Pre-market charges for medical device firms

Medical devices firms will be forced to pay significant pre-market “risk assessment” charges if they want to sell their products under new patient safety laws.

The Irish Medicines Board wants the Government to impose the rule change by 2015 to prevent another DePuy hips or PIPs breast implant crisis — and ensure the public does not have to pay to resolve future problems.

Speaking at an Oireachtas Health Committee meeting, the independent watchdog’s chief executive, Pat O’Mahony, said the controversies — which damaged thousands of patients in Ireland — must not be repeated.

He said in light of the “high-profile issues”, key “shortcomings” in the regulatory system have been underlined meaning a “complete revision” of existing EU rules is now necessary.

Similar conclusions have been made by other patient watchdogs across the EU, with proposals focussed on introducing a pre-market risk assessment check which would be funded by a charge on firms pushing the medical devices.

Pan-European legislative changes will not be in place for “at least another four to five years”, the committee was told. However, Mr O’Mahony said Ireland should put its own “fee regime” in place as soon as possible, and called for medical devices firms to be told to pay for the pre-sale safety check within two years.

“This [the regulatory changes] will require a reconfiguration of resources and indeed some additional resources. It is anticipated that from 2015 onward these additional funding needs will be met by the introduction of a fee model to the medical devices sector.

“Some countries in Europe already have a fee regime in place and while we are continuing efforts to seek a common agreement at European level for the introduction of fee models and systems. If this is not achieved in this time scale we anticipate a national fee arrangement will be introduced in Ireland for 2015.”

Any change to the current system will only be possible via new laws put forward by the Department of Health.

In addition, the extra charge runs the risk the expense could still be passed onto patients through an increase in treatment prices.

However, the IMB said the extra layer of protection would significantly reduce the risk of yet more patient safety scandals.

In the past two years more than 4,000 Irish people have been caught up in two separate medical devices crises.

They include 1,100 Irish women given breast implants by French firm Poly Implant Prothese (PIP).

The items contained non-medical grade silicone used in mattresses and are twice as likely to rupture than medical implants. However, studies suggest they are not carcinogenic.

The DePuy hips scandal, uncovered in 2011, affected more than 3,000 Irish people whose bloodstream may have been exposed to “toxic” chemicals linked to the metal-on-metal tool.

The Department of Health’s last year said 350 patients underwent surgery to remove the hips, while 160 more were preparing for the treatment. However, it is unclear whether promised “alternative care packages” for those affected have been provided.

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