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Parliamentary question - E-004885/2017Parliamentary question

Restrictions in the availability of emergency contraception in Poland

Question for written answer E-004885-17
to the Commission
Rule 130
Terry Reintke (Verts/ALE) , Malin Björk (GUE/NGL) , Maria Arena (S&D)

In May 2017, the Polish Government pushed a bill limiting access to the only emergency contraception pill available through the lower house of the Parliament. As a result of the C(2015)51 ruling from the Commission, and on recommendation from the European Medicines Agency (EMA), in January 2015, an emergency contraceptive with ulipristal acetate, registered in Poland under the brand name ellaOne, received authorisation to be sold without prescription across the EU. The ulipristal acetate emergency contraceptive pill (UPA ECP) was made available in Polish pharmacies without prescription from April 2015. In November 2016, however, the Polish Minister of Health announced that he was finalising an initiative aimed at restricting access to UPA ECPs and reinstating a doctor’s prescription as mandatory, citing the ‘misuse of the pill’ by teenage girls. A recent market study by Millward Brown showed the following: The biggest age group purchasing UPA ECPs are women between 25-30 years (45%). Only 2% of the buyers are below 18.

1. Does the Polish Government’s categorisation of the pill uphold the criteria laid down in Articles 70-71 of Directive 2001/83/EC?

2. Does the Polish Government’s bill introduce possible discrepancies in drug approval procedure and categorisation, in violation of Directive 2001/83/EC?