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The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose more staff than initially anticipated.   It will need to scale back its activities significantly – which will impact stakeholders, especially pharmaceuticals companies looking to submit clinical data after August 1, 2018 - although we are told that this will be temporary. 

Background

On March 29, 2017, the UK notified the European Council of its intention to withdraw from the European Union (EU), triggering the 'Brexit' process.  The UK will leave the EU on March 30, 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.  We do not yet know what the post-Brexit landscape will look like, but the European Medicines Agency (EMA) has worked on it business continuity plan to ensure that it can continue to deliver on its mission and protect public and animal health after March 30, 2019.

Phases 1 and 2 of the business continuity plan have been launched and involve:
1.    Relocating the EMA to Amsterdam to take up its operations on March 30, 2019 at the latest
2.    The UK becoming a third country as of March 30, 2019, which means that the UK will not be able to engage as (co)-rapporteur for new marketing authorization applications for which the centralized procedure would end after March 30, 2019
3.    Completing the redistribution of the UK's portfolio of over 370 centrally authorized products to rapporteurs and co-rapporteurs from the EU27 Member States plus Iceland and Norway.  The EMA will facilitate knowledge transfer from the UK to the new rapporteurs and co-rapporteurs, who will take full responsibility for these products as of March 30, 2019. 

Impacting of being short-staffed

A number of staff will not be relocating to Amsterdam, and have already begun to leave the EMA's employment.  As employees secure other positions, attrition rates are expected to increase.  Unfortunately, the Netherlands' employment regulations mean that over 130 staff on short-term contracts will not be able to continue working for the EMA.  In total, the EMA is expected to see staff numbers reduce by at least 30% before March 2019.

Some assistance is being provided by the Dutch government to help relocate those staff who are moving to Amsterdam, and a comprehensive staff recruitment program is already underway. However, the short- to mid-term staff shortage means that the EMA needs to focus on essential activities only, as well as training of EMA staff who will be re-assigned to new duties. As a result:

  • Collaboration at international level will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58
  • EMA will only take a reactive role in the harmonization of global medicine regulation EMA’s engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis
  • Development and revision of guidelines will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit
  • Non-product-related working parties will be temporarily reduced as a consequence of the scaling back of guideline development or revision;
  • Organization and attendance at stakeholder meetings will be limited to Brexit-related interactions
  • The EMA publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralized procedure. The launch of new procedures for clinical data publications will be temporarily suspended as of August 1, 2018. However, data packages submitted for medicines until the end of July 2018 will be processed and finalized.

Detailed plans for the implementation of these measures are currently being developed and will be communicated to stakeholders concerned and the public as soon as they are available.

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