Brussels, 01 February 2019
Interinstitutional files:
2018/0161(COD)
WK 1583/2019 INIT
LIMITE
PI
CODEC
COMPET
PHARM
IA
WORKING PAPER
This is a paper intended for a specific community of recipients. Handling and
further distribution are under the sole responsibility of community members.
NOTE
From:
General Secretariat of the Council
To:
Delegations
N° prev. doc.:
5411/19
N° Cion doc.:
9485/18 + ADD1 + ADD2 + ADD3 + ADD4
Subject:
Proposal for a Regulation amending Regulation (EC) No 469/2009 concerning the
supplementary protection certificate for medicinal products
- 4 column table
Delegations will find attached the first version of the 4-column table on the above proposal, setting out
the text of the Commission proposal (9485/18) in the first column, the EP position as adopted by the JURI
Committee on 23 January and approved by EP plenary on 31 January 2019 in the second column, and the
Council negotiating mandate as approved by Coreper on 16 January 2019 (5411/19) in the third column.
WK 1583/2019 INIT
LIMITE
EN
Version 1
01.02.2019
Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009
concerning the supplementary protection certificate for medicinal products (SPC)
COM (2018) 317 final -
2018/0161 (COD)
Cell in green: The text can be deemed as already agreed
Cell in yellow: The issue needs further discussion at technical level
Cell in red: The issue needs further discussion in depth at the trilogue meetings
Note:
Differences between the EP's position and the Commission's proposal are highlighted in Bold/Italics. Deletions are marked with strikethrough.
Differences between the Council's position and the Commission's proposal are highlighted in Bold/Underlined. Deletions are marked with
strikethrough.
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1
Proposal for a
Proposal for a
Proposal for a
2
REGULATION OF THE
REGULATION OF THE
REGULATION OF THE
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
AND OF THE COUNCIL
AND OF THE COUNCIL
AND OF THE COUNCIL
3
amending Regulation (EC) No
amending Regulation (EC) No
amending Regulation (EC) No
469/2009 concerning the
469/2009 concerning the
469/2009 concerning the
supplementary protection
supplementary protection
supplementary protection
certificate for medicinal products
certificate for medicinal products
certificate for medicinal products
4
(Text with EEA relevance)
(Text with EEA relevance)
(Text with EEA relevance)
5
THE EUROPEAN
THE EUROPEAN
THE EUROPEAN
PARLIAMENT AND THE
PARLIAMENT AND THE
PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN COUNCIL OF THE EUROPEAN COUNCIL OF THE EUROPEAN
UNION,
UNION,
UNION,
6
Having regard to the Treaty on the Having regard to the Treaty on the Having regard to the Treaty on the
Functioning of the European
Functioning of the European
Functioning of the European
Union, and in particular Article
Union, and in particular Article
Union, and in particular Article
114 thereof,
114 thereof,
114 thereof,
7
Having regard to the proposal
Having regard to the proposal
Having regard to the proposal
from the European Commission,
from the European Commission,
from the European Commission,
8
After transmission of the draft
After transmission of the draft
After transmission of the draft
legislative act to the national
legislative act to the national
legislative act to the national
parliaments,
parliaments,
parliaments,
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9
Having regard to the opinion of the Having regard to the opinion of the Having regard to the opinion of the
European Economic and Social
European Economic and Social
European Economic and Social
Committee1,
Committee1
Committee1,
10
Acting in accordance with the
Acting in accordance with the
Acting in accordance with the
ordinary legislative procedure,
ordinary legislative procedure,
ordinary legislative procedure,
11
Whereas:
Whereas:
Whereas:
12
(1) Regulation (EC) No
(1) Regulation (EC) No
(1) Regulation (EC) No
469/2009 of the European
469/2009 of the European
469/2009 of the European
Parliament and of the Council2
Parliament and of the Council2
Parliament and of the Council2
provides that any product
provides that any product
provides that any product
protected by a patent in the
protected by a patent in the
protected by a patent in the
territory of a Member State and
territory of a Member State and
territory of a Member State and
subject, prior to being placed on
subject, prior to being placed on
subject, prior to being placed on
the market as a medicinal product, the market as a medicinal product, the market as a medicinal product,
to an administrative authorisation
to an administrative authorisation
to an administrative authorisation
procedure as laid down in
procedure as laid down in
procedure as laid down in
Directive 2001/83/EC of the
Directive 2001/83/EC of the
Directive 2001/83/EC of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
Council3 or Directive 2001/82/EC
Council3 or Directive 2001/82/EC
Council3 or Directive 2001/82/EC
of the European Parliament and of of the European Parliament and of of the European Parliament and of
1 OJ C , , p. .
2 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152,
16.6.2009, p. 1).
3 Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311,
28.11.2001, p.67).
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the Council4, may be the subject of the Council4, may be the subject of the Council4, may be the subject of
a supplementary protection
a supplementary protection
a supplementary protection
certificate under the terms and
certificate under the terms and
certificate under the terms and
conditions provided for in
conditions provided for in
conditions provided for in
Regulation (EC) No 469/2009.
Regulation (EC) No 469/2009.
Regulation (EC) No 469/2009.
13
(2) By providing for a period of
(2) By providing for a period of
(2) By providing for a period of
supplementary protection of up to
supplementary protection of up to
supplementary protection of up to
five years, Regulation (EC) No
five years, Regulation (EC) No
five years, Regulation (EC) No
469/2009 seeks to promote, within 469/2009 seeks to promote,
469/2009 seeks to promote, within
the Union, the research and
provide a solution at Union level
the Union, the research and
innovation that is necessary to
to prevent new disparities being
innovation that is necessary to
develop medicinal products, and to
created in national law, which
develop medicinal products, and to
contribute to preventing the
could hinder the free movement
contribute to preventing the
relocation of pharmaceutical
of medicines within the internal
relocation of pharmaceutical
research outside the Union to
market, while promoting, within
research outside the Union to
countries that may offer greater
the Union, the research and
countries that may offer greater
protection.
innovation that is necessary to
protection.
develop
new generation of
medicinal products
that support
the treatment of new diseases or
offer more significant therapeutic
effects, and to contribute
contributing to preventing the
relocation of pharmaceutical
research outside the Union to
countries that may offer greater
4 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001,
p. 1).
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protection,
while at the same time
ensuring access to medicines
within the Union.
14
(2 a) The timely entry of generics
and biosimilars onto the Union
market is important as regards
increasing competition, reducing
prices and ensuring the
sustainability of healthcare
systems. Amending Regulation
(EC) No 469/2009 so as to allow
the production of generics and
biosimilars for export and storage
should not conflict with
intellectual property rights, which
remain one of the cornerstones of
innovation, competitiveness and
growth in the Member States.
This Regulation should not
interfere with the duration of
market exclusivity rights during
the term of a patent, which is
underscored by the fact that
immediate import is allowed after
expiry, but represents a
competitive disadvantage for the
European generic medicines
industry. This Regulation should
take into account the concerns
expressed by the European
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Parliament and by the Council
regarding the increasing number
of examples of market failure in a
number of Member States, where
patients´ access to effective and
affordable essential medicines is
endangered by very high and
unsustainable price levels.
15
(3) Since the adoption in 1992
(3) Since the adoption in 1992
(3) Since the adoption in 1992
of the predecessor to Regulation
of the predecessor to Regulation
of the predecessor to Regulation
(EC) No 469/2009, markets have
(EC) No 469/2009, markets have
(EC) No 469/2009, markets have
evolved significantly and there has evolved significantly and there has evolved significantly and there has
been huge growth in the
been huge growth in the
been huge growth in the
manufacture of generics and
manufacture of generics and
manufacture of generics and
especially of biosimilars, in
especially of biosimilars
and
especially of biosimilars, in
particular in third countries where
active ingredients, in particular in
particular in third countries
protection does not exist or has
countries outside the Union (in
outside the EU (‘third
expired.
‘third countries
’) where protection
countries’) where protection does
does not exist or has expired.
not exist or has expired.
16
3a) Pharmaceuticals are one of
the pillars of healthcare rather
than a mere object of trade.
Insufficient access to essential
medicinal products and the high
prices of innovative medicines
pose a serious threat to patients
and to the sustainability of
national health care systems.
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(3b) The Council, in its
conclusions of 17 June 2016 on
strengthening the balance in the
pharmaceutical systems in the
Union and its Member States,
underlined the importance of
timely availability of generics and
biosimilars in order to facilitate
patients' access to pharmaceutical
therapies and to improve the
sustainability of national health
systems.
