EU Member States May Restrict Or Totally Prohibit Sale of ‘Morning-After-Pill’ ellaOne

April 24, 2015

Brussels — In January of this year, the European Commission urged Member States to act according to a decision which allowed the prescription-free sale of ellaOne, a contraceptive with an abortifacient effect. As a result, many countries – among them Germany – took this as a sign that any legislation which foresaw its sale only on the basis of a medical prescription should be abolished. However, the Commission this week clarified that there is in fact no obligation for Member States to do so.

What happened? In November 2014 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended that ellaOne be made available across Europe as an emergency contraceptive without a prescription. EllaOne is one of two ‘morning-after-pills’ available on the European market and, since its launch in 2009, was available only with a prescription in EU Member States.

The European Commission’s Implementing Decision of January 2015 permitted the pill’s over-the-counter sale in the EU and put further pressure on Member States to change the status quo. In other words, its recommendation was interpreted as an obligation for Member States to end their restrictions by liberalizing the sale of ellaOne.

However, in a later written question submitted to the European Commission, 15 MEPs referred to the judgment of the European Court of Justice’s Grand Chamber dated 18 October 2011, which stated that “the legal protection stemming from the dignity of the human being starts from the moment of conception and the earliest embryonic phase, ‘since fertilisation is such as to commence the process of development of a human being’”. Relying on this passage, the MEPs asked how the Commission’s January 2015 decision could be justified as it would violate the EU Charter of Fundamental Rights and allow the use of a medicine that could act as an abortifacient. Pharmacists warned that making it readily available would cause extremely high demand for ellaOne in the coming months, especially among young clients under 35 years of age who – displaying an alarming ignorance of what it means, biologically and emotionally, to be pregnant – might be tempted to ask for the abortifacient drug as if it were just aspirin.

Given the irreversible societal harm that easy access to such a drug could cause, one needs to ask why several EU Member States chose to quickly abolish their stringent regulation of the sale of ellaOne – especially since the Commission’s decision was controversial from the start.

The written question of the 15 MEPs was answered by the Commission as follows: As concerns prescription, Directive 2001/83/EC provides in its Article 4 (4) that application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients shall not be affected.

As the Commission’s answer indicates, Member States are actually not obliged to follow the EU’s directive – contrary to the impression the Commission gave in its earlier decision. In fact, Member States are free to restrict or even prohibit the sale of contraceptives and products that, like ellaOne, act as abortifacients.

EllaOne has already become an irrevocable fact of daily life in several Member States – such as in Germany, where the drug has been available in pharmacies since 15 March 2015. However, it is important to emphasise that today’s clarification means that every EU Member State is free to reconsider over-the-counter availability of the ‘morning-after-pill’ – and to retain or restore legislation that restricts or regulates the sale of ellaOne.