The plans contained in legislation to be announced today would extend the reach of the inspections’ watchdog and would give Hiqa an oversight role on research ethics committees for clinical trials involving medicines and devices.
Health Minister Leo Varadkar will today give further details of the plans, which will be implemented by new legislation in an amendment of the Health Act 2007.
The move comes five years after it emerged that some Irish women had received faulty breast implants that used industrial grade silicone, resulting in possible serious health complications in the event of a rupture.
It is estimated that more than 800 Irish women were affected among tens of thousands of women worldwide caught up in the scandal.
The case emerged in 2010 when it was revealed that manufacturer Poly Implant Prothése (PIP) had been using the wrong silicone. Irish-based clinics such as the now-closed Harley Medical Group had used the PIP implants in some of its surgical procedures.
The Department of Health will now draft the Heads of a Bill for Cabinet approval to amend the Health Act 2007, although any law is not expected to be in place until the middle of next year at the earliest. It is also understood that Hiqa would require more resources due to the extension of its remit.
Mr Varadkar said the measures will alleviate public concerns about the safety and quality of some services provided in the private sector or outside the public health service, such as certain cosmetic surgery.
A working group comprising the HSE, Hiqa, and other service providers to advise on the new Patient Safety Licensing Bill has already been set up.
A number of legal firms are representing the interests of the Irish women affected by the PIP scandal.
In France, where the story first emerged, legal actions have been taken against PIP while a court ruling also meant certification companies were also liable for damages.
A deadline of March 20 this year was set for women with the faulty implants to come forward to join a landmark legal action in France.
French courts also awarded an interim payment of €3,000 for each victim until further damages can be assessed.
Health authorities here agreed to pay for the removal of faulty breast implants following medical advice, but would not pay for replacement implants.