So Brexit has happened, but how will the government's future trade deal between the UK and the EU impact the pharma industry?
The UK is looking for a more divergent stance from the EU than had been previously proposed by Theresa May. The UK is focusing on making its own rules - this includes removing jurisdiction of the Court of Justice of the European Union over the UK. However, it does want to see close co-operation where possible - including in the pharma industry.
Boris Johnson's government is looking for a 'Canada-style' free trade agreement that sees the UK outside the single market and customs union, with the majority of tariffs removed.
The UK is looking to negotiate:
- provisions facilitating trade in specific sectors, such as pharmaceuticals, with mutual recognition agreements focusing on conformity assessment
- the mutual recognition of UK and EU qualifications
- measures to minimise barriers to cross-border supply of services and investment
- commitments by both sides to temporary entry and stay of people for short-term business trips
- participation in particular EU programmes such as Horizon Europe
The Medicines and Healthcare products Regulatory Agency (the MHRA) is likely to have a more independent role in regulating medicines and clinical trials. However, the UK wants to see regulatory co-operation with the European Medicines Agency (the EMA). The aim is to see collaboration between the MHRA and EMA as equal partners.
Meanwhile, The European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe and the Association of the European Self-Care Industry (AESGP) have called for the EU and UK to have the closest possible relationship for pharmaceuticals. They have suggested a working group be set up on pharma and medical devices, together with a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) and an agreement to achieve regulatory alignment and cooperation on medicines.
This includes the waiving of batch and import testing. They said there should be an agreement to allow patients to receive medicines and medical technologies without disruption. They want to see long-term co-operation between the EU and UK in research, clinical trials, pharmacovigilance and access to talent.
However, both sides are talking tough at the beginning of negotiations. The UK Government has said that unless there is sufficient progress by June, it would be willing to walk away and prepare for an 'Australian-style' deal - shorthand for trading with the EU on WTO terms.