We all know it is coming, and a no deal brexit seems more likely than ever. Yet do we know how it will affect our businesses? Here's a short overview of the UK pharmaceutical industry.
Following the technical guidance document issued on the 6th August 2018 by the Medicines & Healthcare products Regulatory Agency (#MHRA), we have more clarity on the UK’s position of what will happen in an immediate post-brexit #pharmaceutical world. The guidance explains that for most parts of the regulatory aspect, everything will remain as is currently. On the 23rd of August, one of the 25 “technical notices” issued by the UK government highlights the unilateral decision to accept QC testing and QP release from the EU without the need to re-test or re-release in the UK. This pragmatic approach by the UK has been welcomed throughout the #pharma industry with a sense of relief.
Sheuli Porkess, deputy chief scientific officer for the Association of British Pharmaceutical Industry (#ABPI), welcomed the guidance but said there were still some unanswered questions. She also re-iterated that the industry will continue to plan for all scenarios, including a ‘no-deal’ #Brexit.
This was also highlighted by Juliette White, VP of AstraZeneca Global External Manufacturing, when she explained that the company is stockpiling in the eventuality of a no deal scenario,
“We always have an additional amount of medicines available. We are increasing that by about 20 percent”.
#AstraZeneca, the FTSE 100 drugs giant, having a 6700 employee workforce in the UK alone and supporting 35,000 jobs, have already spent £40 million preparing for the worst case scenario.
The European Medicines Agency ( #EMA ) has issued some guidance on Brexit also and responded to the industry’s questions in a publication in June 2018.
So what will pharmaceutical companies need to change when the implementation period is over or in a no deal scenario?
Regulatory documentation
· Any product licenced through a European procedure (MRP/DCP/CP) will become a UK national licence with its own sequence.
· Marketing Authorisation Holders (#MAH) of licences in the EU will need to be based in the EU/EEA, meaning that any product which currently had a UK location as am MAH will now need to do an MAH transfer to a location in the EU.
· The UK will not be able to be an RMS for procedures and the CMD(h) already recommends to change this to an other EU agency.
· Combined packs between the UK, Ireland and Malta will not be permissible anymore.
· Clinical trials in the UK will not be able to included in the CTA.
· Developments in pharmaceutical regulation and legislation could diverge in both jurisdictions, resulting in additional time, effort and expense for pharmaceutical companies.
· All imports of active ingredients (APIs) from the UK to the EU and vice versa must be accompanied by a written confirmation from the competent authority of the exporting country.
· CPPs might need to change if the licence they rely on is changing also.
Supply chain
· Product which is currently QC tested in the UK (unless an MRA is agreed between the UK and the EU during the implementation period) will need to be tested again in the EU. Meaning duplication of testing sites and the consequential regulatory submissions.
· QP batch release for products being marketed in the EU/EEA will need to be done in an EU/EEA batch release site.
· Sites doing the QP release for UK manufactured product will need to have an MIA in place since they are performing importation from a third country.
· Parallel imports from the EU will not be able to be sold freely in the UK and vice versa and a new regimen will need to be introduced.
· Until an MRA is reached, the MHRA might need to inspect sites previously inspected by an EU agency. Manufacturers in the UK would be subject to EU GMP inspection, whereas producers in the EU would also face UK GMP inspection.
· Drug costs will increase due to additional supply chain steps and increased licencing costs.
· EU follower markets (eg. Serbia) would rather purchase products from the EU rather than the UK to avoid a 5% surcharge on medicines.
Pharmacovigilance
· Separate QPPVs would be responsible for pharmacovigilance in the EU and the UK
· Pharmacovigilance System Master File (PSMF) will need to be EU specific and UK specific besides being registered in the respective jurisdiction.
The impact on pharmaceutical companies is quite considerate, considering also that the FMD directive is set to be introduced in February 2019 and dossiers in NeeS format will not be accepted by the EU anymore from 1st January 2019.
Hopefully companies are taking measures to mitigate all the risks and potential disruptions as our ultimate goal should be to keep supply availability to our patients.
Still not sure? Reach out to www.regulatoryaffairshub.com and take advantage of our free ‘Brexit Readiness Report’. We will make an analysis of what you need to do to be Brexit ready with no obligations. Let’s all make a success out of Brexit and possibly find out new opportunities.