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Events

2021/02/11
   EC - Commission response to text adopted in plenary
Documents
2020/09/17
   EP - Results of vote in Parliament
2020/09/17
   EP - Decision by Parliament
Details

The European Parliament adopted by 663 votes to 23, with 10 abstentions, a resolution on shortage of medicines - how to address an emerging problem.

The long-standing problem of shortages of medicines within the EU has worsened during the COVID-19 pandemic, with direct negative consequences for the health and safety of patients and the continuation of their treatment.

Parliament called for the establishment of a genuine pharmaceutical industrial strategy to enable the EU to regain its health sovereignty and called for better coordination between EU countries to address the drug shortage.

The European response to the shortage of medicines shall be based on four pillars:

(1) Restoring the EU's independence in health matters by securing supply

With 40% of medicines marketed in the EU today coming from third countries and between 60-80% of chemical active substances being produced in China and India, Parliament considered it geostrategically imperative for the EU to regain its independence in the field of healthcare, to ensure a rapid and efficient supply of medicines, medical equipment, diagnostic tools and vaccines at affordable prices and to prevent shortages in these areas, giving priority to the interests and safety of patients.

Members called on the Commission and Member States to:

- take the necessary measures to guarantee the security of supply of medical products, reduce the EU's dependence on third countries and support the local manufacture of medicines of major therapeutic interest, giving priority to medicines of health and strategic interest;

- establish a precise mapping of potential production sites within the European Union in order to be able to preserve, modernise and strengthen their capacity where necessary;

- make the shortage of medicines one of the pillars of the Commission's forthcoming pharmaceutical strategy and create a Pharmaceutical Forum, overseen by the European Medicines Agency, bringing together relevant stakeholders in the healthcare supply chain to prevent shortages;

- introduce financial measures and incentives in line with state aid rules in order to encourage the industry to locate its activities in Europe, from the production of active ingredients to the manufacturing, packaging and distribution of medicines;

- consider setting up harmonised shortage prevention and management plans that require manufacturers to identify drugs of major therapeutic interest that require the introduction of measures to avoid supply disruptions;

- make security of supply a priority criterion in drug-related tendering procedures;

- create one or more non-profit European pharmaceutical undertakings capable of producing certain medicines of strategic importance for health care in emergencies, in the absence of existing industrial production, in order to prevent possible shortages of medicines in case of emergency;

- assess foreign direct investment in pharmaceutical production sites, which are part of Europe's essential health infrastructure;

- creating an environment to ensure that Europe continues to be an attractive location for R&D investment to encourage research, development and manufacturing in Europe and to ensure that Europe remains the leading region in the world for the manufacture of active ingredients for patent medicines.

Members called for joint action on the prevention of shortage of medicines, to be funded by the future health programme.

(2) Strengthen European action to better coordinate and complement Member States' health policies

Parliament recommended:

- greater transparency in the production and distribution chain of medicines and the creation of a European unit for the prevention and management of shortages;

- the development of health strategies at European level with a common basket of drugs against cancer, infectious diseases, rare diseases and in other areas particularly affected by shortages, as well as examining the possibility of setting harmonised criteria for pricing to make these medicines affordable;

- the creation of a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages and create an emergency European pharmacy;

- the development of innovative and coordinated strategies and the strengthening of the exchange of best practices in stock management;

- the introduction of new European joint procurement procedures to combat shortages, particularly in times of health crises, with simplified and transparent procedures for greater responsiveness.

(3) Strengthening cooperation among Member States

Members considered it essential to improve early communication to both health professionals and patients on the availability of medicines through innovative digital tools. Member States shall share information such as epidemiological forecasts with all relevant stakeholders to help them plan their activities better in the face of rising demand and respond better to needs at times of shortages.

Members pointed out that misinformation can lead to the inappropriate use of medicines and the creation of unnecessary stockpiling.

