Medicines (UK and EU Brexit Preparedness)

Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.

While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.

In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.

Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.

The text in italics is part of the European Medicines Agency (EMA) press release issued today that informs that companies are stepping up and that the focus is now on 39 centrally authorised Medicines down from 108. The Press Release is here.

Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.

More Technical Notices (UK Brexit Preparedness)

The UK has today (24th September 2018) published more Technical Notices, some have a slightly earlier date. The collection to date is here.

Please note in particular the new Notices issued in the topics of Importing and Exporting, and Product Labelling.

Please note there is now a Technical Notice on REACH. This only covers the registration side. Given its tone, I would envisage in the first instance Safety Data Sheets and Marketing and Use Restrictions might not alter much, if at all. I will Blog post again if there is further information issued or made available on this.

(1) The Health and Safety Executive (HSE) would act as the lead UK regulatory authority, from the day the UK leaves the EU, building on its existing capacity and capability.

(2) The new regulatory framework would: enable the registration of new chemicals through a UK IT system that is similar to the existing EU IT system; provide specialist capacity to evaluate the impact of chemicals on health and the environment; ensure sufficient regulatory and enforcement capacity in the HSE, the Environment Agency (EA) and other regulators, enabling them to recommend controls in response to the hazards and risks of substances; and provide for an appropriate policy function in Department for Environment, Food & Rural Affairs (Defra) and the devolved administrations.

(3) In a ‘no deal’ scenario the UK would not be legally committed to medium- or long-term regulatory alignment with the EEA.

Please note there is now a Technical Notice on the CTA between the UK and Ireland.

(1) If you are an Irish citizen you would continue to have the right to enter and remain in the UK, as now. You are not required to do anything to protect your status.

(2) In addition, you would continue to enjoy the reciprocal rights associated with the CTA in the same way that British citizens in Ireland would if there is no deal. These rights include the right to work, study and vote, access to social welfare benefits and health services. Where required domestic legislation and agreements would be updated to ensure that the CTA rights continue to have a clear legal basis.

(3) There would be no practical changes to the UK’s approach to immigration on journeys within the CTA: as now there would be no routine immigration controls on journeys from within the CTA to the UK. The legislation governing this approach will remain unchanged when the UK leaves the EU. So too will the legislative framework of integrated immigration laws between the UK and the Crown Dependencies. The CTA arrangements would be maintained, promoting the benefits of migration between these islands.

Please note the consultations proposed re GMOs.

Please email me if you need to discuss any matter.

More Technical Notices (UK Brexit Preparedness)

The UK has today issued further Brexit Preparedness Notices. The existing online location is updated – here.

Please note particularly :

(1) CE marking – in the “Labelling products and making them safe” group

(2) Driving

(3) BAT standards – in the “Protecting the environment” group

(4) F-gases and ODS – in the “Protecting the environment” group

(5) The three Notices in the “Travelling between the UK and the EU” group

(6) Oil and gas activities – in the “Regulating energy” group

(7) European Works Councils in the “Workplace rights” group (already issued)

Any questions, please email me.

Agriculture Bill 2017-19 (UK)

UPDATE : initial reaction from Scottish Ministers – here.

The Brexit bill – the Agriculture Bill 2017-19 was published today, its second reading is tomorrow. The document is here.

The Agriculture Bill (“the Bill”) will provide the legal framework for the United Kingdom (UK) to leave the Common Agricultural Policy (CAP) and establish a new system based on public money for public goods for the next generation of farmers and land managers. It is the first Agriculture Bill to be published in 70 years.

The Agriculture Bill includes the following:

(1) Powers to give financial assistance and move towards a new system based on paying public money for public goods. Such payments may encompass (but are not limited to) environmental protection, public access to the countryside and measures to reduce flooding.

(2) Powers to collect and share data from those within or closely connected to the agri- food supply chain. The data collected and shared under these provisions will help farmers and producers increase productivity, help producers to manage risk and market volatility, and support animal and plant health and traceability.

(3) Powers to make regulations setting and amending marketing standards for agricultural products and to make provision about the classification of carcasses by slaughterhouses.

(4) Provisions to create a domestic system of recognition of Producer Organisations to encourage collaboration amongst growers. These provisions will provide for exemptions from competition law for recognised organisations.

(5) Provisions for the Secretary of State to make regulations imposing obligations on first purchasers of agricultural products in relation to contracts with producers. This is aimed at protecting producers and consumers from unfair trading practices.

Once the Bill becomes an Act of Parliament the following provisions will extend to England and Wales only:

(1) Part 1 which relates to new financial assistance powers
(2) Part 3 which relates to the collection and sharing of data
(3) Clause 20 which relates to the power to make regulations for marketing standards and carcass classification.

Schedule 3 extends mostly identical powers to the Welsh Ministers as those conferred on the Secretary of State in Parts 1-5 of the Bill.

Schedule 4 extends similar powers to DAERA (Northern Ireland) as those conferred on the Secretary of State in Parts 2-5 of the Bill.

The rest of the Act will extend to the UK. This is because the relevant provisions:

(a) Relate to a reserved matter; or
(b) Amend, or give powers to amend retained EU legislation which will extend to the UK. Such provisions may, however, apply more narrowly to a particular jurisdiction.

Annex A gives more information. Please refer to it for details re Scotland.

Brexit Law Tracker (UK)

UPDATE (6th Sept) : it is today confirmed around half of the new statutory instruments are needed in any event, and the rest are connected with the possible new UK-EU deal.

