COMMITTEE ON LEGAL AFFAIRS
Brussels, 12 July 2021 - 16.45-17.45
Secretariat - CP/ie
VOTING LIST
Pharmaceutical strategy for Europe
(2021/2013(INI))
Rapporteur: Luisa Regimenti
Draft opinion: Fdr 1230727 - PE 692.709 v01-00
Amendments: (AMs 1 - 93) - Fdr 1233410 - PE 693.696 v02-00
Concerned
AM Tabled by
Remarks
Rapp Vote
text
Paragraph 1
CA Rapporteur, EPP, RE
If adopted, 36, 2, 3, 4 and 5
+
1
fall
Paragraph 2 a
36 Niebler
Falls if CA 1 adopted
+
(new)
Paragraph 1a
CA Rapporteur, EPP, RE
If adopted, 7, 10, 16 and 2
+
2
fall
Paragraph 1 a
7 Buxadé Villalba
Falls if CA 2 adopted
+
(new)
Paragraph 1 a
10 Buda
Falls if CA 2 adopted
+
(new)
Paragraph 1 b
16 Złotowski
Falls if CA 2 adopted
+
(new)
Paragraph 1
2 Regimenti, Lebreton,
Falls if CA 1 or CA 2
+
Garraud
adopted
Paragraph 1
3 Niebler, Walsmann
Falls if CA 1 or 2 adopted
+
Paragraph 1
4 Buda
Falls if CA 1 or 3 adopted
+
Compatible with AM 2
Paragraph 1 a
8 Złotowski
+
(new)
Paragraph 1 a
9 Maurel
-
(new)
Paragraph 1 b
12 Toussaint
0
(new)
Paragraph 1 b
13 Maurel
+
(new)
Paragraph 1b
CA Rapporteur, EPP, RE
If adopted, 14, 17, 26 Part 1
+
3
and 26 Part 2 fall
Paragraph 1 b
14 Toom, Vázquez
Falls if CA 3 adopted
-
(new)
Lázara
Paragraph 1 b
17 Niebler, Walsmann
Falls if CA 3 adopted
+
(new)
Paragraph 1 b
15 Buxadé Villalba
0
(new)
Paragraph 1c
CA Rapporteur, EPP, RE
If adopted, 1, 5, 19, 6 and 24
+
4
fall
Paragraph -1
1 Toom, Vázquez
Falls if CA 4 adopted
+
(new)
Lázara
Paragraph 1 a
5 Toussaint
Falls if CA 1 or CA 4
0
(new)
adopted
Paragraph 1 c
19 Niebler
Falls if CA 4 adopted
+
(new)
Paragraph 1 a
6 Toom, Vázquez
Falls if CA 4 adopted
+
(new)
Lázara
Paragraph 1 g
24 Niebler, Walsmann
Falls if CA 4 or 6 adopted
+
(new)
Paragraph 1 d
21 Toom, Vázquez
Split vote (EPP)
+
(new)
Lázara
Part 1
Underlines the important role
played by public investments
in R&D, and calls on the
Commission and the Member
States to establish full
transparency on the results of
publicly financed R&D
Part 2
-
so that patenting and licensing
conditions guarantee a public
health return on public
investments;
Paragraph 2
CA Rapporteur, EPP, RE
If adopted, 20, 25, 26 Part 1,
+
and 2a
5
26 Part 2, 27, 28, 29, 30, 32,
84, 34, 37 Part 1, 37 Part 2
and 62 fall
Paragraph 1 d
20 Niebler, Walsmann
Falls if CA 5 adopted
+
(new)
Paragraph 2
25 Regimenti, Lebreton,
Falls if CA 5 adopted
+
Garraud
Paragraph 2
26 Toussaint
Split vote (EPP)
+
Part 1
Falls if CA 3, 14 or CA 5
adopted
Text without the words “an
adapted”
Compatible with AM 25
Part 2
-
Falls if CA 3, 14 or CA 5
adopted
The words “an adapted”
Paragraph 2
27 Niebler
Falls if CA 5, 26 Part 1 or 26
-
Part 2 adopted
Compatible with AM 25
Paragraph 2
28 Toom
Falls if CA 5, 26 Part 1 or 26
-
Part 2 adopted
Compatible with AM 25, AM
27
Paragraph 2
29 Buda
Falls if CA 5 or 27 adopted
+
Compatible with AM 25, AM
26, AM 28
Paragraph 2
30 Buxadé Villalba
Falls if CA 5, 26 Part 1, 26
+
Part 2, 27, 28 or 29 adopted
Compatible with AM 25
Paragraph 2 b
32 Regimenti, Lebreton,
Falls if CA 5 adopted
+
(new)
Garraud
Paragraph 6 b
84 Buxadé Villalba
Falls if CA 5 adopted
-
(new)
Paragraph 2 a
34 Toom, Vázquez
Falls if CA 5 or 25 adopted
-
(new)
Lázara
Paragraph 2 c
