After a long long run, the Amendment to the Supplementary Protection Certificate for medicinal Products (commonly known as SPC waiver) entered in force in the EU on July 1st, 2019. The new Regulation had been already published at the Official Journal of the European Parliament on June 11th after several years of discussions with the Industry.
Moehs Group has been supporting this revolutionary regulation all those years through the Spanish Fine Chemicals Organization (AFAQUIM) and the Spanish Organization of Generic Companies (AESEG), who supported the lobby actions of Medicines for Europe, who played the leading role in this project.
Using few words, under the SPC waiver EU-based manufacturers of Generics and Biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC, either for the purpose of exporting to a non-EU market without patent protection or for the purpose of creating a stock for the EU market. This stock is only allowed during the 6 months before the SPC expires. The same terms apply to Active Pharmaceutical Manufacturers for the Generic market as Moehs Group supplying our customers willing to use the waiver or supplying our customers in countries where patent or equivalent SPC protection does not exist or has expired.
This means that Moehs Group will be in position to market our pipeline products, under the conditions described by the SPC waiver, to our customers located in countries where patent or equivalent SPC protection does not exist or has expired.
Moreover, Moehs will be ready to support our customers willing to market in EU supplying API material allowing the launch the very first day after the SPC expires. Actually, Moehs Group had been playing in this field by producing patented APIs in free-of-patent territories such as Malta. However, with the SPC waiver, Moehs will be able to supply SPC protected APIs from our own manufacturing plants located in the EU.