NTRODUCTION
What have you adopted today?
The European Commission has today proposed bespoke arrangements to respond to the difficulties that people in Northern Ireland have been experiencing because of Brexit and challenges in East-West trade, in particular (i.e. Great Britain to Northern Ireland). These arrangements are set out in four non-papers, which the College of Commissioners adopted today:
- Sanitary and Phytosanitary Issues (SPS)
- Customs
- Medicines
- Engagement with Northern Ireland Stakeholders and Authorities
Why are you coming forward with these proposals?
These proposals are our reaction to the difficulties that people in Northern Ireland have been facing because of Brexit and the type of Brexit the UK government chose.
This package follows extensive discussion with the UK government as well as outreach by the European Commission over the past months to political leaders, businesses, civil society and other stakeholders in Northern Ireland. Today’s package also comes as a response to the UK’s Command Paper published in July 2021.
Ten months into the implementation of the Protocol we have a clear idea of the core issues that need to be addressed to ensure its smooth implementation. The solutions to be put in place have been the subject of extensive discussions between the Commission and the UK government as well as stakeholders in Northern Ireland, including a visit by Vice-President Šefčovič to Northern Ireland. The package proposed by the Commission today aims to address these issues in a durable way in the interest of stability and predictability on the island of Ireland.
What are the next steps?
The Commission stands ready to engage in intensive discussions with the UK government, with a view to reaching a jointly agreed permanent solution as soon as possible. The Commission will do this in close collaboration and constant dialogue with the European Parliament and Council.
SOLUTIONS IN FOUR AREAS
- Public, plant and animal health (i.e. Sanitary and Phytosanitary (SPS) issues)
What is the problem?
Northern Ireland and Ireland are treated as a single SPS area and share the same EU rules in the area of public, plant and animal health for the purposes of managing the consequences of any health outbreaks.
In order to avoid a hard border on the island of Ireland, checks and controls need to take place on the movement of SPS goods from Great Britain to Northern Ireland. Certain of these checks are not completely new, as they have been in place for many years before Brexit, taking into account the fact that the island of Ireland is a single epidemiological unit. Such checks and controls prevented, for example, the spread of mad cow disease to the island of Ireland.
Until now, there are significant shortcomings in the UK honouring its commitments in this area. Temporary Border Control Posts lack the proper infrastructure and staff to perform the required controls on SPS goods entering Northern Ireland. The Northern Ireland Executive has also halted both the construction of permanent Border Control Posts and the hiring of new staff.
Moreover, people and businesses in Northern Ireland have highlighted disproportionately high administrative burdens on the movement of SPS goods from Great Britain to Northern Ireland.
What is your solution?
The Commission is proposing a bespoke solution in this area. This would result in simplified certification and a reduction of official checks for a significant range of retails goods. This equates to a reduction of approximately 80% of the checks required today.
In order to protect the integrity of the Single Market, this would be subject to a number of conditions and safeguards, such as the UK delivering on its commitment to complete the construction of permanent Border Control Posts, specific packaging and labelling indicating that the goods are for sale only in the UK, and reinforced monitoring of supply chains. In addition, safeguards would include a rapid reaction mechanism to any identified problem in relation to individual products or traders, and unilateral measures by the EU in case of failure by UK competent authorities or the trader concerned to react to or remedy an identified problem. These specific conditions and safeguards would provide a robust monitoring and enforcement mechanism that would make a significant reduction of checks possible without endangering the integrity of the Single Market.
Is this solution in addition to what you have already proposed?
This solution is in addition to the flexibilities that the EU has already identified in order to facilitate the full implementation of the Protocol. This includes, for example, solutions to facilitate the movement of livestock from Great Britain to Northern Ireland, by removing the need for re-tagging when animals move multiple times between Great Britain and Northern Ireland. More information is available here.
- Customs
What is the problem?
One of the key concerns raised by the UK government, and by people and businesses in Northern Ireland, is the additional administrative burden when it comes to customs procedures and documentation when goods move from Great Britain to Northern Ireland, as a result of Brexit and the type of Brexit the UK government chose.
What is your solution?
We propose to expand the scope of the existing scheme on ‘goods not at risk’ of entering the Single Market to a wider group of beneficiaries (i.e. businesses) and products. For example, more small and medium-sized enterprises could benefit from the scheme.
We also propose to cut in half the customs formalities and processes that are required today for these goods. Businesses will only need to provide a set of basic information to the customs authorities, such as the invoice value of the goods and the parties to the transaction. For businesses that are eligible for the UK Trader Scheme, customs formalities will be significantly simplified, as they will rely on the internal records of the companies and periodic declarations.
This is subject to safeguards, such as the UK committing to providing full and real-time access to IT systems, a review and termination clause, as well as the UK customs and market surveillance authorities implementing appropriate monitoring and enforcement measures.
When taken together, the bespoke solutions for SPS and customs rules will create a type of “Express Lane” for the movement of goods from Great Britain to Northern Ireland while at the same providing for a robust monitoring and enforcement mechanism in order to protect the integrity of the Single Market.
- Medicines
What is the problem?
Under the Protocol, Northern Ireland remains aligned to EU rules and regulatory oversight in the area of medicines. The UK will not remain aligned to EU rules. This inevitably creates challenges, particularly in the area of medicines that are supplied to Northern Ireland through or from Great Britain.
What is your solution?
