Medicine watchdog planning for Brexit scenarios

Ireland’s medicines watchdog is at a “sensitive stage” of its contingency planning for Brexit, Health Minister Simon Harris has said.

Medicine watchdog planning for Brexit scenarios

Ireland’s medicines watchdog is at a “sensitive stage” of its contingency planning for Brexit, Health Minister Simon Harris has said.

Mr Harris said the Health Products Regulatory Authority (HPRA) is planning for a number of different scenarios, including a “no deal”.

He was very confident that HPRA, together with the HSE, would ensure that Irish people could continue to access critical medicines after Brexit.

Obviously, he said, a transition agreement allowing for a “decent period of time” would assist in that.

“I do believe there will be an agreement, but I take the point that we have to prepare for all scenarios, including a no-deal scenario, whilst expecting there will be a deal,” he said.

Mr Harris said the Government and the HPRA are working “extraordinarily” hard on preparing for all scenarios, as he opened the International Conference of Drug Regulatory Authorities (ICDRA) in Dublin yesterday.

“The HPRA is at a sensitive stage of its contingency planning for all of those scenarios including a no-deal Brexit,” he said.

There are 500 delegates from more than 94 countries attending the week-long ICDRA to discuss how cross-country collaboration can be improved to ensure faster access for patients to new medicines.

One of the speakers, Emer Cooke, head of regulation of medicines and other health technologies at the World Health Organisation (WHO), said contraband medicines is “one of their big challenges”.

The WHO global surveillance and monitoring system has received more than 1,500 reports of suspected substandard and falsified medicines from 106 member states since 2013.

Of the cases reported, 42% were from the African region, 21% from the European region, 21% from the Americas, and 16% from the rest of the world.

Ms Cooke said they estimated that more than 10% of all medical products are contraband and the cost to society is in excess of €860m.

“And we reckon those figures are grossly underestimated,” she said.

“There are rogue actors. People will always find a way to cheat the system but if we can raise awareness, if we can train regulators, if we can improve the laboratory systems, I think we can do a lot better.”

Ms Cooke said the WHO is piloting an app in Tanzania and Indonesia whereby someone can take a photograph of a medical product and then check it against a database.

“It is a problem everywhere but a strong regulatory system can catch it better,” she said.

Ms Cooke said a good regulatory system gives people confidence that the medical products they need and use are safe and would work as intended.

Ms Cooke said the WHO, by promoting reliance and collaboration among national regulators, is helping countries increase access to quality essential health products.

“With WHO support, countries are improving regulatory preparedness for public health emergencies by building the necessary plans and tools to react quickly when an emergency arises,” she said

HPRA CEO Lorraine Nolan, said the authority had doubled its staffing in the last 10 years and had invested “significantly” in its enforcement strategy.

Dr Nolan said the number of illicit medicines seized by the authority increased from 675,000 in 2016 to more than 1m last year.

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