Léim ar aghaidh chuig an bpríomhábhar

Seanad Éireann díospóireacht -
Wednesday, 22 May 2013

Vol. 223 No. 7

Health (Pricing and Supply of Medical Goods) Bill 2012: [Seanad Bill amended by the Dáil] Report and Final Stages

This is a Seanad Bill which has been amended by the Dáil. In accordance with Standing Order 118, it is deemed to have passed its First, Second and Third Stages in the Seanad and is placed on the Order Paper for Report Stage. On the question "That the Bill be received for final consideration", the Minister of State may explain the purpose of the amendments made by the Dáil. This is looked upon as the report of the Dáil amendments to the Seanad.

For the convenience of Senators, I have arranged for the printing and circulation to them of those amendments. The Minister will deal separately with the subject matter of each group of related amendments. I have also circulated the proposed grouping in the House. A Senator may contribute once on each grouping. I remind Senators that the only matter that may be discussed is the amendments made by the Dáil. I ask the Minister of State to speak on the subject matter of the amendments in the first group.

Question proposed: "That the Bill be received for final consideration."

Group 1 amendments broadly deal with a timeframe for decisions of the Irish Medicines Board on the inclusion of products on the list of interchangeable medicinal products and the reimbursement list. I do not know if I should read out the various amendments but I can deal with them by way of summary if Senators wish. These are amendments Nos. 1 and 3.

Section 5 of the Bill provides that the authorisation holder of a medicinal product may apply to the Irish Medicines Board to have a product added to a group of interchangeable medicinal products or to add a group to the list of interchangeable medicinal products. It sets out that the board shall have 180 days to make decisions on such applications and allows the board to request further information from the authorisation holder if necessary. As originally drafted, the 180 day period did not begin to run until such time as this additional information was provided. In addition, section 18 provides that a supplier of an item may make an application to the HSE seeking the inclusion of a product on the list of reimbursable items. The HSE shall agree a reimbursement price with the supplier and make a final decision for inclusion on the list within 180 days. The HSE may seek further information from the supplier as part of the application process.

As originally drafted, the 180 days did not begin to run until the further information requested was supplied. This was not fully in compliance with article 6 of Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products. Article 6 of the directive provides for the suspension of time limits pending receipt of additional information rather than setting the clock back at zero. This article must be interpreted as applying to any decision influencing the amount of coverage by reimbursement systems, including decisions on reference groups or groups of interchangeable medicinal products as well as pricing decisions.

Sections 5(3)(b) and 18(3)(b) were amended to provide for a clock stopping arrangement so that decisions on interchangeability and reimbursement are taken within a total timeframe of 180 days. This means that if additional information is sought on day 49, for example, the clock will begin to run again at day 50 on receipt of the information. The amendments bring these sections into line with the transparency directive as indicated.

One wonders about the timeframe as there is the potential for the 180 days to be on the never-never. If we consider the 420 modules and the drugs to be considered in the fullness of time, we will begin with the 20 most used, taking a cumulative six months to assess whether a drug will be on the list. There is no doubt it is in the interest of Pfizer, Abbott and others to object to it and it is safe to assume the fullness of the 180 days will be called upon by them with any delay tactics that the companies wish to apply.

If one module takes six months, for the first 20 we will be talking about ten years before generics will be available. In this country there is 20% generic usage and 80% non-generic usage. In the UK, the usage statistics are the other way around, saving people millions of pounds. There has been an indication that we will save €200 million over four years because of a new agreement on branded medicines but the timeframes in the Bill are nonetheless ridiculously long. In many ways it is not about this legislation but about what happens next. When will the top 20 medicines be fully interchangeable? Will it take ten years or longer, given the old rugby approach of stopping the clock when there are dissenters, as will happen?

I have a point on reference pricing but I must be specific to these amendments. There is a concern about whether we are approaching the matter in terms of real change as quickly as possible or whether we are appeasing those behind directives in the EU and the IMF by saying we have legislation in place, although it will be absolutely unenforceable in bringing about real savings and a supply of pharmaceutical products to people as quickly and cheaply as possible. The never-ending approach seems to have more of a hand for the branded sectors than the generic products in the field.

