Cuirim fáilte roimh an Aire Stáit. The Bill is a welcome development, although it is long overdue. Generic substitution and reference pricing have been talked about for a long time but no action was taken by previous Governments. This is something we in Sinn Féin have advocated over many years. In welcoming the Bill, I also welcome the agreement between the Department of Health, the Health Service Executive, HSE, and the Irish Pharmaceutical Healthcare Association announced on Monday by the Minister for Health in so far as it goes.
Exactly how far it goes we are not sure because we do not have the detail. The deal is projected to save in excess of €400 million over the next three years, beginning with €16 million to the end of this year and €116 million next year. I ask the Minister of State for a breakdown of how these figures have been arrived at. More detail on the agreement should be made available. The Minister predicted far greater savings this year. What has happened? Has the pharmaceutical industry successfully used its muscle yet again? Why is the projected return for the rest of this year as low as €16 million?
The Minister will not thank me for reminding him that this was one of the issues raised by his former Minister of State, Deputy Shortall, who expressed frustration at the lack of progress on the reduction of medicine costs. I hope Deputy Shortall speaks in this debate and sets out her experience and concerns at some length and with the freedom of one who is no longer in office in this coalition. What she says may shed some light on how the agreement was handled and progressed.
The Bill is an important step on the road to reducing the costs of medicines. The HSE spent an estimated €1.9 billion in 2010, the last full year for which we have figures, on medicines and non-drug items supplied to patients under the GMS and community drug scheme. This included approximately €384 million paid to community pharmacy contractors in respect of dispensing fees and retail mark-ups. The expenditure more than tripled between the years 2000 and 2010, which is a worrying statistic.
In his remarks on the pharmacy agreement yesterday, the new Minister of State with responsibility for primary care, Deputy Alex White, cited a current figure of more than €2 billion per year. It is a huge challenge to reduce that cost. I wish the new Minister of State well in that task and in his other responsibilities. For years, Sinn Féin and others have been calling for greater use of generic drugs and for control of profiteering by pharmaceutical manufacturers and distributors. Successive Ministers with responsibility for health from 1997 failed to act. I welcome that some steps are being taken.
A survey in The Sunday Business Post last August showed the HSE and patients here are paying up to 12 times more than the National Health Service for the same generic drugs. I did not need The Sunday Business Post to tell me because I live only four miles from the Border. Patients and taxpayers are quite simply being ripped off by the pharmaceutical industry. It has been facilitated by successive Governments' relationship with the industry. For the industry to claim, as it did, that the massive price differential is accounted for by specific packaging required by this State is beyond belief and an insult to people's intelligence. It is quite incredible and in no way explains the colossal North-South differential in the price of patent or generic drugs or between these islands and across member states of the EU. Anyone who took a holiday overseas in better times is able to attest to this if they needed to get prescription drugs in pharmacies in various European settings.
I have repeatedly raised with the Minister for Health, Deputy James Reilly, the need for action to require greater use of generic drugs and to address drug prices overall. The survey showed the situation was even worse than suspected and that it was long past time for the profiteering of the pharmaceutical industry to be confronted once and for all. I hope we are of one mind on that point. I would much rather say we are of one intent in terms of the urgency required.
The Bill focuses on generic substitution and reference pricing. It is a necessary measure, if just one of a range of measures that need to be undertaken. It is a complex Bill and needs to be processed carefully to ensure there are no unintended consequences. The prime consideration at all times must be the health of the people, the rights of citizens as health service users and the provision of the best possible health services.
One of the concerns raised about the Bill is the issue of continuity of supply. It has been raised with me, as an Opposition spokesperson on health, and I am sure other Members have been engaged on the matter. The pharmacy companies have a role, to which I will return, but the Irish Pharmacy Union, IPU, has raised a concern about section 24(2), which provides for the HSE to review the reference price at least once a year but not more than once every three months. The IPU is worried the HSE will err on the side of more frequent reviews - once every three months -and this could lead to problems regarding stock-holding for wholesalers and pharmacists, in turn affecting continuity of supply of medicines to patients. They have asked for the three month period to be replaced by six months. I would like to hear the Minister's view. It can be addressed on Committee Stage.
There are concerns also about the need for the HSE and the Irish Medicines Board to keep pharmacists fully informed and in due time about the addition, removal, retention or refusal of an item on the reimbursement list, about changes to the list of interchangeable medicinal products, or about changes to a reference price. I hope the Minister examines and responds constructively to the detail of the IPU submission with regard to these matters. I know the difficulties recent decisions have presented to pharmacists in a variety of settings throughout the country and in my constituency.
Important points have been raised with regard to ensuring the welfare of the patient is written into relevant sections of the Bill, as well as the taking into consideration of the impact of reference pricing on the continuity of supply of medicines. How far have the Department and the HSE explored the possibility that the reliance in the Bill on competition to reduce prices could have unintended consequences? I alluded to this point earlier. These points are important if the Bill is to be adjudged fit for purpose.
Could it worsen the situation if the presence or absence of necessary medicines on the Irish market is unduly dictated by the profit motive of manufacturers or wholesalers? That is an important question.
Some parts of the Bill are written in impenetrable legalese and require clarification. Could sections 5(12), 5(13) and 19(6) be translated? Section 13 refers to regulations to be made by the Minister. Could the Minister clarify the nature of the regulations referred to? I hope the Minister will address some of these matters in his summing up, but we will address them in detail on Committee Stage when we have a complete sense of what the Bill intends to do.
