Dáil Éireann Debate, Thursday - 4 February 2021
229. Deputy Bernard J. Durkan asked the Minister for Health the extent to which his Department continues to address delays in the approval of new or orphan drugs; the average time taken for approval at present given the urgency of the need for drugs to treat new or rare diseases; and if he will make a statement on the matter. [6287/21]
View answer230. Deputy Bernard J. Durkan asked the Minister for Health the extent to which reduction in the time taken for approval of orphan, new or rare disease drugs has been achieved; if improved levels of reimbursement are being achieved; and if he will make a statement on the matter. [6288/21]
View answerI propose to take Questions Nos. 229 and 230 together.
In the EU, medicines for rare diseases must be authorised by the European Medicines Agency (EMA) and the European Commission under the ‘centralised procedure’. It is therefore not open to Irish authorities to grant a marketing authorisation for orphan medicines outside of this framework.
Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting “clock stops” when applicant companies are requested to provide additional information. It is also possible for an orphan medicine sponsor to submit an application through the EMA’s accelerated assessment procedure. This procedure reduces the timeframe for the EMA to review the marketing-authorisation application to 150 days, not including any clock stops. It will then be up to the sponsor company to respond promptly to requests for additional information or data to support its application to avoid extended clock stops.
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 line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted marketing authorisation by the EMA or the Health Products Regulatory Authority.
In making a 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. The HSE strives to reach reimbursement decisions in as timely a manner as possible. However, it must ensure that the best possible price is achieved, as these commitments often represent multi-million-euro investments on an ongoing basis. This can lead to a protracted deliberation process. The Government wants new and innovative medicines to be available to our citizens as quickly as possible, but this can only be achieved if medicines are priced in a viable and sustainable manner.
