Proposed tighter EU regulation of the medical device manufacturing sector could threaten thousands of jobs in Ireland, warned the head of one of one of the country's biggest medical device companies, Cook Medical.
The proposals come in the wake of the PIP breast implant scandal in France in 2010.
Bill Doherty, the company's Europe, Middle East and Africa vice president, said the Medical Device Directive, which is now under consideration by the European Commission, will mean it takes longer for companies to get their product to market, leaving Irish jobs under threat.
Cook Medical employs 800 people in Limerick, where it announced a new €10million innovation centre yesterday.
He said said the proposed directive would ultimately stifle Cook’s and other manufacturers’ innovation plans.
"We have concerns. There are regulations currently being drafted. They've just come through the European Parliament, and they would, if enacted in their present state, slow down the pathway for devices to market," Mr Doherty said.
“I would have concerns (about jobs) in the longer term, because if innovation was to move out of Europe – companies now deal in a global market – and if there is some other part of the world which has a better regulatory environment, the danger is that that innovation and multinationals like Cook, or anybody else, even start-up companies, will move to a regime where the regulatory system is better. So, that [job losses] is a long-term worry.”
Research
Mr Doherty explained Ireland has developed a major medtech cluster of 250 companies employing 25,000 people in research and development and manufacturing.
It has also enjoyed the fruits of the current European regulatory system whereby companies here can get their products to market up to three years earlier than in the US and Japan, which are Europe’s biggest business competitors.
“That means European patients get the latest technologies. But, we’re concerned that some of the new regulations would slow down that,” Mr Doherty said.
PIP (Poly Implant Prothese) was shut down in March 2010 amidst a worldwide health scare after the company used sub-standard silicone gel, causing many implants to rupture. Yesterday, a French court ordered a German company to pay compensation to hundreds of women who were fitted with the defective implants. “We understand that patient safety is a huge issue here. I think a lot of these regulations are being driven in the wake of the PIP scandal in France – the breast implant scandal – but there is a possibility or a worry that we could go overboard,” Mr Doherty said.
He added: “We’re calling on the Government to look at this. Right now the process is at the EU Council of Minsters level - so Ireland being one of the 27 [members] has to agree their position. So, we are asking them to look at the proposed scrutiny process and simplify it.”
Mr Doherty added: “The time lines are definite [in Europe]. We know, in Europe, that if we go into the [regulatory] system, it’s going to take us a year or two years with clinical evidence to get that product to market.”
