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Events

2017/06/29
   EC - Commission response to text adopted in plenary
Documents
2017/03/02
   EP - Results of vote in Parliament
2017/03/02
   EP - Decision by Parliament, 1st reading/single reading
Details

The European Parliament adopted by 568 votes to 30, with 52 abstentions, a resolution on the EU options for improving access to medicines.

Parliament recalled that public health systems are crucial to guaranteeing universal access to health care, a fundamental right of European citizens. Health systems in the EU face challenges such as an ageing population, the increasing burden of chronic illnesses, the high cost of development of new technologies, high and rising pharmaceutical expenses, and the effects of the economic crisis on healthcare spending. These challenges prompt the need for European cooperation and new policy measures at both EU and national level.

Pharmaceutical market, competition and pricing : Parliament highlighted the importance of both public and private R&D efforts in discovering new treatments. However, it stressed that the high level of public funds used for R&D is not reflected in the pricing which impedes a fair public return on public investment.

Members called for national and EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies , to guarantee the sustainability of EU public healthcare systems, and to ensure future investment in pharmaceutical innovation.

Deploring the litigation cases aiming to delay generic entry, Members pointed out that biosimilar medicines enable increased competition and that their market entry should not be delayed.

Members stressed the importance of assessing the real therapeutic, evidence-based added value of new medicines. The price of a medicine should cover the cost of the development and production of that medicine and should be in line with the therapeutic added value it brings to patients.

Main recommendations : Parliament called on the Commission and the Member States to:

reinforce the negotiation capacities of Member States in order to ensure affordable access to medicines across the EU; develop closer collaboration in order to fight such market fragmentation and to work on shared criteria to instruct price and reimbursement decisions at national level; propose a new directive on transparency of price-setting procedures and reimbursement systems; set up a framework to reinforce the competitiveness and use of generic and biosimilar medicines, guaranteeing their faster entry onto the market and monitoring unfair practices; observe and reinforce the EU competition legislation and its competencies on the pharmaceutical market in order to counter abuse and promote fair prices for patients; propose legislation on a European system for health technology assessment as soon as possible.

The resolution also called for the:

fostering of R&D driven by patients’ unmet needs, such as by researching new antimicrobials, given that drug-resistant diseases could cause 10 million deaths annually worldwide up to 2050; promotion of research in areas such as rare diseases and paediatric diseases ; adoption of strategic plans to ensure access to life-saving medicines (for instance the coordination of a plan to eradicate hepatitis C in the EU); establishment of framework conditions in the areas of research and medicine policy to be established in a way that promotes innovation, particularly against diseases, such as cancer , that cannot yet be treated to a satisfactory degree; evaluation of the implementation of the regulatory framework for orphan medicines ; promotion of ethical behaviour and transparency in the pharmaceutical sector, especially regarding clinical trials and the real cost of R&D, in the authorisation and assessment of innovation procedure.

Intellectual property : the Commission is called upon to analyse the overall impact of intellectual property on innovation on, and on patient access to, medicines, by means of a thorough and objective study, as requested by the Council in conclusions of 17 June 2016, and, in particular, to analyse in this study the impact of supplementary protection certificates (SPCs), data exclusivity and market exclusivity on the quality of innovation and competition.

Lastly, Members urged the Commission and the Member States to launch a high-level strategic dialogue with all the relevant stakeholders, together with representatives of the Parliament on current and future developments in the pharmaceutical system in the EU.

Documents
2017/03/02
   EP - End of procedure in Parliament
2017/03/01
   EP - Debate in Parliament
2017/02/14
   EP - Committee report tabled for plenary, single reading
Details

The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Soledad CABEZÓN RUIZ (S&D, ES) on the EU options for improving access to medicines.

Members recalled that public health systems are crucial to guaranteeing universal access to health care, a fundamental right of European citizens. Health systems in the EU face challenges such as an ageing population, the increasing burden of chronic illnesses, the high cost of development of new technologies, high and rising pharmaceutical expenses, and the effects of the economic crisis on healthcare spending. These challenges prompt the need for European cooperation and new policy measures at both EU and national level.