18
(4) The absence of any
(4) The absence of any
(4) The absence of any
exception in Regulation (EC) No
exception in Regulation (EC) No
exception in Regulation (EC) No
469/2009 to the protection
469/2009 to the protection
469/2009 to the protection
conferred by a supplementary
conferred by a supplementary
conferred by a supplementary
protection certificate has had the
protection certificate has had the
protection certificate has had the
unintended consequence of
unintended consequence of
unintended consequence of
preventing manufacturers of
preventing manufacturers of
preventing manufacturers
makers
generics and biosimilars
generics and biosimilars
of generics and biosimilars
established in the Union from
established in the Union from
established in the Union from
manufacturing, even for the
manufacturing even for the
manufacturing
making in the
exclusive purpose of exporting to
exclusive purpose of exporting to
Union, even for the exclusive
third country markets in which
third country markets in which
purpose of exporting to third
such protection does not exist or
such protection does not exist or
country markets in which such
has expired. A further unintended
has expired. A further unintended
protection does not exist or has
consequence is that the protection
consequence is that the protection
expired. A further unintended
conferred by the certificate makes
conferred by the certificate makes
consequence is that the protection
it more difficult for those
it more difficult for those
conferred by the certificate makes
manufacturers to enter the Union
manufacturers
within the Union,
it more difficult for those
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market immediately after expiry of
with a view to enter
entering the
manufacturers
makers to enter the
the certificate, given that they are
Union market immediately after
Union market immediately after
not in a position to build up
expiry of the certificate
(EU-Day1 expiry of the certificate, given that
production capacity until the
Entry) and/or from exporting to
they are not in a position to build
protection provided by the
third countries in which
up production capacity until the
certificate has lapsed, by contrast
protection does not exist or has
protection provided by the
with manufacturers located in third
expired, given that they are not in
certificate has lapsed, by contrast
countries where protection does
a position to build up production
with manufacturers
makers located
not exist or has expired.
capacity until the protection
in third countries where protection
provided by the certificate has
does not exist or has expired.
lapsed, by contrast with
manufacturers located in third
countries where protection does
not exist or has expired.
19
(5) This puts manufacturers of
(5) This puts manufacturers of
(5) This puts
generics and biosimilars
generics and biosimilars
manufacturers
makers of generics
established in the Union at a
established in the Union at a
and biosimilars established in the
significant competitive
significant competitive
Union at a significant competitive
disadvantage compared with
disadvantage compared with
disadvantage compared with
manufacturers based in third
manufacturers based in third
manufacturers
makers based in
countries that offer less or no
countries that offer less or no
third countries that offer less or no
protection.
protection
or where protection has protection.
expired.
It is imperative,
therefore, that the European
Union strike a balance between,
on the one hand, ensuring a level
playing field between production
activities on its territory and in
third countries and, on the other,
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ensuring that the exclusive rights
of certificate holders are
guaranteed in relation to the
Union market.
20
(6) Without any intervention,
(6) Without any intervention,
(6) Without any intervention,
the viability of the manufacture of the viability of the manufacture
the viability of the
generics and biosimilars in the
manufactures of generics and
manufacture
makers of generics
Union could be under threat, with
biosimilars in the Union could be
and biosimilars
established in the
consequences for the Union’s
under threat, with consequences
Union could be under threat, with
pharmaceutical industrial base as a for the Union’s pharmaceutical
consequences for the Union’s
whole.
industrial base as a whole,
which
pharmaceutical industrial base as a
could affect the very functioning
whole.
of the internal market through
the loss of potential new business
opportunities as well as
diminishing investment at Union
level and possibly hampering the
creation of new jobs.
21
(7) The aim of this Regulation is (7) The aim of this Regulation is (7) The aim of this Regulation is
to ensure that manufacturers
to ensure that manufacturers
to ensure that manufacturers
established in the Union are able to established
promote the
promote the competitiveness of
compete effectively in those third
competitiveness of generics and
the Union, enhancing growth
country markets where
biosimilars producers in the
and job creation in the internal
supplementary protection does not Union are able
, to enhance growth market and contributing to a
exist or has expired. It is intended
and job creation in the internal
wider supply of products under
to complement the efforts of the
market and to contribute to a
uniform conditions, by allowing
Union’s trade policy to ensure
wider supply of products under
makers of generics and
open markets for Union-based
uniform conditions. This will help biosimilars established in the
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manufacturers of medicinal
producers to compete effectively
Union are able
to make in the
products. Indirectly, it is also
in third country markets where
Union medicinal products or
intended to put those
supplementary protection does not
products for the exclusive
manufacturers in a better position
exist or has expired
and to ensure
purpose of export to third
to enter the Union market
EU-Day1 Entry of generic and
country markets where
immediately after expiry of the
biosimilar medicines into the
protection does not exist or has
relevant supplementary protection
Union market after expiry of the
expired, thus also helping these
certificate. It would also help to
relevant supplementary protection makers to compete effectively in
serve the aim of fostering access to
certificate. It is intended to
should those third country markets where
medicines in the Union by helping
also complement the efforts of the supplementary protection does not
to ensure a swifter entry of generic Union’s trade policy to ensure
exist or has expired.
. It is intended
and biosimilar medicines onto the
open markets for Union-based
to
should also complement the
market after expiry of the relevant
manufacturers of medicinal
efforts of the Union’s trade policy
certificate.
products Indirectly, it is also
to ensure open markets for Union-
intended to
or of active
based manufacturers of medicinal
ingredients.
It would put those
products. Indirectly, it is also
manufacturers in a better position
intended to put those
to enter the Union market
manufacturers in a better position
immediately after expiry of the
to enter the Union market
relevant supplementary protection
immediately
makers of medicinal
certificate
, namely the EU-Day1
products or products. Over time,
Entry. It would also help fostering
the Regulation should benefit the
access to medicines in the Union
entire pharmaceutical sector in
by helping to ensure a swifter
the Union, by allowing all
entry of generic and biosimilar
players, including newcomers, to
medicines onto the market after
reap the benefits of the new
expiry of the relevant certificate.
opportunities opening up in the
fast-changing global
pharmaceutical market.
Furthermore, the common
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interest in the Union would be
promoted as, through the
reinforcement of Union-based
supply chains for medicines,
medicines would become more
accessible to patients in the
Union after
the expiry of the
relevant supplementary protection
certificate. It would also help to
serve the aim of fostering access to
medicines in the Union by helping
to ensure a swifter entry of generic
and biosimilar medicines onto the
market after expiry of the relevant
certificate.
22
(8) In those specific and limited (8) In those
these specific and
(8) In those
these specific and
circumstances, and in order to
limited circumstances, and in order limited circumstances, and in order
create a level playing field
to create a level playing field
to create a level playing field
between Union-based
between Union-based
between Union-based
manufacturers and third country
manufacturers and third country
manufacturers
makers and third
manufacturers, it is appropriate to
manufacturers, it is appropriate to
country manufacturers
makers, it
restrict the protection conferred by restrict the protection conferred by is appropriate to restrict the
a supplementary protection
eliminate the unintentional
protection conferred by a
certificate so as to allow making
effects of a supplementary
supplementary protection
for the exclusive purpose of export protection certificate so as to allow certificate so as to allow making
to third countries and any related
making
, but not to the detriment
for the exclusive purpose of export
acts strictly necessary for making
of any other patent or intellectual to third countries and any related
or for the actual export itself.
property right existing in a
acts
in the Union strictly
Member State, so as to allow
necessary for making or for the
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making of generic products,
actual export itself
, where such
biosimilars and active ingredients acts would otherwise require the
for the exclusive the purpose of
consent of the
a certificate-
holder,
export to third countries and any
and are strictly necessary for
related acts strictly necessary for
making for the purpose of export
making or for the actual export
or for the actual export itself.
itself.
of entry into the Union
(‘related acts’). For instance, such
market immediately after expiry
acts may include the
possession,
of the relevant supplementary
supply and
, import
, or making of
protection certificate.
active ingredients
products for the
purpose of making the
a medicinal
product to which the
containing
that product covered by the
certificate corresponds, or
temporary storage of the product
or advertising for the exclusive
purpose of export to third country
destinations.
The exception should also apply
to related acts performed by
third parties who are in a
contractual relationship with the
maker.
