Willie O'Dea (Limerick City, Fianna Fail)
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855. To ask the Minister for Health if tedralan 200mg will be added to the medical card list as this medication is expensive; and if she will make a statement on the matter. [38700/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and devices.

There is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of marketing authorisation, Tedralan 200mg is not authorised for market by the European Medicines Agency.

I have reached out to the Health Product Regulatory Authority (HRPA) for an update on marketing authorisation in Ireland.

The HRPA can confirm that Tedralan 200mg is not authorised in Ireland. A Marketing Authorisation Application has not been received from the Marketing Authorisation Holder (SERP) for this medicinal product to date. The decision to submit a Marketing Authorisation Application to register a medicinal product in Ireland, is for the Marketing Authorisation Holder to make. The HPRA is always willing to discuss proposed marketing authorisation applications with Marketing Authorisation Holders and we do offer a national regulatory advice support service.

It is the understanding of the HRPA that France is the only EU Member State in which Tedralan 200mg is presently marketed.

As outlined above, the national assessment and decision process for pricing and reimbursement cannot commence in the absence of marketing authorisation.