The report called for national and EU-wide measures to guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative therapies, to guarantee the sustainability of EU public healthcare systems, and to ensure future investment in pharmaceutical innovation.

Among other recommendations, Members called on the Commission and the Member States to:

reinforce the negotiation capacities of Member States in order to ensure affordable access to medicines across the EU; develop closer collaboration in order to fight such market fragmentation and to work on shared criteria to instruct price and reimbursement decisions at national level; propose a new directive on transparency of price-setting procedures and reimbursement systems; implement Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare in a fair way, avoiding limitations to the application of the rules on reimbursement of cross-border healthcare, including the reimbursement of medicine; foster R&D driven by patients’ unmet needs , such as by researching new antimicrobials, coordinating public resources for healthcare research in an effective and efficient manner, and promoting the social responsibility of the pharmaceutical sector; promote initiatives for guiding public and private-sector research towards bringing out innovative medicines for curing childhood illnesses ; promote public and private-sector research into medicines for female patients ; adopt strategic plans to ensure access to life-saving medicines; Members called in this regard, for the coordination of a plan to eradicate hepatitis C in the EU ; establish framework conditions in the areas of research and medicine policy to be established in a way that promotes innovation, particularly against diseases, such as cancer , that cannot yet be treated to a satisfactory degree; set up a framework to promote, guarantee and reinforce the competitiveness and use of generic and biosimilar medicines , guaranteeing their faster entry onto the market and monitoring unfair practices; evaluate the implementation of the regulatory framework for orphan medicines (especially as regards the concept of unmet medical need, how this concept is interpreted and what criteria need to be fulfilled in order to identify unmet medical need), to provide guidance on priority unmet medical need; promote ethical behaviour and transparency in the pharmaceutical sector, especially regarding clinical trials and the real cost of R&D, in the authorisation and assessment of innovation procedure; observe and reinforce the EU competition legislation and its competencies on the pharmaceutical market in order to counter abuse and promote fair prices for patients; propose legislation on a European system for health technology assessment as soon as possible; increase cooperation between the Member States as regards price-setting procedures.

The Commission is called upon to analyse the overall impact of intellectual property on innovation on, and on patient access to, medicines, by means of a thorough and objective study, as requested by the Council in conclusions of 17 June 2016, and, in particular, to analyse in this study the impact of supplementary protection certificates (SPCs), data exclusivity and market exclusivity on the quality of innovation and competition.

Lastly, Members urged the Commission and the Member States to launch a high-level strategic dialogue with all the relevant stakeholders, together with representatives of the Parliament on current and future developments in the pharmaceutical system in the EU, with the aim of establishing short-, medium- and long-term holistic strategies for ensuring access to medicines and for the sustainability of healthcare systems and a competitive pharmaceutical industry, leading to affordable prices and faster access to medicines for patients.

Documents
2017/01/31
   EP - Vote in committee, 1st reading/single reading
2016/11/18
   EP - Committee opinion
Documents
2016/11/15
   EP - Committee opinion
Documents
2016/11/09
   EP - Committee opinion
Documents
2016/10/21
   EP - Amendments tabled in committee
Documents
2016/10/21
   EP - Amendments tabled in committee
Documents
2016/09/19
   EP - Committee draft report
Documents
2016/07/11
   EP - DURAND Pascal (Verts/ALE) appointed as rapporteur in JURI
2016/05/02
   EP - MÉLIN Joëlle (ENF) appointed as rapporteur in EMPL
2016/04/28
   EP - Committee referral announced in Parliament, 1st reading/single reading
2016/04/18
   EP - EVI Eleonora (EFDD) appointed as rapporteur in PETI
2016/03/16
   EP - CORRAO Ignazio (EFDD) appointed as rapporteur in DEVE
2016/03/09
   EP - CABEZÓN RUIZ Soledad (S&D) appointed as rapporteur in ENVI