One wonders when generic producers will be cleared to be on the interchangeable list. I am told it can take six to 12 months before producers can be in a position to supply the market. We are talking about 180 days to be added to that six to 12 months, notwithstanding stopping the clock in between. Will the Minister of State give a genuine indication of when the top 20 medicines will be fully interchangeable. I am not trying to take a negative interpretation but I am playing devil's advocate. It seems it could take ten years at a minimum for those 20 medicines to be fully interchangeable and available.

I welcome the Minister of State and thank him for his explanation. It is extremely important that we move forward at a reasonably fast pace in dealing with the matter as we are already way behind the rest of Europe with the availability of generic drugs. The cost of medication and drugs has increased from €574 million in 2000 to more than €2 billion, which is all the more reason we must face up to the issue. I agree that we must ensure the process is fast-tracked as much as possible. The generic drugs about which we are talking are already accepted in other jurisdictions, so we should be able to deal with this matter expeditiously. I very much welcome the amendments, as they are appropriate to deal with the issue.

I thank both Senators. Senator Burke's point is key, as the effect of the amendments to the Bill as passed by Dáil Éireann will be to expedite the matter rather than the contrary. This will mean there will be a total period of 180 days to be considered, rather than a process of waiting until the final information is in before the 180 day period starts. If information is to be provided, the clock will stop but it will resume where it left off. This measure shortens rather than lengthens the process.

I will explain it again if there is a wish to do so. We will not wait until the last piece of information is in before the clock starts on the 180 day period, which is what the original position would have been. Given these amendments, the total period will be 180 days. The effect will be to expedite the process.

If it takes a month to get the information, the clock will not be running.

The purpose of the amendment is not to lengthen the period. I agree with Senator MacSharry on the importance of expediting the applications, which should be done anyway. I agree very much with his emphasis in that respect. It would be wrong to imagine that it would take a period of multiple years to achieve the aims we are setting out. It is not appropriate to aggregate the periods in that way, saying we would do only one set of drugs at a time before taking the next batch.

So the 20 will be taken at one time?

The board can work on different sets of drugs simultaneously and there is no reason to believe the periods would be aggregated in that way. The Senator made a rhetorical point but the directive, to which we must have regard, helps us. We would have to abide by a directive even if it had an adverse effect but in this case it does not as the effect is positive.

The Minister of State may proceed with group 2.

This relates to a pharmacist's discretion not to dispense a medicinal product. The purpose of section 15 of the Bill is to ensure that requirements regarding generic substitution do not affect a pharmacist's discretion not to dispense a medicinal product. As originally drafted, section 15 was explicit in its expectation that the pharmacist's professional opinion will inform the decision to dispense or not on the grounds of the health of the patient. However, in practice under the current regulatory regime, one of the most common scenarios in which a pharmacist might refuse to dispense a prescription is where the pharmacist has a concern that the person presenting the prescription may be planning to sell or supply the medicines to other individuals or on the street. In this case the pharmacist would usually refuse to dispense the prescription not necessarily on the basis of a concern for the health of the person named on the prescription but on the basis of concern for the safety of others and the integrity of the supply chain.

The pharmacy regulator, the Pharmaceutical Society of Ireland, expressed concern that the scope of section 15 be broadened to explicitly provide that a pharmacist would also not dispense a prescription if the pharmacist had a genuine concern that dispensing it might put others at risk. Section 15 was, therefore, amended to broaden its scope to take into account the pharmacist's obligation not to dispense a medicine on a prescription on the basis that it may cause harm to the health of the patient named on the prescription or the health and safety of any member of the public. That is the addition for which this amendment provides.

I welcome the amendment. It is important when we are considering legislation that we take on board not only the person receiving the medication but also the wider view on the general public. This amendment is a welcome addition to the Bill.

Group 3, the subject matter of amendment No. 4.

This relates to the notice period for the relevant decision to add or remove an item from the reimbursement list. As drafted section 19 of the Bill provides that the HSE shall give notice in writing to the supplier of the item of relevant decisions it makes regarding the reimbursement list. Section 19(3) provides that the HSE may specify a date for the implementation of decisions to add or remove items to or from the list. This subsection was amended by Dáil Éireann to provide for a minimum notice period of 28 days before items are removed from the list. This is a reasonable notice period that would facilitate both patients and the pharmaceutical supply chain.

Group 4, amendments Nos. 5 and 6.

