The European Parliament and the Council have introduced the possibility of building up a stock of generics from 6 months before the end of the supplementary protection certificate (SPC) for medicinal products, following an agreement sealed at an interinstitutional meeting on Thursday 14 February.
This means that a drug manufacturer will be able to build up a stock of marketable generics 6 months before the end of the certificate's validity - a proposal that had been made by the European Parliament, which nevertheless wanted this storage possibility to take place two years before the end of the certificate, against the advice of the rapporteur, Luis de Grandes Pascual (EPP, Spain) (see EUROPE 12178).
Another new feature introduced at the request of the Council (see EUROPE 12174) is that the amended Regulation itself becomes enforceable in all Member States 20 days after its publication in the Official Journal. It will apply from 1 July 2022 to supplementary protection certificates that have already been applied for, but whose protection has not yet entered into force.
The CPC is an intellectual property right that allows a patent on a medicine that has been authorised by national or European regulatory authorities to be extended by up to five years to compensate for the loss of patent protection due to the particularly long duration required for mandatory trials and clinical trials before obtaining official marketing authorisation.
Yet, the current rules prevent EU-based generic and/or biosimilar manufacturers from working on a product until the SPC has expired. As a result, their products often enter the market late, unlike those of non-EU manufacturers who are not subject to this impediment.
Undermining pharmaceutical innovation. EFPIA, which represents the pharmaceutical industry at the European level, immediately issued a vitriolic statement, regretting that the EU was “playing” on the back of pharmaceutical innovation. For the organisation, the agreement is simply “unbalanced”; it criticises the proposal to store, an implementation date that is too early and, overall, the “absence of safeguards", which risks making the European economy less competitive on the international scene. (Original version in French by Pascal Hansens)