EBE statement on the European Commission’s proposal to introduce an SPC manufacturing waiver, which puts patient care at risk

Brussels – After the European Commission released its proposal to introduce a Supplementary Protection Certificates (SPCs) manufacturing waiver today, the European Biopharmaceutical Enterprises (EBE) expressed concern that the decision reduces intellectual property (IP) rights and de-values the incentives framework. This jeopardises investment in and patient access to innovative treatments. It also sends a global signal that Europe is weakening its commitment to IP, putting future investments, jobs, the opportunity for economic growth and the advancement of patient care in Europe at serious risk.

EBE President Eduardo Bravo, CEO TiGenix, said, “A dependable IP framework is a key factor that enables the biopharmaceutical industry and smaller companies to bring their innovative medicines to patients. Without it, I would not have been able to secure funding for my company that had to operate with almost no revenues for 17 years. Without incentives, my company and the medicines we are developing would not exist.”

Incentives, particularly IP protection, play a critical role in supporting EU SMEs to discover and develop new medicines for patients. Without patent protection for innovation, it is impossible for small companies to access the finance needed to keep the company and the research going. Investing in biotechnology is a long-term undertaking with a high risk of failure. IP is the mechanism that gives investors the confidence to fund biopharmaceutical research by SMEs. The SPCs are integral part of the European IP system, established in recognition of the long development time needed to bring medicines to patients. They ensure an effective exclusivity of 15 years for an authorised medicinal product when a basic patent results in a new medicine. As a reminder, in Europe a patent affords 20 years of exclusivity.

“We fear that a greater percentage of R&D for innovative biopharmaceutical treatments will move to other parts of the world that value and are strengthening the knowledge based economy”, adds Barbara Freischem, Executive Director of EBE. “This is a real danger, as was highlighted at our ‘Advanced Therapies – Opportunities and Challenges’ conference last November.”

The European Biopharmaceutical Enterprises (EBE) represents developers and manufacturers of innovative biopharmaceuticals of all sizes. Small and medium-sized enterprises (SMEs) are trailblazers in the innovation ecosystem, often working with bigger pharma players to turn early phase research into new medicines for patients. The SME biotech sector was responsible for 27 per cent of all new medicines authorised in Europe from 2010-2012. For orphan indications and rare diseases, the proportion rises to 61 per cent.

SMEs are important contributors to economic growth. The European Commission considers SMEs as the backbone of the European economy, with 99 out of 100 businesses being SMEs, SMEs employing 2 out of every 3 employees (in total 93 million) and producing 57 cents of every Euro of value added.

About EBE
The European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharma association in Europe.
To learn more about EBE, visit

Media Contact
Barbara Freischem, Executive Director
European Biopharmaceutical Enterprises – EBE
Tel: +32 2 626 25 64

See also EBE’s position paper on the SPC Manufacturing Waiver (2 August 2018)