Written answer
Medicinal Products
565. Deputy Jennifer Whitmore asked the Minister for Health if there are pathways for women using trial drugs to treat adenomyosis to have their costs fully or partially covered by the State; and if she will make a statement on the matter. [54676/26]
Comment on this
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 patients in Ireland.
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.
The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU via the centralised procedure. The Health Products Regulatory Authority (HPRA) is the competent authority responsible for the regulation of human medicines in Ireland. A company can submit an application for a marketing authorisation directly to the HPRA if the product in question is not required to be approved through the centralised procedure.
As outlined above, the national assessment and decision process for pricing and reimbursement cannot commence in the absence of marketing authorisation.