39 Toom, Vázquez
-
(new)
Lázara
Paragraph 2 d
40 Toom
-
(new)
Paragraph 3
CA Rapporteur, EPP, RE
If adopted, 11, 18, 45, 46
+
6
Part 1, 46 Part 2, 47, 48 and
49 fall
Paragraph 1 a
11 Niebler, Walsmann
Falls if CA 6 adopted
+
(new)
Paragraph 1 c
18 Toom
Falls if CA 6 adopted
0
(new)
Paragraph 3
45 Regimenti
Falls if CA 6 adopted
+
Paragraph 3
46 Toussaint
Split vote (EPP)
+
Part 1
Falls if CA 6 or 45 adopted
From “Stresses the
importance of supporting
research” until “where
commercial interest is low,
such as orphan and paediatric
drugs;”
Part 2
-
Falls if CA 6 or 45 adopted
From “whereas high degree of
transparency should apply”
until “decision-making to
investment and open science;”
Paragraph 3
47 Buxadé Villalba
Falls if CA 6, 45, 46 Part 1
-
or 46 Part 2 adopted
Paragraph 3
48 Niebler, Walsmann
Falls if CA 6, 46 Part 1 or 46
+
Part 2 adopted
Compatible with AM 45, AM
47
Paragraph 3
49 Toom
Falls if CA 6, 46 Part 1, 46
-
Part 2 or 48 adopted
Compatible with AM 45, AM
47
Paragraph 3a
CA Rapporteur, EPP, RE
If adopted, 42, 43, 50 and 57
+
and 3b
7
fall
Paragraph 2 f
42 Toom, Vázquez
Falls if CA 7 adopted
+
(new)
Lázara
Paragraph 2 g
43 Toom, Vázquez
Falls if CA 7 adopted
-
(new)
Lázara
Paragraph 3 a
50 Regimenti, Lebreton,
Falls if CA 7 or 43 adopted
+
(new)
Garraud
Paragraph 3 d
57 Toussaint
Falls if CA 7 adopted
0
(new)
Paragraph 3 b
51 Regimenti, Lebreton,
No vote
(new)
Garraud
Inadmissible
Paragraph 3 a
53 Toussaint
-
(new)
Paragraph 3 a
54 Niebler
+
(new)
Paragraph 3 b
55 Toussaint
-
(new)
Paragraph 3 c
56 Toussaint
-
(new)
Paragraph 4
CA Rapporteur, EPP, RE
If adopted, 37 Part 1, 37
+
8
Part 2, 58, 61, 68 and 22 fall
Paragraph 2 b
37 Toom
Split vote (EPP)
+
(new)
Part 1
Falls if CA 5, 25 or CA 8
adopted
From “Recalls that Regulation
(EC) No 816/2006” until “to
address public health
problems;”
Part 2
-
Falls if CA 5, 25 or CA 8
adopted
From “calls on the
Commission to consider the
possibility” until “TRIPS
obligations”
Paragraph 4 a
62 Toussaint
Falls if CA 5, 25, 39, 37 Part
-
(new)
1 or 37 Part 2 adopted
Paragraph 4
58 Buxadé Villalba
Fall if CA 8 adopted
-
Identical
59 Złotowski
Deletion
60 Toussaint
Paragraph 4
61 Buda
Falls if CA 8 or 58 adopted
+
Paragraph 4 b
68 Złotowski
Falls if CA 8 adopted
+
(new)
Paragraph 1 e
22 Niebler, Walsmann
Falls if CA 8 adopted
+
(new)
Paragraph 2 a
35 Złotowski
Falls if 56 or 22 adopted
-
(new)
Paragraph 4a
CA Rapporteur, EPP, RE
If adopted, 31, 64 and 91 fall
+
9
Paragraph 2 a
31 Regimenti, Lebreton,
Falls if CA 9 adopted
+
(new)
Garraud
Paragraph 4 a
64 Niebler, Walsmann
Falls if CA 9 adopted
+
(new)
Paragraph 6 f
91 Buxadé Villalba
Falls if CA 9 adopted
+
(new)
Paragraph 4 a
65 Buda
+
(new)
Paragraph 4 a
66 Złotowski
+
(new)
Paragraph 4 b
67 Niebler, Walsmann
+
(new)
Paragraph 4 c
70 Niebler
+
(new)
Paragraph 4 d
71 Niebler
+
(new)
Paragraph 5
CA Rapporteur, EPP, RE
If adopted, 23, 38, 73 and 86
+
10
fall
Paragraph 1 f
23 Niebler, Walsmann
Falls if CA 10 adopted
+
(new)
Paragraph 2 b
38 Niebler
Falls if CA 10 adopted
+
(new)
Paragraph 5
73 Regimenti, Lebreton,
Falls if CA 10 adopted
+
Garraud
Paragraph 6 c
86 Niebler, Walsmann
Falls if CA 10 adopted
+
(new)
Paragraph 5 a