[grey shaded part was taken from
recital 9]
23
(9) That exception should cover (9) That exception should cover (9) That exception should cover
the making of the product,
the making of the product
and of
the making of the product,
including the product which
including the product
resulting
including the product which
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corresponds to the medicinal
from the making, which
corresponds to the medicinal
product protected by a
corresponds to the medicinal
product protected by a
supplementary protection
product
are both protected by a
supplementary protection
certificate in the territory of a
supplementary protection
certificate in the territory of a
Member State, for the exclusive
certificate in the territory of a
Member State, for the exclusive
purpose of export to third
Member State, for the exclusive
purpose of export to third
countries, as well as any upstream
purpose of export to third
countries, as well as any upstream
or downstream acts by the maker
countries, as well as any upstream
or downstream acts by the maker
or by third parties in a contractual
or downstream acts by the maker
or by third parties in a contractual
relationship with the maker, where or by third parties in a contractual
relationship with the maker, where
such acts would otherwise require
relationship with the maker, where such acts would otherwise require
the consent of the certificate-
such acts would otherwise require
the consent of the certificate-
holder, and are strictly necessary
the consent of the certificate-
holder, and are strictly necessary
for making for the purpose of
holder, and are strictly necessary
for making for the purpose of
export or for the actual export
for making for the purpose of
export or for the actual export
itself. For instance, such acts may
export or for the actual export
itself.
. For instance, such acts may
include the supply and import of
itself. For instance, such acts may
include the supply and
, import of
active ingredients for the purpose
include the supply and import of
active ingredients for the purpose
of making the medicinal product to active ingredients for the purpose
of making the medicinal product to
which the product covered by the
of making the medicinal product to which the product covered by the
certificate corresponds, or
which the product covered by the
certificate corresponds, or
temporary storage of the product
certificate corresponds, or
temporary storage of the product
or advertising for the exclusive
temporary storage of the product
or advertising for the exclusive
purpose of export to third country
or advertising for the exclusive
purpose of export to third country
destinations.
purpose of export to third country
destinations.
destinations.
or of placing the
This exception should apply to a
product on the Union market
product, or a medicinal product
after the expiry of the certificate.
containing that product,
protected by a certificate. It
should cover the making of the
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product protected by a
certificate in the territory of a
Member State and the making of
the medicinal product
containing that product.
[grey shaded part was moved to
recital 8]
24
(10) The exception should not
(10) The exception should not
(10) The exception should not
cover placing the product made for cover placing the
a medicinal
cover placing the product
or
the exclusive purpose of export on product made for the purpose of
medicinal product containing
the market in the Member State
export on the market
to third
that product, made for the
where a supplementary protection
countries or placing it on the
exclusive purpose of export
, on the
certificate is in force, either
Union's market on the first day
market in the Member State where
directly or indirectly after export,
after the expiry of the certificate
a supplementary protection
nor should it cover re-importation
in the Member State where a
certificate is in force, either
of the product to the market of a
supplementary protection
directly
, or indirectly after export,
Member State in which a
certificate is in force, either
nor should it cover re-importation
certificate is in force. Moreover, it directly or indirectly after
of the product to the market of a
should not cover any act or activity export,nor should it cover re-
Member State in which a
for the purpose of import of
importation of the
medicinal
certificate is in force. Moreover, it
medicinal products, or parts of
product to the market of a Member should not cover any act or activity
medicinal products, into the Union State in which a certificate is in
for the purpose of import of
merely for the purposes of
force. Moreover, it should not
medicinal products, or parts of
repackaging and re-exporting.
cover any act or activity for the
medicinal products, into the Union
purpose of import of products or
merely for the purposes of
medicinal products, into the Union repackaging and re-exporting
. It
merely for the purposes of
should not cover temporary
repackaging and re-exporting.
storage of the product or
medicinal product containing
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that product for any purposes
other than those set out in this
Regulation.
25
(11) By limiting the scope of the
(11) By limiting the scope of the
(11) By limiting the scope of the
exception to making for the
exception to making for the
exception to making for the
purpose of export outside the
purpose of export outside the
purpose of export outside the
Union and acts strictly necessary
Union and acts strictly necessary
Union and acts strictly necessary
for such making or for the actual
for such making or for the actual
for such making or for the actual
export itself, the exception
export itself,
to third countries and export itself, the exception
introduced by this Regulation will
of placing into the Union market
introduced by this Regulation
not unreasonably conflict with
as from day 1 after the certificate
will
should not unreasonably
normal exploitation of the product
has expired, the exception
conflict with
the normal
in the Member State where the
introduced by this Regulation will
exploitation of the product
or
certificate is in force, nor
should not unreasonably conflict
medicinal product containing
unreasonably prejudice the
with normal exploitation of the
that product in the Member State
legitimate interests of the
product in the Member State
where the certificate is in force,
certificate-holder, taking account
where the certificate is in force,
nor unreasonably
namely with the
of the legitimate interests of third
nor unreasonably prejudice the
core exclusive right of the
parties.
legitimate interests of the
certificate holder to make that
certificate-holder,
whilst also
product for the purpose of
taking account of the legitimate
placing it on the Union market
interests of third parties.
during the term of the
certificate. In addition, the
exception should not
unreasonably prejudice the
legitimate interests of the
certificate-holder, taking account
of the legitimate interests of third
parties.
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26
(12) Safeguards should
(12)
Effective and proportionate (12) Safeguards should
accompany the exception in order
safeguards should accompany the
accompany the exception in order
to increase transparency, to help
exception in order to increase
to increase transparency, to help
transparency, to help
, for the
the holder of a supplementary
purpose of helping
protection certificate to enforce its
the holder of a supplementary
protection in the Union and to
protection certificate to enforce its the holder of a supplementary
reduce the risk of illicit diversion
protection in the Union and to
protection certificate to enforce its onto the Union market during the
reduce the risk of illicit diversion
protection in the Union and to
term of the certificate.
onto the Union market during the
reduce the risk of illicit diversion
term of the certificate.
onto the Union market during the
term
check compliance with the
conditions set out in this
Regulation. Those safeguards
should not negatively affect
competition among companies
and should allow the exception to
work effectively without
hampering achievement of the
main objectives of the certificate
exception.
27
(13) To this end, this Regulation
(13) To this end, this Regulation
(13) To this end, this Regulation
should impose a once-off duty on
should impose a once-off duty on
should impose a once-off duty
an
the person making the product for
the
maker, namely the legal
information obligation on the
the exclusive purpose of export,
person
established in the Union,
maker, namely the person
requiring that person to provide
on whose behalf the making
of a
established in the Union, on
certain information to the authority
product or medicinal product
whose behalf the making the
of a
which granted the supplementary
containing that the product
, for
product or medicinal product
protection certificate in the
the exclusive
purpose of export
to
containing that product for the
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Member State where the making is
third countries or of placing on
exclusive purpose of export,
to take place. The information
the Union market after the expiry requiring that
is done (this
should be provided before the
of the certificate, is carried out,
includes the possibility of the
making is intended to start for the
including the possibility of the
person to
itself directly doing the
first time in that Member State.
legal person itself directly doing
making). Namely, the maker
The making and related acts,
the making,
whereby requiring
should provide certain information
including those performed in
that person
is required to provide
to the authority which granted the
Member States other than the one
certain information to the authority supplementary protection
of making in cases where the
which granted the supplementary
certificate in the Member State
product is protected by a
protection certificate in the
where the making is to take place.
certificate in those other Member
Member State where the making is
A common notification form
States too, should only fall within
to take place.
It is the
should be provided for this
the scope of the exception where
responsibility of the maker
purpose. The information should
the maker has sent this notification
established in the Union to verify
be provided before the making is
to the competent industrial
that protection does not exist or
intended to start
starts for the first
property authority (or other
has expired in a country of
time in that Member State
, or
designated authority) of the
export, or whether it is subject to
before any related act prior to
Member State of making. The
any limitations or exemptions in
that making, whichever is the
once-off duty to provide
that country. A common
earlier. It should be updated as
information to the authority should
notification form for the
and when appropriate. The
apply in each Member State where
notification of the authority
making and related acts, including
making is to take place, both as
should be provided for that
those performed in Member States
regards the making in that Member
purpose. The information should
other than the one of making in
State, and as regards related acts,
be provided before the making is
cases where the product is
whether performed in that or
intended to start for the first time
protected by a certificate in those
another Member State, related to
in that Member State. The making other Member States too, should
that making. The authority should
should only fall within the scope
only fall within the scope of the
be required to publish that
of the exception where the maker
exception where the maker has
information, in the interests of
has sent this notification to the
sent this notification to the
transparency and for the purpose
competent industrial property
competent industrial property
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of informing the holder of the
authority (or other designated
authority (or other designated
certificate of the maker’s intention. authority) of the Member State of
authority) of the Member State of
making The once-off duty to
making. The once-off duty to
provide information to the
provide information to the
authority should apply in each
authority should apply in each
Member State where making is to
Member State where making is to
take place, both as regards the
take place, both as regards the
making
and has informed the
making in that Member State, and
holder of the supplementary
as regards related acts, whether
protection certificate granted
performed in that or another
about the name and address of
Member State, related to that
the maker and the number of the
making. The authority should be
certificate in that Member State
required to publish that
and as regards related acts,
information, in the interests of
whether performed in that or
transparency and for the purpose
another.
