Q4/2016 The Brexit Garden

The year 2017 will mark our 30st anniversary and throughout this lifetime our service portfolio has extended wildly in all directions along with the growth of the regulatory framework in the European Union. Pricing & Reimbursement, Pharmacovigilance and Promotional Compliance initially were rather minor and straightforward but now extensive procedures exist to fulfil the obligations linked to these domains. Likewise, for medical devices, cosmetics and biocides almost no European requirements were defined back in 1987. And since we knew how to handle regulatory compliance issues for pharmaceuticals, quite a few companies came to us for help with these developing regulatory constraints of related products. However, all gardens need regular maintenance and so does ours. Starting in 2017 we will return to our original focus on medicinal products and medical devices and we will no longer offer services related  to cosmetics, biocides or food supplements. 

2017 will also mark the start of the Brexit negotiations and the outcome will definitely alter the European “pharmaceutical borderline” with America,  Asia and Australia. The UK will lose its status as the preferred place of establishment for subsidiaries from other continents and many EU countries will try to take over this position from good old England but we are confident that our country will get a significant part of that cake. Feel free to challenge us if you disagree or let us explain to you why. Quite a few companies from outside the EU already have benefited from our Gateway to Europe and this gateway counts more lanes than you can imagine. And there now are again sufficient empty parcels in our garden.

But we’re not the only ones who care about the Brexit-impact on the global pharmaceutical landscape as the FDA devoted its recent issue of the FDA Voice to it.  Refer to https://t.co/pmKds66hvD for more details. It is all about the Mutual Reliance Initiative, the mutual recognition of Inspectorate’s audits. Understandably, the UK MHRA will now take a stand-alone position in this initiative separate from the other European Inspectorates. We would not be surprised as such mutual recognition between the MHRA and FDA will by far precede that one between the EU and the FDA.