Clare Daly (Dublin Fingal, Independent)
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156. To ask the Minister for Health if there is a State-wide policy in regard to obtaining written patient consent prior to the prescription of an unlicensed drug to that patient. [38918/18]

Clare Daly (Dublin Fingal, Independent)
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157. To ask the Minister for Health if a sanction applies to a clinician who prescribes an unlicensed drug to a patient without having first obtained that patient's written consent. [38919/18]

Clare Daly (Dublin Fingal, Independent)
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158. To ask the Minister for Health if it is the practice in the public health system to obtain written patient consent prior to that patient being prescribed an unlicensed drug [38920/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 156, 157 and 158 together.

Under the Medical Practitioners Act 2007, the Medical Council is the statutory body charged with responsibility for the registration and regulation of medical practitioners in the State. The Council's main role is to protect the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among doctors.  

The Council provides advice to doctors on consent in its Guide to Professional Conduct and Ethics.  It gives the general principles relating to consent at section 9 of the Guide, where it states at 9.2 that: "You must make sure that patients have given their consent before you provide any medical investigation, examination or treatment. Consent is required by law and is an essential part of respect for patients’ autonomy. Patients have the right to decide what happens to their own body."

Disciplinary matters concerning registered medical practitioners are a matter for the Council.  Under its legislation its role is to fully investigate any complaints made about registered practitioners and decide whether they are fit to practice.  Information about this process can be found on the Medical Council's website at: medicalcouncil.ie/Public-Information/Making-a-Complaint-/.

The Council may impose sanctions on medical practitioners where there is a finding of professional misconduct and the ultimate sanction for a medical practitioner is removal from the register.  

Medicines placed on the Irish market must be authorised by the Health Products Regulatory Authority (HPRA) or, in the case of centrally authorised products, by the European Commission. However, European regulations do provide for an exemption to this rule – this is via Article 5 of Directive 2001/83/EC. In this case, unauthorised medicines may be supplied where a registered doctor or dentist has prescribed the product for an individual patient under his or her direct responsibility. This is in order to fulfil the special needs of those patients. Such products are defined as ‘exempt medicinal products’

Exempt medicinal products are often used in clinical practice in Ireland and this reflects the fact that there are not always sufficient approved medicines to address every medical need.

The practice of a doctor, or healthcare professional with prescriptive authority, and the manner in which they counsel and undertake to get informed consent from their patients when initiating or continuing any form of treatment, is a matter for that healthcare professional and/ or their respective regulatory body.