With Article 50 having been triggered on 29th of March 2017, this leaves the UK government as well as the pharmaceutical industry to negotiate and prepare for the day the UK leaves the EU on 29th March 2019.
In a survey conducted by CIPS, 44% of Brexit survey respondents identified their first step towards preparing for Brexit as conducting risk analysis for significant areas of change that may impact financial turnover and production capacity to their organisation, some of which are listed below.
Pricing will remain a top priority along with securing market access for life sciences organisations, several countries such as Australia, France and Germany have focused on reducing pharmaceutical pricing. Many larger biotech companies are re-balancing product portfolios following changes in the payer and pricing landscape in the USA and EU ensuring that broad access to market is maintained and higher price products are not over-represented.
Securing contracts that extend past March 2019 will prove to be challenging without sacrificing flexibility for both parties around fluctuating currency rates and tariff changes. Pharmaceutical companies are starting to negotiate strategic, value based contracts with payers such as the National Health Service (NHS) to ensure that pricing is contingent to the perceived value in the eyes of patients and payers. Curative therapies that are both high cost and high value to payers can benefit from value based contracting and amortize costs over a longer lifetime.
Import & Export
Trade deals will have a significant impact on the import and export of finished products and parts between the US and UK. Improper adjustments to regulatory and shipping documentation could result in delays or even cause shipments to be halted during transit in extreme cases which would have a knock on effect for inventory management, production and sales processes from raw materials to finished drug products.
Along with many areas of the pharmaceutical industry, the regulatory frameworks will also need to adapt to changes in technology and use innovative tools to maximise chances of success post-Brexit. Professor Sir John Bell stated that regulatory and technology changes should be seen as an opportunity to drive economic growth by improving outcomes in the NHS and reduce costs through the use of innovation.
He put forward recommendations to establish a new regulatory, Health Technology Assessment and commercial framework to move the biotech industry forward. It was also announced that the European Medicines Agency (EMA) will be moving its operations from the UK to Amsterdam which would result in the loss of approximately 1,000 jobs for the UK as well as potentially disrupt the drug approval and monitoring process in the EU.