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.)

UK exits the EU (DEFRA preparations)

Ministerial approval is given [prior to the EU (Withdrawal) Bill Royal Assent] to the following projects – to ensure preparation for all negotiation outcomes :

(1) Delivery of a new national import control system for animals, animal products and high risk food and feed. Scheduled to commence building: mid-January 2018. Estimated cost before Royal Assent: £7m.

(2) Delivery of new IT capability to enable registration and regulation of chemical substances placed on the UK market. Scheduled to commence building: February 2018. Estimated cost before Royal Assent: £5.8m.

(3) Delivery of systems for the licensing and marketing of veterinary medicines. Scheduled to commence building: end-January 2018. Estimated cost before Royal Assent: £1.6m.

(4) Development of a new catch certificate system for UK fish and fish products being exported to the EU on Exit. Scheduled to commence: building end-January 2018. Estimated cost before Royal Assent: £1.0m.

(5) Development of a UK system to manage the quota of fluorinated gases and ozone depleting substances required under the UN Montreal Protocol. Scheduled to commence: March 2018. Estimated cost before Royal Assent: £0.5m.

(6) Development of data exchange arrangements to identify the movement of EU and third country vessels in UK waters and the movement of UK vessels in EU or third country waters. Scheduled to commence: April 2018. Estimated cost before Royal Assent: £0.1m

Note : regarding start dates – the Permanent Secretary letter is dated 18 January 2018 – here.

The Civil Service World article dated the next day confirms approval was given on the 18 January 2018 for these projects. The CSW article is here.

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.

Carcinogens and Mutagens (EU)

I posted in 2017 about new developments with the European Carcinogens and Mutagens Directive (2004/37/EC). Find this in the Chemicals archive on this Blog.

A new proposal is now made (the third legislative amendment since the start of this European Commission. Note : the Directive was already amended before these current developments). This third amendment is here. In total, there are three current amendments outlined in this Blog post.

Apart from the third amendment, two previous legislative amendments were proposed by the Commission, in May 2016 and January 2017. Together they proposed limit values to 20 carcinogens. The first of these proposals (the 2016 one) was adopted by the co-legislators as Directive (EU) 2017/2398 (which is an amendment to Directive 2004/37/EC).

NB : Member States have until the start of 2020 to implement Directive (EU) 2017/2398.

The first revision adds 13 new or stricter exposure limits to the EU Directive. Respirable crystalline silica dust, benzene and vinyl chloride monomer are three of the substances affected.

The second proposal for legislative amendments (the 2017 one) is currently being discussed by legislators. The second revision sees new binding occupational exposure limits (Boels), and in some cases skin notations set for:

trichloroethylene;

4,4-methylenedianiline;

epichlorohydrine;

ethylene dibromide;

ethylene dichloride; and

mixtures containing benzo(a)pyrene.

As part of this latest (third) amendment to the CMD, five carcinogens of high relevance for the protection of workers are selected:

• Cadmium and its inorganic compounds;

• Beryllium and inorganic beryllium compounds;

• Arsenic acid and its salts, as well as inorganic arsenic compounds;

• Formaldehyde;

• 4,4′-Methylene-bis(2-chloroaniline) (MOCA).

Background

The EU principles of worker protection from carcinogens are laid out in the over-arching Occupational Safety and Health (OSH) Framework Directive 89/391/EEC and those Directives specifically dealing with chemical risks – notably the Chemical Agents Directive (CAD) and the Carcinogens and Mutagens Directive (CMD).

Under the OSH framework, risks to the safety and health of workers must be eliminated, or, if total elimination is not possible, reduced to a minimum. Employers must identify and assess risks to workers associated with exposure to specific carcinogens and mutagens at the workplace, and must prevent exposure where risks occur. Where this is technically possible, substitution with a non- or less-hazardous process or chemical agent is required. In cases where such substitution is not possible, chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent workers’ exposure. Where this is not possible either, worker exposure must be reduced to as low a level as is technically possible.

