Following up on an opinion released by a scientific committee of the European Medicines Agency (EMA), the European Commission has adopted a decision that authorizes the prescription-free sale of EllaOne, a “morning-after” pill that is marketed as a contraceptive, while in actual fact its typical effect is that of an abortifacient (i.e. it either directly destroys a fertilized ovum, or prevents its nidation in the uterine lining). The official justification for the decision is that the works best if used during the first 24 hours, and can be used safely without a medical prescription. In addition, the point of “emergency contraception” is that it is available without delay; it appears that EMA and the Commission consider appropriate medical advice to be a waste of time.
The decision is highly questionable. On the one hand, EllaOne is an abortifacient, and there is in all Member States legislation on abortion that must be complied with. Re-framing abortion as “emergency contraception” does not change the substance of the matter. On the other hand, Ella One in fact also must be expected to carry very considerable health risks for the women using it.
Currently Ella One requires a doctor’s prescription in Germany, Italy, Poland, Hungary, Croatia and Greece.
The Commission’s Decision has been published in the Community Register of medicinal products. While this Decision is in principle directly effective in all Member States (i.e. it requires no implementing measures at national level), Directive 2001/83/EC on the Community code relating to medicinal products for human use leaves some leeway for Member States to adopt rules that may limit or even prohibit the sale of the product. In particular, Article 4 § 4 of that Directive provides that:
“This Directive shall not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients. The Member States shall communicate the national legislation concerned to the Commission.”