DExEU/EM/7-2018.2 1
EXPLANATORY MEMORANDUM TO
THE INTELLECTUAL PROPERTY (AMENDMENT ETC.) (EU EXIT)
REGULATIONS 2020
2020 No. 1050
1. Introduction
1.1 This explanatory memorandum has been prepared by the Intellectual Property Office
(IPO), an executive agency of the Department for Business, Energy & Industrial
Strategy, and is laid before Parliament by Act.
1.2 This memorandum contains information for the Joint Committee on Statutory
Instruments.
2. Purpose of the instrument
2.1 This instrument amends a number of pieces of intellectual property (IP) legislation
which were made in 2019 in preparation for a potential “no deal” exit from the EU
and the expected retention of EU law as domestic law at that point. This legislation is
listed in paragraph 6.3 and is referred to collectively as “the 2019 Regulations” in this
memorandum.
2.2 As the UK has left the EU under the terms of the Withdrawal Agreement, the retention
of EU law will now take place at the end of the transition period1. The provisions in
this instrument reflect commitments made in the Withdrawal Agreement and ensure
that the retained EU law will continue to function effectively, taking account of the
transition period. They also deal with inoperabilities arising from new EU law which
entered into force during the extended Article 50 period and correct some minor
errors in the 2019 Regulations.
Explanations
What did any relevant EU law do before exit day?
2.3 In brief, and as explained further in paragraphs 7.7, 7.11, 7.15-7.16, and 7.25, the
relevant EU law:
• provided a framework for the EU trade mark;
• established a system of EU-wide registered and unregistered designs;
• provided for a supplementary protection certificate (SPC) system for patented
pharmaceuticals and agrochemicals;
• developed the principle of a regional regime for the exhaustion of IP rights;
and
• established an IP right for databases.
2.4 As set out in more detail in paragraphs 7.8, 7.12, 7.17 and 7.26, these pieces of EU
law were the subject of amendments by the 2019 Regulations, which, amongst other
things:
1 This point in time is defined in s.1A of the European Union (Withdrawal) Act 2018 as “IP completion day”.
DExEU/EM/7-2018.2 2
• created comparable UK intellectual property rights in place of EU trade marks,
registered designs and unregistered designs which would have ceased to have
protection on exit day, including rights which have been protected at an
international level;
• enabled the filing of new UK applications for trade marks and designs where
EU or international applications would have still been pending on exit day
whilst retaining the relevant filing date;
• provided for the continued functioning of the SPC system;
• ensured that goods whose IP rights should be treated as exhausted remain so;
and
• limited eligibility for new database rights to UK nationals while providing for
continued protection of database rights held by EEA individuals and
businesses that were in force on exit day.
2.5 After the 2019 Regulations were made, Regulation (EU) 2019/933 amending
Regulation (EC) No 469/2009 concerning the supplementary protection certificate for
medicinal products2 introduced what is known as the “manufacturing waiver” to the
SPC system. As explained further in paragraph 7.27, this enables third parties to
manufacture SPC-protected products without requiring the consent of the SPC holder,
but only for export outside the EU or for storing in the EU for sale on the EU market
after the SPC has expired. Doing so will not infringe the SPC right.
Why is it being changed?
2.6 The 2019 Regulations do not reflect that there is now a transition period in which EU
law continues to apply in the UK - if they came into force, they would retroactively
make changes as from exit day; 31 January 2020. They also do not address the
commitments made in the Withdrawal Agreement or provide fixes to any
inoperabilities in new EU law which will be retained at the end of the transition
period.
2.7 This last point applies to the manufacturing waiver specifically. The retained EU law
would not be clear on how the waiver would apply in the UK after the transition
period; there would be uncertainty about what actions third parties could take without
infringing the SPC, and without prompting legal action from the rightsholder.
What will it now do?
2.8 For the most part, the changes ensure that the provisions of the 2019 Regulations will
apply with effect from the end of the transition period as opposed to exit day. This
will ensure that, in particular, any EU IP rights arising during that period will be
properly protected in the UK going forward.