The Carcinogens and Mutagens Directive (CMD) sets a number of general provisions to prevent or reduce exposure for all carcinogens and mutagens falling under its scope. In addition to these general minimum requirements, the CMD indicates occupational exposure limit values (OELs) for all those carcinogens or mutagens for which this is possible, as an essential means to protect workers.

From time to time, there are revisions proposed to the CMD (and the CAD).

Email Alerts

Email Alerts are issued closer to the date when Member States must implement the changes to the EU law. Otherwise, please continue to follow this Blog.

Brexit

The first of these amendments must be implemented by early in January 2020. It is not known if the UK will implement this amendment.

UK exits the EU (third country status)

I posted several times regarding EU Notices and Notices from EU regulatory agencies. These remind that the UK will be a third country (as respects the EU) on exit at 12pm CET 29th March 2019. If you have not already done so, please read these Notices.

Any Transition Period that is agreed is in the context of the EU-UK Withdrawal Treaty, and will continue certain EU arrangements only.

One of the aspects is UK membership of EU regulatory agencies (third countries are not members of EU regulatory agencies).

On 11th April 2018, the European Medicines Agency (EMA) confirmed that the EU27 member states and the EMA had completed the task of redistribution of the UK portfolio of centrally authorised medicine and veterinary products. The UK will not be a member of the EMA on its exit. Arrangements were already in place to relocate the EMA (from the UK) to an EU27 member state.

Please read the information that is published about this redistribution here.

New Plant Health Regulation (EU)

Regulation (EU) 2016/2031 is a new European Plant Health Regulation, which entered into force on 13th December 2016, and is a major overhaul of the EU’s Plant Health legislation that has been in place since 1977. It will repeal and replace seven Council Directives on harmful organisms and will become fully applicable on 13 December 2019. The new Regulation is here

It focuses particularly on the prevention of entry or spread of plant pests within the EU territory, and sets out detailed rules for the early detection and eradication of Union quarantine pests if found present in the EU territory. These rules establish obligations for the notification of outbreaks by professional operators, surveys and multiannual survey programmes, demarcation of areas for the purpose of eradication, as well as enhanced requirements for the priority pests as described above.

Under the new Regulation, all Member States will have to immediately proceed with the eradication of a Union quarantine pest if found present in an area where it was not known to be present. This means that they will no longer be allowed to proceed unilaterally with containment, namely to skip the eradication step and simply take measures to restrict the presence of the pests in a particular area.

Details

Plant pests currently fall under different legal acts depending on their quarantine status or whether they affect the quality of plant reproductive material. The new Regulation will list all pests together, under three main categories:

Union quarantine pests: Not present at all in the EU territory or, if present, just locally and under official control (examples include Citrus black spot, which is not present in the EU, and Xylella which is present in a few specific locations only). Strict measures must be taken to prevent their entry or further spread within the EU due to their increased risk for plant health. These pests have to be eradicated immediately if detected.

Protected zone quarantine pests: Present in most parts of the Union, but still known to be absent in certain demarcated areas called ‘protected zones’ (for example grape phylloxera, which is present in the territory of the EU but not in Cyprus which is designated as protected zone for this pest). These pests are thus not allowed to enter and spread within these protected zones. Measures are taken (such as prohibition or restriction of movement of commodities, surveys, etc.) to avoid the introduction of these pests into the protected zones or to ensure their eradication if found present in these zones.

Regulated non-quarantine pests: Widely present in the EU territory but, since they have an impact on the quality of the plants, plant reproductive material on the market should be guaranteed free or almost free from the pest (for example, the fungus Verticillium albo-atrum is known to be harmful to the apple production in the EU, therefore certified apple trees are not allowed to enter the EU market if more than 2% of the examined quantity is contaminated with the fungus). This way the starting quality and economic value of many agricultural crops as well as forestry and fruit plants can be ensured.

The new Regulation introduces the concept of “priority pests“. These are the Union quarantine pests with the most severe potential impacts on the economy, environment and/or society of the EU. They will be subject to enhanced measures concerning surveys, action plans for their eradication, contingency plans and simulation exercises. 

The list of these priority pests will be adopted through a delegated act, as close as possible to the date of application of this Regulation (end of 2019). It will be based on the criteria fixed by the Regulation and the assessments of the severity of the impacts of those pests.

