Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2023/0129(COD)**

**INFORMATION NOTE**

**Brussels, 3 July 2024**
**(OR. en)**

**10634/24**

**CODEC 1423**
**PI 83**
**PHARM 87**
**COMPET 753**
**MI 666**
**IND 348**
**PE 158**

From: General Secretariat of the Council

To: Permanent Representatives Committee/Council

Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on compulsory licensing for crisis management and
amending Regulation (EC) 816/2006

          - Outcome of the European Parliament's first reading
(Strasbourg, 11 to 14 March 2024)

**I.** **INTRODUCTION**

The rapporteur, Adrián VÁZQUEZ LÁZARA (RE, ES), presented a report on the above proposal

for a Regulation on behalf of the Committee on Legal Affairs (JURI) which contained 98

amendments (amendments 1 to 98) to the proposal.

In addition, the Greens/EFA group tabled one amendment (amendment 99) and the Committee on

International Trade (INTA) tabled nine amendments (amendments 100 to 108).

10634/24 LL/ec 1

# GIP.INST EN

**II.** **VOTE**

When it voted on 13 March 2024, the plenary of the European Parliament adopted amendments 1 to

98 to the proposal for a Regulation. No other amendments were adopted.

The Commission's proposal as thus amended constitutes the Parliament's first-reading position

which is contained in its legislative resolution as set out in the Annex hereto.

10634/24 LL/ec 2

# GIP.INST EN

**ANNEX**

**(13.3.2024)**

## **P9_TA(2024)0143** **Compulsory licensing for crisis management and amending Regulation (EC)** **816/2006**

**European Parliament legislative resolution of 13 March 2024 on the proposal for a regulation**
**of the European Parliament and of the Council on compulsory licensing for crisis**
**management and amending Regulation (EC) 816/2006 (COM(2023)0224 – C9-0151/2023 –**
**2023/0129(COD))**

**(Ordinary legislative procedure: first reading)**

_The European Parliament_,

–
having regard to the Commission proposal to Parliament and the Council (COM(2023)0224)),

–
having regard to Article 294(2) and Articles 114 and 207 of the Treaty on the Functioning of
the European Union, pursuant to which the Commission submitted the proposal to Parliament
(C9-0151/2023),

–
having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–
having regard to the opinion of European Economic and Social Committee of 27 September
2023 **[1]**,

–
having regard to Rule 59 of its Rules of Procedure,

–
having regard to the opinion of the Committee on International Trade,

–
having regard to the report of the Committee on Legal Affairs (A9-0042/2024),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially
amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national
parliaments.

**1** OJ C, C/2023/865, 08.12.2023, ELI: http://data.europa.eu/eli/C/2023/865/oj.

10634/24 LL/ec 3

# ANNEX GIP.INST EN

**Amendment 1**

**Proposal for a regulation**
**Recital 1**

_Text proposed by the Commission_ _Amendment_
(1) Crises require the setting-up of (1) Crises require the setting-up of
exceptional, swift, _**and**_ adequate measures exceptional, swift, adequate _**and**_
able to provide means to address the _**proportionate**_ measures able to provide
consequences of the crisis. In this context, means to address the consequences of the
the use of patented products or processes crisis _**, without unnecessarily and**_
could prove indispensable to address the _**disproportionally affecting the rights of**_
consequences of a crisis. Voluntary _**citizens or the protection of intellectual**_
licensing agreements usually suffice to _**property rights of businesses**_ . In this
licence the patent rights on these products context, the use of patented products or
and allow their supply in the Union processes could prove indispensable to
territory. Voluntary agreements are the address the consequences of a crisis.
most adequate, quick, and efficient solution Voluntary licensing agreements usually
to allow the use of patented products _**,**_ suffice to licence the patent rights on these
_**including**_ in crises. Nevertheless, products and allow their supply in the
voluntary agreements may not always be Union territory. Voluntary agreements are
available or only under inadequate the most adequate, quick, and efficient
conditions such as lengthy delivery times. solution to allow the use of patented
In such cases, compulsory licensing can products _**and to scale up production**_ in
provide a solution to allow access to crises. Nevertheless, voluntary agreements
patented products, in particular products may not always be available or only under
necessary to tackle the consequences of a inadequate conditions such as lengthy
crisis. delivery times. In such cases, compulsory

licensing can provide a solution to allow
access to patented products, in particular
products necessary to tackle the
consequences of a crisis.

10634/24 LL/ec 4

# ANNEX GIP.INST EN

**Amendment 2**

**Proposal for a regulation**
**Recital 2**

_Text proposed by the Commission_ _Amendment_
(2) In the context of the _**Union**_ crisis or (2) In the context of the crisis or
emergency mechanisms, the Union should emergency mechanisms _**having a cross-**_
therefore have the possibility to rely on _**border effect in the Union and involving**_
compulsory licensing. The activation of a _**two or more Member States**_, the Union
crisis or an emergency mode or the should therefore have the possibility to rely
declaration of a crisis or a state of on compulsory licensing _**to adequately**_
emergency addresses obstacles to free _**respond to the needs commanded by the**_
movement of goods, services, and persons _**public interest**_ . The activation of a crisis or
in crises and shortages of crisis-relevant an emergency mode or the declaration of a
goods and services. In cases where access crisis or a state of emergency addresses
to crisis-relevant products and processes obstacles to free movement of goods,
protected by a patent cannot be achieved services, and persons in crises and
through voluntary cooperation, compulsory shortages of crisis-relevant goods and
licensing can help in lifting any patent- services. In cases where access to crisis
related barriers and thus ensure the supply relevant products and processes protected
of products or services needed to confront by a patent cannot be achieved through
an ongoing crisis or emergency. It is voluntary cooperation, compulsory
therefore important that, in the context of licensing can help in lifting any patentsaid crisis mechanisms, the Union can rely related barriers and thus ensure the supply
on an efficient and effective compulsory of products or services needed to confront
licensing scheme at Union level, which is an ongoing crisis or emergency. It is
uniformly applicable within the Union. therefore important that, in the context of
This would guarantee a functioning said crisis mechanisms, the Union can rely
internal market, ensuring the supply and on an efficient and effective compulsory
the free movement of crisis-critical licensing scheme at Union level, which is
products subject to compulsory licencing in uniformly applicable within the Union.
the internal market. This would guarantee a functioning

internal market, ensuring the supply and
the free movement of crisis-critical
products subject to compulsory licencing in
the internal market.

10634/24 LL/ec 5

# ANNEX GIP.INST EN

**Amendment 3**

**Proposal for a regulation**
**Recital 5**

_Text proposed by the Commission_ _Amendment_
(5) National compulsory licensing (5) National compulsory licensing
systems only operate within the national systems only operate within the national
territory. They are designed to meet the territory. They are designed to meet the
needs of the population of the issuing needs of the population of the issuing
Member State and to satisfy the public Member State and to satisfy the public
interest of that Member State. This limited interest of that Member State. This limited
territorial reach of a national compulsory territorial reach of a national compulsory
licensing system is reinforced by the fact licensing system is reinforced by the fact
that there is no exhaustion of the patent that there is no exhaustion of the patent
right regarding products manufactured right regarding products manufactured
under a compulsory licence. Consequently, under a compulsory licence. Consequently,
compulsory licensing schemes do not compulsory licensing schemes do not
provide an adequate solution for cross- provide an adequate solution for crossborder manufacturing processes, and border manufacturing processes, and
therefore there is no functioning internal therefore there is no functioning internal
market for product manufactured under a market for product manufactured under a
compulsory licence. Apart from the fact compulsory licence. Apart from the fact
that the issuance of multiple national that the issuance of multiple national
compulsory licences is a high hurdle for compulsory licences is a high hurdle for
cross-border supply within the single cross-border supply within the single
market, it also bears the risk of market, it also bears the risk of
contradicting and incoherent decisions contradicting and incoherent decisions
among Member States. Consequently, the among Member States. Consequently, the
current compulsory licensing framework current compulsory licensing framework
appears inadequate to address the realities appears inadequate to address the realities
of the internal market and its inherent of the internal market and its inherent
cross-border supply chains. This cross-border supply chains. This
suboptimal compulsory licensing suboptimal compulsory licensing
framework prevents the Union from framework prevents the Union from
relying on an additional instrument when relying on an additional instrument when
facing crises _**, in particular**_ when voluntary facing crises _**and**_ when voluntary
agreements are unavailable _**or inadequate**_ . agreements are unavailable _**and cannot be**_
At a time where the Union and its Member _**reached within four weeks**_ . At a time
States are striving to improve their where the Union and its Member States are
resilience to crises, it is necessary to striving to improve their resilience to
provide for an optimal compulsory crises, it is necessary to provide for an
licensing system for crisis management optimal compulsory licensing system for
that takes the full advantage of the internal crisis management that takes the full
market and allows Member States to advantage of the internal market and
support one another in crises. allows Member States to support one

another in crises.

10634/24 LL/ec 6

# ANNEX GIP.INST EN

**Amendment 4**

**Proposal for a regulation**
**Recital 6 a (new)**

_Text proposed by the Commission_ _Amendment_
_**(6a)**_ _**The Commission might only issue a**_
_**Union compulsory license for a crisis**_
_**emergency-related product where the**_
_**rights holder, who has been given the**_
_**opportunity to engage in negotiations with**_
_**a potential licensee, did not reach an**_
_**agreement within 4 weeks.**_

**Amendment 5**

**Proposal for a regulation**
**Recital 15**

_Text proposed by the Commission_ _Amendment_
(15) In order to ensure as much coherence (15) In order to ensure as much coherence
as possible with existing crisis mechanisms as possible with existing crisis mechanisms
and with other Union legislation, the _**and their requirements pertaining to the**_
definition of a ‘crisis-relevant product’ _**public interest**_ and with other Union

                                                      
should be based on the definition adopted legislation, the definition of a ‘crisis
in the Single Market Emergency relevant product’ should be based on the
Instrument (SMEI) but should be more definition adopted in the Single Market
general in order to cover products related Emergency Instrument (SMEI) but should
to different kinds of crises or emergencies. be more general in order to cover products

related to different kinds of crises or
emergencies.

10634/24 LL/ec 7

# ANNEX GIP.INST EN

**Amendment 6**

**Proposal for a regulation**
**Recital 16**

_Text proposed by the Commission_ _Amendment_
(16) A Union compulsory licence (16) A Union compulsory licence
authorises the use of a protected invention authorises the use of a protected invention
without the consent of the rights-holder. without the consent of the rights-holder.
Therefore, it must only be granted Therefore, it must only be granted
exceptionally and under conditions that exceptionally _**with the purpose of**_
take into account the interests of the rights- _**safeguarding the public interest, as a last**_
holder. This includes a clear determination _**resort mechanism,**_ and under conditions
of the scope, duration and territorial that take into account the interests of the
coverage of the licence. In the context of a rights-holder. This includes a clear
Union level crisis mechanism, the crisis determination of the scope, duration and
mode or emergency mode is activated or territorial coverage of the licence which are
declared for a limited period of time. _**strictly in line with the duration of the**_
Where a Union compulsory licence is _**crisis and the purpose for which the**_
granted within such framework, the _**compulsory licence was granted**_ . In the
duration of the licence shall not extend context of a Union level crisis mechanism,
beyond the duration of the activated or the crisis mode or emergency mode is
declared crisis or emergency mode. In activated or declared for a limited period of
order to ensure that the compulsory licence time. Where a Union compulsory licence is
fulfils its objective as well as its granted within such framework, the
conditions, the use of the invention should duration of the licence shall not extend
only be authorised to a qualified person beyond the duration of the activated or
able to manufacture the crisis-relevant declared crisis or emergency mode _**and in**_
product and to pay a reasonable _**principle should not exceed 12 months,**_
remuneration to the rights-holder. _**unless a renewal is necessary due to the**_

_**continued existence of the circumstances**_
_**that had led to the granting of the licence.**_
In order to ensure that the compulsory
licence fulfils its objective as well as its
conditions, the use of the invention should
only be authorised to a qualified person
able to manufacture the crisis-relevant
product and to pay a reasonable
remuneration to the rights-holder.

