As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and collaborating with global regulators outside Europe. This shifting landscape offers the industry some new strategies to bring their products to the UK market.
Since the UK’s historic decision to leave the European Union (EU) in June 2016, the pharmaceutical industry has understandably focused its attention on business continuity. While politicians loudly debated the future relationship, EU pharmaceutical law continued to apply in the UK, and a number of regulatory changes were introduced to avoid disruption to supply chains. The most visible effect of Brexit was the relocation of the European Medicines Agency (EMA) from London to Amsterdam.
After months of political wrangling, the final trade deal was announced on December 24th, 2020 and became effective on January 1st, 2021. Since then, we have seen its effect on the regulation of medicines, which has been dramatic. The MHRA no longer plays any part in the EU’s regulatory network, not even as an observer. The UK lies completely outside the EU’s Single Market and the Customs Union; as such, it is treated as a “third country” for the purpose of medicine exports and imports. The exception is Northern Ireland, where EU legislation continues to apply in order to protect the peace agreement with the Republic of Ireland.
In general, industry has responded well to Brexit, establishing new legal entities within the EU where needed, and adjusting its operations to facilitate batch release and drug safety monitoring independently in both territories. So far, so good.
Now that the Brexit separation is complete, attention shifts to new opportunities. Registration of new medicines in the EU will continue similarly to the way it was handled before Brexit was concluded, but the UK has the chance to innovate. In the short term, EU pharmaceutical law has been copied over into UK national legislation. However, this is expected to diverge in the coming years. Furthermore, the MHRA already has extensive freedoms which allow it to operate more efficiently than the EMA, which runs a committee system with seats for 27 countries. As the European Commission President Ursula Von der Leyen recently admitted, “I'm aware that a country might be a speedboat and the EU more a tanker.”
There are already signs that the UK is able to approve orphan designations and pediatric plans more expeditiously than the EU. Scientifically, the MHRA may be more adventurous in approving products with limited efficacy data, and it may choose to impose less stringent post-marketing obligations. Clinical trials approvals were always a national matter, and the MHRA remains among the fastest authorities outside the US to approve new studies.
The UK is also looking outside Europe for regulatory collaboration. MHRA has joined the ACSS Consortium, sharing some regulatory evaluations with its counterparts in Canada, Switzerland, and Singapore. And in the field of oncology, MHRA has joined the Food and Drug Administration’s (FDA) Project Orbis, a collaborative program that also involves Australia, Canada, Switzerland, Singapore, and Brazil.
As a major G7 economy, the UK remains an important pharmaceutical market. In the past, market access challenges have sometimes discouraged industry from launching expensive new products in the UK. Access to the country’s National Health Service involves a strict cost-effectiveness evaluation performed by the health technology assessment bodies, NICE (England and Wales) and SMC (Scotland). Recognizing this challenge, the new Innovative Licensing Access Program (ILAP) offers companies earlier dialogue and support from MHRA, NICE, and SMC.
The UK’s new regulatory innovations are still in their infancy, but ProPharma Group already has experience supporting our clients with UK marketing applications, ILAP, and Project Orbis. Contact our team of experts today to learn how we can provide consulting advice or support with execution related to Brexit compliance.
April 5, 2013
No matter where I go I am always amazed at how many times the words calibration and verification are misused. I often hear statements like, “The instrument doesn’t need to be calibrated, the accuracy...
March 27, 2014
How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...
September 11, 2013
In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...