Four Brexit laws have Royal Assent and the Customs Bill (Taxation (Cross-border Trade)) passed its second reading in the Lords last night. No progress has yet begun on the Migration Bill, but all other Bills are underway or at White Paper consultation stage.

Some 800 new statutory instruments are now expected by February.

I will commence compiling in October the Brexit Law List for EHS Legislation Registers , so please look out for that appearing in systems.

River Basin Management (Ireland)

The Department of Housing, Planning and Local Government has published the (second) River Basin Management Plan 2018-2021 for Ireland. An earlier RBMP had been published. This second RBMP plans on the basis that Ireland is defined as a single River Basin District – the Ireland RBD (NOT including Northern Ireland). The areas bordering Northern Ireland are included in two other River Basin Districts – the North Western RBD and the Neagh Bann RBD that are run from Northern Ireland (part of the UK, a separate country and currently exiting the EU).

The River Basin Management Plan for Ireland 2018-2021 is here.

[The Neagh Bann River Basin Management Plan 2015-2021 is here.]

[The North Western River Basin Management Plan 2015-2021 is here.]

RBMPs set out the actions that an EU member state will take to improve water quality and achieve ‘good’ ecological status in water bodies (rivers, lakes, estuaries and coastal waters) by 2027. EU member states are required to produce river basin management plans under the EU Water Framework Directive (WFD).

BREXIT : it is not yet clear how River Basin Management planning will occur in the UK going forward. I will issue a separate Blog on this, when there is further information.

Water quality in Ireland has deteriorated over the past two decades. This second RBMP provides a more coordinated framework for improving the quality of waters — to protect public health, the environment, water amenities and to sustain water-intensive industries, including agri-food and tourism, particularly in rural Ireland.

The Irish River Basin District (RBD) covers an area of 70,273km2, with 46 catchment management units — consisting of 583 sub-catchments, with 4,829 water bodies. With regard to protected areas within the District, there are 140 designated bathing waters, 64 shell fish waters, 47 nutrient sensitive areas and 358 special areas of conservation (SACs) with water dependency. These SACs are geographically concentrated along the western seaboard – with a significant overlap between high-status waters and SACs. The RBD has a population of around 4.76 million, with 33% of people living in cities, 29% in towns and 38% in rural areas. The requirement for water and waste-water services reflects these spatial patterns. Nationally, the economy is strongly export-focused, but the sectoral drivers of economic growth across the RBD are diverse – with the agriculture and food sectors being particularly important in rural areas.

Key measures during the first RBMP included the licensing of urban waste-water discharges (with an associated investment in urban waste-water treatment) and the implementation of the Nitrates Action Programme (Good Agricultural Practice Regulations). The urban waste-water licensing made significant progress in terms both of compliance levels and of the impact of urban waste-water on water quality. The Nitrates Action Programme created an environmental baseline which all Irish farmers must achieve and has resulted in improving trends in the level of nitrates and phosphates in rivers and groundwater.

This second RBMP will establish :

(1) an Agricultural Sustainability Support and Advisory Programme to be implemented by 30 new Advisors — funded by Department of Housing, Planning and Local Government (DHPLG), Department of Agriculture, Food and the Marine (DAFM) and the dairy co- ops — who will work under Teagasc and the dairy co-ops. The Advisors will work on a one-to-one basis with farmers to bring about behavioural change through improved agricultural practices in areas which have identified pressures on water bodies.

(2) Local Authority Support and Advisory Teams to carry out scientific assessments and to drive the implementation of mitigation measures at local level. Recruitment of investigative assessment personnel commenced in Quarter 1 2018 and provision has been made for up to 43 specialist staff to be in place by mid-2018. These resources will be assigned across the five regions.

(3) Agri-environment schemes implemented through the Rural Development Programme (RDP) to lead to investment in manure storage and improved nutrient utilisation. In particular, the targeted approach to the Green, Low-Carbon, Agri- Environment Scheme (GLAS), which has 50,000 participants, is intended to ensure appropriate supporting measures on farms to protect and improve water quality.

(4) improved compliance with the existing Good Agriculture Practice Regulations through implementation of the enhanced Nitrates Action Programme (NAP) for 2018–2021 and of the associated inspection regime. The Programme entails new strengthened water- protection measures, focused on intercepting and breaking nutrient transport pathways and on preventing sediment and nutrient losses to waters.

(5) a National Inspection Plan 2018–21 for domestic waste-water treatment systems, currently being finalised by the EPA – this will use the outputs of the catchment characterisation work to further improve the risk-based approach to inspection of septic tanks. It is expected that approximately 1,000 inspections will be carried out by local authorities nationally each year.

(6) significant planned investment in urban waste-water collection and treatment infrastructure. Over the period 2017–2021, the plan is for Irish Water to invest approximately €1.7 billion in waste-water projects, programmes and asset maintenance.

(7) a register of water abstractions (held by the DPHLG), who will consult on a proportionate and risk-based framework for the regulation of abstractions to ensure continued sustainable use of our water resources. The EPA will continue work on assessing risk due to abstractions, making use of new information as it emerges during the second cycle.

Technical Notices (UK Brexit Preparedness)

UPDATE : government letter to the health care sector (this calls for stockpiling to ensure continuity of supply) – here.

The UK government has today issued its first tranche of Technical Notices in the subject area of UK Brexit Preparedness. These Technical Notices create requirements for Government to have online portals and other IT in place, and for stakeholders to use these, and make other arrangements.

The Technical Notices are here.

Please read the Notices carefully, any questions, please email them directly to me.