2.9 In relation to trade marks and designs, the changes also implement commitments
contained in the Withdrawal Agreement so that, as set out in paragraphs 7.22-7.23,
certain decisions taken by EU bodies or courts on the validity of such rights are
recognised in the UK.
2.10 In relation to the manufacturing waiver, as set out in paragraph 7.29, the retained law
will allow third parties to manufacture SPC-protected products in the UK, without the
2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.153.01.0001.01.ENG
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rightsholder’s consent, either for export outside of the UK or EU or for stockpiling in
the UK for sale in the UK or EU once the SPC has expired.
3. Matters of special interest to Parliament
Matters of special interest to the Joint Committee on Statutory Instruments
3.1 This instrument corrects several drafting errors identified in the 2019 Regulations. In
particular:
• regulation 3 fixes an error where a reference was retained to a schedule which
was repealed in the same instrument;
• regulation 19(b) corrects a provision where the wrong type of unregistered
design was named;
• regulation 23 fixes an error where the period in which no additional fees are
due for renewing a converted EU registered design was set to expire, rather
than begin, on a specific date; and
• regulation 25 fixes an error where a conflicting amendment was made to the
underlying Act by two different sets of amending regulations.
Other provisions fix typographical errors.
3.2 The Department and the IPO have therefore followed the requirement in paragraph
4.7.6 of Statutory Instrument Practice to consult the SI Registrar, and the free issue
procedure has been applied because of the length and mix of the new and correcting
provisions.
Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House
of Commons relating to Public Business (English Votes for English Laws)
3.3 The territorial application of this instrument includes Scotland and Northern Ireland.
3.4 The powers under which this instrument is made cover the entire United Kingdom
(see section 24(1) of the European Union (Withdrawal) Act 2018) and the territorial
application of this instrument is not limited either by the Act or by the instrument.
4. Extent and Territorial Application
4.1 The territorial extent of this instrument is all of the United Kingdom.
4.2 The territorial application of this instrument is to all of the United Kingdom.
5. European Convention on Human Rights
5.1 The Parliamentary Under Secretary of State (Minister for Science, Research and
Innovation), Amanda Solloway MP, has made the following statement regarding
Human Rights:
“In my view the provisions of the Intellectual Property (Amendment etc.) (EU Exit)
Regulations 2020 are compatible with the Convention rights.”
6. Legislative Context
6.1 These regulations are made primarily under section 8 of the European Union
(Withdrawal) Act 2018 (EUWA). This allows a Minister to make regulations to
resolve any deficiencies in law that arise as a result of the UK’s departure from the
European Union, including in EU law which continues to form part of domestic law at
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the end of the transition period under section 2 and 3 of the EUWA (namely the
saving of EU-derived domestic legislation and the incorporation of direct EU
legislation) and under section 4 (which relates to certain enforceable EU rights).
6.2 The European Union (Withdrawal Agreement) Act 2020 (WAA) amended the powers
in section 8 EUWA to include the ability to deal with any deficiencies in law which
arise as a result of the transition period. It also added section 8B, which allows a
Minister to make regulations to implement the provisions set out in Part 3 of the
Withdrawal Agreement. These Regulations are also made under section 8B.
6.3 As part of the Government’s legislative programme to prepare for a “no deal”
outcome, five statutory instruments relating to intellectual property were laid before
Parliament in 2019 and approved (the 2019 Regulations)3. These instruments, which
relied upon the power in section 8 EUWA, are:
• The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019
(SI 2019/265; “the Exhaustion Regulations”),
• The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (SI
2019/269; “the Trade Mark Regulations”),
• The Intellectual Property (Copyright and Related Rights) (Amendment) (EU
Exit) Regulations 2019 (SI 2019/605; “the Copyright Regulations”),
• The Designs and International Trade Marks (Amendment etc.) (EU Exit)
Regulations 2019 (SI 2019/638; “the Designs Regulations”), and
• The Patents (Amendment) (EU Exit) Regulations 2019 (SI 2019/801; “the
Patents Regulations”).
