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“I told you so”: post-Brexit access to medicines and medical device technologies

Continuing the theme of looking at life sciences, healthcare implications for the UK exiting the EU.

  1. The NHS, the UK’s public healthcare system, procures medicines in many cases through the benefits of the single market. While it is not clear what impact an exit will have on pricing itself, failure to ensure access to that single market will inevitably lead to the increase in drug costs. I’d hazard a guess of 10%. Given the difficult financing circumstances of healthcare expenditure in the UK, an increase of this magnitude, will have a knock-on effect on patients and their care.
  2. Apart from the price impact, UK patients may find access to medicines and medical devices restricted as the UK exits the wider European market overseen by the European Medicines Agency. The UK is not every companies’ first choice of a market to launch a new medicine or device, but with an exit, it clearly will drop further down the queue. Excluded from products launched in the rest of the EU, the UK can only wait for companies to ‘get around’ to including the UK.
  3. And apart from the loss of a degree of certainty of access to medicines and devices within the EU, a UK exit, the UK will need to introduce a separate regulatory scheme to replace the European Medicines Agency approach, adding costs and an additional regulatory hurdle for companies. The UK can, of course, try to harmonise itself with EMA, but in the end, departing EMA will reduce patient access to medicines.
  4. Is the UK market big enough to make a difference? Perhaps for some, but I suspect the economics coupled with the overall difficulty new products face contesting the UK market points to a general decline in product availability. At least with the EU, access to medicines and devices could be compared to other EU states; with an exit, the UK stands alone and does not look particularly welcoming.
  5. Of course, the NHS could have a rethink as is slowly underway and move to ensure access to new medicines and technologies. But that may require a different assessment whether the current way of financing the NHS itself is sustainable and that has really little to do with leaving the EU, although the EU does offer a safety value for patients denied care by the NHS. All this is now in jeopardy.
  6. The European Medicines Agency will need to leave the UK, and with it will go not just those jobs, but a whole domain of expertise. That expertise with EMA made the UK within the EU, one of two global centres of excellence in medicines regulation, along with the US FDA, Few people outside this area will appreciate the consequences of EMA departing, but it will be felt within pharmaceutical who maintain many high-paid and knowledgeable staff focused on medicines regulation. All this expertise goes and with it a capability within the UK that can never be regained. Whoever gets the agency, Sweden, Denmark, elsewhere, will be a net gainer of  talent from which to build tremendous domestic capabilities.

What Cognology says

Perhaps, I told you so?