Government legislation ministry finds pregnancy-termination drug import approvals legal

The government legislation ministry said that import product approvals for pregnancy-termination drugs do not breach the Mother and Child Health Act because the law governs surgical procedures rather than medicines.

The opinion, issued in response to a query from the Ministry of Food and Drug Safety, said Article 14 allows doctors to perform artificial termination surgery only in specified cases. The act defines only such surgery and contains no provision permitting or barring pregnancy-termination drugs or their import approvals.

It also concluded that import approval is a binding administrative act. The Pharmacy Act requires the regulator to "grant approval" when applicants meet statutory safety, efficacy and quality requirements. The ministry said the requirements are assessed against clear, objective criteria and leave no discretion to deny imports on other grounds.

The ministry said an approval allows a medicine to be imported and distributed, rather than determining whether a particular termination method is lawful or directing its use.

The act's surgery-specific wording, in place since 1973, does not reflect later medical advances or varied termination methods and cannot be used to bar import approvals.

Key criminal abortion provisions lapsed Jan. 1, 2021, following a Constitutional Court decision on April 11, 2019. The court said restrictions should not excessively limit women's right to self-determination and should balance that right with protection of fetal life. Reading surgical rules as an independent prohibition on non-surgical terminations would lack explicit legal grounds.