This post refers to just adopted amendments to a waiver proposed by the European Commission to allow pharmaceutical companies in Europe to produce generic versions of medicines that are under SPC exclusivity in Europe, for export to countries where the medicine is no longer under patent protection or where no SPC applies
By Dimitri Eynikel*
EU Policy and Advocacy Advisor for the MSF Access Campaign
European Parliament Calls for Regular Evaluation of SPC System, Including its Effect on Access to Medicines in Europe
Yesterday (23 January 2019), the European Parliament’s Committee on Legal Affairs (JURI) adopted important amendments to a proposal for the introduction of a manufacturing waiver for Supplementary Protection Certificates (SPC’s). Particularly, amendments introducing stockpiling and regular evaluations of the overall impact of the SPC system, including on access to medicines, stand out. SPCs are intellectual property rights that extend patent protection up to five years for certain products, including medicines, beyond the original twenty-year patent term. The waiver as proposed by the European Commission would allow pharmaceutical companies in Europe to produce generic versions of medicines that are under SPC exclusivity in Europe, for export to countries where the medicine is no longer under patent protection or where no SPC applies.
The adopted proposal for a waiver shouldn’t obscure the fact that SPCs limit people’s access to treatment by enabling pharmaceutical companies to extend their patent monopolies and delay or block the production of generic and biosimilar medicines. In several European countries, for example, an SPC on Truvada hampers people at risk of contracting HIV from getting access to preventive medication (PrEP), as you can read in my earlier blog post. Many civil society groups have called for the SPC system to be abolished and for the European Commission to refrain from promoting the use of SPCs beyond the EU. Despite these concerns, the European Union continues to actively promote the adoption of patent term extensions as SPCs outside Europe, including in developing countries, through trade agreements.
Regular, transparent evaluations of the SPC system may eventually lend more weight to important concerns that have been raised about the public health impact of SPCs – and can inform and improve the European Union’s policies on the granting of intellectual property rights for medicines.
In the discussions leading up to yesterday’s vote, Members of the European Parliament (MEPs) across a range of committees helped to amplify the health needs of people and to raise awareness about the harm that intellectual property rights can inflict when they are granted without an assessment of public health impacts. All too often, the EU’s intellectual property policies have been dominated by economic and industrial perspectives, while not sufficiently taking into account the effects on public health. It’s important to note that also the SPC manufacturing waiver proposal primarily seeks to rebalance the competing commercial interests of originator and generic pharmaceutical industries in Europe, and as such does not aim to address the challenges of access to affordable medicines in Europe or elsewhere.
Yet, the amendments to SPC manufacturing waiver proposal clearly show the need and willingness by the European Parliament for greater scrutiny and involvement in evaluating the impact of intellectual property rights on access to medicines. The debates surrounding the SPC manufacturing waiver have brought access to medicines issues to the forefront in the European Parliament, and could catalyse more significant improvements in the EU’s intellectual property policies for the benefit of patients in the EU and elsewhere.
* Republished from
Views presented here by the author are his personal opinions
On the same topic recently on PEAH:
‘The Contradictory Case of EU SPC Mechanism and Waiver‘ by Daniele Dionisio