# CE2004084EN.01033601.xml

| 3.4.2004 | EN | Official Journal of the European Union | CE 84/336 |
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3.4.2004

EN

Official Journal of the European Union

CE 84/336

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(2004/C 84 E/0396)

WRITTEN QUESTION E-0228/04

by Erik Meijer (GUE/NGL) to the Commission

(2 February 2004)

Subject:   Timely development and production of drugs to combat the merging of avian influenza virus H5N1 and influenza A occurring in humans

Subject:

| 1. | Is the Commission aware of the source of infection which recently emerged in Vietnam for ‘bird flu’ (avian influenza A), a constantly mutating virus which, in this instance, has occurred as variant H5N1? Is the Commission aware that it affects domestically kept birds in particular, such as poultry, but that the preventive culling of millions of birds in Vietnam could not prevent the virus from claiming five lives between 30 December 2003 and 19 January 2004 or, now, from spreading to South Korea and Japan via bird droppings? |
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1.

Is the Commission aware of the source of infection which recently emerged in Vietnam for ‘bird flu’ (avian influenza A), a constantly mutating virus which, in this instance, has occurred as variant H5N1? Is the Commission aware that it affects domestically kept birds in particular, such as poultry, but that the preventive culling of millions of birds in Vietnam could not prevent the virus from claiming five lives between 30 December 2003 and 19 January 2004 or, now, from spreading to South Korea and Japan via bird droppings?

| 2. | Is the Commission bearing in mind the possibility that the virus will combine naturally with a human pathogen known as the influenza A virus and subsequently reach Europe in a form which cannot be combated with currently available anti-viral drugs and that this will lead to a recurrence of the 1918-1919 pandemic which claimed 40 to 50 million lives? |
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2.

Is the Commission bearing in mind the possibility that the virus will combine naturally with a human pathogen known as the influenza A virus and subsequently reach Europe in a form which cannot be combated with currently available anti-viral drugs and that this will lead to a recurrence of the 1918-1919 pandemic which claimed 40 to 50 million lives?

| 3. | Are attempts already being made within the EU to combine the two viruses artificially, with a view to developing antibodies in time and making them available on a sufficient scale? In which Member States is this taking place? Who has the authority to take decisions on this? |
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3.

Are attempts already being made within the EU to combine the two viruses artificially, with a view to developing antibodies in time and making them available on a sufficient scale? In which Member States is this taking place? Who has the authority to take decisions on this?

| 4. | Is the research referred to in question 3 being obstructed or restricted in any way, for fear that a virus whose production has been accelerated through human intervention cannot be kept in isolation and that, potentially, this will cause an epidemic? Are there EU Member States in which, because of those fears, such research is not permitted? |
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4.

Is the research referred to in question 3 being obstructed or restricted in any way, for fear that a virus whose production has been accelerated through human intervention cannot be kept in isolation and that, potentially, this will cause an epidemic? Are there EU Member States in which, because of those fears, such research is not permitted?

| 5. | What contribution is the Commission making towards ensuring that anti-viral drugs are made available in time on a sufficient scale in Europe? |
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5.

What contribution is the Commission making towards ensuring that anti-viral drugs are made available in time on a sufficient scale in Europe?

Sources:TV Nederland 1, Netwerk 18.1.2004, www.netwerk.tv; World Health Organisation: www.who.int (in English); Erasmus medical Centre Rotterdam: www.virology.nl (in English).

Answer given by Mr Byrne on behalf of the Commission

(18 March 2004)

(18 March 2004)

| 1. and 2. | The Commission is very well aware of the risks posed by the current Avian Influenza epidemics in certain Asian countries. It is working in close contact with the animal and public health authorities of the Member States, the World Health Organization (WHO), the Food and Agriculture Organisation (FAO) and the World Organization for Animal Health (OIE) and it has already adopted three measures to prevent the introduction of avian influenza from the countries affected in Asia (1), in line with the EU veterinary legislation based on international guidelines. |
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1. and 2.

The Commission is very well aware of the risks posed by the current Avian Influenza epidemics in certain Asian countries. It is working in close contact with the animal and public health authorities of the Member States, the World Health Organization (WHO), the Food and Agriculture Organisation (FAO) and the World Organization for Animal Health (OIE) and it has already adopted three measures to prevent the introduction of avian influenza from the countries affected in Asia (1), in line with the EU veterinary legislation based on international guidelines.

