Liz McManus (Wicklow, Labour)
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Question 128: To ask the Tánaiste and Minister for Health and Children if a submission has been received on the extent of the current risk to patients in view of the fact that for animals there is full protection from malpractice in the pharmaceutical sector while for humans there is not, and that there is no statutory fitness to practise or fitness to operate legislation on pharmacy; the steps she intends to take to protect patients and within what timeframe; if she can be held liable in any claims arising from malpractice in this area; and if she will make a statement on the matter. [3280/06]

Mary Harney (Dublin Mid West, Progressive Democrats)
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The practice of pharmacy is governed by the Pharmacy Acts 1875 to 1962. I am aware that the current fitness to practise provisions in these Acts are inadequate for the modern practice of pharmacy. On foot of the recommendations of the pharmacy review group I obtained Government approval in June 2005 to commence the process of drafting, as a priority, new pharmacy legislation to allow, among other things, the making of fitness to practise regulations for pharmacists. The purpose of these new provisions is to ensure the highest standards from pharmacists and to safeguard the safe and effective delivery of pharmaceutical services.

My Department is at an advanced stage in drawing up the heads and general scheme of a pharmacy fitness to practise Bill and I intend to take a memorandum to Government in the very near future, seeking approval for the draft heads and general scheme and requesting that the legislation be referred to the parliamentary counsel's office for formal drafting of the Bill.

Liz McManus (Wicklow, Labour)
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Will the Minister accept that there is an urgency to this matter? Does she not find it extraordinary that animals here have better protection against pharmacy malpractice than humans? Does she not have a serious concern that the registry body has no power to strike pharmacists off the register? It has power only to put people on the register. In its estimate, two to three pharmacists should be struck off the register each year. That is the approximate level of malpractice. Does the Minister accept that she has responsibility to ensure not just fitness to practise legislation is speeded through the House, but also fitness to operate a pharmacy? Fitness to operate a pharmacy has not been mentioned and I ask her to include it and comment on it.

We are all conscious of scandals, for example, where terrible things were done by Dr. Shipman. The role of the pharmacy in that scandal is relevant and germane to this issue where we do not have proper regulation. If such a scandal arises here, which seems more likely than unlikely, will the Department be exposed to litigation because of its failure to deal with what is clearly a matter of protection and public safety?

Mary Harney (Dublin Mid West, Progressive Democrats)
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I accept that the legislation governing the regulation of pharmacy is unsatisfactory. It dates back to 1962 and much has changed in the intervening period. At a recent event I was told by the incoming president of the pharmaceutical society that when his father was its president many years ago, he expected the new law during that year. That was 30 years ago. I do not know why we have not been able to frame legislation in the intervening period, but the matter is urgent. There are many urgent matters on my desk, including the Medical Practitioners Bill, the regulation of the nursing profession, illegal charges in nursing homes etc.

There are two issues here. The Pharmaceutical Society of Ireland only has a role with regard to recommending removal from the register where there is a breach of criminal law. It has no right to strike off others. The tool used traditionally by the State to penalise malpractice is the GMS contract. While it was the case in the past that there was hardly a pharmacy that did not have a GMS contract, there are a growing number that do not. Therefore, that route is not available to the State. The matter is a priority.

Recently, I had a good meeting with the pharmaceutical union and it raised with me the issue of the operation of the premises as well as the individual. I have asked my officials to examine that in the context of the first Bill. A second Bill will deal with the service aspect, the physical conditions and such matters which, while important, are less urgent. To deal with the legislation quickly, we want to deal with the regulatory aspects, particularly with regard to fitness to practise. I hope to bring the scheme to the Government within a matter of weeks.