Regina Doherty (Meath East, Fine Gael) | Oireachtas source

I propose to share time with Deputy Lawlor. This is a much easier topic for me to speak about than the last debate. I am grateful for the opportunity to speak. Many factors contributed to the health care spend in Ireland. Costs of technology, hospitalisations and hospital-based services, fees and drug costs are all major factors that drive the cost of care higher. To be effective, health care reform must address all aspects equally. Regulation and cost containment must be applied to each of these entities to lower cost successfully while maintaining superior quality of care. Across Europe, the pharmaceutical sector has been forced to reduce profits as governments go in search of savings on medical bills. Nothing like the rigour applied across Europe has been applied here, although prices have fallen since 2009. In the past decade, the cost to the State of drugs and medicines has risen to three times the European average, and pharmaceuticals in Ireland are among the most expensive in the world. Ireland has one of the highest spends on pharmaceuticals, with OECD data for 2009 showing that Ireland was fourth highest among OECD countries after the United States, Canada and Greece.

This legislation is one of a number of Government initiatives that aim to drive down the State's medicines bill. October 2012 saw the Irish Pharmaceutical Healthcare Association agree a new medicines supply agreement with the Department of Health and the HSE. The three-year agreement took effect from 1 November 2012 and will provide €400 million in savings. Under the agreement, when a patent on a medicine expires, its price to wholesalers will be reduced to 70% of the original price. After 12 months, the price will be further reduced to 50% of the original price. For existing patent-expired medicines, the price was reduced to 60% of the original price on 1 November, to be followed by a further reduction to 50% of the original price in November 2013. Recently, negotiations were also finalised with the Association of Pharmaceutical Manufacturers in Ireland, representing generic manufacturers, which heralds further significant savings. Added to this, a national task force on prescribing and dispensing has been established to deliver additional cost savings by achieving more cost-conscious prescribing. Due to become operational before the end of 2012, it will address prescribing and dispensing of medicines from the perspective of quality and patient safety and it will assess the suitability of maintaining supply of certain items with limited efficiency where more appropriate items are available.

In parallel with these changes, today’s Bill is making its way through the legislative process. The Government envisages that, once enacted, the new legislation will reduce expenditure by increasing the rate of generic prescribing, which currently stands at approximately 18%. Against this backdrop, it is proposed that a system of generic substitution and reference pricing be established, allowing pharmacists to substitute a cheaper equivalent medicine when a more expensive product has been prescribed by a practitioner. Under the proposed reference pricing system, where two or more medicines are interchangeable, the State will reimburse only the reference price for the group of medicines. The reference price will be the price of the cheapest medicine in the group.

The Bill also provides for the regular review of the reference price for groups of interchangeable medicines and outlines the criteria to be considered by the HSE when setting or reviewing a reference price. What is new is the power the HSE will have to set or review the price of listed items. The Bill sets out the criteria to be taken into account by the HSE when considering the proposed price of an item. It allows the HSE to review and alter the price of items listed and to use a competitive process to determine that price. The Bill also allows the HSE to attach conditions to the supply or reimbursement of listed items in the interests of ensuring patient safety, improving cost effectiveness, maximising appropriate use of the items covered or appropriately applying the resources available to the HSE. The introduction of generic substitution and reference pricing has the potential to deliver significant savings for the State in the medium and long term. The Department of Health said it hopes to cut the drugs bill by another €50 million a year using generics.

I welcome reform and innovation in health care and the pharmaceutical industry in particular. However, it is also important not to lose focus on how such reforms will affect the needs of particular patients. I add my support to the amendment proposed by Brainwave, the Irish Epilepsy Association. Professor Norman Delanty, director of the epilepsy programme in Beaumont, has stated that anti-epilepsy medications cannot be substituted by a generic drug without having profound consequences for the well-being of those who suffer from epilepsy. The doses of epilepsy medications are concentrated carefully for each individual to ensure good seizure control. Any variation may disturb the balance and result in an otherwise avoidable seizure, even if the active ingredient of the drug is not changed. This can have a major impact on the patient’s quality of life, as well as having clinical and financial implications to the primary and-or secondary health care system. Anti-epileptic drugs should not be subject to generic substitution and should be permanently excluded from any legislation introduced in the country. Furthermore, the exclusion of anti-epileptic drugs from any new system of generic substitution was recommended in a report, entitled Proposed Model for Reference Pricing and Generic Substitution, and known as the Moran report, which was published jointly in May 2010 by the Department of Health and a HSE working group.

The campaign to exclude anti-epilepsy drugs from the Bill is supported by the entire epilepsy community and the health care professionals who treat and care for people with epilepsy. There is a model for this amendment as the United Kingdom, Austria, Belgium, the Czech Republic and Greece do not allow substitution of anti-epilepsy drugs for generics. Countries which have excluded many anti-epilepsy drugs from substitution include Denmark, Finland, Germany, Portugal, Spain, Sweden and Switzerland.

Over-spending on medications means the Government has less money to invest in other areas of health care. This legislation will have significant consequences for all stakeholders in the pharmaceutical supply chain. I am supportive of it but I appeal for the exclusion with regard to anti-epilepsy medication to be considered seriously. The patient must remain at the heart of our health care reforms.

Professor Charles Normand, professor of health policy and management at Trinity College Dublin, has contended that the economic crisis has provided the health service with an opportunity to restructure itself and that better services to patients can be delivered at a lower cost. Despite the enormous and continuing challenges facing the health services, particularly on the funding front, the Government’s ongoing structural reform is well on its way to leading to a better service for patients. The transformation of our health care services calls for a change not only in what we do but also in how we do things, how we work together and how we commit to each other. By implementing the Bill as part of the reform programme, we can collectively bring about change that will fulfil our hopes and ambitions for health care services in Ireland. Building on the commitment and the success that has been delivered will take us to a position where we all feel proud of what we have achieved.

See this speech in context