75 Maurel
-
(new)
Paragraph 5 a
76 Garraud, Beck,
-
(new)
Lebreton
Paragraph 5a
CA Rapporteur, EPP, RE
If adopted, 44, 74, 77, 85 and
+
11
92 fall
Paragraph 2 h
44 Toom
Falls if CA 11 adopted
+
(new)
Paragraph 5 a
74 Buxadé Villalba
Falls if CA 11 adopted
+
(new)
Paragraph 5 b
77 Garraud, Beck,
Falls if CA 11 adopted
+
(new)
Lebreton, Regimenti
Paragraph 6 b
85 Niebler, Walsmann
Falls if CA 11 adopted
+
(new)
Paragraph 6 g
92 Buxadé Villalba
Falls if CA 11 adopted
0
(new)
Paragraph 5b
CA Rapporteur, EPP, RE
If adopted, 33, 78 and 83 fall
+
12
Paragraph 2 c
33 Regimenti
Falls if CA 12 adopted
+
(new)
Paragraph 5 b
78 Buxadé Villalba
Falls if CA 12 adopted
+
(new)
Paragraph 6 a
83 Niebler, Walsmann
Falls if CA 12 adopted
0
(new)
Paragraph 6
CA Rapporteur, RE
If adopted, 79, 80, 82 and 90
+
13
fall
Paragraph 6
79 Toom
Falls if CA 13 adopted
-
Deletion
Paragraph 6
80 Toussaint
Falls if CA 13 or 79 adopted
-
Paragraph 6 a
82 Buxadé Villalba
Falls if CA 13 adopted
0
(new)
Paragraph 6 e
90 Buxadé Villalba
Falls if CA 13 or 82 adopted
0
(new)
Paragraph 6a
CA Rapporteur, EPP, RE
If adopted, 63, 41, 69, 72, 81
+
14
and 52 fall
Paragraph 4 a
63 Garraud, Beck,
Falls if CA 14 adopted
-
(new)
Lebreton
Paragraph 2 e
41 Toom
Falls if CA 14 adopted
0
(new)
Paragraph 4 c
69 Złotowski
Falls if CA 14 or 41 adopted
0
(new)
Paragraph 4 e
72 Niebler
Falls if CA 14 or 69 adopted
+
(new)
Paragraph 6 a
81 Złotowski
Falls if CA 14 adopted
+
(new)
Paragraph 3 a
52 Złotowski
Falls if CA 14 adopted
-
(new)
Paragraph 6 c
87 Buxadé Villalba
Falls if 40 adopted
+
(new)
Paragraph 6 d
88 Buxadé Villalba
-
(new)
Paragraph 6 d
89 Niebler, Walsmann
+
(new)
Paragraph 6 h
93 Buxadé Villalba
+
(new)
Final vote – Draft as amended (Roll-call vote)
COMPROMISE AMENDMENTS
COMP 1- paragraph 1
AM 2 (ID), AM 4 (EPP), AM 5 (Greens/EFA), AM 36 (EPP)
1. Stresses the
need and importance of
introducing a new EU pharmaceutical strategy, which
is consistent with the Union’s competences under the Treaties and with the principles of
proportionality and subsidiarity, as a means of stimulating the development of European
enterprises and making them competitive at global level,
driving scientific progress, as well
as guaranteeing better prevention and preparedness and
a more
efficient and rapid response
to future health emergencies
; calls for
decisions and policies to provide solutions that enable
an industrial ecosystem in the pharmaceutical sector in which the balance between the
various interests at stake is duly taken into account;
calls on the Commission to carefully
analyse what lessons should be learned from the challenges posed by the COVID-19
pandemic for the pharmaceutical strategy;
COMP 2 - paragraph 1a
AM 2 (ID), AM 10 (EPP), AM 16 (ECR), AM 7 (ECR)
1a. Recalls that the European Union is aiming to ensure the well-being of European citizens
by promoting healthy lifestyles, fair and equitable access to healthcare and the marketing of
safe, effective and affordable medicines in the single market; stresses the need to draw up
future European framework provisions for regulatory approval, access and incentives for
innovation, accompanied by vigorous industrial policies, with attractiveness and predictable
