EU NIP announcements (Northern Ireland)

On 13 October, the EU announced its October 2021 package of proposed measures to amend the Northern Ireland Protocol (to the UK-EU Withdrawal Agreement). This October 2021 package is here. (scroll down)

The October 2021 package is a series of “non papers”, these are not binding. The UK has it’s similar not binding “command paper” issued July – here. Both sets of documents contain a certain amount of spin.

UKG (UK Government) and the EU will discuss the documents over the next weeks. In the meantime, UKG had already extended indefinitely existing NIP grace periods and this is reflected in UKG Brexit Guidance (instructions) found collated in Cardinal Environment EHS Legislation Registers and Checklists.

The Northern Ireland Protocol regulates Northern Ireland’s access to the EU single market, but also affects it’s arrangements with the rest of the UK. This has since 1 Jan 2021 impacted on goods movements from Britain (GB) to Northern Ireland (UKG itself relaxed NIP rules for movement from Northern Ireland to GB); and it’s state aid rules.

Governance of the Northern Ireland Protocol arrangements is currently by the ECJ or CJEU as the court is known as in the EU. It is also an ask of UKG that this governance be altered and the role of the ECJ removed. This was a UKG ask at the time of negotiation of the Withdrawal Agreement.

In the event that agreement is not reached between the parties (UKG unilateral extension of grace periods is itself not agreed), it is open to one or the other to take unilateral action.

Further announcements are awaited.

EU further detail re NI Protocol (Northern Ireland)

The EU issued (a few days ago) a set of non-papers that give further detail on its proposals for changes to its Single Market rules to ease movements between NI and GB under the Ireland/Northern Ireland Protocol (a schedule to the UK-EU Withdrawal Agreement).

The first set deals with sanitary and phytosanitary (SPS) – here.

(1) re guide dogs (assistance dogs) – European Commission’s services had clarified (some time ago) that assistance dogs accompanying their owner when entering the EU territory and Northern Ireland, may benefit from the flexibility offered by Article 32 of Regulation (EU) No 576/2013 on the non- commercial movement of pet animals.

The above was recalled in the technical meetings the EU held with the UK Cabinet Office and the British DEFRA ministry, especially those held on 27 April and 12 May 2021, where the UK side confirmed that the Northern Ireland ministry DAERA would propose an operating procedure for the practical implementation of Article 32.

DAERA updated its guidance on 2 June 2021 – here.

(2) re identification and re-identification of cattle, sheep and goats – the document points out that EU rules on traceability of terrestrial animals require that certain species (bovines, ovines, caprines, camelids and cervids) shall be individually identified on the establishment where they are born. The same requirement applies to animals of those species when they enter into the Union from a non-EU country; those animals have to be individually identified at the establishment of arrival.

Under the EU animal health legislation (Delegated Regulation (EU) 2019/2035), bovine, ovine and caprine animals need to be identified with an eartag bearing a code as laid down in Implementing Regulation (EU) 2021/520 so that the first element of the identification code is the country code of the Member State where the means of identification was first applied to. The country code can be either a two-letter code (mirroring ISO standard 3166-1 alpha-2) or a three-digit country code (ISO standard 3166-1 numeric).

The EU has now issued Implementing Regulation (EU) 2021/1064 to provide that ‘XI’ is the two-letter code to be used in United Kingdom in respect of Northern Ireland and the three-digit code assigned is ‘899’.

–  New-born animals in NI after 01/07/21 should bear the “XI or “899” code in their eartags;

–  Animals introduced from third countries (or GB) into NI after 01/07/21 and identified not in accordance with EU rules (e.g. bearing a UK code) should be re-identified with eartags bearing “XI” or “899” establishments of the first arrival;

–  Animals introduced from third countries (or GB) into NI already identified in accordance with EU rules (e.g. bearing a XI code) do not need to be re-identified.

It must be remembered that EU Animal Health Law already moved on since 31st Dec 2020.

