The UK government moved, at the end of August, to clarify its provisional plans should it leave the EU without a deal having been agreed. Many companies have already begun planning for a ‘hard’ Brexit, with a number announcing plans to stockpile drugs before the March 2019 deadline. The government weighed in on the matter by advising companies to build an additional six weeks of medicines supply.
This was far from the only advice that came out of the guidance, as the government’s notes also indicated the need to fly certain medical goods into the country, such as radioisotopes. To elaborate on what the guidance indicates for the industry, in-PharmaTechnologist (IPT) spoke to Jane Summerfield (JS), an advisor to life sciences companies at international law firm Hogan Lovells.
IPT: What are the most significant pieces of information released as part of the guidance?
JS: The main points in the notices for pharmaceutical companies include that the UK would automatically issue a separate UK national marketing authorisation (MA) for medicines that are authorised at a European Union (EU) level via the centralised procedure, the UK would continue to accept batch testing of medicines carried out in the EU, and the UK would no longer be part of the EU regulatory network or systems with the MHRA taking on the European Medicines Agency's (EMA) current functions for medicines on the UK market.
IPT: How about the information specifically impacting the manufacture of medicine?
JS: For me, the significant points out of the notices, in relation to manufacturing, have to be on the UK’s approach to good manufacturing practices (GMP) and good distribution practices (GDP) in the event of a ‘no deal’ scenario. The notices confirm that the UK wouldn’t be looking to move away from the EU’s GMP or GDP guidelines, at least not to start with. I think this is reassuring for UK manufacturers. What would be different is that if they are manufacturing a product which currently has a European MA via the centralised procedure, they would find themselves manufacturing product for the UK market under a separate UK national MA, which, in practice, may not make too much difference from a manufacturing perspective; they would still have the Medicines and Healthcare products Regulatory Agency (MHRA) as the national competent authority carrying out inspections of UK manufacturing sites.
IPT: How have the notes been received by industry?
JS: I think the pharmaceutical industry has been one of the most proactive, in terms of understanding the consequences and preparations for Brexit, so I don’t think there will be too much in the notes that come as a surprise, but there are some useful things that have been confirmed. Concerns around timing have been present for a while now and certainly what we’re seeing with clients is that many are fairly well down the path of Brexit preparations.
IPT: Are any regulations expected to change?
JS: There is nothing in any of the notices that suggest a real change on any regulatory front. There are some caveats within, not in the short- but in the long-term, that suggest that the government may consider changes in particular areas, but it’s hard to judge how much of that is due to the context of the political situation; there has to be the possibility to change things, one of the core elements of Brexit is that ability, but I think the UK government has been quite careful to say, ‘We will consult on any changes’.
IPT: What advantages or disadvantages can already be seen in the ‘no deal’ Brexit scenario?
JS: For some companies, they may need to move or duplicate certain activities in other parts of the EU – for example, when it comes to batch release, where it has to take place in the EU for products intended for the EU market. Equally, there may be activities that would move into the UK, such as needing a UK Qualified Person Responsible for Pharmacovigilance (QPPV) for UK products where the QPPV is currently based in the EU by the end of 2020.
IPT: The government revealed an ambition to match MA timelines between the EU and the UK – is this a possibility and how would it work?
JS: There isn’t much detail in the notes about how they would do that, other than that the MHRA would take a ‘streamlined’ approach. Potentially the MHRA could rely on the EMA’s Committee for Medicinal Products for Human Use (CHMP)'s opinion or could carry out a parallel assessment and then look at whether it aligns with the CHMP's view; however, there is not that level of detail, which perhaps isn’t surprising at this stage.
From the UK’s perspective, it wouldn’t make sense to be in a position where the CHMP gave a positive opinion on a new medicine and the MHRA didn't. There is also the concern regarding the duplication of work so there has to be some kind of operational tie-in. The overall view is that MHRA would be pragmatic and not reinvent the wheel, you’d imagine they would try and find something that would work from an applicant’s perspective, in respect to alignment and process.
IPT: The notes suggest an expanded role for the MHRA, how feasible will the extra workload be for the agency?
JS: The notes outline the roles the MHRA would take on, but don’t address how the MHRA would manage those. There would be a new national portal for submitting regulatory information on medicines to the MHRA, such as pharmacovigilance information, which is currently submitted to an EU system. Getting that portal up-and-running in time should be possible, but equally those kinds of technology projects, from an operational perspective, are often quite challenging. This can be seen in the EU Clinical Trial portal, which has had significant delays. I don’t think a national portal would be quite as complicated, but alongside all the other responsibilities the MHRA would be taking on-board at the same time, it would add to the logistical challenge.
In a ‘no deal’ scenario, the new portal would need to be operational by the end of March 2019, which is a fairly a tight timeline. The question is: should the MHRA be working on it now or waiting, given this type of system requires significant investment?
Jane Summerfield is a lawyer at Hogan Lovells and advises life sciences companies on regulatory requirements ranging from clinical trials, marketing authorisations, licensing, pricing and reimbursement, through to advertising and marketing.
