Written answers

Wednesday, 16 December 2020

Department of Health

European Medicines Agency

Photo of Neale RichmondNeale Richmond (Dublin Rathdown, Fine Gael)
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302. To ask the Minister for Health the plans in place to decrease the time between EMA approval and reimbursement of new treatments to promote earlier access in Ireland with the latest innovations in care; and if he will make a statement on the matter. [43747/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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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. The Act specifies the criteria for decisions on the reimbursement of medicines.

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 market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

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 (the NCPE). They use a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

As outlined in the IPHA agreement, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving an 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.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that 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.

When there is a proposed decision by the HSE not to support reimbursement of a medicine, there is an extension in this timeline. This is due to the requirement of the HSE to issue a “notice of proposal”, and to allow 28 days for manufacturers to make representations to reconsider their decision. The HSE must then consider those representations and make a formal decision.

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 by the pharmaceutical industry in a viable and sustainable manner.

Ireland has been engaging over the past number of years with a number of voluntary EU forums. In June 2018, Ireland joined the Beneluxa Initiative on Pharmaceutical Policy. This Agreement is in line with the objective of working with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for patients to new medicines in an affordable and sustainable way. 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 Beneluxa.

As the Deputy will be aware, additional funding of €50m was provided for new medicines in Budget 2021. This funding will allow the HSE Executive Management Team to approve new and innovative medicines which have been recommended by the HSE Drugs Group on the basis of efficacy and value for money in line with the 2013 Health Act.

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