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Medicinal Products Prices

Dáil Éireann Debate, Tuesday - 24 June 2014

Tuesday, 24 June 2014

Questions (640, 641)

Michael Healy-Rae

Question:

640. Deputy Michael Healy-Rae asked the Minister for Health with regard to contraception, if his Department will make an agreement, as is implemented with prescription drugs, with manufacturer HRA Pharma regarding the cost of NorLevo to pharmacies, and set a maximum price of the drug to patients; and if he will make a statement on the matter. [27249/14]

View answer

Michael Healy-Rae

Question:

641. Deputy Michael Healy-Rae asked the Minister for Health his views that emergency contraception be available free to medical card holders without prescription; and if he will make a statement on the matter. [27250/14]

View answer

Written answers

I propose to take Questions Nos. 640 and 641 together.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The supplier can make an application to the HSE for their product to be included on the list of products covered under the GMS and other community drug schemes. The application is considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association (IPHA) for the assessment of new medicines. In accordance with these procedures, the HSE may ask the National Centre for Pharmacoeconomics (NCPE) to conduct a pharmacoeconomic evaluation of the new product which provides detailed information on the potential budget impact of the medicine. It also assesses whether the product is cost effective at the price quoted by the company in question. The NCPE report is an important input to assist the HSE in its decision making process and informs further discussions between the HSE and the supplier. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable.

There are currently two levonorgestrel emergency hormonal contraception products licensed for sale on the Irish market – Levonelle® and NorLevo®. Levonelle® is a prescription only product which is currently included on the List of Reimbursable Items for the GMS and other community drug schemes. This product is therefore available to medical card holders under the GMS Scheme, subject to the prescription charge, 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.

However, as NorLevo® is an over-the-counter product it no longer complies with the applicable reimbursement criteria for the GMS Scheme and other community drug 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.

In the case of drugs and medicines which are paid for by the HSE, prices are set in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013 or the terms of the framework agreements between the Department of Health and the HSE and the representative bodies for pharmaceutical manufacturers in Ireland. However, neither the Minister for Health nor the HSE has any power to set the prices of drugs and medicines purchased by private patients.

The HSE advises the public that if they are being charged prices which exceed the reimbursement price listed on the HSE website (http://www.pcrs.ie/), plus a dispensing fee of between €3.50 and €5, then they should discuss the differential with their pharmacist to ensure they get the best possible price for the medicine concerned. In addition, measures have been taken to increase price transparency among retail pharmacies. In March of this year the Pharmaceutical Society of Ireland issued guidelines to pharmacists on procedures and minimum standards of information to be provided to customers, including a requirement to provide an itemised receipt of purchase of medicines.

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