BETA


2021/2013(INI) A Pharmaceutical Strategy for Europe

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI MONTSERRAT Dolors (icon: EPP EPP) MORETTI Alessandra (icon: S&D S&D), SØGAARD-LIDELL Linea (icon: Renew Renew), METZ Tilly (icon: Verts/ALE Verts/ALE), BALDASSARRE Simona (icon: ID ID), SLABAKOV Andrey (icon: ECR ECR), KONEČNÁ Kateřina (icon: GUE/NGL GUE/NGL)
Committee Opinion ITRE BOTENGA Marc (icon: GUE/NGL GUE/NGL) Joëlle MÉLIN (icon: ID ID), Dominique RIQUET (icon: RE RE), Jutta PAULUS (icon: Verts/ALE Verts/ALE), Ivo HRISTOV (icon: S&D S&D), Pernille WEISS (icon: PPE PPE), Margarita DE LA PISA CARRIÓN (icon: ECR ECR)
Committee Opinion TRAN
Committee Opinion IMCO
Committee Opinion JURI REGIMENTI Luisa (icon: ID ID) Emmanuel MAUREL (icon: GUE/NGL GUE/NGL), Angelika NIEBLER (icon: PPE PPE), Jana TOOM (icon: RE RE), Tiemo WÖLKEN (icon: S&D S&D), Kosma ZŁOTOWSKI (icon: ECR ECR), Marie TOUSSAINT (icon: Verts/ALE Verts/ALE)
Lead committee dossier:
Legal Basis:
RoP 54, RoP 57

Events

2022/03/18
   EC - Commission response to text adopted in plenary
Documents
2021/11/24
   EP - Decision by Parliament
Details

The European Parliament adopted by 527 votes to 92, with 70 abstentions, a resolution on a pharmaceutical strategy for Europe.

Health is fundamental to the well-being of Europeans and equitable access to healthcare is a cornerstone of the EU and Member States’ national health policies. 40 % of medicinal end products marketed in the EU originate in non-EU countries , while 60 % to 80 % of active pharmaceutical ingredients are produced in China and India. The disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector.

Putting patients at the centre of all health policies

Recognising the existence of inequalities in access to quality health services between and within Member States, Members called for national and European measures, including legislation, to address these disparities and ensure patients' right to universal, affordable, effective, safe and timely access to essential and innovative medicines .

Particular attention should be paid to people in vulnerable situations, including pregnant women, children, the elderly, people with disabilities, patients with chronic diseases and comorbidities, patients in intensive care units and people on long-term treatment.

Antimicrobial resistance (AMR)

Considering that AMR constitutes a serious threat to public health, Members recommend that the Commission introduce an EU therapeutic guide for antimicrobials , setting up traceable antimicrobial use reduction targets at EU level, and that communication campaigns on AMR be coordinated through a single calendar at EU level.

Research in pharmaceuticals

Parliament called on the Commission to assess, and revise where appropriate, the system of incentives to promote research into and the development of new medicines for unmet diagnostic and therapeutic needs , prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry to combat cancers, including paediatric cancers, rare diseases and neurodegenerative diseases. Members suggested that an EU framework should be created to guide and regularly evaluate the implementation of national plans to fight these diseases.

Pricing and costs of pharmaceuticals

Members called on the Commission to:

- promote dialogue with the Member States and all relevant stakeholders to promote ‘Made in Europe’ pharmaceuticals by strengthening manufacturing and supply resilience;

- promote information sharing among Member States on net medicine prices through the European Integrated Price Information Database (EURIPID) collaboration;

- introduce measures to increase transparency in the area of research into and the development and production of medicinal products;

- explore the possibility of establishing, subject to conditionalities, an EU fund, co-financed by the Member States, for negotiating and purchasing orphan medicines and other new medicines;

- address the root causes of shortages of pharmaceuticals and propose sustainable solutions and mitigations plans;

- be alert to anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry.