The EU is determined to ensure not only a high level of public health protection, but also an undisrupted supply of medicines to Northern Ireland. This was already made clear when the Commission presented the package of solutions in June 2021.
The result of our proposal will be that pharmaceutical companies in Great Britain can keep all their regulatory functions where they are currently located, when supplying the Northern Irish market with medicines that have been authorised by the UK regulatory authority in accordance with the Protocol. In addition, it includes a conditional derogation from the manufacturing authorisation required to bring medicines into Northern Ireland from Great Britain.
This means, for instance, that Great Britain would continue acting as a hub for the supply of generic medicines for Northern Ireland, even though it is now a third country. In this way, the long-term supply of medicines to Northern Ireland can be ensured without any disruption. The Commission will hold further discussions with the UK and stakeholders before finalising its proposal.
This proposal involves the EU changing its own rules on medicines.
Does this mean that cancer drugs will be fully available in Northern Ireland?
The Protocol already ensures full access to life-saving medicines. There is no evidence of any shortage of such medicines in Northern Ireland. This was never an issue in the context of the implementation of the Protocol.
Innovative, new life-saving medicines (i.e. containing a new active substance) like those needed to treat cancer or other illnesses such as diabetes, neurodegenerative diseases, auto-immune or other immune dysfunctions, viral diseases (e.g. COVID-19), are centrally approved in the EU, via the European Medicines Agency (EMA) procedure. Generics of centrally approved medicines – or providing a significant innovation or advantage for patients – also need to undergo the EMA procedure. Medicines centrally approved in the EU, via the EMA procedure, can be placed on the Northern Ireland market without any further formalities, and are therefore automatically available to Northern Ireland as well.
If a new cancer drug is submitted for approval to both the EMA and the UK regulatory authority, and if the latter is quicker in issuing its approval, it will always be possible to bridge this short gap, and supply and administer the medicine concerned in Northern Ireland. This can be done under the special procedure for exemptions for compassionate use that is available in EU legislation on human medicines. This involves the administration of a medicine that has not yet received the necessary regulatory approvals to individual patients under the direct personal responsibility of a doctor (this procedure was used, for instance, to allow the immediate availability of the AstraZeneca vaccine to Northern Irish patients pending the EU’s approval).
- Democratic participation
What is the problem?
The EU is aware that there is a real interest in Northern Ireland for greater transparency in how the Protocol is applied. Businesses, civic society groups and public authorities highlighted this in discussions with the Commission.
What is your solution?
These proposals aim to improve the exchange of information with stakeholders and authorities in Northern Ireland with regard to the implementation of the Protocol and relevant EU measures. This would make the application of the Protocol more transparent, while at the same time respecting the UK’s constitutional order. This solution consists of establishing structured dialogues between Northern Ireland stakeholders (authorities, civic society and businesses) and the Commission. This would involve the creation of structured groups with the participation of experts to discuss relevant aspects of Union measures that are important for the implementation of the Protocol. Northern Irish stakeholders would also be invited to attend some meetings of the Specialised Committees. It will also create a stronger link between the Northern Ireland Assembly and the EU-UK Parliamentary Partnership Assembly. A website will also be set up to show in a clear and comprehensive way the EU legislation applicable in Northern Ireland.
ARTICLE 16
Do you think your proposals are enough to prevent the UK government from triggering Article 16 of the Protocol?
The European Commission is responding to challenges as raised by Northern Irish stakeholders during a series of outreach activities, including the visit of Vice-President Maroš Šefčovič to Northern Ireland in September. We are therefore focusing on solving practical problems with practical solutions. Our ultimate goal is to provide predictability, stability and certainty for the people of Northern Ireland.
The package does this. It lays the ground for a solution-oriented period of talks to jointly agree the way forward. It proves that the Protocol and EU law is flexible enough to find credible, creative solutions that make a real difference on the ground.
THE PROTOCOL
What is the Protocol?
The Protocol on Ireland/Northern Ireland is the solution found jointly by the European Union and the United Kingdom to the challenges created by Brexit and the type of Brexit chosen by the UK government. It is a fully legally operative solution that avoids a hard border on the island of Ireland, protects the all-island economy and the Good Friday (Belfast) Agreement in all its dimensions, and safeguards the integrity of the Single Market.
Northern Ireland remains aligned to a limited set of rules related to the EU’s Single Market and the Customs Union in order to avoid a hard border: legislation on goods, sanitary rules for official controls (“SPS rules”), rules on agricultural production/marketing, VAT and excise in respect of goods, and state aid rules. This allows Northern Ireland to access both the UK markets and the Single Market.
What is the consent mechanism?
The Protocol provides for a “consent” mechanism, which will give the Northern Ireland Assembly a decisive voice on the long-term application of relevant EU law in Northern Ireland.
This consent mechanism concerns the substantive issues of regulatory alignment on goods and customs, the Single Electricity Market, VAT and state aid.
In practice, this means that four years after the end of the transition period, the Assembly can by simple majority give consent to the continued application of relevant Union law, or vote to discontinue its application, in which case the United Kingdom would notify the EU. In such a case, the Protocol will cease to apply two years later.
Every four years thereafter, the Assembly can vote on the continued application of relevant Union law. In case a vote of the Assembly gathers cross-community support for the continued application of relevant Union law, the next vote can only take place 8 years thereafter.
For More Information
Factsheet: concrete examples of today’s package
Factsheet: the benefits of the Protocol
Factsheet: Examples of flexibilities already identified
*Updated 15/10/2021 at 17:00
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