03 Aug 2018

The proposed launch by the European Medicines Agency (EMA) of Phase 3 of its business continuity plan on 1 October 2018 will no doubt be impacted by the greater staff losses than initially anticipated which the EMA publicly announced on 1 August 2018. 

As a result, the EMA stated that it will need to scale back its activities significantly – impacting stakeholders, especially pharmaceuticals companies, looking to submit clinical data after 1 August 2018 – although the EMA assures that this will be temporary. 

Background

On 29 March 2017, the United Kingdom ("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 30 March 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 EMA has worked on it business continuity plan to ensure that it can continue to deliver on its mission and to protect public and animal health after 30 March 2019.

Phases 1 and 2 of the business continuity plan have been launched and involve:

  • relocating the EMA to Amsterdam to take up its operations on 30 March 2019 at the latest
  • the UK becoming a third country as of 30 March 2019, which means that the UK will not be able to engage as (co-)rapporteur for new marketing authorisation applications for which the centralised procedure would end after 30 March 2019
  • completing the redistribution of the UK's portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the remaining 27 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 30 March 2019. 

Impact 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.

Assistance is being provided by the Dutch government to help relocate those staff who are moving to Amsterdam, and a comprehensive staff recruitment programme 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 put primary focus on to product-related requests, supply-chain integrity and procedures under Article 58
  • EMA will only take a reactive role in the harmonisation of global medicine regulation and its 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 and, as a consequence, non-product-related working parties will be temporarily reduced 
  • organisation and attendance at stakeholder meetings will be limited to Brexit-related interactions
  • the launch of new procedures for the EMA's publication of clinical data (submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure) will be temporarily suspended as of 1 August 2018 – however, data packages submitted for medicines until the end of July 2018 will be processed and finalised

The EMA has confirmed that detailed plans for the implementation of these measures are being developed and will be communicated to relevant stakeholders and the public as soon as they are available.