On Monday 11th of March, after years of delay, the European Commission finally adopted its Communication on the ‘Strategic Approach to Pharmaceuticals in the Environment’. Now that it is here, what should the pharmaceutical sector expect from it in the context of the upcoming EU Institutional Changeover?
With the end of the current European Commission’s mandate in sight EU officials are busy tying up loose ends and preparing dossiers for the incoming President and Commissioners. One of these loose ends was the long-awaited strategy on how to deal with Pharmaceuticals in the Environment (PiE), an issue that has been discussed and debated for many years in the Brussels bubble and beyond.
In its strategic approach the Communication sets out a series of actions that are addressed at different points in the product lifecycle of pharmaceuticals. It’s a broad mix of awareness raising activities, research incentives, guidelines, policy exchanges and regulatory measures involving a wide range of stakeholders that should ultimately lower the concentrations of pharmaceuticals in the environment. Some of these actions build on existing policy, others suggest the initiation of new policy and legislative initiatives. The key message however is one of ‘stay tuned’ and handing over the political responsibility for taking forward and implementing the strategy to the next European Commission.
When looking at the life cycle approach and proposed action areas it is clear that, one way or another, a large piece of the PiE will be served to industry through increased scrutiny pre- and post-production requirements. As the policy and regulatory measures are largely undefined it is clear the upcoming EU elections matter as it will decide the political color and dynamics of not just the European Parliament, but also the next European Commission.
The seat projections published by the European Parliament offer a good indication of the expected change in political dynamics, including more pressure on mainstream parties from radical forces. With the established and more constructive political groups EPP and S&D being unlikely to be able to muster a majority between them this time around, we should brace ourselves for a much more challenging, complex and uncertain political arena for the next five years.
The only certainty is uncertainty at the moment. This does not mean the pharmaceutical sector should wait and see, quite the opposite actually. Companies and associations are well advised to start re-assessing their approach to EU Institutional outreach and engagement to get ready for a new age of policymaking.