Council of the
European Union
Brussels, 16 January 2019
(OR. en)
5411/19
Interinstitutional File:
2018/0161(COD)
PI 12
CODEC 114
COMPET 41
PHARM 2
IA 10
NOTE
From:
General Secretariat of the Council
To:
Delegations
No. prev. doc.:
5130//19
No. Cion doc.:
9485/18 + ADD1 + ADD2 + ADD3 + ADD 4
Subject:
Proposal for a Regulation amending Regulation (EC) No 469/2009
concerning the supplementary protection certificate for medical products
- Mandate for negotiations with the European Parliament
Delegations will find attached the mandate for negotiations with the European Parliament on the
above-mentioned proposal as approved by the Permanent Representatives Committee on
16 January 2019.
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ANNEX
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114
thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the ordinary legislative procedure,
1 OJ C , , p. .
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Whereas:
(1) Regulation (EC) No 469/2009 of the European Parliament and of the Council2 provides that
any product protected by a patent in the territory of a Member State and subject, prior to being
placed on the market as a medicinal product, to an administrative authorisation procedure as
laid down in Directive 2001/83/EC of the European Parliament and of the Council3 or
Directive 2001/82/EC of the European Parliament and of the Council4, may be the subject of a
supplementary protection certificate under the terms and conditions provided for in
Regulation (EC) No 469/2009.
(2) By providing for a period of supplementary protection of up to five years, Regulation (EC)
No 469/2009 seeks to promote, within the Union, the research and innovation that is
necessary to develop medicinal products, and to contribute to preventing the relocation of
pharmaceutical research outside the Union to countries that may offer greater protection.
(3) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have
evolved significantly and there has been huge growth in the manufacture of generics and
especially of biosimilars, in particular in countries outside the EU (‘third countries’) where
protection does not exist or has expired.
(4) The absence of any exception in Regulation (EC) No 469/2009 to the protection conferred by
a supplementary protection certificate has had the unintended consequence of preventing
makers of generics and biosimilars established in the Union from making in the Union, even
for the exclusive purpose of exporting to third country markets in which protection does not
exist or has expired. A further unintended consequence is that the protection conferred by the
certificate makes it more difficult for those makers to enter the Union market immediately
after expiry of the certificate, given that they are not in a position to build up production
capacity until the protection provided by the certificate has lapsed, by contrast with makers
located in third countries where protection does not exist or has expired.
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).
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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(5) This puts makers of generics and biosimilars established in the Union at a significant
competitive disadvantage compared with makers based in third countries that offer less or no
protection.
(6) Without any intervention, the viability of makers of generics and biosimilars established in
the Union could be under threat, with consequences for the Union’s pharmaceutical industrial
base as a whole.
(7) The aim of this Regulation is to promote the competitiveness of the Union, enhancing growth
and job creation in the internal market and contributing to a wider supply of products under
uniform conditions, by allowing makers of generics and biosimilars established in the Union
to make in the Union medicinal products or products for the exclusive purpose of export to
third country markets where protection does not exist or has expired, thus also helping these
makers to compete effectively in those third country markets. It should also complement the
efforts of the Union’s trade policy to ensure open markets for Union-based makers of
medicinal products or products. Over time, the Regulation should benefit the entire
pharmaceutical sector in the Union, by allowing all players, including newcomers, to reap the
benefits of the new opportunities opening up in the fast-changing global pharmaceutical
market. Furthermore, the common interest in the Union would be promoted as, through the
reinforcement of Union-based supply chains for medicines, medicines would become more
accessible to patients in the Union after the expiry of the certificate.
(8) In these specific and limited circumstances, and in order to create a level playing field
between Union-based makers and third country makers, it is appropriate to restrict the
protection conferred by a certificate so as to allow making for the exclusive purpose of export
to third countries and any related acts in the Union strictly necessary for making or for the
actual export itself, where such acts would otherwise require the consent of a certificate
holder (‘related acts’). For instance, such acts may include the possession, supply, import, or
making of products for the purpose of making a medicinal product containing that product, or
temporary storage of the product or advertising for the exclusive purpose of export to third
country destinations. The exception should also apply to related acts performed by third
parties who are in a contractual relationship with the maker.
