Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Pharmaceutical regulatory landscape in the United Kingdom after the Brexit and current regulatory changes, with focus on the Windsor Framework and the International Recognition Procedure ***

Dr. Jana Heidemann (Abschlußjahr: 2024)

Summary
Language: English
After more than 40 years of EU membership UK withdrew from the European Union in 2020. From this day on the entire “acquis communautaire” which is harmonised throughout the EU did not apply in UK anymore and the UK government took back control of the legal framework. Due to the tense situation between the EU member states Ireland and Northern Ireland the EU and UK agreed, during exit negotiations, on an IE/NI protocol. This protocol regulated that the Union law still applied to NI to avoid a hard border between IE and NI. Right after the IE/NI protocol entered into force it became clear that this agreement had not been the ultimate solution for the everyday’s live after the Brexit. NI faced supply shortages which is especially problematic in the pharmaceutical environment. It took several rounds of negotiations between the EU and UK to agree on a final solution on how the operation of the IE/NI protocol could be amended. In this thesis the differences between the previous agreed IE/NI protocol and the new solution captured in the Windsor Framework are presented showing that these changes mean extra work for the health authority MHRA and the pharmaceutical industry but that these are also necessary to safeguard medical supply in NI. In addition, the access to innovative medicines in UK in comparison to the EU is presented showing that UK slightly lacks behind the EU and therefore also behind the US, the huge pharma market for innovation. This is probably due to the EU reliance procedure introduced after the Brexit. This procedure was introduced to not jeopardise the access to innovative and generic medicines but also to give the government time to adapt the pharmaceutical legislation to the new situation. At the beginning of 2024 a new procedure called the International Recognition Procedure (IRP) has been introduced by the MHRA. In this thesis the IRP is compared to the previously applicable EU reliance procedure. The main difference between both procedures is the possibility for the IRP to also rely on marketing authorisation approvals from other regulatory authorities beside the EMA or approvals obtained via the MRP/DCP. This enables UK to break free from EU dependency in terms of marketing authorisation approvals in UK and may strengthen its position in a highly competitive pharma world. Reliance and recognition procedures are well-established procedures all over the world to obtain marketing authorisation. A comparison of the IRP with similar international procedures shows that all procedures follow the same principle but slightly differ in their execution.
Pages: 64