Brussels, 15 February 2019
Interinstitutional files:
2018/0161(COD)
WK 2211/2019 INIT
LIMITE
PI
CODEC
COMPET
PHARM
IA
WORKING PAPER
This is a paper intended for a specific community of recipients. Handling and
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NOTE
From:
General Secretariat of the Council
To:
Delegations
N° prev. doc.:
5411/19, WK 1583/2019 REV 1
N° Cion doc.:
9485/18 + ADD1 to ADD4
Subject:
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)
Delegations will find attached the 4-column table on the above proposal setting out in the 4th column the
compromise text as it results from the Political Agreement reached with the EP at the trilogue on 14
February 2019 .
WK 2211/2019 INIT
LIMITE
EN
Version after 2nd trilogue
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
Proposal for a
2
REGULATION OF THE
REGULATION OF THE
REGULATION OF THE
REGULATION OF THE
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
EUROPEAN PARLIAMENT
AND OF THE COUNCIL
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
amending Regulation (EC) No
469/2009 concerning the
469/2009 concerning the
469/2009 concerning the
469/2009 concerning the
supplementary protection
supplementary protection
supplementary protection
supplementary protection certificate
certificate for medicinal products
certificate for medicinal products
certificate for medicinal products
for medicinal products
4
(Text with EEA relevance)
(Text with EEA relevance)
(Text with EEA relevance)
(Text with EEA relevance)
5
THE EUROPEAN
THE EUROPEAN
THE EUROPEAN
THE EUROPEAN PARLIAMENT
PARLIAMENT AND THE
PARLIAMENT AND THE
PARLIAMENT AND THE
AND THE COUNCIL OF THE
COUNCIL OF THE EUROPEAN COUNCIL OF THE EUROPEAN COUNCIL OF THE EUROPEAN EUROPEAN UNION,
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 Having regard to the Treaty on the
Functioning of the European
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
Union, and in particular Article 114
114 thereof,
114 thereof,
114 thereof,
thereof,
7
Having regard to the proposal
Having regard to the proposal
Having regard to the proposal
Having regard to the proposal from
from the European Commission,
from the European Commission,
from the European Commission,
the European Commission
8
After transmission of the draft
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
legislative act to the national
parliaments,
parliaments,
parliaments,
parliaments
2
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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 Having regard to the opinion of the
European Economic and Social
European Economic and Social
European Economic and Social
European Economic and Social
Committee1,
Committee1
Committee1,
Committee1,
10
Acting in accordance with the
Acting in accordance with the
Acting in accordance with the
Acting in accordance with the
ordinary legislative procedure,
ordinary legislative procedure,
ordinary legislative procedure,
ordinary legislative procedure,
11
Whereas:
Whereas:
Whereas:
Whereas:
12
(1) Regulation (EC) No
(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
469/2009 of the European
Parliament and of the Council2
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
provides that any product protected
protected by a patent in the
protected by a patent in the
protected by a patent in the
by a patent in the territory of a
territory of a Member State and
territory of a Member State and
territory of a Member State and
Member State and subject, prior to
subject, prior to being placed on
subject, prior to being placed on
subject, prior to being placed on
being placed on the market as a
the market as a medicinal product, the market as a medicinal product, the market as a medicinal product, medicinal product, to an
to an administrative authorisation
to an administrative authorisation
to an administrative authorisation
administrative authorisation
procedure as laid down in
procedure as laid down in
procedure as laid down in
procedure as laid down in Directive
Directive 2001/83/EC of the
Directive 2001/83/EC of the
Directive 2001/83/EC of the
2001/83/EC of the European
European Parliament and of the
European Parliament and of the
European Parliament and of the
Parliament and of the Council3or
Council3 or Directive 2001/82/EC Council3 or Directive 2001/82/EC
Council3 or Directive 2001/82/EC
Directive 2001/82/EC of the
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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of the European Parliament and of of the European Parliament and of of the European Parliament and of European Parliament and of the
the Council4, may be the subject of the Council4, may be the subject of the Council4, may be the subject of Council4, may be the subject of a
a supplementary protection
a supplementary protection
a supplementary protection
supplementary protection
certificate under the terms and
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
conditions provided for in
Regulation (EC) No 469/2009.
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
(2) By providing for a period of
supplementary protection of up to
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
five years, Regulation (EC) No
469/2009 seeks to promote, within 469/2009 seeks to promote,
within 469/2009 seeks to promote, within 469/2009 seeks to promote, within
the Union, the research and
the Union, the research and
the Union, the research and
the Union, the research and
innovation that is necessary to
innovation that is necessary to
innovation that is necessary to
innovation that is necessary to
develop medicinal products, and to develop medicinal products
and to develop medicinal products, and to develop medicinal products, and to
contribute to preventing the
contribute to preventing the
contribute to preventing the
contribute to preventing the
relocation of pharmaceutical
relocation of pharmaceutical
relocation of pharmaceutical
relocation of pharmaceutical
research outside the Union to
research outside the Union to
research outside the Union to
research outside the Union to
countries that may offer greater
countries that may offer greater
countries that may offer greater
countries that may offer greater
protection.
protection,
while at the same time protection.
protection.
ensuring access to medicines
within the Union.
14
(2 a) The timely entry of generics
Deleted (partly moved to new
and biosimilars onto the Union
recital 6a, row 20a)
market is important as regards
increasing competition, reducing
prices and ensuring the
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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sustainability of healthcare
systems. Amending Regulation
(EC) No 469/2009 so as to allow
the production of generics and
biosimilars for export and storage
to make it possible for them to
enter the Union market when the
patent expires 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
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
5
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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
(3) Since the adoption in 1992 of
of the predecessor to Regulation
of the predecessor to Regulation
of the predecessor to Regulation
the predecessor to Regulation (EC)
(EC) No 469/2009, markets have
(EC) No 469/2009, markets have
(EC) No 469/2009, markets have
No 469/2009, markets have
evolved significantly and there has 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
been huge growth in the
manufacture of generics and
manufacture of generics and
manufacture of generics and
manufacture of generics and
especially of biosimilars, in
especially of biosimilars
and
especially of biosimilars, in
especially of biosimilars,
and their
particular in third countries where
active ingredients, in particular in
particular in third countries
active ingredients, in particular in
protection does not exist or has
countries outside the Union (in
outside the EU (‘third
third countries
outside the EU
expired.
‘third countries
’) where protection
countries’) where protection does
(‘third countries’) where
does not exist or has expired.
not exist or has expired.
protection does not exist or has
expired.
16
3a) Pharmaceuticals are one of
Deleted
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.
17
(3b) The Council, in its
Deleted (partly moved to new
conclusions of 17 June 2016 on
recital 6a, row 20a)
strengthening the balance in the
pharmaceutical systems in the
Union and its Member States,
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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
(4) The absence of any exception
exception in Regulation (EC) No
exception in Regulation (EC) No
exception in Regulation (EC) No
in Regulation (EC) No 469/2009 to
469/2009 to the protection
469/2009 to the protection
469/2009 to the protection
the protection conferred by a
conferred by a supplementary
conferred by a supplementary
conferred by a supplementary
supplementary protection
protection certificate has had the
protection certificate has had the
protection certificate has had the
certificate has had the unintended
unintended consequence of
unintended consequence of
unintended consequence of
consequence of preventing
preventing manufacturers of
preventing manufacturers of
preventing manufacturers
makers
manufacturers
makers of generics
generics and biosimilars
generics and biosimilars
of generics and biosimilars
and biosimilars established in the
established in the Union from
established in the Union from
established in the Union from
Union from manufacturing
making
manufacturing, even for the
manufacturing even for the
manufacturing
making in the
in the Union, even for the
exclusive purpose of exporting to
exclusive purpose of exporting to
Union, even for the exclusive
exclusive purpose of exporting to
third country markets in which
third country markets in which
purpose of exporting to third
third country markets in which
such protection does not exist or
such protection does not exist or
country markets in which such
such protection does not exist or
has expired. A further unintended
has expired. A further unintended
protection does not exist or has
has expired.
Likewise, they are
consequence is that the protection
consequence is that the protection
expired. A further unintended
prevented from making for the
conferred by the certificate makes
conferred by the certificate makes
consequence is that the protection
purpose of storing for a limited
it more difficult for those
it more difficult for those
conferred by the certificate makes
period before the expiry of the
manufacturers to enter the Union
manufacturers
within the Union,
it more difficult for those
certificate. ThisA
n further
market immediately after expiry of
with a view to enter
entering the
manufacturers
makers to enter the
unintended consequence is that the
the certificate, given that they are
Union market immediately after
Union market immediately after
protection conferred by the
not in a position to build up
expiry of the certificate
(EU-Day1 expiry of the certificate, given that certificate makes it more difficult
production capacity until the
Entry) and/or from exporting to
they are not in a position to build
for those manufacturers
makers to
protection provided by the
third countries in which
up production capacity until the
enter the Union market
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certificate has lapsed, by contrast
protection does not exist or has
protection provided by the
immediately after expiry of the
with manufacturers located in third
expired, given that they are not in
certificate has lapsed, by contrast
certificate, given that they are not
countries where protection does
a position to build up production
with manufacturers
makers located in a position to build up production
not exist or has expired.
capacity until the protection
in third countries where protection capacity
for export and for the
provided by the certificate has
does not exist or has expired.
purpose of entering the market of
lapsed, by contrast with
a Member State until the
manufacturers located in third
protection provided by the
countries where protection does
certificate has
expired, by contrast
not exist or has expired.
with manufacturers
makers 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
(5) This puts
generics and biosimilars
generics and biosimilars
manufacturers
makers of generics
manufacturers
makers of generics
established in the Union at a
established in the Union at a
and biosimilars established in the
and biosimilars established in the
significant competitive
significant competitive
Union at a significant competitive
Union at a significant competitive
disadvantage compared with
disadvantage compared with
disadvantage compared with
disadvantage compared with
manufacturers based in third
manufacturers based in third
manufacturers
makers based in
manufacturers
makers based in
countries that offer less or no
countries that offer less or no
third countries that offer less or no third countries that offer less or no
protection.
protection
or where protection has protection.
protection.
The Union should
expired.
