Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-01-18-Speech-2-499-000"
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"en.20110118.20.2-499-000"2
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"Mr President, ladies and gentlemen, I have to say that I, too, am puzzled about why this question has been combined with the previous report, but the important thing, to my mind, is that this House is today focusing on the issue contained in the question I tabled on behalf of the Committee on Petitions.
I would also add that, during the six years in which the product was distributed – and there are documents on this, including ones provided by the Commission – it was found that significant savings were made in public health expenditure due to the low cost of the product, and that the product had a positive impact on asthma sufferers.
In 2008, having seen all his attempts to get somewhere with the other authorities fail, Mr Klein, the manufacturer, turned to the Committee on Petitions. The committee is initiating the procedure during this legislative term. Moreover, in view of the length of time the matter referred to in the petition has been going on, it is also launching an informal consultation process with the Commissioner to request that a response be provided within a shorter timeframe, because the petitioner is requesting confirmation that his product complies with European legislation or, failing that, at least to have a ruling that he can challenge before the Court and which will therefore allow him to have justice.
None of this has happened, and during the debate within the Committee on Petitions, the European Commission unfortunately avoided answering our questions once again. Hence, the committee has taken the unanimous decision to come to Parliament and ask the Commission to provide clear answers in this House, because this affair undeniably raises serious doubts with regard to a violation of the Charter of Fundamental Rights. This is not only because of the Commission’s inertia; it is also and, above all, because of the petitioner Mr Klein’s inability to take legal action.
The affair raises obvious doubts with regard to the violation of market rules and the protection afforded to small businesses, which is why we are insisting that answers be provided, here, to the points raised in our question.
This question refers to a case in which a small European business has been denied justice because of the inertia that the Commission has unfortunately demonstrated from 1997 until now. This finding is supported by the Committee on Legal Affairs, which has been asked to issue an opinion by the committee which I chair.
The issue concerns a medical device – specifically an asthma inhaler – which was patented in 1990 and lawfully placed on the market. This product is regulated by Directive 93/42/EEC, which stipulates that manufacturers must certify that they have complied with requirements and which empowers the national authorities to verify that this self-certification is valid, through monitoring and sample checks.
The product, which was successfully distributed on the market for six years – thus, until 1996 – and for which not a single specific complaint or comment was recorded in over 15 years, was submitted for an inspection by the government of Upper Bavaria, which asked the commission of Magdeburg to review the authorisation granted to the company.
In December of that year, the commission and the Minister for Health in Saxony-Anhalt carried out this inspection and concluded the procedure by stating that the product fully complied with the legislative requirements in force. At the end of the procedure, they also questioned the legitimacy of the request made by the government of Upper Bavaria and invited it to initiate the safeguard clause procedure pursuant to the aforesaid directive if it continued to have doubts.
The following year, there was a series of undocumented activities about which we were only indirectly informed, and then, suddenly, in 1997, without any communication with the manufacturer, the Federal Minister for Health ordered the product to be withdrawn from the market.
The Ministry initiated the procedure – the procedure pursuant to Article 8 of the aforesaid directive – at the end of 1997, but it drew a blank, because no information was provided and the process of consulting the manufacturer was not initiated. Amid the general silence, in mid-2003, the manufacturer, thinking that this silence meant that the German authorities’ unexplained comments had clearly been refuted, placed the product back on the market.
Unfortunately, in 2005 – and again without any communication – the German authorities ordered the product to be withdrawn from the market once more. To be clear, despite repeated requests, there has been no explanation to this day for why the product was withdrawn.
Hence, there has been no communication, no investigation and no opportunity for the manufacturer to legitimately challenge the other party’s findings. This has had a serious economic impact on the manufacturer, because he has been waiting for a response for more than 15 years and cannot place his product on the market."@en1
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