Róisín Shortall (Dublin North West, Labour)

It is very important to emphasise that patients will continue to be able to obtain their necessary medications from their community pharmacist and that patients and tax payers will benefit from paying less for their medications. Moreover, this Bill also provides that if, in the opinion of a prescriber, there is a clinical reason why a medicine should not be substituted, then the patient shall receive the prescribed medicine at no extra cost.

The second core element of this Bill is the placing of the current HSE reimbursement list on a statutory footing. This is a timely provision and will support the introduction of a system of reference pricing and generic substitution.

Senator MacSharry raised the question of the transparency directive and in that context I wish to clarify that this Bill, if passed, and the associated regulations will meet the requirements of the current and proposed directive. A number of Members raised the question of safety, which is of paramount concern to us all. The IMB has, and will continue to have, responsibility for the approval of medicines, both originator and generic, on the basis of safety, quality and efficacy. The IMB will designate medicines as interchangeable with strict regard to safety. The robust systems that are being provided for will ensure that the issue of safety continues to be of paramount importance.

Senator Quinn raised the issue of falsified medicines which is a matter of grave concern, particularly because of the wider use of the Internet. In that context, a directive is due to be transposed in January of 2013 which will greatly improve the powers to deal with counterfeit medicines.

Senator Byrne and others raised the question of savings in the health budget. We all know that the bill for medicines in this country is unacceptably high. The most recent figures available indicate that it represents approximately 17% of total health spending, which is not sustainable. The equivalent figure for the UK is approximately 9%. The Acting Chairman referred to the fact that medicines are much cheaper across the Border. We must bring costs and prices more into line with the UK. It is important to point out that the savings targeted in the budget are largely related to direct price cuts and not the provisions of this legislation. We certainly must get better value for the considerable spend we make. We must reduce the prices and get a better deal from the suppliers in the industry. There is much talk about the need to bring new medicines on stream as soon as possible but we can only afford to do that if we manage to drive down the total drugs bill. There is no space within the health budget for the very considerable additional costs of many of the new medicines coming on stream unless we can drive down the cost of existing medicines.

This legislation is important from a cost point of view but it will not deliver a big bang this year or next. The target savings in a full year from this legislation are approximately €10 million. However, over the medium to longer term, the potential exists to make significant savings on an ongoing basis, principally by driving competition in the market. In that way, prices will be driven down and we will all benefit from that. It is not something that will happen overnight, however, but over a longer period of time.

The Acting Chairman raised the issue of Warfarin and Pradaxa and the HSE is seeking to identify the opportunity costs from moving from Warfarin to Pradaxa. This is an ongoing process. The issue of drug addiction was also raised by Members and the fact that the extent of the problem is clear if one walks through the centre of Dublin. It has taken quite some time to get acceptance for drug addiction treatment facilities, a number of which now operate in the city centre. It is a good thing that such facilities are available but while there is a perception that there is a concentration of them in the city centre, the figures do not bear that out. There is a very wide spread of facilities across the greater Dublin area. I recently looked at the figures for people attending the four treatment centres in the city centre and 85% of them were from the immediate local area. Often those services are blamed for the very unacceptable anti-social activity and drug dealing that is going on in the city centre but that is predominantly a policing issue, in my view, which needs to be addressed. In the past week I saw some very welcome figures indicating that the waiting lists for drug treatment centres have reduced considerably over the past year.

Under Section 13 (2), the Minister shall make regulations regarding GP and clinical exemptions. The Medical Practitioners Act, 2007, will be amended accordingly to take note of these regulations.

In conclusion, the general criteria set out in the Bill and the regulations to come from it will assist the HSE in making timely decisions regarding reimbursement, will provide clarity for the pharmaceutical industry on the application process and ensure that the HSE achieves best value in the provision of medicines under the General Medical Services and the Community Drugs schemes.

I thank all Members of the House for their contributions and I look forward to the Bill being further considered on Committee Stage.