The Slovak media have reported an undercover investigation in Slovakia by Britain’s Daily Telegraph newspaper which reported that Slovakia's poor monitoring mechanism allowed low-quality health aids to be imported via Slovakia into Europe.
The reporters set up a fictitious Chinese firm, produced a brochure about an artificial lumbar joint and tried to get a licence for their product in several European countries including Slovakia, the Sme daily wrote, citing the British newspaper. They asked a private institute in Nová Dubnica to check one of the lumbar joints, which was faulty. The certification firm did not note any faults and promised the reporters that it would obtain a certificate.
The director of the institute has since rejected the reports and told Sme that the reporters manipulated the evidence. The Slovak Health Ministry said that the case comes under the jurisdiction of the Economy Ministry, which in turn has said that a subordinate office, dealing with metrology, should deal with the issue. That office is standing by the institute, arguing that its response consisted of only “consultations” that are not binding. Despite this, the police’s Office for the Fight Against Corruption will investigate the case.
British Health Secretary [i.e. minister] Jeremy Hunt has pledged to stop a “worrying and completely unacceptable weakness in the regulatory system”, exposed by The Daily Telegraph, which allows potentially dangerous artificial hips to be implanted in British patients. It can be disclosed that medical regulators are also secretly advising some Chinese and Indian firms to market artificial hips and other devices as “Made in Europe” to unsuspecting British patients. Their health is being put at risk because some European regulators, known as notified bodies, are prepared to license potentially dangerous medical implants. Official regulatory bodies in Slovakia and the Czech Republic were prepared to approve a “toxic” hip replacement, which means it could be sold to the due British authority and legally used in unsuspecting British patients, the investigation found. The hip – designed by medical experts for the investigation – had similar specifications to another banned product which is suspected of poisoning patients and leaving them in severe pain.
The British health secretary said there were “problems in the European regulatory system” which needed to be addressed and that patient safety could be “compromised”. British MPs and senior doctors criticised the European regulatory system, which involves more than 70 private regulators competing for business, meaning the process is susceptible to corrupt practices, with those policing the safety of medical products apparently also advising Asian firms on entering the European market. Representatives of several notified bodies said Asian and Indian companies were able to mark their products as “Made in Europe” because of a loophole known as “Own Brand Labelling”. At EVPU, a notified body in Slovakia, representatives said this form of re-labelling was “standard procedure”. The representative said: “We have lots of customers from the UK which buy the product from an Indian manufacturer and put on their own label.”
Sources: Sme, Daily Telegraph
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25. Oct 2012 at 10:00