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La Grande Rentrée – brace yourself, autumn is coming!

This year has been more intense than what we ever experienced before. At least, the summer break has given us a short breather from the last few months. Much like on our private lives, the Corona pandemic also had a huge impact on the political Agenda. However, the show must go on.

There is a lot on the political plate which already seems “challenging” for the last four months of any year – but is exceptionally demanding in times of a worldwide pandemic. First of all, there are the very ambitious, but also very essential, health care priorities of the German Presidency which took over the lead of the Council on the 1st of July. The German Presidency wanted to push for a European health data space, tackling shortages of medicinal products and progressing the long-awaited HTA dossier. But then “Corona” happened. How much the German Presidency will be able to work on these original health care priorities, remains to be seen. And, of course, there are also some new issues that popped up or rather could not have been solved until now, namely the budget negotiations and a possible agreement with the United Kingdom.

The challenging negotiations about the new Multiannual Financial Framework (MFF) are still ongoing because the crisis demanded for a huge change in the budget. Much to the distaste of some. The European Parliament warned not to accept the latest version of the Council since major cuts on the health and research budget have been made. Parliament’s biggest groups even came together to put Angela Merkel and Ursula von der Leyen on notice as they threaten to sink the budget. In an open letter, the four largest political blocs said they refuse to discuss the MFF until sufficient progress is made on certain aspects related to the budget.

To make things even more complicated, there is still an unsolved Brexit looming over us. Oh wait, you thought that was done already? Not really, it is just that nothing really happens. Which – in this case – isn’t exactly good. The negotiations with the United Kingdom about the future relations need to be completed until autumn 2020 because this decision has to be ratified by the parliaments as well. Not reaching an agreement at all would mean dealing with the ever so frightening “Hard Brexit” and all its very uncertain consequences for our sector. However, rumour has it that the last negotiation rounds looked darker than the Union Jack’s signature navy blue.

Also on the Commission side, adaptions had to be made. Its work programme, which sets the EU’s policy priorities, had to be completely revised. But one thing wasn’t changed: The Commission’s Pharmaceutical Strategy, which basically presents what Europe’s pharma sector is going to look like in the future, is still set to be published by the end of this year. The ambitious strategy will determine the policy and legislative priorities for the remainder of this Commission’s term – if not longer. From fighting antimicrobial resistance, strengthening the competitiveness of the sector to ensuring access to medicines across the whole of Europe, the strategy is supposed to basically tackle all existing challenges. It will include the beloved Action Plans (most of the times much ado about nothing) as well as concrete legislative proposals. Think a possible reopening of the Directive 2001/83/EG which will be equally rough as the review of the medical device directive. It also includes the possible reopening of the regulations of orphan medicinal products and paediatrics, a review process that has already started years ago. Either way, the next years are not going to be a cake walk.

And if that wasn’t already enough, we have to brace ourselves for an upcoming Intellectual Property Action Plan which will most likely also influence existing legislation. But this outlook isn’t quite so gloomy: the Roadmap and the outlined plans promise a well balanced approach which will not leave the pharmaceutical Industry too unhappy (fingers crossed).

In the end, the European Union needs to use all its cooperation and solidarity to deal with this outstanding situation to come back as more united and stronger than before. In the meantime, we will be here to guide you through the Brussels maze with all its unpredictable turns.

Until then, stay safe and sound and we wish Europe “Gesundheit!


Kontakt: Julia Rumsch (Büro Brüssel),