Faulty medical implants investigation: 'We’re paid by manufacturer so want deal to succeed'

The shiny office block in a business district of Seoul is not the most obvious place to find an organisation offering to authorise a medical product for use in patients throughout Europe.

But, earlier this month, in a meeting on the 14th floor of the building in South Korea, two undercover reporters from The Daily Telegraph posing as representatives from a Chinese company were discussing just such a licence.

As the air conditioning hummed in the background, the four smartly dressed Korean men began their presentation — in reality, a sales pitch about how they would effectively be able to guarantee that a metal-on-metal hip implant which should be banned could soon find its way legally into British operating theatres.

The president of the company, Dr Gong, said that the firm was the "best in the world" and the "exclusive partner" of a medical devices regulator in the Czech Republic. As part of their relationship with the regulator they did "all the results" for Asian companies that applied for the necessary CE certification.

With more than 1,000 clients, they could offer a "competitive" fee to the undercover reporters sitting before them. "We only focus on how to help our clients", said one of the employees as he flicked through the presentation.

Towards the end of the meeting, when asked by an undercover reporter why features of the European system were so attractive, Dr Gong rubbed his fingers together, saying "money".

The path to the meeting in Seoul had begun several months earlier during a joint investigation by The Daily Telegraph and the British Medical Journal into the regulation of artificial hips and other medical devices in Europe. Undercover reporters had travelled to eastern European countries, including Hungary, Slovakia and the Czech Republic to meet representatives of notified bodies — the organisations charged with offering licences — to discuss approving a potentially dangerous implant.

As this newspaper has exposed this week, several regulatory bodies were prepared to offer such licences.

But during meetings in Slovakia and the Czech Republic another loophole emerged. Two companies — 3eC in Bratislava and ITC in Zlin — said that they had Asian "representatives" who could deal with applications outside the European Union.

Under European rules, the regulatory bodies are only supposed to assess whether applications for medical devices meet the required standard. They are not supposed to offer consultancy services on how to receive the certification.

Upon arriving in the offices of ITC Cert in Seoul, the representative of the Czech notified body, the journalists were offered the services of two companies. One would assess the licence, the other would offer consultancy. The two firms appeared to share many members of staff.

Dr Gong, the president of "ITC Asia", said the firms were "separate" and "independent".

However, one of the company's employees later claimed this was not the case. "He [the president] said the company is — the companies are separate — are separately [sic]. But actually the working people are the same," said Kenneth Lee as he was driving the reporters to their hotel after the meeting.

The cost of the consultancy service was an extra $12,000 (£7,500) on top of the $17,000 certification fee. The $17,000 which was quoted was four times more than what was suggested by the company's office in the Czech Republic.

For the high fees, the ITC office in South Korea said that their clients enjoyed a high success rate. When a reporter asked the general manager, Mr Shin, about the company's success rate during a telephone call before the meeting he said that "there was no case … which [was] rejected".

Mr Lee also said that the European system was "easier" than the regulatory procedure in America because the notified bodies were paid by the manufacturer and therefore wanted an application to succeed.

The sales pitch in Seoul was similar at BS Certification Services, a "partner" firm of 3eC, which has its headquarters in Hong Kong. The undercover reporters telephoned Vidyyut Kr Bera, of BS Certification Services, in September to find out how he could help their application.

When they asked Mr Bera how many of his clients obtained CE approval for medical devices, he laughed: "It is a 100 per cent success rate as of now." He said he would charge the same as the regulator in Slovakia — thousands of euros. He said he would pay the regulator and the manufacturer did not need to pay anything to the notified body in Slovakia.

Mr Bera said that the "advantage" of using his services instead of dealing with the notified body directly was that the client "will come to know a lot of things in advance before it is done a final review" and that he was "in a position to support the client in many ways because the entire review before the file goes to notified body … is taken care of by me".

He added: "So most of the time it happens that when I approve the file and everything is completed it is very, you can say, that there will high chances that the file will pass in one attempt." However, although he would write a report for the client outlining "what is required, what is missing", he would not officially be able to act as a paid consultant.

There is now growing pressure on the British authorities to put their own checks into the system amid fears that hundreds of medical devices, which have passed through the offices in Asia, are being used on unsuspecting patients in this country.

ITC Korea said that the meeting was "simply a private talk". The spokesman defended the company, saying that "there will be also wrong and exaggerated explanation for easier understanding".