EllaOne® (ulipristal acetate) has been marketed in France since May 2009 by the HRA Pharma laboratory. It is indicated in “emergency contraception within 120 hours (5 days) following unprotected sexual intercourse or if a contraceptive method fails”.
Since its marketing authorisation was granted in 2009, this product has been included in list 1, i.e. based on the classification of medicinal products, on the list of poisonous substances subject to prescription.
In the spring of 2013, the HRA Pharma Laboratory provided the results of preclinical and clinical studies according to which the EMA deemed that “EllaOne® can be used safely and effectively without medical prescription“. This suggests that the medicinal product should be removed from the list.
The European Commission ratified the change of drug status
Based on this advice, the European Commission made its decision and agreed to modify the MA on 7 January 2015. The HRA Pharma Laboratory announced that the measure would be effective in France on 15 April 2015, when the product packaging would be changed, but the decision could have already applied. In fact, EllaOne® has been available in pharmacies without a prescription since January.
This change of category authorises, ipso facto, the anonymous issuing, free of charge, of EllaOne® for minors in accordance with Decree No. 2002-39 dated 9 January 2002, like the morning after pill (Norlevo®). The change deprives young women of the advantages of prior medical consultation and guarantees of a medical prescription in terms of the relevance of using the medicinal product and the frequency of use. Pharmacists are powerless to control dosing frequency.
Furthermore, free access facilitates the trivialisation of medicinal products and prevents traceability since dispensing is no longer governed by prescriptions.
The European Community responds to the reservations of 15 Euro MPs
On 2 February 2015, 15 Euro MPs presented the European Commission with a written question. They referred to:
The Charter of Fundamental Rights of the European Union “states that human dignity is inviolable andguarantees protection”;
The ruling of the European Court dated 18 October 2011 (Brüstle versus Greenpeace), stated that “legal protection of the dignity of human beings begins right from conception and the very first embryonic state”.
Since “EllaOne® only has contraceptive action during the phase preceding ovulation, after which it becomes abortive”, MPs enquired whether the Commission had taken into account the obligation to “guarantee the protection of human dignity”in its decision dated 7 January and if, following this question, it considered withdrawing its authorisation to market “a potentially abortive medication without a prescription”.
The Commission gave its response on 26 March 2015
Firstly, it recognises the potentially abortive characteristics of EllaOne® since the drug is placed in the “contraceptive or abortive product category”. In France, EllaOne® is an “emergency contraceptive”, which perpetuates the lack of clarity regarding its mode of action.
Lastly, although the Commission did not withdraw the decision taken on 7 January, it limited the application. Member States are free “to prohibit or limit the sale, supply or use of contraceptive or abortive medicinal products”.
Note from Gènéthique:
Ulipristal acetate as RU486 acts by binding to progesterone receptors (mainly present in the ovaries). This binding antagonises the action of progesterone, which mostly prevents the uterine mucosa from remaining in place during implantation, thus triggering the elimination of the embryo.
 This laboratory also markets the morning after pill, Norlevo®.
 Marketing authorisation.
 European Medicines Agency, responsible for the scientific evaluation of European applications for medicinal product marketing authorisations (centralised procedure).