UK medicines – Is the Northern Ireland Protocol now unsustainable?

Quick read

With the EU Commission conceding that medicines entering Northern Ireland from Great Britain can be monitored without 'hard border' checks after all, is the protocol that has partitioned the UK market since Brexit now unsustainable?

A problem and (not quite) a solution

At the end of 2019, newly installed Prime Minister Boris Johnson was in a difficult position. On the one hand, his predecessor had left him with a draft EU withdrawal agreement that Parliament would not pass, because it would have kept the whole of the UK in large parts of the EU single market, possibly indefinitely, as well as its customs union (the so-called 'Irish backstop'). On the other hand, time was running out for re-negotiation before exit day.

The Irish backstop was designed to avoid the need for a 'hard border' (infrastructure allowing physical customs and regulatory checks) between Northern Ireland and the Republic of Ireland. Northern Ireland is part of the UK and the Republic is part of the EU.

EU negotiators argued that the backstop was necessary to maintain peace between the two communities on either side. Brexit proponents argued unsuccessfully that digital technology could be employed to manage checks on any goods crossing into the EU (which would be minimal anyway), avoiding the need for a hard border without the backstop.

And so, the Prime Minister's answer was to hastily renegotiate the withdrawal agreement, scrapping the Irish backstop and replacing it with the "Northern Ireland Protocol" (the Protocol). The Protocol took both Great Britain and Northern Ireland out of the EU customs territory and, for the most part, outside the writ of EU law and the Court of Justice of the European Union (CJEU). But it also contained commitments for Northern Ireland (but not Great Britain) to remain in the EU single market and aligned with EU regulatory laws on goods, including medicinal products.

This arrangement avoided a hard border, because customs and regulatory checks were effectively undertaken along the Irish Sea, instead.

Problems caused to medicines by the Protocol

As we've explained previously (here and here), to regulate medicines and many of the market exclusivity rights that attach to them, the Protocol has effectively partitioned the UK market into two legal regimes: one for Great Britain and one for Northern Ireland. Separate marketing authorisations, data and market exclusivity regimes, orphan drug protection and paediatric extensions now apply in these territories. Supplementary protection certificates (SPCs), although governed solely by domestic law across the UK, have also been made more complex.

This is not merely an issue of duplication, because it also introduces subtleties that may trip up unwary applicants.

For example, UK SPCs must be granted upon the basis of a first UK marketing authorisation (NI, GB or UK), and the six-month time limit for filing the UK SPC will be six months from the earliest grant of those UK authorisations (when the authorisation is granted after the underlying patent). By contrast, however, the period of protection of an SPC will be calculated based on the first of a UK authorisation or an EEA/EU authorisation. Furthermore, applications for generic marketing authorisations, data and market exclusivity periods may not necessarily run concurrently within the United Kingdom itself.

These practical complexities could be a disincentive for companies to obtain regulatory approval in Northern Ireland. At the same time, moves to increase the speed and efficiency of medicines regulation in Great Britain (like in the case of biosimilars, for example) also risk the population of Northern Ireland having to wait longer for EU approval to access drugs that are available in Great Britain.

Ultimately, the only solution to these potential problems is to be rid of the Protocol. But is that realistic?

Is it realistic for the Protocol to be removed?

Perhaps, if recent developments are anything to go by.

The reason is that, due to wider problems that the UK government argues are being caused by the Protocol – such as disproportionately intrusive EU border checks along the Irish Sea and the resulting diversion of trade to the Republic of Ireland – the government has sought to renegotiate the Protocol. It has even threatened to unilaterally disapply it under provisions designed for these circumstances.

In response, the European Commission has suggested that border checks may be unnecessary. This would, however, depend on the UK giving the Commission access to UK databases relating to trade flows to ensure British goods (including medicines) that are meant for Northern Ireland do not cross into the Republic of Ireland.

Without more, this proposal may not be accepted by the UK, since it would still leave Northern Ireland under the jurisdiction of EU regulation and CJEU rulings in these areas – yet it is an interesting concession. This is because of the reason the Irish Backstop was drafted in the first place: the EU Commission would not accept that digital tracking measures were enough to prevent goods entering the single market from Northern Ireland without a hard border. However, the latest offer has been compared to exactly these measures.

In other words, if digital methods are enough to monitor the movement of certain goods (such as medicines) after all, then there is no need for the Protocol. If there is no need for the Protocol, then how long is its partitioning effect on UK medicines regulation and exclusivity rights sustainable?