6.4 Parts 1 to 6 of these Regulations amend each of these instruments, whilst Parts 7 and 8
make new changes to the Patents Act 1977 and Regulation 469/2009.
7. Policy background
What is being done and why?
7.1 The UK has left the EU under the terms of the Withdrawal Agreement, and there is
now a transition period until the end of 2020 while the UK and EU negotiate
additional arrangements. The current rules on trade, travel, and business for the UK
and EU continue to apply during the transition period.
7.2 The 2019 Regulations were drafted and designed to function in the event that the UK
left the EU without an agreement being reached by exit day. They do not reflect the
legal situation that now exists following the UK’s entry into the Withdrawal
Agreement. This instrument is needed to ensure that the law properly reflects the
obligations in the Withdrawal Agreement, and to ensure that it otherwise works
effectively at the end of the transition period.
7.3 Because the 2019 Regulations take a similar approach to the arrangements set out in
the Withdrawal Agreement, the legislative gap between the two is minimal. This
instrument will ensure that the arrangements set out in the Withdrawal Agreement are
fully implemented.
3 An additional instrument, the Design Right (Semiconductor Topographies) (Amendment) (EU Exit)
Regulations 2018 (SI 2018/1052), was made in 2018, but is not amended by this draft instrument.
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7.4 As the 2019 Regulations were intended to take effect on exit day, they do not take
account of the transition period, or that EU law now continues to apply until the end
of that period. The WAA has deferred the coming into force of instruments made
under the EUWA, including the 2019 Regulations, by glossing their commencement
provisions so that they refer to IP completion day instead of exit day4. However, this
change does not extend to other references to exit day in the 2019 Regulations (such
as in transitional provisions). If those references are not updated when the 2019
Regulations come into force, the law will be changed retroactively and rights which
currently exist may not be properly recognised.
7.5 In addition, the 2019 Regulations could only operate on the UK and EU law as it
stood at the time they were made. Any new legislation, or any amendment to existing
legislation, since that time needs to be accounted for and, if necessary, any
inoperabilities addressed. As far as possible, the approach remains to ensure that the
law which currently applies in the UK will continue to do so at the end of the
transition period, to ensure continuity and certainty for businesses and rightsholders.
7.6 This instrument covers a number of different IP rights. The specific policy
background to each is explored in more detail in the following sections.
Copyright and database rights
7.7 Database rights are a form of IP protection unique to EU law. They give database
creators the right to prevent others copying or sharing the contents of their databases
where a substantial investment has been made in obtaining, verifying or presenting
the data. The right is automatic and unregistered; however, only databases made by
EEA nationals, residents and businesses are eligible for the right.
7.8 Among other things, the Copyright Regulations amended the retained EU law on
database rights so that only databases created by UK nationals, residents and
businesses will be eligible for the right in the UK after exit day. However, it included
a transitional provision (regulation 38) which ensured that any database rights existing
before exit day would continue to be recognised for the remainder of their duration,
including those made by EEA nationals, residents or businesses.
7.9 Article 58 of the Withdrawal Agreement requires the UK to continue to recognise any
database rights which arose before the end of the transition period. As the Copyright
Regulations only do so for database rights from EEA makers that existed before exit
day, an amendment is needed to ensure any rights arising during the transition period
are properly protected. Regulation 4 does this by changing the provision to cover any
database right existing before IP completion day.
7.10 In addition, regulation 3 corrects an error in the Copyright Regulations in relation to
orphan works (orphan works are copyright works where one or more rightsholders are
unknown or cannot be found). A reference to Schedule ZA1 to the Copyright, Designs
& Patents Act 1988 had been inadvertently retained in regulation 31(a), despite its
deletion from that Act by an earlier provision of the Copyright Regulations.
Exhaustion of rights
7.11 IP rights are said to be “exhausted” if the IP-protected product has been first sold with
the approval of the rightsholder. As a result, the rightsholder cannot use their IP rights
to prevent the product being resold. In the EU, exhaustion occurs if the product is
4 As provided in paragraph 1(1) of schedule 5 to the WAA.
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lawfully sold anywhere in the EEA; the product can be resold freely within the EEA
and the rightsholder cannot stop it moving between Member States even if they have
IP rights in a particular country. This forms part of the principle of free movement of
goods set out in the EU treaties.
