Results 1,181-1,200 of 2,629 for speaker:Tim O'Malley

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: A comma was added because a new section is being inserted.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: Amendment No. 27 inserts a new sub-paragraph (w), which confers an additional function on the IMB arising from Directive 2004/23/EC relating to the setting of standards of quality and safety for the donation, storage and distribution of human tissues and cells. The scope of the directive does not apply to blood and blood products, organs or in vitro research. Amendment No. 28 is a...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: My understanding is that we have until April 2006 to transpose the directive.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: As far as I am aware, some more regulations will be necessary.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

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

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I thank Senators Quinn, Henry and Browne for their contributions on this matter. The Department is examining the increased use of generics as part of a wider review of all aspects of the GMS and community drugs schemes. As a first step, negotiations will shortly commence on the renegotiation of the IPHA-APMI agreement which sets the supply terms, conditions and prices of medicines supplied to...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: My understanding is that under EU directives being implemented, all decisions of public bodies such as the one the Senator mentioned are taken on a consensus basis. I do not know if it would be the intention of the IMB to publish whether a decision was made on the casting vote of the chairperson. I do not see how that would be useful. It is still a consensus if the majority agree. That is the...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: As far as generic drugs are concerned, I may have omitted to discuss the issue regarding items going out of stock. The Senator is correct that such items may be out of stock for quite some time. Frequently, one company is taken over by another and, unfortunately, when a given product comes back into stock, it can cost approximately ten times the original price of the inexpensive product that...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I omitted to answer a question from Senator Browne concerning the small figure "8". It was a reference to the EU's Official Journal, where the directive has been published. The full reference may be found at the bottom of page 12 of the published Bill.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: It has always been the case that whenever the Irish Medicines Board proposes to refuse the grant of an authorisation or licence in respect of a medicinal product, either human or veterinary, it must consult with the appropriate independent expert scientific advisory committee. This consultation is only mandatory where the refusal is on grounds relating to safety, quality or efficacy of a...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: In amendment No. 33, the substitution of lines three and four on page 15 arises from the need to make it clear that the Minister has power under subsection 2(a) of section 32 of the Irish Medicines Board Act 1995 to make regulations in respect of the administration of medicinal products. For that purpose the word "administration" is being inserted into section 32(2)(a) of the 1995 Act....

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: We had a fair amount of discussion last week about nurses prescribing. Nurses work as part of a multidisciplinary team and it is anticipated that only a small number of nurses will be involved in independent prescribing. It will be in the context of their work with the multidisciplinary team. Examples are nurse-led services such as minor injury units, chronic disease management, such as...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: The parameters regarding which nurses it will apply to have not been set out. That will follow consultation with the nursing profession. It could cover midwives as a specialty but that will be set out in regulation.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: This amendment is one of a number made necessary by the judgment of the Supreme Court in the case of Vincent Browne v. the Attorney General and others, where powers are being created which would enable the implementation of Acts of the European Communities, such as directives and regulations, by means of secondary legislation. This amendment, taken with other related amendments which follow...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I thank Senator Browne for raising this matter. The Attorney General and the Government have decided that it would be a matter for the Oireachtas to change the penalty amounts. If fines were index linked, it may make it more difficult for the Oireachtas to change the amount at a later time. This is why fines are not currently index linked.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: Amendment No. 52 extends the definition of authorised officer to include officers of the Customs and Excise. This is an important extension in view of the amount of medicinal products passing through our ports, which are supervised by officers of the Customs and Excise. It will increase the effectiveness of their surveillance, particularly with regard to areas of counterfeit medicines and the...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: They will have the same powers under this Bill.

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I will not comment on Senator Ryan's love life as he is not here. The purchase of medicines over the Internet is an international problem. Many of these companies, which possibly operate in the US and theBahamas, move constantly and it is very difficult to locate and bring charges against them. This matter was first brought to my attention by Stephen McMahon of the Irish Patients Association...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I do not see it as a problem for people to procure medicine legally in other countries. I would hate to see people get excited about it. Ryanair would have major problems if the luggage of every passenger on every flight was to be inspected to see whether they procured medication legally abroad. The same would be true of Aer Lingus and all other operators bringing in tourists. The point about...

Seanad: Irish Medicines Board (Miscellaneous Provisions) Bill 2005: Committee Stage (Resumed). (6 Dec 2005)

Tim O'Malley: I covered that question when I said earlier that this is a complex area. Senator Browne is correct in saying that many of these items would be small and come through the post in ordinary envelopes. The Irish Medicines Board does a great deal of work in collaboration with customs officers and there have been someseizures of drugs.