Saturday, June 25, 2016

Top 10 Possible Effects of Brexit on Clinical Research



So, now that the people of the U.K have voted to leave the European Union, I wanted to know how this is going to affect Clinical Research and the Pharmaceutical Industry.  I've been reading a few things, talking to a few of my colleagues and here is Pharma Mama's summary, (in no particular order), a quick reference guide and a few questions post vote:



  1. The European Medicines Agency (EMA) headquarters will  be moving from London, (the move of about 600 jobs).
  2. Will the Medicines and Healthcare products Regulatory Agency, (MHRA), continue to conduct inspections with the EMA?  
  3. Are the UK now going to have their own drug approval system as these have typically been determined at the EU level?
  4. Will the EMA now lose the ease of accessibility to MHRA experts? The Financial Times highlighted that MHRA experts led the review of more drug applications that any other domestic EU regulatory in 2014.  That's a lot of expertise!
  5. Even though the UK will be departing, there will be laws that will remain in place because there were EU Directives that required them to implement relevant legislation into national law, (unless the government decide otherwise). 
  6. We have been used to seeing the MHRA and EMA working side-by-side inspecting manufacturing facilities.  Are we now going to see the MHRA functioning more like the Swissmedic, (Switzerland's regulator), independently authorizing medical products but working with the EMA under mutual recognition and shared agreements?  Or are we going to see an addition to the list of countries outside working with the EMA?  (Norway, Iceland and Liechtenstein function in this way).   
  7. Most major players in the world of big pharma seem to have expressed that they would have preferred for the vote to be remain.
  8. It is argued that the UK is currently involved in about 40% adult rare disease trials.  Now that the vote to leave has been cast, could this be now undermined? 
  9. As the UK will no longer be part of harmonized procedures in the conduct of clinical trials, are they going to lose out on trials that could be beneficial to patients?
  10. It could take years before the full impact of the decision for the UK to leave the EU is felt on the pharmaceutical industry.


What the industry experts are saying:




Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry  - the decision "creates immediate challenges for future investment research and jobs in our industry in the UK".




Steve Bates, chief executive of the BioIndustry Association (BIA) - "several key issues for our sector are now in flux.......Key questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the UK with Europe are now upon us".




Sarah Hanson, Head of UK Lifesciences, CMS Cameron McKenna LLP - "First and foremost we must consider its effect on the significant body of EU legislation which governs the development and supply of medicines and medical devices........Companies engaging in any way with the EEA markets will face increased regulatory burdens from having to deal with separate UK and EU regulations so the industry faces an arduous job ahead, keeping abreast of all relevant legislation to work out which parts of the UK and EU regulatory regimes will remain the same and which parts will diverge" 


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