The UK Government's Chequers plan and White Paper in July were widely praised by the pharma industry, who saw it as a big step forward in maintaining regulatory alignment with the EU, and notably a unilateral statement of intent to work with and accept the rules of the European Medicines Agency (EMA). The offer also included a desire to contribute towards the EMA's costs, and mutual recognition of qualified persons and qualified persons for pharmacovigilance in each territory and the regulatory experts at the Medicines and Healthcare products Regulatory Agency.
The UK Government has also issued notices of its "no deal" Brexit planning, featuring heavily on pharma and life sciences. In that scenario, the UK would continue to accept batch testing of medicines carried out in EEA countries and those with whom the EU has a mutual recognition agreement. The UK would also continue to recognise qualified person certification and release of human medicines carried out in the EU without the need for re-testing in the UK.
The unilateral position is less helpful from the other side.
Many key questions remain, with concerns over shortages and stockpiling.
In an article in the European Pharmaceutical Review recently, I discussed these and other questions, including: would medicines get to the patients?
We will be holding a PING (Pharmaceutical Industry Network Group) Conference, in association with EMIG, on 3 April 2019 just after Brexit date, on how Brexit is affecting the pharma supply chain.