The European Commission is preparing to start monitoring the impact of a waiver that will allow generics and biosimilars developers to manufacture products in the EU while the originators' supplementary protection certificates (SPCs) are still in force. A plenary vote by the European Parliament in mid-April is expected to be one of the final steps in the approval of the waiver, the commission's Alfonso Calles-Sánchez told delegates at Medicines for Europe’s 15th legal affairs conference in the Dutch capital Amsterdam last week.
Noting that the inter-institutional agreement between the European Council, the European Parliament and the commission unveiled in mid-February this year...