European Parliament Passes SPC Waiver in Landslide Vote

Regulatory NewsRegulatory News | 17 April 2019 |  By 

The European Parliament on Wednesday voted through a proposal to allow manufacturing waivers to supplementary protection certificates (SPCs) by an overwhelming majority, with more than 75% of members voting in favor of the measure.
In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.
Under the proposal, generic and biosimilar makers will be able to obtain a waiver to manufacture SPC-protected products for export to non-EU countries where intellectual property protections for those products have expired or never existed. The proposal will also allow for the stockpiling of generic and biosimilars during the final six months of SPC protection to enable day-one market entry for those products.
According to the European Commission, the SPC waiver regulations will “remove a major competitive disadvantage of EU manufacturers compared to manufacturers based in non-EU countries and ultimately ensure a better deal for patients.”
The Commission also estimates that SPC manufacturing waivers could generate upwards of €1 billion in annual sales of generics and biosimilars and create 25,000 jobs over the next decade.
Now that the Parliament has voted in favor of the proposal, it will head to the Council of the EU for endorsement. Once endorsed, there is a three-year transition period before the regulations are fully in effect. With endorsement by the Council expected in the coming months the SPC waiver regulations are likely to be fully in effect in mid-2022.
Speaking to Parliament on Tuesday, European Commission Vice President for Jobs, Growth, Investment and Competitiveness Jyrki Katainen said the transition period “respects the dual imperative of being both legally sound and economically useful” and noted that the Commission will review the effectiveness of the provisions surrounding stockpiling every five years to ensure they are working as intended.
While the SPC waiver proposal is strongly supported by Europe’s generic and biosimilar industry, the European Federation for Pharmaceutical Industries and Associations (EFPIA) argues the proposal will weaken the EU’s intellectual property protections and disincentivize investment in the EU by branded drugmakers.
“The adoption of the SPC manufacturing waiver will ultimately impact on our capacity to develop new treatments for patients living with diseases like cancer, diabetes and dementia. It sends a negative signal to the world that Europe is devaluing its intellectual property framework, making Europe a less attractive location for research and development, impacting on jobs and investment,” EFPIA said in a press release calling for redress from the next Commission presidency following the vote on Wednesday.
European Commission


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