(3) re re-entry of animals for exhibitions/events – the document points out that EU animal health legislation (Delegated Regulation (EU) 2020/692) stipulates ungulate animals (except racing horses) to be introduced into the EU have to fulfil all the requirements and respect a residency period of 6 months in an authorised third country of origin for such imports.

To enable the participation of EU animals in events, exhibitions or shows, the Commission has drafted an amendment to Delegated Regulation (EU) 2020/692 to set up for certain species of ungulates (bovine, ovine and caprine animals) :

* a derogation from certain general requirements, including from the 6 months residency in the “guest” country;

* minimum specific animal health requirements for the re-entry into the Union of those animals:

–  they are moved for a period not exceeding 15 days to participate in events, exhibitions;

–  the third country is listed for the entry into the EU of cattle, sheep, goats;

–  the establishment complies with the requirements for assembly operations of ungulates;

–  the transport is direct and in appropriate vehicles;

–  the animals do not have contact with animals of a lower health status during the stay in the third country.

In addition, the Commission has drafted a new legal text (amending Implementing Regulation (EU) 2021/403 as regards the new model certificate and amending Regulation (EU) 2021/404 as regards the list of third countries authorised) to lay down:

–  a specific model certificate for entry into the EU of those animals reflecting the requirements described above;

–  the list of third countries authorised for this special re-entry into the EU of animals which took part to such events.

(4) re animal products that originate in the Union and move to a third country and then move back again after unloading, storage and reloading in that third country

The document states that animal health policy for entry into the EU of products of animal origin does not allow third countries to certify for import into the EU products which have been imported in that third country, including products of EU origin.

Therefore, the EU’s Implementing Regulation (EU) 2020/2235, which establishes the model certificates for entry into the EU of products of animal origin, does not include any model certificate to cover the entry into the Union of products of animal origin which originate in the EU and which are moved to a third country or territory, and are then moved back to the Union from that third country or territory after unloading, storage and reloading.

The lack of such certificate model would prohibit EU products of animal origin to re-enter the EU after being stored in a third country.

The Commission has drafted a new Implementing Regulation amending Implementing Regulation (EU) 2020/2235 to add a model certificate for that purpose. This will allow re-entry into the EU of products of EU origin which are packaged and stored under the control of the competent authority of the third country.

The change will also amend Annex XXII to Implementing Regulation (EU) 2021/404 to establish a list of third countries that are authorised to use that certificate (including GB and the Crown Dependencies).

A separate non-paper addresses medicines – here.

This document points out that medicines placed on the market in Northern Ireland (NI) must be covered by a valid marketing authorisation issued by the Commission (EU-wide authorisations) or the UK for NI in applying the Union legislation for medicinal products listed in Section 20 of Annex 2 to the Ireland/Northern Ireland Protocol (UK national authorisations).

The Protocol provides for two possible UK national authorisation routes: purely UK national authorisations (“NI-only authorisations”), which concern medicines that are made available in NI only, and UK national authorisations granted via the Mutual Recognition or Decentralised Procedures (MRP/DCP), which is mandatory.

European Commission Notice of 25 January 20212 provides for a grace period of one year (until end-December 2021) for maintaining batch testing and manufacturing / logistics in Great Britain (GB) to ensure undisrupted supply of medicines to NI and those EU Member States (Cyprus, Ireland and Malta) that have been historically dependent on medicines supply from or through GB.

Bear in mind that medicines supply in Northern Ireland is the responsibility of the UK authorities, not the EU.