rules being regarded as the key to innovation, and to facilitate patients’ access to medicines;
welcomes the Commission's intention to assess and review the existing incentive framework;
believes that the EU Pharmaceutical Strategy and legislative measures should support
European developers and manufacturers in driving scientific progress and remaining
globally competitive; recalls the need to develop intra-European production chains, through
the development of a rational and compatible regulatory framework between Member States,
with the aim of developing a medicine supply system that looks at the whole production
chain; calls on the Commission to stimulate competition by creating an appropriate
regulatory framework;
COMP 3 - paragraph 1b
AM 14 (Renew), AM 17 (EPP)
1b. stresses that support for the competitiveness and innovative capacity of the EU
pharmaceutical industry is crucial; Calls, in this regard, on the Commission and the
Member States to introduce fiscal and financial incentives, in order to encourage
manufacturers to relocate the production of active ingredients and medicines of strategic
importance for health care to Europe;
COMP 4 - paragraph 1c
AM 1 (Renew), AM 5 (Greens/EFA), AM 19 (EPP), AM 24 (EPP)
1c. Considers that the preparation to next global health crisis urges decision and policy
making to bring solutions allowing long-term resilience in society, and in particular to
design an industrial ecosystem in the pharmaceutical sector where the balance between the
different interests at stake is duly considered in the light of the circumstances; Believes
that the strategic autonomy of the EU has to be a key objective when addressing the
shortage of medicines for a better access of patients to these; Recalls the European
Commission’s ‘Updating the 2020 New Industrial Strategy: Building a stronger Single
Market for Europe’s recovery’ of May 2021 which states that the EU is strategically
dependent on third countries regarding pharmaceutical ingredients and other health
related products, which could lead to vulnerabilities for the EU and affect the EU’s core
interests, and refers to the pharmaceutical strategy to address these issues;
COMP 5 - paragraph 2 and 2a
AM 20 (EPP), AM 30 (ECR), AM 32 (ID), AM 25 (ID), AM 84 (ECR)
2.
Emphasises the key importance of intellectual property protection in the EU,
as an
essential
element for the EU not to be dependent on third countries and for enhancing its
strategic autonomy in the field of medicines;
stresses that intellectual property rights promote
accessibility, innovation and competitiveness in the sector and improve the safety of
medicines and of patients;
notes that a balance should be struck between intellectual property
protection, encouraging innovation, ensuring access to medicines and protecting public
health; calls for
the role of the Member States to be enhanced by improving communication
and cooperation between the European institutions,
national authorities, health professionals,
industry and stakeholders, with a view to identifying shared approaches, particularly to the
challenges posed by the COVID-19 pandemic;
2a.
