Consultation To Help Determine Whether EU SPC Framework Fit For Purpose
Executive Summary
The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.
The European Commission has launched a consultation that could pave the way for new measures that would update the supplementary protection certificate (SPC) system, including a unitary SPC and an SPC manufacturing waiver for export purposes. It says the findings will help it determine whether the EU SPC framework is still fit for purpose.
Through its consultation the commission wants to better understand stakeholder experience and knowledge of SPCs with a view to introducing proposals set out in the EC’s 2015 Single Market Strategy. This strategy explored a possible “recalibration” of some aspects of the patent and SPC system and the commission’s consultation document points to three of its suggestions: creating a European SPC title; updating the scope of the EU patent research exemptions; and introducing an SPC manufacturing waiver for export purposes.
A group of more than 30 NGOs recently urged the commission to consider abolishing the system of granting SPCs to pharmaceutical companies to compensate, saying they delay generic competition and affects the availability of affordable medicines. (Also see "EU Supplementary Protection Certificate Mechanism Needs To Go, Say Campaigners" - Pink Sheet, 13 Sep, 2017.)
Problems and solutions
The consultation document points out that a unitary SPC could improve the EU’s current SPC system. SPCs that are already in place have been granted and enforced on a national level rather than an EU level across all member states. In some cases, this has led to “single market fragmentation”. This is when some markets have granted an application that other member states have either refused or granted with a different scope. The consultation document points out that a single SPC could improve the current system; how it would work alongside the unitary patent is an issue that will be explored.
Meanwhile, generics and biosimilars manufacturers based outside of the EU, for example in India or China, are able to enter markets where patent protection has expired up to five years earlier than their EU-based rivals. This is because EU-based generics or biosimilars manufacturers are not permitted to produce in the EU during the duration of a reference product’s SPC protection. “Such a situation could lead to a lack of playing field between EU and non EU manufacturers with an advantage for non EU manufacturers,” says the consultation document. An “SPC manufacturing waiver” for exports could provide a solution, says the document.
Bolar exemption
The commission also wants to iron out inconsistencies across the EU in the way member states apply the Bolar exemption. This exemption is meant to get generic medicines to the market more quickly by allowing companies to conduct early preparatory development in order to obtain pre-marketing regulatory approval, even when the SPC is in force. However, different member states have different ways of implementing the Bolar exemption. For example, some member states do not allow the supply of active pharmaceutical ingredients to EU-based generic medicines manufacturers for the purpose of seeking marketing authorization. Also, in some markets it is unclear whether originator firms can take advantage of the exemption to conduct tests to meet new regulatory or pricing and reimbursement requirements, for example studies that compare drugs for health technology assessment purposes.
The consultation closes on January 4 and the commission will report back on its findings. These findings, coupled with ongoing evaluation studies, will “help the Commission assess whether the EU SPC framework is still fit for purpose or needs to be recalibrated, notably as regards the aspects set out in Single Market Strategy.”
Mike Snodin, a British patent attorney with considerable expertise in SPC-related matters, says the consultation provides an important, further opportunity for stakeholders in the SPC system to provide their views to the Commission. He adds that this new consultation is distinct from the legal study on SPCs that is being conducted by Max Planck Institute for Innovation and Competition in relation to which stakeholder opinions were sought earlier this year.
From the editors of Scrip Regulatory Affairs.