‘Not Enough Time’ To Transfer All Marketing Authorizations In Case Of ‘No-Deal’ Brexit, says EFPIA
Executive Summary
A survey of EFPIA member companies has revealed some alarming statistics on the effects that a “no-deal” Brexit would have on trade, marketing authorizations, batch release and clinical trials.
Almost half of the member companies of the European pharmaceutical industry federation, EFPIA, expect delays to trade in medicines if the UK leaves the EU without a deal and falls back on World Trade Organization rules.
In such an event there would not be enough time in the period to the March 2019 Brexit date to transfer up to 12,000 European marketing authorizations held in the UK, and thousands of review months would be required to move batch release activities out of the UK. Moreover, half of the 1,500 clinical trials underway in the EU with a UK-based sponsor will still be ongoing by the Brexit date.
These are just a few of the alarming statistics to emerge from a survey conducted by EFPIA among its members. Concerns about trade, marketing authorizations, and other regulatory implications of Brexit have already been widely aired (Also see "Massive Reallocation of UK Rapporteurships Likely As EMA Plans For Future; UK’s Interim Role Uncertain" - Pink Sheet, 11 May, 2017.) but the survey results serve to put some flesh on the bones.
Survey underlines “the sheer scale and importance of the medicines issues that must be addressed as part of the Brexit discussions” – EFPIA
The survey’s results underline “the sheer scale and importance of the medicines issues that must be addressed as part of the Brexit discussions in order to protect public health,” EFPIA said.
Stressing the need for urgent action on some form of regulatory collaboration agreement post-Brexit, the federation’s director general, Nathalie Moll, said the UK and the EU “cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU.”
To illustrate some of the challenges facing the industry in the event of a “no-deal” Brexit, EFPIA noted that more than 2,600 finished medicinal products sold across the EU have some part of their manufacturing process conducted in the UK. Around 45 million product packs are supplied from the UK to the other 27 EU and EEA (European Economic Area) member states each month, and more than 37 million packs travel in the opposite direction.
“In this context, 45% of EFPIA members expect trade delays if the UK and Europe fell back to WTO rules,” EFPIA said. To prevent these delays, the EU and UK “should agree a comprehensive agreement that ensures maximum alignment between EU and UK pharmaceutical laws.”
It noted that 400 centrally authorized products have a UK legal entity as the marketing authorization (MA) holder, and given that there are multiple MAs per product, a total of 2,400 MAs will need transferring to a legal entity in the EU if they are to continue being marketed. EFPIA estimates that these transfers will take up a total of 5,000 review months based on a standard 60-day transfer timeline.
There will also be problems for products approved through the decentralized and mutual recognition systems in Europe: 5,800 MAs held by UK legal entities will need to be transferred.
There is not enough time between now and March 2019 to transfer all these marketing authorizations and “a more flexible approach is needed from regulators,” EFPIA said.
Batch Release And Clinical Trials
Another area where additional costs and disruption are inevitable in the event of a no-deal Brexit is the need to move batch release activities out of the UK. At present, according to EFPIA, 60% of its members conduct batch release from the UK, amounting to a total of 1,300 products sent out for EU distribution from UK sites.
Moving these sites would involve some 4,000 review months based on a 90-day standard Type II CMC (chemistry, manufacturing and controls) variation timeline, EFPIA said. It also noted that 40% of its member companies believe that their qualified person and laboratory capacity is insufficient for the retesting of products released from the UK, raising the specter of shortages and supply disruptions.
On the clinical trials front, a total of 1,500 studies are currently under way in multiple EU countries with the UK as sponsor, and half of those will still be ongoing in March 2019, the survey found. The figures “underline the importance of scientific research collaboration between the UK and EU. Scientific collaboration strengthens the EU’s global position in life sciences, attracting global life science investment to the EU,” EFPIA commented.
“Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it is important to recognise that the medicines sector is different,” Moll stated. “The medicines we make impact directly on peoples’ health. Securing ongoing cooperation on medicines regulation between the UK and EU is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines.”
From the editors of Scrip Regulatory Affairs.