QP or Not QP – That is the UK post-Brexit question

There is nothing straightforward about the Brexit situation in the United Kingdom (UK). Less than 3 months from the deadline for defining the future relationship with Europe the solution as it will relate to pharmacovigilance (PV) is still unclear especially regarding the future UK qualified person responsible for pharmacovigilance (QPPV) role.  In the early days the Medicines and Healthcare products Regulatory Agency (MHRA) made their preference very clear i.e. that they wanted to remain aligned and involved with European PV regulatory system.  This position was wholeheartedly supported by the pharmaceutical industry as this would result in minimal duplication and low risk of divergent requirements.  As uncertainty prevailed MHRA inevitably began to plan for a ‘no deal’ Brexit and their direction of travel was clear.  As far as possible MHRA would transpose European Union (EU) PV requirements into UK legislation resulting in a similar, if parallel, PV system to EU.  At this point MHRA announced the requirement for Marketing Authorisation Holders to appoint a UK QPPV who would have identical legal obligations to EU QPPV for all products authorised in UK.  The UK QPPV would reside and operate within UK and be responsible for set up and maintenance of the PV system as it pertained to UK authorised products.

This announcement followed the realisation that existing UK based EU QPPVs would not be able to continue in the role of EU QPPV post-Brexit if they wanted to remain resident in UK as the law requires them to reside and operate in the European Economic Area (EEA).  Hard decisions were made, some upped sticks and relocated to an EEA member state, some found different roles within their organisation and some licked their wounds following redundancy packages – some careers were significantly impacted.

The concept of an UK QPPV presents opportunities for ex-EU QPPVs and aspirational pharmacovigilantes, the next generation of PV professionals who will shape the future for PV.  The industry should work with MHRA to shape this new role and expectations.  Clearly this role would be an important role and incumbents would be expected to have robust oversight and knowledge of the PV system as it supports UK authorisations. Like the EU QPPV they will be the face of the company during inspection and the go-to person for all safety related questions.  To avoid duplication and maintain consistency the UK QPPV would need to be closely aligned with EU QPPV for those companies where the UK products are also authorised in EEA. Many companies have now implemented the concept of an ‘International QPPV’ due to the large number of countries who have adopted EU like legislation and have a requirement for a national QPPV. The UK QPPV could easily slot into that infrastructure allowing access to all the information they need to meet the UK legal requirements. Where this set up does not exist the UK QPPV would need to establish strong connections with EU QPPV.

On 15^th September 2020 MHRA revised the requirements for UK based QPPV due to the impact of the proposed Northern Ireland protocol.  So now things become even more complicated.  Under the Northern Ireland protocol, MAHs for medicines authorised to be placed on the market in Northern Ireland (NI) MUST follow EU medicines legislation and the MHRA will act in the capacity of the EU national competent authority in respect of NI.  So this potentially throws a spanner in the works with respect to UK QPPV because the NI authorisation will need to be under the purview of the EU QPPV.  For England, Scotland and Wales there will be a GB licence requiring a UK QPPV and as mentioned above the original thinking of MHRA was that this person needs to reside and operate in UK.  There is the recognition that because of NI protocol there needs to be some flexibility and the MHRA have now advised that the UK QPPV may reside and operate in UK or EU.  This means that the EU QPPV can play the role of both EU QPPV and UK QPPV.  This is an interesting concept, as early in the BREXIT discussions it was clarified that the EU QPPV could not, under any circumstances be located in UK, so it is hard to understand how in future it will be possible for UK QPPV to be located in EU.  The EU QPPV will have to operate under two separate pieces of legislation (Article 10 of Commission Implementing Regulation (EU) No 520/2012 AND Schedule 12A paragraph 10 of the Human Medicines Regulation (HMR) 2012 as amended) although, at least in the first instance, the requirements in both will be identical.  MAHs who have EU licences are highly likely to appoint EU QPPV as UK QPPV but this is adding potentially additional work to the EU QPPV who may need to be more closely linked to UK and certainly brings additional legal responsibilities for the EU QPPV in a 3^rd country (the UK) – the potential impact of which is unclear at this stage.

For small companies who operate solely within UK the requirement for products authorised for distribution in NI to follow EU regulations would imply that these companies would need an EU QPPV.  Apparently, this is not the case, Northern Ireland Protocol explicitly includes an exemption to EU law in relation to the legal presence of the QPPV for national products in respect of Northern Ireland. It states:

“The references to Community in Articles 8(2) and 16b(1) of that Directive as well as the reference to Union in the second subparagraph of Article 104(3) of that Directive shall not be read as including the United Kingdom in respect of Northern Ireland, with the exception of authorisations by the United Kingdom in respect of Northern Ireland.”

This allows a QPPV for national products in Northern Ireland to reside and operate in the UK.

In the event that a company chooses to appoint EU QPPV as UK QPPV also then there is a requirement for a national contact person (NCP) to be appointed in UK.  This person will need to reside and operate in UK and should have access to the reports of suspected adverse reactions referred to in regulation 187 of the HMR and the PV system master file (PSMF) for UK authorised products. The individual should also be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.  The NCP will need to ‘report’ to EU QPPV – this would not mean that NCP needs to be a direct report of the EU QPPV but a dotted line or demonstrable close working relationship would be needed. Details of the NCP will need to be notified to MHRA.

The requirement for a UK QPPV, regardless of location will apply as of 01 January 2021 and there will be no grace period.  For NCP there will be a 12 month exemption period in place to allow for MAHs to recruit an appropriate individual.

So this is the situation at time of writing but is based on the assumption that the proposed NI protocol will be implemented.  Should this change then presumably MHRA will revert to UK based QPPV requirement for all products authorized in UK – or maybe the MHRA have other ideas in the mix yet to be revealed. At the moment it seems advisable to make flexible plans and wait with baited breath to see what happens next!