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Pugatch Consilium releases new study on the negative economic consequences of an SPC export exemption in Europe

Today Pugatch Consilium releases UNINTENDED CONSEQUENCES: How introducing a manufacturing and export exemption to supplementary protection certificates would weaken global standards of IP protection and result in direct losses to Europe’s research-based biopharmaceutical industry.

The study (which is also available via the Social Science Research Network, SSRN) models the economic impact an SPC manufacturing and export exemption would have on the European and global research-based biopharmaceutical industry.

In October 2015 the European Commission released its report Upgrading the Single Market: more opportunities for people and business, which details the overarching initiative to reform and deepen the single market with the purpose of spurring economic growth, job creation and reducing administrative burdens. As part of this review the Commission announced its intentions to explore options for recalibrating certain elements of SPC protection. One such option put forth by the Commission is to provide European manufacturers of generic drugs and biosimilars with an SPC manufacturing exemption.

Yet unanswered remains the question of what the effect of an SPC manufacturing and export exemption would be on the European and global research-based biopharmaceutical industry. This is a question of real import as the research based biopharmaceutical industry’s contribution to European GDP and job creation is substantial. In 2016 industry estimates suggests that this sector:

  • directly employed 745,000 people in the EU (with over 113,000 employed directly in innovative R&D);
  • generated over EUR238 billion in pharmaceutical production; and
  • invested some EUR33.5 billion in R&D activities across the EU.

Our study finds that implementation of an EU wide SPC manufacturing and export exemption would potentially result in annual losses ranging between USD2.675 billion and up to USD5.35 billion to the global innovative biopharmaceutical industry, with approximately USD1.34 billion to USD2.27 billion of these attributed to the European innovative biopharmaceutical industry.

Translating these losses to current levels of biopharmaceutical sector employment and R&D investment the effect of the introduction of an EU wide SPC manufacturing and export exemption could be between 4,500-7,700 direct job losses (with an additional 19,000-32,000 indirect job losses) and a decrease of between EUR215 million to EUR364 million in R&D investment.

The full study and modelling results is accessible via the following link:

The study is also publicly available through the Social Science Research Network (SSRN) at: http://ssrn.com/abstract=3051545

For further information about this please contact Dr David Torstensson davidt@pugatch-consilium.com


About the Author:

David’s focus is policy and economic analysis related to innovation, health care, pharmaceuticals, tax and intellectual property. He has wide experience in quantitative research methods including index-building and data sampling and is the author of a number of both academic and commissioned publications. David’s knowledge spans from North America and Europe to the BRIC economies, and he speaks fluent Swedish. Prior to his work with Pugatch Consilium, David was with Deloitte LLP where he worked on a broad range of UK and international tax compliance and advisory projects. David holds a Master of Studies and DPhil (PhD) from Oxford University.
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