Dáil Éireann Debate, Tuesday - 26 April 2022
1716. Deputy Colm Burke asked the Minister for Health the details of the plans that are in place to reduce the time it takes the Health Products Regulatory Authority to approve a drug for rare disease in Ireland considering that it is currently taking in excess of 1,100 days; and if he will make a statement on the matter. [20730/22]
View answerThe 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.
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.
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.
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 next year which will provide access to new innovative medicines for patients, including those with rare diseases.