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(9) This exception should apply to a product, or a medicinal product containing that product,
protected by a certificate. It should cover the making of the product protected by a certificate
in the territory of a Member State and the making of the medicinal product containing that
product.
(10) The exception should not cover placing the product or medicinal product containing that
product, made for the exclusive purpose of export, on the market in the Member State where a
certificate is in force, either directly, or indirectly after export, nor should it cover re-
importation of the product to the market of a Member State in which a certificate is in force.
Moreover, it should not cover any act or activity for the purpose of import of products or
medicinal products into the Union merely for the purposes of repackaging and re-exporting. It
should not cover temporary storage of the product or medicinal product containing that
product for any purposes other than those set out in this Regulation.
(11) By limiting the scope of the exception to making for the purpose of export outside the Union
and acts strictly necessary for such making or for the actual export itself, the exception
introduced by this Regulation should not conflict with the normal exploitation of the product
or medicinal product containing that product in the Member State where the certificate is in
force, namely with the core exclusive right of the certificate holder to make that product for
the purpose of placing it on the Union market during the term of the certificate. In addition,
the exception should not unreasonably prejudice the legitimate interests of the certificate
holder, taking account of the legitimate interests of third parties.
(12) Safeguards should accompany the exception in order to increase transparency, to help the
holder of a certificate to enforce its protection in the Union and to reduce the risk of illicit
diversion onto the Union market during the term of the certificate.
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(13) To this end, this Regulation should impose an information obligation on the maker, namely
the person established in the Union, on whose behalf the making of a product or medicinal
product containing that product for the exclusive purpose of export is done (this includes the
possibility of the person itself directly doing the making). Namely, the maker should provide
certain information to the authority which granted the certificate in the Member State where
the making is to take place. A common notification form should be provided for this purpose.
The information should be provided before the making starts for the first time in that Member
State, or before any related act prior to that making, whichever is the earlier. It should be
updated as and when appropriate. The making and related acts, including those performed in
Member States other than the one of making in cases where the product is protected by a
certificate in those other Member States too, should only fall within the scope of the exception
where the maker has sent this notification to the competent industrial property authority (or
other designated authority) of the Member State of making and has informed the holder of the
certificate granted in that Member State. Should making take place in more than one Member
State, a notification should be required in each of these Member States. In the interests of
transparency, the authority should be required to publish, as soon as possible, the information
it receives, together with the date of notification of that information. Member States should be
allowed to require that notifications, and updates to notifications, be subject to the payment of
a once-off fee. This fee should be set at a level which does not exceed the administrative cost
of processing notifications and updates.
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(13a) The maker should also inform the certificate holder, through appropriate and documented
means, of the intention to make a product or medicinal product containing that product
pursuant to the exception, by providing the certificate holder with the same information as
notified to the authority. That information is limited to what is necessary and appropriate for
the certificate holder to assess whether the rights conferred by the certificate are being
respected, and does not include confidential or commercially sensitive information. The
information to the certificate holder may be provided by making use of the same common
notification form, and the information provided should be updated as and when appropriate.
(13b) Regarding related acts prior to the making, if any, the notification should list the name of the
Member State where the first related act, which would otherwise require the consent of a
certificate holder, is to take place, as this information is relevant to the timing of the
notification.
(13c) If the local marketing authorisation, or equivalent, in a specific third country, for a given
medicinal product, is published after the notification is made, the notifcation should be
promptly updated to include the reference number of that marketing authorisation, at the latest
before the actual export of the medicinal product to that third country takes place. If a
marketing authorisation or equivalent mechansim applies, but the reference number of the
granted authorisation is not published or is pending publication, the maker should be required
to provide, in the notification, either that reference number or the name of the third country of
export. As a failsafe, if no marketing authorisation or equivalent applies in that country, the
maker should then be required to provide, in the interests of transparency, the name of the
third country of export.