The EU is now proposing that regulatory compliance functions may exceptionally be located in UK (GB) in respect of medicines covered by any national authorisations issued by the UK authorities in respect of NI, provided that the following conditions are met:

a. the UK fully applies the relevant Union legislation on medicines: on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to NI;

b. the marketing authorisation contains a legal prohibition of sale (resale) outside its geographical scope: medicines with an authorisation for UK(NI) cannot be legally sold anywhere else in the EU and the specific authorisation code for NI is stamped on each pack;

c. the safety features required under applicable Union law are placed on each pack ensuring that medicines can only be sold in conformity with a valid marketing authorisation in NI;

d. the UK ensures and demonstrates the correct implementation/application of the Falsified Medicines Directive in respect of NI. The EU end-to-end verification system must generate an alert if a medicine specifically authorised for NI is scanned elsewhere in the EU Internal Market;

e. enforcement and supervision by the UK competent authorities on economic operators and regulatory compliance activities located in GB are carried out in accordance with applicable Union law.

The document sets out additional requirements.

Information on the EU’s controls on medicines for human use is – here.

Bear in mind that the UK has signed up to the separate (non-EU) Project ORBIS and the MHRA has issued its first authorisation here. I wrote a blog post about this at the time.

Bear in mind that the BGMA has issued a press release about withdrawal of medicines a few days ago – reported by the BBC – here. The BGMA press release is – here.

EU announcements re NI Protocol (Northern Ireland)

The Protocol on Ireland and Northern Ireland (often referred to in the UK as the Northern Ireland Protocol), as an integral part of the EU-UK Withdrawal Agreement, was agreed jointly and ratified by both the EU and the UK. It has been in force since 1 February 2020 and has legal effects under international law.

The EU has announced the following re Northern Ireland (as respects the NI Protocol):

(1) the EU extends the non-application of third country rules (grace period) for meat products to 30th September (1st October is the date when the UK will apply its own ban on chilled meat imports) – the EU declaration is here – the UK declaration is here.

This will mean that meat products can continue to move from Britain (a third country in EU terms) to Northern Ireland (a part of the UK subject to the NI Protocol).

This temporary solution is subject to strict conditions. For example, the meat products that are subject to the channelling procedure referred to in the United Kingdom’s unilateral declaration must remain under the control of the Northern Ireland competent authorities at all stages of that procedure. These meat products must be accompanied by official health certificates issued by the UK competent authorities, can exclusively be sold to end consumers in supermarkets located in Northern Ireland, and must be packed and labelled accordingly. (EU declaration)

(2) the EU will change its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the NI Protocol, may be located in Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market – the European Commission will put forward a legislative proposal in the early autumn (the grace period runs out at the end of 2021)

(3) the EU will facilitate the movements of guide dogs accompanying persons travelling from Britain to Northern Ireland – this is communicated to the UK authorities and it is for the Northern Irish competent authorities to define the details for its implementation on the ground

(4) the EU waives the obligation to show the motor insurance Green Card for drivers from the UK – applicable for Northern Irish motorists crossing the border into Ireland (not for British motorists travelling to Ireland)

(5) the EU has removed the need for re-tagging when animals move multiple times between Britain and Northern Ireland during their life – the European Commission adopted an implementing act to that effect on 29 June 2021 (Commission Implementing Regulation (EU) 2021/1064).

The EU also announces the European Commission is working on a regulatory solution to facilitate the swift return of livestock to Northern Ireland from exhibitions or trade fairs in Britain, so that the animals concerned will not have to wait for a minimum residency period in Britain – the relevant delegated and implementing acts will be adopted in October 2021.

The EU also announces work is ongoing on a solution regarding the risk control of scrapie, to facilitate the movement of sheep and goats between Britain and Northern Ireland.

First Project Orbis Cancer Treatment Authorisation (UK)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has just announced its first authorisation (of a post-surgery lung cancer treatment) under Project Orbis.

Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments.

It involves the regulatory authorities of:

• Australia (TGA)

• Canada (Health Canada)

• United Kingdom (MHRA)

• Singapore (HSA)

• Switzerland (Swissmedic)

• Brazil (ANVISA)

The UK joined Project Orbis on 1 January 2021 following its departure from the EU (and the European Medicines Agency with the ending of the Brexit transition period on 31 Dec 2020). While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision. Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations.