It is imperative,
strike a balance between
therefore, that the European
restoring a level playing field
Union strike a balance between,
between those makers and
on the one hand, ensuring a level
ensuring that the essence of the
playing field between production
exclusive rights of certificate
activities on its territory and in
holders is guaranteed in relation
third countries and, on the other,
to the Union market.
ensuring that the exclusive rights
of certificate holders are
guaranteed in relation to the
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Union market.
20
(6) Without any intervention,
(6) Without any intervention,
(6) Without any intervention,
(6) Without any intervention, the
the viability of the manufacture of the viability of the manufacture
the viability of the
viability of the manufacture
makers
generics and biosimilars in the
manufactures of generics and
manufacture
makers of generics
of generics and biosimilars
Union could be under threat, with
biosimilars in the Union could be
and biosimilars
established in the
established in the Union could be
consequences for the Union’s
under threat, with consequences
Union could be under threat, with
under threat, with consequences for
pharmaceutical industrial base as a for the Union’s pharmaceutical
consequences for the Union’s
the Union’s pharmaceutical
whole.
industrial base as a whole,
which
pharmaceutical industrial base as a industrial base as a whole.
This
could affect the very functioning
whole.
may affect the fully effective
of the internal market through
functioning of the internal
the loss of potential new business
market, through the loss of
opportunities as well as
potential new business
diminishing investment at Union
opportunities for generics and
level and possibly hampering the
biosimilars, possibly diminishing
creation of new jobs.
related investments within the
Union, thereby possibly
hampering job creation.
20a
(6a) The timely entry of generics
and biosimilars onto the Union
market is important, notably to
increase competition,to reduce
prices and to ensure both the
sustainability of national healthcare
systems and better access to
affordable medicines by patients in
the EU. The importance of such
timely entry has been underlined by
the Council in its conclusions of 17
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June 2016 on strengthening the
balance in the pharmaceutical
systems in the Union and its
Member States.
Regulation (EC)
No 469/2009 should therefore be
amended so as to allow the
production of generics and
biosimilars for export and
storage, while recalling that
intellectual property rights
remain one of the cornerstones of
innovation, competitiveness and
growth in the internal market.
[taking up parts of recitals 2a and
3b of EP text (rows 14 and 17),
reworded]
21
(7) The aim of this Regulation is (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
to ensure that
established in the Union are able to established
promote the
promote the competitiveness of
manufacturers
promote the
compete effectively in those third
competitiveness of generics and
the Union, enhancing growth
competitiveness of the Union,
country markets where
biosimilars producers in the
and job creation in the internal
enhancing growth and job
supplementary protection does not Union are able
, to enhance growth market and contributing to a
creation in the internal market
exist or has expired. It is intended
and job creation in the internal
wider supply of products under
and contributing to a wider
to complement the efforts of the
market and to contribute to a
uniform conditions, by allowing
supply of products under
Union’s trade policy to ensure
wider supply of products under
makers of generics and
uniform conditions, by allowing
open markets for Union-based
uniform conditions. This will help biosimilars established in the
makers of generics and
manufacturers of medicinal
producers to compete effectively
Union are able
to make in the
biosimilars established in the
products. Indirectly, it is also
in third country markets where
Union medicinal products or
Union are able
to make in the
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intended to put those
supplementary protection does not
products for the exclusive
Union medicinal products or
manufacturers in a better position
exist or has expired
and to ensure
purpose of export to third
products for the purpose of
to enter the Union market
EU-Day1 Entry of generic and
country markets where
export to third country markets
immediately after expiry of the
biosimilar medicines into the
protection does not exist or has
where protection does not exist
relevant supplementary protection
Union market after expiry of the
expired, thus also helping these
or has expired, thereby also
certificate. It would also help to
relevant supplementary protection makers to compete effectively in
helping these makers to compete
serve the aim of fostering access to
certificate. It is intended to
should those third country markets where
effectively in those third country
medicines in the Union by helping
also complement the efforts of the supplementary protection does not markets where supplementary
to ensure a swifter entry of generic Union’s trade policy to ensure
exist or has expired.
. It is intended protection does not exist or has
and biosimilar medicines onto the
open markets for Union-based
to
should also complement the
expired.
. The Regulation should
market after expiry of the relevant
manufacturers of medicinal
efforts of the Union’s trade policy
also allow these makers to make
certificate.
products Indirectly, it is also
to ensure open markets for Union-
and store medicinal products or
intended to
or of active
based manufacturers of medicinal
products in a Member State for a
ingredients.
It would put those
products. Indirectly, it is also
defined period pending the
manufacturers in a better position
intended to put those
expiry of the certificate for the
to enter the Union market
manufacturers in a better position
purpose of entering the market of
immediately after expiry of the
to enter the Union market
any Member State upon expiry of
relevant supplementary protection
immediately
makers of medicinal
the corresponding certificate (EU
certificate
, namely the EU-Day1
products or products. Over time, ‘Day-one’ entry), thereby helping
Entry. It would also help fostering
the Regulation should benefit the these makers to compete
access to medicines in the Union
entire pharmaceutical sector in
effectively in the Union
by helping to ensure a swifter
the Union, by allowing all
immediately after protection has
entry of generic and biosimilar
players, including newcomers, to expired. It is intended to
should
medicines onto the market after
reap the benefits of the new
also complement the efforts of the
expiry of the relevant certificate.
opportunities opening up in the
Union’s trade policy to ensure open
fast-changing global
markets for Union-based
pharmaceutical market.
manufacturers of medicinal
Furthermore, the common
products. Indirectly, it is also
interest in the Union would be
intended to put those manufacturers
promoted as, through the
in a better position to enter the
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reinforcement of Union-based
Union market immediately
makers
supply chains for medicines,
of medicinal products or
medicines would become more
products. Over time, the
accessible to patients in the
Regulation should benefit the
Union after
the expiry of the
entire pharmaceutical sector in
relevant supplementary protection
the Union, by allowing all
certificate. It would also help to
players, including newcomers, to
serve the aim of fostering access to
reap the benefits of the new
medicines in the Union by helping
opportunities opening up in the
to ensure a swifter entry of generic
fast-changing global
and biosimilar medicines onto the
pharmaceutical market.
market after expiry of the relevant
Furthermore, the common
certificate.
interest in the Union would be
promoted as, through the
reinforcement of Union-based
supply chains for medicines, and
by allowing storing in view of
entry onto the Union market
upon expiry of the certificate, 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.
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22
(8) In those specific and limited (8) In those
these specific and
(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 limited circumstances, and in order
create a level playing field
to 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
between Union-based
manufacturers and third country
manufacturers and third country
manufacturers
makers and third
manufacturers
makers and third
manufacturers, it is appropriate to
manufacturers, it is appropriate to
country manufacturers
makers, it
country manufacturers
makers, it
restrict the protection conferred by restrict the protection conferred by is appropriate to restrict the
is appropriate to restrict the
a supplementary protection
eliminate the unintentional
protection conferred by a
protection conferred by a
certificate so as to allow making
effects of a supplementary
supplementary protection
supplementary protection
for the exclusive purpose of export protection certificate so as to allow certificate so as to allow making
certificate so as to allow making for
to third countries and any related
making
, but not to the detriment
for the exclusive purpose of export the exclusive purpose of export to
acts strictly necessary for making
of any other patent or intellectual to third countries and any related
third countries and any related acts
or for the actual export itself.
property right existing in a
acts
in the Union strictly
in the Union strictly necessary for
Member State, so as to allow
necessary for making or for the
making or for the actual export
making of generic products,
actual export itself
, where such
itself
, where such acts would
biosimilars and active ingredients acts would otherwise require the
otherwise require the consent of
for the exclusive the purpose of
consent of the
a certificate-
holder, the
a certificate-
holder, and are
export to third countries and any
and are strictly necessary for
strictly necessary for making for
related acts strictly necessary for
making for the purpose of export
the purpose of export or for the
making or for the actual export
or for the actual export itself.
actual export itself.
(‘related
itself.
of entry into the Union
(‘related acts’). For instance, such
acts’). For instance, such acts may
market immediately after expiry
acts may include the
possession,
could include the
possession,
of the relevant supplementary
supply and
, import
, or making of
supply,
offering to supply and
,
protection certificate.
active ingredients
products for the import
, using or synthesis of an
purpose of making the
a medicinal
active ingredient making of active
product to which the
containing
ingredients
products for the
that product covered by the
purpose of making the
a medicinal
certificate corresponds, or
product to which the
containing
temporary storage of the product
that product covered by the
or advertising for the exclusive
certificate corresponds, or
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purpose of export to third country
temporary storage of the product or
destinations.
advertising for the exclusive
The exception should also apply
purpose of export to third country
to related acts performed by
destinations.
The exception should
third parties who are in a
also apply to related acts
contractual relationship with the performed by third parties who
maker.
are in a contractual relationship
with the maker.
[grey shaded part was taken from
recital 9]
[grey shaded part was taken from
recital 9 of the intial Commission
proposal]
23
(9) That exception should cover (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,
the making of the product,
including the product which
including the product
resulting
including the product which
including the product which
corresponds to the medicinal
from the making, which
corresponds to the medicinal
corresponds to the medicinal
product protected by a
corresponds to the medicinal
product protected by a
product protected by a
supplementary protection
product
are both protected by a
supplementary protection
supplementary protection
certificate in the territory of a
supplementary protection
certificate in the territory of a
certificate in the territory of a
Member State, for the exclusive
certificate in the territory of a
Member State, for the exclusive
Member State, for the exclusive
purpose of export to third
Member State, for the exclusive
purpose of export to third
purpose of export to third countries,
countries, as well as any upstream
purpose of export to third
countries, as well as any upstream
as well as any upstream or
or downstream acts by the maker
countries, as well as any upstream
or downstream acts by the maker
downstream acts by the maker or
or by third parties in a contractual
or downstream acts by the maker
or by third parties in a contractual
by third parties in a contractual
relationship with the maker, where or by third parties in a contractual
relationship with the maker, where relationship with the maker, where
such acts would otherwise require
relationship with the maker, where such acts would otherwise require
such acts would otherwise require
the consent of the certificate-
such acts would otherwise require
the consent of the certificate-
the consent of the certificate-
holder, and are strictly necessary
the consent of the certificate-
holder, and are strictly necessary
holder, and are strictly necessary
for making for the purpose of
holder, and are strictly necessary
for making for the purpose of
for making for the purpose of
export or for the actual export
for making for the purpose of
export or for the actual export
export or for the actual export
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itself. For instance, such acts may
export or for the actual export
itself.