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| 3. | In the context of the ‘Fifth Research and Technological Development (RTD) Framework Programme’, the Commission is providing financial support to the following projects on influenza virus infections in animals and humans and developing of new tools to combat influenza infections:






  — | ‘Pathogenesis and improved diagnosis and control of avian influenza infections’ (Project Reference: QLK2-CT-2002-01454, Community funding: EUR 1,84 million). |
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3.

In the context of the ‘Fifth Research and Technological Development (RTD) Framework Programme’, the Commission is providing financial support to the following projects on influenza virus infections in animals and humans and developing of new tools to combat influenza infections:

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‘Pathogenesis and improved diagnosis and control of avian influenza infections’ (Project Reference: QLK2-CT-2002-01454, Community funding: EUR 1,84 million).

| — | ‘European surveillance network for influenza in pigs’, (Community financing: EUR 269 984). |
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‘European surveillance network for influenza in pigs’, (Community financing: EUR 269 984).

| — | ‘Preparing for an influenza pandemic — Flupan’ (Project reference: QLK2-CT-2001-01786, Community funding: EUR 2,1 million). |
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‘Preparing for an influenza pandemic — Flupan’ (Project reference: QLK2-CT-2001-01786, Community funding: EUR 2,1 million).

| — | ‘Novel vaccination strategies and vaccine formulations for epidemic and pandemic influenza control Novaflu2001’ (Project Reference: QLK2-CT-2002-01034, Community funding: EUR 1,76 million). |
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‘Novel vaccination strategies and vaccine formulations for epidemic and pandemic influenza control Novaflu2001’ (Project Reference: QLK2-CT-2002-01034, Community funding: EUR 1,76 million).

| 4. | The Commission is not aware of any restrictions or obstructions to this research within the European Union. Laboratory safety and handling of microorganisms is regulated in Council Directives 90/219/EEC of 23 April 1990 (2) (Directive on the contained use of genetically modified micro-organisms), 90/220/EEC of 23 April 1990 (2) (Directive on the deliberate release into the environment of genetically modified organisms), 89/391/EEC of 12 June 1989 (3) (Directive on the introduction of measures to encourage improvements in the safety and health of workers at work), in Directive 2000/54/EC of the Parliament and of the Council of 18 September 2000 (4) (Directive on the protection of workers from risks related to exposure to biological agents at work), and guided by EU-norms EN 12128, 12738, 12740, and 12741. |
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4.

The Commission is not aware of any restrictions or obstructions to this research within the European Union. Laboratory safety and handling of microorganisms is regulated in Council Directives 90/219/EEC of 23 April 1990 (2) (Directive on the contained use of genetically modified micro-organisms), 90/220/EEC of 23 April 1990 (2) (Directive on the deliberate release into the environment of genetically modified organisms), 89/391/EEC of 12 June 1989 (3) (Directive on the introduction of measures to encourage improvements in the safety and health of workers at work), in Directive 2000/54/EC of the Parliament and of the Council of 18 September 2000 (4) (Directive on the protection of workers from risks related to exposure to biological agents at work), and guided by EU-norms EN 12128, 12738, 12740, and 12741.

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| 5. | The Commission consults widely on health protection issues in order to strengthen the Community preparedness and response to influenza pandemic threats. Part of these consultations concerns the pharmaceutical industry and its associations, including the European Federation of the Pharmaceutical Industry Association (EFPIA). On the Commission's initiative information is shared among the Member States' authorities on strategies for the availability of efficient antiviral drugs for prophylaxis and treatment. |
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5.

The Commission consults widely on health protection issues in order to strengthen the Community preparedness and response to influenza pandemic threats. Part of these consultations concerns the pharmaceutical industry and its associations, including the European Federation of the Pharmaceutical Industry Association (EFPIA). On the Commission's initiative information is shared among the Member States' authorities on strategies for the availability of efficient antiviral drugs for prophylaxis and treatment.

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(1)  Commission Decision 2004/84/EC of 23.1.2004, OJ L 17, 24.1.2004, Commission Decision 2004/93/EC of 29.1.2004, OJ L 27, 30.1.2004, and Commission Decision 2004/122/EC of 6.2.2004, OJ L 36, 7.2.2004.

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(2)  OJ L 117, 8.5.1990.

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(3)  OJ L 183, 29.6.1989.

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(4)  OJ L 262, 17.10.2000.

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