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(13d) For reasons of proportionality, failure to comply with these requirements regarding a third
country would only affect exports to that country, and exports to such third country would
thus not benefit from the exception. It should be the responsibility of the maker established in
the Union to verify that protection does not exist or has expired in a country of export, subject
to any limitations or exemptions in that country. A notification to an authority and the
corresponding information to the certificate holder may be provided during the period
between the entry into force of the Regulation and the date on which the exception itself
becomes applicable.
(14) In addition, this Regulation should impose certain due diligence requirements on the maker as
a condition for the exception to operate. The maker should be required to inform persons
within its supply chain in the Union, including the exporter, through appropriate and
documented means, in particular contractual means, that the product or medicinal product
containing that product is covered by the exception introduced by this Regulation and is
intended for the exclusive purpose of export. A maker who failed to comply with these due
diligence requirements would not benefit from the exception, nor would any third party
performing a related act in the same or a different Member State where a certificate conferring
protection for the product was in force, and the holder of the relevant certificate would
therefore be entitled to enforce its rights under the certificate, while paying due regard to the
general obligation, set out in Directive 2004/48/EC of the European Parliament and of the
Council5, not to engage in abusive litigation.
(15) Furthermore, this Regulation should impose labelling requirements on the maker, in order to
facilitate, by means of a logo, identification of the product or medicinal product containing
that product as being exclusively intended for the purpose of export to third countries. The
making and related acts should only fall outside the protection conferred by a certificate if the
product or medicinal product containing that product is labelled in this manner. This labelling
obligation would be without prejudice to labelling requirements of third countries.
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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(16) Any act not covered by the exception introduced by this Regulation will remain within the
scope of the protection conferred by a certificate. Any illicit diversion onto the Union market,
during the term of the certificate, of any product or medicinal product containing that product
made within the terms of the exception, will remain prohibited.
(17) This Regulation is without prejudice to the respect of other intellectual property rights that
may protect other aspects of a medicinal product. This Regulation does not affect the
application of Union measures that aim to prevent infringements and facilitate enforcement of
intellectual property rights, including Directive 2004/48/EC and Regulation (EU) No
608/2013 of the European Parliament and of the Council6. Furthermore, this Regulation does
not affect the rules on the unique identifier provided for by Directive 2001/83/EC of the
European Parliament and of the Council and by Commission Delegated Regulation (EU)
2016/161. According to Directive 2001/83/EC, medicinal products produced exclusively for
export do not need to bear unique identifiers.
(18) This Regulation does not affect the application of Directives 2001/83/EC and 2001/82/EC, in
particular the requirements related to the manufacturing authorisation of medicinal products
manufactured for export. This includes compliance with the principles and guidelines of good
manufacturing practices for medicinal products and the use of active substances that have
been manufactured in accordance with good manufacturing practices for active substances
and distributed in accordance with good distribution practices for active substances.
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).
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(19) To safeguard the rights of certificate holders, the exception should not apply to a certificate
that has already entered into effect at the date of entry into force of the Regulation. In order to
ensure that the rights of certificate holders are not excessively restricted, the exception
provided for in this Regulation should apply to certificates that are applied for on or after the
day of the entry into force of this Regulation. At the same time, in order to safeguard the aim
of this Regulation, and since a certificate enters into effect a relatively long time after its date
of filing, it is justified to bring within the scope of the Regulation, over a certain period of
time, a certificate that was applied for before the entry into force of this Regulation, but has
not yet entered into effect before that entry into force, and irrespective of whether or not that
certificate has been granted before the entry into force of the Regulation. Therefore, the
exception should apply, as from 1 July 2022, to a certificate that enters into effect as from that
entry into force. This ‘certain period of time’ for each individual certificate that enters into
effect after that entry into force should ensure that the exception is applied, on a progressive
basis, to such a certificate, depending on its date of entry into effect and its duration. Such
application of the exception would allow the holder of a granted certificate that is not yet in
effect by the date of the entry into force of the Regulation a reasonable period of transition to
adapt to the changed legal context, while at the same time ensuring that makers of generics
and biosimilars can benefit effectively, without excessive delay, from the exception.
