SPC generics waiver comes into force
The controversial supplementary protection certificate (SPC) manufacturing waiver has come into force today, July 1.
Earlier this year, in April, the European Parliament voted to approve the waiver, which allows for the stockpiling of generic versions of patented drugs. The European Commission had originally proposed a change in the rules in May 2018.
One month later, the European Council adopted the regulation, which introduces an exception to the protection granted to an original medicine by an SPC.
Under the waiver, EU-based manufacturers will be able to produce generic or biosimilar versions of SPC-protected medicines for the purpose of exporting out of the EU where protection for the drug has expired or doesn’t exist.
Companies will be able to stockpile generics and biosimilars during the last six months of an SPC’s protection period ahead of entry onto the EU market. This provides generic makers with the opportunity for a day one launch so they are able to launch their products in the EU as soon as the SPC expires.
Generics manufacturers must notify the relevant national patent office and the SPC holder at least three months before the start date of manufacture.
According to Niculae Bădălău, the Romanian minister of economy, the regulation “will enable generics manufacturers based within the EU to compete with non-EU manufacturers on equal terms”.
The EU has projected that the waiver will generate, over the next ten years, additional net annual export sales of more than €1 billion ($1.1 billion), which could translate into 20,000 to 25,000 new jobs over that period.
However, the waiver has drawn criticism from across the pharmaceutical industry for its stockpiling provision.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), a Brussels-based organisation which represents research-based pharmaceutical companies in Europe, claimed that the EU was taking a gamble on Europe’s future in medical innovation.
Following the European Council’s political agreement on the proposal in February 2019, Nathalie Moll, EFPIA director general, said: “Stockpiling without adequate safeguards risks the further erosion of IP rights beyond the waiver itself, sending the wrong signal to global investors and innovators.
“The need for adequate safeguards should be of paramount importance to anyone that believes in medical innovation in Europe.”
Other organisations have been more optimistic—Medicines for Europe, an association representing the European generic and biosimilar industries, welcomed the move.
The waiver will “contribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to manufacture and supply its own medicines,” according to Medicines for Europe.
The SPC manufacturing waiver will apply to new SPCs filed on or after today, the day the legislation comes into force. It will also apply to SPCs that have been filed and/or granted already, but in such cases only from July 2, 2022 (thereby applying a three-year transitional period to this second category).
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