This relates to the criteria for price setting. Section 21 of the Bill sets out the criteria to be taken into account by the HSE when it is considering the proposed price of an item for inclusion on the list of reimbursable items. To address concerns regarding the need for the HSE to safeguard continuity of supply when setting prices, section 21(2) was amended to add "the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item," to the list of criteria to which the HSE must have regard when setting a price for an item. I am satisfied this amendment is necessary, given the difficulties experienced by some countries in securing an adequate supply of necessary medicinal products following price reductions. This amendment brings section 21 into line with section 24, which already provides that the HSE must have regard to this criterion when setting a reference price for a group of interchangeable medicinal products. In addition, sections 21 and 24 were amended to include a reference to agreements such as those recently agreed with the Irish Pharmaceutical Healthcare Association, IPHA, and the Association of Pharmaceutical Manufacturers in Ireland, APMI, to ensure the State can continue to benefit from price reductions contained in those agreements.

Group 5, amendment No. 7.

This relates to compliance regulations. Section 32 of the Bill provides for amendments to the Pharmacy Act 2007 to ensure compliance with the relevant provisions of this Bill. Section 7 of the Pharmacy Act is amended to ensure it will be a function of the Pharmaceutical Society of Ireland, PSI, to ensure that pharmacists operate generic substitution in accordance with the legislation. Section 18 of the Pharmacy Act is amended to allow for the making of regulations imposing duties on pharmacy owners and supervising pharmacists to supervise compliance by pharmacists with the generic substitution provisions. Section 35 of the Pharmacy Act is amended to include failure to comply with the generic substitution provisions as a ground for complaint against pharmacists.

A further amendment has been made to section 35(1) of the Pharmacy Act 2007 to provide that a failure by a pharmacist to comply with regulations made under section 18(1A) of the Pharmacy Act, as inserted by section 32(b) of this Bill, will constitute a ground for complaint. Section 36 of the Pharmacy Act, which refers to complaints about registered retail pharmacy businesses, has been also amended. The amendments at subsections d(i) and d(ii) are technical recommended by the Parliamentary Counsel. These are to ensure the terminology here is in line with standard usage. The substantive amendment at subsection (d)(iii) provides that failure by a pharmacy owner to comply with any of the duties referred to in section 18(1A) of the Pharmacy Act 2007 will constitute a ground for a complaint. This provision addresses concerns that section 32 as originally drafted places an unfair burden on pharmacists when compared to pharmacy owners. This amendment will allow pharmacy owners to be held accountable for breaches of duties to supervise compliance with the generic substitution provisions of this Bill.

Would it be in order to make some very quick general points? It is Report Stage and obviously we are supporting the Bill, but I want to raise the points I made on the timeframe. When will be in any position to know? The Minister of State is saying there is the capacity to look at the top 20 medicines simultaneously. Has the IMB staffed up to deal with that so that we would have the 20 within a relatively short period of time? We all want the same thing here. Also, when would the manufacturers know the reference price? I touched on the issue that these outfits need a lead-in time to get production levels up to supply a market, which could be six to 12 months. Perhaps that could be done in advance or at least as quickly as possible so we have the top 20 generic drugs available and the reference price is available as early as possible so the generic companies can increase production in line with the demands of this market.

If we save at the bottom we will get to spend more at the top. As new breakthrough wonder drugs for critical diseases come our way, we will have more to spend on the upper end if we can save on the bottom end. My thanks, as always, to the Minister of State for making himself available.

This legislation is long overdue. To comment generally on this matter, it is also interesting that the recent survey by the National Consumer Agency, NCA, is frightening in that there is a huge variation in what pharmacies are charging. In one case the lowest price for a drug was €16.62 while the highest price was €49.69 for the same quantity, a difference of 199%. There is quite a variation between different areas of the country, in Dublin, Cork, Limerick and Galway. That survey raises the issue about whether people are aware they can move pharmacy and get better value.

A major concern is that where somebody who has no medical card is having to buy medication with a total cost in excess of €144, only the receipt for €144 is being furnished to them, not a full breakdown of the cost of medication. For instance, if the total cost of medication for the month is €500 they are not given the cost of that. I am extremely concerned, in particular with the price variation in that regard. The people who are not on medical cards are all taxpayers. They are entitled to get full details on what the taxpayer is having to pay. The first €144 is not refundable but anything over €144 is being paid by the taxpayer and this is one of the reasons we have allowed the cost of medication to go so high, because of lack of accountability.