10634/24 LL/ec 8

# ANNEX GIP.INST EN

**Amendment 7**

**Proposal for a regulation**
**Recital 18**

_Text proposed by the Commission_ _Amendment_
(18) The participation of an advisory body (18) The participation of an advisory body
aims at guaranteeing a comprehensive, aims at guaranteeing a comprehensive,
thorough, and concrete assessment of the thorough, and concrete assessment of the
situation, taking into consideration the situation, taking into consideration the
individual merits of each situation. It is individual merits of each situation. It is
therefore important that the advisory body therefore important that the advisory body
has the right composition, expertise, and has the right composition, expertise, and
procedures to support the Commission procedures to support the Commission
when deciding on whether to grant a Union when deciding on whether to grant a Union
compulsory licence and under what compulsory licence and under what
conditions. Union crisis mechanisms conditions. Union crisis mechanisms
usually include the setting-up of an usually include the setting-up of an
advisory body ensuring coordination of advisory body ensuring coordination of
action of the Commission and relevant action of the Commission and relevant
bodies and agencies, the Council and the bodies and agencies, the Council and the
Member States. In this respect, an advisory Member States. In this respect, an advisory
group is set up under SMEI. Regulation group is set up under SMEI. Regulation
(EU) No 2022/2371 provides for a Health (EU) No 2022/2371 provides for a Health
Crisis Board and under Regulation (EU) Crisis Board and under Regulation (EU)
No XXX/XX (Chips Act) [COM/2022) No XXX/XX (Chips Act) [COM/2022)
46], the Commission relies on the 46], the Commission relies on the
Semiconductor Board. Those advisory Semiconductor Board. Those advisory
bodies have the right composition, bodies have the right composition,
expertise, and procedures to address the expertise, and procedures to address the
crises and emergencies for which they have crises and emergencies for which they have
been set-up. When compulsory licensing is been set-up. When compulsory licensing is
being discussed in the context of such being discussed in the context of such
crisis instrument, relying on the advisory crisis instrument, relying on the advisory
body set-up for the specific instrument body set-up for the specific instrument
allows the Commission to be adequately allows the Commission to be adequately
advised and avoid duplication of advisory advised and avoid duplication of advisory
bodies, leading to incoherences between bodies, leading to incoherences between
processes. The competent advisory bodies processes. The competent advisory bodies
_**shall**_ be listed, together with the _**should**_ be listed, together with the
corresponding crisis mechanisms, in an corresponding crisis mechanisms, in an
Annex to this Regulation. In case the Annex to this Regulation. _**The**_
Union crisis mechanism does not provide _**Commission should ensure that**_
for an advisory body, the _**Commission**_ _**representatives of other crisis-relevant**_
_**should set up an ad hoc**_ advisory body _**for**_ _**bodies at Union level participate in, and**_
_**the granting**_ of the _**Union (the ‘ad hoc**_ _**are invited as observers to, the relevant**_
_**advisory body’)**_ . _**meetings of the advisory body in order to**_

_**ensure consistency with the measures**_
_**implemented through other Union**_
_**mechanisms. It is important that the**_
_**Commission invites as observers national**_

10634/24 LL/ec 9

# ANNEX GIP.INST EN

_**representatives from all national**_
_**authorities responsible for issuing**_
_**compulsory licenses under their national**_
_**patent laws.**_ In case the Union crisis
mechanism does not provide for an
advisory body, the advisory body _**should**_
_**be constituted on an ad-hoc basis by the**_
_**Commission and should be composed of**_
_**representatives**_ of the _**institutions and**_
_**bodies of the Member States that exercise**_
_**the competence to grant national**_
_**compulsory licences under national laws**_ .

**Amendment 8**

**Proposal for a regulation**
**Recital 19**

_Text proposed by the Commission_ _Amendment_
(19) The role of the advisory body is to (19) The role of the advisory body is to
advise the Commission when discussions advise the Commission when discussions
arise on the need to rely on compulsory arise on the need to rely on compulsory
licensing at Union level. It should provide licensing at Union level. It should provide
the Commission with a non-binding the Commission with a non-binding
opinion. Its main tasks include assisting of opinion. Its main tasks include assisting of
the Commission in the determination of the the Commission in the determination of the
necessity to rely on compulsory licensing necessity to rely on compulsory licensing
at Union level, and in the determination of at Union level, and in the determination of
the conditions for such licensing. When the the conditions for such licensing. When the
advisory body is already set up, its existing advisory body is already set up, its existing
rules of procedure should apply. As regards rules of procedure should apply. As regards
ad hoc advisory bodies, they should be ad hoc advisory bodies, they should be
composed of _**one representative of each**_ composed of _**those representatives of**_
_**Member State**_ in order to provide the _**national competent authorities**_ in order to
Commission with information and input provide the Commission with information
concerning the situation on the national and input concerning the situation on the
level, including information on national level, including information on
manufacturing capacities, potential manufacturing capacities, potential
licensees and _**, if applicable,**_ proposals for licensees and proposals for voluntary
voluntary solutions. In addition, the solutions. In addition, the advisory body
advisory body should have the function of should have the function of collecting and
collecting and analysing relevant data, as analysing relevant data, as well as ensuring
well as ensuring coherence and cooperation coherence and cooperation with other crisis
with other crisis relevant bodies at Union relevant bodies at Union and national level
and national level in order to ensure an in order to ensure an adequate, coordinated
adequate, coordinated and coherent crisis and coherent crisis reply at Union level.
reply at Union level.

10634/24 LL/ec 10

# ANNEX GIP.INST EN

**Amendment 9**

**Proposal for a regulation**
**Recital 20**

_Text proposed by the Commission_ _Amendment_
(20) The Commission should grant the (20) The Commission should grant the
Union compulsory licence in the light of Union compulsory licence in the light of
the non-binding opinion of the advisory the non-binding opinion of the advisory
body. Persons, in particular the licensee body. Persons, in particular the licensee
and the rights-holder, whose interests may and the rights-holder, whose interests may
be affected by the Union compulsory be affected by the Union compulsory
licence should be given the opportunity to licence should be given the opportunity to
submit their comments. These elements submit their comments _**, within a**_
should enable the Commission to consider _**reasonable timeframe, to the advisory**_
the individual merits of the situation and _**body upon receiving the case file and**_
determine, on that basis, the adequate _**analyses presented to or conducted by the**_
conditions of the licence, including an _**advisory body, and be provided with any**_
adequate remuneration to be paid by the _**other pertinent information they require**_
licensee to the rights-holder. To avoid _**for their evaluation of the potential**_
overproduction of products manufactured _**repercussions of a proposed Union**_
under a Union compulsory licence, the _**compulsory license on their intellectual**_
Commission should also consider any _**property rights**_ . These elements should
existing compulsory licences at national enable the Commission to consider the
level. individual merits of the situation and

determine, on that basis, the adequate
conditions of the licence, including an
adequate remuneration to be paid by the
licensee to the rights-holder. To avoid
overproduction of products manufactured
under a Union compulsory licence, the
Commission should also consider any
existing compulsory licences at national
level.

10634/24 LL/ec 11

# ANNEX GIP.INST EN

**Amendment 10**

**Proposal for a regulation**
**Recital 21**

_Text proposed by the Commission_ _Amendment_
(21) The Commission should guarantee (21) The Commission should guarantee
that the rights-holder has the right to be that the rights-holder has the right to be
heard before the adoption of the Union heard before the adoption of the Union
compulsory licence. Therefore, the compulsory licence. Therefore, the
Commission should inform the concerned Commission should inform the concerned
rights-holder, _**where possible**_ individually, rights-holder, individually, without undue
without undue delay that a Union delay that a Union compulsory licence
compulsory licence might be granted. The might be granted. The involvement of the
involvement of the rights-holder should be rights-holder should be possible once there
possible once there are ongoing advanced are ongoing advanced discussions in the
discussions in the relevant advisory body relevant advisory body as regards the
as regards the granting of a Union granting of a Union compulsory licence.
compulsory licence.

10634/24 LL/ec 12

# ANNEX GIP.INST EN

**Amendment 11**

**Proposal for a regulation**
**Recital 22**

_Text proposed by the Commission_ _Amendment_
(22) _**When informed of advanced**_ (22) _**Considering that voluntary**_
_**discussions as regards**_ the granting of a _**agreements are the most suitable way to**_
Union compulsory licence, the rights- _**deal with patented products or processes**_
holder _**should have the possibility to**_ _**in a time of crisis, prior to any decision by**_
_**propose a voluntary**_ agreement _**,**_ should _**the**_ _**the Commission on**_ the granting of a
_**circumstances of the Union crisis or**_ Union compulsory licence, the rights_**emergency, including**_ the urgency of the holder _**should be provided with a**_
situation _**, allow it**_ . The rights-holder should _**reasonable opportunity to negotiate such**_
also be given the opportunity to comment _**an**_ agreement _**. A time period of four weeks**_
on the need for a Union compulsory should _**be sufficient to enable good faith**_
licence and on the conditions of the _**and meaningful negotiations, taking into**_
licence, including remuneration, should it _**account**_ the urgency of the situation. The
be granted. To this end, the rights-holder rights-holder should also be given the
should be allowed to provide the opportunity to comment on the need for a
Commission with written or oral comments Union compulsory licence and on the
and any information the rights-holder conditions of the licence, including
considers useful to allow the Commission remuneration, should it be granted. To this
to make a fair, comprehensive, and end, the rights-holder should be allowed to
thorough assessment of the situation. The provide the Commission with written or
Commission should allow the rights-holder oral comments and any information the
a reasonable period of time to provide rights-holder considers useful to allow the
comments and information, considering the Commission to make a fair,
situation of the rights-holder _**and**_ the comprehensive, and thorough assessment
urgency of the situation. The comments of of the situation. The Commission should
the rights-holder should, where relevant, be allow the rights-holder a reasonable period
transmitted by the Commission to the of time to provide comments and
competent advisory body. In order for information, considering the _**balance to be**_
confidential information to be shared with _**struck between the public interest and the**_
the Commission, the Commission shall situation of the rights-holder _**, and**_
ensure a safe environment for the sharing _**considering**_ the urgency of the situation.
of this information and should take The comments of the rights-holder should,
measures to preserve the confidentiality of where relevant, be transmitted by the
the documents provided by the rights- Commission to the competent advisory
holder in the context of that procedure. body _**on a timely basis**_ . In order for
Once a Union compulsory licence has been confidential information to be shared with
granted, the Commission should notify the the Commission, the Commission shall
rights-holder as soon as reasonably ensure a safe environment for the sharing
practicable. of this information and should take

measures to preserve the confidentiality of
the documents provided by the rightsholder in the context of that procedure.
Once a Union compulsory licence has been
granted, the Commission should notify the
rights-holder as soon as reasonably
practicable.