. For instance, such acts may itself.
. For instance, such acts may
include the supply and import of
itself. For instance, such acts may
include the supply and
, import of
include the supply and
, import of
active ingredients for the purpose
include the supply and import of
active ingredients for the purpose
active ingredients for the purpose
of making the medicinal product to active ingredients for the purpose
of making the medicinal product to of making the medicinal product to
which the product covered by the
of making the medicinal product to which the product covered by the
which the product covered by the
certificate corresponds, or
which the product covered by the
certificate corresponds, or
certificate corresponds, or
temporary storage of the product
certificate corresponds, or
temporary storage of the product
temporary storage of the product or
or advertising for the exclusive
temporary storage of the product
or advertising for the exclusive
advertising for the exclusive
purpose of export to third country
or advertising for the exclusive
purpose of export to third country
purpose of export to third country
destinations.
purpose of export to third country
destinations.
destinations.
This exception should
destinations.
or of placing the
This exception should apply to a apply to a product, or a
product on the Union market
product, or a medicinal product
medicinal product containing
after the expiry of the certificate.
containing that product,
that product, protected by a
protected by a certificate. It
certificate. It should cover the
should cover the making of the
making of the product protected
product protected by a
by a certificate in the territory of
certificate in the territory of a
a Member State and the making
Member State and the making of of the medicinal product
the medicinal product
containing that product.
containing that product.
[grey shaded part was moved to
[Note to translators: Grey shaded
recital 8]
part was moved to recital 8]
24
(10) The exception should not
(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
cover placing the product
or
the exclusive purpose of export on product made for the purpose of
medicinal product containing
medicinal product containing
the market in the Member State
export on the market
to third
that product, made for the
that product, which is made for
where a supplementary protection
countries or placing it on the
exclusive purpose of export
, on the the exclusive purpose of export to
certificate is in force, either
Union's market on the first day
market in the Member State where third countries
or storing in view
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directly or indirectly after export,
after the expiry of the certificate
a supplementary protection
of EU Day-one entry, on the
nor should it cover re-importation
in the Member State where a
certificate is in force, either
market in the Member State where
of the product to the market of a
supplementary protection
directly
, or indirectly after export,
a supplementary protection
Member State in which a
certificate is in force, either
nor should it cover re-importation
certificate is in force, either
certificate is in force. Moreover, it directly or indirectly after
of the product to the market of a
directly
, or indirectly after export,
should not cover any act or activity export,nor should it cover re-
Member State in which a
nor should it cover re-importation
for the purpose of import of
importation of the
medicinal
certificate is in force. Moreover, it of the product to the market of a
medicinal products, or parts of
product to the market of a Member should not cover any act or activity Member State in which a certificate
medicinal products, into the Union State in which a certificate is in
for the purpose of import of
is in force. Moreover, it should not
merely for the purposes of
force. Moreover, it should not
medicinal products, or parts of
cover any act or activity for the
repackaging and re-exporting.
cover any act or activity for the
medicinal products, into the Union purpose of import of medicinal
purpose of import of products or
merely for the purposes of
products, or parts of medicinal
medicinal products, into the Union repackaging and re-exporting
. It
products, into the Union merely for
merely for the purposes of
should not cover temporary
the purposes of repackaging and re-
repackaging and re-exporting.
storage of the product or
exporting
. The exception should
medicinal product containing
not cover any storage of the
that product for any purposes
product or medicinal product
other than those set out in this
containing that product for any
Regulation.
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
(11) By limiting the scope of the
exception to making for the
exception to making for the
exception to making for the
exception to
the making for the
purpose of export outside 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
Union
or to the making for the
for such making or for the actual
for such making or for the actual
for such making or for the actual
purpose of storing , and
to acts
export itself, the exception
export itself,
to third countries and export itself, the exception
strictly necessary for such making
introduced by this Regulation will
of placing into the Union market
introduced by this Regulation
or for the actual export
or the
not unreasonably conflict with
as from day 1 after the certificate
will
should not unreasonably
actual storing itself, the exception
normal exploitation of the product
has expired, the exception
conflict with
the normal
introduced by this Regulation
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in the Member State where the
introduced by this Regulation will
exploitation of the product
or
will
should not unreasonably
certificate is in force, nor
should not unreasonably conflict
medicinal product containing
conflict with
the normal
unreasonably prejudice the
with normal exploitation of the
that product in the Member State exploitation of the product
or
legitimate interests of the
product in the Member State
where the certificate is in force,
medicinal product containing
certificate-holder, taking account
where the certificate is in force,
nor unreasonably
namely with the that product in the Member State
of the legitimate interests of third
nor unreasonably prejudice the
core exclusive right of the
where the certificate is in force, nor
parties.
legitimate interests of the
certificate holder to make that
unreasonably
namely with the
certificate-holder,
whilst also
product for the purpose of
core exclusive right of the
taking account of the legitimate
placing it on the Union market
certificate holder to make that
interests of third parties.
during the term of the
product for the purpose of
certificate. In addition, the
placing it on the Union market
exception should not
during the term of the certificate.
unreasonably prejudice the
In addition, the exception should
legitimate interests of the
not unreasonably prejudice the
certificate-holder, taking account
legitimate interests of the
of the legitimate interests of third
certificate-
holder,
whilst taking
parties.
account of the legitimate interests
of third parties.
26
(12) Safeguards should
(12)
Effective and proportionate (12) Safeguards should
(12)
Effective and proportionate
accompany the exception in order
safeguards should accompany the
accompany the exception in order
sSafeguards should accompany the
to increase transparency, to help
exception in order to increase
to increase transparency, to help
exception in order to increase
transparency, to help
, for the
the holder of a supplementary
transparency, to help the holder of
purpose of helping the holder of a protection certificate to enforce its a supplementary protection
the holder of a supplementary
supplementary protection
protection in the Union and to
certificate to enforce its protection
protection certificate to enforce its certificate to enforce its protection reduce the risk of illicit diversion
in the Union
, to check compliance
protection in the Union and to
in the Union and to reduce the risk onto the Union market during the
with the conditions set out in this
reduce the risk of illicit diversion
of illicit diversion onto the Union
term of the certificate.
Regulation and to reduce the risk
onto the Union market during the
market during the term
check
of illicit diversion onto the Union
term of the certificate.
compliance with the conditions
market during the term of the
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set out in this Regulation. Those
certificate.
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
(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
should impose a once-off duty
an
the person making the product for
the
maker, namely the legal
information obligation on the
information obligation on the
the exclusive purpose of export,
person
established in the Union,
maker, namely the person
maker, namely the person
requiring that person to provide
on whose behalf the making
of a
established in the Union, on
established in the Union, on
certain information to the authority
product or medicinal product
whose behalf the making the
of a
whose behalf the making the
of a
which granted the supplementary
containing that the product
, for
product or medicinal product
product or medicinal product
protection certificate in the
the exclusive
purpose of export
to
containing that product for the
containing that product for the
Member State where the making is
third countries or of placing on
exclusive purpose of export,
exclusive purpose of export
or
to take place. The information
the Union market after the expiry requiring that
is done (this
storing, requiring that
is done
should be provided before the
of the certificate, is carried out,
includes the possibility of the
(this includes the possibility of
making is intended to start for the
including the possibility of the
person to
itself directly doing the the person to
itself directly doing
first time in that Member State.
legal person itself directly doing
making). Namely, the maker
the making). Namely, the maker
The making and related acts,
the making,
whereby requiring
should provide certain information
should provide certain information
including those performed in
that person
is required to provide
to the authority which granted the
to the authority which granted the
Member States other than the one
certain information to the authority supplementary protection
supplementary protection
of making in cases where the
which granted the supplementary
certificate in the Member State
certificate in the Member State
product is protected by a
protection certificate in the
where the making is to take place.
where the making is to take place.
certificate in those other Member
Member State where the making is
A common notification form
A common notification form
States too, should only fall within
to take place.
It is the
should be provided for this
should be provided for this
the scope of the exception where
responsibility of the maker
purpose. The information should
purpose. The information should
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the maker has sent this notification
established in the Union to verify
be provided before the making is
be provided before the making is
to the competent industrial
that protection does not exist or
intended to start
starts for the first intended to start
starts for the first
property authority (or other
has expired in a country of
time in that Member State
, or
time in that Member State
, or
designated authority) of the
export, or whether it is subject to
before any related act prior to
before any related act prior to
Member State of making. The
any limitations or exemptions in
that making, whichever is the
that making, whichever is the
once-off duty to provide
that country. A common
earlier. It should be updated as
earlier. It should be updated as
information to the authority should
notification form for the
and when appropriate. The
and when appropriate. The
apply in each Member State where
notification of the authority
making and related acts, including making and related acts, including
making is to take place, both as
should be provided for that
those performed in Member States those performed in Member States
regards the making in that Member
purpose. The information should
other than the one of making in
other than the one of making in
State, and as regards related acts,
be provided before the making is
cases where the product is
cases where the product is
whether performed in that or
intended to start for the first time
protected by a certificate in those
protected by a certificate in those
another Member State, related to
in that Member State. The making other Member States too, should
other Member States too, should
that making. The authority should
should only fall within the scope
only fall within the scope of the
only fall within the scope of the
be required to publish that
of the exception where the maker
exception where the maker has
exception where the maker has sent
information, in the interests of
has sent this notification to the
sent this notification to the
this notification to the competent
transparency and for the purpose
competent industrial property
competent industrial property
industrial property authority (or
of informing the holder of the
authority (or other designated
authority (or other designated
other designated authority) of the
certificate of the maker’s intention. authority) of the Member State of
authority) of the Member State of
Member State of making. The
making The once-off duty to
making. The once-off duty to
once-off duty to provide
provide information to the
provide information to the
information to the authority should
authority should apply in each
authority should apply in each
apply in each Member State where
Member State where making is to
Member State where making is to
making is to take place, both as
take place, both as regards the
take place, both as regards the
regards the making in that Member
making
and has informed the
making in that Member State, and
State, and as regards related acts,
holder of the supplementary
as regards related acts, whether
whether performed in that or
protection certificate granted
performed in that or another
another Member State, related to
about the name and address of
Member State, related to that
that making. The authority should
the maker and the number of the
making. The authority should be
be required to publish that
certificate in that Member State
required to publish that
information, in the interests of
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and as regards related acts,
information, in the interests of
transparency and for the purpose of
whether performed in that or
transparency and for the purpose
informing the holder of the
another.