The making should be
of informing the holder of the
notified.
Should making take
certificate of the maker’s intention
place in more than one Member
and has informed the holder of
State, related to that making.
a
the certificate granted in that
notification should be required in Member State. Should making
each of those Member States. The
take place in more than one
authority should be required
in
Member State, a notification
each of these Member States. The should be required in each of
authority should be required to
these Member States. In the
publish that information
the
interests of transparency, the
certificate number of the relevant authority should be required to
product or medicinal product, in
publish, as soon as possible, the
the interests of transparency
. and
information it receives, together
for the purpose of informing the
with the date of notification of
holder of the certificate of the
that information. Member States
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maker’s intention.
Certain
should be allowed to require that
confidential or commercially
notifications, and updates to
sensitive information notified to
notifications, be subject to the
the authority should not be
payment of a once-off fee. This
published, but could be provided,
fee should be set at a level which
if so requested by a court or other does not exceed the
competent authority and in those
administrative cost of processing
circumstances only.
notifications and updates.
28
(13 a)
Without prejudice to
(13a) The maker should also
the protection of confidential or
inform the certificate holder,
commercially sensitive
through appropriate and
information, the maker should
documented means, of the
also inform the certificate holder, intention to make a product or
in writing, of its intention to make medicinal product containing
a product pursuant to the
that product pursuant to the
exception.
exception, by providing the
certificate holder with the same
information as notified to the
authority. That information is
limited to what is necessary and
appropriate for the certificate
holder to assess whether the
rights conferred by the
certificate are being respected,
and does not include confidential
or commercially sensitive
information. The information to
the certificate holder may be
provided by making use of the
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same common notification form,
and the information provided
should be updated as and when
appropriate.
29
(13b) Regarding related acts
prior to the making, if any, the
notification should list the name
of the Member State where the
first related act, which would
otherwise require the consent of
a certificate holder, is to take
place, as this information is
relevant to the timing of the
notification.
30
(13c) If the local marketing
authorisation, or equivalent, in a
specific third country, for a
given medicinal product, is
published after the notification is
made, the notifcation should be
promptly updated to include the
reference number of that
marketing authorisation, at the
latest before the actual export of
the medicinal product to that
third country takes place. If a
marketing authorisation or
equivalent mechansim applies,
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but the reference number of the
granted authorisation is not
published or is pending
publication, the maker should be
required to provide, in the
notification, either that reference
number or the name of the third
country of export. As a failsafe,
if no marketing authorisation or
equivalent applies in that
country, the maker should then
be required to provide, in the
interests of transparency, the
name of the third country of
export.
31
(13d) For reasons of
proportionality, failure to
comply with these requirements
regarding a third country would
only affect exports to that
country, and exports to such
third country would thus not
benefit from the exception. It
should be the responsibility of
the maker established in the
Union to verify that protection
does not exist or has expired in a
country of export, subject to any
limitations or exemptions in that
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country. A notification to an
authority and the corresponding
information to the certificate
holder may be provided during
the period between the entry
into force of the Regulation and
the date on which the exception
itself becomes applicable.
32
(14) In addition, this Regulation
(14) In addition, this Regulation
(14) In addition, this Regulation
should impose certain due
should impose certain due
should impose certain due
diligence requirements on the
diligence requirements on the
diligence requirements on the
maker as a condition for the
maker as a condition for the
maker as a condition for the
exception to operate. The maker
exception to operate. The maker
exception to operate. The maker
should be required to inform
should be required to inform
should be required to inform
persons within its supply chain,
persons within its supply chain,
persons within its supply chain
in
through appropriate means, in
through appropriate
and
the Union, including the
particular contractual means, that
documented means, in particular
exporter, through appropriate
and
the product is covered by the
contractual means, that the product
documented means, in particular
exception introduced by this
is covered by the exception
contractual means, that the
Regulation and is intended for the
introduced by this Regulation and
product or medicinal product
exclusive purpose of export. A
is intended for the purpose of
containing that product is covered
maker who failed to comply with
export
and/or EU-Day1 Entry. A
by the exception introduced by this
these due diligence requirements
maker who failed to comply with
Regulation and is intended for the
would not benefit from the
these due diligence requirements
exclusive purpose of export. A
exception, nor would any third
would not benefit from the
maker who failed to comply with
party performing a related act in
exception, nor would any third
these due diligence requirements
the same or a different Member
party performing a related act in
would not benefit from the
State where a certificate conferring the same or a different Member
exception, nor would any third
protection for the product was in
State where a certificate conferring party performing a related act in
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force, and the holder of the
protection for the product was in
the same or a different Member
relevant certificate would therefore force, and the holder of the
State where a certificate conferring
be entitled to enforce its rights
relevant certificate would therefore protection for the product was in
under the certificate.
be entitled to enforce its rights
force, and the holder of the
under the
supplementary
relevant certificate would therefore
protection certificate.
be entitled to enforce its rights
under the certificate
, while paying
due regard to the general
obligation, set out in Directive
2004/48/EC of the European
Parliament and of the Council5,
not to engage in abusive
litigation.
33
(15) Furthermore, this Regulation (15) Furthermore, this Regulation (15) Furthermore, this Regulation
should impose labelling
should impose labelling
should impose labelling
requirements on the maker, in
requirements on the maker, in
requirements on the maker, in
order to facilitate, by means of a
order to facilitate, by means of a
order to facilitate, by means of a
logo, identification of the product
logo, identification of the product
logo, identification of the product
as a product exclusively intended
as a product exclusively intended
as a
or medicinal product
for the purpose of export to third
for the purpose of export to third
containing that product as being
countries. The making and related
countries. The making and related
exclusively intended for the
acts should only fall outside the
acts should only fall outside the
purpose of export to third
protection conferred by a
protection conferred by a
countries. The making and related
supplementary protection
supplementary protection
acts should only fall outside the
certificate if the product is labelled certificate if the product is labelled protection conferred by a
in this manner. This labelling
in this manner. This labelling
supplementary protection
obligation would be without
obligation would be without
certificate if the
product or
5 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L157, 30.4.2004, p. 45).
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prejudice to labelling requirements prejudice to labelling requirements
medicinal product containing
of third countries.
of third countries.
that product is labelled in this
manner. This labelling obligation
would be without prejudice to
labelling requirements of third
countries.
34
(16) Any act not covered by the
(16) Any act not covered by the
(16) Any act not covered by the
exception introduced by this
exception introduced by this
exception introduced by this
Regulation will remain within the
Regulation will remain within the
Regulation will remain within the
scope of the protection conferred
scope of the protection conferred
scope of the protection conferred
by a supplementary protection
by a supplementary protection
by a supplementary protection
certificate. This includes any
certificate. This includes any
certificate. This includes any
product made within the terms of
product made within the terms of
product made within the terms of
the exception and illicitly diverted the exception and illicitly diverted the exception and illicitly diverted
onto the Union market during the
onto the Union market during the
Any illicit diversion onto the
term of the certificate.
term of the certificate.
Union market
, during the term of
the certificate
, of any product or
medicinal product containing
that product made within the
terms of the exception, will
remain prohibited.
35
(17) This Regulation does not
(17) This Regulation does not
(17)
This Regulation is without
affect the application of Union
affect the application of Union
prejudice to the respect of other
measures that aim to prevent
measures that aim to prevent
intellectual property rights that
infringements and facilitate
infringements and facilitate
may protect other aspects of a
enforcement of intellectual
enforcement of intellectual
medicinal product. This
property rights, including
property rights, including
Regulation does not affect the
Directive 2004/48/EC of the
Directive 2004/48/EC of the
application of Union measures that
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European Parliament and of the
European Parliament and of the
aim to prevent infringements and
Council6 and Regulation (EU) No
Council6 and Regulation (EU) No
facilitate enforcement of
608/2013 of the European
608/2013 of the European
intellectual property rights,
Parliament and of the Council7.
