Seán Fleming (Laois-Offaly, Fianna Fail) | Oireachtas source

I thank the Senator for raising this issue. I will be providing an answer on behalf of my colleague, the Minister for Health, Deputy Stephen Donnelly.

This issue is becoming well known, and there is not a pharmacy, region or family with many prescriptions that has not encountered it. The HSE has statutory responsibility for pricing and reimbursement decisions under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Under that Act, the company that holds the marketing authorisation must apply to the HSE to add its medicine to the reimbursement list. The Act also permits community pharmacists to dispense alternative products on the basis of prescriptions. However, to do so, the medicines must have been designated as interchangeable by the Health Products Regulatory Authority, HPRA.

Many interchangeable alternatives are available to patients availing of the community drug schemes. These schemes include the general medical services scheme - the medical card scheme - which provides access to healthcare for people on a means-tested basis and, in some cases, on a discretionary basis. The drugs payment scheme, which is available to any person normally resident in the State, limits the cost of approved medicines to €80 per month. Spending above this threshold, which was reduced twice last year, is refunded, provided that the medicines dispensed are eligible.

In its reimbursement list, the HSE sets a common reimbursement price for all medicines in any group of interchangeable products. This is known as reference pricing and includes both generics and branded medicines. Where a patient chooses to receive a product above the reference price, he or she is required to pay the difference. This probably applies more to private patients rather than those on the schemes I mentioned. Generally, if a generic manufacturer chooses not to apply to the HSE to be added to the reimbursement list, the medicine will not be eligible for reimbursement under the community drug schemes. However, in cases where a medicine is not on the reimbursement list and the full cost must be paid, an application can be made for discretionary hardship arrangements to be considered by the HSE. All applications under these arrangements are reviewed on an individual basis. The HSE must be satisfied that the patient requires the item for clinical reasons and that there is no item on the reimbursement list that is a suitable alternative for that patient.

Shortages of medicines are not unique to Ireland. There is no evidence that shortages disproportionately impact patients here compared with other countries.Ireland has a medicine shortage framework in place that is operated by the HPRA, which I referred to earlier, on behalf of the Minister for Health. This framework aims to help avert potential shortages occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise. The multi-stakeholder framework includes representation from the Department of Health, the pharmaceutical industry, healthcare professionals, the HSE and patients.

In the case of medicines that are used most often in Ireland, when there is a shortage, there are typically multiple forms, strengths, brands and generic medicines available from a range of sources. In the event there are some supply issues for individual medicines, alternative options such as alternative strengths, brands and generic medicines may be available to ensure continuity of treatment. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.