>SPC Manufacturing Waiver



SPC Regulation

Supplementary Protection Certificates (SPC) in the EU extend the market exclusivity provided by patents by up to five years. Similar protection also exists in the USA and Japan for up to five years, depending on the relevant legal criteria. Supplementary Protection Certificates are designed to compensate for the time lapse between the patent application and the granting of the marketing authorisation, when the originator company has to complete the development of its product and obtain regulatory approval. The relevant piece of EU regulation is Regulation (EC) No. 469/2009.

Current situation in Europe

At present, EU-based manufacturers of generic and biosimilar medicines are not permitted to make these products for export to non-European markets for as long as the reference medicinal product is protected by an SPC, even if protection for the product has already expired in the export markets. In addition, EU-based manufacturers cannot even start manufacturing during the SPC period for launch in EU markets immediately after the expiry of the SPC.
Indeed, during both the patent and the SPC protection period, the makers of the protected medicinal product have the manufacturing and marketing monopoly for it, i.e. production of the generic medicine for commercial use is prohibited.

The current situation forces European generic and biosimilar manufacturers to delocalise outside of the EU where the SPC does not exist or is already expired.


Medicines for Europe position

The current text of the proposal does not reflect the positive findings of all the studies published by the European Commission. 

The current proposal covers production during the SPC period for the purpose of export to non-EU countries only. It does not cover production for EU day-1 launch (i.e. launch of generics and biosimilars in EU markets immediately after SPC expiry). The proposal includes anti-competitive, unnecessary and unjustified anti-diversion measures (i.e. notification, labelling, due diligence). The manufacturing waiver does not apply to existing SPCs.

As a result, the current text does NOT serve the purpose for which the SPC manufacturing waiver has been conceived for, with negative or no impact on patients, Member States’ healthcare budgets and the EU business developments of the generic and biosimilar medicines industry.

Therefore, Medicines for Europe strongly encourages the European Parliament and the Council to work with the European Commission to improve the SPC manufacturing waiver amendment and actually stimulate investments with the three following elements:

  • Introduce the “EU day-1 launch”
  • Remove anti-competitive, unjustified and unnecessary anti-diversion measures
  • Allow an immediate applicability of the SPC manufacturing waiver

Without these three key elements, the SPC manufacturing waiver would be practically impossible to use and would produce no benefits for patients, Member States’ healthcare budgets and the generic and biosimilar medicines.