The making should be
of informing the holder of the
certificate of the maker’s intention
notified.
Should making take
certificate of the maker’s intention
and has informed the holder of
place in more than one Member
and has informed the holder of
the certificate granted in that
State, related to that making.
a
the certificate granted in that
Member State. Should making
notification should be required in Member State. Should making
take place in more than one
each of those Member States. The
take place in more than one
Member State, a notification
authority should be required to
Member State, a notification
should be required in each of
publish that information
the
should be required in each of
these Member States. In the
certificate number of the relevant these Member States. In the
interests of transparency, the
product or medicinal product, in
interests of transparency, the
authority should be required to
the interests of transparency
. and
authority should be required to
publish, as soon as possible, the
for the purpose of informing the
publish, as soon as possible, the
information it receives, together
holder of the certificate of the
information it receives, together
with the date of notification of
maker’s intention.
Certain
with the date of notification of
that information. Member States
confidential or commercially
that information. Member States should be allowed to require that
sensitive information notified to
should be allowed to require that notifications, and updates to
the authority should not be
notifications, and updates to
notifications, be subject to the
published, but could be provided,
notifications, be subject to the
payment of a once-off fee. This
if so requested by a court or other payment of a once-off fee. This
fee should be set at a level which
competent authority only.
fee should be set at a level which does not exceed the
does not exceed the
administrative cost of processing
administrative cost of processing notifications and updates.
notifications and updates.
28
(13 a)
Without prejudice to
(13a) The maker should also
(13a) The maker should also
the protection of confidential or
inform the certificate holder,
inform the certificate holder,
commercially sensitive
through appropriate and
through appropriate and
information, the maker should
documented means, of the
documented means, of the
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also inform the certificate holder, intention to make a product or
intention to make a product or
in writing, of its intention to make medicinal product containing
medicinal product containing
a product pursuant to the
that product pursuant to the
that product pursuant to the
exception.
exception, by providing the
exception, by providing the
certificate holder with the same
certificate holder with the same
information as notified to the
information as notified to the
authority. That information is
authority. That information is
limited to what is necessary and
limited to what is necessary and
appropriate for the certificate
appropriate for the certificate
holder to assess whether the
holder to assess whether the
rights conferred by the
rights conferred by the certificate
certificate are being respected,
are being respected, and does not
and does not include confidential include confidential or
or commercially sensitive
commercially sensitive
information. The information to information. The information to
the certificate holder may be
the certificate holder may be
provided by making use of the
provided by making use of the
same common notification form, same common notification form,
and the information provided
and the information provided
should be updated as and when
should be updated as and when
appropriate.
appropriate.
29
(13b) Regarding related acts
(13b) Regarding related acts
prior to the making, if any, the
prior to the making, if any, the
notification should list the name
notification should list the name
of the Member State where the
of the Member State where the
first related act, which would
first related act, which would
otherwise require the consent of
otherwise require the consent of
a certificate holder, is to take
a certificate holder, is to take
place, as this information is
place, as this information is
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relevant to the timing of the
relevant to the timing of the
notification.
notification.
30
(13c) If the local marketing
(13c) If the local marketing
authorisation, or equivalent, in a authorisation, or equivalent, in a
specific third country, for a
specific third country, for a given
given medicinal product, is
medicinal product, is published
published after the notification is after the notification is made, the
made, the notifcation should be
notification should be promptly
promptly updated to include the updated to include the reference
reference number of that
number of that marketing
marketing authorisation, at the
authorisation, as soon as it is
latest before the actual export of publicly available. If the
the medicinal product to that
reference number of the granted
third country takes place. If a
authorisation is pending
marketing authorisation or
publication, the maker should be
equivalent mechansim applies,
required to provide, in the
but the reference number of the
notification, that reference
granted authorisation is not
number as soon as it is publicly
published or is pending
available.
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
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name of the third country of
export.
31
(13d) For reasons of
(13d) For reasons of
proportionality, failure to
proportionality, failure to comply
comply with these requirements
with these requirements
regarding a third country would regarding a third country would
only affect exports to that
only affect exports to that
country, and exports to such
country, and exports to such
third country would thus not
third country would thus not
benefit from the exception. It
benefit from the exception. It
should be the responsibility of
should be the responsibility of the
the maker established in the
maker established in the Union to
Union to verify that protection
verify that protection does not
does not exist or has expired in a exist or has expired in a country
country of export, subject to any of export, subject to any
limitations or exemptions in that limitations or exemptions in that
country. A notification to an
country. A notification to an
authority and the corresponding authority and the corresponding
information to the certificate
information to the certificate
holder may be provided during
holder may be provided already
the period between the entry
during the period between the
into force of the Regulation and
entry into force of the Regulation
the date on which the exception
and the date on which the
itself becomes applicable.
exception itself becomes
applicable.
32
(14) In addition, this Regulation
(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
should impose certain due diligence
diligence requirements on the
diligence requirements on the
diligence requirements on the
requirements on the maker as a
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maker as a condition for the
maker as a condition for the
maker as a condition for the
condition for the exception to
exception to operate. The maker
exception to operate. The maker
exception to operate. The maker
operate. The maker should be
should be required to inform
should be required to inform
should be required to inform
required to inform persons within
persons within its supply chain,
persons within its supply chain,
persons within its supply chain
in
its supply chain
in the Union,
through appropriate means, in
through appropriate
and
the Union, including the
including the exporter and the
particular contractual means, that
documented means, in particular
exporter, through appropriate
and person doing the storing, through
the product is covered by the
contractual means, that the product
documented means, in particular
appropriate
and documented
exception introduced by this
is covered by the exception
contractual means, that the
means, in particular contractual
Regulation and is intended for the
introduced by this Regulation and
product or medicinal product
means, that the
product or
exclusive purpose of export. A
is intended for the purpose of
containing that product is covered
medicinal product containing
maker who failed to comply with
export
and/or EU-Day1 Entry. A
by the exception introduced by this
that product is covered by the
these due diligence requirements
maker who failed to comply with
Regulation and is intended for the
exception introduced by this
would not benefit from the
these due diligence requirements
exclusive purpose of export. A
Regulation and is intended for the
exception, nor would any third
would not benefit from the
maker who failed to comply with
exclusive purpose of export
or
party performing a related act in
exception, nor would any third
these due diligence requirements
storing, as applicable. A maker
the same or a different Member
party performing a related act in
would not benefit from the
who failed to comply with these
State where a certificate conferring the same or a different Member
exception, nor would any third
due diligence requirements would
protection for the product was in
State where a certificate conferring party performing a related act in
not benefit from the exception, nor
force, and the holder of the
protection for the product was in
the same or a different Member
would any third party performing a
relevant certificate would therefore force, and the holder of the
State where a certificate conferring related act in the same or a
be entitled to enforce its rights
relevant certificate would therefore protection for the product was in
different Member State where a
under the certificate.
be entitled to enforce its rights
force, and the holder of the
certificate conferring protection for
under the
supplementary
relevant certificate would therefore the product was in force, and the
protection certificate.
be entitled to enforce its rights
holder of the relevant certificate
under the certificate
, while paying would therefore be entitled to
due regard to the general
enforce its rights under the
obligation, set out in Directive
certificate
, while paying due
2004/48/EC of the European
regard to the general obligation,
Parliament and of the Council5,
set out in Directive 2004/48/EC of
not to engage in abusive
the European Parliament and of
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litigation.
the Council5, not to engage in
abusive litigation.
33
(15) Furthermore, this Regulation (15) Furthermore, this Regulation (15) Furthermore, this Regulation (15) Furthermore
, in respect of
should impose labelling
should impose labelling
should impose labelling
products to be exported, this
requirements on the maker, in
requirements on the maker, in
requirements on the maker, in
Regulation should impose labelling
order to facilitate, by means of a
order to facilitate, by means of a
order to facilitate, by means of a
requirements on the maker, in order
logo, identification of the product
logo, identification of the product
logo, identification of the product
to facilitate, by means of a logo,
as a product exclusively intended
as a product exclusively intended
as a
or medicinal product
identification of the product as a
or
for the purpose of export to third
for the purpose of export to third
containing that product as being medicinal product
containing that
countries. The making and related
countries. The making and related
exclusively intended for the
product as being exclusively
acts should only fall outside the
acts should only fall outside the
purpose of export to third
intended for the purpose of export
protection conferred by a
protection conferred by a
countries. The making and related
to third countries. The making
for
supplementary protection
supplementary protection
acts should only fall outside the
the purposes of export and related
certificate if the product is labelled certificate if the product is labelled protection conferred by a
acts should only fall outside the
in this manner. This labelling
in this manner. This labelling
supplementary protection
protection conferred by a
obligation would be without
obligation would be without
certificate if the
product or
supplementary protection
prejudice to labelling requirements prejudice to labelling requirements
medicinal product containing
certificate if the
product or
of third countries.
of third countries.
that product is labelled in this
medicinal product containing
manner. This labelling obligation
that product is labelled in this
would be without prejudice to
manner. This labelling obligation
labelling requirements of third
would be without prejudice to
countries.
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
(16) Any act not covered by the
exception introduced by this
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
Regulation will remain within the
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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scope of the protection conferred
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
by a supplementary protection
certificate. This includes any
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
product made within the terms of
the exception and illicitly diverted the exception and illicitly diverted the exception and illicitly diverted the exception and illicitly
onto the Union market during the
onto the Union market during the
Any illicit diversion onto the
diverted
Any illicit diversion onto
term of the certificate.
term of the certificate.
Union market
, during the term of
the Union market
, during the term
the certificate
, of any product or
of the certificate
, of any product
medicinal product containing
or medicinal product containing
that product made within the
that product made within the
terms of the exception, will
terms of the exception, will
remain prohibited.
remain prohibited.
