Bernard Durkan (Kildare North, Fine Gael) | Oireachtas source

I am sympathetic to the issue of orphan drugs, particularly where it has been shown that they work and that a patient cohort will benefit from them. The problem, which the committee has discussed many times, is where the determination as to their benefit and safety comes from. Is it made at EU level? There is a vetting system at EU level but, as we found out in this committee a year or so ago, we have an internal system that vets them again. I do not see the purpose of that exercise at all. We appear to have, and to contribute to, two systems, as the vetting system we have here is also replicated at European level. When it comes down to it, the EU is in the best position to command a price. If someone is negotiating on behalf of 500 million people, the case is an awful lot stronger than on behalf of three or four. Despite the good cause, it comes down to the power of the market but we do not use that argument in this country at all. An average of 14 member states are involved in these processes. The Bill referred to by Deputy Brassil is a classic example. Why could it not be the entire EU 27? It could have been 28 member states up to recently but could still be 27 from here on in. Whoever is vetting and dictating the going rate to individual states, no individual state can have the same power, except perhaps the larger states. We should get to that point as early as possible. I spoke about this issue 20 or 30 years ago in another capacity. It has not changed over the years. We are still engaged in procurement standing alone on our own two feet and it is not working. It does not, and cannot, work. Having a duplicate system where we have one system operating at EU level and another one superimposed on it here is daft and stupid in the extreme.

I acknowledge the benefit of patient representative groups but I would also balance that benefit against the points raised by Deputy O'Reilly. We could find ourselves in an awkward position. We have the telling tales of the patients and lobby groups on the one hand, while, on the other, we have this amorphous system, which we do not know how to deal with and cannot manage. Everything comes down to cost in the final analysis. Deputy Brassil makes a useful point about the 2013 Act. It was framed and passed in the midst of the worst economic crisis this country or any other European country ever had the misfortune to experience. It might be a good idea to examine it again in a different light. However, as a note of caution, before the economic crash we believed we were one of the wealthiest countries in the world but that was a figment of our imaginations. We were not and we are not. There is no use pretending we are. Wealth is made up of series of factors of which housing, goods, services and trade are a part. They tend to float with the market and can leave us high and dry when the tide goes out. We need to be cautious that we do not walk ourselves into trouble, not necessarily in respect of pharmaceuticals and health only but in other respects as well.

Diagnosis is an important issue, particularly for rare diseases. For example, Guillain-Barré syndrome is a rare disease. I know five people who have been unfortunate enough to wake up and find themselves paralysed. There is no answer to it at all and they spent considerable time in hospital while their cases were examined before diagnosis eventually happened, sometimes on a haphazard basis. That needs to be examined. Modern communication should make it much easier to compare cases across the country and the continent. This condition is curable. The same people were walking around six months after being diagnosed. They had to go a long route to learn to walk again and needed rehabilitation but it happens. Early diagnosis is of considerable economic benefit in that area.

I would be one of those strongly in favour of utilising it as much as possible.

I have already referred to my final point. We need a single system of adjudication. It is either in Europe or it is here. We do it one way or the other; there is no use doing it twice because there is a cost involved in that. From a safety point of view, utilising new drugs on the market is of paramount importance. Years ago, there was considerable anxiety and questions were raised about the manner and methodology used to test the drugs and those on whom the tests were carried out. Considerable controversy arose at the time and people remain concerned. It must be one of the issues we consider. We need to move on. We need to remove the emotional situation that arises on a daily basis where it requires a significant amount of publicity or attention to be drawn to a particular condition before there is a response but that response must be tempered by the ability of the State. We return to the question of how much a life costs, a point raised by Deputy O'Reilly.