7.12 The Exhaustion Regulations preserved the effect of the EEA exhaustion regime in the
UK by reference to the retention of EU law and enforceable rights in the EUWA on
exit day. This meant that the IP rights of any product lawfully sold in the EEA, either
before or after exit day, would continue to be treated as having been exhausted in the
UK.
7.13 Article 61 of the Withdrawal Agreement commits the UK and the EU to recognise that
any IP rights which are exhausted before the end of the transition period will continue
to be treated as such.
7.14 Regulation 6 replaces references to “exit day” in the Exhaustion Regulations with “IP
completion day”. This ensures that, although any products sold during the transition
period would be correctly treated as exhausted under the existing provision, the rights
which are enforceable are those which are available at the end of the transition period.
This also provides legal certainty.
Trade marks, registered designs and unregistered designs
7.15 Trade marks and designs are intellectual property rights that distinguish the goods or
services from one trader to another, or protect the appearance of a product,
respectively. EU law provides for EU-wide trade marks, registered and unregistered
designs, the first two of which are granted by the EU Intellectual Property Office
(EUIPO). These rights will cease to apply in the UK when it is no longer treated as an
EU Member State, although they continue to have effect during the transition period.
7.16 EU-wide protection of trade marks and registered designs can also be obtained by
applying through the World Intellectual Property Organisation and designating the
territories in which protection is sought. International trade marks and designs
designating the EU will also cease to apply in the UK when it is no longer treated as
an EU Member State.
7.17 The Trade Mark Regulations and the Designs Regulations provided for comparable
rights to be granted under UK law for any EU trade marks or designs, or international
rights designating the EU, that were in force on exit day. They also enabled new UK
applications to be filed where an application for an EU right was pending on exit day,
retaining the original filing date of the EU application.
7.18 Articles 54-57 and 59 of the Withdrawal Agreement require the UK to take these
measures for EU rights in force, and applications pending, at the end of the transition
period. This instrument therefore amends the Trade Mark Regulations and the
Designs Regulations so that the grant of comparable rights and the right to file
replacement applications both operate with effect from IP completion day, rather than
exit day.
7.19 Failing to do so would mean that any EU rights which were granted during the
transition period would not be converted and could potentially be lost - this could be
as many as 200,000 rights.
7.20 The amendments in Parts 4 and 5 make the necessary substitutions.
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7.21 In addition, some minor errors found in the two sets of regulations have been
corrected. Regulation 19(b) provides a fix so that UK “design courts” correctly have
exclusive jurisdiction over converted EU unregistered designs. Regulation 23 corrects
an error in the Designs Regulations so that the period where no additional fees would
be due on top of the applicable fee to renew a converted EU registered design is
correctly set at six months, instead of one day as originally, inadvertently, drafted.
Regulation 25 corrects a conflict of amendments between the Design Regulations and
the Exhaustion Regulations.
7.22 Third parties can challenge the registration of an EU trade mark or registered design at
the EUIPO, or as a counterclaim in infringement actions heard before courts
designated as EU courts in Member States; the right may be cancelled or reduced in
scope if the challenge is successful. Article 54(3) of the Withdrawal Agreement
requires the UK to honour decisions made by the EUIPO, the CJEU on appeal from
the EUIPO, or Member State courts on cancellation actions which were in progress at
the end of the transition period, and to apply the decision to the comparable UK right.
This means that successful parties will not need to launch a separate cancellation
action in the UK. There is an exception where the grounds for revocation/invalidity
would not apply if considered under UK law.
7.23 Regulations 9(b)(ii) and 11 (for trade marks) and 21(c)(ii) and 24 (for registered
designs) provide for the IPO to take account of cancellation decisions on the EU
rights, to determine if the exception applies based on evidence from the rightsholder,
and to take action on the comparable right. A right of appeal is provided against the
decision of the IPO on whether the exception applies.