10634/24 LL/ec 13

# ANNEX GIP.INST EN

**Amendment 12**

**Proposal for a regulation**
**Recital 23**

_Text proposed by the Commission_ _Amendment_
(23) The initiation of _**the**_ compulsory (23) The initiation of _**any**_ compulsory
licensing procedure should be publicised _**,**_ licensing procedure should _**first involve the**_
by means of a notice published in the _**identification of the intellectual property**_
Official Journal of the European Union. _**rights concerned, the rights-holders**_
_**This notice should include information on**_ _**concerned, as well as potential licensees,**_
_**the discussions about the granting of a**_ _**with the involvement of the**_ _**national**_
_**Union compulsory licence in the context**_ _**authorities responsible for issuing**_
_**of a Union crisis or emergency**_ _**compulsory licenses under their national**_
_**mechanism**_ . _**This notice should also help**_ _**patent laws. It should**_ be publicised by
_**the Commission in identifying the**_ means of a notice published in the Official
_**intellectual property rights concerned, the**_ Journal of the European Union. .
_**rights-holders concerned as well as**_
_**potential licensees.**_

10634/24 LL/ec 14

# ANNEX GIP.INST EN

**Amendment 13**

**Proposal for a regulation**
**Recital 24**

_Text proposed by the Commission_ _Amendment_
(24) The Commission should, assisted by (24) The Commission should, assisted by
the advisory body, _**make its best efforts to**_ the advisory body, identify in its decision
identify in its decision the patent, patent the patent, patent application,
application, supplementary protection supplementary protection certificate and
certificate and utility model related to the utility model related to the crisis-relevant
crisis-relevant products, and the rights- products, and the rights-holders of those
holders of those intellectual property intellectual property rights. In certain
rights. In certain circumstances, the circumstances, the identification of
identification of intellectual property rights intellectual property rights and of their
and of their respective rights-holders may respective rights-holders may require
require lengthy and complex lengthy and complex investigations. _**The**_
investigations. _**In such cases, a complete**_ Commission should identify all applicable
_**identification of all intellectual property**_ and relevant intellectual property rights and
_**rights and of their rights-holders may**_ their rights-holder _**before granting the**_
_**seriously undermine the efficient use of**_ _**compulsory licence. The**_ implementing act
_**the Union compulsory licence to swiftly**_ should identify any necessary safeguards
_**tackle the crisis or the emergency.**_ and remuneration to be paid to each
_**Therefore, where the identification of all**_ identified rights-holder.
_**those intellectual property rights or rights-**_
_**holders would significantly delay the**_
_**granting of the Union compulsory licence,**_
_**the**_ Commission should _**be able to initially**_
_**only indicate in the licence the non-**_
_**proprietary name of the product for which**_
_**it is sought. The Commission should**_
_**nevertheless**_ identify all applicable and
relevant intellectual property rights and
their rights-holder _**as soon as possible and**_
_**amend the implementing act accordingly.**_
_**The amended**_ implementing act should
_**also**_ identify any necessary safeguards and
remuneration to be paid to each identified
rights-holder.

10634/24 LL/ec 15

# ANNEX GIP.INST EN

**Amendment 14**

**Proposal for a regulation**
**Recital 25**

_Text proposed by the Commission_ _Amendment_
(25) Where the rights-holder or not all the (25) Where the rights-holder or not all the
rights-holders could be identified in a rights-holders could be identified in a
reasonable period of time, the Commission reasonable period of time, the Commission
should _**exceptionally be entitled to**_ grant should _**not**_ grant the Union compulsory
the Union compulsory licence _**by referring**_ licence.
_**only to the non-proprietary name of the**_
_**crisis-relevant product where it is**_
_**absolutely necessary considering the**_
_**urgency of the situation**_ . _**Nevertheless,**_
_**after the granting of the Union**_
_**compulsory licence, the Commission**_
_**should identify, notify and consult the**_
_**concerned rights-holders as quickly as**_
_**possible, including by relying on**_
_**publication measures and on national**_
_**Intellectual Property Offices.**_

10634/24 LL/ec 16

# ANNEX GIP.INST EN

**Amendment 15**

**Proposal for a regulation**
**Recital 27**

_Text proposed by the Commission_ _Amendment_
(27) The licensee should pay an adequate (27) The licensee should pay an adequate
remuneration to the rights-holder as remuneration to the rights-holder as
determined by the Commission. The determined by the Commission. The
amount of the remuneration should be amount of the remuneration should be
determined considering the economic value determined considering _**the total gross**_
of the exploitation authorised under the _**revenue generated by the licensee from**_
licence to the licensee and to the Member _**the pertinent activities governed by the**_
States concerned by the crisis, any public _**Union compulsory licence,**_ the economic
support received by the rights-holder to value of the exploitation authorised under
develop the invention, the degree to which the licence to the licensee and to the
development costs have been amortized as Member States concerned by the crisis, any
well as humanitarian circumstances public support received by the rightsrelating to the granting of the Union holder to develop the invention, the degree
compulsory licence. _**In addition, the**_ to which development costs have been
Commission should consider the comments amortized as well as humanitarian
made by the rights-holder and the circumstances relating to the granting of
assessment made by the advisory body the Union compulsory licence. _**The**_
with regard to the amount of the Commission should _**also**_ consider the
remuneration. _**In any case, the**_ comments made by the rights-holder and
_**remuneration should not exceed 4 % of**_ the assessment made by the advisory body
_**the total gross revenue generated by the**_ with regard to the amount of the
_**licensee through the acts under the Union**_ remuneration.
_**compulsory licence. This percentage is the**_
_**same as the one provided for under**_
_**Regulation 816/2006. In the event of a**_
_**compulsory licence granted on the basis**_
_**of a published patent application that**_
_**ultimately does not lead to the granting of**_
_**a patent, the rights-holder would have no**_
_**ground to receive remuneration under the**_
_**compulsory licence, as the subject matter**_
_**for the receipt of the remuneration has**_
_**not materialised. In such circumstances,**_
_**the rights-holder should refund the**_
_**remuneration it received under the**_

_**compulsory licence.**_

10634/24 LL/ec 17

# ANNEX GIP.INST EN

**Amendment 16**

**Proposal for a regulation**
**Recital 32 a (new)**

_Text proposed by the Commission_ _Amendment_
_**(32a)**_ _**Where appropriate, the Commission should**_
_**oblige the rights-holder to disclose the trade**_
_**secrets which are strictly necessary in order to**_
_**achieve the purpose of the Union compulsory**_
_**licence. In such cases, rights holders should**_
_**receive an adequate remuneration. It is possible**_
_**that a detailed description of how to carry out the**_
_**invention might not be sufficient and complete**_
_**enough to enable the licensee to efficiently use**_
_**that invention. This could encompass, without**_
_**being exhaustively limited to, the comprehensive**_
_**transfer of necessary technology, expertise, data,**_
_**samples, and reference products essential for**_
_**production and obtaining market authorisation in**_
_**collaboration with the licensee, taking into**_
_**account both the rights-holder and the licensee’s**_
_**interests. In cases where that additional**_

_**information and know-how is necessary, some of**_
_**which is an undisclosed trade secret, the disclosure**_
_**of that necessary trade secret, with a view to only**_
_**achieving the purpose of exercising the Union**_
_**compulsory licence pursuant to this Regulation,**_
_**should be considered to be lawful within the**_
_**meaning of Article 3(2) and Article 5 of Directive**_
_**(EU) 2016/943 of the European Parliament and**_
_**the Council. While this Regulation requires the**_
_**disclosure of trade secrets only when they are**_
_**strictly necessary in order to achieve the purpose**_
_**of the Union compulsory licence, it should be**_
_**interpreted in such a manner as to preserve the**_
_**protection afforded to trade secrets under Directive**_
_**(EU) 2016/943. The Commission should require**_
_**the licensee(s) to put in place all appropriate**_
_**measures reasonably identified by the rights-**_
_**holder, including contractual, technical and**_
_**organisational measures, to ensure the**_
_**confidentiality of trade secrets, in particular vis-à-**_
_**vis third parties and the protection of the**_
_**legitimate interests of all parties. To that end, right**_
_**holders should identify trade secrets prior to the**_
_**disclosure. Those appropriate measures may**_
_**consist of model contractual terms, confidentiality**_
_**agreements, strict access protocols, technical**_
_**standards and the application of codes of conduct.**_
_**Where the licensee fails to implement the**_

10634/24 LL/ec 18

# ANNEX GIP.INST EN

_**measures required for preserving the**_
_**confidentiality of the trade secrets, the**_
_**Commission should be able to withhold or suspend**_
_**the disclosure of trade secrets until the situation is**_
_**corrected by the licensee. Any use, acquisition or**_
_**disclosure of trade secrets which would not be**_
_**necessary to fulfil the objective of the Union**_
_**compulsory licence or which would go beyond the**_
_**duration of the Union compulsory license should**_
_**be considered to be unlawful within the meaning**_
_**of that Directive.**_

**Amendment 17**

**Proposal for a regulation**
**Recital 32 b (new)**

_Text proposed by the Commission_ _Amendment_
_**(32b)**_ _**This Regulation should guarantee**_
_**that the Commission has the authority to**_
_**oblige rights-holders to provide all**_
_**necessary information to facilitate the**_
_**rapid and efficient production of critical**_
_**crisis-related products, such as**_
_**pharmaceuticals and other health-related**_
_**items. This information should encompass**_
_**details about know-how, particularly**_
_**when it is essential for the effective**_
_**implementation of compulsory licensing.**_
_**While patent licensing alone might suffice**_
_**to enable other manufacturers to quickly**_
_**produce simple pharmaceuticals, in case**_
_**of more intricate pharmaceutical**_
_**products, such as vaccines during a**_
_**pandemic, it is often insufficient. Where it**_
_**is essential for the implementation of the**_
_**compulsory licence, an alternative**_
_**producer will also require access to know-**_
_**how.**_

10634/24 LL/ec 19

# ANNEX GIP.INST EN

**Amendment 18**

**Proposal for a regulation**
**Recital 33**

_Text proposed by the Commission_ _Amendment_
(33) In order to respond appropriately to (33) In order to respond appropriately to
the crisis situations, the Commission the crisis situations, the Commission
should be authorised to review the should be authorised to review the
conditions of the Union compulsory conditions of the Union compulsory
licence and adapt them to changed licence and adapt them to changed
circumstances. This should include the circumstances. This should include the
modification of the compulsory licence to modification of the compulsory licence to
indicate the complete list of rights and indicate the complete list of rights and
rights-holders covered by the compulsory rights-holders covered by the compulsory
licence _**, where this complete identification**_ licence. This should also include the
_**had not be done initially**_ . This should also termination of the licence if the
include the termination of the licence if the circumstances which led to it cease to exist
circumstances which led to it cease to exist and are unlikely to recur. When deciding
and are unlikely to recur. When deciding on the revision of the Union compulsory
on the revision of the Union compulsory licence, the Commission _**should**_ consult
licence, the Commission _**may decide to**_ the competent advisory body for that
consult the competent advisory body for purpose _**, as well as the rights-holders and**_
that purpose. If the Commission intends to _**licensees**_ . If the Commission intends to
change essential components of the Union change essential components of the Union
compulsory licence, such as its duration or compulsory licence, such as its duration or
remuneration or if the change itself could remuneration or if the change itself could
be the subject of a separate compulsory be the subject of a separate compulsory
licence, it should be required to consult the licence, it should be required to consult the
advisory body. advisory body.

**Amendment 19**

**Proposal for a regulation**
**Recital 34**

_Text proposed by the Commission_ _Amendment_
(34) To prevent and stop any misuse of (34) To prevent and stop any misuse of
the Union compulsory licence, specific the Union compulsory licence, specific
safeguards should be in place to allow the safeguards should be in place to allow the
Commission to take action. In addition to Commission to take action. In addition to
the possibility to terminate the Union the possibility to terminate the Union
compulsory licence, the Commission compulsory licence, the Commission
should be authorised to impose fines and should be authorised to impose fines and
periodic penalty payments on the rights- periodic penalty payments on the rightsholder and the licensee in order to enforce holder and the licensee in order to enforce
the obligations under this Regulation. The the obligations under this Regulation. The
penalties should be effective, proportionate penalties should be effective, proportionate
and dissuasive. and dissuasive _**, and should not contravene**_

_**the usual enforcement measures of**_
_**intellectual property rights as provided by**_
_**Directive 2004/48/EC**_ .

10634/24 LL/ec 20

# ANNEX GIP.INST EN

**Amendment 20**

**Proposal for a regulation**
**Recital 35**

_Text proposed by the Commission_ _Amendment_
(35) Compliance with the relevant (35) Compliance with the relevant
obligations imposed under this Regulation obligations imposed under this Regulation
should be enforceable by means of fines should be enforceable by means of fines
and periodic penalty payments. To that and periodic penalty payments. To that
end, appropriate levels of fines and end, appropriate levels of fines and
periodic penalty payments should be laid periodic penalty payments should be laid
down and the imposition of fines and down and the imposition of fines and
periodic penalty payments should be periodic penalty payments should be
subject to appropriate limitation periods in subject to appropriate limitation periods in
accordance with the principles of accordance with the principles of
proportionality and ne bis in idem. All proportionality and ne bis in idem. All
decisions taken by the Commission under decisions taken by the Commission under
this Regulation are subject to review by the this Regulation are subject to review by the
Court of Justice of the European Union in Court of Justice of the European Union in
accordance with the TFEU. The Court of accordance with the TFEU. The Court of
Justice of the European Union should have Justice of the European Union should have
unlimited jurisdiction in respect of fines unlimited jurisdiction in respect of _**the**_
and penalty payments in accordance with _**implementing act granting the**_
Article 261 TFEU. _**compulsory licence, as well as the**_

_**decisions on**_ fines and penalty payments in
accordance with Article 261 TFEU.

