Intellectual Property Rights Series no. 16

Supplementary Protection Certificates and Their Impact on Access to Medicines in Europe: Case Studies of Sofosbuvir, Trastuzumab and Imatinib

By Yuanqiong Hu, Dimitri Eynikel, Pascale Boulet and Gaelle Krikorian

Publisher: TWN
ISBN: 978-967-0747-43-9
Year: 2020   No. of pages: 36
16 cm x 24 cm

About the Book

In recent years, there has been increasing pressure on public health systems in high-income countries due to high medicines prices, one of the underlying causes of which are the market monopolies granted to pharmaceutical undertakings. These monopolies have been facilitated by expanded forms of intellectual property protections, including the extension of the exclusivity period after the expiration of the patent term concerning medicinal products.

In the European Union, such an approach lies in the Supplementary Protection Certificate, a mechanism formally introduced under Regulation 1768/92/EEC (now: Regulation 469/2009/EC, amended). After more than 20 years of implementation, the common justifications for SPCs are being challenged by recent findings as to their functioning and impact. Similarly, legitimate questions have been voiced as to the negative impact of SPCs on timely access to affordable medicines.

On the basis of an analysis of three medicines for hepatitis C and cancer treatment, this paper critically engages with the policy justifications underlying SPCs. It then analyses access challenges to a hepatitis C medicine and an HIV treatment in Europe, highlighting the social cost of the introduction of SPCs. Both the normative and empirical analyses have demonstrated that the common justifications supporting the SPC regime are deeply questionable. The addition of SPC exclusivity has also heavily delayed competition and maintained high medicines prices in European countries. Ultimately, the granting of such extended exclusive private rights on medicines may result in unnecessary suffering and be a factor in the erosion of access to medicines for all.

YUANQIONG HU is Senior Legal and Policy Adviser, MSF Access Campaign, Médecins Sans Frontières; and Postdoctoral Research Associate at the School of Law, School of Oriental and African Studies (SOAS), University of London. DIMITRI EYNIKEL is Advocacy Adviser at MSF Access Campaign, Médecins Sans Frontières. PASCALE BOULET is a Consultant with Medicines Law & Policy. GAELLE KRIKORIAN is Head of Policy, MSF Access Campaign, Médecins Sans Frontières.



1     Background                                                                                            

2     Medicines Pricing and SPCs                                                            

3     SPCs in the European Union                                                                   

4     SPCs: A Fair Mechanism to Recover R&D Investments?                       

5     High Drug Prices Eroding Access to Medicines                               

6     The Social Cost of SPCs                                                                                      

7     Recommendations and Conclusions