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The European Commission said on Thursday it would toughen the regulation of medical devices as a result of concerns raised by breast implants produced by the defunct French company PIP, even as a scientifi c expert review it ordered concluded there was currently “insuffi cient evidence” that women using its products faced greater health risks than others.
John Dalli, health and consumer policy commissioner, pledged to examine surveillance and operation of the “notifi ed bodies” that scrutinise medical devices across the EU in a current review of legislation, stressing: “The capacity to detect and minimise the risk of fraud must be increased.”
His comments followed an offi cial report released on Wednesday in France that called for national and EU-wide co-operation including random inspections and sampling of medical devices to prevent a repeat of the fraudulent use of substandard non-medical-grade silicone by PIP in implants sold to up to 400,000 women around the world.
Xavier Bertrand, France’s minister of health, called for enhanced action in France and across Europe in the wake of the study, which highlighted that Afssaps, the French medical regulator, did not inspect PIP from 2001 until a tip-off led offi cials to inspect and close down the company in 2010. Jean-Claude Mas, its founder, is under police investigation for manslaughter.
Mr. Bertrand has pledged to hire more health inspectors and undertake random checks on medical device companies following growing concerns over its regulatory system highlighted by the widespread use of PIP’s substandard breast implants.
A French decision at the end of last year to offer all women free removal of PIP implants triggered similar proposals in the UK, Germany and the Czech Republic and has helped spark a fresh debate over tougher EU regulation of medical devices, which are subject to far less scrutiny than pharmaceuticals.
However, a review released on Thursday by the EU’s own Scientifi c Committee on Emerging and Newly Identifi ed Health Risks concluded: “Breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. In most cases, breast implant failure appears to be without identifi able health consequences for the patient with the exception of possible local complications.”
It stressed that limited data meant that while there was no link between breast implants and cancer, there was a need for further work to understand the specifi c risks from the PIP products.
Mr. Bertrand has endorsed calls for a parliamentary inquiry in France as well as a report from the country’s social affairs inspectorate, mirroring similar moves that led to tough new requirements for the pharmaceutical industry introduced last year in the wake of concerns about Servier’s drug Mediator.
Medical device manufacturers have called for reforms to ensure that the national “notifi ed bodies” which audit the quality of their products across Europe are of a consistently high standard, while cautioning that tough new regulatory requirements could harm the EU’s competitive advantage.
The French study showed that Afssaps had received multiple warnings over the relatively high failure rate of PIP implants compared with those made by other companies, even though the overall proportion remained modest.
From Financial Times, February 2, 2012
1. _______ is the manufacturer of the breast implants under scrutiny.
A. European Commission B. PIP C. Afssaps D. Xavier
2. According to the passage, “notifi ed bodies” in Paragraph 2 are responsible for _______.
A. proposing legislation, implementing decisions in European Union
B. producing and marketing the medical devices across the EU
C. providing some scientifi c advice to the European Commission
D. assessing whether a product meets certain preordained standards
3. Which of the following statements is INCORRECT according to the passage?
A. Women using the breast implants faced greater health risks.
B. The capacity to detect the risk of fraud should be increased.
C. An offi cial report called for cooperation in France and in other parts of EU.
D. France’s minister of health has pledged to hire more health inspectors.
4. Which of the following countries have not all proposed to offer women free removal of PIP implants?
A. France, Germany, UK B. Germany, UK, Czech
C. US, Germany, Czech D. Germany, France, Czech
5. Which of the following statements is true according to the passage?
A. There is a consensus on the EU regulation of medical devices in the European Union.
B. All breast implant failure appears to be without identifi able health consequences.
C. Tough new regulatory requirements could harm the EU’s competitive advantage.
D. The overall proportion of the implant failure is relatively high compared with others.
试题分析：本题为细节题。根据第一段“...breast implants produced by the defunct French company PIP”可知B正确。
试题分析：本题为语义题。根据第二段“...‘notified bodies’ that scrutinise medical devices...”和倒数第二段“‘notified bodies’ which audit the quality of their products...”可知D正确；A是European Commission的职责；B是制药公司的职责；C是Scientifi c Committee on Emerging and Newly Identifi ed Health Risks的职责。
试题分析：本题为概括题。根据第一段“there was currently ‘insuffi cient evidence’ that women using its products faced greater health risks than others”可知A错误；根据第二段“The capacity to detect and minimise the risk of fraud must be increased”
可知B正确；根据第三段“...an offi cial report ... that called for national and EUwide co-operation...”可知C正确；根据第五段“Mr. Bertrand has pledged to hire more health inspectors and...”可知D正确。
试题分析：本题为细节题。根据第六段“A French decision at the end of last year to offer Germany and the Czech Republic”可知提出这项建议的国家为France, UK,
Germany and Czech。全文都在讲EU，没有提到US。故C错误。
试题分析：本题为概括题。根据第六段“spark a fresh debate over tougher EU regulation of medical devices”可知A错误；根据第七段“breast implant failure appears to be without identifi able health consequences for the patient with the exception of possible local complications”可知B错误；根据倒数第二段“while cautioning that tough new regulatory requirements could harm the EU’s competitive advantage”可知C正确；根据最后一段“even though the overall proportion remained modest”可知D错误。