Next year, Britain will leave the EU, but what does that mean for Pharmaceutical companies that outsource their EU batch release testing? In this blog, we share with you our interpretation of industry shared information including communications during our regular attendance of BGMA meetings. Discussions to date have been centred around the probable agreements which may be implemented during the potential transition period.
During a recent meeting of the Life Science Industry Coalition with the European Commission, the indication was that if a transitional period is agreed (currently expected to be until December 2020) then it’s likely that QC Batch Release testing would not need to be duplicated in the EU. This would allow companies more time to make the necessary arrangements in case a Mutual Recognition Agreement (MRA), such as the Canadian model, can’t be agreed upon.
Below, we highlight four scenarios which will drive the detail behind the new legislation.
EU-UK Partnership Model
Often referred to as mutual recognition. Under this scenario the EU and UK regulatory bodies agree that nothing changes with batch release in the UK and EU treated the same. In other words, this would allow the use of UK generated batch release data for EU as well as UK markets and vice versa.
At the moment, this is looking like the most likely scenario. One of the main drivers for this is the fear that changes will lead to catastrophic drug product shortages.
Standalone with UK Cooperation
Under this scenario the UK accepts product tested in the EU but the EU does not accept UK batch tested product; however, the UK is currently exporting more products than it imports, and this would likely leave the EU with supply chain issues.
An unlikely scenario unless the UK fears the shortage of products and accepts that this is more important than fighting its corner effectively.
Standalone with EU cooperation
Under this scenario the EU accepts product tested in the UK but the UK does not accept EU batch tested product.
This is the reverse of the above. Under this scenario companies that are batch releasing their products in the EU will need to contract with a UK based laboratory.
Standalone with no cooperation
Under this scenario the UK does not accept product batch tested in the EU and vice versa.
Probably the second most likely scenario, but this could create a standoff and product shortages so is deemed to be unlikely.
For further comprehensive perspectives on Brexit for the pharma industry, NSF have a published this blog and this webinar which explain the implications of the legislation with respect to regulatory inspections, and QPs to clinical trials and pharmacovigilance.
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