No need to stockpile medicines ahead of Brexit, says Health Products Regulatory Authority
There is no need for patients, hospitals or healthcare professionals to stockpile medicines ahead of Brexit, according to the Health Products Regulatory Authority (HPRA).
Lorraine Nolan, HPRA chief executive, told the Oireachtas health committee that a key part of its Brexit planning is to ensure sufficient stock in Ireland so that temporary delays - eg if medicines face transportation delays - will not affect patient access.
As part of its engagement with companies supplying the market, the HPRA has requested them to confirm they will have eight to 10 weeks stock at October 31, Brexit D-Day.
“The important thing is that industry doesn’t wait until the final week (pre-Oct 31) to replenish,” said Jim Breslin, Department of Health Secretary General.
Sinn Féin health spokesperson Louise O’Reilly asked if there were any companies that weren’t putting the necessary buffer in place.
Mr Breslin said they did not have a “current concern that there will be on Day One, Week One, (post-Brexit) products that won’t be available to us”.
He said there was capacity on shipping routes to bring product directly into Ireland from Europe, although he conceded it would add about “20 hours to the journey” and would also add to the cost because of additional payment for the driver.
Mr Breslin said a criticality assessment exercise was ongoing looking at areas where there would be “high impact if we didn’t have a product”.
“The biggest risk in the initial period is the short shelf life of some drugs,” he said. Asked by Fianna Fáil health spokesperson Stephen Donnelly which drugs were at highest risk, Mr Breslin said:
There are no specific drugs or devices (medical) that we see at the moment as a Brexit problem for us
Ms Nolan said she could not “fully rule out all risks” in relation to ongoing supply of radiopharmaceuticals post-Brexit, as the majority are flown from Continental Europe to Ireland via East Midlands Airport. She said the companies who supply the Irish markets had confirmed to them that they would continue to do so post-Brexit.
Fine Gael TD Kate O’Connell asked if there were concerns new medical devices coming on the market might not be available to patients in Ireland as they require a CE mark (quality assurance) from a notifying body located in an EU member state.
Ms Nolan conceded that while larger manufacturers had “measures in place” to switch from UK medical device certificates to an EU27 notified body, a “significant number” of UK certification files had not transitioned to another EU member state.
“It doesn’t necessarily represent any threat,” she said.
However HSE chief strategy officer Dean Sullivan, said: “The number of medical devices that will have regulatory issues is significant and represents a particular risk to maintaining service continuity from early 2020 in the event of a “No Deal” Brexit."
He said to address this issue, they were “taking in additional stock in these vulnerable product lines and looking for alternatives that don’t have certification issues”.
