The European Commission (EC) has issued draft legislation amending Directive 2001/83/EC (EU Medicines Directive) to introduce derogations from certain obligations concerning medicinal products for human use made available in the UK in respect of Northern Ireland (NI), as well as other historically dependent markets (Cyprus, Ireland and Malta). While the changes to EU Medicines Directive are not applicable, the EC has extended the grace periods for the movement of medicines from Great Britain (GB) to NI to the end of 2022. On its part, the UK government recently introduced legislation to establish a new route for the lawful supply of prescription-only medicines from GB to NI.
The Protocol on Ireland/Northern Ireland (Protocol) of the Agreement on the withdrawal of the UK from the EU was implemented as a result of Brexit to avoid a hard border on the Island of Ireland. While the Protocol tries to solve some issues, its implementation has also generated a variety of practical problems. One of these relates to the supply of medicines to NI from or through GB. Currently, NI is substantially subject to the EU's medicines legislation, but a large part of the medicines used in NI are still supplied from GB. Different regulatory requirements for medicines in NI and GB has given rise to serious issues that impact on the availability of medicines in NI.
EC legislative changes
We previously discussed the EC's medicines "non-paper" outlining proposed changes to the supply of medicines from GB to NI to ensure an uninterrupted supply of medicines to the people of NI. On 17 December 2021, the EC issued a draft new EC Notice on the application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK other than NI. The new notice extends the various grace periods initially introduced by the previous one beyond 1 January 2022 and until the necessary changes are made to EU law to address the number of issues which have arisen after the end of the Brexit transition period, including the lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries, difficulties to carry out quality control testing and difficulties with the placement and verification of the unique identifier. On this last point, the derogation from the requirement to decommission the unique identifier on medicines exported to the UK, initially granted for one year, will continue to apply for a period of three more years (that is, until 31 December 2024) under the new EC Notice.
Importantly, the EC has also issued a proposal for a Directive amending the EU Medicines Directive, which is now open for feedback from stakeholders and the general public by way of a public consultation that will end on 14 February 2022. The proposal aims at ensuring that the same medicines are available in NI at the same time as they are in the rest of the UK. Amongst other things, the proposal allows exceptionally that:
- A marketing authorisation (MA) holder of a non-centrally authorised MA valid in NI may be established in parts of the UK other than NI.
- For certain non-centrally authorised MAs valid in NI quality control testing will be permitted in parts of the UK other than NI under certain conditions, and the same will apply for the same types of MAs valid in Cyprus, Ireland and Malta until 31 December 2024;
- The qualified person for batch testing and pharmacovigilance related to a MA valid in NI may be located in parts of the UK other than NI;
- An EU wholesaler located in NI (and in Cyprus, Ireland, or Malta until 31 December 2024) may purchase and obtain medicines from a third country (that is, from parts of the UK other than NI) without holding a manufacturing import authorisation and without re-testing the products under certain conditions;
- The MHRA will be able to issue a MA valid in NI for medicines belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 while no equivalent centrally authorised MA is granted or refused by the EC, under certain conditions and for a maximum of six months.
UK legislative changes
On 16 December 2021, the UK government laid before Parliament the Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (SI 2021/1452)1 which will come into force on 1 January 2022. The statutory instrument makes amendments to the Human Medicines Regulations 2012, as amended, to establish the NI MHRA Authorised Route (NIMAR) for the lawful supply of prescription-only medicines from GB to NI where licenced alternatives are not available in NI. Medicines will only be supplied under the NIMAR if they are a "listed NIMAR product" which are prescription-only products with a UKMA(UK) or UKMA(GB) marketing authorisation from the MHRA, as further detailed in a Department of Health and Social Care (DHSC) guidance2 published on the same day.
The EC proposal is a significant step in harmonising the regulatory requirements placed on suppliers of medicines that wish to supply medicines in both GB and NI markets. The NI market is not large enough for suppliers to be willing or able to comply with different regulations in GB, where the medicines are mostly supplied from or through, so derogations from the general rules should be welcomed by all to ensure the availability of medicines in the region.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.