UK Brexit Preparedness – Medicines (UK Brexit)

Exit day is 31st October (127 days)

Today, 26th June, sees the following :

(1) Ministerial Statement – here

(2) Letter to Suppliers re Medicines – here

Ministerial Statement – extracts

Guaranteeing the supply of critical ‘category 1’ goods, including medicines, medical products, veterinary medicines and chemicals remains an essential element of the Government’s No Deal contingency planning. The Government is therefore undertaking steps to secure freight capacity for suppliers of these goods in a No Deal scenario.

The Department of Health and Social Care is starting the process of setting up an express freight contingency arrangement to support continuity of supply of medicines and medical products. This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal. This express freight contingency arrangement forms part of the Department’s multi-layered approach, which includes rerouting medical supplies from the short strait crossings, extra warehouse space, stockpiling, buffer stocks, clarifying regulatory requirements, supporting traders to have all necessary paperwork in place at the border, and strengthening the processes used to deal with shortages to ensure that patients have uninterrupted access to medicines and medical products if the UK leaves the EU without a deal. Government will only pay for capacity as and when it is needed and used. This will be designed to cover all of the UK. The Department will be writing to industry to set out further details of these preparations.

The Department for Transport is putting in place a freight capacity framework agreement that will provide government departments with the ability to secure freight capacity for our critical supply chains as and when required. This framework does not commit the Government to purchasing or reserving any freight capacity, but it does provide a flexible list of operators and options for the provision of the capacity that can be drawn upon if needed.

In the coming months, the Government will make further announcements on its preparations for a possible No Deal Exit on 31 October, including on trade continuity agreements to limit disruption to our trade with third countries after we leave the EU.

Letter to Suppliers re Medicines – extracts

All no-deal preparedness plans should contain a mix of the following, depending on each company’s specific situation:

–  Secured capacity for rerouting freight away from the short straits after no-deal exit day, in order to avoid the worst restrictions on flow outlined above.

–  Stockpiling product above and beyond business-as-usual inventory levels; as a default, this is recommended as six weeks’ stock above business as usual inventory, the same as last time.

–  Assurance on the readiness of a company’s logistics and supply chains to meet the new customs and border requirements for both import and export (sometimes referred to as “trader readiness”).

Where companies have not yet done so [made a plan] the Government asks that they build a plan which includes a stockpile of an additional six weeks’ supply in the UK, on top of operational buffer stocks, in addition to developing a robust re-routing plan away from the short straits. As before, for products with a short shelf life or where production constraints mean stockpiling is not possible, for example, medical radioisotopes, we ask for alternative air freight plans to be made.

In the coming days, companies will be asked to provide information at product level, focused on the minimum key data set necessary for assurance of the programme. This will build on information from the 29th March exercise, including stock levels expected to be held on 31st October and plans for re-routing away from the short straits.

EU Brexit Preparedness (EU Brexit)

UK Exit day is 31st October 2019

Please read this Blog post carefully, if you have any questions or uncertainties as to your actions, please email to arrange a telecon.

Today, 12th June, the EU Commission published its fifth Brexit Preparedness Communication – it is a review of the state of the EU Brexit preparedness and contingency measures, and is important for activities in the EU and in the UK. The document is here.

Key elements :

(1) As stated in the fourth Brexit Preparedness Communication of 10 April 2019, the Commission is ready to propose financial support measures (applicable to the E27) to mitigate the impact in the most affected areas and sectors, taking into account the funds that are available and any adjustments on the expenditure and revenue side of the EU budget that might result from a disorderly withdrawal. For more immediate support to affected stakeholders, EU State aid rules offer flexible solutions for national measures. But see Item (4) below.

(2) In this review, the Commission screened all the EU-level measures to assess whether they are still fit for purpose given the extension of the Article 50(3) TEU period. On the basis of this screening, the Commission considers that the legislative and non-legislative Union acts continue to meet their intended objectives. There is therefore no need to amend them on substance. The Commission does not plan any new measures ahead of the new withdrawal date (31st October).

(3) The Commission adopted 16 non-legislative contingency acts under the EU sanitary and phytosanitary legislation in view of the previous withdrawal date of 12 April 2019 on the basis of assurances given by the United Kingdom. These measures are now obsolete due to the extension. However, if the United Kingdom continues to provide the necessary assurances, the measures will be re-adopted to apply as of 1 November 2019.

These acts cover the listing of the United Kingdom and its Crown Dependencies as a third country allowed to export live animals and animal products to the EU; and the approval of new or extended Border Inspection Posts in the EU27 Member States most concerned by UK imports.

