# CE2012136EN.01004401.xml

| 11.5.2012 | EN | Official Journal of the European Union | CE 136/44 |
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11.5.2012

EN

Official Journal of the European Union

CE 136/44

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Wednesday 19 January 2011Asthma inhalers

P7_TA(2011)0017

European Parliament resolution of 19 January 2011 on Petition 0473/2008 by Christoph Klein (German), concerning the failure of the Commission to take action regarding a competition case and the harmful impact of this on the company concerned

2012/C 136 E/08

The European Parliament,

The European Parliament

| — | having regard to the question of 10 November 2010 to the Commission on Petition 0473/2008 by Christoph Klein (German), concerning the failure of the Commission to take action regarding a competition case and the harmful impact of this on the company concerned (O-0182/2010 – B7-0666/2010), |
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having regard to the question of 10 November 2010 to the Commission on Petition 0473/2008 by Christoph Klein (German), concerning the failure of the Commission to take action regarding a competition case and the harmful impact of this on the company concerned (O-0182/2010 – B7-0666/2010),

| — | having regard to Article 227 of the Treaty on the Functioning of the European Union, |
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having regard to Article 227 of the Treaty on the Functioning of the European Union,

| — | having regard to Rules 115(1) and 110(2) of its Rules of Procedure, |
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having regard to Rules 115(1) and 110(2) of its Rules of Procedure,

| — | having regard to Rules 201 and 202 of its Rules of Procedure, |
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having regard to Rules 201 and 202 of its Rules of Procedure,

| A. | whereas the applicable legal framework in this case is Council Directive 93/42/EEC (1) concerning medical devices, which provides that manufacturers of Class I medical devices can place such a device on the market without intervention by a notified body or an authority, and that is up to manufacturers to demonstrate that their devices meet the requirements of the directive, |
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A.

whereas the applicable legal framework in this case is Council Directive 93/42/EEC (1) concerning medical devices, which provides that manufacturers of Class I medical devices can place such a device on the market without intervention by a notified body or an authority, and that is up to manufacturers to demonstrate that their devices meet the requirements of the directive,

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| B. | whereas Member States, in order to ensure that these requirements are met, are under an obligation to carry out market surveillance and to take the necessary measures, which include the safeguard clause procedure under Article 8 and measures under Article 18 in the case of an unduly affixed CE marking, |
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B.

whereas Member States, in order to ensure that these requirements are met, are under an obligation to carry out market surveillance and to take the necessary measures, which include the safeguard clause procedure under Article 8 and measures under Article 18 in the case of an unduly affixed CE marking,

| C. | whereas the manufacturer concerned demonstrated to the responsible authority in the Member State that its device fulfilled all legal requirements for the placing of a Class I medical device and product carrying the CE marking on the market, |
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C.

whereas the manufacturer concerned demonstrated to the responsible authority in the Member State that its device fulfilled all legal requirements for the placing of a Class I medical device and product carrying the CE marking on the market,

| D. | whereas a Member State through the responsible authority, when it takes the appropriate interim measures to withdraw a device from the market or prohibit or restrict its being placed on the market, is required to inform the Commission immediately of any such measures, indicating the reasons for its decision, |
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D.

whereas a Member State through the responsible authority, when it takes the appropriate interim measures to withdraw a device from the market or prohibit or restrict its being placed on the market, is required to inform the Commission immediately of any such measures, indicating the reasons for its decision,

| E. | whereas the German authorities had been expressing safety concerns about the device in question (an inhaler) since 1996 and had informed the Commission about the matter with a view to a safeguard procedure, but the Commission did not consult the manufacturer and never issued a ruling; and whereas, as a result, a decision on the matter is still pending and the petitioner is left without any available means of legal redress, |
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E.