The import of most plants and plant products from non-EU countries will in principle be allowed, subject to certain conditions. Some will be prohibited or subject to very strict requirements if a risk assessment indicates that this is necessary due to the pests they might host. The new Regulation sets out more precise rules about the risk assessment and risk management supporting such measures.

Under the new Regulation, the Commission is further required to adopt within two years a list of so-called high risk plants or plant products. The import of these commodities will be prohibited as long as no detailed risk assessment has been carried out to determine if such imports should be acceptable and, if yes, under which conditions.

All living plant material (namely entire plants, fruits, vegetables, cut flowers, seeds, etc.) will only be imported into the EU if accompanied by a phytosanitary certificate confirming their compliance with the EU legislation. The Commission will adopt within two years a list of plant materials to be exempted from that certification if they are deemed safe for the EU territory.

Finally, for specific cases where there is little experience with trade of certain plants or plant products and where related pest risks are still unknown, the new Regulation sets out the possibility to introduce temporarily phytosanitary import restrictions or even a prohibition until more scientific information becomes available. 

Imports by Passengers

In principle, passengers will no longer be allowed to introduce into the EU plants/plant products from non-EU countries if they are not accompanied by a phytosanitary certificate. However, harmonised exemptions to this general rule might be granted through a Commission implementing act, setting out the maximum quantity of plant material that might be allowed to be introduced by the passengers into the EU without phytosanitary certificate.

Plant Passports

Plant passports are the documents that accompany plants and certain plant products while moving within the Union and certify their phytosanitary health status. Under the new Regulation, all plant passports will be issued using a common format, thus facilitating their visibility and making them more easily recognisable throughout the EU.

Plant passports will now be required for the movement of all plants for planting, (under the current legislation, plant passports are required only for certain plants for planting). However, in order to avoid disproportionate administrative burdens, no plant passports will be required when the plants are transferred to non-professional consumers (e.g. in places like flower shops or other retail shops).

Professional Operators

Professional operators will have to notify any quarantine pest they find in the areas of their control. For the purpose of more efficient controls, the professional operators will have to be registered by the competent authorities. The professional operators will also have to ensure the traceability of the regulated plants/plant products they receive from and submit to other professional operators.

Professional operators will be allowed to issue plant passports, under the supervision of the competent authorities. To that purpose they will have to be authorised specifically by the authorities, subject to specific conditions.

National Authorities

Member States’ competent authorities will play a key role in the implementation of these rules. They will be responsible for activities such as surveys, eradication of outbreaks, contingency plans, simulation exercises, notification of pest occurrences, controls of imports, registration of professional operators, authorisation of professional operators to issue plant passports and other attestations.

In this respect, the new Regulation will be complemented, in the coming months, by the Regulation on Official Controls which will set out the obligations of Member States with regards to official controls and other official activities.

Why will the Regulation be applicable only in three years’ time?

To replace the existing legislation, it was decided that an EU Regulation was the right instrument, since it is directly and universally applicable throughout the EU. During the next three years, a string of delegated and implementing acts needs to be adopted. This period will also be used by competent authorities and professional operators to adjust to the new common rules.

Neonicotinoids (UK/EU)

UPDATE : the DEFRA statement is here

UK DEFRA has confirmed an article in this morning’s Guardian online – the UK will back a total EU ban on neonicotinoids. This newspaper article is here

“A total ban on insect-harming pesticides in fields across Europe will be backed by the UK, environment secretary Michael Gove has revealed. The decision reverses the government’s previous position and is justified by recent new evidence showing neonicotinoids have contaminated the whole landscape and cause damage to colonies of bees. It also follows the revelation that 75% of all flying insects have disappeared in Germany and probably much further afield, a discovery Gove said had shocked him.”

In 2013, three neonicotinoids were restricted by the EU.

Per The Guardian : “The European Commission now wants a total ban on their use outside of greenhouses, with a vote expected in December, and the UK’s new position makes it very likely to pass.”

The European Commission’s information on its regulatory activities in this area is here