35
(17) This Regulation does not
(17) This Regulation does not
(17)
This Regulation is without
(17)
This Regulation is without
affect the application of Union
affect the application of Union
prejudice to the respect of other
prejudice to the respect of other
measures that aim to prevent
measures that aim to prevent
intellectual property rights that
intellectual property rights that
infringements and facilitate
infringements and facilitate
may protect other aspects of a
may protect other aspects of a
enforcement of intellectual
enforcement of intellectual
medicinal product. This
medicinal product. This
property rights, including
property rights, including
Regulation does not affect the
Regulation does not affect the
Directive 2004/48/EC of the
Directive 2004/48/EC of the
application of Union measures that application of Union measures that
European Parliament and of the
European Parliament and of the
aim to prevent infringements and
aim to prevent infringements and
Council5 and Regulation (EU) No
Council5 and Regulation (EU) No
facilitate enforcement of
facilitate enforcement of
608/2013 of the European
608/2013 of the European
intellectual property rights,
intellectual property rights,
Parliament and of the Council6.
Parliament and of the Council6.
including Directive 2004/48/EC5
including Directive 2004/48/EC5 of
Furthermore, a medicinal product of the European Parliament and of the European Parliament and of the
bearing an active Unique
the Council and Regulation (EU)
Council and Regulation (EU) No
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Identifier as per Articles 3(d) of
No 608/2013 of the European
608/2013 of the European
Commission Delegated
Parliament and of the Council6
.
Parliament and of the Council6
.
Regulation (EU) 2016/1617a
Furthermore, this Regulation
Furthermore, this Regulation
would indicate that the product is does not affect the rules on the
does not affect the rules on the
not exclusively intended for the
unique identifier provided for by unique identifier provided for by
purpose of export to third
Directive 2001/83/EC of the
Directive 2001/83/EC of the
countries. Therefore, this
European Parliament and of the European Parliament and of the
Regulation should only prohibit a Council and by Commission
Council as amended by Directive
product exclusively intended for
Delegated Regulation (EU)
2011/62/EU and as provided for
the purpose of export to third
2016/161. According to Directive by Commission Delegated
countries bearing such an active
2001/83/EC, medicinal products
Regulation (EU) 2016/1617a. The
Unique Identifier. That
produced exclusively for export
maker ensures that the medicinal
prohibition shall not apply to
do not need to bear unique
product made pursuant to point
products intended for the purpose identifiers.
(a)(i) of paragraph 2 does not
of storage for EU-Day1 Entry.
bear an active unique identifier
within the meaning of Directive
2011/62/EC. However, the
requirement to affix an active
unique identifier applies to
medicinal products to be placed
on the market of a Member State
upon expiry of the corresponding
6 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).
7a Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down
detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
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certificate.
36
(18) This Regulation does not
(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 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
2001/83/EC and 2001/82/EC, in
particular the requirements related particular the requirements related particular the requirements related particular the requirements related
to the manufacturing authorisation to the manufacturing authorisation to the manufacturing authorisation to the manufacturing authorisation
of medicinal products
of medicinal products
of medicinal products
of medicinal products
manufactured for export. This
manufactured for export. This
manufactured for export. This
manufactured for export. This
includes compliance with the
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
principles and guidelines of good
manufacturing practices for
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
medicinal products and the use of
active substances that have been
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
manufactured in accordance with
good manufacturing practices for
good manufacturing practices for
good manufacturing practices for
good manufacturing practices for
active substances and distributed
active substances and distributed
active substances and distributed
active substances and distributed in
in accordance with good
in accordance with good
in accordance with good
accordance with good distribution
distribution practices for active
distribution practices for active
distribution practices for active
practices for active substances.
substances.
substances.
substances.
37
(19) In order to ensure that
(19) In order to ensure that
(19) In order to ensure that
(19) In order to ensure that holders
holders of supplementary
holders of supplementary
holders of supplementary
of supplementary protection
protection certificates already in
protection certificates already in
protection certificates already in
certificates already in force are not
force are not deprived of their
force are not deprived of their
force are not deprived of their
deprived of their acquired rights,
acquired rights, the exception
acquired rights,
The exception
acquired rights, the exception
the exception provided for in this
provided for in this Regulation
provided for in this Regulation
provided for in this Regulation
Regulation should only apply to
should only apply to certificates
should only apply to certificates
should only apply to certificates
certificates that are granted on or
that are granted on or after a
that are granted on or after a
that are granted on or after a
after a specified date after entry
specified date after entry into
specified date after entry into
specified date after entry into
into force, irrespective of when the
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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
application for the certificate was
first lodged. The date specified
first lodged. The date specified
first lodged. The date specified
the first lodged. The date specified
should allow a reasonable time for
should allow a reasonable time for
basic patent for which expired on should allow a reasonable time for applicants and other relevant
applicants and other relevant
or after 1 January 2021.
That
applicants and other relevant
market players to adjust to the
market players to adjust to the
date
takes into account the need
market players to adjust to the
changed legal context and to make
changed legal context and to make
to provide for a transitional
changed legal context and to make appropriate investment and
appropriate investment and
period sufficiently long to ensure
appropriate investment and
manufacturing location decisions in
manufacturing location decisions
that holders of supplementary
manufacturing location decisions
a timely way. The date should also
in a timely way.
protection certificates are not
in a timely way. The date should
allow sufficient time for public
The date should also allow
deprived of their acquired rights
also allow sufficient time for
authorities to put in place
sufficient time for public
and should allow a reasonable
public authorities to put in place
appropriate arrangements to receive
authorities to put in place
time for applicants and other
appropriate arrangements to
and publish notifications of the
appropriate arrangements to
relevant market players to adjust to receive and publish notifications of intention to make, and should take
receive and publish notifications of the changed legal context and to
the intention to make, and should
due account of pending
the intention to make, and should
make appropriate investment and
take due account of pending
applications for certificates.
To
take due account of pending
manufacturing location decisions
applications for certificates.
safeguard the rights of certificate
applications for certificates.
in a timely way. The
That date
To safeguard the rights of
holders, the exception should not
should also allow sufficient time
certificate holders, the exception apply to a certificate that has
for public authorities to put in
should not apply to a certificate
already taken effect at the date of
place appropriate arrangements to
that has already entered into
entry into force of the
receive and publish notifications of
effect at the date of entry into
Regulation. In order to ensure
the intention to make, and should
force of the Regulation. In order that the rights of certificate
take due account of pending
to ensure that the rights of
holders are not excessively
applications for certificates.
certificate holders are not
restricted, the exception provided
excessively restricted, the
for in this Regulation should
exception provided for in this
apply to certificates that are
Regulation should apply to
applied for on or after the day of
certificates that are applied for
the entry into force of this
on or after the day of the entry
Regulation. At the same time, in
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into force of this Regulation. At
order to safeguard the aim of this
the same time, in order to
Regulation, and since a
safeguard the aim of this
certificate takes effect at the end
Regulation, and since a
of the lawful term of the basic
certificate enters into effect a
patent, which can be a relatively
relatively long time after its date long time after the date of filing
of filing, it is justified to bring
of the application for the
within the scope of the
certificate, it is justified to bring
Regulation, over a certain period within the scope of the
of time, a certificate that was
Regulation, over a certain period
applied for before the entry into of time, a certificate that was
force of this Regulation, but has
applied for before the entry into
not yet entered into effect before force of this Regulation, but has
that entry into force, and
not yet taken effect before that
irrespective of whether or not
entry into force, and irrespective
that certificate has been granted of whether or not that certificate
before the entry into force of the has been granted before the entry
Regulation. Therefore, the
into force of the Regulation.
exception should apply, as from
Therefore, the exception should
1 July 2022, to a certificate that
apply, as from 1 July 2022, to a
enters into effect as from that
certificate that takes effect as
entry into force. This ‘certain
from that entry into force. This
period of time’ for each
‘certain period of time’ for each
individual certificate that enters
individual certificate that takes
into effect after that entry into
effect after that entry into force
force should ensure that the
should ensure that the exception
exception is applied, on a
is applied, on a progressive basis,
progressive basis, to such a
to such a certificate, depending
certificate, depending on its date on its date of taking effect and its
of entry into effect and its
duration. Such application of the
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duration. Such application of the exception would allow the holder
exception would allow the holder of a granted certificate that has
of a granted certificate that is
not yet taken effect by the date of
not yet in effect by the date of
the entry into force of the
the entry into force of the
Regulation a reasonable period of
Regulation a reasonable period
transition to adapt to the
of transition to adapt to the
changed legal context, while at
changed legal context, while at
the same time ensuring that
the same time ensuring that
makers of generics and
makers of generics and
biosimilars can benefit
biosimilars can benefit
effectively, without excessive
effectively, without excessive
delay, from the exception.
delay, from the exception.
38
(19a) This Regulation should not
(19a) An applicant for a
(19a) An applicant for a
have any retroactive effect.
certificate might be expected to
certificate might be expected to
file an application at around the file an application at around the
same date in each Member State same date in each Member State
of filing. However due to
of filing. However due to
differences in national
differences in national
procedures for examination of
procedures for examination of
applications, the date of grant
applications, the date of grant
might vary significantly from
might vary significantly from one
one Member State to another,
Member State to another,
thereby creating disparities in
thereby creating disparities in the
the legal situation of the
legal situation of the applicant in
applicant in the different
the different Member States
Member States where the
where the certificate is applied
certificate is applied for.
for. Introducing the exception on
Introducing the exception on the the basis of the date of filing of
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basis of the date of filing of the
the application for a certificate
application for a certificate
would therefore promote
would therefore promote
uniformity and limit this risk of
uniformity and limit this risk of
disparities.
disparities.
39
(20) The Commission should
(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
carry out an
regular evaluation of
Regulation. Pursuant to paragraph
this Regulation.
