Bernard Durkan (Kildare North, Fine Gael)
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702. To ask the Minister for Health the position regarding approval of new or orphan drugs; the number of such drugs awaiting approval in the system; if Covid-19-related drugs are under consideration at present; if access to or reimbursement of Covid-19-related drugs is being expedited at a European or national level, in light of the ongoing pandemic; and if he will make a statement on the matter. [36220/20]

Stephen 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. 

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 (EMA) or the Health Products Regulatory Authority (HPRA).

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.

While the 2013 Health Act does not include provision for a different ruleset when assessing orphan drugs, the HSE seeks as far as possible to take into account issues such as the small patient numbers and the nature of the condition to be treated when evaluating these medicines.  The criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs.

The HSE has advised that, as of 30 October 2020, there were 81 applications for reimbursement (including new medicines and new uses of existing medicines) undergoing assessment.  Of these, 25 had orphan designation.

As of 16 November 2020, the HSE has confirmed that no pricing and reimbursement applications have been received for drugs indicated for either the management or prevention of COVID-19.

The Department of Health is participating in the European Commission Joint Procurement Agreement (JPA) for medicines for the treatment of COVID-19 including Remdesivir (Veklury®). This JPA provides for a voluntary mechanism enabling participating EU countries and the EU institutions to jointly purchase medical countermeasures for different categories of cross-border health threats including vaccines, antivirals and other treatments. The JPA falls outside current pricing and reimbursement application processes.