(19a) An applicant for a certificate might be expected to file an application at around the same date
in each Member State of filing. However due to differences in national procedures for
examination of applications, the date of grant might vary significantly from one Member State
to another, thereby creating disparities in the legal situation of the applicant in the different
Member States where the certificate is applied for. Introducing the exception on the basis of
the date of filing of the application for a certificate would therefore promote uniformity and
limit this risk of disparities.
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(20) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22
of the Interinstitutional Agreement between the European Parliament, the Council of the
European Union and the European Commission on Better Law-Making of 13 April 20167,
that evaluation should be based on the five criteria of effectiveness, efficiency, relevance,
coherence and added value and should provide the basis for impact assessments of possible
further measures. The evaluation should take into account exports to outside the Union and
the ability of generics and especially biosimilars to enter markets in the Union as soon as
possible after a certificate lapses. In particular, this evaluation should review the effectiveness
of the exception in the light of the aim to restore a global level playing field for generic and
biosimilar firms in the Union and a swifter entry of generic and especially biosimilar
medicines onto the market after a certificate lapses. It should also study the impact of the
exception on research and production of innovative medicines in the Union by holders of
certificates and consider the balance between the different interests at stake, including those
of public health.
(21) It is necessary and appropriate for the achievement of the basic objective, of providing a level
playing field for makers of generic and biosimilar with their competitors in third country
markets where protection does not exist or has expired, to lay down rules restricting the
exclusive right of a certificate holder to make the product in question during the term of the
certificate, and also to impose certain information and labelling obligations on makers
wishing to take advantage of those rules
. This Regulation complies with the principle of
proportionality, and does not go beyond what is necessary in order to achieve the objectives
pursued, in accordance with Article 5(4) of the Treaty on European Union.
7 OJ L 123, 12.5.2016, p. 1.
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(22) This Regulation respects fundamental rights and observes the principles recognised by the
Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to
ensure full respect for the right to property in Article 17 of the Charter by maintaining the
core rights of the certificate, by confining the exception provided for in this Regulation to the
making of a product or a medicinal product containing that product only for the purpose of
export outside the Union and to the acts strictly necessary for such making or for the actual
export itself. This exception does not go beyond what is necessary and appropriate in the light
of the overall objective of this Regulation, which is to promote the competitiveness of the
Union by avoiding delocalisations and allowing Union-based makers of generics and
biosimilars to compete on fast-growing, global markets where protection does not exist or has
already expired. Indeed, it is necessary to benefit from those positive economic effects arising
from the exception, as otherwise the Union would risk substantially weakening its position as
a hub for pharmaceutical development and manufacturing. It is therefore appropriate to
introduce that exception in order to increase the competitive position of Union-based makers
of generics and biosimilars in third countries whose markets are in any event open to
competition, whilst leaving the scope and duration of the protection granted by the certificate
in the Union untouched. The appropriateness of the measure is further ensured by providing
for appropriate safeguards regulating the use of the exception. The Regulation should allow
sufficient time for public authorities to put in place the necessary arrangements to receive and
publish notifications,
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HAVE ADOPTED THIS REGULATION:
Article 1 – Amendment of Regulation (EC) No 469/2009
Regulation (EC) No 469/2009 is amended as follows:
(0) in Article 1, the following point is added:
‘(f) ‘maker’ means the person established in the Union on whose behalf the making of a
product or a medicinal product containing that product, for the exclusive purpose of
export to third countries, is done;’
(1) Article 5 is replaced by the following:
‘Article 5 – Effects of the certificate
1.
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred
by the basic patent and shall be subject to the same limitations and the same obligations.
2.
By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not
confer protection against a particular act which would otherwise require the consent of the
holder of the certificate referred to in Article 11 (‘the certificate holder’) if the following
conditions are met:
(a) the act comprises:
(i)
making a product or a medicinal product containing that product, for the
exclusive purpose of export to third countries; or
(ii) any related act that is strictly necessary for that making in the Union or for
the actual export itself;
(b) the maker, through appropriate and documented means, notifies the authority
referred to in Article 9(1) of the Member State where that making is to take place
and informs the certificate holder of the information listed in paragraph 3 no later
than three months before the start date of making in that Member State, or no later
than three months before the first related act prior to that making that would
otherwise be prohibited by the protection conferred by a certificate, whichever is
the earlier;
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(ba) if the information listed in paragraph 3 changes, the maker shall notify the
authority referred to in Article 9(1) and shall inform the certificate holder, before
these changes take effect;
(c) the maker ensures that a logo, in the form set out in Annex -II, is affixed to the
outer packaging of the product or of the medicinal product containing that
product, referred to in paragraph 2(a)(i), and, where feasible, to its immediate
packaging;
(d) the maker complies with the requirements of paragraph 4 and, if applicable, of
Article 12(2).