10634/24 LL/ec 21

# ANNEX GIP.INST EN

**Amendment 21**

**Proposal for a regulation**
**Proposal for a regulation**
**Recital 37**

_Text proposed by the Commission_ _Amendment_
(37) The possibility of a compulsory (37) The possibility of a compulsory
licence at Union level should not only be licence at Union level should not only be
available for the supply of the Union available for the supply of the Union
market but also _**under certain conditions**_ market but also for export purposes
for export purposes concerning countries concerning countries with public health
with public health problems, already problems, already regulated by Regulation
regulated by Regulation (EC) No 816/2006 (EC) No 816/2006 of the European
of the European Parliament and of the Parliament and of the Council [11] . Under that
Council [11] . Under that Regulation, the Regulation, the granting of such
granting of such compulsory licences is compulsory licences is decided and
decided and performed nationally by the performed nationally by the competent
competent authorities of the Member States authorities of the Member States that have
that have received a corresponding received a corresponding application from
application from a person that intends to a person that intends to manufacture and
manufacture and sell pharmaceutical sell pharmaceutical products covered by a
products covered by a patent or a patent or a supplementary protection for
supplementary protection for export to export to eligible third countries.
eligible third countries. Regulation (EC) Regulation (EC) No 816/2006 only allows
No 816/2006 only allows compulsory compulsory licensing covering the
licensing covering the manufacturing of manufacturing of products across several
products across several Member States Member States through national
through national procedures. In the context procedures. In the context of a cross-border
of a cross-border manufacturing process manufacturing process different national
different national compulsory licences compulsory licences would be needed.
would be needed. This can lead to a This can lead to a burdensome and lengthy
burdensome and lengthy process as this process as this would require the launch of
would require the launch of different different national procedures with possibly
national procedures with possibly different different scope and conditions. In order to
scope and conditions. In order to achieve achieve the synergies and efficient process
the synergies and efficient process as for as for the Union crisis mechanisms, a
the Union crisis mechanisms, a Union Union compulsory licence should also be
compulsory licence should also be available, in the context of Regulation (EC)
available, in the context of Regulation (EC) No 816/2006. This _**should be further**_
No 816/2006. This will facilitate _**facilitated by reviewing the conditions for**_
manufacturing of the relevant products _**issuing compulsory licences for export, in**_
across several Member States and provide _**order to make them fully in line with the**_
Union-level solution in order to avoid a _**TRIPS Agreement and its full spectrum of**_
situation where several compulsory _**flexibilities. The Union compulsory**_
licences for the same product in more than _**licence**_ will facilitate _**the use of this**_
one Member States would be required for _**mechanism and all the**_ manufacturing of
licensees to manufacture and export the the relevant products across several
products as planned. Any person Member States and provide Union-level
considering to apply for a compulsory solution in order to avoid a situation where
licence _**under**_, for the purposes and within several compulsory licences for the same

10634/24 LL/ec 22

# ANNEX GIP.INST EN

the scope of Regulation (EC) No 816/2006
should have the possibility to request, with
a single application, a compulsory licence
under that Regulation that is valid
throughout the Union, if that person, when
relying on national compulsory licencing
schemes of the Member States, would
otherwise need to apply for multiple
compulsory licences for the same crisisrelevant product in more than one Member
State in order to realise its intended

activities of manufacture and sale for
export under Regulation (EC) No
816/2006. Therefore, Regulation (EC) No
816/2006 should be amended accordingly.

the scope of Regulation (EC) No 816/2006 product in more than one Member States
should have the possibility to request, with would be required for licensees to
a single application, a compulsory licence manufacture and export the products as
under that Regulation that is valid planned. Any person considering to apply
throughout the Union, if that person, when for a compulsory licence, for the purposes
relying on national compulsory licencing and within the scope of Regulation (EC)
schemes of the Member States, would No 816/2006 should have the possibility to
otherwise need to apply for multiple request, with a single application, a
compulsory licences for the same crisis- compulsory licence under that Regulation
relevant product in more than one Member that is valid throughout the Union, if that
State in order to realise its intended person, when relying on national
activities of manufacture and sale for compulsory licencing schemes of the
export under Regulation (EC) No Member States, would otherwise need to
816/2006. Therefore, Regulation (EC) No apply for multiple compulsory licences for
816/2006 should be amended accordingly. the same crisis-relevant product in more

than one Member State in order to realise

its intended activities of manufacture and
sale for export under Regulation (EC) No
816/2006. Therefore, Regulation (EC) No
816/2006 should be amended accordingly.

__________________ __________________
11 Regulation (EC) No 816/2006 of the 11 Regulation (EC) No 816/2006 of the
European Parliament and of the Council of European Parliament and of the Council of
17 May 2006 on compulsory licensing of 17 May 2006 on compulsory licensing of
patents relating to the manufacture of patents relating to the manufacture of
pharmaceutical products for export to pharmaceutical products for export to
countries with public health problems (OJ countries with public health problems (OJ
L 157, 9.6.2006, p. 1). L 157, 9.6.2006, p. 1).

11 Regulation (EC) No 816/2006 of the
European Parliament and of the Council of
17 May 2006 on compulsory licensing of
patents relating to the manufacture of
pharmaceutical products for export to
countries with public health problems (OJ
L 157, 9.6.2006, p. 1).

10634/24 LL/ec 23

# ANNEX GIP.INST EN

**Amendment 22**

**Proposal for a regulation**
**Recital 38**

_Text proposed by the Commission_ _Amendment_
(38) In order to ensure uniform conditions
for the implementation of this Regulation,
implementing powers should be conferred
on the Commission as regards the granting,
complementing, modification or complementing, modification or
termination of a Union compulsory license,
the determination of the remuneration to be the determination
paid to the rights-holder, the procedural
rules for the ad hoc advisory body and the _**the licensee,**_
characteristics allowing the identification
of products produced under a Union
compulsory licence. Those powers should
be exercised in accordance with Regulation
(EU) No 182/2011 of the European
Parliament and of the Council [12] . The
advisory procedure should be used for the
adoption of implementing acts granting, Parliament and of the Council
complementing, modifying or terminating
a Union compulsory licence, and
implementing acts determining the
remuneration. The choice of the advisory a Union compulsory licence, and
procedure is justified given that those implementing acts determining the
implementing acts would be adopted in the
context of a procedure with considerable
participation of the Member States through
the consultation of the advisory body. The
examination procedure should be used for
the adoption of implementing acts
establishing procedural rules for the ad hoc
advisory body and implementing acts the adoption of implementing acts
establishing the characteristics allowing the
identification of products produced under a
Union compulsory licence.

(38) In order to ensure uniform conditions (38) In order to ensure uniform conditions
for the implementation of this Regulation, for the implementation of this Regulation,
implementing powers should be conferred implementing powers should be conferred
on the Commission as regards the granting, on the Commission as regards the granting,
complementing, modification or complementing, modification or
termination of a Union compulsory license, termination of a Union compulsory license,
the determination of the remuneration to be the determination _**, in the absence of an**_
paid to the rights-holder, the procedural _**agreement between the rights-holder and**_
rules for the ad hoc advisory body and the _**the licensee,**_ of the remuneration to be paid
characteristics allowing the identification to the rights-holder, the procedural rules
of products produced under a Union for the ad hoc advisory body and the
compulsory licence. Those powers should characteristics allowing the identification
be exercised in accordance with Regulation of products produced under a Union
(EU) No 182/2011 of the European compulsory licence. Those powers should
Parliament and of the Council [12] . The be exercised in accordance with Regulation
advisory procedure should be used for the (EU) No 182/2011 of the European
adoption of implementing acts granting, Parliament and of the Council [12] . The
complementing, modifying or terminating advisory procedure should be used for the
a Union compulsory licence, and adoption of implementing acts granting,
implementing acts determining the complementing, modifying or terminating
remuneration. The choice of the advisory a Union compulsory licence, and
procedure is justified given that those implementing acts determining the
implementing acts would be adopted in the remuneration. The choice of the advisory
context of a procedure with considerable procedure is justified given that those
participation of the Member States through implementing acts would be adopted in the
the consultation of the advisory body. The context of a procedure with considerable
examination procedure should be used for participation of the Member States through
the adoption of implementing acts the consultation of the advisory body. The
establishing procedural rules for the ad hoc examination procedure should be used for
advisory body and implementing acts the adoption of implementing acts
establishing the characteristics allowing the establishing procedural rules for the ad hoc
identification of products produced under a advisory body and implementing acts
Union compulsory licence. establishing the characteristics allowing the

identification of products produced under a
Union compulsory licence.

_**_________________**_ 12 Regulation (EU) No 182/2011 of the _**_________________**_ 12 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of European Parliament and of the Council of
16 February 2011 laying down the rules 16 February 2011 laying down the rules
and general principles concerning and general principles concerning
mechanisms for control by the Member mechanisms for control by the Member
States of the Commission's exercise of States of the Commission's exercise of
implementing powers (OJ L 55, 28.2.2011, implementing powers (OJ L 55, 28.2.2011,
p. 13). p. 13).

12 Regulation (EU) No 182/2011 of the
European Parliament and of the Council of
16 February 2011 laying down the rules
and general principles concerning
mechanisms for control by the Member
States of the Commission's exercise of
implementing powers (OJ L 55, 28.2.2011,
p. 13).

10634/24 LL/ec 24

# ANNEX GIP.INST EN

**Amendment 23**

**Proposal for a regulation**
**Recital 40**

_Text proposed by the Commission_ _Amendment_
(40) Union compulsory licensing for crisis (40) Union compulsory licensing for crisis
management is a tool that is _**only**_ used in management is a _**last resort**_ tool that is
exceptional circumstances. The evaluation used in exceptional circumstances. The
should therefore be conducted only where evaluation should therefore be conducted
a Union compulsory licence has been only where a Union compulsory licence
granted by the Commission. The has been granted by the Commission. The
evaluation report should be submitted by evaluation report should be submitted by
the last day of the third year following the the last day of the third year following the
granting of the Union compulsory licence, granting of the Union compulsory licence,
to allow an adequate and substantiated to allow an adequate and substantiated
assessment of this Regulation. assessment of this Regulation.

