Medicines registration delays could scupper anti-counterfeit plans
Under an EU directive that comes into force in 2017, it will take two years to register prescription medicines that are at risk of being counterfeited
Anti-counterfeiting plans will fail unless the EU reduces the time it takes to register medicines for barcode scanning, generics manufacturers have warned.
Under an EU directive that comes into force in 2017, pharmacists will be required to scan the barcodes of most prescription-only and some over-the-counter medicines to check their authenticity.
If medicines that do not come under the remit of the legislation are later found to be at risk of being counterfeited, it will take two years to register them with the system, said Adrian van den Hoven, director general of manufacturers' body the European Generic medicines Association (EGA).
Any delay to anti-counterfeiting measures could cause safety issues, says European generics chief Adrian van den Hoven |
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This delay could cause safety issues, as it means pharmacists will be unable to verify the authenticity of certain medicines even if they know there is a risk they are counterfeits, Mr van den Hoven told the annual conference of the British Association of Pharmaceutical Wholesalers (BAPW) on Monday (June 23). |
"You can imagine the scenario where there would be products that have been falsified but the industry would not be able to put protective measures on those products," he told the conference.
Mr van den Hoven called for greater flexibility from the EU to reduce the time it will take to register medicines on the system.
Although details of the directive have not been finalised, a delegated act published in 2011 suggested that a "black list" should be created for over-the-counter products that will need to be scanned, as well as a "white list" of prescription-only medicines that will not be included.
There is still confusion about how to categorise medicines that can be bought over the counter in some EU countries but are available only on prescription in others, Mr van den Hoven said. European stakeholders need to address these practical issues before the system is put in place, he stressed.
It will be a "serious challenge" to get the system rolled out in every country before the directive comes into effect in 2017, and failing to do so could lead to shortages of certain drugs, he said.
The EGA is trying to engage in dialogue with governments to test the system before it comes into effect and to minimise the time pharmacists will have to spend scanning medicines, Mr van den Hoven told C+D. He expects "teething problems" once the system is set up.
Earlier this month, the secretary general of the Pharmaceutical Group of the European Union warned that the UK is in a "minority of one" with its opposition to the directive being applied to every prescription medicine.
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