Seanad debates

Thursday, 19 June 2014

Adjournment Matters

Medicinal Products Availability

3:00 pm

Photo of Kathleen LynchKathleen Lynch (Cork North Central, Labour) | Oireachtas source

We have had brief discussions already on this matter, which I thank Senator Burke for raising. There are currently two emergency hormonal contraception products licensed for sale on the Irish market - Levonelle and NorLevo. Levonelle is a prescription-only product which is available to medical card holders under the GMS scheme, subject to the prescription charge – that everyone has to pay - once they have a prescription from their GP. The other levonorgestrel emergency hormonal contraception product licensed for sale on the Irish market is NorLevo. In February, 2011 the Irish Medicines Board announced its decision to allow the sale of NorLevo without prescription. This product may, therefore, be supplied from pharmacies without a prescription by or under the personal supervision of the pharmacist.

The Pharmaceutical Society of Ireland, PSI, has issued guidelines under section 18 of the Pharmacy Act 2007 to pharmacists requiring that the emergency hormonal contraceptive may only be supplied to a patient by the pharmacist personally, following a private consultation between the patient and pharmacist in order that the pharmacist can determine the appropriateness of the supply and to provide an opportunity to meet the appropriate patient counselling requirements. This consultation is required to take place in the pharmacy's patient consultation area. However, as NorLevo is an over-the-counter product it no longer complies with the applicable reimbursement criteria for the GMS scheme and the community drugs schemes, as a prescription is not normally required for its supply to a patient. Therefore, for all recipients of this product, the supply process is essentially a private transaction between the patient and the pharmacy. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. In that context, one of the criteria which the HSE must have regard to when deciding whether a product should be added to the list of items reimbursable under the GMS and other community drugs schemes is that the product must be such that it is ordinarily supplied to the public on foot of a prescription. Therefore, over-the-counter products are not normally covered under the GMS and other community drugs schemes. Any change in this policy approach would have wide-ranging implications.

The central point is that there is a product which can only be used in emergency contraceptive situations and it is only available on prescription. Anyone who has a medical card can avail of it. I take on board Senator Burke’s point that requiring a prescription makes it a very expensive way to make the product available.

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