**Amendment 24**

**Proposal for a regulation**
**Recital 40 a (new)**

_Text proposed by the Commission_ _Amendment_
_**(40a)**_ _**While the Annex is to be updated by**_
_**any future legislative act in relation to an**_
_**emergency or crisis mode, the**_
_**Commission should nevertheless monitor**_

_**the situation and assess whether the list in**_

_**the Annex has been properly updated. If it**_
_**appears that this list is no longer up-to-**_
_**date, the Commission should assess its**_
_**consequences. In any event, the**_
_**Commission should submit its assessment**_

_**to the European Parliament and the**_
_**Council accompanied, where appropriate,**_
_**by legislative proposals to amend the**_
_**Annex. Although the Commission should**_
_**carry out this assessment every two years**_
_**from the date of entry into force of this**_
_**Regulation, it is expected that, given the**_
_**rapid changes in current European and**_
_**global situation, the Commission should**_
_**carry out that assessment without undue**_
_**delay in the event of exceptional threats to**_
_**public safety or to national security.**_

10634/24 LL/ec 25

# ANNEX GIP.INST EN

**Amendment 25**

**Proposal for a regulation**
**Recital 41 a (new)**

_Text proposed by the Commission_ _Amendment_
_**(41a)**_ _**Since the objective of this**_
_**Regulation, namely to ensure access to**_
_**crisis-relevant patented products needed**_
_**to address crises in the internal market,**_
_**cannot be sufficiently achieved by the**_
_**Member States because of the**_
_**fragmentation of compulsory licensing in**_
_**the Union and the insufficient territorial**_
_**scope of national compulsory licensing**_
_**but can rather, by reason of the scale and**_
_**effects of the necessary solution, be better**_
_**achieved at Union level, the Union may**_
_**adopt measures, in accordance with the**_
_**principle of subsidiarity as set out in**_
_**Article 5 of the Treaty on European**_
_**Union. In accordance with the principle**_
_**of proportionality as set out in that**_
_**Article, this Regulation does not go**_
_**beyond what is necessary in order to**_
_**achieve those objectives.**_

10634/24 LL/ec 26

# ANNEX GIP.INST EN

**Amendment 26**

**Proposal for a regulation**
**Article 1 – paragraph 1**

_Text proposed by the Commission_ _Amendment_
This Regulation has the objective to ensure This Regulation has the objective to ensure
that _**in crises**_ the Union _**has access to**_ that _**a temporary and non-exclusive Union**_
_**crisis-relevant products**_ . _**To this end,**_ this _**compulsory license may be granted to**_
Regulation lays down rules on the _**protect the public interest in the context of**_
procedure and conditions for the granting _**cross-border crisis or emergency**_
of a Union compulsory licence of _**situations in**_ the Union. This Regulation
intellectual property rights that are lays down rules on the procedure and
necessary for the supply of crisis-relevant conditions for the granting _**as a last resort**_
products to the Member States in the of a Union compulsory licence of
context of a Union crisis or emergency intellectual property rights that are
mechanism. necessary for the supply of crisis-relevant

products to the Member States in the
context of a Union crisis or emergency
mechanism. _**To this end, if no prior**_
_**voluntary agreement has been reached**_
_**within four weeks between right holder**_
_**and licensee, the Commission may grant a**_
_**Union compulsory license.**_

**Amendment 27**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point -a (new)**

_Text proposed by the Commission_ _Amendment_
_**(-a)**_ _**‘crisis mode or emergency mode’**_
_**means a crisis mode or an emergency**_
_**mode, as applicable, listed in the Annex to**_
_**this Regulation, which has been activated**_
_**or declared in the context of a Union**_
_**crisis or emergency mechanism listed in**_
_**that Annex in accordance with one of the**_
_**Union acts listed therein;**_

10634/24 LL/ec 27

# ANNEX GIP.INST EN

**Amendment 28**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point a**

_Text proposed by the Commission_ _Amendment_
(a) ‘crisis-relevant products’ means (a) ‘crisis-relevant products’ means
products or processes that are products or processes that are
indispensable for responding to a crisis or indispensable for responding to a crisis or
emergency or for addressing the impacts of emergency or for addressing the impacts of
a crisis or emergency in the Union; a crisis or emergency in the Union _**and for**_

_**which the granting of a compulsory**_
_**license is the only means of ensuring the**_
_**sufficient and timely availability and**_
_**supply of such products or processes, as**_
_**determined by the Commission through**_
_**the guidance of the advisory body in**_
_**accordance with Article 6;**_

**Amendment 29**

**Proposal for a regulation**
**Article 4 – paragraph 1**

_Text proposed by the Commission_ _Amendment_
The Commission may grant a Union The Commission may grant a Union
compulsory licence _**where**_ a crisis mode or compulsory licence _**in the event of**_ a crisis
an emergency mode _**listed**_ in _**the**_ _**Annex to**_ mode or an emergency mode in _**case no**_
_**this Regulation**_ has been _**activated or**_ _**voluntary agreement with a view to**_
_**declared in accordance with one of the**_ _**ensuring the supply of crisis-relevant**_
_**Union acts listed in that Annex**_ . _**products**_ has been _**reached between right-**_

_**holder and the potential licensee within**_
_**four weeks**_ .

**Amendment 30**

**Proposal for a regulation**
**Article 5 – paragraph 1 – introductory part**

_Text proposed by the Commission_ _Amendment_
1. The Union compulsory licence shall 1. The Union compulsory license _**that**_
_**may be granted by the Commission in**_
_**accordance with Article 4**_ shall _**,**_
_**notwithstanding the obligations pursuant**_
_**to Article 10:**_

10634/24 LL/ec 28

# ANNEX GIP.INST EN

**Amendment 31**

**Proposal for a regulation**
**Article 5 – paragraph 1 – point b**

_Text proposed by the Commission_ _Amendment_
(b) have a scope _**and**_ duration that is (b) have a _**strict limitation concerning**_
_**limited to the**_ purpose for which the scope _**, field of use, necessary quantities,**_
compulsory licence is _**granted and limited**_ _**and a**_ duration that is _**fully in line with the**_
to the scope and duration of the crisis or _**specific**_ purpose for which the compulsory
emergency mode _**in the framework of**_ licence is _**issued, as well as strictly linked**_
which it is granted; to the scope and duration of the crisis or

emergency mode _**under**_ which it is granted
_**within the Union**_ ;

**Amendment 32**

**Proposal for a regulation**
**Article 5 – paragraph 1 – point c**

_Text proposed by the Commission_ _Amendment_
(c) be strictly limited to the relevant (c) be strictly limited to the relevant _**and**_
activities of crisis-relevant products in the _**properly justified**_ activities of crisisUnion; relevant products in the Union;

**Amendment 33**

**Proposal for a regulation**
**Article 5 – paragraph 1 – point d**

_Text proposed by the Commission_ _Amendment_
(d) only be granted against payment of (d) only be granted against payment of
an adequate remuneration to the rights- an adequate remuneration to the rightsholder; holder _**determined in accordance with**_

_**Article 9**_ ;
**Amendment 34**

**Proposal for a regulation**
**Article 5 – paragraph 1 – point e**

_Text proposed by the Commission_ _Amendment_
(e) be limited to the territory of the (e) be _**strictly**_ limited to the _**precisely**_
Union; _**defined**_ territory of the Union;

**Amendment 35**

**Proposal for a regulation**
**Article 5 – paragraph 1 – point f a (new)**

_Text proposed by the Commission_ _Amendment_
_**(fa)**_ _**clearly state that the licensee is**_
_**responsible for any liability or warranties**_
_**related to the production and distribution**_
_**of crisis-relevant products, excluding the**_
_**rights-holder from product liability**_
_**claims.**_

10634/24 LL/ec 29

# ANNEX GIP.INST EN

**Amendment 36**

**Proposal for a regulation**
**Article 6 – paragraph 2 – introductory part**

_Text proposed by the Commission_ _Amendment_
2. The advisory body referred to in 2. The advisory body referred to in
paragraph 1 shall be the advisory body paragraph 1 shall be the advisory body
competent for the Union crisis or competent for the Union crisis or
emergency mechanism as listed in Annex I emergency mechanism as listed in Annex I
to this Regulation (the ‘competent advisory to this Regulation (the ‘competent advisory
body’). For the purposes of the present body’). For the purposes of the present
Regulation, the competent advisory body Regulation, the competent advisory body _**,**_
shall assist and advise the Commission as _**which is to act in the public interest,**_ shall
regards the following tasks: assist and advise the Commission as

regards the following tasks:

**Amendment 37**

**Proposal for a regulation**
**Article 6 – paragraph 2 – point a a (new)**

_Text proposed by the Commission_ _Amendment_
_**(aa)**_ _**the assessment of whether the**_
_**obligation to give the rights-holder an**_
_**opportunity to engage in negotiations for**_
_**a voluntary agreement to be reached**_
_**within four weeks, laid down in Article 4,**_
_**has been complied with;**_

**Amendment 38**

**Proposal for a regulation**
**Article 6 – paragraph 2 – point b a (new)**

_Text proposed by the Commission_ _Amendment_
_**(ba)**_ _**the determination of crisis-relevant**_
_**products;**_

**Amendment 39**

**Proposal for a regulation**
**Article 6 – paragraph 2 – point f**

_Text proposed by the Commission_ _Amendment_
(f) the identification and consultation of (f) the identification and consultation of
the representatives of right holders or their the representatives of right holders or their
representatives as well as potential representatives as well as potential
licensees and consulting other economic licensees and consulting other _**stakeholders**_
operators, _**and the**_ industry; _**and**_ economic operators, _**including**_

industry _**, academia and civil society**_ ;

10634/24 LL/ec 30

# ANNEX GIP.INST EN

**Amendment 40**

**Proposal for a regulation**
**Article 6 – paragraph 4 – point a a (new)**

_Text proposed by the Commission_ _Amendment_
_**(aa)**_ _**shall invite representatives of the**_
_**European Parliament as observers to the**_
_**relevant meetings of the advisory bodies,**_
_**where possible under the applicable legal**_
_**acts referred to in Annex;**_

**Amendment 41**

**Proposal for a regulation**
**Article 6 – paragraph 4 – point b**

_Text proposed by the Commission_ _Amendment_
(b) may invite representatives of the (b) may invite representatives of the
_**European Parliament**_, representatives of _**national authorities responsible for**_
economic operators _**, right holders**_, _**issuing compulsory licences under**_
potential licensees, stakeholder _**national laws**_, representatives of economic
organisations, social partners and experts operators, potential licensees, stakeholder
to attend meetings of the advisory body as organisations, social partners and experts
observers. to attend meetings of the advisory body as

observers.

**Amendment 42**

**Proposal for a regulation**
**Article 6 – paragraph 5**

_Text proposed by the Commission_ _Amendment_
5. In the absence of any existing 5. In the absence of any existing
competent advisory body, the tasks competent advisory body, the tasks
referred to in paragraph 2 shall be referred to in paragraph 2 shall be
performed by an ad hoc advisory body set performed by an ad hoc advisory body set
up by the Commission (the ‘ad hoc up by the Commission (the ‘ad hoc
advisory body’). The Commission shall advisory body’). The Commission shall
chair the ad hoc advisory body and ensure chair the ad hoc advisory body and ensure
its secretariat. _**Each Member State shall**_ its secretariat. The ad hoc advisory body
_**have the right to be represented in**_ the ad _**shall be composed of representatives of**_
hoc advisory body. _**the institutions and bodies of each**_

_**Member State that exercise the**_

_**competence to grant national compulsory**_
_**licences under national law**_ .

10634/24 LL/ec 31

# ANNEX GIP.INST EN

**Amendment 43**

**Proposal for a regulation**
**Article 6 – paragraph 6**

_Text proposed by the Commission_ _Amendment_
6. The Commission shall adopt an 6. The Commission shall adopt an
implementing act laying down the rules of implementing act laying down the rules of
procedure for the ad hoc advisory body procedure for the ad hoc advisory body
referred to in paragraph 5. The rules of referred to in paragraph 5. The rules of
procedure shall specify that the ad hoc procedure shall specify that the ad hoc
advisory body shall not be set up for a advisory body shall not be set up for a
period exceeding the duration of the crisis period exceeding the duration of the crisis
or emergency. That implementing act shall or emergency. _**The rules of procedure**_
be adopted in accordance with the _**shall specify that the ad hoc advisory body**_
examination procedure referred to in _**shall enforce stringent safeguards to**_
Article 24 (3). _**avoid any potential conflicts of interest,**_

_**and to ensure accountability and**_
_**transparency.**_ That implementing act shall
be adopted in accordance with the
examination procedure referred to in
Article 24 (3).