Other measures to address the cost of medicines in our health care system need to be considered. Sinn Féin would go much further than the Bill and urge consideration of the establishment of a State wholesale distributor of drugs. The cost savings of such an undertaking regarding the Exchequer outlay on medicines and medical products could be very significant. After all, public health and not private profit must be the primary consideration in the supply of medicines.
The expansion of the role of pharmacists to include medicine use review, to help ensure that patients get optimum benefit from medication and that waste is reduced, should also be considered. Significant waste is caused by over-prescription of medication, from blister pack to blister pack. Tackling this calls for a holistic response by everyone who has a role to play. Can that be accommodated in the Bill? The Minister for Health should initiate the carrying out of a comprehensive national audit of drug prescriptions, in hospitals and in the community. We know that over-prescription is a major problem. We do not have an overview of how prescribed medicines are taken. In many cases they are not taken and go to waste. GPs and consultants have a major responsibility in that regard, yet the Bill deals only with pharmacists. Can this matter be dealt with in the Bill or does it require further legislation? If it does, we must do that.
In Monday's announcement of the agreement with the Irish Pharmaceutical Healthcare Association, IPHA, it was stated that a national task force on prescribing and dispensing has been established to deal with the prescribing and dispensing of medicines. I welcome that. We are told it will address this issue from the perspective of quality and patient safety primarily, but that it can be anticipated that the work of the task force will also deliver significant cost savings through more cost-conscious prescribing. We are told also that the work of the task force will be wide ranging and will include providing advice, guidance and support to prescribers and dispensers to help them improve prescribing practices, and assessing the suitability of maintaining supply of certain items with limited efficacy where more appropriate items are available. These are important commitments. I welcome them, but they must be kept and honoured in practice.
The former Minister for Health and Children, Ms Mary Harney, introduced the notorious prescription charges for medical card patients. It would be remiss of me not to mention this. We all agree, and I said it at the time, that the cost of medicines to the State and to individuals is too high and we acknowledge that there is wastage and over-prescription of medicines. We all agree that measures must be undertaken to address these problems. The very last way to address this, however, was to punish those who are least able to pay. I do not accept the notion that the charge is merely a token, and I did not accept it then. It can build up to a significant sum on a monthly basis.
In opposition, the Minister, Deputy James Reilly, as Fine Gael spokesperson on health, opposed the charges and promised to abolish them when the opportunity presented itself. The Government has been in office for 19 months and we are still waiting. I earnestly urge a revisitation of that measure. It is part of the legacy of Mary Harney and the former Government. The Fine Gael and Labour parties roundly and rightly opposed it when in opposition. Age Action said of the prescription charges:
Over-prescribing and inappropriate prescribing is a problem in Ireland but the Minister needs to address this issue with the doctors who write the prescriptions, rather than hitting their patients. The patient is not the person writing the prescription so penalising them will do little to change prescribing practices.
The prescription charge has had no impact on prescribing practices. It is time for the charge to be abolished. The Age Action statement is still relevant. The problem of over-prescribing needs to be addressed, first and foremost on health grounds for the benefit of individual patients and, second, because it is important to address this issue as a contributor to the costs of medicine in our health care system.
The pharmaceutical industry also needs to be reined in. Earlier this year, the giant multinational GlaxoSmithKline was found guilty of massive malpractice in the United States, incurring fines totalling $3 billion. This malpractice included marketing drugs for unauthorised uses and holding back safety data. There can be no mistake about the gravity of what was being done. The courts in the United States did not make this decision lightly. The $3 billion fine was meant to underscore the seriousness of what was involved. It was not only patients in the United States who were at risk from the withholding of safety data and the marketing of drugs for unauthorised use. It affects each of us as citizens and our families. There needs to be an immediate investigation into the granting by the previous Government of an absolute indemnity to GlaxoSmithKline, the manufacturers of the swine 'flu vaccine, Pandemrix, which caused the sleeping disorder, narcolepsy, in a number of Irish children. When the Joint Committee on Health and Children met on 8 September 2009 to address the swine 'flu issue, I and other members, including the Minister, Deputy James Reilly, then in opposition, expressed serious concern about the indemnity granted to GlaxoSmithKline.
When I asked the Minister in September 2011, six months after he took office, if the nature of that indemnity was such that GlaxoSmithKline will be legally absolved from any accountability for the drug causing narcolepsy in Irish children, he did not reply. I have had no response to that question to date. I would welcome that matter being addressed by the new Minister of State. It is not a party political issue but something that is in the interest of all citizens. The safety of our citizens is at stake and GlaxoSmithKline, like many of these major conglomerates in the pharmaceutical sector, needs to know that it does not have a green light to do as it pleases in every situation.
I welcome the Bill, although I wish it was part of a comprehensive and radical reform of our health services based on public good, not private profit. The Bill demonstrates the potential for real savings in preference to the savage cuts to services now being imposed by this Government. We addressed those cuts at some length over the past two evenings but, sadly, it appears they will proceed. The passage of the Bill, as far as it goes, should be facilitated. I will play my part in that and, if possible, help to improve it on Committee and Report Stages. The Minister's responses to my questions would help greatly in achieving a better understanding of all that is intended in order that we can play a fully informed role on the remaining Stages.