3.
The information for the purposes of paragraph 2(b) shall be as follows:
(a) the name and address of the maker;
(b) the Member State where the making is to take place and the Member State where
the
first
related act prior to that making is to take place;
(c) the number of the certificate granted in the Member State of making, and the
number of the certificate granted in the Member State of the
first
related act prior
to that making;
(d) (deleted)
(e) (deleted)
(f)
for medicinal products, the reference number of the marketing authorisation or
equivalent in each third country of export or, failing that, the name of that third
country.
3a. Annex -I includes a standard form that shall be used by makers for notifications to authorities
under paragraph 2(b).
3b. Failure to comply with the requirements of paragraph 3(f) in respect of a third country shall
only affect exports to that country, and such exports would thus not benefit from the
exception.
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4.
The maker shall ensure, through appropriate and documented means, that any person in a
contractual relationship with the maker who performs acts falling within paragraph 2(a) is
fully informed and aware of the following:
(a) that those acts are subject to the provisions of paragraph 2;
(b) that the placing on the market, import or re-import of the product referred to in
paragraph 2(a)(i) might infringe the certificate referred to in paragraph 2 where,
and as long as, that certificate applies.
5.
Paragraph 2 shall apply to certificates that are applied for on or after the entry into force of
this Regulation.
From 1 July 20228, paragraph 2 shall also apply to certificates that have been applied for
before the entry into force of this Regulation and that enter into effect on or after the entry
into force of this Regulation.
Paragraph 2 shall not apply to certificates that enter into effect before the entry into force of
this Regulation.’;
(2) in Article 11, the following paragraph is added:
4.
‘The authority referred to in Article 9(1) shall publish, as soon as possible, the information
listed in Article 5(3), together with the date of notification of that information. It shall also
publish, as soon as possible, any changes to this information notified in accordance with
Article 5(2)(ba).’;
8
Date to be replaced by the actual date of entry into force of the Regulation, plus 3 years.
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(3) Article 12 is replaced by the following:
‘Article 12 –
Fees
1.
Member States may require that the certificate be subject to the payment of annual fees.
2.
Member States may require that the notifications referred to in Article 5(2)(b) and (ba) be
subject to the payment of a fee.’;
(4) the following Article is inserted:
‘Article 21a – Evaluation
No later than five years after the date referred to in Article 5(5), and every five years thereafter,
the Commission shall carry out an evaluation of Articles 5(2) to (4) and 11 and present a report
on the main findings to the European Parliament, the Council and the European Economic and
Social Committee.’;
(5) the Annexes to this Regulation are inserted as Annex –II and –I.
Article 2 – Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament
For the Council
The President
The President
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ANNEX -II
Logo
This logo should appear in black colour and of such size as to be sufficiently visible.
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ANNEX -I
Form for notification pursuant to Article 5(2)(b)
Tick the appropriate box
New notification
Update of an existing notification
(a) Name and address of the maker
…
(b) Member State where making is to take place and
Member State of
…
Member State where first
related act (if any) prior to
making:
making is to take place
(Member State of
first related act (if
…
any))
(c) Number of certificate granted in the Member
Certificate of
State of making and number of certificate granted in
Member State of
…
Member State of first
related act (if any) prior to
making
making
(Certificate of
Member State of
…
first related act (if
any))
(d)*
(deleted)
(e)*
(deleted)
(f) for medicinal products, reference number of
…
marketing authorisation or equivalent in each third
country of export, or name of third country of export
…
…
*points (d) and (e) of Article 5(3) have been deleted; however, for ease of reference in the neogotiations, the
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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