Given the
Regulation. Pursuant to paragraph
this Regulation. Pursuant to
22 of the Interinstitutional
paramount importance of access
22 of the Interinstitutional
paragraph 22 of the
Agreement between the European
to and affordability of medicinal
Agreement between the European
Interinstitutional Agreement
Parliament, the Council of the
products for public health and
Parliament, the Council of the
between the European Parliament,
European Union and the European
public expenditure, a regular
European Union and the European the Council of the European Union
Commission on Better Law-
evaluation cycle of this
Commission on Better Law-
and the European Commission on
Making of 13 April 20167, that
Regulation is justified. Pursuant to Making of 13 April 20167, that
Better Law-Making of 13 April
evaluation should be based on the
paragraph 22 of the
evaluation should be based on the
20167, that evaluation should be
five criteria of effectiveness,
Interinstitutional Agreement
five criteria of effectiveness,
based on the five criteria of
efficiency, relevance, coherence
between the European Parliament, efficiency, relevance, coherence
effectiveness, efficiency, relevance,
and added value and should
the Council of the European Union and added value and should
coherence and added value and
provide the basis for impact
and the European Commission on
provide the basis for impact
should provide the basis for impact
assessments of possible further
Better Law-Making of 13 April
assessments of possible further
assessments of possible further
measures. The evaluation should
20167, that evaluation should be
measures. The evaluation should
measures. The evaluation should
take into account exports to
based on the five criteria of
take into account exports to
take into account
on the one hand,
outside the Union and the ability
effectiveness, efficiency,
outside the Union and the ability
exports to outside the Union
, and
of generics and especially
relevance, coherence and added
of generics and especially
on the other, the effects of storing
biosimilars to enter markets in the
value and should provide the basis biosimilars to enter markets in the
on swifter entry of generic and
Union as soon as possible after a
for impact assessments of possible Union as soon as possible after a
especially biosimilar medicines
certificate lapses. In particular, this further measures. The evaluation
certificate lapses. In particular, this and the ability of generics and
7 OJ L 123, 12.5.2016, p. 1.
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evaluation should review the
should take into account
the
evaluation should review the
especially biosimilars
onto enter
effectiveness of the exception in
impact of the SPC system on
effectiveness of the exception in
markets in the Union as soon as
the light of the aim to restore a
access to affordable medicines as
the light of the aim to restore a
possible after a certificate lapses.
global level playing field for
well as the waiver, including
global level playing field for
Such regular evaluation should
generic and biosimilar firms in the exports to outside the Union and
generic and biosimilar firms in the
also address the effects of this
Union and a swifter entry of
the ability of generics and
Union and a swifter entry of
Regulation on making within the
generic and especially biosimilar
especially biosimilars to enter
generic and especially biosimilar
Union by generic and biosimilar
medicines onto the market after a
markets in the Union as soon as
medicines onto the market after a
makers based in the Union. In
certificate lapses. It should also
possible after a certificate lapses
.
certificate lapses. It should also
this context, it would be
study the impact of the exception
Such regular evaluation should
study the impact of the exception
important to ascertain whether
on research and production of
also address the effects of this
on research and production of
making that was previously
innovative medicines by holders of
Regulation on manufacturing
innovative medicines
in the Union taking place outside of the Union
certificates in the Union and
within the Union by Union
by holders of certificates in the
would be moved to within its
consider the balance between the
established makers for reasons of Union and consider the balance
territory. In particular, this
different interests at stake,
stockpiling with a view to Day1
between the different interests at
evaluation should review the
including those of public health.
entry into the Union market when stake, including those of public
effectiveness of the exception in
a certificate lapses. In this
health.
the light of the aim to restore a
context, it would be important to
global level playing field for
ascertain whether manufacturing
generic and biosimilar firms in the
previously taking place outside of
Union and a swifter entry of
the Union, has been moved to
generic and especially biosimilar
within its territory. In particular,
medicines onto the market after a
this evaluation should review the
certificate lapses. It should also
effectiveness of the exception in
study
the impact of the exception
the light of the aim to restore a
on research and production of
global level playing field for
innovative medicines
in the Union
generic and biosimilar firms in the
by holders of certificates in the
Union and a swifter entry of
Union and consider the balance
generic and especially biosimilar
between the different interests at
medicines onto the market after a
stake,
notably including those of
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certificate lapses
and examine the
public health
, public expenditure
case for a possible extension of
and, in this context, access to
the scope of the exception granted
medicines within the Union.
It
by the waiver so as to allow
should also study whether the
Union-based manufacturers of
period foreseen for making for
generics and biosimilars to
the purpose of storing is
manufacture for stockpiling
sufficient to achieve the objective
purposes. It should also study the
of EU Day-one entry, including
impact of the exception
and its
its effects on public health.
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
(21) It is necessary and
appropriate for the achievement of 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
the basic objective, of providing a
level playing field for generic and
level playing field for makers of
level playing field for
makers of
level playing field for
makers of
biosimilar manufacturers with
generic and biosimilar
generic and biosimilar
generics and biosimilars
their competitors in third country
manufacturers with their
manufacturers with their
manufacturers with their
markets where protection does not competitors in third country
competitors in third country
competitors in third country
exist or has expired, to lay down
markets where protection does not markets where protection does not markets where protection does not
rules restricting the exclusive right exist or has expired, to lay down
exist or has expired, to lay down
exist or has expired, to lay down
of a supplementary protection
rules restricting the exclusive right rules restricting the exclusive right rules restricting the exclusive right
certificate holder to make the
of a supplementary protection
of a supplementary protection
of a supplementary protection
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product in question during the
certificate holder to make
enabling certificate holder to make the
certificate holder,
enabling the
term of the certificate, and also to
the making of the product in
product in question during the
making of to make the product in
impose certain information and
question during the term of the
term of the certificate, and also to
question during the term of the
labelling obligations on makers
certificate.and also to impose
impose certain information and
certificate, and also
to provide
wishing to take advantage of those certain information and labelling
labelling obligations on makers
impose certain information and
rules
. This Regulation complies
obligations on makers wishing to
wishing to take advantage of those labelling obligations on makers
with the principle of
take advantage of those rules
. This rules
. This Regulation complies
using those ruleswishing to take
proportionality, and does not go
Regulation complies with the
with the principle of
advantage of those rules
. This
beyond what is necessary in order
principle of proportionality, and
proportionality, and does not go
Regulation complies with the
to achieve the objectives pursued,
does not go beyond what is
beyond what is necessary in order
principle of proportionality, and
in accordance with Article 5(4) of
necessary in order to achieve the
to achieve the objectives pursued,
does not go beyond what is
the Treaty on European Union.
objectives pursued, in accordance
in accordance with Article 5(4) of
necessary in order to achieve the
with Article 5(4) of the Treaty on
the Treaty on European Union.
objectives pursued, in accordance
European Union.
with Article 5(4) of the Treaty on
European Union.
41
(22) This Regulation respects
(22) This Regulation respects
(22) This Regulation respects
(22) This Regulation respects
fundamental rights and observes
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
the principles recognised by the
Charter of Fundamental Rights of
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, the European Union. In particular,
this Regulation seeks to ensure full 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
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
Article 17
, and the right to health
maintaining the core rights of the
maintaining the core rights of the
maintaining the core rights of the
care under Article 35, of the
supplementary protection
supplementary protection
supplementary protection
Charter
. The Regulation should
certificate, by confining the
certificate, by confining the
certificate, by confining the
by maintaining the core rights of
exception to certificates granted on exception to certificates by
exception to certificates granted on the supplementary protection
or after a specified date after entry confining the exception to
or after a specified date after entry certificate, by confining the
into force of this Regulation and
certificates granted
basic patent of into force of this Regulation and
exception to certificates granted on
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by imposing certain conditions on
which expired on or after
1
by imposing certain conditions on
or after a specified date after entry
the application of the exception,
January 2021 a specified date
the application of the exception
into force of this Regulation and by
after entry into force of this
certificate, by confining the
imposing certain conditions on the
Regulation and by imposing
exception provided for in this
application of the
certain conditions on the
Regulation to the making of a
exception
certificate, by confining
application of the exception,
as
product or a medicinal product
the exception provided for in this
well as respect for the right to
containing that product only for Regulation to the making of a
health care set out in Article 35 of the purpose of export outside the product or a medicinal product
the Charter by making medicines
Union and to the acts strictly
containing that product only for
more accessible to Union
necessary for such making or for the purpose of export outside the
patients, for the principle of
the actual export itself. This
Union or for the purpose of
proportionality set out in Article
exception does not go beyond
storing it during a limited period
52 of the Charter, and the right to what is necessary and
of time in view of entry onto the
health protection for European
appropriate in the light of the
Union market upon expiry of the
citizens set out in point (a) of
overall objective of this
protection, and to the acts strictly
Article 6 TFEU .
Regulation, which is to promote
necessary for such making or for
the competitiveness of the Union the actual export or storing itself.
by avoiding delocalisations and
This exception does not go
allowing Union-based makers of beyond what is necessary and
generics and biosimilars to
appropriate in the light of the
compete on fast-growing, global
overall objective of this
markets where protection does
Regulation, which is to promote
not exist or has already expired.
the competitiveness of the Union
Indeed, it is necessary to benefit
by avoiding delocalisations and
from those positive economic
allowing Union-based makers of
effects arising from the
generics and biosimilars to
exception, as otherwise the
compete, on the one hand, on
Union would risk substantially
fast-growing, global markets
weakening its position as a hub
where protection does not exist
for pharmaceutical development or has already expired, and on
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and manufacturing. It is
the other, on the Union market
therefore appropriate to
upon expiry of the certificate.
introduce that exception in order Indeed, it is necessary to benefit
to increase the competitive
from those positive economic
position of Union-based makers
effects arising from the
of generics and biosimilars in
exception, as otherwise the Union
third countries whose markets
would risk substantially
are in any event open to
weakening its position as a hub
competition, whilst leaving the
for pharmaceutical development
scope and duration of the
and manufacturing. It is
protection granted by the
therefore appropriate to
certificate in the Union
introduce that exception in order
untouched. The appropriateness to increase the competitive
of the measure is further
position of Union-based makers
ensured by providing for
of generics and biosimilars in
appropriate safeguards
third countries whose markets
regulating the use of the
are in any event open to
exception. The Regulation
competition, whilst leaving the
should allow sufficient time for
scope and duration of the
public authorities to put in place protection granted by the
the necessary arrangements to
certificate in the Union
receive and publish notifications, 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
HAVE ADOPTED THIS
REGULATION:
REGULATION:
REGULATION:
REGULATION
43
Article 1 – Amendment of
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
Regulation (EC) No 469/2009
44
Regulation (EC) No 469/2009 is
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:
amended as follows:
45
(-1) in Article 1, the following
(0) in Article 1, the following
(-1) in Article 1, the following
point is added:
point is added:
point is added:
46
(ea) ‘maker’ means a legal person ‘(f) ‘maker’ means the person
‘(f) ‘maker’ means the person
established in the Union on
established in the Union on established in the Union on
whose behalf the making of a
whose behalf the making of whose behalf the making of a
product or a medicinal product
a product or a medicinal
product or a medicinal product
containing that product, for the
product containing that
containing that product, for the
purpose of export to third
product, for the exclusive
purpose of export to third
countries or storing during the
purpose of export to third
countries or for the purpose of
final 2 years of validity of the
countries, is done;’
storing, 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
1)
Article 4
5 is replaced by
following:
the following:
the following:
the following:
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48
‘Article 4 – Subject matter of
‘Article 4 – 5 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 protection and exceptions to rights
conferred
conferred Effects of the certificate 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
1.
