Ruth Coppinger (Dublin West, Solidarity)
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60. To ask the Minister for Health if he has discussed the seizure of Mifepristone and Misoprostol with the Health Products Regulatory Authority; and if he will make a statement on the matter. [28324/18]

Simon Harris (Wicklow, Fine Gael)
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Misoprostol and mifepristone are both classified as prescription-only medicines in Ireland and may only be supplied on foot of a valid prescription. A prescription-only medicine should be taken only when it has been prescribed for an individual by their medical practitioner, or other appropriate health professional, who has taken the person’s medical history into account.

Under the Medicinal Products (Prescription and Control of Supply) Regulations 2003 the mail order supply of prescription-only medicines is prohibited. Supply of prescription-only medicines by way of information society services (which includes internet sales) is also not permitted. The supply of unauthorised prescription-only medicines in any manner in or into Ireland is prohibited.

There are significant concerns associated with the purchase of prescription-only medicines over the internet. There is no guarantee as to the safety, quality or efficacy of the unauthorised products purchased online. Medicines purchased in this manner are often found to be counterfeit or have inaccurate labelling or product information.

The Health Products Regulatory Authority is the competent authority for the regulation of medicines in Ireland. The HPRA, in co-operation with Revenue’s Customs Service and An Garda Síochána, employs enforcement actions to identify the unauthorised supply of prescription-only medicines, including those containing misoprostol and mifepristone, to the public. The HPRA uses a range of enforcement powers to tackle this activity, including seizing the products.

Following the outcome of referendum on 25 May, a provisional result was published in Iris Oifigiúil on 29 May. However, three applications for permission to challenge the result of the referendum have been made to the High Court under section 42 of the Referendum Act 1994. On 26th June the High Court began to hear the applications. It is possible that the hearings may run over a number of days, after which a decision will be made by the Court.

The Constitution is not yet amended, and until the legislation to regulate termination of pregnancy is enacted, the Protection of Life During Pregnancy Act 2013 remains the law on termination of pregnancy. The 2013 Act allows for termination of pregnancy only where there is a risk to the life of the pregnant woman. The use of any medicinal products for the termination of pregnancy must be in line with the 2013 Act.

Work is ongoing on the legislation to regulate termination of pregnancy and the services necessary to support its implementation.