This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this means in practice for the UK pharmaceutical industry.
Background
The Northern Ireland Protocol (the “Protocol”) – a key part of the UK-EU Withdrawal Agreement – was intended to safeguard Northern Ireland’s (“NI”) position as a member of the UK while ensuring the integrity of the 1998 Belfast Good Friday Agreement. However, in practice, since the UK’s departure from the EU on 1 January 2020, many aspects of the Protocol have proven unworkable.
To address the criticisms levelled against it, an amended version of the Protocol called the Windsor Framework (the “Framework”) (here) was presented on 27 February 2023 by UK Prime Minister Rishi Sunak and European Commission President Ursula von der Leyen.
The Framework was approved by the UK Parliament on 22 March 2023 and adopted by the UK-EU Joint Committee two days later. The compromises reached under the Framework have been praised by politicians on both sides of the Channel and across the pond in the US, with the agreement itself symbolising an easing of tensions and ensuring stability on the island of Ireland after Brexit.
Big changes for product compliance
Under the Protocol’s product compliance regime, EU law applied to all products placed on the NI market, resulting in a complicated dual regulatory regime. Our earlier product compliance and liability article (here) outlines the regulatory position applicable to NI under the Protocol. The UK Government guidance (here) sets out the current regulatory position, including the use of the UKNI marking under certain circumstances.
From a UK internal market perspective (i.e. trade between Great Britain (“GB”) to NI), the Framework abolishes this dual regulatory regime. It will mean that products placed on the NI market, which are intended to stay within NI (and the rest of the UK), will be freed of unnecessary paperwork, checks and duties. Instead, under the new regime, only ordinary commercial information such as a product’s description and its value will have to be declared.
In contrast, goods moving from NI into the EU will continue to be subject to ordinary third country processes and requirements, including customs procedures. This general principle – called the “green lane versus red lane” – was foreshadowed in the draft NI Protocol Bill, which has since been halted (see our earlier update here).
What does this mean for product compliance generally?
While the Windsor Framework does not address general product compliance matters such as CE/UKCA marking and conformity assessment, it does address specific product categories (such as agrifood, medicines, etc.) and suggests that UK product compliance requirements (currently applicable to GB) will also apply to products intended for the NI market (which currently need to comply with EU legislation).
And what about medicines?
The Framework brings positive developments for patients in NI and the wider UK pharmaceutical industry more generally. Below are four ways the Framework will affect how medicines are treated in NI:
1. The EU’s Falsified Medicines Directive will no longer apply to NI
The EU’s Falsified Medicines Directive (the “Directive”) is seen as a real burden for pharmaceutical stakeholders in GB and NI. Under the Directive, all medicines exported from GB to NI are subject to labelling and packaging requirements that no longer apply to GB post-Brexit. Examples of these requirements include the need for anti-tampering security on packaging and the labelling of medicines with unique barcode-like identifiers. The disapplication of the Directive will come as a relief to pharmaceutical manufacturers exporting medicines between GB and NI.
2. The MHRA will approve medicines in NI
Under the Framework, the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK regulator – will now approve all medicines placed on the NI market and the European regulator (EMA) will cease to have regulatory control in NI. This will allow new medicines authorised in GB to be immediately available in NI creating a single UK regulatory market for pharmaceuticals.
3. Medicines moving between GB and NI will take the “green lane”
Medicines moving between GB and NI will move along the new “green lane” which benefits from the removal of all unnecessary red tape. Only a description of the goods being imported, their value and other ordinary commercial information will need to be declared. Medicines moving to the EU will take the “red lane” and will be subject to regular EU import requirements.
4. Veterinary medicines and medical devices are not addressed by the Framework
The Framework does not amend the current legislation under the Protocol on veterinary medicines and therefore these will not immediately benefit from UK wide regulatory approval. The Framework instead provides for a grace period which will allow for veterinary medicines approved in GB to be placed on the NI market. This grace period will last until December 2025.
Comment
In light of the agreed Framework and with the easing of tensions more generally, there is renewed hope of collaboration between the UK and the EU. Notwithstanding the UK government’s reluctancy in re-joining the coveted Horizon Project, there is a belief within the life sciences industry that closer ties between the UK and the EU will now be possible.
For any questions regarding these and any other product compliance and life sciences and healthcare questions in the UK, EU and elsewhere, please get in touch.
