The United Kingdom’s (UK) Business, Energy & Industrial Committee have released a report which raises concerns about the prospect of regulatory divergence between the UK and the European Medicines Agency (EMA) as the “deepest concern” for industry.
Regulatory divergence from the EMA would mean pharmaceutical companies would need to duplicate their facilities and roles across the UK and European Union (EU). The report states that separate UK regulations “could impose extra costs of £45,000 for each new product released, making the UK an unattractive market for new and innovative medicines.”
The call for continued membership in the EMA has been echoed by other UK officials, and some experts have said that the relationship between the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and EMA could mirror the way in which Switzerland cooperates with the EMA.
The committee acknowledges the need for EMA’s headquarters to move to Amsterdam, however they recommend that as part of a new association with the EMA, the UK government should seek to retain a presence for EMA jobs and facilities in the UK.
The chair of the committee, made the following statement: “The Government’s own analysis identifies pharmaceuticals as the sector for which UK/EU market access is the most important given the industry is reliant on friction-free border movement for their products. Any delays at the border faced by short-life pharmaceuticals for emergency treatments would have a hugely detrimental impact on patients.”
To view the UK Parliament report on how the government must protect UK’s pharmaceutical industry post-Brexit, please click here.