Explanatory Memorandum to COM(2021)997 - Amendment of Directives as regards derogations from obligations concerning medicinal products made available in the UK (in respect of Northern Ireland), Cyprus, Ireland, Malta - Main contents
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| dossier | COM(2021)997 - Amendment of Directives as regards derogations from obligations concerning medicinal products made available in the UK (in ... |
|---|---|
| source | COM(2021)997  |
| 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”), medicines placed on the market in Northern Ireland must be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisations) or the United Kingdom (UK) in respect of Northern Ireland. These national authorisations shall be in compliance with the obligations of the EU acquis for medicinal products.
During these last years, the UK 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 (de facto mostly for generics and over-the-counter medicines). There are two possible national authorisation routes: purely UK national authorisations (“Northern Ireland-only authorisations”), which concern medicines that are made available in Northern Ireland only, and UK national authorisations issued under Union law procedures involving at least another Member State (Mutual Recognition or Decentralised Procedures 2 ).
The Commission Notice of 25 January 2021 3 provides for a grace period of one year (until end-December 2021) for maintaining batch testing and manufacturing / logistics in parts of the United Kingdom other than Northern Ireland to ensure undisrupted supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. 4
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 and move relevant regulatory compliance functions (namely, the marketing authorisation holder, quality control (batch) testing, the qualified persons responsible for batch testing pharmacovigilance) to Northern Ireland or the EU in respect of nationally authorised products, 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.
By the same token, most industry players currently based in parts of the United Kingdom other than Northern Ireland are not prepared to make the necessary regulatory changes to continue to serve the EU Member States (Cyprus, Ireland, Malta) that have been traditionally dependent on medicines supply from or through parts of the United Kingdom other than Northern Ireland. Medicines for these markets are still mainly distributed by wholesalers with logistical hubs in parts of the United Kingdom other than Northern Ireland. The common English leaflet in United Kingdom in respect of Northern Ireland, Cyprus, Ireland and Malta is also one of the element that industry wants to preserve.
The objectives of this proposal are to address the issues related to the human medicinal products, to prevent shortages of medicines and ensure adequate level of public health protection in Northern Ireland, Cyprus, Ireland and Malta.
–A marketing authorisation holder may be established in parts of the United Kingdom other than Northern Ireland;
–The manufacturing authorisation holder may be located in parts of the United Kingdom other than Northern Ireland;
–The batch testing may be carried out in parts of the United Kingdom other than Northern Ireland;
–The qualified person for batch testing and pharmacovigilance may be located in parts of the United Kingdom other than Northern Ireland;
–An EU wholesaler located in Northern Ireland, Cyprus, Ireland, or Malta may purchase and obtain medicines from a third country (parts of the United Kingdom other than Northern Ireland) without holding a manufacturing import authorisation and without re-testing the products.
The Union has an agile system to authorise new and innovative medicinal products through the centralised procedure provided by Regulation (EC) No 726/2004. Those medicinal products will be available to patients in Northern Ireland. However, it is possible that for some of these products the competent authorities of the United Kingdom in respect of other parts of the United Kingdom than Northern Ireland issue a marketing authorisation, while there is no marketing authorisation granted yet for the same medicinal product in the Union. In such an exceptional case, the competent authorities of the United Kingdom in respect of Northern Ireland would be able to supply those medicinal products to patients in Northern Ireland temporarily and until a marketing authorisation is granted or refused in the Union. Those temporary authorisations should be time limited and cease in any case once a decision on the medicinal product is taken by the Commission to grant or refuse the authorisation to market that product.
In addition, if an application for marketing authorisation is submitted in one or more Member States and in the United Kingdom in respect of Northern Ireland, or if an application for marketing authorisation is submitted in the United Kingdom in respect of Northern Ireland for a medicinal product which is already being examined or has already been authorised in a Member State, the proposal provides that the applicant may choose between the mutual recognition/decentralised procedure and the national authorisation procedure in respect of Northern Ireland.
Likewise, the proposal provides that the marketing authorisation holder of a medicinal product for which a marketing authorisation has already been granted for the United Kingdom in respect of Northern Ireland in accordance with the mutual recognition or decentralised procedure may withdraw the marketing authorisation for the United Kingdom in respect of Northern Ireland from the mutual recognition and decentralised procedure and to submit an application for a marketing authorisation for that medicinal product to the competent authorities of the United Kingdom with respect to Northern Ireland in accordance with the national authorisation procedure.
For Cyprus, Ireland and Malta, derogations are temporary as it is expected that these markets will gradually be supplied through Member States. A transition period of 3 years therefore seems sufficient.
• Consistency with existing policy provisions in the policy area
A comprehensive Union medicinal products legislative framework is established, in particular Directive 2001/83/EC 5 and Directive 2001/20/EC 6 , which are of relevance for this initiative that will complement and amend them.
This proposal is consistent with the objective to protect 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 the initiative amends Directive 2001/83/EC and Directive 2001/20/EC, the same legal basis − Article 114 TFEU − is considered the appropriate legal basis for this proposal as well.
• Subsidiarity (for non-exclusive competence)
This proposal provides exemptions to the provisions of the EU pharmaceutical legislation and can only be achieved by an amendment of the relevant basic acts at EU level.
The European Commission has explored the possibility given by the implementation of Article 5 of Directive 2001/83/EC to use non-compliant medicines under the compassionate use procedure for the purposes of medicines supply to Cyprus, Ireland and Malta.
Nevertheless, the competent authorities of the Member States concerned do not want to transfer the liability arising from these derogations to the healthcare professionals. Moreover, the compassionate use should be restricted to a limited number of medicinal products on a case-by-case basis under certain circumstances.
This proposal aims to provide derogations for medicinal products distributed to Northern Ireland, Cyprus, Ireland and Malta.
• Proportionality
The proposal covers the exemptions for regulatory functions that had not been transferred by industry to the EU or Northern Ireland before the end of the transition period provided for in the Withdrawal Agreement. This proposal is not going beyond what is absolutely necessary to ensure continued supply of medicinal products (for human use).
The proposal is restricted to medicinal products made exclusively available in Northern Ireland and the small markets of the Union that are dependent on the UK market for their medicine supplies.
• Choice of the instrument
As the initiative amends Directive 2001/83/EC and Directive 2001/20/EC, a proposal for a Directive 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
• Stakeholder consultations
This initiative is proposed following bilateral discussion with the concerned national authorities and industry, wholesale distributors and pharmacists, who have expressed strong concern due to the risk of shortages of medicines supplies.
• 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 medicinal products in Northern Ireland and the small markets of the Union that are dependent on the UK for their supplies.
• Regulatory fitness and simplification
By waiving certain regulatory requirements for the importation of medicinal products, provided certain conditions are fulfilled, the proposal reduces compliance costs in particular as regards the SMEs.
• Fundamental rights
The proposed Directive 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 UK in respect of Northern Ireland that must implement it and must 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 via the supervision and control mechanism set therein, with the support of the competent authorities of the Member States.
• Explanatory documents (for directives)
The Member States concerned shall transpose this proposal within the set timeframe and take the necessary measures to comply with this Directive.
• Detailed explanation of the specific provisions of the proposal
Not applicable for this proposal.