(4) Preventing and responding to shortages in the event of health crises

Parliament called on the Commission, in close collaboration with the Member States, to adopt a European pandemic preparedness plan in order to ensure a coordinated and effective response. It also called for simplified legislation and more flexible regulatory measures in times of crisis to alleviate shortages and facilitate the movement of medicines between Member States, such as the acceptance of different packaging formats, extended expiry dates or the use of veterinary medicines.

Documents
2020/09/17
   EP - End of procedure in Parliament
2020/07/22
   EP - Committee report tabled for plenary
Details

The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Nathalie COLIN-OESTERLÉ (EPP, FR) on the shortage of medicines - how to address an emerging problem.

The long-standing problem of shortages of medicine in the EU has worsened during the COVID-19 health crisis, with direct negative consequences on the health and safety of patients and their continued treatment.

The report called for the establishment of a genuine pharmaceutical industrial strategy to enable the European Union to regain its health sovereignty and called for better coordination among EU countries to address the shortage of medicines.

Members believe that the European response to the shortage of medicines should be based on four pillars:

1) Restoring the EU's independence in health matters by securing supply

Recalling that 40% of medicinal end products marketed in the EU originate in third countries and 80% of active pharmaceutical ingredients are produced in China and India, Members called on the Commission and Member States to:

- take the necessary measures to guarantee the security of supply of medical products, reduce the EU's dependence on third countries and support the local manufacture of medicines of major therapeutic interest, giving priority to medicines of health and strategic interest;

- establish a precise mapping of potential production sites within the European Union in order to be able to preserve, modernise and strengthen their capacity where necessary;

- make the shortage of medicines one of the pillars of the Commission's forthcoming pharmaceutical strategy and create a Pharmaceutical Forum, overseen by the European Medicines Agency, bringing together relevant stakeholders in the healthcare supply chain to prevent shortages;

- introduce financial measures and incentives in line with state aid rules to protect the EU pharmaceutical industrial base and encourage the industry to locate its activities in Europe, from the production of active ingredients to the manufacturing, packaging and distribution of medicines;

- consider setting up harmonised shortage prevention and management plans that require manufacturers to identify drugs of major therapeutic interest that require the introduction of measures to avoid supply disruptions;

- make security of supply a priority criterion in drug-related tendering procedures;

- create one or more non-profit European pharmaceutical undertakings capable of producing certain medicines of strategic importance for health care in emergencies, in the absence of existing industrial production, in order to prevent possible shortages of medicines in case of emergency;

- create an environment to ensure that Europe remains an attractive location for R&D investment and maintain a strong European intellectual property system in the context of the forthcoming pharmaceutical strategy, in order to encourage research, development and manufacturing in Europe, to ensure that Europe remains a world-class innovator and ultimately to protect and strengthen Europe's strategic autonomy in the field of public health.

Members called for joint action to prevent drug shortages, to be funded by the future health programme.

2) Strengthen European action to better coordinate and complement Member States' health policies

The committee recommended:

- greater transparency in the production and distribution chain of medicines and the creation of a European unit for the prevention and management of shortages;

- the development of health strategies at European level with a common basket of drugs against cancer, infectious diseases, rare diseases and in other areas particularly affected by shortages, as well as examining the possibility of setting harmonised criteria for pricing to make these medicines affordable;

- the creation of a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages and create an emergency European pharmacy;

- the development of innovative and coordinated strategies and the strengthening of the exchange of best practices in stock management;

- the introduction of new European joint procurement procedures to combat shortages, particularly in times of health crises, with simplified and transparent procedures for greater responsiveness.

3) Strengthening cooperation among Member States

- set up an innovative, transparent and centralised digital platform to report harmonised information provided by national agencies and all stakeholders on available stocks and shortages of medicines and medical equipment;

- improve early communication with healthcare professionals and patients on the availability of medicines through the use of innovative digital tools;

- share with all the actors involved information such as epidemiological forecasts to help them plan their activities better in the face of rising demand and respond better to needs at times of shortage.

