deliberately slow, and since the Thalidomide case everyone has accepted that. But here you're dealing with people who, to put it bluntly, are going to die unless something changes the prognosis. It is quite possible that one or other of these new drugs may have unpredictable side effects. But if the alternative is death, it's worth throwing the dice."

Recognising this, the US Food and Drugs Administration has long had a special fast track for the approval of AIDS drugs. In the last year, the EU's new European Medicines Evaluation Agency has also pulled out all the stops to review the scientific data on new drugs such as epivir, norvir, crixivan, and invirase much more rapidly than before. These new drugs bad already been approved in the United States, and the EMVA confirmed to me that it approved three of them very quickly this year.

However - and this is where Brian O'Shea, chair of the EU's Council of Health Ministers, comes in the EU Commission has to approve the approval, as it were, and gives itself 90 days in which to do so, on top of the 210 days allowed to the EMVA to make its assessment. This serves to further widen the gap between the marketing of AIDS treatment drugs in the US and in Europe. The delay is all the more serious because of new medical research is indicating that the chances of eradicating the virus depend crucially on an early start to treatment.

At the Vancouver conference, the European AIDS Treatment Group, a Europe wide network that connects the major AIDS organisations, issued a public appeal to the Irish minister: "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."

AT an EU press conference in Vancouver, Brian O'Shea was asked: "What are you going to do during the next six months to speed up this process?" His reply, according to the specialist journal European AIDS Treatment News, was: "We don't need to rush matters here; 210 plus 90 days is no exorbitant time." The Minister apparently believes that a delay of 300 days while drugs that might keep people alive are kept off the market is not a serious problem.

The Terrence Higgins Trust, the British based AIDS charity, disagrees. Its director of health promotion Robin Gorna told me this week that the bureaucratic delays in Brussels are "absolutely ludicrous" and "a waste of human life". She points out that while most patients in Britain and Ireland are able to get access to the drugs they need under "compassionate release" procedures, operated by hospitals and the drug companies, this is far from being the case in other EU countries such as Spain, Portugal, Italy and Greece.

In Britain itself, she says, the "poorest and most alienated" HIV positive people are also suffering by comparison with the better off and more highly educated patients. She was disturbed by Brian O'Shea's nonchalance in Vancouver, and believes that "there is a need for political leadership at the European level" on the issue.

I asked the Department of Health this week whether Brian O'Shea had actually done anything to try to end the bureaucratic delays and to make sure that the drugs can get to HIV positive Europeans. I was told that "it would not be up to the Minister to change the procedure. He mentioned it at a Commission meeting, but it's not really something that he can do anything about."

This is, as far as it goes, true. The chair of the Council of Ministers cannot, by himself, make the Commission change its way of doing, or rather not doing, business. But he can certainly do more than "mention" a problem that matters very deeply to millions of Europeans.

He can use his office to set wheels in motion, to make proposals, do deals, lean on recalcitrant bureaucrats. Or, if he can't do any of these things, what is the point of holding the EU presidency? Is it just about showing off The Corrs in Temple Bar and the nightlife of Tralee? Is it just a matter of putting a temporary green ribbon on the usual red tape? Or do we have the competence and confidence to provide real leadership on behalf of the EU's more vulnerable citizens?