215. The representative of Ecuador said that the System was not effective and could be further improved. His Government was therefore not ready to proceed with the acceptance of the Protocol. His delegation, like other Members, had considered alternatives to the use of the Paragraph 6 System by compiling and evaluating other countries' practices in respect of the implementation of Articles 30, 31 and 44 TRIPS. Those practices were of significant importance in enabling Members to take informed policy decisions as they strove to transform into reality the spirit of the Doha Declaration on the primacy and safeguarding of public health and the promotion of access to medicines.
216. In that context, he requested that the European Union provide clarification on the Italian Competition Authority's granting of three compulsory licences between 2005 and 2007, which seemed to have occurred under Article 31(k) of the TRIPS Agreement. Under that provision, the conditions established in Article 31(f) could be waived if a licence was granted to remedy a practice determined after judicial or administrative process to be anti-competitive.
217. In the first case, the Italian Competition Authority had launched an investigation in February 2005 regarding the abuse of dominant position by Merck for its refusal to grant licensing rights in respect of the patent-protected active ingredients, which were used to produce the antibiotic Imipenem Cilastatin. On 21 June 2005, the Italian Competition Authority had granted a compulsory licence on the relevant patents for the active ingredients needed for the manufacture of the antibiotic concerned. The product had been patented only in Italy and not in other European countries. The Italian generics industry had sought a licence to produce and market the product in the rest of Europe (not for the Italian market), where this product had not been protected.
218. The second case concerned a decision by the Italian Competition Authority of 8 February 2006 to grant a compulsory licence for the manufacture in Italy of the patent-protected active ingredient Sumatriptan Succinate needed to produce medicines to treat migraine. The licence had been requested by the chemical company Fabbrica Italiana Sintetici SpA (FIS), following GSK's refusal to negotiate a voluntary licence. Initially, FIS had used the compulsory licence primarily for the purpose of supplying the export market by selling its product to generic companies, which marketed it in other countries such as Spain, where the relevant patent had expired. This had been done outside the Paragraph 6 System, from which the EU and its member States had opted out of as beneficiaries.
219. The third case related to the Italian Competition Authority call upon Merck on 21 March 2007 to "grant free licences to allow the manufacture and sale in Italy of the active ingredient Finasteride and related generic drugs two years before the 2009 expiration of the Supplementary Protection Certificate". Finasteride was the active ingredient of a drug initially marketed under the brand names Proscar and Propecia. It was used to treat prostatic hypertrophy, prostate cancer and male pattern baldness. The royalty-free compulsory licences issued by the Italian Competition Authority had remedied Merck's refusal to license its patents to local manufacturers of pharmaceutical active ingredients. Those licences had once again involved exports to other European countries.
220. He asked the delegation of the European Union to provide the Council with further information on these three compulsory licences including, but not limited to, administrative procedures, decision making processes and the legal and factual basis for the grant of the licences. He also requested that the European Union provide examples of other uses under Article 31(k) relating to the export of medical technologies.