They do not cover acts on the recognition of health marks for products of animal origin, heat treated pallets, or fortified flour (UK requests).

(4) In some sectors, companies indicated in March 2019 that they had not had sufficient time to adapt. The Commission strongly encourages stakeholders to take advantage of the extra time until 31 October 2019 to ensure that they have taken all the necessary action to prepare for the United Kingdom’s withdrawal.

They should ensure that the necessary regulatory authorisations are in place, that they have taken the administrative steps for cross-border trade and the necessary action for relocation, corporate reorganisation or contractual adaptations.

In particular, it will not be possible to place on the EU market after Exit day products which do not comply with the necessary requirements and authorisations.

As stated above, the Commission does not plan to adopt any new measure in view of a possible no-deal scenario or to compensate for a failure to prepare by operators.

The Commission considers that the additional time available because of the extension will in principle be sufficient for operators to adapt, so that even in cases where exemptions or derogations are available, they should not be necessary.

(5) EU27 Member States should screen their national contingency measures to ensure that they remain fit for purpose given the extension of the Article 50(3) period. In case of a no-deal withdrawal, the final preparatory measures must apply as of 1 November 2019 at the latest.

(6) Note the specifics on medicinal products, medical devices and chemical substances – page 5 of the document (link above).

(7) In the field of sanitary and phytosanitary controls (SPS), EU27 Member States have set up new Border Inspection Posts (BIPs) or extended existing ones at entry points of imports from the United Kingdom into the EU. As stated above, the non-legislative act approving these BIPs will need to be adopted again given the most recent extension of the Article 50(3) period. In the meantime, EU27 Member States should use the additional time to evaluate the need for any further adjustments to these BIPs to ensure that they are fully functional from the outset.

Furthermore, the Commission maintains regular contacts with the most concerned Member States so that, in a no-deal scenario, a landbridge route between Ireland and the rest of the European Union via the United Kingdom can be implemented swiftly, including support from the necessary IT systems.

(8) The international road haulage measure expiry deadline of 31st Dec 2019 is unaltered.

It is important companies review their supply contracts, and ensure suppliers are Brexit ready.

Review of Marine Protection (England)

DEFRA last week announced the designation of 41 more Marine Conservation Zones in English waters.

Today it is announcing a review of whether and how new stronger protections for areas of the sea known as Highly Protected Marine Areas (HPMAs) could be introduced. This review is to be led by Richard Benyon, a Conservative MP and former Environment and Fisheries Minister who has a particular interest in marine fisheries and their protection. The announcement is here.

The new HPMAs would protect vulnerable areas of England’s coastal, inshore and marine waters by closing them off to any human activity with the potential to cause harm.

The Government’s manifesto includes a commitment to create a Blue Belt of marine protection for Britain’s overseas territories and its own coast.

Per DEFRA – targeted HPMAs would complement the existing network of marine conservation zones and allow vulnerable marine wildlife to fully recover, free from all damaging human activities, with the aim of restoring areas to a pristine state.

The UK’s Blue Belt currently spans 220,000 sq km with 128 Marine Conservation Zones including 89 in English waters.

Targeted Highly Protected Marine Areas would complement the existing network of Marine Conservation Zones, and would mark the most significant expansion of England’s ‘Blue Belt’ of protected areas to date, if it happens.

The review will be asked to establish an evidence-based process and criteria for selecting Highly Protected Marine Areas, and if supported by the evidence, recommend potential locations for pilot sites.

The review is supported by Natural England.

The views of those who use the seas will be at the heart of the review, which will over six months consider the economic and social impacts on businesses and individuals who use the sea, taking into account the views of fishermen, conservation groups, marine industries, and local communities. (DEFRA)

UK Industrial Goods Export to EU (EU Brexit)

Exit day is 31st October 2019.

The EU issued in February a Q&A document answering questions arising on the specifics of UK Industrial Goods circulation in the European market following Exit. This document is here.

Please examine this document carefully, particularly as respects the point in the circulation when the Third Country regime would apply, and the matter of Technical Dossier transfer (Category D).

Any questions not addressed by this Q&A should be made to the UK BEIS department.

The UK has said it would permit CE marked Goods to circulate in the UK market after Exit day, as far as I can determine, this is not reciprocated by the EU (as respects UKCA marked Goods). If anyone has an update on this, perhaps they would email me it. Thank you.

[the Exit day may change, please continue to follow this Blog]