Dr. Elaine Breslin:

I thank the Deputy for that question. I shall address the clinical issues. The usual schedule is that the Mifepristone is taken first. This would be early termination of pregnancy. Depending on the dose, it is one tablet. It is usual that Misoprostol is taken second, which is advised by the Royal College of Obstetricians and Gynaecologists, within 48 hours. The Deputy is probably aware that there are different regimens. Those two products are attractive or useful in the community setting because they are indicative for oral use. Gemeprost is for vaginal use and is perhaps a less useful product. If the intention of the system is for this to operate within the community and for women to take the first medicine under the supervision of the medical practitioner and the second medicine at home, it would be more practical that it be an oral medicine. That is usually the system. We are aware that Gemeprost is used but according to the information we have to date, it is mainly for hospital-based use, and it may be used for the more complex types of terminations, as were discussed at the earlier session.

The Deputy asked if there was more than one player in the market. Three companies supply these medicines throughout the EU and we actively engaging with them. As I clarified earlier, we must initiate a mutual recognition procedure or be involved in that kind of procedure. We have engaged with each of these companies requesting them to make applications. We have also engaged with member states that have authorised those medicines asking them to act as the reference member state. We are approaching this from two aspects with a view to maximising the opportunity of getting applications here.

The pricing is outside the remit of the HPRA. We have nothing to do with that. As I said earlier, we have had close contact with primary care reimbursement service and with the Department, and we have mentioned to them the fact that there are three companies marketing these. There are a limited number of options available but these companies are marketing throughout the EU.

On the conditions of use, the product information requires that pregnancy is diagnosed using biological methods such as a urine or blood test to measure HCG or an ultrasound. The conditions of use do not mandate how a pregnancy is diagnosed, just that pregnancy must be diagnosed prior to the administration of the first medicine. There are exclusion criteria. For example, if there was concern about an ectopic pregnancy when the woman presents with pain or bleeding or with a past medical history, it would be taken into account. If a women has an inter-uterine device, which is a contraceptive device, this is also a contraindication to the use of these medicines. All of this is part of the routine review. The rhesus factor is also assessed. The product information will contain the basic information about the indications, the contraindications to use, the side effects of the treatment and how to use the medicine safely.

Since the Protection of Life During Pregnancy Act 2013, these medicines for the termination of pregnancy have been imported through the exempt scheme for supply to hospitals only. Under the Act, they are permitted for medical terminations of pregnancy in certain circumstances but it has to be a hospital-based treatment. There is an established exempt supply scheme for the companies that manufacture these medicines and that will be helpful moving forward.

Liability is not a matter for us. We permit the exempt scheme and I will ask my colleague, Mr. Lynch, to give more details on that, but essentially the law states that there must be a medical prescription by a medical practitioner who is registered in Ireland and it must be for a patient under his or her care.