I have also raised the issue of the cost of medication in hospitals. We need to visit this issue. We still have a very high cost of medication in hospitals. We should be able to do a lot more regarding getting medication at far better value for money compared to what we are getting now. It is a huge bill on our health service. It has not reduced to any substantial degree in the past five years. I accept the Department has done some work on this matter and that there will be savings over the next three years but we have not made enough progress in this regard.

The misinformation out there on generic drugs needs to be clarified. There is a clear provision in the legislation. The chief medical officer of one hospital contacted me in the past two weeks to express concern about this Bill.

When there is a concern that one cannot transfer from a branded product to a generic product, because of the particular level of care a patient requires, he was not aware that provision was available to him. I found that very strange. It was another public representative who referred him to me and I was able to refer him to the section of the Bill and gave him a copy of the Bill, as recently as two weeks ago. The amount of medication the particular unit would prescribe would be high because of the type of patient being dealt with. It is extremely important that we get information out to general practitioners and also to people who are involved in the management of the drugs programmes within hospitals. The Department and the HSE have a major role to play in getting that information out and that people are accountable on that issue. There is another issue I wish to raise.

I ask the Senator to be brief.

When somebody comes into a hospital which has a budget for the purchase of drugs and it gives a prescription to the patient who is then required to go to the local pharmacist to purchase his or her drugs and go back into the hospital for treatment, that is an additional cost to the Department's budget and needs to be examined.

I wish to address amendment Nos. 5, section 21, paragraph (g), and No. 6, section 24, paragraph (f) as the wording is similar. Section 21(2)(g) provides that the Executive shall take into account, "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". I do not know why that paragraph is included.

Will the Senator please repeat that?

I am referring to section 21(g) which is similar to section 24(f). I should welcome the Minister of State while he is tries to locate his notes. I always welcome his views on these matters. Is it okay for me to proceed?

I am trying to find my notes and if the Senator continues I am sure I will.

Section 21(2)(g)provides that the Executive shall take into account, "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". Is that not the problem we are trying to correct, namely, that this industry has a tradition of high cost agreements with the Department of Health and so on and are we letting them off the hook? I just wonder what the Minister of State's briefing note says on that section.

For example, I would look for a time limit if we have these agreements that have put the problem before us, which the Minister of State is seeking to address, with our support. I agree with Senator MacSharry, in asking should they not expire? It can also be an agreement which comes into force after the commencement of the section. I want them all wound out so far as they are there and I want an end to one of the Pat Kenny themes. He is always saying these drugs are far cheaper in Spain. I get material from the industry stating that Ireland is in a different zone from Spain. I do not go along with that. We are in a free trade area in the European Union and there should not be any of these agreements and they should not be binding on the Department. I say "More power to the Minister of State" to go out and buy at the best price possible, including bringing truckloads of them back from Spain if Pat Kenny tells us they are much cheaper there. I would appreciate the Minister of State's note on that section.

It is strange that paragraph (g ) in section 21 and paragraph (f ) in section 24 were introduced as amendments. I am trying to think whether the pharmaceutical industry has some friends in the Dáil who tabled the amendments because they certainly were not in the spirit of what the Seanad wanted. We were trying to empower the Minister to tackle the problem of a very high cost health service, the estimates for which are the second highest in the world, after the United States. What is the purpose of those two paragraphs because they appear to go against the spirit of what we and the Minister of State have been trying to do?

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.

I thank the Minister of State.

The Senator can do that at the end of the debate.

Question put and agreed to.

When is it proposed to take the next Stage?

Is that agreed? Agreed.

Question proposed: "That the Bill do now pass."

I thank the Minister of State. I was concerned about the traditional agreements of the kind that the Department is trying to correct. His sentiments and ambitions for the Bill all go in the right direction.

I note that the legislation, the Health (Pricing and Supply of Medical Goods) Bill, contains a general wish to curb medical inflation, which we support. There is also a problem with services. I have heard claims that tests, scans, etc., cost far more in Ireland than in other countries. The Milliman report expressed concerns, some of which were mentioned by Senator Colm Burke, about people staying in hospital too long at a cost of €1,000 per night which adds to the State's bill. There is also over prescribing and a lack of awareness about general costs. Many economists who have examined the legislation think that reducing costs would be the real function of the competitive health insurance business which the Department is trying to develop as part of the Government's plan. One should not assume that company A charged less for health insurance because it did not insure old people. Perhaps it followed the Department's advice on drugs. It shopped around for low cost locations to provide scans and tests. Perhaps tests were conducted during normal hours so not to incur overtime rates. When I worked on the Brennan commission I discovered that some tests were deliberately delayed and scheduled for when overtime was available. Perhaps an insurance company, on behalf of the Minister, could better police how services are provided and thus provide cheaper health insurance. I know that the Minister of State is attempting to control the budget but the measure would lift a great weight off the Department's shoulders.

