Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

National Emission Ceilings Directive (EU)

In 2011-2013 the Commission conducted a review of the EU air policy which resulted in the adoption of the Clean Air Policy Package. As part of the package, the Commission proposed a Clean Air Programme for Europe, updating the 2005 Thematic Strategy on Air Pollution in order to set new objectives for EU air policy for 2020 and 2030.

The main legislative instrument to achieve the 2030 objectives of the Clean Air Programme is new Directive 2016/2284/EU on the reduction of national emissions of certain atmospheric pollutants which entered into force on 31 December 2016. This Directive sets national reduction commitments for the five pollutants (sulphur dioxide, nitrogen oxides, volatile organic compounds, ammonia and fine particulate matter) responsible for acidification, eutrophication and ground-level ozone pollution which leads to significant negative impacts on human health and the environment.

The new Directive repeals and replaces Directive 2001/81/EC, the National Emission Ceilings Directive (NEC Directive) from the date of its transposition (30 June 2018) ensuring that the emission ceilings for 2010 set in that Directive shall apply until 2020. Directive 2016/2284 also transposes the reduction commitments for 2020 taken by the EU and its Member States under the revised Gothenburg Protocol and sets more ambitious reduction commitments for 2030 so as to cut the health impacts of air pollution by half compared with 2005.

Directive 2016/2284/EU is here. A Q&A about the Directive is here.

Some customers have already requested this Directive or have the Directive already. The national implementing regulations will be inserted into the ENV Air Register. Email Alerts will be sent out. If you need this Directive (and it’s local implementing regulations), please email me direct.

The role of the Member States in coordinating and implementing the Directive at national level is very important. Member States must transpose the Directive into national legislation by 30 June 2018 and produce a National Air Pollution Control Programme by 2019 setting out measures to ensure that emissions of the five main air pollutants are reduced by the percentages agreed by 2020 and 2030.  They must also coordinate with plans in fields such as transport, agriculture, energy and climate.

The Commission will work with Member States to ensure sound implementation, for example by setting up a new Clean Air Forum by autumn 2017. This will bring together stakeholders to exchange experience and good practice. The Commission will also facilitate access to EU funding instruments.

BREXIT : the UK has enacted implementing regulations (in force 1st July 2018) – here

The obligations rest with national implementing authorities, the new National Emission Ceilings Directive does not create direct obligations for facility managers or owners.

UK exits the EU (EU Brexit Preparedness)

You notice I have been posting about EU Notices and my last post is entitled Brexit Preparedness, and this post identifies the EU is also publishing Brexit Preparedness legislative proposals.

The European Commission has now re-organised the EU Notice site online, and retitled it as Brexit Preparedness.

Today they also show the state of play of planned legislative proposals (at 12 June 2018) as a link from the Legislative initiatives tab on the Brexit Preparedness site. That state of play is here. But you can find for yourself on the site where this document is.

Note : the EU Notices are retitled Preparedness Notices, and are identified by European Commission department. This makes them easier to locate, but at moment they are not sortable by date of issue.

Note : the Notices issued by the EU regulators (described as EU decentralised agencies) are found on the original page – this is linked behind the words “Read more on EU Brexit Preparedness Notices”. Here

The reorganised EU Brexit Preparedness online site is here.

UK exits the EU (Brexit Preparedness)

I posted so far a number of times (marked EU Notices) about the guidance issued to stakeholders by the European Commission and the EU regulators. Note : there are now 65 EU Notices issued, and this material is gathered here.

In addition, please note I posted in 2017 about the going forward invalidity of UK issued carbon credits (EUETS scheme).

On 18th April, the FT published an article about approximately 40 new legislative proposals to be issued over the next 10 weeks or so (in addition to the EU Notices). This article is here. At EU level, these legislative proposals are marked “Brexit Preparedness”.

So far :

(1) a wider consultation on WTO schedules (separation of UK from EU) – here.

(2) a proposal on EU type-approval legislation – here.

Yesterday, the Irish state broadcaster RTÉ published an article of a briefing by the Secretary General of the European Commission to the Brexit Steering Group of the European Parliament (and an associated internal document of the planned Brexit Preparedness legislative proposals).

This article identifies the list of areas for these new proposals – banking, tariffs, energy efficiency, medicines, visa, and transport.

Among the proposals is a plan to design a maritime route to link Ireland and the Continental part of the North Sea-Mediterranean Corridor.

The RTE report is here.

Single-use plastics : new rules proposed (EU)

The European Commission is proposing new EU-wide rules to target the 10 single-use plastic products most often found on Europe’s beaches and seas, as well as lost and abandoned fishing gear.

The proposed new rules (if agreed) will introduce :

(1) Plastic ban in certain products: Where alternatives are readily available and affordable, single-use plastic products will be banned from the market. The ban will apply to plastic cotton buds, cutlery, plates, straws, drink stirrers and sticks for balloons which will all have to be made exclusively from more sustainable materials instead. Single-use drinks containers made with plastic will only be allowed on the market if their caps and lids remain attached;

(2) Consumption reduction targets: Member States will have to reduce the use of plastic food containers and drinks cups. They can do so by setting national reduction targets, making alternative products available at the point of sale, or ensuring that single-use plastic products cannot be provided free of charge;

(3) Obligations for producers: Producers will help cover the costs of waste management and clean-up, as well as awareness raising measures for food containers, packets and wrappers (such as for crisps and sweets), drinks containers and cups, tobacco products with filters (such as cigarette butts), wet wipes, balloons, and lightweight plastic bags. The industry will also be given incentives to develop less polluting alternatives for these products;

(4) Collection targets: Member States will be obliged to collect 90% of single-use plastic drinks bottles by 2025, for example through deposit refund schemes;

(5) Labelling Requirements: Certain products will require a clear and standardised labelling which indicates how waste should be disposed, the negative environmental impact of the product, and the presence of plastics in the products. This will apply to sanitary towels, wet wipes and balloons;

(6) Awareness-raising measures: Member States will be obliged to raise consumers’ awareness about the negative impact of littering of single-use plastics and fishing gear as well as about the available re-use systems and waste management options for all these products.

The Commission’s proposals will now go to the European Parliament and Council for adoption.

NOTE : some EU member states already have legislation in place or planned, for part or all of these measures.

See here, for the European Commission press release.

Insecticide Restrictions Upheld (EU)

The General Court of the European Union this morning confirmed the validity of the restrictions introduced at EU level in 2013 against the insecticides clothianidin, thiamethoxam and imidacloprid (neonicotinoids) because of the risks those substances pose to bees.

However, it largely upheld the action brought by BASF and annulled the measures restricting the use of the pesticide fipronil, since they were imposed without a prior impact assessment.

The press release is here.

The General Court (EGC) is a constituent court of the Court of Justice of the European Union.

The European Commission had already decided on 27 April to extend existing measures to ban the outdoor use of the three neonicotinoids, after realising the necessary qualified majority among EU member states. Information about this is here.

18 member states, including France, Germany, Italy and the UK, endorsed the Commission proposal to further restrict the use of the three active substances used in pesticides (Bayer’s imidacloprid and clothianidin, and Syngenta’s thiamethoxam).

The countries that voted against were Hungary, Romania, Denmark and the Czech Republic.

The new ban on outdoor use will be in effect by the end of 2018.