Parliament and of the Council7.
including Directive 2004/48/EC6
Furthermore, a medicinal product of the European Parliament and of
bearing an active Unique
the Council and Regulation (EU)
Identifier as per Articles 3(d) of
No 608/2013 of the European
Commission Delegated
Parliament and of the Council8
.
Regulation (EU) 2016/1617a
Furthermore, this Regulation
would indicate that the product is does not affect the rules on the
not exclusively intended for the
unique identifier provided for by
purpose of export to third
Directive 2001/83/EC of the
countries. Therefore, this
European Parliament and of the
Regulation should only prohibit a Council and by Commission
product exclusively intended for
Delegated Regulation (EU)
the purpose of export to third
2016/161. According to Directive
countries bearing such an active
2001/83/EC, medicinal products
Unique Identifier. That
produced exclusively for export
prohibition shall not apply to
do not need to bear unique
products intended for the purpose identifiers.
of storage for EU-Day1 Entry.
36
(18) This Regulation does not
(18) This Regulation does not
(18) This Regulation does not
affect the application of Directives affect the application of Directives affect the application of Directives
2001/83/EC and 2001/82/EC, in
2001/83/EC and 2001/82/EC, in
2001/83/EC and 2001/82/EC, in
6 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L157, 30.4.2004, p. 45).
7 Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights (OJ L 181, 29.6.2013,
p. 15).
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particular the requirements related particular the requirements related particular the requirements related
to the manufacturing authorisation to the manufacturing authorisation to the manufacturing authorisation
of medicinal products
of medicinal products
of medicinal products
manufactured for export. This
manufactured for export. This
manufactured for export. This
includes compliance with the
includes compliance with the
includes compliance with the
principles and guidelines of good
principles and guidelines of good
principles and guidelines of good
manufacturing practices for
manufacturing practices for
manufacturing practices for
medicinal products and the use of
medicinal products and the use of
medicinal products and the use of
active substances that have been
active substances that have been
active substances that have been
manufactured in accordance with
manufactured in accordance with
manufactured in accordance with
good manufacturing practices for
good manufacturing practices for
good manufacturing practices for
active substances and distributed
active substances and distributed
active substances and distributed
in accordance with good
in accordance with good
in accordance with good
distribution practices for active
distribution practices for active
distribution practices for active
substances.
substances.
substances.
37
(19) In order to ensure that
(19) In order to ensure that
(19) In order to ensure that
holders of supplementary
holders of supplementary
holders of supplementary
protection certificates already in
protection certificates already in
protection certificates already in
force are not deprived of their
force are not deprived of their
force are not deprived of their
acquired rights, the exception
acquired rights,
The exception
acquired rights, the exception
provided for in this Regulation
provided for in this Regulation
provided for in this Regulation
should only apply to certificates
should only apply to certificates
should only apply to certificates
that are granted on or after a
that are granted on or after a
that are granted on or after a
specified date after entry into
specified date after entry into
specified date after entry into
force, irrespective of when the
force, irrespective of when the
force, irrespective of when the
application for the certificate was
application for the certificate was
application for the certificate was
first lodged. The date specified
first lodged. The date specified
the first lodged. The date specified
should allow a reasonable time for
basic patent for which expired on should allow a reasonable time for
applicants and other relevant
or after 1 January 2021.
That
applicants and other relevant
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market players to adjust to the
date
takes into account the need
market players to adjust to the
changed legal context and to make
to provide for a transitional
changed legal context and to make
appropriate investment and
period sufficiently long to ensure
appropriate investment and
manufacturing location decisions
that holders of supplementary
manufacturing location decisions
in a timely way.
protection certificates are not
in a timely way. The date should
The date should also allow
deprived of their acquired rights
also allow sufficient time for
sufficient time for public
and should allow a reasonable
public authorities to put in place
authorities to put in place
time for applicants and other
appropriate arrangements to
appropriate arrangements to
relevant market players to adjust to receive and publish notifications of
receive and publish notifications of the changed legal context and to
the intention to make, and should
the intention to make, and should
make appropriate investment and
take due account of pending
take due account of pending
manufacturing location decisions
applications for certificates.
applications for certificates.
in a timely way. The
That date
To safeguard the rights of
should also allow sufficient time
certificate holders, the exception
for public authorities to put in
should not apply to a certificate
place appropriate arrangements to
that has already entered into
receive and publish notifications of
effect at the date of entry into
the intention to make, and should
force of the Regulation. In order
take due account of pending
to ensure that the rights of
applications for certificates.
certificate holders are not
excessively restricted, the
exception provided for in this
Regulation should apply to
certificates that are applied for
on or after the day of the entry
into force of this Regulation. At
the same time, in order to
safeguard the aim of this
Regulation, and since a
certificate enters into effect a
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relatively long time after its date
of filing, it is justified to bring
within the scope of the
Regulation, over a certain period
of time, a certificate that was
applied for before the entry into
force of this Regulation, but has
not yet entered into effect before
that entry into force, and
irrespective of whether or not
that certificate has been granted
before the entry into force of the
Regulation. Therefore, the
exception should apply, as from
1 July 2022, to a certificate that
enters into effect as from that
entry into force. This ‘certain
period of time’ for each
individual certificate that enters
into effect after that entry into
force should ensure that the
exception is applied, on a
progressive basis, to such a
certificate, depending on its date
of entry into effect and its
duration. Such application of the
exception would allow the holder
of a granted certificate that is
not yet in effect by the date of
the entry into force of the
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Regulation a reasonable period
of transition to adapt to the
changed legal context, while at
the same time ensuring that
makers of generics and
biosimilars can benefit
effectively, without excessive
delay, from the exception.
38
(19a) This Regulation should not
(19a) An applicant for a
have any retroactive effect.
certificate might be expected to
file an application at around the
same date in each Member State
of filing. However due to
differences in national
procedures for examination of
applications, the date of grant
might vary significantly from
one Member State to another,
thereby creating disparities in
the legal situation of the
applicant in the different
Member States where the
certificate is applied for.
Introducing the exception on the
basis of the date of filing of the
application for a certificate
would therefore promote
uniformity and limit this risk of
disparities.
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39
(20) The Commission should
(20) The Commission should
(20) The Commission should
carry out an evaluation of this
carry out
a regular evaluation of
carry out an evaluation of this
Regulation. Pursuant to paragraph
this Regulation.
Given the
Regulation. Pursuant to paragraph
22 of the Interinstitutional
paramount importance of access
22 of the Interinstitutional
Agreement between the European
to and affordability of medicinal
Agreement between the European
Parliament, the Council of the
products for public health and
Parliament, the Council of the
European Union and the European
public expenditure, a regular
European Union and the European
Commission on Better Law-
evaluation cycle of this
Commission on Better Law-
Making of 13 April 20168, that
Regulation is justified. Pursuant to Making of 13 April 20169, that
evaluation should be based on the
paragraph 22 of the
evaluation should be based on the
five criteria of effectiveness,
Interinstitutional Agreement
five criteria of effectiveness,
efficiency, relevance, coherence
between the European Parliament, efficiency, relevance, coherence
and added value and should
the Council of the European Union and added value and should
provide the basis for impact
and the European Commission on
provide the basis for impact
assessments of possible further
Better Law-Making of 13 April
assessments of possible further
measures. The evaluation should
201643, that evaluation should be
measures. The evaluation should
take into account exports to
based on the five criteria of
take into account exports to
outside the Union and the ability
effectiveness, efficiency,
outside the Union and the ability
of generics and especially
relevance, coherence and added
of generics and especially
biosimilars to enter markets in the
value and should provide the basis biosimilars to enter markets in the
Union as soon as possible after a
for impact assessments of possible Union as soon as possible after a
certificate lapses. In particular, this further measures. The evaluation
certificate lapses. In particular, this
evaluation should review the
should take into account
the
evaluation should review the
effectiveness of the exception in
impact of the SPC system on
effectiveness of the exception in
the light of the aim to restore a
access to affordable medicines as
the light of the aim to restore a
global level playing field for
well as the waiver, including
global level playing field for
8 OJ L 123, 12.5.2016, p. 1.
9 OJ L 123, 12.5.2016, p. 1.
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generic and biosimilar firms in the exports to outside the Union and
generic and biosimilar firms in the
Union and a swifter entry of
the ability of generics and
Union and a swifter entry of
generic and especially biosimilar
especially biosimilars to enter
generic and especially biosimilar
medicines onto the market after a
markets in the Union as soon as
medicines onto the market after a
certificate lapses. It should also
possible after a certificate lapses
.
