UK researchers in Queens University Belfast (QUB) have published an article on the implications of a “no deal” Brexit for orphan and paediatric medicines. The research, published in the British Medical Journal (BMJ), stressed that the impending exit of the UK from the EU “would have considerable adverse consequences on pharmaceutical research and development and access in the UK”. According to the comments, “Brexit is currently scheduled to occur on 31 October 2019. Nevertheless, little has been said about the consequences of Brexit for the development of and access to medicines for orphan (rare) diseases and children”. As ophthalmic disorders include orphan and paediatric conditions it is unclear how Brexit will impact on both pharmaceutical industry or academic clinical research.
If the UK Withdrawal Act is ratified by October 31, then an amendment of the Human Medicines Regulations 2012 (2012 Regulations) will provide orphan and paediatric medicines legislation to apply in the UK, at least until the end of the transition period. However, if the Withdrawal Act is rejected by Oct 31 and the UK leaves the EU without a deal, then the Human Medicines Regulations 2012 (2012 Regulations) may not be in force in the UK so an orphan product, for example, may not have certain marketing authorisations. As marketing authorisations are submitted by commercial entities, most pharmaceutical organisations will prioritize the bigger markets – USA, followed by the EU, and then perhaps the UK. according to commercial decisions independent of the UK, or of any government. As a result, new orphan and paediatric products will reach the UK market at a much later stage than the present.
Concluding in the commentary, the authors state that “as we have indicated, a “no deal” Brexit is not likely to yield any advantage for the development of and access to orphan and paediatric medicines. Consequently, in the case of “no deal,” some of the most vulnerable in society risk finding it harder to access the best medicines available”.