Documents

Activities

Votes

A8-0040/2017 - Soledad Cabezón Ruiz - § 8

2017/03/02 Outcome: +: 320, -: 306, 0: 23
IT ES FR AT SE PT RO EL GB DE CY MT FI IE HU EE BE DK LU LT NL SI LV HR BG SK CZ PL
Total
64
48
59
17
16
19
29
18
62
81
6
5
12
10
14
5
18
10
6
9
23
7
7
10
13
12
20
48
icon: S&D S&D
164

Cyprus S&D

2

Malta S&D

3

Ireland S&D

For (1)

1

Estonia S&D

For (1)

1

Luxembourg S&D

For (1)

1

Lithuania S&D

1

Netherlands S&D

3

Slovenia S&D

For (1)

1

Latvia S&D

1

Croatia S&D

2

Czechia S&D

3
icon: Verts/ALE Verts/ALE
47

Italy Verts/ALE

For (1)

1

Austria Verts/ALE

3

Finland Verts/ALE

For (1)

1

Hungary Verts/ALE

For (1)

1

Estonia Verts/ALE

For (1)

1

Belgium Verts/ALE

For (1)

1

Luxembourg Verts/ALE

For (1)

1

Lithuania Verts/ALE

For (1)

1

Netherlands Verts/ALE

2

Latvia Verts/ALE

1

Croatia Verts/ALE

For (1)

1
icon: GUE/NGL GUE/NGL
42

France GUE/NGL

2

Portugal GUE/NGL

3

Cyprus GUE/NGL

2

Finland GUE/NGL

For (1)

1

Denmark GUE/NGL

For (1)

1

Netherlands GUE/NGL

3
icon: ENF ENF
32

Austria ENF

Abstain (1)

4

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1

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1

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1

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2

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2
icon: EFDD EFDD
37

France EFDD

1

Sweden EFDD

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icon: NI NI
14

Italy NI

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1

France NI

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2

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2

Germany NI

2

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2

Poland NI

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1
icon: ALDE ALDE
59

Austria ALDE

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1

Sweden ALDE

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1

Portugal ALDE

1

Romania ALDE

3

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1

Ireland ALDE

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1

Estonia ALDE

Against (2)

2

Denmark ALDE

2

Luxembourg ALDE

Against (1)

1

Slovenia ALDE

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Latvia ALDE

1

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Bulgaria ALDE

2
icon: ECR ECR
66

Italy ECR

2

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icon: PPE PPE
187

Cyprus PPE

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Malta PPE

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Estonia PPE

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1

Belgium PPE

4

Denmark PPE

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1

Luxembourg PPE

3

Lithuania PPE

2
5

A8-0040/2017 - Soledad Cabezón Ruiz - Am 5

2017/03/02 Outcome: +: 331, -: 295, 0: 28
PL FR BG SK SI CZ FI HR LT NL BE LV LU DK EE DE HU RO IE PT MT CY GB SE AT EL ES IT
Total
48
60
13
12
7
20
12
10
9
23
19
7
6
10
5
81
15
29
10
19
5
6
62
16
17
18
49
65
icon: PPE PPE
188

Finland PPE

2

Belgium PPE

4

Luxembourg PPE

3

Denmark PPE

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1

Estonia PPE

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1

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2

Cyprus PPE

1
icon: ECR ECR
66

Bulgaria ECR

2

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2
2

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1

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2

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2

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1

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2
icon: ALDE ALDE
59

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1

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icon: ENF ENF
33

Poland ENF

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2

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1
icon: NI NI
14

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1

France NI

2

Germany NI

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2

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2

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icon: EFDD EFDD
37

Poland EFDD

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France EFDD

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icon: GUE/NGL GUE/NGL
42

France GUE/NGL

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3
icon: Verts/ALE Verts/ALE
48

Finland Verts/ALE

Against (1)