4) Preventing and responding to shortages in the event of health crises

Members called on the Commission, in close collaboration with the Member States, to adopt a European pandemic preparedness plan in order to ensure a coordinated and effective response. They also called for simplified legislation and more flexible regulatory measures in times of crisis to alleviate shortages and facilitate the movement of medicines between Member States, such as the acceptance of different packaging formats, extended expiry dates or the use of veterinary medicines.

Documents
2020/07/14
   EP - Vote in committee
2020/06/17
   EP - Committee opinion
Documents
2020/06/16
   EP - Committee opinion
Documents
2020/06/15
   EP - Specific opinion
Documents
2020/06/11
   EP - Committee opinion
Documents
2020/06/08
   EP - Amendments tabled in committee
Documents
2020/06/08
   EP - Amendments tabled in committee
Documents
2020/06/08
   EP - Amendments tabled in committee
Documents
2020/05/28
   EP - Committee opinion
Documents
2020/05/27
   EP - Committee referral announced in Parliament
2020/05/27
   EP - Referral to associated committees announced in Parliament
2020/05/13
   EP - KEMPA Beata (ECR) appointed as rapporteur in DEVE
2020/05/04
   EP - LEBRETON Gilles (ID) appointed as rapporteur in JURI
2020/04/30
   EP - Committee draft report
Documents
2020/04/28
   EP - CAMPOMENOSI Marco (ID) appointed as rapporteur in TRAN
2020/04/23
   EP - MÉLIN Joëlle (ID) appointed as rapporteur in ITRE
2020/04/15
   EP - KOVATCHEV Andrey (EPP) appointed as rapporteur in INTA
2020/03/25
   EP - COLIN-OESTERLÉ Nathalie (EPP) appointed as rapporteur in ENVI

Documents

Votes

A9-0142/2020 - Nathalie Colin-Oesterlé - § 60 #

2020/09/16 Outcome: +: 376, -: 256, 0: 58
FR BE HU ES DE PT FI AT RO IE CY CZ DK EE MT LT LU SK SI LV EL NL BG HR SE PL IT
Total
79
21
20
59
95
20
14
19
29
12
6
21
14
7
6
11
5
14
8
8
20
28
17
11
21
50
75
icon: S&D S&D
143

Cyprus S&D

2

Estonia S&D

2

Lithuania S&D

2

Luxembourg S&D

For (1)

1

Slovenia S&D

2

Latvia S&D

2

Greece S&D

2
icon: Renew Renew
96

Hungary Renew

2

Finland Renew

3

Austria Renew

For (1)

1

Ireland Renew

2

Estonia Renew

3

Lithuania Renew

2

Luxembourg Renew

For (1)

1

Slovakia Renew

2

Slovenia Renew

2

Latvia Renew

For (1)

1

Croatia Renew

For (1)

1

Italy Renew

For (1)

1
icon: Verts/ALE Verts/ALE
68

Belgium Verts/ALE

3

Spain Verts/ALE

3

Portugal Verts/ALE

1

Finland Verts/ALE

3

Austria Verts/ALE

3

Ireland Verts/ALE

2

Czechia Verts/ALE

3

Denmark Verts/ALE

2

Lithuania Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Netherlands Verts/ALE

3

Sweden Verts/ALE

3
icon: GUE/NGL GUE/NGL
38

Belgium GUE/NGL

For (1)

1

Portugal GUE/NGL

3

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2

Czechia GUE/NGL

1

Denmark GUE/NGL

1

Netherlands GUE/NGL

For (1)

1

Sweden GUE/NGL

For (1)

1
icon: NI NI
28

Hungary NI

1

Germany NI

2

Slovakia NI

2

Netherlands NI

Abstain (1)

1

Croatia NI

2
icon: ID ID
75

Finland ID

2
3

Czechia ID

2

Denmark ID

Abstain (1)

1

Estonia ID

Against (1)

1

Netherlands ID

Against (1)