Role of generic and biosimilar medicines

Parliament stressed the importance of generic, biosimilar and value-added medicines for consistently increasing equitable access for patients and making healthcare systems sustainable in a European Union where access is still uneven. It called on the Commission to ensure healthy competition after the expiry of intellectual property exclusivities by ensuring access to biosimilar medicines from day one and removing all barriers to access to competition.

Parliament also recommended, inter alia, to:

- address the differences in the average number of days between the approval of a medicine and the moment it becomes available to patients in the EU, and implement solutions to reduce delays to the market entry of medicines ;

- facilitate the launch of large clinical trials conducted in a harmonised and coordinated manner at EU level;

- reassess the system that leads from conditional marketing authorisation to standard marketing authorisation or exceptional renewal of authorisation, based on robust clinical data;

- develop an early warning system for drug shortages based on a European digital platform;

- ensure full and harmonised application of the General Data Protection Regulation (GDPR) with regard to the conduct of clinical research across the EU;

- establish a structured dialogue on manufacturing and the supply chain and a broader, high-level political pharmaceutical forum to share the lessons learned from the COVID-19 emergency and to define an effective policy framework to prevent long-term shortages;

- ensure quality and environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries and address the problem of pharmaceutical household waste, through measures to reduce packaging.

Documents
2021/11/23
   EP - Results of vote in Parliament
2021/11/22
   EP - Debate in Parliament
2021/11/08
   EP - Committee report tabled for plenary
Details

The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Dolors MONTSERRAT (EPP, ES) on a pharmaceutical strategy for Europe.

Health is fundamental to the well-being of Europeans and equitable access to healthcare is a cornerstone of the EU and Member States’ national health policies. 40 % of medicinal end products marketed in the EU originate in non-EU countries, while 60 % to 80 % of active pharmaceutical ingredients are produced in China and India. The report noted that the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector.

Putting patients at the centre of all health policies

Members regretted the disparities in access to high-quality healthcare services, including access to medicinal products, among Member States and also among different regions within Member States. They called for national and EU measures, including legislative measures where appropriate, to address these disparities and guarantee the right of patients to universal, affordable, effective, safe and timely access to essential and innovative medicines.

Antimicrobial resistance (AMR)

Considering that AMR constitutes a serious threat to public health, Members recommend to the Commission to introduce an EU therapeutic guide for antimicrobials, setting up traceable antimicrobial use reduction targets at EU level, and that communication campaigns on AMR be coordinated through a single calendar at EU level.

Research in pharmaceuticals

The report called on the Commission to assess, and revise where appropriate, the system of incentives to promote research into and the development of new medicines for unmet diagnostic and therapeutic needs, prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry to combat cancers, including paediatric cancers. They suggested that an EU framework should be created to guide and regularly evaluate the implementation of national plans to fight these diseases.

Pricing and costs of pharmaceuticals

Members called on the Commission to:

- promote dialogue with the Member States and all relevant stakeholders to promote ‘ Made in Europe ’ pharmaceuticals by strengthening manufacturing and supply resilience;

- promote information sharing among Member States on net medicine prices through the European Integrated Price Information Database (EURIPID) collaboration;

- introduce measures to increase transparency in the area of research into and the development and production of medicinal products;

- address the root causes of shortages of pharmaceuticals and propose sustainable solutions and mitigations plans;

- be alert to anti-competitive conduct and investigate anti-competitive practices in the pharmaceutical industry.

Access to medicines in the EU

Members are concerned that the accessibility and affordability of medicines remain a challenge for national health systems, and that innovative medicines are expensive or in certain Member States not even brought to the market for commercial reasons. In this regard, the Commission is called on to assess policy options that help guarantee that centrally authorised medicines are marketed in all Member States and not just in those that are commercially interesting.

