EU FMD: The Brexit Challenge & Its Current Situation

EU FMD Compliance during Brexit Uncertainity

By Marc Blekkink, Managing Partner, Movilitas.Cloud

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 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 Falsified Medicines Directive (EU FMD) for stakeholders?

Recent European Regulations

The EU FMD took effect in February 2019. Its purpose is to fight counterfeit medicines and, thus, improving patient safety. The directive introduced item-level serialization of drugs and stakeholders of the life sciences industry must 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 help ease the transition. These grace periods were not only granted because there is still a notable number of false alerts, mainly occurring because of errors made by dispensers, but also because of the significant number of wholesalers, hospitals and pharmacies in Europe 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 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 the end-users uncertainties on the necessity to connect. As a result, most of them are taking advantage of the stabilization period.”

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 (EMVS) “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) concludes in a recent statement 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 further argues in its position paper “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 patients’ access to high-quality and safe medicines, it is of utmost importance that pharma stakeholders of the UK and EU are still able to effectively share data after the Brexit.

Stable Connectivity

Movilitas.Cloud can provide some peace of mind. The Software-as-a-Service solution is designed to easily share data with relevant stakeholders and business partners. Additionally, it is connected to the EU Hub and to all National Medicine Verification Systems in Europe. These features make compliance simple. It has dedicated applications for:

  • manufacturers (MAH and CMO)
  • wholesalers
  • 3PLs (pre-wholesaler)
  • 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. Pharma 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. We’re ready to help you tackling all uncertainties and compliance challenges. Start a conversation with our experts today.

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