whereas the German authorities had been expressing safety concerns about the device in question (an inhaler) since 1996 and had informed the Commission about the matter with a view to a safeguard procedure, but the Commission did not consult the manufacturer and never issued a ruling; and whereas, as a result, a decision on the matter is still pending and the petitioner is left without any available means of legal redress,

| F. | whereas the authorities of Saxony-Anhalt imposed a sales ban on the device in 1997, at the insistence of the Bavarian authorities, |
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F.

whereas the authorities of Saxony-Anhalt imposed a sales ban on the device in 1997, at the insistence of the Bavarian authorities,

| G. | whereas the company legally sold products before the first sales injunction was issued in 1997, and, according to the authority responsible, satisfied all the provisions of Council Directive 93/42/EEC, |
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G.

whereas the company legally sold products before the first sales injunction was issued in 1997, and, according to the authority responsible, satisfied all the provisions of Council Directive 93/42/EEC,

| H. | whereas the manufacturer placed the device on the market under a new name in 2003, and in 2005 the Government of Upper Bavaria ordered it to be withdrawn from the market, under the German Medical Devices Act, without informing the Commission accordingly, |
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H.

whereas the manufacturer placed the device on the market under a new name in 2003, and in 2005 the Government of Upper Bavaria ordered it to be withdrawn from the market, under the German Medical Devices Act, without informing the Commission accordingly,

| I. | whereas, in 2006, the manufacturer informed the Commission of the second sales prohibition with a view to initiating infringement proceedings against Germany for breach of Article 8(1) of Directive 93/42/EEC, |
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I.

whereas, in 2006, the manufacturer informed the Commission of the second sales prohibition with a view to initiating infringement proceedings against Germany for breach of Article 8(1) of Directive 93/42/EEC,

| J. | whereas the Commission claims that there was insufficient proof that the inhaler satisfied the essential requirements, as stipulated in Directive 93/42/EEC, and it concluded that there was no need for a new product safety review because the case fell under Article 18 rather than Article 8 of the Directive, |
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J.

whereas the Commission claims that there was insufficient proof that the inhaler satisfied the essential requirements, as stipulated in Directive 93/42/EEC, and it concluded that there was no need for a new product safety review because the case fell under Article 18 rather than Article 8 of the Directive,

| K. | whereas the manufacturer submitted a petition to the European Parliament in 2008 stating that the Commission, in its handling of the case, had breached its obligations under the directive and failed to fulfil its duty to act as the Guardian of the Treaties, |
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K.

whereas the manufacturer submitted a petition to the European Parliament in 2008 stating that the Commission, in its handling of the case, had breached its obligations under the directive and failed to fulfil its duty to act as the Guardian of the Treaties,

| 1. | Considers that the Commission’s reply to the Committee on Petitions failed to respond sufficiently to the questions raised by the petitioner and the committee members or to the concerns raised in the opinion of the Committee on Legal Affairs; |
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1.

Considers that the Commission’s reply to the Committee on Petitions failed to respond sufficiently to the questions raised by the petitioner and the committee members or to the concerns raised in the opinion of the Committee on Legal Affairs;

| 2. | Calls on the Commission immediately to take the steps needed to end the still-pending procedure initiated in 1997 under the safeguard clause of Article 8 of Directive 93/42/EEC; |
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2.

Calls on the Commission immediately to take the steps needed to end the still-pending procedure initiated in 1997 under the safeguard clause of Article 8 of Directive 93/42/EEC;

| 3. | Calls on the Commission urgently to respond to the legitimate concerns of the petitioner – who has been experiencing this intolerable situation for 13 years and has consequently suffered considerable loss of earnings – and to take the necessary steps to enable the petitioner to assert his rights; |
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3.

Calls on the Commission urgently to respond to the legitimate concerns of the petitioner – who has been experiencing this intolerable situation for 13 years and has consequently suffered considerable loss of earnings – and to take the necessary steps to enable the petitioner to assert his rights;

| 4. | Instructs its President to forward this resolution to the Commission and to the German Federal Government. |
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4.

Instructs its President to forward this resolution to the Commission and to the German Federal Government.

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(1)  OJ L 169, 12.7.1993, p. 1.

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