certificate lapses. It should also
study the impact of the exception
Such regular evaluation should
study the impact of the exception
on research and production of
also address the effects of this
on research and production of
innovative medicines by holders of
Regulation on manufacturing
innovative medicines
in the Union
certificates in the Union and
within the Union by Union
by holders of certificates in the
consider the balance between the
established makers for reasons of Union and consider the balance
different interests at stake,
stockpiling with a view to Day1
between the different interests at
including those of public health.
entry into the Union market when stake, including those of public
a certificate expires. In this
health.
context, it would be important to
ascertain whether manufacturing
previously taking place outside of
the Union, would be moved to
within its territory. In particular,
this evaluation should review the
effectiveness of the exception in
the light of the aim to restore a
global level playing field for
generic and biosimilar firms in the
Union and a swifter entry of
generic and especially biosimilar
medicines onto the market after a
certificate lapses
and examine the
case for a possible extension of
the scope of the exception granted
by the waiver so as to allow
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Union-based manufacturers of
generics and biosimilars to
manufacture for stockpiling
purposes. It should also study the
impact of the exception
and its
possible extension on research and
production of innovative
medicines by holders of
certificates in the Union and
consider the balance between the
different interests at stake,
including
access to medicines
within the Union and those of
public health.
40
(21) It is necessary and
(21) It is necessary and
(21) It is necessary and
appropriate for the achievement of appropriate for the achievement of appropriate for the achievement of
the basic objective, of providing a
the basic objective of providing a
the basic objective, of providing a
level playing field for generic and
level playing field for generic and
level playing field for
makers of
biosimilar manufacturers with
biosimilar manufacturers with
generic and biosimilar
their competitors in third country
their competitors in third country
manufacturers with their
markets where protection does not markets where protection does not competitors in third country
exist or has expired, to lay down
exist or has expired, to lay down
markets where protection does not
rules restricting the exclusive right rules restricting the exclusive right exist or has expired, to lay down
of a supplementary protection
of a supplementary protection
rules restricting the exclusive right
certificate holder to make the
certificate holder to make
enabling of a supplementary protection
product in question during the
the making of the product in
certificate holder to make the
term of the certificate, and also to
question during the term of the
product in question during the
impose certain information and
certificate.and also to impose
term of the certificate, and also to
labelling obligations on makers
certain information and labelling
impose certain information and
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wishing to take advantage of those obligations on makers wishing to
labelling obligations on makers
rules
. This Regulation complies
take advantage of those rules
. This wishing to take advantage of those
with the principle of
Regulation complies with the
rules
. This Regulation complies
proportionality, and does not go
principle of proportionality, and
with the principle of
beyond what is necessary in order
does not go beyond what is
proportionality, and does not go
to achieve the objectives pursued,
necessary in order to achieve the
beyond what is necessary in order
in accordance with Article 5(4) of
objectives pursued, in accordance
to achieve the objectives pursued,
the Treaty on European Union.
with Article 5(4) of the Treaty on
in accordance with Article 5(4) of
European Union.
the Treaty on European Union.
41
(22) This Regulation respects
(22) This Regulation respects
(22) This Regulation respects
fundamental rights and observes
fundamental rights and observes
fundamental rights and observes
the principles recognised by the
the principles recognised by the
the principles recognised by the
Charter of Fundamental Rights of
Charter of Fundamental Rights of
Charter of Fundamental Rights of
the European Union. In particular, the European Union. In particular, the European Union. In particular,
this Regulation seeks to ensure full this Regulation seeks to ensure full this Regulation seeks to ensure full
respect for the right to property in
respect for the right to property in
respect for the right to property in
Article 17 of the Charter by
Article 17 of the Charter by
Article 17 of the Charter by
maintaining the core rights of the
maintaining the core rights of the
maintaining the core rights of the
supplementary protection
supplementary protection
supplementary protection
certificate, by confining the
certificate, by confining the
certificate, by confining the
exception to certificates granted on exception to certificates by
exception to certificates granted on
or after a specified date after entry confining the exception to
or after a specified date after entry
into force of this Regulation and
certificates granted
basic patent of into force of this Regulation and
by imposing certain conditions on
which expired on or after
1
by imposing certain conditions on
the application of the exception,
January 2021 a specified date
the application of the exception
after entry into force of this
certificate, by confining the
Regulation and by imposing
exception provided for in this
certain conditions on the
Regulation to the making of a
application of the exception,
as
product or a medicinal product
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well as respect for the right to
containing that product only for
health care set out in Article 35 of the purpose of export outside the
the Charter by making medicines
Union and to the acts strictly
more accessible to Union
necessary for such making or for
patients, for the principle of
the actual export itself. This
proportionality set out in Article
exception does not go beyond
52 of the Charter, and the right to what is necessary and
health protection for European
appropriate in the light of the
citizens set out in point (a) of
overall objective of this
Article 6 TFEU .
Regulation, which is to promote
the competitiveness of the Union
by avoiding delocalisations and
allowing Union-based makers of
generics and biosimilars to
compete on fast-growing, global
markets where protection does
not exist or has already expired.
Indeed, it is necessary to benefit
from those positive economic
effects arising from the
exception, as otherwise the
Union would risk substantially
weakening its position as a hub
for pharmaceutical development
and manufacturing. It is
therefore appropriate to
introduce that exception in order
to increase the competitive
position of Union-based makers
of generics and biosimilars in
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third countries whose markets
are in any event open to
competition, whilst leaving the
scope and duration of the
protection granted by the
certificate in the Union
untouched. The appropriateness
of the measure is further
ensured by providing for
appropriate safeguards
regulating the use of the
exception. The Regulation
should allow sufficient time for
public authorities to put in place
the necessary arrangements to
receive and publish notifications,
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42
HAVE ADOPTED THIS
HAVE ADOPTED THIS
HAVE ADOPTED THIS
REGULATION:
REGULATION:
REGULATION:
43
Article 1 – Amendment of
Article 1 – Amendment of
Article 1 – Amendment of
Regulation (EC) No 469/2009
Regulation (EC) No 469/2009
Regulation (EC) No 469/2009
44
Regulation (EC) No 469/2009 is
Regulation (EC) No 469/2009 is
Regulation (EC) No 469/2009 is
amended as follows:
amended as follows:
amended as follows:
45
(-1) in Article 1, the following
(0) in Article 1, the following
point is added:
point is added:
46
(ea) ‘maker’ means a legal person ‘(f) ‘maker’ means the person
established in the Union on
established in the Union on
whose behalf the making of a
whose behalf the making of
product or a medicinal product
a product or a medicinal
containing that product, for the
product containing that
purpose of export to third
product, for the exclusive
countries or storing during the
purpose of export to third
final 2 years of validity of the
countries, is done;’
certificate is done;’
47
(1) Article 4 is replaced by the
(1) Article 4
5 is replaced by
(1) Article 4
5 is replaced by
following:
the following:
the following:
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‘Article 4 – Subject matter of
‘Article 4 – 5 Subject matter of
‘Article 4 –
5 – Subject matter of
protection and exceptions to rights protection and exceptions to rights protection and exceptions to rights
conferred
conferred Effects of the certificate conferred Effects of the certificate
49
1. Within the limits of the
1.
Within the limits of the
1.
Within the limits of the
protection conferred by the basic
protection conferred by the basic
protection conferred by the basic
patent, the protection conferred by patent, the protection conferred by patent, the protection conferred by
a certificate shall extend only to
a certificate shall extend only to
a certificate shall extend only to
the product covered by the
the product covered by the
the product covered by the
authorisation to place the
authorisation to place the
authorisation to place the
corresponding medicinal product
corresponding medicinal product
corresponding medicinal product
on the market and for any use of
on the market and for any use of
on the market and for any use of
the product as a medicinal product the product as a medicinal product the product as a medicinal product
that has been authorised before the that has been authorised before the that has been authorised before the
expiry of the certificate.
expiry of the certificate.
expiry of the certificate.
Subject to the provisions of
Subject to the provisions of
Article 4, the certificate shall
Article 4, the certificate shall
confer the same rights as
confer the same rights as
conferred by the basic patent and conferred by the basic patent
shall be subject to the same
and shall be subject to the same
limitations and the same
limitations and the same
obligations.
obligations.
50
2. The certificate referred to in
2.
By way of derogation from
2.