Per the MHRA press release – Osimertinib (Tagrisso), a medicine made by AstraZeneca, is a licensed treatment for patients with mid and later stage non-small cell lung cancer (NSCLC) who test positive for a specific gene mutation called EGFR. EGFR mutations occur in approximately 12% of lung cancer patients. The licence has now been extended to include a new population of patients in early-stage disease. The extended licence offers a novel treatment option for these patients, after their cancer has been surgically removed, in an area of significant unmet need.

NHS England, NICE (the National Institute for Health and Care Excellence) and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal.

The MHRA press release is here. The press release sets out further detail.

Please note different Medicines supply stipulations apply in Northern Ireland from 1 Jan 2021 – here.

Counting GB divergence from EU law (Britain)

To date (end Feb 2021) divergence (this is not a definitive list) :

(1) international waste shipment – divergent waste transshipment law – EU bans plastics to non-OECD, Britain has enhanced pre-notification

(2) lead shot in fishing/hunting – EU Reach ban in/around wetlands from Feb 2023 (no announcement in Britain)

(3) carcinogen OELs – EU has further 2021 OELs (EH40 unchanged thus far)

(4) medicines licensing – Britain has ILAP launched 1st Jan – further information is here

(5) safety data sheets – EU has new Reach Annex II, one year grace (UK Reach unchanged so far)

There are other minor divergences

Additionally, and off topic, GB will not implement the latest proposed update to the EU motor insurance directive.

EU-UK Trade and cooperation agreement (2) (UK & EU)

I updated my post this morning with the link to the UK published legal text (1,246 pages – it’s the same text in the individual sections and chapters). Look back on the blog itself.

I also updated my post this morning (online) with the link to the EU document now loaded on a dedicated website, this also includes an EU Q&A – here.

A couple of points (identified in the Q&A) –

(1) Trading under ‘FTA’ (free trade agreement) terms from 1st Jan will differ substantively to trading in EU’s Customs Union and Single Market.

In particular:

• rules of origin will apply to goods in order to qualify for preferential trade terms under the agreement;

• all imports will be subject to customs formalities and will need to comply with the rules of the importing party;

• all imports into the EU must meet all EU standards and will be subject to regulatory checks and controls for safety, health and other public policy purposes.

(2) Traders will account not only for the origin of materials used, but also if their processing took place in the territory of one of the Parties. This is called ‘full cumulation’. Exporters will be able to self-certify the origin of the goods, and will have additional flexibility in collecting documentary evidence to prove origin during the first year.

(3) The Parties will recognise each other’s ‘Authorised Economic Operators’ programmes, enabling trusted traders with this status to use certain simplifications and/or facilitations relating to security and safety in their customs operations with the customs authorities of the other Party. But there is no waiver on security and safety declarations, as this requires alignment between the Parties on security standards.

(4) From 1st Jan, the EU and the UK will be two separate regulatory and legal spaces. This means that all products exported from the EU to the UK will need to comply with UK technical regulations and will be subject to any applicable regulatory compliance checks and controls. Similarly, all products imported from the UK to the EU will need to comply with EU technical regulations and will be subject to all applicable regulatory compliance obligations, checks and controls for safety, health and other public policy purposes.

(5) Both Parties agreed on a definition of international standards that identifies the relevant international standard-setting bodies. This is intended to ensure that both sides’ domestic product standards and technical regulations are based on the same international references and are therefore compatible to the extent possible.

(6) In the field of conformity assessment, the Parties agreed to maintain simplified access to each other’s markets through, in particular, the continued use of self-certification of conformity by the manufacturer where this is currently applied in both the EU and the UK. This covers a very large share of bilateral trade.

(7) Re Automotive Products – the Parties agreed that regulatory convergence will be based on the use of the international technical standards set at UNECE (United Nations Economic Commission for Europe) level. Both Parties will accept, in their respective markets, products that are covered by a valid UN type-approval certificate.