1

Croatia Verts/ALE

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Lithuania Verts/ALE

Against (1)

1

Netherlands Verts/ALE

2

Belgium Verts/ALE

2

Latvia Verts/ALE

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1

Luxembourg Verts/ALE

Against (1)

1

Estonia Verts/ALE

Against (1)

1

Hungary Verts/ALE

Against (1)

1

United Kingdom Verts/ALE

6

Austria Verts/ALE

3

Italy Verts/ALE

Against (1)

1
icon: S&D S&D
166
3
3

Slovenia S&D

Against (1)

1

Czechia S&D

3

Finland S&D

2

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2

Lithuania S&D

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Netherlands S&D

3

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Against (1)

1

Luxembourg S&D

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1
3

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1

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1

Malta S&D

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Cyprus S&D

2

A8-0040/2017 - Soledad Cabezón Ruiz - commission ENVI résolution

2017/03/02 Outcome: +: 568, 0: 52, -: 30
DE IT ES FR PL RO CZ PT BE AT HU GB BG NL FI SK IE HR SE EL LT DK LV SI LU CY EE MT
Total
80
63
49
59
48
29
20
19
19
17
15
62
13
23
12
12
10
10
16
18
9
10
7
7
6
6
5
5
icon: PPE PPE
188

Finland PPE

2

Denmark PPE

For (1)

1

Luxembourg PPE

3

Cyprus PPE

1

Estonia PPE

For (1)

1

Malta PPE

2
icon: S&D S&D
165

Czechia S&D

3

Netherlands S&D

3

Ireland S&D

For (1)

1

Croatia S&D

2

Lithuania S&D

1

Latvia S&D

1

Slovenia S&D

For (1)

1

Luxembourg S&D

For (1)

1

Cyprus S&D

2

Estonia S&D

For (1)

1

Malta S&D

3
icon: ALDE ALDE
59

Romania ALDE

3

Portugal ALDE

1

Austria ALDE

For (1)

1

United Kingdom ALDE

1

Bulgaria ALDE

2

Ireland ALDE

For (1)

1

Croatia ALDE

For (1)

1

Sweden ALDE

1

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2

Latvia ALDE

1

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1

Luxembourg ALDE

For (1)

1

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2
icon: Verts/ALE Verts/ALE
48

Italy Verts/ALE

For (1)

1

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2

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3

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For (1)

1

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2

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For (1)

1

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For (1)

1

Sweden Verts/ALE

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4

Lithuania Verts/ALE

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1

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1

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For (1)

1
icon: ECR ECR
66

Italy ECR

2

Romania ECR

For (1)

1

Czechia ECR

2

Belgium ECR

2

Bulgaria ECR

2

Netherlands ECR

2
2

Slovakia ECR

Abstain (1)

3

Croatia ECR

For (1)

1

Greece ECR

For (1)

1

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1

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1

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1
icon: GUE/NGL GUE/NGL
42

France GUE/NGL

2

Portugal GUE/NGL

3

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3

Finland GUE/NGL

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1

Denmark GUE/NGL

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1

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2
icon: EFDD EFDD
36

France EFDD

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1

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1

Czechia EFDD

Abstain (1)

1

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2

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1
icon: ENF ENF
32

Poland ENF

2

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Abstain (1)

1

Belgium ENF

Abstain (1)

1

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1

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2
icon: NI NI
13

Germany NI

For (1)

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2

Italy NI

For (1)

1

France NI

1

Poland NI

Against (1)

1

Hungary NI

2

United Kingdom NI

Against (1)

Abstain (1)

2
AmendmentsDossier
958 2016/2057(INI)
2016/07/25 PETI 97 amendments...
source: 582.218
2016/09/07 EMPL 85 amendments...
source: 587.640
2016/09/09 DEVE 84 amendments...
source: 589.201
2016/10/04 JURI 93 amendments...
source: 592.063
2016/10/21 ENVI 599 amendments...