Encourages the strengthening of the role of Member States through collaboration and
the development of best practices to identify and address the root causes of shortfall of
medicines on EU markets, in order to tackle remaining obstacles to timely and effective
access for patients; points out that affordability of medicines remains a challenge for
national healthcare systems; recalls that in health crisis or emergency situations, making
changes to the intellectual property regime is insufficient to address short-term needs and
that compulsory licensing should only be possible in exceptional cases where no other
solution can be found and where a compulsory licence appears to be justified and necessary
to effectively increase production capacity;
COMP 6 - paragraph 3
AM 11 (PPE), AM 45 (Rapporteur), AM 47 (ECR), AM 48 (PPE)
3.
stresses that R&D is crucial for the development of innovative medicines, therapies
and diagnostics; stresses the importance of
investment and facilitated support for research
in the EU to
create a thriving EU pharmaceutical sector, and to be world market leader in
improving existing and developing new medicines which could then lead to an increase
of
the number of patents filed in the Member States; stresses that one of the priorities should be
to develop medicines in areas where needs have been met only inefficiently or not at all or
where commercial interest is low;
points out that public research should particularly focus
on areas of low commercial interest such as
orphan and paediatric medicines and
medicines to respond to antimicrobial resistance (AMR); recalls, in this respect, the key
role played by AI and its potential as a driver of research and development in the health and
pharmaceutical sector;
COMP 7 - Paragraph 3a and 3b
AM 42 (Renew), AM 43 (Renew), AM 50 (ID), AM 51 (ID), AM 57 (Greens/EFA)
3a. emphasises that full enjoyment of the potential of new innovative technologies also
depends on proper exploitation of and access to health data, which can help speed up the
identification of potential active substances, and support the development of new medicines
or therapies; notes that the current COVID-19 crisis has already demonstrated that data
sharing has been useful in accelerating research and strengthening public health
surveillance systems across the EU with the aim of saving lives;
3b. Believes that secure and open access to interoperable health data must be increased
while fully respecting EU data protection rules, and encourages the development of
platforms to monitor and provide information on the safety and efficacy of vaccines after
the authorisation procedure;
COMP 8 - Paragraph 4
AM 22 (EPP), AM 37(RE), AM 61 (EPP), AM 68 (ECR)
4. Recalls that Regulation (EC) No 816/2006 harmonises the procedure for granting
compulsory licences in relation to patents and supplementary protection certificates
concerning the manufacture and sale of pharmaceutical products, when such products are
intended for export to eligible importing countries in need of such products in order to
address public health problems; draws attention to the existing differences between the
Member States in terms of the validity of patents and supplementary protection certificates
and supports in this regard the IP Action Plan proposal including improving the
supplementary protection certificate (SPC) or patented medicinal products; recommends a
consistent EU application of the IP Enforcement Directive and stresses the importance of
launching the unitary patent without delay in order to create a one-stop-shop for patent
protection and enforcement across the EU and to
eliminate the fragmentation of the patent
market and the obstacle that may pose to research and innovation;
COMP 9 - Paragraph 4a
AM 31 (ID), AM 64 (EPP), AM 91 (ECR)
4a. emphasises that intellectual property plays a pivotal role in the expansion and growth
of SMEs, which are penalised by a lack of knowledge of procedures and by the lack of, or
inadequate, publicity about opportunities for them; calls for making the IP system more
effective for SMEs, through measures to simplify IP registration procedures (e.g. reform of
EU legislation on industrial designs), to improve access to strategic IP advice and to
facilitate the use of IP as a lever to access funding; highlights the need to allocate more
resources at European level to the fight against unfair and abusive practices on the market
for medicines; stresses in this regard the need to create new funding lines to support the
efforts of new start-ups and SMEs in the field of medical biotechnology;
COMP 10 - Paragraph 5
AM 23 (EPP), AM 38 (EPP), AM 73 (ID), AM 86 (EPP)
5.
