I propose to take Questions Nos. 623, 635 and 643 together.
The Government has decided to develop a new policy framework providing for eligibility for a range of appropriate health services to take account of medical conditions. The HSE has established an Expert Panel to examine the range of conditions and services that should be considered as part of this process. A public consultation has also been undertaken to seek the views of the public, including patients, patient representative groups and professional bodies. The submissions received will inform the work of the Expert Panel. The panel has been asked to report to the Director General of the Health Service by September 2014.
The first step for a medicine to be placed on the Irish market involves the manufacturer seeking an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency. A determination on the application for authorisation is based on a rigorous scientific assessment of the application against legal and regulatory requirements. Once authorised on the Irish market, the supplier must make an application to the Health Service Executive (HSE) for the product to be included on the list of products covered under the GMS and other community drug schemes. The 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.
Applications for reimbursement are considered in line with the procedures and timescales agreed by the Department of Health and the HSE with the Irish Pharmaceutical Healthcare Association 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.