After Brexit

An assessment of the European Medicines Agency’s performance in tackling the COVID-19 pandemic shows that the agency was “well prepared” with a crisis management plan but that it faced a range of challenges such as the fallout from Brexit, a heavy workload and how to maintain the public’s trust in medicines regulation.

The European Medicines Agency said Noël Wathion, who retired two years ago, will be remembered for steering the agency through challenges such as Brexit and COVID-19, in addition to being a champion of transparency and public engagement.

One of the many consequences of Brexit is that medicines for marketing across the UK will have to carry the words “UK Only,” which will involve companies having to notify the regulator of changes to their product artwork.

Digitalization is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode of Over The Counter, HBW Insight speaks to Jamie Hatzel, regulatory associate at law firm Bristows, to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics.

Countries from all over the world were plying their wares as desirable biotech clusters at the recent BIO meeting in Boston and Northern Ireland made a strong case for its potential as a prime location for life sciences starts-ups.

Prompted by Brexit, the UK is weighing up an overhaul of how novel foods are regulated. The Food Standards Agency has drawn up options for new regulatory models, some of which it says represent a "radical" departure from the current framework.

As part of post-Brexit arrangements to make sure new drugs are made available to people in all four countries of the UK, an interim mechanism has been set up for when a product is approved in the UK before the EU.

Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.

Giving the UK regulator the power to issue UK-wide marketing authorizations for products that fall within the scope of the EU centralized procedure will reduce the regulatory burden on companies marketing medicines in Northern Ireland.

The long-awaited extension of the UK MHRA’s standstill period for CE-marked devices circulating on the Great Britain market was announced in late April, offering new transition deadlines that go beyond the one extra year promised by the agency in fall 2022. Industry is studying the implications.

Although money is too tight to mention for some biotechs, last year the value of preclinical partnerships actually went up and Switzerland’s big two pharma players are on the lookout for more.

Numerous political and legislative procedures will be needed before new rules on the UK-wide approval of new medicines and their marketing in Northern Ireland can be implemented.

UK consumer healthcare industry association, PAGB, has welcomed the landmark “Windsor Framework” agreed by the UK and the EU, which proposes that medicines will take a “green lane” from Great Britain to Northern Ireland, while the UK regulator, MHRA, will have UK-wide responsibility for all drug approvals.

A landmark agreement struck between the UK and EU covering medicines supply to Northern Ireland has been welcomed by the UK generics industry as offering certainty to companies operating in the sector as well as patients.

Under the landmark “Windsor Framework” agreed by the UK and the EU, medicines will take the “green lane” from Great Britain to Northern Ireland, while the UK regulator will have UK-wide responsibility for all drug approvals. In addition, the provisions of the EU Falsified Medicines Directive will no longer apply in Northern Ireland.

As heated discussions continue on the future of the protocol that keeps Northern Ireland within the EU’s single market, the UK government has been urged to ensure concerns over medicines supply are addressed before “rushing to get a deal done.”