At the initiative of CMS Bureau Francis Lefebvre in particular, the French Council of State is shortly expected to pronounce the annulment of some of the provisions of the order of 19 December 2012 concerning the online sale of medicines.
The purpose of the order was the transposition in France of the European Directive 2011/62/EU of 8 June 2011.
This partial cancellation would have three main consequences:
- The other provisions of the order should soon undergo legislative ratification; they concern the importing of raw materials, the security and traceability of medicinal products, and brokering;
- Concerning online selling, the Government is expected to “review its draft” within the limit of the cancelled provisions and in accordance with modalities still to be determined;
- Until that date, the conditions governing online selling would be significantly relaxed, with the European Directive alone remaining applicable.
Most provisions of the European Directive 2011/62/EU of 8 June 2011 had to be transposed by Member States by 2 January 2013.
At the public sitting of 26 June France's Council of State examined the three challenges submitted to it against the order of 19 December 2012 and the implementing decree of 31 December 2012 transposing this directive into French law.
Like the directive which it transposes, the order of 19 December 2012 has four objectives:
- firstly, it defines the legal framework of the future drug security and traceability mechanism;
- secondly, it incorporates into French law the new obligations concerning the importing of raw materials and active ingredients;
- thirdly, it organises the new activity of broker for the purchase and sale of medicinal products which has existed since 1 April;
- fourthly and lastly, it sets forth the conditions of the online selling of proprietary medicinal products to or from the French territory.
Of these four series of provisions, the challenges submitted to the French Council of State relate exclusively to the question of the sale of medicinal products via the Internet. Consequently, the other three parts of the order of 19 December 2012 could soon undergo legislative ratification.
The Government is under no time constraints with regard to legislative ratification. Ratification should thus take place as soon as the parliamentary calendar permits it, perhaps at the next parliamentary session. In any event, the ratification bill filed with the National Assembly on 13 March 2013 has already been submitted to Parliament.
Concerning the online sale of medicinal products, it should be noted that the order of 19 December 2012 has been partially suspended since 14 February 2013 by an interim ruling of the Council of State.
At the public sitting of 26 June, the Rapporteur Public submitted a proposal to the Council of State for a cancellation of the provisions of the order that have already been suspended relative to the nature of medicinal products which may be sold online.
The cases are now under deliberation and the decision of the Council of State is expected in mid-July. If, as is often the case, the decision is in line with the arguments evoked during the public sitting by the Rapporteur Public, the Government, in order to fulfil its European obligations, will have to “review its draft”. It will then have the choice either of obtaining a new authorisation from Parliament which would allow it to legislate again by way of order, or – more likely – of causing the adoption by Parliament of a law on the subject, for example, by amending the abovementioned ratification bill to take account of the Council of State's decision.
If they fail to choose one of these two solutions, the French authorities will run the risk of European Commission action before the European Court of Justice in Luxembourg. In any event, until these new provisions were passed, Directive 2011/62/EU, applicable since 2 January 2013, would be fully applicable and would replace the annulled French order.
The order of 19 December 2012 poses three main problems in relation to the European directive:
- the list of the medicinal products which may be sold online, limited in France to freely-available medicinal products (just over 400), is too narrow because EU law authorises the sale of all medicinal products which are not subject to regulation (approximately 4,000); moreover, it is these provisions that were suspended by the French Council of State on 14 February 2013 and which the Rapporteur Public proposes to annul.
The latter proposed the rejection of two other objections made to the mechanism put in place by the French authorities:
- a pharmacy that wishes to engage in online selling must be authorised by the ARS even though it already holds an authorisation to open a pharmacy and the directive merely requires that the authorities be notified, i.e. simply that they be informed;
- the obligation to associate each online sale website with one and only one “bricks and mortar” pharmacy is excessively restrictive and has no apparent public health justification.
In any event, if it is in conformity with the suggestions of the Rapporteur Public, the decision of the French Council of State should create a legal environment that is more conducive to the online selling of medicinal products.
In these cases, CMS Bureau Francis Lefebvre (Bernard Geneste, lawyer-partner, and Saliha Rhaimoura, jurist) assisted one of the three plaintiffs in the dispute before the Council of State as well as with the creation of a website for the sale of medicinal products.
For more information, please contact