(8) Re Medicinal Products – the Parties agreed to recognise the results of inspections carried out by the authorities of the other Party in manufacturing facilities located in the territory of the issuing authority. This will avoid unnecessary duplication of inspections of manufacturers of medicinal products to assess their compliance with Good Manufacturing Practice requirements.

(9) Re Chemicals – the Parties agreed to cooperate, while respecting each Party’s right to regulate, both bilaterally and in relevant international fora, on the assessment of hazards and risks of chemicals and the formats for documenting the results of such assessment. The Parties already implement the UN GHS and this will continue. The Parties agreed to use transparent procedures for the classification of substances and possibly to exchange non-confidential information.

(10) Re Organic Products – the Parties agreed reciprocal recognition of equivalence of the current EU and UK organic legislation and control system, for all categories of organic products. Organic products complying with EU law and certified by control bodies recognised by the EU will be accepted on the UK market and vice-versa. In view of new EU rules for organic products applying as of 1.1.2022, equivalence will be reassessed by end-2023.

(11) Re SPS – there will be no changes to EU food safety standards. UK agri-food exporters will need to meet all EU SPS import requirements and be subject to official controls carried out by Member States’ authorities at Border Control Posts. Where required, these controls will include the verification of health certificates in line with international standards. Similarly, EU agri-food exporters will need to meet all UK SPS import requirements.

The Agreement allows for either party to unilaterally decide to reduce the frequency of certain types of border import controls, taking into account the extent to which their SPS rules converge.

It also ensures a simplified process for the approval of imports, where relevant by drawing up lists of establishments that are eligible to export to the other party, based on guarantees provided by the authorities of the exporting Party.

(12) Re Northern Ireland – the EU acquis, including the Union Customs Code, legislation on goods, sanitary rules for veterinary controls (“SPS rules”), rules on agricultural production/marketing, or VAT and excise in respect of goods, will apply to all goods entering Nortern Ireland.

As a result, from 1 January, goods entering Northern Ireland from Great Britain will constitute “imports”.  This means that such goods will need to comply with EU product rules and be subject to checks and controls for safety, health and other public policy purposes, including all necessary SPS controls applicable between the EU and the UK.

An agreement in principle (under the separate Withdrawal Agreement) has been found in the following areas, amongst others: export declarations, the supply of medicines, the supply of certain chilled meats and other food products to supermarkets, and a clarification on the application of State aid under the terms of the Protocol. There are some facilitations –

For example, certain chilled meat, for which imports in the Union market are normally prohibited, will be accepted for delivery to supermarkets in Northern Ireland during a limited period of 6 months:

• Minced meat of poultry, frozen or chilled. Chilled minced meat from animals other than poultry (e.g. minced beef.

• Chilled meat preparations (e.g. sausages, meatballs, pork pies)..

• Any fresh meat, including minced meat and meat preparations, produced from triangular trade (e.g. EU meat exported to Great Britain, cut or minced in Great Britain and re-exported to Northern Ireland).

Another example is that, during a limited period of 3 months, the goods coming from Great Britain and destined for supermarkets located in Northern Ireland will be accompanied with a simplified, collective certificate covering all the goods transported in the same truck, instead of individual certificates.

During this period of time, the UK shall maintain its current EU SPS legislation for the products concerned.

The scope is limited to a restricted number of food suppliers for supermarkets which are approved by the UK authorities after demonstrating that they meet a range of trust criteria. This list of members will be established by the United Kingdom in cooperation with the European Commission before 31 December 2020 and cannot be extended after that date.

(13) Re Business Persons Mobility – the temporary movement of natural persons for business purposes (often refered to as ‘mode 4‘), the EU and the UK have agreed on a broad range of reciprocal commitments facilitating the ability of companies located in a Party to transfer certain employees, as intra-corporate transferees, to work in an associated company located in the other Party. As intra-corporate transferees constitute temporary migration, the maximum duration of such transfers is capped at three years. With respect to UK nationals transferred to the EU, this duration includes periods of mobility between Member States. This is in line with current EU practice with other third countries.