Patents and supplementary protection certificates
7.24 A patent protects an invention and lets the owner of that patent take legal action
against anyone who makes, uses, sells or imports that invention without the owner’s
permission – this is known as infringement of the patent. A patent can provide such
protection for up to twenty years.
7.25 Supplementary protection certificates (SPCs) provide a period of additional protection
for patented medicines and agrochemicals, to compensate for the need for lengthy
regulatory approval procedures during the patent lifetime before the product can be
sold and research investment recouped. The SPC gives the approved product the same
rights and protection as the patent, subject to the same limitations, for up to five years
after the patent expires. SPCs are provided by EU Regulations but operate as
individual national rights.
7.26 The Patents Regulations, amongst other things, ensured that the retained EU SPC
Regulations would continue to function as domestic law, replacing references to EU
regulatory legislation with their UK equivalents and ensuring that the method for
calculation of an SPC’s duration would remain the same. The provisions of the
Patents Regulations do not, in general, refer to “exit day”, and so do not need
changing to be able to work correctly when brought into force at the end of the
transition period.
7.27 In July 2019 - during the extended Article 50 period - the EU introduced a new
exception to the rights provided by an SPC. This “manufacturing waiver” allows third
parties to manufacture SPC-protected medicinal products, without needing the
permission of the SPC holder. The product can only be manufactured for export to
countries outside the EU where protection does not exist or has expired, or (in the
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final 6 months of the SPC term) for storing the product in the Member State of
making (“stockpiling”), ready for sale in the EU when the corresponding SPC expires.
Acts which are necessary for the manufacture of the product, its export or storage, are
also permitted as these too would otherwise infringe the protection provided by the
SPC. The product must be specifically labelled with an “EU export” logo so it can be
identified as having been made under the waiver; this is intended to prevent illicit
diversion of the product back onto the EU market.
7.28 Article 60 of the Withdrawal Agreement requires that any applications for an SPC
which are pending at the end of the transition period should be considered in
accordance with the EU law in force at that time, and any SPC granted based on those
applications should provide for the same level of protection provided for in EU law.
This will now need to include the manufacturing waiver.
7.29 Regulations 40-43 and the accompanying Schedule make additional amendments to
Regulation 469/2009 to fix inoperabilities in the manufacturing waiver legislation and
make consequential amendments to other legislation. These maintain the scope of the
waiver so that third parties can manufacture SPC-protected products in the UK,
without the rightsholder’s consent, either for export outside of the UK or EU or (in the
final 6 months of the SPC term) for stockpiling in the UK for sale in the UK or EU
once the SPC has expired. This means that the scope of the waiver within the UK will
remain essentially unchanged at the end of the transition period.
7.30 Paragraph 3(d) of the Schedule changes the labelling requirement so that the product
must be identified with “UK export” wording; this allows it to be distinguished from
one made in the EU under its waiver. Paragraph 3(k) provides a power to further
regulate the form and manner of that wording by negative statutory instrument, whilst
a transitional provision in regulation 43 ensures that any product which has already
been manufactured under the waiver does not require relabelling. The provision also
preserves the effect of any notification of intention to use the waiver filed before the
end of the transition period; as regulation 42 amends the Patents Rules 2007 to
designate a specific form for such notifications after 1 January 2021.
7.31 Beyond the manufacturing waiver, Article 60 of the Withdrawal Agreement also
applies to applications to extend the duration of an SPC for a medicine which has
been tested for paediatric use; regulation 37 updates transitional provisions in the
Patents Regulations so that they apply to applications pending at the end of the
transition period, as well as extensions already granted.
7.32 In addition, some small changes have been made to other provisions of the Patents
Regulations, to correct minor typographical errors and update cross-references to
other domestic law. Regulation 29 ensures that plant breeders’ rights which have been
converted from Community plant variety rights are able to be cross-licensed.
Regulations 28 and 39 replace a provision which preserved pre-exit day EU
legislation with a cross-reference to equivalent domestic definitions.
