Explanatory Memorandum to COM(2021)998 - Amendment of Regulation as regards derogations from obligations concerning medicinal products made available in the UK (in respect of Northern Ireland), Cyprus, Ireland, Malta

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dossier COM(2021)998 - Amendment of Regulation as regards derogations from obligations concerning medicinal products made available in the UK (in ...
source COM(2021)998 EN
date 17-12-2021


1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Pursuant to the Protocol on Ireland/Northern Ireland (“the Protocol”) of 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 1 (the ‘Withdrawal Agreement’), the importation of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the possession of a manufacturing and import authorisation. These shall be in compliance with the obligations of the EU acquis for clinical trials.

During these last years, the United Kingdom in respect of Northern Ireland as well as the small markets of the European Union (i.e. Malta, Ireland and Cyprus) that are dependent on supply of medicinal products from the United Kingdom, have raised issues with respect to the ability of economic operators to comply with all provisions of the acquis for medicines after the end of the transition period provided for in the Withdrawal Agreement, including medicines used in clinical trials, having regard in particular to the importation requirements.

The Commission Notice of 25 January 2021 2  provides for a grace period of one year (until end-December 2021), including for the importation requirements for investigational medicines, to ensure undisrupted supply of medicines to Northern Ireland, Cyprus, Ireland and Malta.

Despite the transition period, it still proves very difficult for certain operators currently based in parts of the United Kingdom other than Northern Ireland to adapt as required by the Protocol. The main reasons are the too high adjustment costs relative to the small size of the Northern Irish market and the complex logistics involved, for which no viable alternative logistical hubs in Northern Ireland have been identified.

For the markets of Cyprus, Malta and Ireland, the same issues arose, and in addition, difficulties were seen with to ensure that clinical trial participants have access to certain medicinal products due to supply chains reliance on other parts of the United Kingdom than Northern Ireland. 

Disruption in supply of investigational medicinal products would pose potential risk to the safety and well-being of participants in ongoing clinical trials as well as hinder the setting up of new clinical trials in these Member States and in Northern Ireland.

The objectives of this proposal are to address the issues related to investigational medicinal products, to prevent an adverse impact on their supply and, as a result, on the execution of clinical trials authorised under Regulation (EU) 536/2014 3 in Northern Ireland, Cyprus, Ireland and Malta.

This proposal allows exceptionally that the manufacturing and import authorisation is not required for investigational medicinal products imported into Cyprus, Ireland, Malta and Northern Ireland from parts of the United Kingdom other than Northern Ireland, provided that certain conditions are fulfilled. For Cyprus, Ireland and Malta, this derogation is of a temporary nature as it is expected that these markets will gradually be supplied through Member States. A transition period of 3 years seems sufficient.

Although Regulation (EU) 536/2014 entered into force in 2014, its applicability was made dependent on the full functionality of the European Portal and Database. The Commission published the notice of full functionality on 31 July 2021, triggering a 6-month period before applicability on 31 January 2022. 4  As a transitional measure, during the first year (until 31 January 2023), sponsors can chose to submit a clinical trial application in line with the rules of Regulation (EU) 536/2014 or through the rules of Directive 2001/20/EC 5 . Trials authorised under that Directive can continue until 31 January 2025.

Therefore, this proposal should be read in conjunction with the conceptually identical changes to Directive 2001/20 proposed in COM(2021)997 of 17 December 2021 as both legal acts can apply to different clinical trials in the EU until 31 January 2025. For this reason, this separate proposal was given an exemption from an additional fiche for the agenda planning. Considering the urgency needed to address the issues, the roadmap for this initiative will not be provided.

• Consistency with existing policy provisions in the policy area

A comprehensive Union medicinal products legislative framework was established, in particular Directive 2001/83/EC 6 , Directive 2001/20/EC and Regulation (EU) No 536/2014, which are of relevance for this initiative that will complement and amend them.

This proposal is consistent with the objective to protect participants of clinical trials and public health in the small markets of the Union and in Northern Ireland.

• Consistency with other Union policies

This proposal does not affect other Union policies, except for the health and internal market rules. As a consequence, the assessment of the consistency with other Union policies is not considered necessary.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

As this proposal amends Regulation (EU) No 536/2014, the same legal basis − Articles 114 and 168(4)(c) TFEU − are considered the appropriate legal basis for this proposal as well.

• Subsidiarity (for non-exclusive competence)

This proposal provides exemptions from the provisions of the EU pharmaceutical legislation and can only be achieved by an amendment of the basic act at EU level.

This proposal aims to provide derogations for medicinal products distributed to Northern Ireland, Cyprus, Ireland and Malta that are used as investigational medicinal products in clinical trials in those countries.

• Proportionality

The proposal covers the exemption from the importation requirements for investigational medicinal products to ensure their continued supply and avoid delays or interruptions to the setting up and conduct of clinical trials in the Union and in Northern Ireland.

The proposal is restricted to investigational medicines made exclusively available in Northern Ireland and the small markets of those EU Member States − Cyprus, Malta and Ireland − that are dependent on the UK market.

• Choice of the instrument

As the initiative amends Regulation (EU) No 536/2014, a proposal for a Regulation of the European Parliament and Council is considered the appropriate instrument.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex-post evaluations/fitness checks of existing legislation

Not applicable

• Stakeholder consultations

This initiative is proposed following bilateral discussion with the concerned national authorities and industry associations, who have expressed strong concerns due to the risk of interruptions of ongoing or future clinical trials due to the requirements for importation of investigational medicinal products.

Considering that targeted consultations with the Member States concerned and the stakeholders took place, another open public consultation will not be carried out.

• Impact assessment

The proposal is exempted from the impact assessment due to the urgency of the situation, to ensure public health through the continued supply of investigation medicinal products for clinical trials in Northern Ireland and the small markets of the EU Member States that are dependent on the United Kingdom for their supplies.

• Regulatory fitness and simplification

By waiving certain regulatory requirements for the importation of investigational medicinal products, provided certain conditions are fulfilled, the proposal reduces compliance costs in particular as regards SMEs.

• Fundamental rights

The proposed Regulation contributes to achieving a high level of human health protection as set out in Article 35 of the EU Charter of Fundamental Rights.

4. BUDGETARY IMPLICATIONS

No budgetary implications are foreseen.

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The initiative applies to the United Kingdom in respect of Northern Ireland that must implement it and notify to the Commission the implementation planning associated with this initiative. The Member States concerned as well must take the necessary measures to implement the initiative. The Commission will further monitor its implementation.

• Detailed explanation of the specific provisions of the proposal

Not applicable for this proposal.