**Amendment 44**

**Proposal for a regulation**
**Article 7 – paragraph 1 – point b a (new)**

_Text proposed by the Commission_ _Amendment_
_**(ba) the rights and interests of the rights-**_
_**holder and the potential licensee;**_

**Amendment 45**

**Proposal for a regulation**
**Article 7 – paragraph 1 – point b b (new)**

_Text proposed by the Commission_ _Amendment_
_**(bb)**_ _**existing national compulsory**_
_**licences reported to the Commission in**_
_**accordance with Article 22 in order to**_

_**avoid overlaps or a situation of**_
_**overproduction;**_

10634/24 LL/ec 32

# ANNEX GIP.INST EN

**Amendment 46**

**Proposal for a regulation**
**Article 7 – paragraph 2 a (new)**

_Text proposed by the Commission_ _Amendment_
_**2a.**_ _**The Commission shall take the**_

_**utmost account of the opinion of the**_
_**advisory body. Where the Commission**_
_**does not follow the opinion of the advisory**_
_**body, it shall explain the reasons for its**_
_**decision to the advisory body, without**_
_**prejudice to the Commission's powers**_
_**under paragraphs 7 and 8 of this Article.**_
**Amendment 47**

**Proposal for a regulation**
**Article 7 – paragraph 3 – introductory part**

_Text proposed by the Commission_ _Amendment_
3. Before _**the granting of a Union**_ 3. Before _**issuing the opinion, the**_
_**compulsory licence, the Commission**_ shall _**advisory body**_ shall give the rights-holder
give the rights-holder and the licensee an and the licensee an opportunity to
opportunity to comment on _**the following**_ : comment _**within a reasonable timeframe**_

on:

**Amendment 48**

**Proposal for a regulation**
**Article 7 – paragraph 3 – point a**

_Text proposed by the Commission_ _Amendment_
(a) the possibility to reach a voluntary (a) the possibility to _**promptly**_ reach a
licensing agreement with manufacturers on voluntary licensing agreement with
intellectual property rights for the purpose manufacturers on intellectual property
of manufacturing, using and distributing rights for the purpose of manufacturing,
the crisis-relevant products; using and distributing the crisis-relevant

products _**and the fulfilment of the**_
_**conditions referred to in Article 4(1a) for**_
_**conducting meaningful negotiations for**_
_**that purpose**_ ;
**Amendment 49**

**Proposal for a regulation**
**Article 7 – paragraph 4**

_Text proposed by the Commission_ _Amendment_
4. The Commission shall notify the 4. The Commission shall _**identify and**_
rights-holder and the licensee as soon as notify the rights-holder and the licensee as
possible of the fact that a Union soon as possible of the fact that a Union
compulsory licence may be granted. compulsory licence may be granted. The
_**Wherever the identification of the rights-**_ Commission shall notify _**the rights-holders**_
_**holders is possible and does not cause**_ individually.
_**significant delay,**_ the Commission shall
notify _**them**_ individually.

10634/24 LL/ec 33

# ANNEX GIP.INST EN

**Amendment 50**

**Proposal for a regulation**
**Article 7 – paragraph 6**

_Text proposed by the Commission_ _Amendment_
_**6.**_ _**When assessing whether a Union**_ _**deleted**_
_**compulsory licence is to be granted, the**_
_**Commission shall consider the following:**_

_**(a)**_ _**the opinion referred to in paragraph**_
_**2;**_

_**(b)**_ _**the rights and interests of the rights-**_
_**holder and the licensee;**_

_**(c)**_ _**existing national compulsory**_
_**licences reported to the Commission in**_
_**accordance with Article 22.**_

**Amendment 51**

**Proposal for a regulation**
**Article 8 – paragraph 1 – point a**

_Text proposed by the Commission_ _Amendment_
(a) the patent, patent application, (a) the patent, patent application,
supplementary protection certificate or supplementary protection certificate or
utility model for which the licence is utility model for which the licence is
granted _**or, where the identification of**_ granted;
_**those rights would significantly delay the**_
_**granting of the licence, the non-**_
_**proprietary name of the products which**_
_**are to be manufactured under the licence**_ ;

**Amendment 52**

**Proposal for a regulation**
**Article 8 – paragraph 1 – point b**

_Text proposed by the Commission_ _Amendment_
(b) the right-holder _**, provided they can**_ (b) the right-holder;
_**be identified with reasonable efforts**_
_**having regard to the circumstances,**_
_**including the urgency of the situation**_ ;

10634/24 LL/ec 34

# ANNEX GIP.INST EN

**Amendment 53**

**Proposal for a regulation**
**Article 8 – paragraph 1 – point h**

_Text proposed by the Commission_ _Amendment_
(h) measures complementing the (h) measures complementing the
compulsory licence, _**which are**_ necessary compulsory licence, _**as referred to in**_
to achieve the objective of the compulsory _**Article 13a, including, where strictly**_
licence. necessary to achieve the objective of the

compulsory licence _**, the obligation for the**_
_**rights-holder to disclose trade secrets to**_
_**the licensee when the conditions provided**_
_**for in Article 13a (2) and (3) are fulfilled**_ .

**Amendment 54**

**Proposal for a regulation**
**Article 9 – paragraph 1 a (new)**

_Text proposed by the Commission_ _Amendment_
_**1a.**_ _**The rights-holder shall receive the**_
_**remuneration within a pre-established**_
_**timeframe as agreed with the**_
_**Commission.**_

**Amendment 55**

**Proposal for a regulation**
**Article 9 – paragraph 2**

_Text proposed by the Commission_ _Amendment_
2. The remuneration shall _**not exceed 4**_ 2. The remuneration shall _**be**_
_**% of**_ total gross revenue generated by the _**determined based on the**_ total gross
licensee _**through the relevant**_ activities revenue generated by the licensee _**from the**_
_**under**_ the Union compulsory licence. _**pertinent**_ activities _**governed by**_ the Union

compulsory licence.

**Amendment 56**

**Proposal for a regulation**
**Article 9 – paragraph 3 – point d a (new)**

_Text proposed by the Commission_ _Amendment_
_**(da)**_ _**the possible disclosure of trade**_
_**secrets pursuant to Article 13a(2) and (3)**_
_**and the relevant limitations to the**_

_**protection of trade secrets according to**_
_**Directive (EU) 2016/94; that disclosure**_
_**shall give rise to adequate compensation**_
_**for the rights-holder.**_

10634/24 LL/ec 35

# ANNEX GIP.INST EN

**Amendment 57**

**Proposal for a regulation**
**Article 10 – paragraph 1 – subparagraph 1 – point a**

_Text proposed by the Commission_ _Amendment_
(a) the number of crisis-relevant (a) the number of crisis-relevant
products manufactured under the Union products manufactured under the Union
compulsory licence does not exceed what compulsory licence does not exceed _**the**_
is necessary to meet the needs of the _**defined quantities and**_ what is necessary to
Union; meet the needs of the Union;

**Amendment 58**

**Proposal for a regulation**
**Article 10 – paragraph 1 – subparagraph 1 – point c a (new)**

_Text proposed by the Commission_ _Amendment_
_**(ca)**_ _**a detailed account of the products**_
_**produced under the Union compulsory**_
_**licence;**_

**Amendment 59**

**Proposal for a regulation**
**Article 10 – paragraph 1 – subparagraph 1 – point c b (new)**

_Text proposed by the Commission_ _Amendment_
_**(cb)**_ _**treat the information acquired in**_
_**relation to the Union compulsory licence**_
_**with utmost confidentiality, refraining, in**_
_**particular, from making trade secrets**_
_**available to a third party without the**_
_**consent of the Commission, which should**_
_**inform and consult the rights-holder in**_
_**this regard;**_

10634/24 LL/ec 36

# ANNEX GIP.INST EN

**Amendment 60**

**Proposal for a regulation**
**Article 10 – paragraph 1 – subparagraph 1 – point c c (new)**

_Text proposed by the Commission_ _Amendment_
_**(cc)**_ _**implement all necessary measures to**_
_**preserve the confidentiality of the rights-**_
_**holder’s trade secrets, as ordered by the**_
_**Commission pursuant to Article 13a(3);**_

**Amendment 61**

**Proposal for a regulation**
**Article 10 – paragraph 1 – subparagraph 1 – point c d (new)**

_Text proposed by the Commission_ _Amendment_
_**(cd)**_ _**do not use trade secrets disclosed**_
_**pursuant to Article 13a(2) beyond the**_
_**duration of the Union compulsory licence**_
_**or for any other purpose than those**_
_**considered as lawful uses under Article**_
_**13a(2);**_

**Amendment 62**

**Proposal for a regulation**
**Article 10 – paragraph 2 – point a**

_Text proposed by the Commission_ _Amendment_
(a) terminate the Union compulsory (a) _**immediately**_ terminate the Union
licence in accordance with Article 14(3); or compulsory licence in accordance with

Article 14(3); or

**Amendment 63**

**Proposal for a regulation**
**Article 10 – paragraph 2 – point b**

_Text proposed by the Commission_ _Amendment_
(b) impose fines _**or**_ periodic penalties on (b) impose fines _**and**_ periodic penalties
the licensee in accordance with Articles 15 on the licensee in accordance with Articles

and 16. 15 and 16.

10634/24 LL/ec 37

# ANNEX GIP.INST EN

**Amendment 64**

**Proposal for a regulation**
**Article 10 – paragraph 3**

_Text proposed by the Commission_ _Amendment_
3. The European Anti-Fraud Office 3. The European Anti-Fraud Office
(OLAF) in cooperation with the relevant (OLAF) in cooperation with the relevant
national authorities of the Member States national authorities of the Member States
may, at the request of the rights-holder or may, at the request of the rights-holder or
on its own initiative, request access to on its own initiative _**, and on the basis of**_
books and records kept by the licensee, for _**sufficient elements of proof of misuse**_,
the purpose of checking whether the request access to books and records kept by
content and the conditions of the Union the licensee, for the purpose of checking
compulsory licence, and in general the whether the content and the conditions of
provisions of this Regulation, have been the Union compulsory licence, and in
complied with. general the provisions of this Regulation,

have been complied with.

**Amendment 65**

**Proposal for a regulation**
**Article 13 – paragraph 2**

_Text proposed by the Commission_ _Amendment_
2. In compliance with the good faith 2. In compliance with the good faith
obligation, the rights-holder and the obligation, the rights-holder and the
licensee shall make their best efforts to licensee shall make their best efforts to
fulfil the objective of the Union fulfil the objective of the Union
compulsory licence, taking into account compulsory licence, taking into account
each other's interests. each other's interests _**as well as the public**_

_**interest**_ .

10634/24 LL/ec 38

# ANNEX GIP.INST EN

**Amendment 66**

**Proposal for a regulation**
**Article 13 a (new)**

_Text proposed by the Commission_ _Amendment_
_**Article 13a**_

_**Additional measures complementing the**_

_**Union compulsory licence**_
_**1.**_ _**Where necessary, the Commission**_
_**shall decide, upon a reasoned request from**_
_**the rights-holder or the licensee, or on its**_
_**own initiative, on additional measures**_
_**complementing the Union compulsory**_
_**licence to ensure it achieves its objective as**_
_**well as to facilitate and ensure the good**_
_**collaboration between the rights-holder and**_
_**the licensee.**_

_**2.**_ _**Where strictly necessary, the**_
_**Commission shall request the disclosure of**_
_**the rights-holder’s**_ _**trade secrets to the**_
_**licensee to the extent required to provide him**_
_**with the necessary know-how to achieve the**_
_**objective for which the Union compulsory**_
_**licence is granted under this Regulation. The**_
_**lawful uses of the trade secrets by the**_
_**licensee shall be strictly limited to the**_
_**manufacturing of the crisis-relevant**_
_**products in view of fulfilling the objective for**_
_**which the Union compulsory licence has**_
_**been granted.**_
_**3.**_ _**Where the rights-holder is requested to**_
_**disclose his trade secrets in accordance with**_

_**paragraph 3, the Commission shall, prior to**_
_**the disclosure of trade secrets, order the**_
_**licensee to put in place all appropriate**_
_**technical and organisational**_ _**measures that**_
_**the rights-holder reasonably identifies as**_
_**necessary to preserve the confidentiality of**_
_**trade secrets, in particular in relation to**_
_**third parties, including, as appropriate, the**_
_**use of model contractual terms,**_
_**confidentiality agreements, strict access**_
_**protocols, technical standards or the**_
_**application of codes of conduct.**_
_**If the licensee fails to implement the**_
_**necessary measures required by the**_
_**Commission, the Commission may withhold**_
_**or, as the case may be, suspend the**_
_**disclosure of trade secrets until the situation**_
_**is corrected by the licensee.**_

10634/24 LL/ec 39

# ANNEX GIP.INST EN

_**4.**_ _**Appropriate remuneration to the**_
_**rights-holders in compensation for the**_
_**disclosure of their trade secrets shall be**_
_**granted in accordance with Directive (EU)**_
_**2016/943.**_

_**5.**_ _**Where the Commission considers**_

_**adopting additional measures as referred to**_
_**in paragraphs 1 and 2, it shall consult the**_
_**advisory body referred to in Article 6.**_
_**6.**_ _**The implementing acts referred to in**_
_**paragraphs 1 and 2 shall be adopted in**_
_**accordance with the rules referred to in**_
_**Article 7(6), points (a) and (b), and Article**_
_**7(7) and (8).**_

**Amendment 67**

**Proposal for a regulation**
**Article 14 – paragraph 2**

_Text proposed by the Commission_ _Amendment_
_**2.**_ _**Where necessary, the Commission**_ _**deleted**_
_**shall decide upon reasoned request by the**_
_**rights-holder or the licensee or on its own**_
_**initiative on additional measures**_

_**complementing the Union compulsory**_
_**licence to ensure it achieves its objective**_
_**as well as to facilitate and ensure the good**_
_**collaboration between the rights-holder**_
_**and the licensee.**_

**Amendment 68**

**Proposal for a regulation**
**Article 14 – paragraph 4**

_Text proposed by the Commission_ _Amendment_
4. When the Commission considers 4. When the Commission considers
modifying _**, adopting additional measures**_ modifying, or terminating the Union
_**as referred to in paragraph 2**_, or compulsory licence, it _**shall**_ consult the
terminating the Union compulsory licence, advisory body referred to in Article 6 _**as**_
it _**may**_ consult the advisory body referred _**well as the rights-holders and licensees**_ .
to in Article 6.