Structured dialogue with stakeholders

Members considered that a wider political High Level Pharmaceutical Forum is needed, bringing together policymakers and other relevant stakeholders in the healthcare supply chain, in order to share the lessons learnt from the COVID-19 emergency situation and to establish an effective policy framework to prevent shortages in the long term, enable access to medicines for patients, reduce delays, and ensure competitiveness and innovation.

Sustainable and environmentally friendly medicines

Lastly, the report stressed the need for the pharmaceutical industry to be environmentally friendly and climate-neutral throughout the lifecycles of medicinal products, while ensuring access to safe and effective pharmaceutical treatments for patients. The Commission is urged to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries and to address the problem of pharmaceutical household waste, through measures to reduce packaging .

Documents
2021/10/12
   EP - Vote in committee
2021/10/07
   EP - Committee opinion
Documents
2021/07/14
   EP - Committee opinion
Documents
2021/06/10
   EP - Amendments tabled in committee
Documents
2021/05/03
   EP - Committee draft report
Documents
2021/03/18
   EP - REGIMENTI Luisa (ID) appointed as rapporteur in JURI
2021/03/11
   EP - Committee referral announced in Parliament
2021/03/11
   EP - Referral to associated committees announced in Parliament
2021/02/17
   EP - MONTSERRAT Dolors (EPP) appointed as rapporteur in ENVI
2021/02/08
   EP - BOTENGA Marc (GUE/NGL) appointed as rapporteur in ITRE

Documents

Activities

Votes

Une stratégie pharmaceutique pour l’Europe - A Pharmaceutical Strategy for Europe - Arzneimittelstrategie für Europa - A9-0317/2021 - Dolors Montserrat - § 163 - Am 1 #

2021/11/23 Outcome: -: 501, +: 148, 0: 16
EL CY LU MT FR IE SK DK PT FI LT LV AT EE SI CZ HR BE SE HU BG NL DE ES RO PL IT
Total
18
6
6
6
56
13
14
14
18
14
11
8
19
7
8
21
12
20
21
21
17
28
93
54
33
52
75
icon: Verts/ALE Verts/ALE
72

Luxembourg Verts/ALE

For (1)

1

Ireland Verts/ALE

2

Denmark Verts/ALE

2

Portugal Verts/ALE

1

Finland Verts/ALE

3

Lithuania Verts/ALE

2

Latvia Verts/ALE

1

Austria Verts/ALE

3

Czechia Verts/ALE

3

Belgium Verts/ALE

3

Sweden Verts/ALE

3

Netherlands Verts/ALE

3

Spain Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: The Left The Left
38

Cyprus The Left

2

Ireland The Left

Against (2)

4

Denmark The Left

1

Finland The Left

For (1)

1

Czechia The Left

1

Belgium The Left

For (1)

1

Sweden The Left

For (1)

1

Netherlands The Left

For (1)

1
icon: NI NI
36

Greece NI

Against (1)

3

Slovakia NI

2

Lithuania NI

Abstain (1)

1

Croatia NI

Against (1)

Abstain (1)

2

Netherlands NI

Against (1)

1

Germany NI

2
icon: ID ID
45

Denmark ID

Against (1)

1

Finland ID

2

Austria ID

3

Estonia ID

Against (1)

1

Czechia ID

2
icon: ECR ECR
63

Greece ECR

1

Slovakia ECR

Against (1)

1

Lithuania ECR

Against (1)

1

Latvia ECR

2

Croatia ECR

Against (1)

1
3

Bulgaria ECR

2

Netherlands ECR

4

Germany ECR

Against (1)

1

Romania ECR

Against (1)

1
icon: Renew Renew
97

Luxembourg Renew

For (1)

Against (1)

2

Ireland Renew

2

Slovakia Renew

3

Finland Renew

3

Lithuania Renew

Against (1)

1

Latvia Renew

Against (1)

1

Austria Renew

Against (1)

1

Estonia Renew

3

Slovenia Renew

2

Croatia Renew

Against (1)

