Dáil Éireann Debate, Tuesday - 12 July 2022
780. Deputy Alan Dillon asked the Minister for Health the reason that it takes on average 870 days approval in Ireland and 636 days European Union average to make new orphan medicines available; and the steps that his Department and the HSE are taking to resolve this delay in making these orphan medicines available in a more time efficient manner. [37051/22]
View answer982. Deputy Colm Burke asked the Minister for Health the steps that can be taken to expedite the reimbursement process given that it currently takes on average 870 days for a patient to gain access to European Medicines Agency-approved orphan medicine in Ireland; the work that his Department is undertaking in partnership with the HSE to ensure that this delay improves; and if he will make a statement on the matter. [37818/22]
View answerI propose to take Questions Nos. 780 and 982 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.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 final decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.
Under the 2013 Act, reimbursement is for licenced indications which have been granted market authorisation either by the European Medicines Agency (EMA) or by the Health Products Regulatory Authority.The majority of new, innovative medicines are evaluated by the EMA and authorised via the European Commission’s centralised procedure in order to be marketed in the EU.
In line with the 2013 Health Act and the national framework agreed with industry, once a new medicine has received marketing authorisation, a company must submit an application to the HSE to have the product added to the reimbursement list.
The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. As outlined in the Framework Agreement with industry on the pricing and supply of medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving a company’s pricing/reimbursement application (or a longer period if further information is sought from the company), whether to approve a new medicine for reimbursement. The HSE must ensure that the best possible price is achieved for new medicines as these commitments often represent multimillion-euro investments over several years. This can lead to protracted commercial negotiations. The fundamental challenge that applies to consideration of almost all new medicines in Ireland is their price and affordability in a budget-limited health service. However, the allocation of dedicated funding for new medicines has had a positive impact on the reimbursement of orphan drugs. The allocation of €50m for new medicines in 2021 enabled the HSE to approve 52 new medicines/expanded uses of existing medicines in 2021, 19 of which were for the treatment of rare diseases. Budget 2022 has allocated a further €30m for new medicines this year which will provide access to new innovative medicines for patients.
