Arrangements for medicines supply immediately following Brexit from 29 March 2019 and through a proposed transition period until 2020, may not be clear until “the 11th hour”, creating a real risk of supply chain disruption and medicines shortages, delegates heard at a conference for the industry.
Larger pharmaceutical companies, such as GSK, are already spending millions of pounds to prepare for Brexit, while a trade deal is still being negotiated by government, and have suggested that it will significantly increase their ongoing annual costs, warned Dr Pete Gough of NSF Pharma Biotech, at the annual Pharmaceutical Industry Network Group meeting.
Companies are being forced to invest in planning for Brexit in anticipation of what the final arrangements could, but may not, be, he said. For example, it is not yet clear whether or not the UK will be able to work in collaboration with the European Medicines Agency, or if the MHRA will operate as standalone agency. The impact of Brexit falls broadly across the industry, involving licensing, importing, exporting and clinical trials, for example.
“In reality, we really have a deadline of October this year, because it will then take another six months to ratify that deal,” he said. “That process all takes time, and of course it can then fall over.” Experts in the industry had suggested that would actually need a minimum of five years for the sector to achieve the changes required. And while a transition implementation period until 2020 has been proposed in theory, “nothing’s agreed until everything’s agreed, and it’s not certain”, he said. Final arrangements may not actually be known until 28 March 2019, he suggested, immediately prior to Brexit.
Implementation of the Falsified Medicines Directive, from 9 February 2019, an EU-driven initiative, happens just weeks before Brexit. “This means that the UK will have been actively participating in this for a whole six or seven weeks; we still don’t know if we will have access to the European database post-Brexit. Do we then drop out? We just don’t know yet,” questioned Mr Gough.
Lobbying continues to try to preserve parallel trade between the UK and EU countries after Brexit. UK drug prices could rise, said Julian Maitland-Walker, British Association of European Pharmaceutical Distributors (BAEPD), if the free movement of goods was eliminated.
Parallel trade currently leads to direct savings of at least £100 million annually through competitive pricing, allows access to specialist medicines not available in the UK, and helps to alleviate temporary shortages, he said.
Six per cent of branded medicines dispensed in the UK are sourced through parallel trade.
In a video presentation to the event, Dr Ian Hudson, chief executive of the Medicines and Healthcare Products Regulatory Agency, said that the preservation of working links between the MHRA and the European Medicines Agency would be beneficial.
"The UK Government’s preferred position is in line with the Government's desire to see the UK have associate membership of the European Medicines Agency. The MHRA are also looking to develop other opportunities with our international work," he said.
Paul Gershlick, chair of PING and head of pharmaceuticals and life sciences at Veale Wasbrough Vizards, commented on the dilemmas for the sector, saying: "The event focused on the key areas of uncertainty surrounding Brexit's future impact on the UK pharma sector and economy. The speakers were very informative and gave delegates practical suggestions about what to do to prepare in light of regulatory changes, trading with Europe, access to talent, and funding. Despite the uncertainty, what remains clear is that doing nothing is not an option."