Briefing note on supplementary protection certificates (SPCs)

Threatening access to affordable medicines across the European Union

Since the requirement of patent protection on pharmaceutical products through the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) in 1995, there has been enormous pressure for all countries, including across the European Union, to further restrict the legal and policy channels that are beneficial to safeguarding access to generic medicines.

Supplementary protection certificates (SPCs) are one such example of an additional monopoly right, intended to expand monopoly protection for medicines beyond the twenty-year patent term. By prolonging the monopolies of originator pharmaceutical companies, SPCs lead to unaffordable medicines prices that prevail for longer periods of time – threatening the sustainability of national healthcare systems and delaying patients’ access to lifesaving medical innovation.

Presently, the European Commission is reviewing the SPC mechanism established by Regulation EC No. 469/2009. As civil society organisations working on access to medicines and public health, we have witnessed the detrimental impact of some intellectual property rules on access to affordable medicines. We recommend that the European Commission focus this enquiry on how SPCs contribute to high medicines prices and therefor undermine universal access to treatments patients need. We recommend that the European Commission abolish the SPC mechanism, and refrain from encouraging SPCs and similar mechanisms through free trade agreements.