OBJECTIVES: Following Brexit, the UK’s pharmaceutical sector has seen changes surrounding regulatory process, with a shift towards conducting market authorisation (MA) in-house at the Medicines and Healthcare Products Regulatory Agency. This research explores the impact of changes in MA processes in the UK post-Brexit on access to medicines, characterised by pharmaceutical launch priority.

METHODS: Desk-based research was conducted for key markets (EU4, US and the Australia/Canada/Switzerland/Singapore consortium) around likely drivers of pharmaceutical launch sequence, as well as the factors underpinning these. A weighted scoring model was used to quantify this research, with Pearson correlation coefficients and corresponding p values calculated for the relationship between these likely drivers and underpinning factors, and the pharmaceutical launch priority of a market.

RESULTS: Both ease of MA (p=0.28, r= –0.52) and ease of market access (p=0.61, r=0.20) were not significantly correlated with launch priority. There was, however, a significant positive correlation between overall profit potential and launch priority (p<0.05, r=0.95). Through investigation of the factors underpinning profit potential, it was found that size of population significantly positively correlated with launch priority (p<0.05, r=0.97), whilst healthcare expenditure (%GDP) did not (p=0.89, r=0.05).

CONCLUSIONS: Overall, ease of MA process and ease of market access are not key drivers in determining pharmaceutical launch priority. Rather, it seems that the greater the profit potential of a market, the higher its priority for launch. Further analysis of the factors underpinning profit potential showed that only population size significantly correlated with launch priority, suggesting that profit potential is predominantly driven by the size of the population. As such, it is unlikely that changes in regulatory process due to Brexit will have a detrimental impact on launch priority, and thus access to medicine of the UK, as the UK remains one of the most densely populated countries in Europe.