Search This Blog

Wednesday 22 November 2017

Impact of decision to move European Medicines Agency to Amsterdam

As one of many consequences of Brexit, following a very close vote by member states on Monday 20th November, Amsterdam has been confirmed as the new home for the European Medicines Agency. On current plans, the EMA will be operating in Amsterdam from April 2019, following a likely shadow hosting of the EMA there for some months before the formal date for completing the move of the agency.

The EMA's Patients and Consumers Working Party annual meeting
Meantime the EMA's Patients and Consumers Working Party (PCWP) is holding its annual meeting with all EMA eligible patient/consumer consumer organisations to consider relocation preparedness, patient and consumer involvement in EMA activities, highlights from major EMA committees and updates on pharmacovigilance, information on medicines and future work programmes in 2018 and 2019 for the PCWP and the EMA's Healthcare Professionals Working Party.

Effective medicines have both powerful therapeutic actions as well as the potential for serious unwanted adverse effects. The EMA was founded in 1995 with initial funding from the European Union and the pharmaceutical industry, and further support from EU member states. The European Medicines Agency is concerned with regulation, supply chain and pharmacovigilance for medicines and other advanced therapies for 28 countries across the European Union - from the Baltic countries to Ireland and from Scandinavia to the Balkans and the Mediterranean. All these roles concern balancing benefits and risks when it comes to patient safety with regard to medicines.

The EMA has established mechanisms for involving patients in regulatory assessment: patients’ value perception and value systems. The EMA also has an increasing remit to engage with stakeholder organisations and to improve transparency in its activities for the ~510 million citizens of the European Union. Furthermore the EMA has a major role in educating patients, carers and health care professionals about medicines. There have for example been recent workshops on
  • combating antibiotic resistance: a partnership with the European Centre for Disease Control 
  • biosimilars
  • personalised medicine initiatives
  • applying big data to improved regulation of medicines in Europe which raises important questions about clinical utility, quality, accessibility and systems for data mining
There remain many decisions and actions for the coming months needed to ensure continuity of the EMA's business. These involve the smooth relocation of the EMA to Amsterdam and either developing systems to retain UK expertise for the EMA or replacing that expertise from other EU member states. For the EMA, priorities include:

  • minimising the impact on staff of the move to maximise staff retention
  • maintaining capacity to continue the work of the EMA 
  • the resulting need to prioritise EMA core and planned further activities
  • continuing productive engagement with stakeholder groups: patients, carers, healthcare professionals ...
  • maintaining the capacity of the EMA to engage with the public
For the UK, there are pressing questions regarding the future regulation of medicines in the UK post-Brexit, the impact of loss of international influence of UK regulators and other experts on medicines and the impact of loss of biotech and pharmaceutical companies from London to Amsterdam.

The EMA has been based in London for over 20 years. Many staff have strong family and other personal ties in the UK - for example partners' work, children at school, dependent relatives ...  Adapting to a new country is no simple matter. The working language of the EMA is currently English however full integration within Amsterdam will need competency in the native language in the Netherlands. There will also be practical challenges arising from the simultaneous impact of the arrival of up to 800 families on the Amsterdam housing market and schools system.


© Donald Singer 



No comments:

Post a Comment