"No Deal Brexit" - What Must Pharma Do to Prepare?
As the clock keeps ticking towards Brexit on 29 March 2019 ("Brexit Date"), there is continued uncertainty. Will there be a deal or no deal? What are the implications? Businesses across the board are struggling to know what to do.
Pharma is even more affected than most by these decisions, due to the regulatory requirements and whether there will be mutual acceptance or recognition by the UK and EU of each other's regulatory requirements and processes.
The Government has published its first 25 technical notices on what businesses should do to prepare for a "no deal" scenario. Whilst the Government states in those notices that this is unlikely given the mutual interests of the UK and EU in securing a negotiated outcome, and it believes that an orderly negotiated Brexit is in the interests of all, it is preparing for all outcomes to seek to ensure stability for citizens, consumers and businesses.
The Government says people should be reassured rather than alarmed by its Brexit planning. It says it has 7,000 civil servants working on Brexit already, and the Treasury has approved funding to recruit 9,000 more.
In its technical notices, the Government has focused on taking unilateral decisions to minimise disruption as the UK transitions to a new phase. At its heart are the technical notices focused on pharma and life sciences.
If there is no deal, then the Government highlights the following would happen:
- The UK's participation in the European medicines regulatory network, including the European Medicines Agency (EMA), would cease.
- Medicines on the UK market already with a UK Marketing Authorisation would be unaffected.
- Medicines that are approved by the EU as Centrally Authorised Products would be automatically converted into having UK Marketing Authorisations and so could be sold in the UK.
- To market a new product in the UK, a Marketing Authorisation application will need to be submitted to the UK's regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA will look to take a streamlined approach to approving UK applications to place no greater burden on industry and ensure patients can access new and innovative medicines at the same time as EU patients. However, the UK will no longer be part of the EU's centralised, mutual recognition and decentralised procedures.
- Any medicines that received a Marketing Authorisation for the UK via the mutual recognition or decentralised procedure routes prior to Brexit Date will be unaffected as they already have a UK Marketing Authorisation.
- For generics products, as the MHRA will not have access to data provided in support of EU approved products, new applications would need to be based on reference products that have been authorised in the UK. However, existing Marketing Authorisations for generics that are based on a reference product authorised in the EU would remain valid.
- The MHRA will continue to require a Qualified Person for Pharmacovigilance (QPPV) who can be contacted in the event of a safety issue. The QPPV should be established in the UK from Brexit Date, except for a grace period for some who do not have a UK presence on Brexit Date.
- The UK will continue to accept batch testing of manufactured medicines carried out by people in a country on a list set out by the MHRA. This list of countries will include all EEA countries and any third countries with whom the EU has a mutual recognition agreement.
- The UK will continue to recognise the certification, release and assurance of compliance with the Marketing Authorisation and Good Manufacturing Practice guidelines of medicines, by a Qualified Person (QP) based in a country that is on the MHRA white list. That list will include any country in the EEA.
- A QP for products made in the UK or directly imported into the UK from outside a country on a white list must reside and operate in the UK.
- Orphan medicines will be subject to consultation on the proposed UK approach to regulation post Brexit Date, including to consider incentives to encourage those medicines onto the UK market.
- Pharmacovigilance is currently co-ordinated at EU level. The MHRA would take over primary responsibility for conduct and oversight of all pharmacovigilance activities. This will be subject to separate consultation. Sharing common systems and formal exchange and recognition of data submitted for regulatory activities between the UK and EU would cease.
- Online sales - The EU common logo for online sellers can currently be issued by the MHRA and other EU competent authorities. UK-based online sellers would no longer need this, and there would be a proposed new UK logo from 2021.
- GxP - The UK would continue to apply Good Manufacturing Practice (GMP and Good Distribution Practice (GDP) guidelines until further notice.
- Parallel imports - The UK may choose its own exhaustion of rights regime, so will unilaterally choose to be aligned with the EEA on Brexit Date to allow parallel imports to continue into the UK from the EEA.
- The UK would recognise medical devices approved for the EU market and CE-marked, for the time being.
- Clinical trials - the 2004 Clinical Trial Regulations would remain in force. The new 2014 Clinical Trials Regulation would not be in force as at Brexit Date and so would not be incorporated into UK law, although the UK would look to align where possible with the Regulation. The Government will provide more information in due course on where a sponsor or legal representative will need to be based.
Comment
This is very positive to see Brexit planning by the UK Government against all scenarios, including a continued push to reach agreement with the EU. What this shows is a lot of stability for medicines being put onto the market in the UK, with a sensible and pragmatic approach in the event that no deal is reached.
However, this is not the same the other way round. The European Commission and EMA take the view that the UK would be deemed to be a "third country" for regulatory purposes. For pharma businesses that want to sell into the EEA after Brexit, unless there is a deal that alleviates the need for this, they should ensure that they have operations in place to test and release in the EEA post-Brexit Date.