My Department does not collate data on the average time taken for new medicines to become available in Ireland compared to other European countries.
While Industry likes to quote "league tables" comparing speed of reimbursement in Ireland with other countries, the fact of the matter is that several countries have quite different and often less rigorous statutory assessment arrangements then Ireland. Furthermore, many of the newer products being licensed are falling well short of cost-effectiveness thresholds, with limited clinical benefits.
As the Deputy is aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the Reimbursement List.
As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
The process for assessing applications works very well where the new medicines have strong evidence of clinical effectiveness and are priced in a cost effective manner. Delays in reimbursement decisions for new products do occur in cases where the evidence of clinical effectiveness is weak, and where prices are set well outside of cost effectiveness parameters. The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved in many of these applications, it must ensure the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.
In line with the 2013 Health Act, the HSE is obliged to ensure that any new drug has sufficient clinical benefit to justify using it and that it is affordable and the best use of finite health resources. In 2019 to date, the HSE has approved 26 new medicines and 5 new uses of existing medicines. 17 of these medicines are for the treatment of rare diseases. As the Deputy will be aware, It is extremely rare for a medicine to be refused reimbursement in Ireland.
My Department and the HSE are working on making greater efficiencies in medicines usage through a range of initiatives internationally and domestically to ensure the greatest possible access to new treatments for patients in Ireland. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative which is being established as part of the work programme of the Beneluxa Initiative on Pharmaceutical Policy.