Supplementary protection certificates and their impact on access to medicines in Europe Case studies of sofosbuvir, trastuzumab and imatinib

Supplementary protection certificates and their impact on access to medicines in Europe Case studies of sofosbuvir, trastuzumab and imatinib

Journal article

12 pages

2052-3211

In recent years, there has been increasing pressure on public health systems in high-income countries due to highmedicines prices, one of the underlying causes of which are the market monopolies granted to pharmaceuticalundertakings. 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 medicinalproducts. In the European Union such an approach lies in the Supplementary Protection Certificate, a mechanismformally introduced under Regulation 1768/92/EEC (now: Regulation 469/2009/EC, amended). After more than 20years of implementation since it was first introduced, the common justifications for SPCs are being challenged byrecent findings as to their functioning and impact. Similarly, legitimate questions have been voiced as to thenegative impact of SPCs on timely access to affordable medicines.On the basis of an analysis of three medicines for hepatitis C and cancer treatments, the present article criticallyengages with the policy justifications underlying SPCs. It then analyses access challenges to a hepatitis C medicineand an HIV treatment in Europe, highlighting the social cost of the introduction of SPCs. Both the normative andempirical analyses have demonstrated that the common justifications supporting the SPC regime are deeplyquestionable. The addition of SPC exclusivity has also heavily delayed competition and maintained high medicinesprices in European countries. Ultimately, the granting of such extended exclusive private rights on medicines mayresult in unnecessary suffering and be a factor in the erosion of access to medicines for all.

This resource was extracted from the Directory of Open Access Journals (DOAJ)

Published in : Journal of Pharmaceutical Policy and Practice, vol. 13, no. 1 (2020), pp. 1-12.

London, United Kingdom : BMC, 2020.

English