Explanatory Memorandum to COM(2023)122 - Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)122 - Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland. |
|---|---|
| source | COM(2023)122  |
| date | 27-02-2023 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the Withdrawal Agreement) 1 , and in particular Article 5 i of the Protocol on Ireland/Northern Ireland (“the Protocol”) in conjunction with Annex 2 to that Protocol, Regulation (EC) No 726/2004 2 and Directive 2001/83/EC 3 as well as the Commission acts based on them, apply to and in the United Kingdom (UK) in respect of Northern Ireland.
Medicines placed on the market in Northern Ireland must therefore be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisation) or by the UK in respect of Northern Ireland in accordance with the abovementioned acts.
Despite the transition period provided for in the Withdrawal Agreement, it proved difficult for certain economic operators based in parts of the UK other than Northern Ireland to adapt and move relevant regulatory compliance functions (namely, the marketing authorisation holder, quality control (batch) testing, the qualified persons responsible for batch testing and release and for pharmacovigilance) to Northern Ireland or the Union in respect of nationally authorised medicines, as required by the Protocol.
To ensure the uninterrupted supply of medicines covered by UK national authorisations from Great Britain to Northern Ireland, as well as to other markets that have been historically dependent on supplies from the UK market, the Union adopted Directive (EU) 2022/642 4 , which introduced derogations from certain obligations concerning certain medicinal products for human use made available in the UK in respect of Northern Ireland (and in Cyprus, Ireland and Malta). These derogations allowed economic operators to maintain batch testing and release and manufacturing / regulatory functions in parts of the UK other than Northern Ireland.
Directive (EU) 2022/642 also introduced a bridging solution on novel medicines that under Union law are authorised through the centralised procedure provided by Regulation (EC) No 726/2004. That solution allows the competent authorities of the UK to authorise the supply to patients in Northern Ireland of a novel medicine for which a marketing authorisation has been issued by the competent authority of the UK, while there is no marketing authorisation granted yet for the same medicine in the Union. This possibility was granted on a temporary basis, until a marketing authorisation is granted or refused in the Union, and in any case for a maximum period of six months.
The practical application of the above provisions on novel medicines has shown that any divergence between the terms of the marketing authorisations granted for the same medicine in the Union and in the UK would require manufacturers to provide separate packs and patient leaflets for Great Britain and Northern Ireland. This would represent a significant economic burden for the manufacturers concerned relative to the small size of the Northern Ireland market and could put at risk the uninterrupted supply of novel medicines to patients in Northern Ireland. Both the UK authorities and stakeholders have also raised concerns that the coexistence of potentially divergent marketing authorisations for Great Britain and Northern Ireland for the same medicine would create legal uncertainty as to the applicable rules for medicines that need to be made available at all times across the UK to the same cohorts of patients.
Additionally, medicines subject to prescription intended for the Northern Ireland market must carry safety features in accordance with Union law. To prevent the reintroduction of exported medicines into the EU single market, Article 22(a) of Commission Delegated Regulation (EU) 2016/161 5 obliges wholesalers to decommission the unique identifier on all medicines they export outside the Union before they are exported. If the exported medicines are subsequently reimported into the Union, the requirements for importation under Directive 2001/83/EC must be met and a new unique identifier affixed and uploaded to the repositories system. These operations can only be performed by the holder of a manufacturing and importation authorisation. In December 2021, the Commission Delegated Regulation (EU) 2022/315 6 amended Delegated Regulation (EU) 2016/161 with a view to introducing a derogation from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the UK for a period of three years. This was to prevent supply disruptions in Northern Ireland as many medicines were purchased from the UK by wholesalers not holding a manufacturing and importation authorisation and therefore unable to meet the importation requirements laid down in Directive 2001/83/EC and Delegated Regulation (EU) 2016/161.
Despite the above-mentioned derogations, the UK and certain stakeholders based in the UK have raised concerns that the need for separate marketing authorisations for Great Britain and Northern Ireland in respect of novel medicines and the application of the Union unique identifier requirement for medicines subject to prescription impose unnecessary administrative burdens for medicines that are to be placed only on the Northern Ireland market and will not be made available in any Member State.
The Commission and the Government of the UK have thus reached a comprehensive set of joint solutions to address these concerns, while protecting the integrity of both the Union’s and the UK’s internal markets.
These joint solutions mark a new way forward to implement the Protocol to ensure legal clarity, predictability and prosperity for the people and businesses in Northern Ireland while at the same time preventing any risks to public health in the internal market.
This Proposal reflects these joint solutions, to provide that:
–New and innovative medicines lawfully placed on the market in Northern Ireland are to be only covered by a valid marketing authorisation issued by the UK according to the law of the UK. The placing on the market of these medicines will therefore not anymore be regulated by EU-wide authorisations granted by the Commission.
–The EU safety features that must be displayed on packs of medicines subject to prescription in the Union should not appear on packs of medicines made available to patients in Northern Ireland.
These solutions are accompanied by safeguards to ensure that all medicines placed on the market in Northern Ireland will not be made available in any Member State. These include labelling UK packs with a specific label: “UK only”, continuous monitoring by the UK competent authorities as well as the possibility for the Commission to unilaterally suspend the application of the new rules in case of UK non-compliance with its obligations.
• Consistency with existing policy provisions in the policy area
A comprehensive Union medicinal products legislative framework is established, including Regulation (EC) 726/2004 and Directive 2001/83/EC, which are of relevance for this initiative that will complement and amend them.
• Consistency with other Union policies
This proposal does not affect other Union policies, except for the health and internal market rules. Therefore, the assessment of the consistency with other Union policies is not considered necessary.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
Contents
Article 114 of the Treaty on the Functioning of the European Union, which is the same legal basis for the existing Union legislation in the area of medicinal products.
• Subsidiarity (for non-exclusive competence)
This Proposal provides for specific rules for the placing on the market in Northern Ireland of medicinal products for human use.
• Proportionality
This Proposal lays down a comprehensive framework of conditions, specific rules and safeguards. It lays down specific rules for the placing on the market in Northern Ireland of medicines for human use. It empowers the Commission to adopt the necessary delegated acts for the suspension of specific rules if there is evidence that the UK does not take appropriate measures to tackle serious or repeated infringements of the specific rules. The act also provides for a number of safeguard mechanisms to ensure that the integrity of the Union’s internal market is protected.
• Choice of the instrument
As the initiative concerns the adoption of specific rules in an area to which several Union acts apply, a proposal for a Regulation of the European Parliament and Council is considered to be the appropriate instrument.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
• Stakeholder consultations
This initiative is proposed following bilateral discussions with the UK and industry associations and other relevant stakeholders. No open public consultation will be carried out.
• Collection and use of expertise
• Impact assessment
The proposal is exempted from the impact assessment due to the urgency of the situation.
• Regulatory fitness and simplification
• Fundamental rights
The proposed Regulation contributes to achieving a high level of human health protection as set out in Article 35 of the Charter of Fundamental Rights of the European Union.
4. BUDGETARY IMPLICATIONS
There are no implications for the Union budget.
5. OTHER ELEMENTS
Implementation plans and monitoring, evaluation and reporting arrangements
• Explanatory documents (for directives)
• Detailed explanation of the specific provisions of the proposal
Not applicable