1
icon: ECR ECR
61

Germany ECR

Against (1)

1

Lithuania ECR

Against (1)

1

Slovakia ECR

2

Latvia ECR

2

Greece ECR

Against (1)

1

Netherlands ECR

4

Bulgaria ECR

2

Croatia ECR

Against (1)

1
3
icon: PPE PPE
181

Finland PPE

3

Cyprus PPE

For (1)

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2

Denmark PPE

Against (1)

1

Estonia PPE

Against (1)

1

Malta PPE

2

Luxembourg PPE

2

Slovenia PPE

4

Latvia PPE

2

A9-0142/2020 - Nathalie Colin-Oesterlé - § 93/1 #

2020/09/16 Outcome: +: 649, -: 28, 0: 13
FR DE IT ES PL RO NL HU CZ PT AT SE BE BG EL SK IE LT FI HR LV SI DK CY MT LU EE
Total
79
95
75
59
50
29
28
20
21
20
19
21
21
17
20
14
12
11
14
11
8
8
14
6
6
5
7
icon: PPE PPE
181

Latvia PPE

2

Denmark PPE

For (1)

1
2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
icon: S&D S&D
143

Greece S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2
icon: Renew Renew
96

Italy Renew

For (1)

1

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Ireland Renew

2

Lithuania Renew

2

Finland Renew

3

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Luxembourg Renew

For (1)

1

Estonia Renew

3
icon: Verts/ALE Verts/ALE
68

Spain Verts/ALE

3

Netherlands Verts/ALE

3

Czechia Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

3

Sweden Verts/ALE

3

Belgium Verts/ALE

3

Ireland Verts/ALE

2

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Latvia Verts/ALE

1

Denmark Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1
icon: ID ID
75

Netherlands ID

Against (1)

1

Czechia ID

For (1)

Against (1)

2
3

Finland ID

2

Denmark ID

Abstain (1)

1

Estonia ID

Against (1)

1
icon: GUE/NGL GUE/NGL
38

Netherlands GUE/NGL

For (1)

1

Czechia GUE/NGL

1

Portugal GUE/NGL

Abstain (1)

3

Sweden GUE/NGL

For (1)

1

Belgium GUE/NGL

For (1)

1

Finland GUE/NGL

For (1)

1

Denmark GUE/NGL

1

Cyprus GUE/NGL

2
icon: ECR ECR
61

Germany ECR

For (1)

1

Netherlands ECR

4
3

Bulgaria ECR

2

Greece ECR

1

Slovakia ECR

Against (1)

2

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: NI NI
28

Germany NI

2

Netherlands NI

1

Hungary NI

1

Slovakia NI

2

Croatia NI

2

A9-0142/2020 - Nathalie Colin-Oesterlé - § 93/2 #

2020/09/16 Outcome: +: 395, -: 286, 0: 9
ES FR PT BE DE IE FI AT LU CY EE RO MT SK BG LT LV CZ SE SI EL HR NL DK HU PL IT
Total
59
79
20
21
95
12
14
19
5
6
7
29
6
14
17
11
8
21
21
8
20
11
28
14
20
50
75
icon: S&D S&D
143

Luxembourg S&D

For (1)

1

Cyprus S&D

2

Estonia S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Greece S&D

2
icon: Renew Renew
96

Ireland Renew

2

Finland Renew

3

Austria Renew

For (1)

1

Luxembourg Renew

For (1)

1

Estonia Renew

3

Slovakia Renew

2

Lithuania Renew

2

Latvia Renew

For (1)

1

Sweden Renew

Abstain (1)

3

Slovenia Renew

2

Croatia Renew

For (1)

1

Hungary Renew

2

Italy Renew

For (1)

