On 1 October 2008, Eurovet Animal Health also won the second arbitration case brought against the registration of Solacyl 100%. This means that the product can finally – after a delay of almost a year – be rolled out in more European markets.

In March 2006 we announced our intention in fourteen EU Member States to submit a European application for Solacyl (sodium salicylate 100%). The dossier was submitted at the end of August of that year. During the course of 2007, all outstanding issues were resolved and the procedure should have been concluded in September of the same year. Unfortunately, this was obstructed when just one Member State raised objections to the registration. They first wanted additional evidence of the clinical efficacy of Solacyl.

Procedural EU directives
According to EU directives, applications must be approved by all Member States involved in a procedure. In the event of objections – even if raised by just a single Member State – a European arbitration procedure is automatically started that involves all the 25 countries. A decision is then taken based on a vote by roll call. We won this procedure in February 2008 and were not required to submit any further studies. In the wake of this decision, the majority of the Member States involved allowed registration of Solacyl during the course of 2008.

Twice victorious – one year lost
The opposing Memberstate, however, decided it was not satisfied with this outcome and began a second arbitration procedure. The argument put forward this time was that any benefits gained by treatment with sodium salicylate were cancelled out by the possible side-effects. Since this arbitration procedure did not target Solacyl alone but sodium salicylate in general, two other registration holders with a similar product also became entangled in the case. On 1 October 2008, this arbitration case was also concluded and the application for Solacyl was approved by a comfortable majority of votes, subject to a small number of amendments to the registration. These amendments will be incorporated into the product information over the coming months. We have since started marketing Solacyl in a number of countries (including Germany and Belgium). The launch in the rest of Europe will follow this winter – after an almost 12-month delay.

European unity
This double arbitration illustrates how difficult it can be to reach agreement in Europe. Fortunately, the initial veto right of one Member State can eventually be overruled. Even so, arbitration procedures brought by one country can have a major influence on the marketing plans of an applicant in all the other countries. This further complicates the decision whether or not to register a product in a particular Member State. The Registration and Marketing departments take this decision jointly and weigh up the risks of a veto against the commercial interest of registration. It should be clear that this choice is far from always being an easy one to make.