SENATE SPEECHES
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Irish Medicines Board (Miscellaneous Provisions) Bill 2005
06 December 2005

Dr. Henry: Is this in accordance with the tissue directive from the European Union, which Ireland must bring in next April? Will this legislation cover that or must we bring in other legislation as well?

Mr. T. O'Malley: My understanding is that we have until April 2006 to transpose the directive.

Dr. Henry: That is right. Will this legislation cover that or will we be required to introduce additional legislation?

Mr. T. O'Malley: As far as I am aware, some more regulations will be necessary.

Dr. Henry: The United Kingdom has asked for a derogation from the tissue directive regarding human gametes. Do we propose to do that?

Mr. T. O'Malley: I do not believe a decision has been made on that question.

Dr. Henry: I thank the Minister of State.

Amendment agreed to.

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Dr. Henry: I do not query the Acting Chairman's ruling on amendment No. 17 being out of order but would accepting it not have incurred a saving for the State rather than a charge? As Senator Quinn said, perhaps the Minister of State could re-examine it before Report Stage. Speaking as a member of the medical profession, there is much pressure to continue prescribing the most heavily advertised drugs. Naturally, they are foremost in one's mind and pharmaceuticals make significant efforts irrespective of cheerleaders encouraging people to prescribe their expensive products. It is difficult to keep names in one's head.

I had an interesting experience a number of weeks ago. A Member of the House forgot his prescribed anti-inflammatory tablets and he asked me whether I could get him some. I went to a chemist and got him ten 100 mg tablets, saying they were for someone who forgot his as I was obviously not his doctor. The pharmacist asked why I had not suggested he get an alternative, which was exactly the same but came in 50 mg tablets as pharmacists were only allowed to give that amount over the counter.

It was the same product, which I had not realised. It is not something one can keep in one's head all of the time, although pharmacists are better than doctors. If a person was buying two 50 mg tablets over the counter, it would be the same as going to a doctor to get a prescription for one 100 mg tablet. It was not a question of a patent. An Internet site would be useful in order to view such information immediately.

The costs of producing drugs from basic research are extraordinarily high. The Minister of State knows that, over the past 20 years, few important drugs have been produced de novo. As Senator Quinn pointed out, most have been variations on themes. Changing them slightly allows drugs to stay in patent for much longer. Someone I know involved in the Global Fund wants to know why, in respect of artemisinin, the drug recently found to be suitable for malaria that has been used in China for years, we could not crush the leaves as Chinese peasants did for hundreds of years and give them to patients rather than having them made into various patented tablets. This incurs a significant cost on treating malaria as we are making matters more expensive and difficult. If one examines the costs of producing a drug, the main cost is advertising, including cheerleaders. By producing something simple, such as an Internet website, people would be able to see whether they want the tablet - expensive due to advertising - or the alternative, which is much cheaper because it is not heavily advertised.

Claims of a new improved product may be greatly exaggerated. The Minister of State knows that there have been dreadful situations where trials on drugs have too often been multicentred, involving members of the medical and pharmaceutical professions. The results are sent back to pharmaceutical companies, for example, for reports to be extrapolated. Some years ago, Dr. Marcia Angell, a former editor of the New England Journal of Medicine - one of the most reputable of journals - said she would not produce articles in it anymore when those involved in the research had more than a certain amount of financial involvement in the firms. After approximately two years, she wrote an editorial stating she was removing the stipulation because she was not receiving enough papers.

This is a serious issue. The Minister of State is allowed to incur costs on the State. He would do a great service in terms of saving the State money if he could examine Senator Quinn's amendment and determine how he could frame it to ensure that those involved in the medical and pharmaceutical professions and others who will be allowed to prescribe could determine which drugs are the same and could also make price comparisons more easily.

I was not here for Committee Stage last week as I was in Barcelona with members of the Joint Committee on Health and Children to examine aspects of its health service. A significant difference is the cost of drugs to that service. This amendment would allow people to make a choice without forcing them into any type of prescription. They would have knowledge, which is what people generally want before they make decisions.

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Dr. Henry: I support the Minister of State in what he stated at the end of his reply about a small number of people on useful drugs which have been around for a long time. What makes one a little suspicious is that price is important and these drugs are frequently very cheap. Those patients who take them are being obliged to try to make do with a much more expensive alternative. It would be most useful if the Minister of State, relying on his professional experience, raised this within the Council of Ministers. One finds people trying to get these drugs when they go abroad because they have been prescribed for them for decades and proved suitable. They could really be put under the class of orphan drugs. One must remember the important humanitarian side of the issue. If one has been on a drug for decades that has proved suitable, it is a great pity to have to make a change, especially if the person has a serious condition.

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Dr. Henry: Like Senator Browne, I support the amendment. I would not have agreed to go on the visit to Barcelona if I had known nurse prescribing was being included in this Bill. I only discovered it from one sentence in the Minister's speech on Second Stage. In fact, I might have missed it only a friend of mine, who is a nurse, told me it would arise in this Bill. She was better informed about the legislation being introduced than me, and I am a Member of the House. I am sure there is a good reason for that but I do not like the minimising of this change in powers to prescribe being brought forward in what seems a casual way because of the unfortunate way it is perceived by the public.

One member of the public who I thought would have been a little more thoughtful about these matters said to me: "Why should nurses not prescribe? Why should they not be able to give you four to six antibiotics if that is what you want?" I would much prefer they were giving morphine to terminally-ill patients, which is the type of area where such involvement will really be needed, rather than the general public thinking that the regulations regarding prescribing will become loose. It will not become loose under this legislation. However, the impression is being given that there was little discussion by Members about the philosophy behind it. The reasons for allowing nurse prescribing are extremely good. It was recommended a long time ago in Ms Justice Carroll's report on the nursing profession.

However, like Senator Browne, I am concerned that this came into the Bill quite unexpectedly. It was not in the Bill as drafted and I nearly missed the reference to it in the Minister's speech on Second Stage. Now we are faced with a considerable amount of legislation being introduced as amendments to an important Bill.

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Dr. Henry: With regard to amendment No. 52, will a person appointed under section 32B(1) as an authorised officer have the same powers as officers of the Customs and Excise? They will both be called authorised officers but will they have the same powers?

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Dr. Henry: I support the Minister of State and Senators Glynn and Browne. It is very unfortunate that the overuse and abuse of antibiotics has not come to the fore in the debate on methicillin resistant staphylococcus aureus, MRSA. We need to highlight that point not only for the prescribing professions but for the general public because the points made in this debate are not being raised in the debate on MRSA.

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