1
icon: Verts/ALE Verts/ALE
68

Spain Verts/ALE

3

Portugal Verts/ALE

1

Belgium Verts/ALE

3

Ireland Verts/ALE

2

Finland Verts/ALE

3

Austria Verts/ALE

3

Luxembourg Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Latvia Verts/ALE

1

Czechia Verts/ALE

3

Sweden Verts/ALE

3

Netherlands Verts/ALE

3

Denmark Verts/ALE

2
icon: GUE/NGL GUE/NGL
38

Portugal GUE/NGL

Abstain (1)

3

Belgium GUE/NGL

For (1)

1

Ireland GUE/NGL

Against (1)

4

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2

Czechia GUE/NGL

1

Sweden GUE/NGL

Against (1)

1

Netherlands GUE/NGL

For (1)

1

Denmark GUE/NGL

1
icon: NI NI
28

Germany NI

2

Slovakia NI

For (1)

Abstain (1)

2

Greece NI

Abstain (1)

3

Croatia NI

2

Netherlands NI

1

Hungary NI

1
icon: ID ID
75

Finland ID

2
3

Estonia ID

Against (1)

1

Czechia ID

Against (2)

2

Netherlands ID

Against (1)

1

Denmark ID

Abstain (1)

1
icon: ECR ECR
61

Germany ECR

Against (1)

1

Slovakia ECR

2

Bulgaria ECR

2

Lithuania ECR

Against (1)

1

Latvia ECR

2
3

Greece ECR

Against (1)

1

Croatia ECR

Against (1)

1

Netherlands ECR

4
icon: PPE PPE
181

Finland PPE

Against (1)

3

Luxembourg PPE

2

Cyprus PPE

Against (1)

2

Estonia PPE

Against (1)

1

Malta PPE

2

Latvia PPE

Against (1)

Abstain (1)

2

Slovenia PPE

4

Denmark PPE

Against (1)

1

A9-0142/2020 - Nathalie Colin-Oesterlé - Résolution #

2020/09/17 Outcome: +: 663, -: 23, 0: 10
IT FR DE ES PL RO NL HU BE PT AT CZ BG SE EL DK SK IE LT HR FI LV SI CY MT LU EE
Total
75
79
94
59
51
31
29
21
20
21
19
20
17
21
21
14
14
12
11
12
14
8
8
6
6
6
7
icon: PPE PPE
185

Denmark PPE

For (1)

1

Latvia PPE

2
2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
icon: S&D S&D
144

Greece S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2
icon: Renew Renew
97

Italy Renew

For (1)

1

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Ireland Renew

2

Lithuania Renew

2

Croatia Renew

For (1)

1

Finland Renew

3

Latvia Renew

For (1)

1

Slovenia Renew

2

Luxembourg Renew

2

Estonia Renew

3
icon: Verts/ALE Verts/ALE
67

Spain Verts/ALE

3

Netherlands Verts/ALE

3

Belgium Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

3

Czechia Verts/ALE

3

Sweden Verts/ALE

3

Denmark Verts/ALE

2

Ireland Verts/ALE

2

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: ECR ECR
61

Germany ECR

For (1)

1

Bulgaria ECR

2
3

Greece ECR

Abstain (1)

1

Slovakia ECR

Against (1)

2

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: ID ID
75

Netherlands ID

Against (1)

1
3

Czechia ID

Against (1)

1

Denmark ID

Abstain (1)

1

Finland ID

2

Estonia ID

Against (1)

1
icon: GUE/NGL GUE/NGL
38

Netherlands GUE/NGL

For (1)

1

Belgium GUE/NGL

For (1)

1

Portugal GUE/NGL

4

Czechia GUE/NGL

1

Sweden GUE/NGL

For (1)

1

Denmark GUE/NGL

1

Ireland GUE/NGL

3

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2
icon: NI NI
29

Germany NI

2

Netherlands NI

1

Hungary NI

1

Slovakia NI

2

Croatia NI

Abstain (1)

2
AmendmentsDossier
1068 2020/2071(INI)
2020/05/18 INTA 69 amendments...
source: 652.313
2020/05/19 ITRE 254 amendments...