By way of derogation from
paragraph 1 shall not confer
paragraph 1, the The certificate
paragraph 1, the The certificate
protection against a particular act
referred to in paragraph 1 shall not referred to in paragraph 1 shall not
against which the basic patent
confer protection against a
confer protection against a
conferred protection if, with
particular act
certain acts against
particular act against which the
which the basic patent conferred
basic patent conferred protection
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respect to that particular act, the
protection if, with
respectwhich
if, with respect
which would
following conditions are met:
would otherwise require the
otherwise require the consent of
consent of the holder of the
the holder of the certificate
certificate referred to that
referred to that particular act,
in
particular act,
in Article 11 (‘the
Article 11 (‘the certificate
certificate holder’) if the
holder’) if the following
following conditions are met:
conditions are met:
51
(a)
the act comprises:
(a)
the
acts comprises:
(a)
the act comprises:
52
(i)
making for the exclusive
(i)
making
a product, or a
(i)
making
a product or a
purpose of export to third
medicinal product containing
medicinal product
countries; or
that product, for the exclusive
containing that product, for
purpose of export to third
the exclusive purpose of
countries; or
export to third countries; or
53
(ii) making a product, or a
medicinal product containing that
product, for the purpose of
storing it in the Member State of
making, during the final 2 years
of validity of the certificate
referred to in paragraph 1, in
order to place that product on the
market of Member States as from
day 1 after the expiry of the
certificate in those Member
States;
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54
(ii) any related act that is strictly
(iii) any related act that is strictly
(ii)
any related act that is
necessary for that making or for
necessary for that making or for
strictly necessary for that
the actual export itself;
the actual export itself;
making
in the Union or for
the actual export itself
55
(iv) the act excludes any act or
activity for import of medicinal
products, or parts thereof, onto
the Union merely for the purpose
of repackaging and re-exporting.
56
(b) the authority referred to in
(b)
the maker notifies the
(b)
the maker, through
Article 9(1) of the Member State
authority referred to in Article 9(1)
appropriate and documented
where that making is to take place
of the Member State where that
means, notifies the authority
(‘the relevant Member State’) is
making is to take place (‘the
referred to in Article 9(1) of the
notified by the person doing the
relevant Member State’) is notified Member State where that making
making (‘the maker’) of the
by the person doing the making
is to take place (‘the relevant
information listed in paragraph 3
(‘the maker’) of the information
Member State’) is notified by the
no later than 28 days before the
listed in
points (a), (b), (c), (e) and person doing the making (‘the
intended start date of making in
(f) of paragraph 3 no later than 28
maker’)
and informs the
that Member State;
days
two months before the
certificate holder of the
intended start date of making in
information listed in paragraph 3
that Member State;
no later than 28 days
three
months before the intended start
date of making in that Member
State
, or no later than three
months before the first related
act prior to that making that
would otherwise be prohibited
by the protection conferred by a
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certificate, whichever is the
earlier;
57
(ba) if the information listed in
paragraph 3 changes, the maker
shall notify the authority
referred to in Article 9(1) and
shall inform the certificate
holder, before these changes
take effect;
58
(c) the maker
informs the
certificate holder, in writing, of
the information listed in point (a)
and (c) of paragraph 3, no later
than two months before the start
date of making in that Member
State; ensures that a logo, in the
form set out in Annex -I, is affixed
to the outer packaging of the
product or, if there is no outer
packaging, to its immediate
packaging;
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59
(d) the notification to the
certificate holder does not contain
any confidential or commercially
sensitive information;
60
(e) the information provided by
the maker to the certificate holder
is treated as strictly confidential
by the certificate holder and is not
published; in addition, the
information provided to the
certificate holder is used
exclusively for the purposes of
verifying whether the
requirements of this Regulation
have been met and, where
applicable, initiating legal
proceedings for non-compliance;
61
(c) the maker ensures that a
(f)
in the case of products made (c) the maker ensures that a
logo, in the form set out in Annex
for the purpose of export to third
logo, in the form set out in Annex
-I, is affixed to the outer packaging
countries, the maker ensures that a -I
II, is affixed to the outer
of the product or, if there is no
logo, in the form set out in Annex
packaging of the product or, if
outer packaging, to its immediate
-Ia, is affixed to the outer
there is no outer packaging
of the
packaging;
packaging of the product
referred
medicinal product containing
to in paragraph 2(a)(i) or, if there
that product, referred to in
is no outer packaging, to its
paragraph 2(a)(i), and, where
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immediate packaging
the product
feasible, to its immediate
forms part of a medicinal product, packaging;
the outer packaging of the
medicinal product;
62
(g) the maker ensures that the
medicinal product manufactured
pursuant to paragraph 2(a)(i)
does not bear an active Unique
Identifier as laid down in Articles
3(d) of Commission Delegated
Regulation (EU) 2016/161. Where
appropriate, the competent
authority shall have access to the
data in the repositories mandated
by Directive 2011/62/EU and
Delegated Regulation (EU)
2016/161 in order to verify
compliance;
63
(d) the maker complies with the
(h) the maker complies with the (d) the maker complies with the
requirements of paragraph 4.
requirements of
paragraph 4.
requirements of paragraph 4.
and,
if applicable, of Article 12(2).
64
3. The information for the
3. The information for the
3.
The information for the
purposes of paragraph 2(b) shall
purposes of paragraph 2(b)
, which purposes of paragraph 2(b) shall
be as follows:
shall be treated in a strictly
be as follows:
confidential manner by all
parties, shall be as follows:
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65
(a) the name and address of the
(a) the name and address of the
(a) the name and address of the
maker;
maker;
maker;
66
(b) the address, or addresses, of
(b) the address, or addresses, of the (b) the address, or addresses, of the
the premises where the making is
premises
Member State where the premises
Member State where the
to take place in the relevant
making
and, if applicable, also the making is to take place in
and the
Member State;
storage, is to take place in the
relevant Member State
where the
relevant Member State
;
first related act prior to that
making is to take place;
67
(c) the number of the certificate
(c) the number of the certificate
(c) the number of the certificate
granted in the relevant Member
granted in the relevant Member
granted in the relevant Member
State, and identification of the
State
of making, and identification State
of making, and identification
product, by reference to the
of the product, by reference to the
of the product, by reference to the
proprietary name used by the
proprietary name used by the
proprietary name used by the
holder of that certificate;
holder of that certificate;
holder of that
the number of the
certificate
granted in the
Member State of the first related
act prior to that making;
68
(d) the number of the
Deleted
(d)
(deleted)
authorisation granted in
the number of the authorisation
accordance with Article 40(1) of
granted in accordance with Article
Directive 2001/83/EC or Article
40(1) of Directive 2001/83/EC or
44(1) of Directive 2001/82/EC for
Article 44(1) of Directive
the manufacture of the
2001/82/EC for the manufacture of
corresponding medicinal product
the corresponding medicinal
or, in the absence of such
product or, in the absence of such
authorisation, a valid certificate of
authorisation, a valid certificate of
good manufacturing practice as
good manufacturing practice as
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referred to in Article 111(5) of
referred to in Article 111(5) of
Directive 2001/83/EC or Article
Directive 2001/83/EC or Article
80(5) of Directive 2001/82/EC
80(5) of Directive 2001/82/EC
covering the premises where the
covering the premises where the
making is to take place;
making is to take place;
69
(e)
the intended start date of
(d)
the intended start date of
(e)
(deleted)
making in the relevant Member
making in the relevant Member
the intended start date of making
State;
State;
in the relevant Member State;
70
(f)
an indicative list of the
(e)
an indicative list of the
(f)
for medicinal products, the
intended third country or third
intended third country or third
reference number of the
countries to which the product is to countries to which the product is to
marketing authorisation or
be exported.
be exported.
equivalent in each an indicative
list of the intended third country
of
export or
, failing that, the name
of that third
country countries to
which the product is to be
exported.
71
4.
For the purposes of the
3a. Annex -I includes a
notification under point (b) of
standard form that shall be used
paragraph 2, the maker shall use
by makers for notifications to
the standard form contained in
authorities under paragraph
Annex -I to this Regulation.
2(b).
72
3b. Failure to comply with the
requirements of paragraph 3(f)
in respect of a third country
shall only affect exports to that
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country, and such exports would
thus not benefit from the
exception.
73
5.
The authorities of the
Member States referred to in
Article 9(1) shall under no
circumstances disclose any
business sensitive information
provided by the maker, neither to
the certificate holder nor to the
public.
74
4. The maker shall ensure, through
6.
The maker shall ensure,
4.