8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the
European Union
8.1 This instrument is being made using the power in section 8 of the European Union
(Withdrawal) Act 2018 in order to address failures of retained EU law to operate
effectively or other deficiencies arising from the withdrawal of the United Kingdom
from the European Union. The instrument is also made under the powers in section
8B of that Act in order to implement provisions in Part 3 of the Withdrawal
DExEU/EM/7-2018.2 9
Agreement. In accordance with the requirements of that Act the Minister has made the
relevant statements as detailed in Part 2 of the Annex to this Explanatory
Memorandum.
9. Consolidation
9.1 No consolidation of the relevant legislation is planned at present. Informal
consolidated texts of domestic intellectual property legislation are publicly available
for free on the gov.uk website5. The Intellectual Property Office is considering
whether informal consolidation of the retained EU law as amended by this instrument
will be necessary.
10. Consultation outcome
10.1 In relation to the manufacturing waiver, a public call for views was issued, seeking
feedback on draft legislation to fix the inoperabilities in the EU law in the event of a
“no deal” outcome6. The call for views was open from 5 July 2019 to 9 August 2019.
In addition, meetings were held with major representative bodies from the innovative
pharmaceutical industry, the manufacturers of generic pharmaceuticals, and the patent
attorney profession during the period to discuss the proposed draft.
10.2 Six responses were received before the call for views closed, from representative
organizations of rightsholders, pharmaceutical innovators, legal representatives, and
the generics industry. All of the respondents were in favour of ensuring the proper
functioning of the waiver and avoiding legal uncertainty. Most of the respondents
highlighted the importance of preserving the status quo regarding the territory to
which export could take place; the consultation draft would have allowed manufacture
for export to any country outside the UK. Other issues raised included the requirement
for a logo or other indication on the packaging for medicines intended for export and
the need for transitional arrangements.
10.3 In response to the feedback received, the Government made changes to the drafting of
the provisions to maintain the current markets for export and stockpiling, to provide
powers to allow for additional labelling requirements if necessary, and to include
additional transitional arrangements covering use of forms and the use of the pre-
existing labelling requirements on any products manufactured before the end of the
transition period. The drafting was then incorporated into this instrument.
10.4 The Government response to the call for views was published on 13 July 20206;
publication was initially delayed because the ratification of the Withdrawal
Agreement made it necessary to reassess the drafting of both the response and the
legislation itself. The Government’s focus on prioritising communications relating to
coronavirus necessitated a further delay.
10.5 As the other changes were largely technical and minor in nature, in line with Cabinet
Office principles on consultation, a formal public consultation was not considered to
be useful in determining the Government’s approach on drafting. Informal views on
the drafting of those changes were sought from relevant stakeholders; in particular,
the provisions on cancelling trade marks and designs were provided to representative
organisations and key users of the trade mark and design systems for comment and to
5 https://www.gov.uk/topic/intellectual-property/law-practice 6 https://www.gov.uk/government/consultations/supplementary-protection-certificate-waiver-no-deal-legislation
DExEU/EM/7-2018.2 10
familiarise them with the proposed approach. Responses generally approved of the
drafting of the legislation.
11. Guidance
11.1 Guidance was published in January 2020 on the effect of the transition period on
intellectual property rights, how the law will change at the end of that period, and
what preparations businesses may need to make7. The Intellectual Property Office
expects to update that guidance to reflect the contents of this instrument once it has
been approved by Parliament.
12. Impact
12.1 There is no, or no significant, impact on business, charities or voluntary bodies.
12.2 There is no, or no significant, impact on the public sector.
12.3 An Impact Assessment has not been prepared for this instrument because the changes
being made are largely technical in nature. The Government’s assessment is that the
combined policy impacts of this instrument fall below the threshold for a formal
impact assessment; a de minimis assessment has been carried out. The instrument will
update existing EU Exit regulations that were designed for a ‘no deal’ outcome to
account for the transition period and the obligations of the Withdrawal Agreement,
and address inoperabilities in the retained EU SPC Waiver Regulation arising as a
result of EU Exit. In both cases, the changes will ensure that existing legislation
continues to operate in the same way as before. As the status quo is being maintained,
it imposes no new obligations or burdens on private, public or third sector bodies and
does not require re-familiarisation; the changes are therefore not expected to result in
costs for businesses.
