Brexit withdrawal and transition terms (almost) agreed
On 29 March 2018, David Davis and Michel Barnier announced that, in principle, agreement has been reached between the UK and the remaining EU27 on a substantial number of the terms of the UK's withdrawal from the EU, together with the terms of transition for that withdrawal (the Draft Agreement) that will apply until the end of the transition period on 31 December 2020.
It is first important to note that not all areas in the published draft have been agreed, although most have. It has been agreed that unless otherwise provided in the Draft Agreement, EU law will continue to apply to the United Kingdom during the transition period.
However, it is also important to note that there is very little detail included in the agreement and it is to be assumed that other agreements will be needed in particular areas if cooperation is to be continued (as it currently does or in some amended form). This is particularly so when it comes to applications for marketing authorisations for pharmaceutical products.
Despite Theresa May's suggestion of an "Associate Membership" of the EMA last month in her Mansion House speech, the MHRA must transfer material relating to any ongoing applications (Article 40) and is prohibited from acting as the lead authority for marketing authorisation applications and clinical trials during transition, apparently meaning that the UK will not be able to act as a reference member state for authorisations during this period.
The other key provisions to patents and pharmaceutical regulation that have been agreed are as follows:
The following matters have not yet been agreed and are currently set out in the Draft Agreement in the terms put forward for negotiation by the Commission:
The Draft Agreement follows less than a month after Prime Minister Theresa May confirmed in her Mansion House speech that the UK still wants to be part of the EMA.
However, that subject remains to be negotiated as part of the future relationship that will exist between the UK and the EU27 after the transition period ends. As mentioned above, this draft agreement puts the onus on the UK to agree such a relationship going forward because it is not preserved in this draft and so it is clear that another agreement will be needed.
As regards pharmaceuticals and medical devices, the focus of attention will now move to the issue of continuing partnership between the MHRA and the EMA and the possibility of mutual recognition of authorisations and conformity assessments, and associated issues of surveillance and quality control, made by bodies in the UK and the EU27.
The current Article 123(6) would seem to take a backward step from mutual recognition, but it should be remembered that the terms of the Draft Agreement are conditional on heads of terms on the future relationship being entered into in the Autumn of 2018. The Draft Agreement should therefore be viewed as a holding position on this issue until later in the year, albeit that the holding position is a long way away from where the UK would wish to be.