Medicine and clinical trial supplies after Brexit

The UK is due to leave the EU on 31 October 2019. Top priority for the government is to negotiate a deal with the EU. However, if this is not possible, the UK might leave the EU without a deal. Government organisations, such as the NHS, and businesses are making all necessary preparations in case this happens.

The government has put in place contingency measures to help ensure medicines and clinical trial supplies continue to be available. This includes:

  1. Improving trader readiness for new border arrangements.
  2. Building up buffer stocks of prescription-only and pharmacy medicines. These stocks will continue to be replenished as used. Buffer stocks of clinical trial supplies will ensure at least 6 weeks worth of supplies.
  3. Procuring extra warehouse space for stockpiled medicines.
  4. Securing additional ferry capacity for all medicines, not just those included in the stockpiling. This will be done in two ways:
    1. Buying extra space on ferries, with the opportunity to use freight capacity on routes away from the ports where delays are more likely to occur.
    2. Procuring an ‘Express Freight Service’ that is able to deliver small consignments on a 24-hour basis and a two-to-four-day pallet delivery service.
  5. Changing or clarifying regulatory requirements to ensure that medicines, devices and clinical trials licensed or tested in the EU can continue to be used and recognised in the UK in the event of a no deal Brexit.
  6. Strengthening the processes and resources used to deal with medicines shortages.

Brexit will not affect the management of clinical trials that are being run across borders between the EU and UK. Pharmaceutical sponsors are responsible for the safety of patients on clinical trials and should consider the clinical trial supply chain in advance of 31 October 2019 to ensure continuity of supply.

There are no changes to the process of sending personal data from the UK to the EU; however, contractual arrangements to safeguard personal data sent from the EU to the UK need to be in place by 31 October 2019.

Read more about the NHS’s plans to ensure continuity of supply of medicines, including clinical trial supplies on the NHS website here

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