12.4 Where this instrument departs from the status quo is in implementing Article 54(3) of
the Withdrawal Agreement, under which the UK is obliged to recognise the outcome
of cancellation proceedings against EU-level registered rights that are underway as of
the end of the transition period. The impact of this is expected to be a small saving for
businesses, as separate cancellation proceedings will not need to be prosecuted in both
territories. This provision is expected to impact only around 1200 registered rights.
13. Regulating small business
13.1 The legislation applies to activities that are undertaken by small businesses.
13.2 No specific action is proposed to minimise regulatory burdens on small businesses.
13.3 The basis for the final decision on what action to take to assist small businesses is that,
as the principal purpose of the instrument is to maintain the status quo, it introduces
no new burdens to small businesses that need to be mitigated.
14. Monitoring & review
14.1 The approach to monitoring of this legislation is to assess the effect of the changes
being made as part of the course of normal departmental business.
14.2 As this instrument is made under the EU Withdrawal Act 2018, no review clause is
required.
7 https://www.gov.uk/government/news/intellectual-property-and-the-transition-period
DExEU/EM/7-2018.2 11
15. Contact
15.1 Michael Warren at the Intellectual Property Office, Telephone: 01633 813988 or
email: Michael.Warren@ipo.gov.uk can be contacted with any queries regarding the
instrument.
15.2 James Porter, Deputy Director at the Intellectual Property Office can confirm that this
Explanatory Memorandum meets the required standard.
15.3 Amanda Solloway MP, Parliamentary Under Secretary of State at the Department for
Business, Energy & Industrial Strategy can confirm that this Explanatory
Memorandum meets the required standard.
DExEU/EM/7-2018.2 12
Annex Statements under the European Union (Withdrawal) Act
2018
Part 1
Table of Statements under the 2018 Act
This table sets out the statements that may be required under the 2018 Act.
Statement Where the requirement sits To whom it applies What it requires
Sifting Paragraphs 3(3), 3(7) and
17(3) and 17(7) of Schedule
7
Ministers of the Crown
exercising sections 8(1), 9 and
23(1) to make a Negative SI
Explain why the instrument should be
subject to the negative procedure and, if
applicable, why they disagree with the
recommendation(s) of the SLSC/Sifting
Committees
Appropriate-
ness
Sub-paragraph (2) of
paragraph 28, Schedule 7
Ministers of the Crown
exercising sections 8(1), 9 and
23(1) or jointly exercising
powers in Schedule 2
A statement that the SI does no more than
is appropriate.
Good Reasons Sub-paragraph (3) of
paragraph 28, Schedule 7
Ministers of the Crown
exercising sections 8(1), 9 and
23(1) or jointly exercising
powers in Schedule 2
Explain the good reasons for making the
instrument and that what is being done is a
reasonable course of action.
Equalities Sub-paragraphs (4) and (5)
of paragraph 28, Schedule 7
Ministers of the Crown
exercising sections 8(1), 9 and
23(1) or jointly exercising
powers in Schedule 2
Explain what, if any, amendment, repeals
or revocations are being made to the
Equalities Acts 2006 and 2010 and
legislation made under them.
State that the Minister has had due regard
to the need to eliminate discrimination and
other conduct prohibited under the
Equality Act 2010.
Explanations Sub-paragraph (6) of
paragraph 28, Schedule 7
Ministers of the Crown
exercising sections 8(1), 9 and
23(1) or jointly exercising
powers in Schedule 2
In addition to the statutory
obligation the Government has
made a political commitment
to include these statements
alongside all EUWA SIs
Explain the instrument, identify the
relevant law before exit day, explain the
instrument’s effect on retained EU law and
give information about the purpose of the
instrument, e.g., whether minor or
technical changes only are intended to the
EU retained law.
