Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

656. To ask the Minister for Health the additional duty of care placed on a doctor prescribing an unlicensed medicine; and the additional steps the doctor must take to ensure patients' attention is being drawn to the various risks attached to prescribing of the medicine in view of the fact that the Health Products Regulatory Authority, HPRA, has no involvement in the safety of the medicine. [24542/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Under European and Irish legislation, before a medicine can be placed on the market the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA), or in the case of certain medicines, the European Medicines Agency.

Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and in order to meet the special needs of a patient. The process for this is described in the ‘Guide to the Notification System for Exempt Medicinal Products’ which is available on the website of the HPRA. For this notification scheme, there are a number of specialist wholesalers which deal with the importation of ‘exempt medicines’ into Ireland, via pharmacies and subject to a prescription.

The responsibility for the clinical use of unlicensed medicines lies with the prescriber. In accordance with the Medical Council’s Guide to Professional Conduct and Ethics, medical practitioners must ensure as far as possible that any treatment, medication or therapy prescribed for a patient is safe, evidence-based and in the patient’s best interests. This applies equally to licensed and unlicensed medicinal products.