10634/24 LL/ec 40

# ANNEX GIP.INST EN

**Amendment 69**

**Proposal for a regulation**
**Article 14 – paragraph 4 a (new)**

_Text proposed by the Commission_ _Amendment_
_**4a.**_ _**When considering terminating the**_
_**Union compulsory licence, the**_
_**Commission shall ensure that a sufficient**_
_**transitional period is put in place.**_

**Amendment 70**

**Proposal for a regulation**
**Article 14 – paragraph 6**

_Text proposed by the Commission_ _Amendment_
6. The implementing acts referred to in 6. The implementing acts referred to in
paragraph 1 _**, 2**_ and 3 shall be adopted in paragraph 1 and 3 shall be adopted in
accordance with the rules referred to in accordance with the rules referred to in
Article 7(6) (a) and (b), 7(7) and 7(8). Article 7(6) (a) and (b), 7(7) and 7(8).

**Amendment 71**

**Proposal for a regulation**
**Article 15 – paragraph 1 – point c**

_Text proposed by the Commission_ _Amendment_
(c) the rights-holder or the licensee fail (c) the rights-holder or the licensee fail
to comply with any obligation resulting to comply with any obligation resulting
from the additional measures from the additional measures
complementing the Union compulsory complementing the Union compulsory
licence as referred to in Articles 8(1)(h) licence as referred to in Articles 8(1)(h)
and _**14(2)**_, as specified in the relevant and _**Article 13a(1) and (2)**_, as specified in
implementing act. the relevant implementing act.

**Amendment 72**

**Proposal for a regulation**
**Article 15 – paragraph 1 – point c a (new)**

_Text proposed by the Commission_ _Amendment_
_**(ca)**_ _**the licensee does not comply with**_
_**the prohibition referred in Article 11;**_

10634/24 LL/ec 41

# ANNEX GIP.INST EN

**Amendment 73**

**Proposal for a regulation**
**Article 16 – paragraph 1 – point c**

_Text proposed by the Commission_ _Amendment_
(c) the rights-holder or the licensee to (c) the rights-holder or the licensee to
comply with any obligation resulting from comply with any obligation resulting from
the additional measures complementing the the additional measures complementing the
Union compulsory licence as referred to in Union compulsory licence as referred to in
Articles 8(1)(h) and _**14(2)**_, as specified in Articles 8(1)(h) and _**Article 13a(1) and (2)**_,
the relevant implementing act. as specified in the relevant implementing

act.

**Amendment 74**

**Proposal for a regulation**
**Article 16 – paragraph 1 – point c a (new)**

_Text proposed by the Commission_ _Amendment_
_**(ca)**_ _**the licensee to put an end to an**_
_**infringement of the prohibition referred**_
_**in Article 11;**_

**Amendment 75**

**Proposal for a regulation**
**Article 19 – paragraph 1**

_Text proposed by the Commission_ _Amendment_
1. Before adopting a decision pursuant 1. Before adopting a decision pursuant
to Article 15 or 16, the Commission shall to Article 15 or 16, the Commission shall
give the licensee or the rights-holder the give the licensee or the rights-holder the
opportunity of being heard on the alleged opportunity of being heard _**and fully**_
infringement which is to be made subject _**involved in the procedure**_ on the alleged
to a fine or periodic penalty payments. infringement which is to be made subject

to a fine or periodic penalty payments.

**Amendment 76**

**Proposal for a regulation**
**Article 19 – paragraph 2 a (new)**

_Text proposed by the Commission_ _Amendment_
_**2a.**_ _**The Commission shall reply to the**_
_**observations made by the licensee or the**_
_**right holder and in case of a rejection of**_
_**the observations, it shall provide a**_
_**justification within a reasonable period of**_
_**time which shall not exceed 7 days.**_

10634/24 LL/ec 42

# ANNEX GIP.INST EN

**Amendment 77**

**Proposal for a regulation**
**Article 19 – paragraph 4**

_Text proposed by the Commission_ _Amendment_
4. The rights of defence of the parties 4. The rights of defence of the parties
concerned shall be fully respected in the concerned shall be fully respected in the
proceedings. They shall be entitled to have proceedings. They shall be entitled to have
access to the Commission's file under the access to the Commission's file under the
terms of a negotiated disclosure, subject to terms of a negotiated disclosure, subject to
the legitimate interest of the licensee or the the legitimate interest of the licensee or the
rights-holder or other person concerned in rights-holder or other person concerned in
the protection of their commercially the protection of their commercially
sensitive information and trade secrets. The sensitive information and trade secrets
Commission shall have the power to adopt _**fully in line with existing legislation on**_
decisions setting out such terms of _**the protection of data and trade secrets**_ .
disclosure in case of disagreement between The Commission shall have the power to
the parties. The right of access to the file of adopt decisions setting out such terms of
the Commission shall not extend to disclosure _**,**_ in case of disagreement
confidential information and internal between the parties. The right of access to
documents of the Commission, other the file of the Commission shall not extend
competent authorities or other public to confidential information and internal
authorities of the Member States. In documents of the Commission, other
particular, the right of access shall not competent authorities or other public
extend to correspondence between the authorities of the Member States. In
Commission and those authorities. Nothing particular, the right of access shall not
in this paragraph shall prevent the extend to correspondence between the
Commission from disclosing and using Commission and those authorities. Nothing
information necessary to prove an in this paragraph shall prevent the
infringement. Commission from disclosing and using

information necessary to prove an
infringement.

**Amendment 78**

**Proposal for a regulation**
**Article 21 – paragraph 1**

_Text proposed by the Commission_ _Amendment_
In accordance with Article 261 TFEU, the In accordance with Article 261 _**and 263**_
Court of Justice of the European Union has TFEU, the Court of Justice of the European
unlimited jurisdiction to review decisions Union has unlimited jurisdiction to review
by which the Commission _**has imposed**_ decisions by which the Commission _**:**_
_**fines or periodic penalty payments. It may**_
_**cancel, reduce or increase the fine or**_
_**periodic penalty payment imposed.**_

10634/24 LL/ec 43

# ANNEX GIP.INST EN

**Amendment 79**

**Proposal for a regulation**
**Article 21 – paragraph 1 – point 1 (new)**

_Text proposed by the Commission_ _Amendment_
_**(1)**_ _**has granted a compulsory licence. It**_
_**may cancel or amend its terms and**_
_**conditions;**_

**Amendment 80**

**Proposal for a regulation**
**Article 21 – paragraph 1 – point 2 (new)**

_Text proposed by the Commission_ _Amendment_
_**(2)**_ _**has imposed fines or periodic**_
_**penalty payments. It may cancel, reduce**_
_**or increase the fine or periodic penalty**_
_**payment imposed.**_

**Amendment 81**

**Proposal for a regulation**
**Article 22 – paragraph 1 – introductory part**

_Text proposed by the Commission_ _Amendment_
When a national compulsory licence has When a national compulsory licence has
been granted for the purpose of addressing been granted _**for the public interest or**_ for
a national crisis or emergency, the Member the purpose of addressing a national crisis
State shall notify the Commission of the or emergency, the Member State shall
granting of the licence and of the specific notify the Commission of the granting of
conditions attached to it. The information the licence and of the specific conditions
provided shall include the following: attached to it.The information provided

shall include the following:

**Amendment 82**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a (new)**
Regulation (EC) No 816/2006
Article 6 – paragraph 2

_Present text_ _Amendment_

_**(-a) Article 6(2) is replaced by the**_
_**following:**_
2. If the person applying for a _**2.**_ If the person applying for a
compulsory licence is submitting compulsory licence is submitting multiple
applications to authorities _**in more than**_ applications to authorities for the same
_**one country**_ for the same product, he shall product, he shall indicate that fact in each
indicate that fact in each application, application, together with details of the
together with details of the quantities and quantities and importing countries
importing countries concerned. concerned.

10634/24 LL/ec 44

# ANNEX GIP.INST EN

**Amendment 83**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a a (new)**
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point c

_Present text_ _Amendment_

_**(-aa) Point (c) of Article 6(3) is replaced**_
_**by the following:**_
(c) the amount of pharmaceutical (c) the _**expected**_ amount of
product which the applicant seeks to pharmaceutical product which the
produce under the compulsory licence; applicant seeks to produce under the

compulsory licence;

**Amendment 84**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a b (new)**
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point e

_Present text_ _Amendment_

_**(-ab) Point (e) of Article 6(3) is replaced**_
_**by the following:**_
(e) where applicable, evidence of prior (e) where applicable, evidence of _**efforts**_
negotiation with the rights-holder pursuant _**of**_ prior negotiation with the rights-holder
to Article 9 pursuant to Article 9 _;_

**Amendment 85**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a c (new)**
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point f

_Present text_ _Amendment_

_**(-ac) Point (f) of Article 6(3) is replaced**_
_**by the following:**_
(f) evidence of a specific request from: (f) evidence of a specific request from:
(i) authorised representatives of the (i) authorised representatives of the
importing country or countries; or importing country or countries; or

(i) authorised representatives of the (i) authorised representatives of the
importing country or countries; or importing country or countries; or

(ii) a non-governmental organisation (ii) a non-governmental organisation
acting with the formal authorisation of one acting with the formal authorisation of one
or more importing countries; or or more importing countries; or

(ii) a non-governmental organisation (ii) a non-governmental organisation
acting with the formal authorisation of one acting with the formal authorisation of one
or more importing countries; or or more importing countries; or

(iii) UN bodies or other international (iii) UN bodies or other international
health organisations acting with the formal health organisations acting with the formal
authorisation of one or more importing authorisation of one or more importing
countries, countries,

(iii) UN bodies or other international (iii) UN bodies or other international
health organisations acting with the formal health organisations acting with the formal
authorisation of one or more importing authorisation of one or more importing
countries, countries,

indicating the quantity of product required. indicating the _**expected**_ quantity of product
required.

10634/24 LL/ec 45

# ANNEX GIP.INST EN

**Amendment 86**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a d (new)**
Regulation (EC) No 816/2006
Article 7

_Present text_ _Amendment_

_**(-ad) Article 7 is replaced by the**_
_**following:**_
Article 7 Article 7
Rights of the rights-holder Rights of the rights-holder
The competent authority shall notify the The competent authority shall notify the
rights-holder without delay of the rights-holder without delay of the
application for a compulsory licence. application for a compulsory licence.
Before the grant of the compulsory licence, Before the grant of the compulsory licence,
the competent authority _**shall**_ give the the competent authority _**may**_ give the
rights-holder an opportunity to comment rights-holder an opportunity to comment
on the application and to provide the on the application and to provide the
competent authority with any relevant competent authority with any relevant
information regarding the application. information regarding the application.