What we have done today regarding medical goods should be applied to services. Market mechanisms that can extract a similar gain from excess costs should be implemented. We have a high cost system so we should examine excessive stays in hospitals, excessive prescribing and excessively costly procedures. Perhaps, as part of the Croke Park agreement, we could ensure that procedures are carried out during normal hours so as not to incur overtime rates, reduce high costs and reduce waiting lists. The health service still has many critics and has not met the goals set by us.

I thank the Minister of State for his response. I need clarification on a few points but I know that he may not be able to provide that today. We should change the guidelines covering drugs that cost over €140 per month.

The Danes have introduced a patient medication card system. The card is the size of a visa card and prescriptions no longer need to be handed out. A GP can access a file using the card and return it to the patient. A pharmacy can also access the patient's file using the card. Therefore, no mistakes are made and relevant information is available to the pharmacist. As much as 27% of all prescriptions written by hospital doctors cannot be understood or are misunderstood. By the end of the year, 48% of the population will have a GP card or a medical card so we should be able to computerise the system and adopt the Danish system.

I thank the Senators for their participation and contribution to the debate. I also thank them for their helpful insights into the relatively small number of issues that we have dealt with today. Last autumn the Seanad dealt with the Bill and Senators made a very helpful input. Today, the amendments have returned from the Dáil and the contributions have been helpful and very much on point.

I agree with Senator Barrett's call to reduce costs, where we can, across the system. The Bill is a very important initiative on medicines and reminds us of the necessity to reduce costs, where possible. As the Senator said, that aim is not confined to the area of medicines and suggested that we reduce the cost of services. We should be preoccupied with that aim.

I take Senator Barrett's point on the broader issue of health insurance, what insurance companies can achieve and the contribution that they can make to reduce costs. We are faced with an enormous challenge. I know that we describe everything in the health service as a challenge. It must be acknowledged that many great things are happening in the health services all the time. There are challenges because of medical inflation. The cost of procedures are genuinely increasing but in other cases one must wonder how the cost is configured. Questions must be asked, and will continue to be asked, about cost structures and are being addressed. The Department will redouble its efforts in that regard. I thank Senator Barrett for his assistance and contributions.

Equally, I thank Senator Colm Burke. I agree with his emphasis on the IT dimension to this and what can be achieved. We can see it in other countries. I have had an opportunity to study what happens in other comparable countries. One development the Government wants to see is the introduction of a unique patient identifier which would put the management of data and efficiencies in the system right at the heart of what we are doing. We must press on with that. Our plan is to introduce legislation later this year which will provide for a unique patient identifier, which I hope could then be deployed and used right across the entire system, not least in the area of prescriptions and prescribing, but also right across all of the management of the health services. In primary care, it would be crucial to have that.

I remind the House that the programme for Government includes a commitment that: "Reference pricing and greater use of generics will be introduced to reduce the State's large drugs bill and the cost to individuals of their medications." That commitment in the programme for Government, I am happy to say, has been addressed and has now been achieved by the passing of this legislation in the Houses.

The Bill improves and updates the statutory basis for the supply of medicines and other prescribed items under the General Medical Services and community drugs schemes. I reiterate my commitment and the commitment of the Government to maintain access to new medicines for Irish patients. This needs to be done in the most cost-effective and efficient manner possible.

The core objective of the Bill is to achieve value while maintaining and improving levels of service. In doing so, the Bill will introduce a system of reference pricing and generic substitution for prescribed drugs and medicines which will ultimately lead to savings for taxpayers and patients.

I again thank the Senators for their constructive input to the debate on this Bill. I assure them that, as always, the Government has carefully considered all of the issues and concerns that have been raised during the course of the debate in the House last autumn when the Seanad first addressed this Bill and today, and also by Deputies in the Lower House. I am satisfied that the provisions of the Bill address the concerns raised by Members of both Houses. To reference back to Senator MacSharry's point, I will keep the implementation of reference pricing and generic substitution under constant review, as I am sure Members of the House will also.

I commend the Bill to the House.

Question put and agreed to.