Within the limits of the
protection conferred by the basic
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 patent, the protection conferred by
a certificate shall extend only to
a certificate shall extend only to
a certificate shall extend only to
a certificate shall extend only to the
the product covered by the
the product covered by the
the product covered by the
product covered by the
authorisation to place the
authorisation to place the
authorisation to place the
authorisation to place the
corresponding medicinal product
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
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 the product as a medicinal product
that has been authorised before the 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.
expiry of the certificate.
Subject to the provisions of
Subject to the provisions of
Subject to the provisions of
Article 4, the certificate shall
Article 4, the certificate shall
Article 4, the certificate shall
confer the same rights as
confer the same rights as
confer the same rights as
conferred by the basic patent and conferred by the basic patent
conferred by the basic patent and
shall be subject to the same
and shall be subject to the same
shall be subject to the same
limitations and the same
limitations and the same
limitations and the same
obligations.
obligations.
obligations.
50
2. The certificate referred to in
2.
By way of derogation from
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
paragraph 1, the The certificate
protection against a particular act
referred to in paragraph 1 shall not 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
confer protection against a
conferred protection if, with
particular act
certain acts against
particular act against which the
particular act
certain acts against
respect to that particular act, the
which the basic patent conferred
basic patent conferred protection
which the basic patent conferred
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following conditions are met:
protection if, with
respectwhich
if, with respect
which would
protection if, with respect
which
would otherwise require the
otherwise require the consent of
would otherwise require the
consent of the holder of the
the holder of the certificate
consent of the holder of the
certificate referred to that
referred to that particular act,
in
certificate, referred to that
particular act,
in Article 11 (‘the
Article 11 (‘the certificate
particular act
in Article 11 (‘the
certificate holder’) if the
holder’) if the following
certificate holder’) if the
following conditions are met:
conditions are met:
following conditions are met:
51
(a)
the act comprises:
(a)
the
acts comprise:
(a)
the act comprises:
(a)
the act
s comprises:
52
(i)
making for the exclusive
(i)
making
a product, or a
(i)
making
a product or a (i)
making
a product, or a
purpose of export to third
medicinal product
medicinal product
medicinal product containing that
countries; or
containing that product,
containing that product, for
product, for the exclusive purpose
for the exclusive purpose
the exclusive purpose of
of export to third countries; or
of export to third
export to third countries; or
countries; or
53
(ii) making a product, or a
(ii) any related act that is strictly
medicinal product containing that
necessary for that making
in the
product, for the purpose of
Union or for the actual export
storing it in the Member State of
itself
;or
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
Deleted
(ii)
any related act that is
(iii) making, no earlier than 6
necessary for that making or for
(iii) any related act that is strictly
strictly necessary for that
months before the expiry of the
the actual export itself;
necessary for that making or for
making
in the Union or for
certificate, a product, or a
the actual export itself;
the actual export itself
medicinal product containing that
product, for the purpose of storing
it in the Member State of
makingduring the final 2 years of
validity of the certificate referred
to in paragraph 1,in order to place
that product, or a medicinal
product containing that product,
on the market of Member States as
from day 1after the expiry of the
certificatein those Member
States;or
54a
(iv) any related act that is strictly
necessary for the making in the
Union as referred to in point (iii),
or for the actual storing itself,
provided that such related act is
carried out no earlier than
6
months before the expiry of the
certificate.
55
(iii) the act excludes any act or
[Moved to new row 63a]
activity for import of medicinal
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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
(b) the maker, through
Article 9(1) of the Member State
authority referred to in Article 9(1)
appropriate and documented
appropriate and documented
where that making is to take place
of the Member State where that
means, notifies the authority
means, notifies the authority
(‘the relevant Member State’) is
making is to take place (‘the
referred to in Article 9(1) of 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
Member State where that making is
making (‘the maker’) of the
by the person doing the making
is to take place (‘the relevant
to take place (‘the relevant Member
information listed in paragraph 3
(‘the maker’) of the information
Member State’) is notified by the
State’) is notified by the person
no later than 28 days before the
listed in
points (a), (b), (c), (e) and person doing the making (‘the
doing the making (‘the maker’)
and
intended start date of making in
(f) of paragraph 3 no later than 28
maker’)
and informs the
informs the certificate holder of
that Member State;
days
two months before the
certificate holder of the
the information listed in paragraph
intended start date of making in
information listed in paragraph 3
3 no later than 28 days
three
that Member State;
no later than 28 days
three
months before the intended start
months before the intended start
date of making in that Member
date of making in that Member
State
, or no later than three
State
, or no later than three
months before the first related
months before the first related
act prior to that making that
act prior to that making that
would otherwise be prohibited by
would otherwise be prohibited
the protection conferred by a
by the protection conferred by a certificate, whichever is the
certificate, whichever is the
earlier;
earlier;
57
(ba) if the information listed in
(ba) if the information listed in
paragraph 3 changes, the maker paragraph 3 changes, the maker
shall notify the authority
shall notify the authority referred
referred to in Article 9(1) and
to in Article 9(1) and shall inform
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shall inform the certificate
the certificate holder, before
holder, before these changes
these changes take effect;
take effect;
58
(c) the maker informs the
Deleted
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;
59
(d) the notification to the
Deleted (as this objective is already
certificate holder does not contain
mentioned in recitals)
any confidential or commercially
sensitive information;
60
(e) the information provided by
(first phrase deleted; second phrase
the maker to the certificate holder
moved to new para 2b, row 63b)
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;
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61
(c) the maker ensures that a
(f)
in the case of products made (c) the maker ensures that a
(c)
in the case of products
logo, in the form set out in Annex
for the purpose of export to third
logo, in the form set out in Annex
made for the purpose of export to
-I, is affixed to the outer packaging
countries, the maker ensures that a -I
II, is affixed to the outer
third countries, the maker ensures
of the product or, if there is no
logo, in the form set out in Annex
packaging of the product or, if
that a logo, in the form set out in
outer packaging, to its immediate
-Ia, is affixed to the outer
there is no outer packaging
of the
Annex -I
I, is affixed to the outer
packaging;
packaging of the product
referred
medicinal product containing
packaging of the product or, if
to in paragraph 2(a)(i) or, if there
that product, referred to in
there is no outer packaging
of the
is no outer packaging, to its
paragraph 2(a)(i), and, where
medicinal product containing
immediate packaging
the product
feasible, to its immediate
that product, referred to in
forms part of a medicinal product, packaging;
paragraph 2(a)(i), and, where
the outer packaging of the
feasible, to its immediate
medicinal product;
packaging;
62
(g) the maker ensures that the
Deleted (Moved to new row 72a)
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 (d) the maker complies with the
requirements of paragraph 4.
requirements of
paragraph 4.
requirements of paragraph 4.
and,
requirements of paragraph 4.
and,
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if applicable, of Article 12(2).
if applicable, of Article 12(2).
63a
(2a) The exception referred to in
paragraph 2 shall not apply to any
act or activity for import of
medicinal products, or parts
thereof, into the Union merely for
the purpose of repackaging and
re-exporting or storing.
63b
(2b) The information provided to
the certificate holder shall be 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.
(second phrase of row 60 of EP
text)
64
3. The information for the
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
purposes of paragraph 2(b) shall be
be as follows:
shall be treated in a strictly
be as follows:
as follows:
confidential manner by all
parties, shall be as follows:
65
(a) the name and address of the
(a) the name and address of the
(a) the name and address of the
(a) the name and address of the
maker;
maker;
maker;
maker;
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65a
(aa) an indication of whether the
making is for the purpose of
export, for the purpose of
storing, or for the purpose of
both export and storing;
66
(b) the address, or addresses, of
(b) the address, or addresses, of the (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 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
making
and if applicable, also the
Member State;
storage, is to take place in the
relevant Member State
where the
storing s to take place in
and the
relevant Member State
;
first related act prior to that
relevant Member State
where the
making is to take place;
first related act, if any, 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
(c) the number of the certificate
granted in the relevant Member
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 State
of making, and identification
product, by reference to the
of the 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
proprietary name used by the
holder of that certificate;
holder of that certificate;
holder of that
the number of the
holder of that
the number of the
certificate
granted in the
certificate
granted in the Member
Member State of the first related State of the first related act, if
act prior to that making;
any, prior to that making;
68
(d) the number of the
Deleted
(d)
(deleted)
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
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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
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)
(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
(f)
for medicinal products to be
intended third country or third
intended third country or third
reference number of the
exported to third countries, the
countries to which the product is to countries to which the product is to
marketing authorisation or
reference number of the
be exported.
be exported.
equivalent in each an indicative
marketing authorisation or
list of the intended third country
of equivalent in each an indicative
export or
, failing that, the name
list of the intended third country
of
of that third
country countries to
export or third countries to which
which the product is to be
the product is to be exported
or,
exported.
failing that, the name of that
third country, as soon as it is
publicly available.
71
4.
For the purposes of the
3a. Annex -I includes a
3a. For the purposes of
notification under point (b) of
standard form that shall be used notification to the competent
paragraph 2, the maker shall use
by makers for notifications to
authority under points (b) and
the standard form contained in
authorities under paragraph
(ba) of paragraph, the maker
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Annex -I to this Regulation.
2(b).
shall use the standard form
contained in Annex -Ia includes a
standard form that shall be used
by makers shall use for
notifications to authorities under
72
3b. Failure to comply with the
3b. Failure to comply with the
requirements of paragraph 3(f)
requirements of paragraph 3(f)
in respect of a third country
in respect of a third country shall
shall only affect exports to that
only affect exports to that
country, and such exports would country, and such exports would
thus not benefit from the
thus not benefit from the
exception.
exception.
72a
3c. The maker ensures that the
medicinal product made
pursuant to point (a)(i) of
paragraph 2 does not bear an
active unique identifier within
the meaning of Commission
Delegated Regulation (EU)
2016/161.
73
5.
The authorities of the
Deleted
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
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public.
74
4. The maker shall ensure, through
6.
The maker shall ensure,
4.
The maker shall ensure,
4.
