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BGMA and BBA reaction to draft withdrawal agreement and SPCs

Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA), said: “We very much welcome the assurance that SPCs granted or filed in the UK during the transition period will be maintained beyond it. In order to maintain stability of supply, it is paramount manufacturers are given assurances over the next three years wherever possible. Nothing should be put in place which disrupts getting medicines to the right patient at the right time.
“More widely, following the end of the transition period or in the event of a no deal situation, we think that the UK Government should maintain continuity around SPC start dates – to peg the UK start date against the date of the first marketing authorisation among EU Member States and the UK – and to continue parity around the duration period. This move will best support UK patients having early access to new medicines, the NHS getting savings from the onset of generic and biosimilar competition after the SPC expiry as quickly as possible, and ensuring as much certainty for manufacturers as we can.”