The EU-UK Agreement also facilitates the movement of “contractual service suppliers” or “independent professionals” to supply services under certain conditions. Business visitors not providing services will also be allowed short-term entry in order to carry out certain activities.

(14) Re Legal Services – the EU and its Member States, and the UK will allow lawyers from the other Party to provide legal services relating specifically to the practice of international law and the law of the country where they are authorised under their “home” title.

However, it should be noted that EU law is not considered to be international law, but instead the law of the Member State in which EU lawyers are established or hold their “home title”.

(15) Re Energy – the UK will leave the EU’s internal energy market on 1st Jan, Northern Ireland will maintain the Single Electricity Market with Ireland (Republic of Ireland) (under the separate Withdrawal Agreement). The EU and the UK have agreed to establish a new framework for their future cooperation in the energy field. The UK Energy (Electricity) Guidance was updated on Dec 24th (see the Brexit Guidance List on Cardinal Environment Registers & Checklists).

The UK also leaves the EU ETS (see the Brexit Guidance List) and Euratom.

The UK will define its own climate change targets and policies and the UK committed to implementing a system of carbon pricing as of 1 January 2021. The Parties agreed a framework for cooperation in the fight against climate change, and their ambition to achieve economy-wide climate neutrality by 2050. The Parties will give serious consideration to linking their respective carbon pricing systems in a way that preserves the integrity of these systems and provides for the possibility to increase their effectiveness, for instance by adding further sectors, such as buildings. This would be subject to an agreement to be negotiated separately in the future.

There are also agreed provisions for cooperation in the development of offshore energy, with a focus on the North Sea.

(16) Re Euratom – the Agreement contains a separate agreement between Euratom and the UK on the safe and peaceful uses of nuclear energy.

This Agreement enables:

• the supply and transfer of nuclear material, non-nuclear material, technology and equipment;

• trade and commercial cooperation relating to the nuclear fuel cycle;

• cooperation in the safe management of spent fuel and radioactive waste;

• nuclear safety and radiation protection;

• use of radioisotopes and radiation in agriculture, industry and medicine;

• geological and geophysical exploration;

• development, production, further processing and use of uranium resources.

(17) Re Rebalancing (Level Playing Field, includes OHS and ENV Standards) – the Agreement provides the possibility to apply unilateral rebalancing measures in the case of significant divergences in the areas of labour and social, environment or climate protection, or of subsidy control, where such divergences materially impact trade or investment between the Parties.

This might be relevant, for example in a situation where one Party would significantly increase its levels of protection related to labour or social standards, the environment or climate above the levels of the other Party. This may entail an increase in the costs of production and hence a competitive disadvantage.

Another example would be a situation where one Party would have a system of subsidy control that would systemically fail to prevent the adoption of trade distorting subsidies, which would provide a competitive advantage for that Party.

In such cases, a Party would be able to adopt measures to rebalance the competitive advantage of the other Party.

Each Party could also, at regular intervals and if rebalancing measures have been taken frequently or for more than 12 months, seek a review of the trade and other economic parts of the Agreeent to ensure an appropriate balance between the commitments in the Agreement on a durable basis. In this case, the Parties could negotiate and amend relevant parts of the Agreement. Any trade or economic part of the Agreement, including aviation, that would remain in place or be renegotiated would retain appropriate level playing field commitments.

(18) Re OHS and ENV – the EU and the UK agreed to uphold levels of protection in the areas reated to labour and social standards, and environment and climate.

Labour and social levels of protection cover the following areas:

• fundamental rights at work;

• occupational health and safety standards;

• fair working conditions and employment standards;

• information and consultation rights at company level; or

• restructuring of undertakings.

Environmental levels of protection include the following areas:

• industrial emissions;

• air emissions and air quality;

• nature and biodiversity conservation;

• waste management;

• the protection and preservation of the aquatic environment;

• the protection and preservation of the marine environment;

• the prevention, reduction and elimination of risks to human health or the environment arising from the production, use, release or disposal of chemical substances; or

• the management of impacts on the environment from agricultural or food production, notably through the use of antibiotics and decontaminants.

