Brexit-related change will define the European pharmaceutical and healthcare sector in 2019, both in terms of how drug products are regulated and how they are marketed.
But, while Brexit is certain to impact the development, manufacture and sale of drugs, the ongoing lack of clarity on the future relationship between the UK and EU makes gauging the precise impact very difficult. The following predictions for 2019 are based on those certainties that are available at the time of going to press.
One certain impact of Brexit is that the European Medicines Agency (EMA), the EU agency tasked with regulating pharmaceutical, medical devices and veterinary medicines, is moving from London to Amsterdam. The agency1 has started preparing and is on track to have moved into a temporary headquarters in the Sloterdijk area of Amsterdam before the UK officially withdraws from the EU on 29 March 2019. It is due to complete its final move to its tailor-made premises in the city’s Zuidas district next November. The move will impact regulation of the pharmaceutical industry. In August2, EMA predicted it will lose 30% of its workforce and said it will need to temporarily suspend non-core activities, including non-essential guideline development and some aspects of international collaboration.Likewise, it is not clear what impact EMA’s departure will have on its interaction with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in areas like policy development. Previously, the UK regulator has been very visible in Europe, providing input and perspective that supported EU regulatory developments that have been pragmatic, positive to innovation and forward-looking while protecting patient interests.
It is unclear how full alignment of UK and EU regulations and regulatory processes for pharmaceuticals and medical devices can be managed without daylight opening up, and whether fully reciprocal acceptance by all EU Member States can be achieved.
There are still key questions regarding pharmacovigilance activities, which must take place in an EU member state or EEA territory, manufacturing facility inspections and batch release and certification.
What impact these issues will have on drug supplies in the UK is unclear. Earlier this year, the UK Government called on pharmaceutical manufacturers and medical device companies to develop contingency plans to ensure patients will continue to have access to medicines after Brexit.
UK Health and Social Care Secretary, Matt Hancock asked3 manufacturers to stockpile six additional weeks of supplies to try to prevent shortages. He also said that, even if no trade deal is struck with the EU before withdrawal, the UK will continue to accept products that have been batch tested and released in accordance with EU rules.
‘This means there will be no requirement for any further manufacturer-led batch testing and release of medicines in the UK,’ Hancock wrote4.
The regulation of clinical trials is another area where some detailed information on the post-Brexit landscape is available.
In August5, MHRA issued guidance on the expected impact of the EU’s new Clinical Trials Regulation (CTR), which is likely to be implemented during the transition period.
It wrote: ‘If the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.’
And in September6, the European Commission issued its advice on the likely impact of Brexit on clinical trials, based on the assumption the UK becomes a ‘third country’ after withdrawing from the EU.
It said sponsors wishing to import trial supplies from a third country need a qualified person (QP) ‘permanently and continuously at his disposal’ in the EU to ensure the medicine was made in accordance with good manufacturing practices (GMP).
The Commission also pointed out that after the UK leaves the EU, sponsors will no longer have to file UK-specific clinical trial information to EudraCT. The exception being if the country is the only location in a study that is part of an agreed paediatric investigation plan.
FMD ‘Safety feature’ packaging rule
Another certainty is that EU rules on drug safety features that come into force next year willapply to products made in the UK after Brexit.
From February, the Falsified Medicines Directive (FMD) calls for two distinct safety features to be added to saleable units: a unique identifier (UI) and a tamper-evident device.
According to MHRA7: ‘The UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations.
‘When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.’
UK role in EU pharmaceutical sector
The UK plays a key role in the development, manufacture and supply of medicines in the EU. In addition, MHRA is a major part of the EU’s regulatory apparatus.
According to EMA, a third (427/1165) of centrally authorised products on the EU market are made by UK drug companies. Likewise, a quarter of centrally authorised drugs have a UK-based QP for pharmacovigilance.
With this in mind, in January8 the agency set out to assess how drug industry preparations for Brexit were progressing. The results, which were released in July9, were mixed.
EMA wrote9 that 58% of marketing authorisation holders (MAHs) for the 694 centrally authorised products that have an important step in their regulatory processes in the UK, are on track to maintain their authorisations after Brexit.
However, it also raised ‘serious concerns’ about the ability of companies behind 108 UK-made, centrally authorised products to make the necessary changes to be in compliance
with regulations before 29 March next year.
The role of regulatory professionals
Regulatory professionals are accustomed to leading and establishing predictability in activities where the outcomes are inherently unpredictable, and it is part of their role to mitigate the risk. The outcomes and consequences of Brexit are still far from certain, but as a regulatory professional, their role is critically important to be able to make the transition with minimal disruption. The main objective is that access to the most effective, affordable, safe and innovative healthcare products is maintained for all Europeans.
RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals of the latest news and insights as they develop.
Paul Brooks is Executive Director, RAPS. Go to www.raps.org
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