DExEU/EM/7-2018.2 13
Criminal
offences
Sub-paragraphs (3) and (7)
of paragraph 28, Schedule 7
Ministers of the Crown
exercising sections 8(1), 9, and
23(1) or jointly exercising
powers in Schedule 2 to create
a criminal offence
Set out the ‘good reasons’ for creating a
criminal offence, and the penalty attached.
Sub-
delegation
Paragraph 30, Schedule 7 Ministers of the Crown
exercising sections 10(1), 12
and part 1 of Schedule 4 to
create a legislative power
exercisable not by a Minister
of the Crown or a Devolved
Authority by Statutory
Instrument.
State why it is appropriate to create such a
sub-delegated power.
Urgency Paragraph 34, Schedule 7 Ministers of the Crown using
the urgent procedure in
paragraphs 4 or 14, Schedule
7.
Statement of the reasons for the Minister’s
opinion that the SI is urgent.
Explanations
where
amending
regulations
under 2(2)
ECA 1972
Paragraph 14, Schedule 8 Anybody making an SI after
exit day under powers outside
the European Union
(Withdrawal) Act 2018 which
modifies subordinate
legislation made under s. 2(2)
ECA
Statement explaining the good reasons for
modifying the instrument made under s.
2(2) ECA, identifying the relevant law
before exit day, and explaining the
instrument’s effect on retained EU law.
Scrutiny
statement
where
amending
regulations
under 2(2)
ECA 1972
Paragraph 15, Schedule 8 Anybody making an SI after
exit day under powers outside
the European Union
(Withdrawal) Act 2018 which
modifies subordinate
legislation made under s. 2(2)
ECA
Statement setting out:
a) the steps which the relevant authority
has taken to make the draft instrument
published in accordance with paragraph
16(2), Schedule 8 available to each House
of Parliament,
b) containing information about the
relevant authority’s response to—
(i) any recommendations made by a
committee of either House of Parliament
about the published draft instrument, and
(ii) any other representations made to the
relevant authority about the published draft
instrument, and,
c) containing any other information that
the relevant authority considers appropriate
in relation to the scrutiny of the instrument
or draft instrument which is to be laid.
DExEU/EM/7-2018.2 14
Part 2
Statements required when using enabling powers
under the European Union (Withdrawal) 2018 Act
1. Appropriateness statement
1.1 The Parliamentary Under Secretary of State (Minister for Science, Research and
Innovation), Amanda Solloway MP, has made the following statement regarding use
of legislative powers in the European Union (Withdrawal) Act 2018:
“In my view the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020
do no more than is appropriate”.
1.2 This is the case because the changes ensure compliance with the specific provisions of
the Withdrawal Agreement, and only correct deficiencies to the extent necessary to
maintain the continued functioning of the intellectual property system at the end of
the transition period.
2. Good reasons
2.1 The Parliamentary Under Secretary of State (Minister for Science, Research and
Innovation), Amanda Solloway MP, has made the following statement regarding use
of legislative powers in the European Union (Withdrawal) Act 2018:
“In my view there are good reasons for the provisions in this instrument, and I have
concluded they are a reasonable course of action”.
2.2 These are: that it is critical to implement the commitments agreed in the Withdrawal
Agreement and to ensure that EU law retained at the end of the transition period
functions effectively as domestic law.
3. Equalities
3.1 The Parliamentary Under Secretary of State (Minister for Science, Research and
Innovation), Amanda Solloway MP, has made the following statement(s):
“The draft instrument does not amend, repeal or revoke a provision or provisions in
the Equality Act 2006 or the Equality Act 2010 or subordinate legislation made under
those Acts.”.
3.2 The Parliamentary Under Secretary of State (Minister for Science, Research and
Innovation), Amanda Solloway MP, has made the following statement regarding use
of legislative powers in the European Union (Withdrawal) Act 2018:
“In relation to the draft instrument, I, Amanda Solloway have had due regard to the
need to eliminate discrimination, harassment, victimisation and any other conduct that
is prohibited by or under the Equality Act 2010.”.
4. Explanations
4.1 The explanations statement has been made in section 2 of the main body of this
explanatory memorandum.