The maker shall ensure,
appropriate means, that persons in through appropriate
and
through appropriate
and
a contractual relationship with the
documented means,
that persons
documented means, that persons
maker who perform acts falling
in a contractual relationship with
any person in a contractual
within paragraph 2(a)(ii) are fully
the maker who perform acts falling relationship with the maker who
informed and aware of the
within paragraph
2(a) are fully
perform
performs acts falling
following:
informed and aware of the
within paragraph 2(a)(ii) are
is
following:
fully informed and aware of the
following:
75
(a) that those acts are subject to
(a) that those acts are subject to
(a) that those acts are subject to
the provisions of paragraph 2;
the provisions of paragraph 2;
the provisions of paragraph 2;
76
(b) that the placing on the
(b) that the placing on the
(b) that the placing on the
market, import or re-import of the
market, import or re-import of the
market, import or re-import of the
product might infringe the
product
referred to in point (a)(i)
product
referred to in paragraph
certificate referred to in that
of paragraph 2 might infringe
2(a)(i) might infringe the
could amount to an infringement
certificate referred to in that
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paragraph where, and as long as,
of the certificate referred to in that paragraph
2 where, and as long as,
that certificate applies.
paragraph
paragraph 1 where, and that certificate applies.
as long as, that certificate applies.
77
5. Paragraph 2 shall apply in the
7.
Paragraph 2 shall apply in
5. Paragraph 2 shall apply in the
case only of certificates granted on the case only of
to certificates
case only of
to certificates granted
or after [OP: please insert the date
granted
that are applied for on or
that are applied for on or after
of the first day of the third month
after [OP: please insert the date of [OP: please insert the date of the
that follows the month in which
the first day of the third month that first day of the third month that
this amending Regulation is
follows the month in which this
follows the month in which
the
published in the Official
amending Regulation is published
entry into force of this amending
Journal)].’;
in the Official Journal)]
the entry
Regulation is published in the
into force of this Regulation. It
Official Journal)].
shall also apply in the case of
From 1 July 202210, paragraph 2
certificates for which the basic
shall also apply to certificates
patent expired on or after 1
that have been applied for
January 2021.
before the entry into force of this
Regulation and that enter into
effect on or after the entry into
force of this Regulation.
Paragraph 2 shall not apply to
certificates that enter into effect
before the entry into force of this
Regulation.’;
78
(2) in Article 11, the following
(2) in Article 11, the following
(2) in Article 11, the following
paragraph is added:
paragraph is added:
paragraph is added:
10
Date to be replaced by the actual date of entry into force of the Regulation, plus 3 years.
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79
4. ‘The notification sent to an
4.
The notification sent to an
4.
‘The notification sent to an
authority
authority as
the competent
authority as referred to in
as referred to in Article 4(2)(b)
industrial property office as
Article 4(2)(b)
9(1) shall be
shall be published by that authority referred to in Article 4(2)(b)
9(1)
published by that authority within
within 15 days of receipt of the
shall
publish without undue delay 15 days
publish, as soon as
notification.’;
the information listed in point (c) possible, the information listed
of Article 5(3).
The remaining
in Article 5(3), together with the
information notified under Article date of receipt of the notification
5 (3) shall not be published
by
that
of that information.
It shall also
the authority within 15 days of
publish, as soon as possible, any
receipt of the notification
or made changes to this information
available for inspection by the
notified in accordance with
public. However, the office shall
Article 5(2)(ba).’;
provided that information, upon
request, to a court or other
competent authority for the
purposes of any legal proceedings
in which Article 5(2) is
considered. The national
authority shall take appropriate
measures to preserve the
confidentiality of that
information.
80
(3) Article 12 is replaced by
the following:
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81
‘Article 12 – Fees
82
1.
Member States may
require that the certificate be
subject to the payment of annual
fees.
2.
Member States may
require that the notifications
referred to in Article 5(2)(b) and
(ba) be subject to the payment of
a fee.’;
83
(3) the following Article is
(3) the following Article is
(3)
(4) the following Article is
inserted:
inserted:
inserted:
84
‘Article 21a – Evaluation
‘Article 21a – Evaluation
‘Article 21a – Evaluation
85
No later than five years after the
No later than five
Every three
No later than five years after the
date referred to in Article 4(5), and years after the date referred to in
date referred to in Article 4
5(5),
every five years thereafter, the
Article 4(5), and every five years
and every five years thereafter, the
Commission shall carry out an
thereafter, the Commission shall
Commission shall carry out an
evaluation of Articles 4(2) to (4)
carry out an evaluation of
the SPC evaluation of Articles 4
5(2) to
and 11 and present a report on the
manufacturing waiver pursuant
(4) and 11 and present a report on
main findings to the European
to Articles 4(2) to (4) and 11
as
the main findings to the European
Parliament, the Council and the
well as of the SPC system
Parliament, the Council and the
European Economic and Social
regarding the ability of generics
European Economic and Social
Committee.’;
to enter the Union market and
Committee.’;
the access to medicines and
public health, and present a report
on the main findings to the
48
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European Parliament, the Council
and the European Economic and
Social Committee
. Special
account shall be taken on the
effects of stockpiling with a view
to Day1 entry into the Union
market when a certificate
expires;’;
86
(4) the Annex to this Regulation (4) the Annex to this Regulation (4)
(5) the Annex
Annexes to this
is inserted as Annex -I.
is inserted as Annex -I.
Regulation is
are inserted as
Annex
-II and -I.
87
Article 2 – Entry into force
Article 2 – Entry into force
Article 2 – Entry into force
88
This Regulation shall enter into
This Regulation shall enter into
This Regulation shall enter into
force on the twentieth day
force on the twentieth day
force on the twentieth day
following that of its publication in following that of its publication in following that of its publication in
the
Official Journal of the
the
Official Journal of the
the
Official Journal of the
European Union.
European Union.
European Union.
49
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89
This Regulation shall be binding in This Regulation shall be binding in This Regulation shall be binding in
its entirety and directly applicable
its entirety and directly applicable
its entirety and directly applicable
in all Member States.
in all Member States.
in all Member States:
90
Done at Brussels,
Done at Brussels,
Done at Brussels,
91
For the European Parliament
For the European Parliament
For the European Parliament
The President
The President
The President
For the Council
For the Council
For the Council
The President
The President
The President
92
ANNEX -I
[see Council’s text, row 102]
93
Standard form to be used by
[see Council’s text, row 103]
makers for notifications under
point (b) of Article 4(2)
94
a. Name and address of the maker [see Council’s text, row 104]
95
b. Address(es) of the premises
[see Council’s text, row 104]
where the making is to take place
in the relevant Member State
96
c. Number of the certificate
[see Council’s text, row 104]
granted in the relevant Member
State, and identification of the
product, by reference to its
50
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international non-proprietary
name, if available;
97
d. Earliest intended start date of
[see Council’s text, row 104]
making in the relevant Member
State
98
e. Indicative list of the third
[see Council’s text, row 104]
country or third countries to
which the product is intended to
be exported
99
ANNEX
ANNEX - Ia
ANNEX
-II
100
Logo
Logo
Logo
101
This logo should appear in black
colour and of such size as to be
sufficiently visible.
102
103
[see EP’s text, row 91]
ANNEX -I
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104
[see EP’s text, row 92]
Form for notification pursuant
to Article 5(2)(b)
52
New notification
[see EP’s text, rows
93 to 97
]
Tick the
appropriate box
Update of an
existing
105
notification
(a) Name and
…
address of the
maker
(b) Member State
Member
where making is to
State of
…
take place and
making:
Member State
where first related
(Member
act (if any) prior to
State of
…
making is to take
first related
place
act (if any))
(c) Number of
Certificate
certificate granted
of Member
…
in the Member
State of
State of making
making
and number of
certificate granted
(Certificate
in Member State
of Member
…
of first related act
State of
(if any) prior to
first related
making
act (if any))
(d)* (deleted)
(e)* (deleted)
(f) for medicinal
…
products,
reference number
of marketing
authorisation or
…
equivalent in each
third country of
export, or name of
…
third country of
export
[
*points (d) and (e) of Article 5(3) have
been deleted; however, for ease of
reference in the neogotiations, the
53
numbering of paragraphs, both in the
form above and in Article 5, is retained,
but will be adjusted before adoption of
the Regulation. In addition, the current
points (a) to (f) will be re-numbered at
the jurists-linguists stage (i.e. meaning
that current point (f) will become point
(d)). These changes will also be carried
through in Article.]
54
Document Outline
