Despite the savings from these measures, the HSE budget for new drugs has increased relatively little. As a result, suppliers face considerable challenges in ensuring reimbursement for new drugs, particularly high-tech and orphan drugs. In addition, there is currently no separate authorisation procedure for these products, which are inevitably considered ineffective when evaluated according to standard pharmaceutical criteria. However, even products considered profitable should expect delays in reimbursement, as the Irish health system as a whole is not affordable. It remains to be seen what impact the COVID 19 pandemic will have on health spending on innovative medicines. In July 2016, the government and the Irish Pharmaceutical Healthcare Association agreed on new conditions for the provision of medicines to Irish health services. The new agreement covers the period up to 31 August 2020 and could save around EUR 600 million over the next four years, so that Ireland has an ageing population and, as a result, the demand for medicines, particularly for chronic diseases, is increasing. In recent years, the state has reformed Ireland`s pricing and reimbursement system and introduced a series of measures to reduce health spending. Suppliers also enter into new contractual agreements to add value and demonstrate the profitability of their products. Nevertheless, suppliers face considerable challenges in ensuring reimbursement for new medicines in Ireland, particularly high-tech medicines and rare orphan drugs.
“These drugs have met the clinical effectiveness and value for money of the state. They are all widespread in the EU. Patients deserve the best treatments. We hope that an extension can be agreed this week. It`s in everyone`s interest. In the absence of an extension of the current agreement on the pharmaceutical industry, rebates of around 5 million euros per month to the HSE could be jeopardized. Pricing and the pricing mechanism have been increasingly criticised in recent years, with the cost of medicines in Ireland still at the top of the European scale. Pharmaceutical spending amounted to 1.7 billion euros in 2015 and is expected to increase by a third over the next four years due to increased volumes and the introduction of new drugs. The new agreement aims to control these costs. The new deal will focus on a new pricing mechanism. Historically, the initial price of a new drug in Ireland could only reflect the average prices in the nine EU Member States where the drug is currently on the market, knowing that the price of the drug would be recalculated, since the new drug has been made available in other Member States to reflect its wider availability.
In practice, the price has been less adapted in Ireland than in other countries. In fact, the evidence indicates that the drug was introduced in Ireland at an early stage, so that most new Irish drugs in the Member States are only available with a small number of first users of new drugs – Denmark, Germany and the United Kingdom – who have free or unregulated prices and therefore , have relatively high prices for drugs, and that there is only a limited reorientation thereafter.