EU FMD: The Brexit Challenge & Its Current Situation

UK Brexit vs. The EU Falsified Medicines Directive

The status of Brexit has been in limbo for many months. Now, its first hurdle has been cleared. On December 20, 2019, the House of Commons voted in favor of Boris Johnson’s Withdrawal Agreement Bill. With the European parliament approving it yesterday (January 29th), the United Kingdom (UK) will formally leave the European Union on Friday, January 31, 2020. However, many aspects of the UK’s future relationship with the EU, such as the trade relationship, law enforcement, data sharing and security,still need to be determined within the transition period that lasts until December 31, 2020. This process creates a huge amount of uncertainty in many industries. What is Brexit’s impact on the European Union’s Falsified Medicines Directive (EU FMD) for stakeholders?

Recent European Regulations for Traceability

The EU FMD took effect in February 2019. Its purpose is to fight counterfeit medicines and, thus, improve patient safety. The directive introduced item-level serialization of drugs and stakeholders of the life sciences industry, who must now verify the authenticity of each medicinal product manufactured or distributed in Europe. Many European countries implemented post-deadline stabilization periods to prevent medicine shortages and smooth the transition. These grace periods were not only granted because there is still a high number of false alerts, but also because of the significant number of wholesalers and hospital pharmacies that are still not FMD-compliant.

In the UK, the current situation of the EU FMD has already been significantly impacted by Brexit. According to an European Medicines Verification Organisation (EMVO) 2019 report, 58.13% of the UK’s wholesalers are still not connected to the UK’s Medicines Verification System SecurMed and, therefore, are not compliant. The study stated that the main reason of this lack of registration to SecurMed is the Brexit which creates for end user uncertainties on the necessity to connect. As a result, most of them are taking advantage of the stabilization period.

Track & Trace Compliance Challenges

It is expected that the EU FMD will continue to be applied in the UK during the transition period until December 31, 2020. In case of a no-deal Brexit, SecurMed proposed to remain temporarily connected to the European Medicines Verification System to prevent inappropriate system errors and alerts being triggered in the EMVS and other national databases. For example, they might occur if multi-market packs, which are sold in more than one country, are decommissioned on import to the UK from the EU. If those packs are later reshipped back to the EU, but are not re-commissioned when leaving the UK, each pack will trigger an alert when it is dispensed.

Without being connected to the EMVS, FMD compliance is not possible. The UK’s healthcare stakeholders would no longer be able to upload, verify and decommission the unique identifier on packs of medicines. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) concluded that, in the event of a no-deal Brexit, the legal obligation related to this would be removed for actors in the UK supply chain. However, medicines destined for the UK from the EU still need to be decommissioned as exports on the FMD system. Additionally, the MHRA confirms that it considers a UK-only version of the law in the interest of public safety.

The uncertainties regarding Brexit’s impact on EU FMD remain not only for the healthcare stakeholders from the UK but also from the entire EU. With 82 million packs of medicines moving between the EU and UK monthly, it is a pressing matter which needs to be clarified and prepared in order to ensure a smooth transition. The European Federation of Pharmaceutical Industries and Associations argues that a no-deal scenario presents a clear threat of disruption to the supply of medicines throughout the EU. Major challenges would also appear during the manufacturing process of drugs, as ingredients and components often cross the borders several times during this phase. To guarantee patient access to high-quality and safe medicines, it is of utmost importance that pharmaceutical stakeholders in the UK and EU are still able to effectively share data after the Brexit.

Stable Connectivity with Movilitas.Cloud

Movilitas.Cloud can provide some peace of mind. The Software-as-a-Service solution is designed to enable players across the supply chain to easily share data with relevant stakeholders and business partners. Additionally, Movilitas.Cloud is connected to the EU Hub and to all National Medicine Verification Systems in Europe. Movilitas.Cloud has dedicated applications for:

  • Manufacturers – Contract Manufacturing Organizations (CMOs) and Marketing Authorization Holders (MAHs)
  • Wholesalers
  • Third-Party Logistics (3PLs) Providers / Pre-Wholesalers
  • Parallel Importers
  • Repackers
  • Hospital Pharmacies

The solution helps healthcare stakeholders in continental Europe who still need to decommission medicines destined for the UK as exports on the FMD system, as well as those in the UK. If the UK does leave the EU with a deal, EU FMD might stay in effect. Pharmaceutical stakeholders need to be prepared for this scenario, too. Regardless of the Brexit outcome, Movilitas.Cloud enables you to stay compliant. It is quick to set up without disrupting your current operations. Our team of experts are ready to help you as you tackle all uncertainties and compliance challenges on the road ahead. Contact us today.