1

Sweden Renew

3

Hungary Renew

2

Bulgaria Renew

3

Poland Renew

1

Italy Renew

3
icon: S&D S&D
138

Greece S&D

Against (1)

1

Cyprus S&D

2

Luxembourg S&D

For (1)

1
4

Slovakia S&D

3

Finland S&D

2

Lithuania S&D

2

Latvia S&D

2

Estonia S&D

2

Slovenia S&D

Against (2)

2

Czechia S&D

Against (1)

1

Belgium S&D

3
icon: PPE PPE
176

Cyprus PPE

For (1)

Abstain (1)

2

Luxembourg PPE

2

Malta PPE

2

Denmark PPE

Against (1)

1

Latvia PPE

2

Estonia PPE

Against (1)

1

Slovenia PPE

4

Hungary PPE

Against (1)

1

Une stratégie pharmaceutique pour l’Europe - A Pharmaceutical Strategy for Europe - Arzneimittelstrategie für Europa - A9-0317/2021 - Dolors Montserrat - Proposition de résolution (ensemble du texte) #

2021/11/24 Outcome: +: 527, -: 92, 0: 70
IT DE ES PL RO HU FR NL AT BG EL PT SE SK BE LT SI CZ FI DK LV IE HR MT LU EE CY
Total
75
93
54
52
33
21
78
28
19
17
20
19
21
14
20
11
8
20
14
14
8
13
12
6
6
7
6
icon: PPE PPE
177

Hungary PPE

1

Denmark PPE

Against (1)

1

Latvia PPE

2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
2
icon: S&D S&D
141

Greece S&D

2

Lithuania S&D

2

Slovenia S&D

2

Czechia S&D

For (1)

1

Latvia S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2

Cyprus S&D

2
icon: Renew Renew
97

Italy Renew

3

Poland Renew

1

Hungary Renew

2

Austria Renew

For (1)

1
3

Lithuania Renew

1

Slovenia Renew

2

Finland Renew

3

Latvia Renew

For (1)

1

Ireland Renew

2

Croatia Renew

For (1)

1

Luxembourg Renew

2

Estonia Renew

3
icon: Verts/ALE Verts/ALE
70

Spain Verts/ALE

3

Poland Verts/ALE

For (1)

1

Netherlands Verts/ALE

3

Austria Verts/ALE

3

Portugal Verts/ALE

1

Sweden Verts/ALE

3

Belgium Verts/ALE

3

Lithuania Verts/ALE

2

Czechia Verts/ALE

3

Finland Verts/ALE

3

Denmark Verts/ALE

2

Latvia Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1
icon: NI NI
37

Germany NI

Against (1)

Abstain (1)

2

Netherlands NI

Against (1)

1

Slovakia NI

2

Lithuania NI

Abstain (1)

1

Croatia NI

Against (1)

Abstain (1)

2
icon: ECR ECR
63

Germany ECR

Abstain (1)

1

Romania ECR

Against (1)

1

Netherlands ECR

Abstain (1)

4

Bulgaria ECR

2

Greece ECR

Against (1)

1
3

Slovakia ECR

Abstain (1)

1

Lithuania ECR

Abstain (1)

1

Latvia ECR

For (1)

Abstain (1)

2

Croatia ECR

Against (1)

1
icon: ID ID
67

Austria ID

3

Czechia ID

Against (1)

1

Finland ID

2

Denmark ID

Against (1)

1

Estonia ID

Abstain (1)

1
icon: The Left The Left
37

Netherlands The Left

Against (1)

1

Sweden The Left

Against (1)

1

Belgium The Left

Against (1)

1

Czechia The Left

Against (1)

1

Finland The Left

Against (1)

1

Denmark The Left

Against (1)

1

Ireland The Left

4

Cyprus The Left

2
AmendmentsDossier
1112 2021/2013(INI)
2021/06/02 ITRE 296 amendments...
source: 692.747
2021/06/03 JURI 93 amendments...
source: 693.696
2021/06/10 ENVI 723 amendments...