Are we prepared for a 'hard brexit' or still hoping it will not happen?
If you are one of the Marketing Authorisation Holders (MAHs) that are still hoping for a ‘softer’ Brexit, the message from the EMA is clear: you need to prepare for the ‘hard’ Brexit scenario. Next week we move into June 2018, only 10 months away from when all European Union law ceases to apply to the UK, and it becomes a ‘third country’ unless a ratified withdrawal agreement establishes another date.
With the current uncertainties around the outcomes of the withdrawal, it is tempting to sit back and wait before actioning any activities relating to Marketing Authorizations. However, at a recent Industry Stakeholder meeting on Brexit which took place on 23rd March 2018, the EMA were clear in their message: preparing for a ‘hard’ Brexit is ‘a matter of today’, and cannot be left to a ‘wait and see what happens’ timeline.
Of note, Diamond Pharma Services (a Regulatory, Pharmacovigilance and Quality and Compliance organization) has established its EU headquarters in The Netherlands, to allow us to maintain our services on a European level, in addition to assisting companies with the necessary UK activities from our UK global headquarters. The EU office is one metro stop from where the new EMA building is planned, and next door to a newly built hotel; as such, we can easily host any meetings that a company may need for EMA access. So – Diamond is prepared for a hard Brexit and has ensured business continuity. The question is, “are you prepared?”
The following is a brief summary of salient points taken from the minutes and presentations of the Stakeholder meeting.
EMA messages and preparedness
The UK will become a third country from 30th March 2019 unless the yet to be ratified Withdrawal Agreement establishes another a date. The Withdrawal Agreement is still in draft form, but there is agreement at negotiators level on what is called the colour-coded text, indicating those areas of agreement, disagreement and where further clarifications are needed. Although the draft Withdrawal Agreement is suggesting a transition period until 31st December 2020 inclusive, it is clear that as of 30th March 2019 the UK will no longer take part in the decision-making of the EU institutions and bodies. It will no longer have a role as Rapporteur in the Centralised Procedure, nor reference Member State within the Decentralised or Mutual recognition procedures.
The EMA, through its Operation Relocation Preparedness (ORP) Task Force have been implementing their preparedness activities focusing on the EMA relocation, Business Continuity Planning, Scientific procedures and Committees, IT and Communication. A critical activity has been the start of the re-distribution of the UK portfolio for human and veterinary centralized medicinal products across the EU Member States, in line with a methodology based on the Member States’ current expertise with a specific class of medicines and overall workloads. The target for finalization of the redistribution was April 2018, and new Rapporteurs being announced to MAHs. During 2Q-3Q knowledge transfer will occur.
With the current uncertainties Industry must prepare for all types of Brexit scenarios for regulatory, trade and supply, clinical trials and workforce, and taking into account the impact on global supply chains and patient access. Company’s need to activate their internal planning now, if they have not yet started to do so.
However, clarity is needed on the implications of the proposed transition period until 31st December 2020.
- How will the Regulatory systems work?
- What role will the UK have during this period?
- What network resources at CMDh, EMA and MHRA will be available?
- What opportunities will there be for dialogue with the regulators on specific portfolios and products and post-Brexit arrangements for future regulatory and trade relationships between UK and EU?
Fast forward 2 months: view from the UK
In a UK Government report released on 23rd May 2018, the UK and EU negotiating teams reached agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. During the implementation period, the UK will no longer be a Member State of the EU, but market access will continue on current terms.
It is acknowledged that the safety of patients is of paramount importance in the exit negotiations for medicines products and devices, and the UK wants to explore with the EU the terms on which the UK could remain part of EU agencies, including the European Medicines Agency (EMA). The UK Government is increasingly confident that the prospect of a “no deal” scenario is highly unlikely and are ‘in a strong position from which to seek to agree a mutually beneficial way forward’.
Additionally, the UK will continue to seek opportunities with the International Council on Harmonisation (ICH), Pharmaceutical Inspection and Co-operation Scheme (PIC/S) and the International Medical Device Regulators Forum (IMDRF).
The implementation period – from 30 March 2019 to 31 December 2020 – has been agreed and during this time, the EU will continue to accept UK batch testing, release and inspections, UK-based Marketing Authorisation Holders (MAH) and other regulatory actions in the UK. The UK is committed to adopting the EU Clinical Trial Regulation.
The report confirms that ‘It is in the interests of both UK and EU patients for the strong relationship between the MHRA and EMA to continue. The MHRA is a strong national regulator with substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The Agency is recognised globally for its expertise and as a leader within the EU regulatory framework’.
Despite the position of an unlikely ‘no deal’ scenario, the UK is working on preparedness should other scenarios prevail.
Fast forward end May 2018: Breaking news
‘The UK would vote to remain in the EU if a second Brexit referendum were held, new polling analysis has suggested.’
‘PRIME Minister Theresa May will ask the European Union for a SECOND transition period to run until at least 2023 it has been claimed - further delaying Britain’s full exit from the bloc by another three years.’
Key points to note to aid preparedness for a ‘hard’ Brexit scenario
- MAHs, MAAs and sponsors of orphan designations need to be established in the EU (EEA).
- Both the QP for batch certification and the QP for Pharmacovigilance (QPPV) need to reside and carry out their tasks in the EU/EEA; the PSMF must located in EU.
- The site(s) for batch testing and release need to be located in the EU/EEA. Therefore, product will be released by UK QP and EU QP, together with additional import testing requirements.
- Likely MA and packaging changes.
- Export certificates (CPPs), packaging, labelling and PILs all subject to change.
- Significant number of variations required.
Diamond Pharma Services can assist companies to prepare for that hard Brexit scenario by performing a regulatory gap analysis on product portfolios, prepare a Brexit Strategy Plan and support you with the numerous variations that will no doubt be required.
Do not wait – be prepared!