**Amendment 87**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a e (new)**
Regulation (EC) No 816/2006
Article 9 – paragraph 1

_Present text_ _Amendment_

_**(-ae) Article 9(1) is replaced by the**_
_**following:**_
1. The applicant shall provide evidence 1. The applicant shall provide evidence
to _**satisfy**_ the competent authority that he to the competent authority that he has made
has made efforts to obtain authorisation efforts to obtain authorisation from the
from the rights-holder and that such efforts rights-holder and that such efforts have not
have not been successful within a period of been successful within a period of thirty
thirty days before submitting the days before submitting the application.
application _**.**_

10634/24 LL/ec 46

# ANNEX GIP.INST EN

**Amendment 88**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a f (new)**
Regulation (EC) No 816/2006
Article 10 – paragraph 1

_Present text_ _Amendment_

_**(-af) Article 10(1) is replaced by the**_
_**following:**_
1. The licence granted shall be non- 1. The licence granted shall be nonassignable, except with that part of the assignable, except with that part of the
enterprise or _**goodwill which enjoys**_ the enterprise or _**organisation that makes use**_
licence, and non-exclusive. It shall contain _**of**_ the licence, and non-exclusive. It shall
the specific conditions set out in contain the specific conditions set out in
paragraphs 2 to 9 to be fulfilled by the paragraphs 2 to 9 to be fulfilled by the
licensee. licensee _**.**_

**Amendment 89**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a g (new)**
Regulation (EC) No 816/2006
Article 10 – paragraph 2

_Present text_ _Amendment_

_**(-ag) Article 10(2) is replaced by the**_
_**following:**_
2. The amount of product(s) 2. The _**expected**_ amount of product(s)
manufactured under the licence shall not manufactured under the licence shall not
exceed what is necessary to meet the needs exceed what is necessary to meet the needs
of the importing country or countries cited of the importing country or countries cited
in the application, taking into account the in the application, taking into account the
amount of product(s) manufactured under amount of product(s) manufactured under
other compulsory licences granted other compulsory licences granted
elsewhere. elsewhere.

10634/24 LL/ec 47

# ANNEX GIP.INST EN

**Amendment 90**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point -a h (new)**
Regulation (EC) No 816/2006
Article 10 – paragraph 8

_Present text_ _Amendment_

_**(-ah) Article 10(8) is replaced by the**_
_**following:**_
8. The competent authority may _**at the**_ 8. The competent authority may, on its
_**request of the rightsholder or**_ on its own own initiative _**,**_ if national law allows the
initiative, if national law allows the competent authority to act on its own
competent authority to act on its own initiative _,_ _**request from**_ the licensee proof
initiative, request _**access to books and**_ of exportation of the product, through a
_**records kept by**_ the licensee, _**for the sole**_ declaration of exportation, certified by the
_**purpose of checking whether the terms of**_ customs authority concerned, and proof of
_**the licence, and in particular those**_ importation from one of the bodies referred
_**relating to the final destination of the**_ to in Article 6(3)(f).
_**products, have been met.**_ _**The books and**_
_**records shall include**_ proof of exportation
of the product, through a declaration of
exportation certified by the customs
authority concerned, and proof of
importation from one of the bodies referred
to in Article 6(3)(f).

**Amendment 91**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point a**
Regulation (EC) No 816/2006
Article 18a – paragraph 1

_Text proposed by the Commissiont_ _Amendment_
1. The Commission may grant a 1. The Commission may _**also**_ grant a
compulsory licence _**where the activities of**_ compulsory licence _**of patents relating to**_
_**manufacture and sale for export spread**_ _**the manufacture of pharmaceutical**_
_**across different Member States and would**_ _**products for export to countries with**_
_**therefore require compulsory licences for**_ _**public health problems.**_
_**the same product in more than one**_
_**Member State**_ .

10634/24 LL/ec 48

# ANNEX GIP.INST EN

**Amendment 92**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point a**
Regulation (EC) No 816/2006
Article 18a – paragraph 2

_Text proposed by the Commission_ _Amendment_
2. Any person may submit an 2. Any person may submit an
application for a compulsory licence under application for a compulsory licence under
paragraph 1. _**The application shall fulfil**_ paragraph 1. _**The application shall contain**_
_**the requirements laid down in Article 6**_ _**the following information:**_
_**(3) and shall specify the Member States to**_
_**be covered by the compulsory licence.**_

_**(a)**_ _**the name and contact details of the**_
_**applicant and of any agent or**_
_**representative whom the applicant has**_
_**appointed to act for him before the**_
_**competent authority;**_
_**(b)**_ _**the non-proprietary name of the**_
_**pharmaceutical product or products**_
_**which the applicant intends to**_
_**manufacture and sell for export under the**_
_**compulsory licence;**_
_**(c)**_ _**the expected amount of**_
_**pharmaceutical product which the**_
_**applicant seeks to produce under the**_
_**compulsory licence;**_
_**(d)**_ _**the importing country or countries;**_
_**(e)**_ _**where applicable, evidence of efforts**_
_**of prior negotiation with the rights-holder**_
_**pursuant to Article 9;**_
_**(f)**_ _**evidence of a specific request from:**_
_**(i)**_ _**authorised representatives of the**_
_**importing country or countries; or**_
_**(ii)**_ _**a non-governmental organisation**_
_**acting with the formal authorisation of**_
_**one or more importing countries; or**_
_**(iii) UN bodies or other international**_
_**health organisations acting with the**_
_**formal authorisation of one or more**_
_**importing countries.**_

10634/24 LL/ec 49

# ANNEX GIP.INST EN

**Amendment 93**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point a**
Regulation (EC) No 816/2006
Article 18a – paragraph 3

_Text proposed by the Commissiont_ _Amendment_
3. The compulsory licence granted 3. The compulsory licence granted in
in accordance with paragraph 1 _**shall**_ accordance with paragraph 1 shall specify that
_**be subject to the conditions set out in**_ it is applicable to the whole territory of the
_**Article 10 and**_ shall specify that it is Union _**and shall be subject to the following**_
applicable to the whole territory of the _**conditions:**_
Union.

_**(a)**_ _**the licence granted shall be non-**_
_**assignable, except with that part of the**_
_**enterprise or organisation that makes use of**_
_**the licence, and non-exclusive. It shall contain**_
_**the specific conditions as set out in this**_
_**paragraph;**_
_**(b)**_ _**the expected amount of product(s)**_
_**manufactured under the licence shall not**_
_**exceed what is necessary to meet the needs of**_
_**the importing country or countries cited in the**_
_**application, taking into account the amount of**_
_**product(s) manufactured under other**_
_**compulsory licences granted elsewhere;**_
_**(c)**_ _**the duration of the licence shall be**_
_**indicated;**_
_**(d)**_ _**the licence shall be strictly limited to all**_
_**acts necessary for the purpose of**_
_**manufacturing the product in question for**_
_**export and distribution in the country or**_
_**countries cited in the application. No product**_
_**made or imported under the compulsory**_
_**licence shall be offered for sale or put on the**_
_**market in any country other than that cited in**_
_**the application, except where an importing**_
_**country avails itself of the possibilities under**_
_**subparagraph 6(i) of the Decision to export to**_
_**fellow members of a regional trade agreement**_
_**that share the health problem in question;**_
_**(e)**_ _**products made under the licence shall be**_
_**clearly identified, through specific labelling or**_
_**marking, as being produced pursuant to this**_
_**Regulation. The products shall be**_
_**distinguished from those made by the rights-**_
_**holder through special packaging or special**_
_**colouring or shaping, provided that such**_
_**distinction is feasible and does not have a**_
_**significant impact on the price. The packaging**_
_**and any associated literature shall bear an**_
_**indication that the product is subject to a**_
_**compulsory licence under this Regulation,**_
_**giving the name of the competent authority**_
_**and any identifying reference number, and**_
_**specifying clearly that the product is**_
_**exclusively for export to and distribution in**_

10634/24 LL/ec 50

# ANNEX GIP.INST EN

_**the importing country or countries concerned.**_
_**Details of the product characteristics shall be**_
_**made available to the customs authorities of**_
_**the Member States;**_
_**(f)**_ _**before shipment to the importing**_
_**country or countries cited in the application,**_
_**the licensee shall post on a website the**_
_**following information:**_
_**(i)**_ _**the quantities being supplied under the**_
_**licence and the importing countries to which**_
_**they are supplied,**_
_**(ii)**_ _**the distinguishing features of the**_
_**product or products concerned.**_
_**The website address shall be communicated to**_
_**the competent authority;**_
_**(g)**_ _**if the product(s) covered by the**_
_**compulsory licence are patented in the**_
_**importing countries cited in the application,**_
_**the product(s) shall only be exported if those**_
_**countries have issued a compulsory licence for**_
_**the import, sale or distribution of the**_
_**products;**_
_**(h)**_ _**the competent authority may, on its own**_
_**initiative, if national law allows the competent**_
_**authority to act on its own initiative, request**_
_**from the licensee proof of exportation of the**_
_**product in the form of a declaration of**_
_**exportation certified by the customs authority**_
_**concerned, and proof of importation from one**_
_**of the bodies referred to in Article 18a(2),**_
_**point (e);**_
_**(i)**_ _**the licensee shall be responsible for the**_
_**payment of adequate remuneration to the**_
_**rights-holder as determined by the competent**_
_**authority as follows:**_
_**(i)**_ _**in situations of national emergency or**_
_**other circumstances of extreme urgency or in**_
_**cases of public non-commercial use, the**_
_**remuneration shall be a maximum of 4 % of**_
_**the total price to be paid by the importing**_
_**country or on its behalf,**_
_**(ii)**_ _**in all other cases, the remuneration**_
_**shall be determined taking into account the**_
_**economic value of the use authorised under**_
_**the licence to the importing country or**_
_**countries concerned, as well as humanitarian**_
_**or non-commercial circumstances relating to**_
_**the issue of the licence;**_
_**(j)**_ _**the licence conditions are without**_
_**prejudice to the method of distribution in the**_
_**importing country.**_
_**Distribution may be carried out for example**_
_**by any of the bodies listed in Article 18a (2),**_
_**point (f), and on commercial or non-**_
_**commercial terms including completely**_
_**without charge**_ .

10634/24 LL/ec 51

# ANNEX GIP.INST EN

**Amendment 94**

**Proposal for a regulation**
**Article 23 – paragraph 1 – point a**
Regulation No 816/2006/EC
Article 18a – paragraph 5 – subparagraph 2

_Text proposed by the Commission_ _Amendment_
Those implementing acts shall be adopted Those implementing acts shall be adopted
in accordance with the advisory procedure in accordance with the advisory procedure
referred to in Article 18b (2). On duly referred to in Article 18b (2). On duly
justified imperative grounds of urgency justified imperative grounds of urgency
relating to _**the impacts of the**_ public health relating to public health problems, the
problems, the Commission shall adopt Commission shall adopt immediately
immediately applicable implementing acts applicable implementing acts in
in accordance with the procedure referred accordance with the procedure referred to
to in Article 18b (3). in Article 18b (3).

**Amendment 95**

**Proposal for a regulation**
**Article 25 – paragraph 1 a (new)**

_Text proposed by the Commission_ _Amendment_
_**By ... [two years after the date of entry**_
_**into force of this Regulation] and every**_
_**two years thereafter, the Commission**_
_**shall assess whether the list in the Annex**_

_**is up-to-date in light of the adoption of**_
_**future legislative acts in relation to an**_
_**emergency or crisis mode. If the list of the**_
_**Annex is no longer up-to-date, the**_
_**Commission shall assess its consequences.**_
_**The Commission shall submit its**_

_**assessment to the European Parliament**_
_**and the Council, accompanied, where**_
_**appropriate, by legislative proposals to**_
_**amend the Annex.**_

**Amendment 96**

**Proposal for a regulation**
**Article 25 – paragraph 1 b (new)**

_Text proposed by the Commission_ _Amendment_
_**In case of exceptional threats to public**_
_**safety or to national security, the**_
_**Commission shall carry out the**_
_**assessment pursuant to paragraph 1a**_
_**without undue delay.**_

10634/24 LL/ec 52

# ANNEX GIP.INST EN

**Amendment 97**

**Proposal for a regulation**
**Article 26 – title**

_Text proposed by the Commission_ _Amendment_
Entry into force Entry into force _**and application**_
**Amendment 98**

**Proposal for a regulation**
**Article 26 – paragraph 1 a (new)**

_Text proposed by the Commission_ _Amendment_
_**It shall apply from [the first day of the**_
_**month following the period of twelve**_
_**months after the date of entry into force].**_

10634/24 LL/ec 53

# ANNEX GIP.INST EN