The maker shall ensure,
appropriate means, that persons in through appropriate
and
through appropriate
and
through appropriate
and
a contractual relationship with the
documented means,
that persons
documented means, that persons
documented means,
that
any
maker who perform acts falling
in a contractual relationship with
any person in a contractual
person
in a contractual relationship
within paragraph 2(a)(ii) are fully
the maker who perform acts falling relationship with the maker who
with the maker who perform
s acts
informed and aware of the
within paragraph
2(a) are fully
perform
performs acts falling
falling within paragraph
2(a) are
following:
informed and aware of the
within paragraph 2(a)(ii) are
is
fully informed and aware of the
following:
fully informed and aware of the
following:
following:
75
(a) that those acts are subject to
(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;
the provisions of paragraph 2;
76
(b) that the placing on the
(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
market, import or re-import of the
product might infringe the
product
referred to in point (a)(i)
product
referred to in paragraph product
referred to in point (a)(i)
certificate referred to in that
of paragraph 2 might infringe
the
2(a)(i) might infringe the
of paragraph 2 or the placing on
paragraph where, and as long as,
certificate referred to in that
certificate referred to in that
the market of the product referred
that certificate applies.
paragraph
paragraph 1 where, and paragraph
2 where, and as long as,
to in point (a)(iii) of paragraph 2
as long as, that certificate applies.
that certificate applies.
might infringe the certificate
referred to in that paragraph
2 where, and 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
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 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
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
[OP: please insert the date of the
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that follows the month in which
the first day of the third month that 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
follows the month in which
the
published in the Official
amending Regulation is published
entry into force of this amending
entry into force of this amending
Journal)].’;
in the Official Journal)]
the entry
Regulation is published in the
Regulation is published in the
into force of this Regulation. It
Official Journal)].
Official Journal)].
shall also apply in the case of
From 1 July 202214, paragraph 2 From 1 July 2022, Paragraph 2,
certificates for which the basic
shall also apply to certificates
shall also apply, to certificates
patent expired on or after 1
that have been applied for
that have been applied for before
January 2021.
before the entry into force of this the entry into force of this
Regulation and that enter into
Regulation and that enter into
effect on or after the entry into
take effect on or after the entry
force of this Regulation.
into force of this Regulation
Paragraph 2 shall not apply to
Paragraph 2 shall only apply to
certificates that enter into effect
such certificates from 1 July
before the entry into force of this 20228.
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
(2) in Article 11, the following
paragraph is added:
paragraph is added:
paragraph is added:
paragraph is added
79
4. ‘The notification sent to an
4.
The notification sent to an
4.
‘The notification sent to an
4.
‘The notification sent to an
authority as referred to in Article
authority as
referred to in Article
authority as referred to in
authority as referred to in
4(2)(b) shall be published by that
4(2)(b)
9(1) of the relevant
Article 4(2)(b)
9(1) shall be
Article 4(2)(b)
9(1) shall be
8
Date to be replaced by the actual date of entry into force of the Regulation, plus 3 years.
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authority within 15 days of receipt
Member State shall
publish
published by that authority within
published by that authority within
of the notification.’;
without undue delay the
15 days
publish, as soon as
15 days
publish, as soon as
information listed in point (c) of
possible, the information listed
possible, the information listed in
Article 5(3).
The remaining
in Article 5(3), together with the Article 5(3), together with the
information notified under Article date of receipt of the notification
date of receipt of the notification
5 (3) shall not be published
by
that
of that information.
It shall also
of that information.
It shall also
the authority within 15 days of
publish, as soon as possible, any
publish, as soon as possible, any
receipt of the notification
or made changes to this information
changes to this information
available for inspection by the
notified in accordance with
notified in accordance with
public, but shall be provided by it, Article 5(2)(ba).’;
Article 5(2)(ba).’;
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
(2a) Article 12 is replaced by the
the following:
following:
81
‘Article 12 – Fees
‘Article 12 – Fees
82
1.
Member States may
1.
Member States may require
require that the certificate be
that the certificate be subject to
subject to the payment of annual the payment of annual fees.
fees.
2.
Member States may require
2.
Member States may
that the notifications referred to
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require that the notifications
in Article 5(2)(b) and (ba) be
referred to in Article 5(2)(b) and subject to the payment of a fee.’;
(ba) be subject to the payment of
a fee.’;
[Note to translators: Paragraph 1
corresponds to the existing Article
12 of Regulation 469/2009]
83
(3) the following Article is
(3) the following Article is
(3)
(4) the following Article is
(3) the following Article is
inserted:
inserted:
inserted:
inserted:
84
‘Article 21a – Evaluation
‘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
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),
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 and every five years thereafter, the
Commission shall carry out an
thereafter, the Commission shall
Commission shall carry out an
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
evaluation of Articles 4
5(2) to (4)
and 11 and present a report on the
manufacturing waiver pursuant
(4) and 11 and present a report on
and 11
in order to assess whether
main findings to the European
to Articles 4
5(2) to (4
6) and 11
as
the main findings to the European
the objectives of these provisions
Parliament, the Council and the
well as of the SPC system
Parliament, the Council and the
have been achieved, and present a
European Economic and Social
regarding the ability of generics
European Economic and Social
report on the main findings to the
Committee.’;
to enter the Union market and
Committee.’;
European Parliament, the Council
the access to medicines and
and the European Economic and
public health, and present a report
Social Committee.
In addition to
on the main findings to the
evaluating the impact of the
European Parliament, the Council
exception of making for the
and the European Economic and
purpose of export, special
Social Committee
. Special
account shall be taken of the
account shall be taken on the
effects of making for the purpose
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effects of stockpiling with a view
of storing with a view to ensuring
to Day1 entry into the Union
EU Day-one entry, on access to
market when a certificate lapses;’;
medicines and on public health
expenditure, and on whether the
period foreseen in point (a)(iii) of
Article 5(2) is sufficient to
achieve the objectives of this
provision, as well as taking into
account its impact on public
health.
86
(4) the Annex to this Regulation (4) the Annex
Annexes to this
(4)
(5) the Annex
Annexes to this (4) the Annex
Annexes to this
is inserted as Annex -I.
Regulation is
are inserted as
Regulation is
are inserted as
Regulation is
are inserted as
Annex -I
and -Ia.
Annex
-II and -I.
Annex
es -I and -I
a.
NOTE: Numbering of Annexes to
be checked by jurist linguists
87
Article 2 – Entry into force
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
This Regulation shall enter into
force on the twentieth day
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 following that of its publication in
the
Official Journal of the
the
Official Journal of the
the
Official Journal of the
the
Official Journal of the
European Union.
European Union.
European Union.
European Union
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89
This Regulation shall be binding in 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
its entirety and directly applicable
in all Member States.
in all Member States.
in all Member States:
in all Member States:
90
Done at Brussels,
Done at Brussels,
Done at Brussels,
Done at Brussels,
91
For the European Parliament
For the European Parliament
For the European Parliament
For the European Parliament
The President
The President
The President
The President
For the Council
For the Council
For the Council
For the Council
The President
The President
The President
The President
92
ANNEX -I
[see Council’s text, row 102]
(see row 102)
93
Standard form to be used by
[see Council’s text, row 103]
(see row 103)
makers for notifications under
point (b) of Article 5(2)
94
a. Name and address of the maker [see Council’s text, row 104]
(see row 104)
95
b. Address(es) of the premises
[see Council’s text, row 104]
(see 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]
(see row 104)
granted in the relevant Member
State, and identification of the
product, by reference to its
international non-proprietary
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name, if available;
97
d. Earliest intended start date of
[see Council’s text, row 104]
(see row 104)
making in the relevant Member
State
98
e. Indicative list of the third
[see Council’s text, row 104]
(see row 104)
country or third countries to
which the product is intended to
be exported
99
ANNEX
ANNEX - Ia
ANNEX
-II
ANNEX -I
100
Logo
Logo
Logo
Logo
101
This logo should appear in black This logo should appear in black
colour and of such size as to be
colour and of such size as to be
sufficiently visible.
sufficiently visible.
102
103
[see EP’s text, row 91]
ANNEX -I
ANNEX -Ia
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104
[see EP’s text, row 92]
Form for notification pursuant
Form for notification pursuant to
to Article 5(2)(b)
Article 5(2)(b) and (ba)
56
New notification
New notification
[see EP’s text, rows
93 to 97
]
Tick the
Tick the
appropriate box
Update of an
appropriate box
Update of an existing notification
existing
(a)
Purpose of
Export
105
notification
Storing
(a) Name and
…
making
Export and storing
address of the
maker
(aa) Name and
…
address of the
(b) Member State
Member
maker
where making is to
State of
…
Member
take place and
making:
(b) Member
State of
…
Member State
State where
making:
where first related
(Member
making is to take
act (if any) prior to
State of
…
place and
making is to take
first related
Member State
(Member
place
act (if any))
where first
related act (if
State of first
…
(c) Number of
Certificate
any) prior to
related act (if
any))
certificate granted
of Member
…
making is to take
in the Member
State of
place
State of making
making
Certificate of
and number of
(c) Number of
Member
certificate granted
(Certificate
certificate
…
State of
in Member State
of Member
granted in the
…
making
of first related act
State of
Member State of
(if any) prior to
first related
making and
making
act (if any))
number of
certificate
(Certificate
(d)* (deleted)
granted in
of Member
…
Member State of
State of first
(e)* (deleted)
first related act
related act (if
any))
(f) for medicinal
…
(if any) prior to
products,
making
reference number
(d)* (deleted)
of marketing
authorisation or
…
(e)* (deleted)
equivalent in each
third country of
(f) for medicinal
…
export, or name of
products to be
…
third country of
exported to third
export
countries,
reference
…
[
*points (d) and (e) of Article 5(3) have
number of
been deleted; however, for ease of
reference in the neogotiations, the
57
numbering of paragraphs, both in the
marketing
…
form above and in Article 5, is retained,
authorisation or
but will be adjusted before adoption of
equivalent in
the Regulation. In addition, the current
each third
points (a) to (f) will be re-numbered at
country of export
the jurists-linguists stage (i.e. meaning
[
*points (d) and (e) of Article 5(3) have
that current point (f) will become point
been deleted; however, for ease of
(d)). These changes will also be carried
reference in the neogotiations, the
through in Article.]
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.]
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Document Outline
