Along with the rest of the world, the pharmaceutical industry anxiously awaits the resolution of Brexit. Their nervous anticipation is for good reason; the past few years after the UK’s vote to leave the European Union have brought great uncertainty for EU licensed pharmaceutical companies with UK operations. Following the abrupt move of European Medicines Agency’s headquarters from London, UK, to Amsterdam, Netherlands, preparation for regulatory compliance under both Brexit deal/no-deal scenarios has been like chasing a moving target. The first Brexit deadline deal was slated for March 29, 2019, then extended to April 12, and is now further delayed until October 31, 2019.
Deal v. no-deal Brexit scenarios
Once the central hub of European pharmaceutical oversight, the UK is now faced with dual scenarios of a deal v. no-deal Brexit with either scenario carrying important implications for the pharma industry. With a Brexit deal, the UK would ideally negotiate a mutual recognition agreement (“MRA”), allowing the UK’s pharmaceutical standards and requirements to be recognized as equivalent to those of the European Union. The scope of each MRA is different, but in essence, it would facilitate the following between the UK, EU, and other countries party to an EU MRA:
- MRA parties can rely on each other’s Good Manufacturing Practice (“GMP”) inspection system;
- share information on inspections and quality defects; and
- waive batch testing of products on import into their territories.
The alternative scenario of a no-deal Brexit without any sort of MRA in place will require pharmaceutical companies to acquire separate marketing authorization licensure under the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). The MHRA has scrambled to provide guidance in the case of no deal to ease market access, minimize impacts to patients, and maintain some sort of relevance as a regional leader in public health. Despite this, a no-deal would still result in more complicated processes based on several factors including the following:
- the UK would no longer be a part of the EU system for sharing pharmacovigilance information;
- impediments and complications to batch control testing for UK exports (and imports);
- and while Britain is committed to following the EU’s Clinical Trial Regulation, there would now need to be a responsible person present in either the UK or EU for conduction of clinical trials, dependent upon the location of the authority authorizing the clinical trial.
What does this mean for records and information management?
The greatest impact for records management would result from a no-deal Brexit scenario since a deal would allow the processes to remain relatively similar under an MRA. A paramount consideration for companies is the location of records. For example, pharmaceutical regulatory inspections typically require that records be made readily “available” for inspection. If records are retained in hard copy, arrangement of storage at the new location of inspection may need to be reconsidered. For electronic records, companies will need to evaluate whether systems are currently configured to allow for capture, accessibility, and easy retrieval within the jurisdiction of inspection whether it be the UK or an EU member jurisdiction.
In addition, samples and specimens may be required on-site within either the UK or a specified EU location whereas an MRA would decidedly permit for storage at either. In particular, EU GMP Guidelines require reference samples of finished medicinal products to be stored at the location of the authorized manufacturer located within the European Union, preferably at the location of importation.
The foregoing factors will need to be considered across the pharmaceutical company’s industry-specific processes including all GXP processes. In addition, there are general business considerations that will come into play with regard to Accounting, Tax, and Human Resource records, to name a few.
There is still time for companies to be proactive in planning for either Brexit scenario. This includes planning for appropriate processes, storage, and systems to support records and information compliance, including those relevant to samples and specimens. Any contingency plan must allow for timely records access and retrieval in the event of an audit, or inspection, as well as support general business or operational needs. Under either Brexit scenario, Zasio can assist pharmaceutical companies in preparing for and complying with new requirements once Brexit is complete, contact Zasio today to speak with one of our consultants!
Disclaimer: The purpose of this post is to provide general education on Information Governance topics. The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.