The climate level of protection applies to:

• emissions and removals of greenhouse gases covering EU’s and the UK’s respective 2030 economy-wide targets including their systems of carbon pricing; and

• the phasing-out of ozone depleting substances.

(19) Re Further OHS and ENV Provisions – the Agreement contains several guarantees in terms of environmental protection, over and above the non-regression provisions applying to environment, climate and labour and social protection. These include:

• A recognition of the shared biosphere;

• Coverage of future targets that are now in the laws of the parties – the 2030 waste recycling targets, the 2027 water targets and the 2030 air pollution ceilings;

• Full inclusion of the key environment principles, including precautionary principle, polluter pays, and integration principle;

• Full inclusion of the principles of the Aarhus Convention with modernised text, including access to justice, access to information and public participation;

• Effective co-operation mechanism foreseen between the supervisory body or bodies in the UK in terms of protection of the environment, and the Commission;

• The recognition of the relevance of procedures for evaluating the likely impact of a proposed activity on the environment, such as an environmental impact assessment or a strategic environmental assessment.

(20) Re Health/Sanitary Quality in Agri/Foods – the broad scope of the commitment on the environment refers to agricultural and food production. In addition, it specifies two important areas for the level playing field with regards to agriculture and food production, namely the use of antibiotics and decontaminants.

(21) Re Aviation – UK carriers will be able to fly across the territory of the EU without landing; make technical stops in the territory of the EU for non-traffic purposes; and carry passengers and/or cargo on any routes between a given point in the UK and a point in the EU. Also, the Agreement will permit Member States and the UK to bilaterally exchange onward travel (termed 5th freedom) rights for extra-EU all-cargo operations only (e.g. Paris-London-New York).

The Agreement defines new arrangements for the recognition of future design and environmental certificates, as well as for production organisation oversight. Existing design certificates issued under EU rules before 1 Jan will remain valid.

(22) Re Road Transport – the Agreement provides for quota-free point-to-point access for operators transporting goods by road between the EU and the UK. This means UK lorries would be able to reach the EU and return from the EU, including when not loaded. The same rights are conferred to EU hauliers travelling from any point in the EU to the UK, and back from the UK to anywhere in the UK.

UK and EU trucks will also be able to perform up to two additional operations in the other party’s territory, once they have crossed the border.

This will allow EU hauliers that carry a load to the UK to perform two cabotage operations in the UK, thus limiting the risk of having to travel back to the EU without a load. 

For UK hauliers, these additional operations can be composed of two cross-trade operations (i.e. transport operations between two Member States) or one cross-trade and one “cabotage” operation (i.e. a transport operation within two points of a single Member State). Special provisions are made in the case of Ireland, as Northern Irish hauliers will be able to perform two cabotage operations in Ireland.

ECMT holders will be able to do 3 cabotage operations.

Medical Supplies (UK from 1st Jan 2021)

Healthcare is devolved in the UK, but contingency planning covers all 4 nations of the UK as well as the Crown Dependencies. Yesterday, the Department of Health & Social Care (DHSC) wrote to medical suppliers. The letter is here.

Re-routing away from the short straits

A large percentage of medical supplies come from the EU or have a supply touchpoint at the short straits (between Calais/Dunkirk/Coquelles and Dover/Folkestone). The DHSC letter asserts the first priority of any contingency should be to maintain replenishment rates at necessary levels by securing capacity to reroute freight away from the short straits potential disruption points. Companies are encouraged to review their own logistics arrangements and consider making plans for avoiding the short straits as a matter of priority.

In 2019, the Department for Transport (DfT) put in place a 4-year procurement framework for freight capacity for ‘Category 1’ goods , which includes all health supplies. This framework is still in place. DHSC is seeking to secure capacity on the government secured freight capacity (GSFC) to support the health and social care sector. More information will be provided when possible, including updates on the procurement timescales and when companies can expect to be able to register and access the service.