Recalls that it is essential to continue to develop, improve and update European
frameworks for intellectual property to ensure that ideas and inventions can be developed
effectively and brought to market, particularly by and for SMEs; emphasises the
importance of a robust, efficient and balanced system of IP and trade secrets protection, as
well as the need for a coherent overall strategy ensuring both protection of innovation and
fair access to it; calls on the Commission to use all the means at its disposal to prevent
counterfeit products from entering the market
in order to protect intellectual property rights
holders and European citizens,
since such products are often of low quality and
dangerous to
health,
and have a major economic impact, estimated at a loss of at least EUR 10 billion to
the European pharmaceutical industry and 37 000 jobs;
notes that technical assistance to
the Member States is necessary for the proper implementation of the EMVS system;
stresses the need to ensure a smart use of IP and to better combat intellectual property
theft, as smart policies in this area are essential to help companies grow, create jobs and
protect and develop what makes them unique and competitive;
COMP 11 - Paragraph 5a
AM 44 (Renew), AM 74 (ECR), AM 77 (ID), AM 85 (EPP), AM 92 (ECR)
5a.
regrets that the EU is less attractive than other countries in terms of research and
development in the pharmaceutical sector; emphasises that the Union should focus on the
development of adequate production capacities for active substances, raw materials and
medicinal products, thus making it possible to reduce dependence on external sources;
recalls the need to bring the production of the most essential medicines back to the EU;
calls, therefore, on the Commission to prioritise pharmaceutical production of vaccines
within the EU and for Member States to be able to conclude public contracts with the
various European pharmaceutical laboratories producing vaccines in order to avoid
shortages of doses and ensure the safety of Europeans during such a crisis;
encourages the
simplification of procedures and the reduction of burdens in order to promote the
proliferation of new products for the market; calls for measures to improve the cooperation
of operations along the entire value chain and to generate strategic investment in research,
development, manufacturing and distribution of medicines and medical devices within the
EU;
COMP 12 - Paragraph 5b
AM 33 (Rapporteur), AM 83 (EPP), AM 78 (ECR)
5b. notes that most of the time radical innovations in the pharmaceutical sector are driven
by SMEs; stresses the importance of building appropriate legal and operational
frameworks that allow industry agility and flexibility to replenish stocks promptly, based on
the needs of patients in each country and using regional supply strategies, and the need to
establish regulatory solutions to facilitate flexible and scalable production and distribution
strategies; highlights the need for a dialogue with the industry to find viable solutions that
increase the joint capacity to prevent shortages; calls on the Commission to develop, at the
lowest possible cost, a digital platform as a contact point between Member States that
provides information and ensures communication and the provision of advice for Member
States to participate in innovation projects at national and European level; in this regard,
calls on Member States to share their practices to promote innovation;
COMP 13 - Paragraph 6
AM 80 (Greens), AM 82 (ECR)
6. Emphasises, lastly, the importance for European companies, in strategic sectors such as
pharmaceuticals, of contractual freedom in the areas of licensing and of the protection and
effective
and balanced enforcement of intellectual property rights, including in third
countries where they operate; calls on the Commission to develop and implement new
measures and tools for this purpose and to improve existing ones, such as the Intellectual
Property Helpdesk for SMEs;
calls on the Commission to provide easy public access to the
conditions governing the patent and licensing system, information on clinical and pre-
clinical trials and public and private contributions;
COMP 14 - Paragraph 6a
AM 41 (Renew), AM 63 (ID), AM 72 (EPP), AM 81 (ECR)
6a. Suggests to the Commission to carefully observe the pharmaceutical market and the
protection of pharmaceutical data, in particular with a view to improving access to generic
and biosimilar medicines, offering affordable treatments to a large number of patients and
achieving savings on healthcare expenditure through the positive price effect of competition;
points out that producers of generic medicines are often regional companies with less
resilience to supply problems and market turbulence; urges the Commission to promote legal
solutions that foster competitiveness in the field of generic medicine production, while
maintaining an appropriate legal balance between generic and innovative medicines;
supports greater generic and biosimilar competition combined with an appropriate market
protection mechanism; stresses that a possible revision of the so-called ‘Bolar’ exemption,
which allow for the conduct of trials on patented products to support generic and biosimilar
marketing authorisation applications without being regarded as infringing patent rights or
supplementary protection certificates for medicinal products, can only take place after a
comprehensive impact assessment;
