OVERVIEW

The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.

On 16 October 2020, the UK Government made changes to the regulation of medicines for COVID-19 and influenza. The regulations set out changes for the temporary authorisation of medicines (including COVID-19 vaccines) and allow the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to set conditions for that authorisation.

These new regulations were accompanied by further guidance published by the MHRA in September and October 2020 setting out new rules that will govern the regulation of medicines after the Brexit transition period (addressed in our previous MHRA On the Subject.

This On the Subject outlines key changes introduced through the regulations and provides an update on the MHRA guidance, and on the current progress of Medicines and Medical Devices Bill.

IN DEPTH

New Regulations: COVID-19 and Influenza

The UK Government made changes to key medicines regulations through the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020. The policy behind the changes is to support the annual influenza vaccination campaign and a roll-out of a COVID-19 vaccine using temporary authorisations.

Until the end of the Brexit transition period, the licensing of certain medicinal products (including a COVID-19 vaccine) must be undertaken by the European Medicines Agency (EMA). However, the United Kingdom and other EU Member States may temporarily authorise unlicensed vaccines if justified on narrow public health grounds. The temporary authorisation routes did not previously set out any conditions with respect to that supply.

The UK Government has said that the preferred route for the deployment of any COVID-19 vaccine remains through the EMA. These new powers mean that there are additional flexibilities and controls around temporary authorisation ahead of an EMA approval. Given that the success of any COVID-19 vaccine roll-out may be affected by public confidence in the safety and efficacy of any authorisation procedure, any exercise of these powers likely will attract attention.

In particular, the changes in the new regulations:

• Enable the MHRA to impose conditions on any temporary COVID-19 vaccine authorisation.

• Following feedback from stakeholders during the consultation run in September 2020, now also require a review and report within one year from the setting of any new conditions. This review must include an evaluation of any adverse consequences for the market in medicines or for patient safety.

• Expand the group of healthcare professionals who may administer COVID-19 or flu vaccines.

• Change provisions allowing for immunity from civil liability to cover this expanded group of individuals administering the medicines and the manufacturers and persons placing any medicine on the market.

New MHRA Guidance: Regulation of Medicines from 1 January 2021

In October 2020, the MHRA published further guidance on the rules that will apply after the end of the Brexit transition period. This follows a set of guidance issued on 1 September 2020. The October guidance provides greater clarity on the procedures for supplies to and from Northern Ireland.

The guidance published so far includes the following:

Clinical Trials

• Guidance for clinical trial applications (16 October 2020). Separate guidance applies for fast-tracked COVID-19 clinical trials.

• Clinical trial guidance (1 September 2020) on the registration and publication of clinical trials, confirming that clinical trials must continue to be registered using existing international registers and that information about trials being conducted in the United Kingdom must continue to be made available to the public.

• Research ethics guidance (1 September 2020) in relation to the role of the Research Ethics Committee and oversight of the trial sponsor or legal representatives.

Licensing and Applications

• Pending application guidance (1 September 2020) setting out how the MHRA will handle applications for authorisations to the EMA which are still pending on 1 January 2021. The approach taken by the MHRA will depend on the stage of the relevant application, and this may affect the authorisation route of COVID-19 vaccines in the United Kingdom after this date.

• Conditional Marketing Application guidance (1 September 2020) setting out the framework for a new national scheme for new medicinal products in Great Britain, which replaces the current EU scheme for the authorisation of medicines intended to fulfil an unmet medical need.

• Packaging and information guidance (1 September 2020) on new packaging and information leaflets following the issuing of new national marketing authorisations.

Importing and Exporting

• Supplying authorised medicines from Great Britain to Northern Ireland guidance (20 October 2020), which permits the continued circulation of medicines to Northern Ireland if certain requirements are met before 11 pm on 31 December 2020 (including one of the following: the ownership transfer to another legal entity or offer to either purchase or take ownership of the medicine).

• Importing medicines guidance (20 October 2020) with respect to the steps to be taken for the import of certified medicines imported from the European Economic Area (EEA). These include requirements for wholesale dealers to notify the MHRA of their intentions to continue to import medicinal products and by 1 January 2021 to nominate a Responsible Person (import) who will carry out certain specified functions set out in the Responsible Person (import) guidance (20 October 2020).

• Approved countries list setting out approved countries for batch testing and importation of medicines and active substances.

Pharmacovigilance

• Guidance on pharmacovigilance procedures (1 September 2020) setting out the submission requirements for data to the MHRA from 1 January 2021 and Guidance on Qualified Persons responsible for pharmacovigilance (23 October 2020).

Medicines and Medical Devices Bill progress

This Bill seeks to enable the UK’s existing regulatory frameworks for medicines and devices to be updated after the end of the Transition Period. Debate of its content in committee stage in the UK House of Lords suggests there is some resistance to it in its current form, particularly regarding a perceived lack of detail and broad principle approach.

Practical Implications and Awaited Guidance

Although the MHRA guidance outlined above covers many areas and provides some certainty to life sciences organisations, there remain some gaps where technical guidance is still awaited. In particular, pharmaceutical organisations are still awaiting updates in relation to the national, decentralised and mutual recognition procedures from 1 January 2021. At the same time, certain elements in respect of medicines supply and mutual recognition in respect of manufacturing may still be affected by the outcome of trade negotiations between the United Kingdom and Europe.