In addition, DHSC has retained its express freight service arrangements with 3 specialist logistics providers to support the urgent movement of medicines and medical products to care providers and patients if other measures experience difficulties. This service will be in place for deployment from 1 Jan 2021 as required.

Buffer stocks where possible

We encourage companies to make stockpiling a key part of contingency plans, and ask industry, where possible, to stockpile to a target level of 6 weeks’ total stock on UK soil. DHSC stands ready to support companies with their plans if required and understands that a flexible approach to preparedness may be required that considers a mixture of stockpiling and rerouting plans as necessary.

Centralised stock build

In the run-up to EU Exit, DHSC, working with NHS Supply Chain, built up a centralised stock build (CSB) of fast-moving medical devices and clinical consumables. Some of this stock remains and accounting for likely demand trends for the time of year, the DHSC plans to build these levels back up to a target level of 6 weeks’ total stock. The devolved nations of the UK may, in addition, choose to build their own stockpiles.

The UK Government also updated its guidance (for 1 Jan 2021) to healthcare providers – here.

And updated its Government contact details for medical supply businesses – here.

COVID-19 Medicines (UK)

1st April, the UK medicines regulator has issued guidance for industry on regulatory flexibilities that apply to the production of medicines in the UK.

The Link is here (this link also links to other relevant guidance)

The regulatory flexibilities are too lengthy and complex to summarise here in this Blog. The reader is asked to use the Link and read the relevant sections.

The Chancellor has also waived import duties and VAT on medical imports – here.

EU Readiness Notices (EU Brexit)

The UK is exiting the transition period on 31st December.

The European Commission is reviewing – and where necessary updating – the over 100 sector-specific stakeholder preparedness notices it published during the Article 50 negotiations with the UK.

The documents (updated so far) are published as ‘notices for readiness’ for 1st January 2021 –

(1) Air Transport – here

(2) Aviation safety – here

(3) Consumer protection and passenger rights – here

(4) Cosmetic products – here

(5) Animal feed – here

(6) Food law – here

(7) Industrial products – here

(8) Medicinal products for human use and veterinary medical products – here

(9) Movements of live animals – here

(10) Online sale of goods with subsequent parcel delivery – here

(11) Plant health – here

The transition period ends on 31st December, unless it is extended by agreement.

Medicines and Medical Devices Bill (UK Brexit)

The (Brexit) Medicines and Medical Devices Bill 2019-20 was announced in the Queen’s Speech on 19 December 2019. The second reading is taking place today.

A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation through section 2(2) of the European Communities Act 1972 (ECA). This enables EU Directives to be transposed into UK law through secondary legislation and has been used to create a body of regulations that include the:

• Human Medicines Regulations 2012

• Medicines for Human Use (Clinical Trials) Regulations 2004

• Veterinary Medicines Regulations 2013

• Medical Devices Regulations 2002.

At the end of the Transition Period, the European Union (Withdrawal) Act 2018 (see the Brexit Law List in subscribers’ systems) will have preserved these frameworks as “retained EU Law”. Since the ECA is now no longer available (due to the Act that implemented the Withdrawal Agreement), there is no other ‘general power’ for updating these regulations from 1st January 2021, except through the introduction of new primary legislation.

The Medicines and Medical Devices Bill seeks to address this regulatory gap through introducing regulation-making, delegated powers covering the fields of

* human medicines,

* clinical trials of human medicines,

* veterinary medicines, and

* medical devices.

Its purpose is to enable the existing regulatory frameworks to be updated at the end of the Transition Period.

The Bill has been drawn to create ‘targeted’ delegated powers which can only be exercised in relation to a restricted number of matters. The Government states in the Explanatory Notes to the Bill that it intends to use these powers to keep the existing regulatory frameworks updated, while also consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions – as an alternative to criminal prosecution – for breaches of the medical device regime.

Further details are set out in this Commons Briefing – here.