Happy New Year from the EFPIA Legal Team
10.01.19
The beginning of a new year is a moment to dust off yearly strategies and to jot down the list of what needs to be done over the next twelve months. However, with 2019 being a European election year, as well as national elections in several member states, we may not have the luxury of a whole twelve months to get through the to do list.
That said, even allowing for electoral and other political uncertainty – and the arrival of a new European Commission – we can be sure that 2019 will establish the foundations for many key topics in the innovative pharmaceutical sector. So my team will be hitting the ground running.
Nathalie Moll has already identified this as a headline goal, writing in her blog “building a strong European economy and cohesive European society largely depends on a healthy population. It’s why ensuring all European citizens live healthier lives must be a priority for the new [EU] legislative mandate, supported by more patient centred health systems and a smart sectorial industrial policy and pro-innovation environment.” This is the vision of the EFPIA Manifesto. Our key input to the European and national debates ahead.
So how does the legal team play its part? We’re not there to say ‘no’, we ask “Why not?” and look for the legal arguments to make things happen; encouraging policy makers to create and defend the right environment that enables innovative health solutions to reach all patients as well as help secure European industry’s place among the world leaders in medical R&D.
Planning ahead it seems we face three distinct phases:
- between now and Easter we’ll be making the case for the EFPIA Manifesto proposals on access to innovative heath solutions, on the need to support Europe’s R&D eco-system and on to join forces to fast track results as key elements of the policy landscape for the next Parliament and the next Commission, as well as upcoming Presidencies starting in 2020.
- from Easter to (hopefully) mid-Autumn, we’ll be preparing for the new Commission, its new team for its new mandate, taking account of the EP election outcome.
- In the final quarter of the year we will be positioning our industry in the context of the new institutional priorities.
Particularly within the first phase, we will be focusing on following two important pending legislative proposals through the final stages of legislative process, while being vigilant that the rush to clear the decks before the European Parliament goes into recess does not produce compromises that fundamentally weaken the objectives that the new rules seek to deliver.
Firstly, this concerns the proposed supplementary protection certificate (SPC) manufacturing waiver. The waiver removes certain exclusive rights currently protected by SPCs and is already sending a negative signal about Europe’s commitment to innovative bio-pharmaceutical development in Europe. In this context, we need to guard against any further erosion of IP incentives in the final text. What the waiver entails and under which conditions it applies needs to be clear and operational. It must ensure the right degree of transparency backed by an effective notification system. Any other outcome would weaken the essential IP basis needed for innovation and dampen investment in medicines of the future.
Firstly, this concerns the proposed supplementary protection certificate (SPC) manufacturing waiver. The waiver removes certain exclusive rights currently protected by SPCs and is already sending a negative signal about Europe’s commitment to innovative bio-pharmaceutical development in Europe. In this context, we need to guard against any further erosion of IP incentives in the final text. What the waiver entails and under which conditions it applies needs to be clear and operational. It must ensure the right degree of transparency backed by an effective notification system. Any other outcome would weaken the essential IP basis needed for innovation and dampen investment in medicines of the future.
The second legislative proposal that might come to fruition before the elections is the Commission’s proposal for an EU Directive on collective redress. This would introduce Europe-wide representative actions designed to protect collective interests of consumers. We welcome efforts to provide a framework for effective consumer redress but the mechanism outlined in the Proposal will fail to reach this goal. History shows that court-based collective redress mechanisms are too complex, costly, and lengthy to bring real consumer benefits. Regulatory solutions or consumer ombudsmen have been far more effective in delivering tangible consumer outcomes.
EFPIA therefore continues to call for a different approach to consumer redress based on real world experience of existing publicly administered national consumer redress schemes, many of which are already delivering results without the need for court-based collective or “class” actions.
Beyond these two legislative ‘hot potatoes’ where the clock is definitely ticking, we will also be supporting other EFPIA priorities which very much feed into the handover between Commission’s and Parliaments, such as the EU incentives analysis, Brexit, competition law policy, trade opportunities and challenges, data for R&D excellence, and Horizon Europe.
Getting it right is critical for a healthy Europe and our legal perspective will always start from patients rights and interests. Enhancing our self-regulation and engagement with patients and partners in research and development, health and social care helps us to show our commitment to deliver more for patients across Europe.
Much to do, so let’s get on with it.
We wish you a happy 2019 and look forward to working with you to build a healthier future for Europe!
