The time for the UK to leave the EU is fast approaching. With March 29th 2019 the official date. The post-Brexit transition period is in fact set to run until December 31st 2020, meaning the chances are very high that the UK-EU relationship will be staying the same until then, but two years in the labelling lifecycle can pass very quickly.
But what does the implication of Brexit mean for the pharma and medical device industries? Speculation is rife, but it is widely assumed that the Medical Healthcare products Regulatory Agency (MHRA) will take over either some, or all, of the duties that have been carried out by the European Medicines Agency (EMA).
So, how will this affect labelling and compliance? Life science companies wanting to register products for distribution in the UK will need authorisation from the MHRA, not EMA. New relationships will need to be forged and to proof of labelling compliance will be high on MHRA’s agenda. This, of course, will be a period of transition, with the government confident of striking a ‘good’ deal with the EU for a ‘frictionless’ a trade as possible, but the MHRA will want to be showing that its teeth are sharp even if it chooses not to bite.
What if it’s a ‘no-deal’?
Martin Sawer of the Healthcare Distributors Association, has previously told MPs that the pharmaceutical industry was ‘very concerned about a no-deal’ outcome as it could have ‘catastrophic’ consequences for the supply of drugs.
To help ease any fears, the UK government has issued several documents to help businesses in planning for the eventuality of a no-deal Brexit. With access to medicines being at the forefront of the concerns of the pharma industry, pharma has pledged to increase their drug stocks by at least six weeks on top of their usual buffer supply in preparation.
The UK imports 37 million packs of medicine each month from the EU, whilst 45 million packs are exported to the EU. The concern is that even with the government’s contingency plans in place, equipment and medicines would be in short stock. And the cut off from EU could extend further into changes to addresses, symbology and warning statements – with identical products needing both EU compliant and UK compliant labelling. At this stage, no one truly knows how big the impact will be, but these are both sensible, yet serious issues to consider.
It is currently acceptable for drugs and devices manufactured outside of the UK and sold into the UK to carry the EU address of the Marketing Authorisation Holder (MAH) to distribute products in the UK, but this would not be the case if a no-deal Brexit was reached. Simply, these products would need to carry a UK address, and post transition could even be required to carry UK and EU MAH addresses.
Changes such as these can have a major downstream impact on supply chain operations. Getting all partners adequately prepared for an unknown set of labelling changes is creating major headaches for the healthcare industry right now. Furthermore, as we move beyond the transition period (assuming there is a deal) we’re likely to see more changes to labelling as the EU and UK could go their separate ways when it comes to future legislation.
The challenges potentially ahead
Practical concerns have been raised about the future status of the UK as a market for new drugs, considering its relatively low priority market in comparison to the EU and US. But this is just one challenge that could lie ahead for the UK and the pharma and medical device industries. There are many others now that are real and need addressing.
It comes down to a question of practicality – how do you locate all of the labels that need to be updated in a time and cost-efficient way and how do you prove compliance without spending days, weeks and potentially months trawling through emails, documents and other communications to find the evidence you need? And if all of the labels have been located, how do you then ensure the label on the same drug or device sold into the EU and the UK contains the appropriate Market Authorisation Holder (MAH) address, or has sufficient space to carry both a UK and EU address, if that’s what you choose to do as part of your contingency plan?
How can greater transparency help?
In times of uncertainty, a transparent, intuitive solution is needed across an organisation to make managing change easier. Labelling content needs to be standardised, version controlled and auditable. It also needs to be visible. The process of locating and amending content needs to be made much clearer, with any user having clear understanding of their tasks, oversight of the overall layout, be able collaborate on changes needed and to participate the review and approval process effectively.
Kallik’s AMS360 solution uses one single platform, taking a data-centric approach. It’s ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button. Appropriate resources can be assigned in the time available, with its cloud-based deployment making the solution quick to adopt across both the broader organisation and by manufacturing partners. This means in times of uncertainty, revisions and updates can be made in confidence as and when is needed, de-risking the uncertainty around Brexit until things become a little clearer.
Plan and prepare for the impact and uncertainty of Brexit with Kallik’s AMS360 solution and learn how it can increase efficiency, speed to market and make it easier to prove compliance in these changing and uncertain times. Get in touch here.