Oireachtas Joint and Select Committees

Wednesday, 19 September 2018

Joint Oireachtas Committee on Health

Licensing of Abortion Medication: Health Products Regulatory Authority

9:00 am

Photo of Kate O'ConnellKate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

In the opening statement, reference was made to the second tablet that contains either Misoprostol or Gemeprost. Is either more effective? Is the Misoprostol the first line and if there is none available, is Gemeprost an equivalent? I am just trying to establish that we get the optimum product.

Dr. Breslin referred to more than one company. While I understand the commercial sensitivity, has more than one company applied for a heath technology assessment on the product? I want to get to the issue of price. If only one company is coming in and if we are under pressure to deliver, there is an argument to be made that the company can, perhaps, name its price. Will the Dr. Breslin elaborate on whether there is only one player in the market? I cannot imagine this would make a company a huge amount.

What are the conditions of use of medicines and the licensing? I understand that in other jurisdictions the two termination of pregnancy pills are licensed for up to ten weeks of pregnancy. Are there special conditions such as dating scans, ectopic situations or other contraindications? Will Dr. Breslin elaborate on other issues that might come down the road?

With regard to the unlicensed medicines scheme, and I am speaking hypothetically, if a product was not available and everything else was available in January, and if it had to be supplied under the exempt medicines scheme by a doctor, if there is a 0.1% chance of something going wrong in that period, where would the liability fall? Would it be the personal liability of the doctor? With many exempt medicines, the liability falls to the practitioner or the prescriber and sometimes the pharmacist.

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