May I first address the points raised by Senators Marc MacSharry and Colm Burke? In regard to the timescales expected, my advice is that we can expect to see movement within two to three months of the signing into law of this Bill by the President which I hope will happen in a matter of a short number of weeks. I would expect that upon enactment, it will take two to three months for the Irish Medicines Board to get going on this work. I have met the Irish Medicines Board which is well geared up for this work. In response to my queries, along the lines raised by Senator MacSharry, it assured me it has sufficient staffing to engage in this important work that we all want to see happening. I would have no concerns in that regard. Certainly it was reasonable to raise that issue and it could be raised again if it were to be an issue in the short or medium term but I do not expect that it will.
I expect that work will be taken up immediately and that we could see some results within two to three months. We have the list of 20 which we have published or, at least, read into the record or the particular lists of drugs, with which the Irish Medicines Board will start. I am reluctant to pinpoint a date for a reference price but if matters proceed as we expect, in terms of the enactment of the legislation within the next few weeks, October or November is not an unreasonable target for that to occur.
Senator Colm Burke raised the legitimate public concern in respect of the variations in prices. Senator Barrett mentioned the comparators internationally. Senator Burke also made the point in terms of the variation that has been shown to exist internally in the State. It is an issue of concern. The enactment of the legislation which is crucially important will not just introduce generic substitution and reference pricing but will also change the culture of our approach to the price of medicines. This should have application across the board. There should be strong public dissemination of information and encouragement of people to use, where appropriate, generic medicines where recommended and where the Irish Medicines Board is satisfied that they have the same efficacy as the branded product. A clear set of criteria are set out in the Bill for the Irish Medicines Board to apply. I hope and expect this will change our whole approach to generic medicine.
Senator Burke is right to emphasise the need for information flow, dissemination of information and encouragement for people to take up generic medicine. One of the companies, this has been referred to publicly recently, Tienda, has already begun a public campaign which is being fronted by an old colleague of mine, Dr. Byrne from RTE, who is involved in the promotion of the use of generic products. That is a good initiative and I hope others do likewise. The law is one thing but the information flow and encouragement is a crucially important aspect.
In regard to Senator Burke's final point, I will have to check the phenomenon of people obtaining a prescription in the hospital and going out to the pharmacist and coming back to the hospital.
That is something that I would need to understand a little better. I shall check it out and revert to the Senator on the matter. I was not aware of it myself.
I agree with Senator Colm Burke and others who made a point about transparency, in general. As Senators will be aware, the Pharmaceutical Society of Ireland is the regulator. Its code of conduct requires pharmacists to: "provide honest, relevant, accurate, current and appropriate information to patients regarding the nature, cost, value and benefit of medicines provided by them. Every pharmacist has an obligation to comply in full with the statutory Code of Conduct". The PSI advises patients that their pharmacists should be in a position to provide them with whatever information or clarification they require about prescribed medicines, including information about the pricing of those medicines. The PSI is examining options to achieve greater price transparency for patients. The HSE reimburses pharmacists for products dispensed under the General Medical Services and other community drug schemes, including the drug payment scheme, referred to Senator Colm Burke, in accordance with the rates set out in its list of reimbursable items. The community pharmacy contractor agreement sets out the duties of pharmacists supplying medicines to patients under the GMS and the community drug schemes. It is the view of the HSE and the Department of Health that there should be total transparency provided when any pharmaceutical service is accessed by a member of the public. The HSE will continue to raise the issue with the Irish Pharmacy Union as part of the current project to enhance between pharmacy computer systems and the State.
I thank Senator Barrett for mentioning reference prices. The fundamental issue to grasp and be reassured by is that the reference price will be set by the HSE, irrespective of any deals that may have been done. The related amendment and section talks about a list of items that regard must be had for and that is the decisive aspect. The HSE will set the reference price in accordance with the rules and principles set out in the Act. It will not be set by any other body. It will not be set by public or private deals. Regard must be given to a number of matters. As section 21(5) states:
(d) the potential budget impact of the item if it were to become a listed item,
(e) the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item,
(f) the resources available to the Executive, and
(g) the terms of any agreement in place (whether entered into before, on or after the commencement of this section) between the Executive and any representative body of the suppliers of drugs, medicines or medicinal or surgical appliances where the agreement relates, whether directly or indirectly, to the price of the item.
A reference price will be set but regard must be had for any existing deal or "any agreement in place." It is not unreasonable to require that to be one of the items that regard has to be had to. I wish to emphasise again, to the Senator and to the House, that the HSE will set the reference price in accordance with the principles set out in the Bill.