A focus on innovation in health care is key to the development of new medicines to meet the needs of patients. From a policy perspective it is important to have a regulatory framework in place to support the development of new medicines. Clinical trials are essential for the development of new medicines and the Clinical Trials Proposal currently being negotiated at EU level, which was a key priority for my Department during the Irish Presidency of the EU Council, is designed to make Europe a more attractive place to carry out clinical trials on new and innovative therapies.
The first step for a medicine to be placed on the Irish market involves the manufacturer seeking an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on the application for authorisation is based on a rigorous scientific assessment of the application against legal and regulatory requirements.
Once authorised, applications for the inclusion of new medicines in the GMS and community drugs schemes are considered in line with procedures and timescales agreed in 2012 between the Department of Health, the HSE and the Irish Pharmaceutical Healthcare Association (IPHA). In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) conducts a Health Technology Assessment (HTA) which provides detailed information on the potential budget impact of the medicine. It also assesses whether the medicine is cost effective at the price quoted by the company in question.
In October 2012 a new deal on drug costs was agreed between the IPHA, the HSE and my Department resulting in major savings on the cost of drugs. The gross savings arising from this deal will be in excess of €400 million over 3 years. €210 million from the gross savings will be used to fund new drugs to patients over this period.