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Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Yes, but I offered section 15 as a possible answer to some of the issues the Deputies reasonably raised. I have to be honest and say I had not considered the specific issue raised by the Deputy. It has just occurred to me that, on a reasonable reading of section 15, it is helpful in dealing with the issue he has raised.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I will consider it.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I have referred to section 15 which I respectfully suggest is relevant. However, perhaps more relevant to what the Deputy is raising is what is included in section 12 which provides that there be no liability on the part of the pharmacist with regard to substitution in the circumstances set out in the section. That is highly relevant in terms of the concern raised by the Deputy. We will...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: We will certainly revisit these issues with the IPU.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Section 12 gives protection in respect of any liability or action conceivably being taken against the pharmacist or the prescriber. I repeat that section 15 is relevant in that it gives discretion to the pharmacist when presented with a prescription.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I move amendment No. 7: In page 22, to delete lines 19 and 20 and substitute the following:"prescription ought not to be dispensed because to do so may be prejudicial to-(a) the health of the patient for whom the prescription was written, or (b) the health or safety of members of the public.".

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: We are dealing with section 15 and I am not sure whether I should deal with my amendment now.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: As we have been discussing, the purpose of section 15 is to ensure requirements regarding generic substitution do not affect a pharmacist's discretion not to dispense a medicinal product. As drafted, the section is explicit in its expectation that the pharmacist's professional opinion will inform the decision to dispense on the grounds of the health of the patient. However, in practice,...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: The pharmacists and their representative body are well engaged with what is proposed here. I am quite sure the points made by Deputies Naughten and Ó Caoláin, which I support, about this new environment are being taken on board by them.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Obviously, we all accept and acknowledge that human error can occur occasionally. We live in a human world where errors can occur. It should be emphasised, leaving aside this legislation completely, that the high degree of reliance we place on the professionalism of those involved in our prescriptions system - doctors, consultants, GPs and pharmacists - is well repaid. I think we can all...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I could not disagree with anything the Deputy has said. Communication is important and it is important the professionals involved, the prescriber and the pharmacist, communicate with the patients concerned so that people know what is being done. When this legislation and new regime are implemented, it will behove everybody involved, particularly the professionals, to ensure there is clarity...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Yes, absolutely. I hope also that all of us, as citizens and patients, will be encouraged to take a closer interest in medication and medicines prescribed for people. We have a role as agents of our own health and well-being in this regard. However, the principal responsibility lies with the professionals to ensure there is proper communication on this.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: The Deputy raises some fair points which probably have a broader application to the whole area of drugs and medicines than the area contemplated in this Bill. It is fair to have regard to people's information and knowledge about the drugs they are prescribed. The professionals across the board have an interest in the communication of accurate information to patients and in ensuring that...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: First, a communications strategy is certainly essential, as I indicated earlier. Second, section 24 is of some relevance to the point raised by the Deputy because it has to do with the intervals between reviews. It is not as if it would take place every week or every couple of weeks. Intervals will be provided for with regard to price reviews.

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Section 13 will provide an additional protection to those listed in section 5. Section 13 states: When a branded interchangeable medicinal product is prescribed for a patient and the prescriber [the doctor] is satisfied that the medicinal product should, for clinical reasons, be exempted from substitution in accordance with Chapter 2, the prescriber shall write, legibly and by hand,...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: Generic products are being dispensed perfectly legally in the system, not improperly. If a medicine is prescribed generically, pharmacists can fill the prescription with the appropriate product. Pharmacists can also supply a parallel-imported product. As matters stand, this is perfectly legal and I am not suggesting it should be otherwise. I have stated we are dealing with a human...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I will try to make my original point in slightly different terms. The Irish Medicines Board will have a central role to play in what is contemplated in the legislation. I do not want any of those present - members, the Chairman and everyone else involved in the legislative process - to react to what I am about to say because it is not intended in a critical way. The point is that we cannot...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I thank the Chairman and committee members for raising this matter. I appreciate the concerns expressed and have met Epilepsy Ireland to discuss the matter. I have carefully considered everything that has been, including the matters raised at the committee last week. I met the relevant body sometime back and had a good discussion with it. With the permission of the Chairman, I will...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: The question of the kind the Deputy mentions would not arise. That is a newly patented drug. That is not what we are talking about here. We are talking about generic substitution. I can understand people's concerns and this is new to our system. We have never had proper legislative provision for generic substitution. It is not a willy-nilly charter for cheap drugs. It is unfortunate...

Committee on Health and Children: Select Sub-Committee on Health: Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage (19 Mar 2013)

Alex White: I move amendment No. 1: In page 14, subsection (3)(b), lines 30 and 31, to delete all words from and including “the” in line 30 down to and including “run” in line 31 and substitute the following:“the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant,...

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