European lawmakers on course to weaken IP incentives environment

Posted on January, 29 - 2019

Lawmakers in Brussels are on track towards weakening the environment for the discovery and adoption of medical innovation, potentially putting at risk the development of new treatments and high-quality jobs at the frontiers of research.

Through a draft regulation allowing for an SPC manufacturing waiver, Europe is sending a signal to innovators around the world that we are weakening our intellectual property (IP) framework. The Legal Affairs Committee of the European Parliament (JURI) has adopted amendments on two-year stockpiling, a very early implementation date and weakened safeguards.

In contrast to this, and in a welcome move, at Council level Ireland has adopted a position that calls for the exclusion of stockpiling.

IPHA, along with our EFPIA colleagues, have argued that the JURI compromise text is imbalanced and undermines principles of legal certainty and legitimate expectation. If adopted in the final text, the amendments would impact patients living with unmet medical needs, significantly weaken Europe’s research and development proposition, and potentially deter future investments and jobs.

It comes at a time when other regions are strengthening their commitment to the knowledge-based economy and bolstering IP regimes. 

The European Parliament could vote on the issue as early as the first half of March or, if the trialogue discussions are delayed, voting could happen in the last plenary session in April before the European elections.

Bernard Mallee, IPHA’s Director of Communications and Advocacy, said: “Brexit is dominating the Irish Government’s time - but it is still important that the industry’s voice is heard and heeded, both a national and European levels. Building a strong, stable and predictable research and development ecosystem, with the SPC at the core, has taken many years. Jeopardising that system is worrying, especially when Brexit and other political developments are causing some uncertainty and instability.

“We must recognise that we are at the meeting place of two futures: one based on science, innovation and access for patients to the best treatments, or another where patients get, at best, today’s medicines using yesterday’s research. Without innovation, there are no new cures. Ireland, both at industry and political levels, must back the innovation that makes our industry strong and fulfils our potential as a centre for advanced manufacturing and breakthrough research.”