On 8 December 2017 the UK Government and the EU negotiators published a Joint Report on the progress made during the first phase of Brexit negotiations. A week later, on 15 December 2017, the European Council formally agreed that enough progress had been made to move to the second stage of the negotiations and they adopted guidelines for the second phase.
On 16 January 2018 the MHRA published an update referring to the Joint Report and the EC’s guidelines, acknowledging that companies who market pharmaceuticals in the EU and the UK will need to make decisions and plan in advance of the UK’s departure from the EU in March next year.
On continuity of the availability of goods on the market, the MHRA referred to the encouraging comment in the Joint Report which states that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight”.
Whilst the MHRA indicates it is preparing for all outcomes including working with the European Medicines Agency, it recognises the importance of establishing the implementation arrangements and the duration of the implementation period. In its update, the MHRA sets out the current regulatory relationship between the UK and the EU and continues to say that if there is no implementation period, it would take the following approach:
- the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the point of exit, so there are no sudden changes to the UK regulatory framework;
- it would be pragmatic in establishing UK regulatory requirements and allowing companies sufficient time to implement any changed requirements;
- it would ensure minimum disruption and burden on companies, whilst building on the existing relationship between the MHRA and business; and
- it would make use of the information it already has to complete the administrative tasks for continuity of work and licences.
The BIA comments on the update, “the MHRA update to biotech/pharmaceutical companies on Brexit preparations is welcome and provides public clarity on the UK’s current regulatory relationship with the European medicines network of Member States and the EMA…….The BIA has long advocated for retaining ongoing UK regulatory cooperation with the European Union on medicines to ensure minimal disruption to patient access in both the UK and EU…this is also the UK government’s preferred outcome”.
It will be interesting to see where this next phase of the negotiations takes us.
Catherine Penny