European-wide legislation is needed to put patient safety at the centre of the fight against counterfeit drugs, the Irish Medicines Board (IMB) has said.
Current European legislation looks at counterfeit medications as an economic issue rather than a healthcare one, said Hugo Bonner, enforcement manager with the IMB.
"In Europe there is no counterfeit medicines legislation," he said. "There is counterfeit legislation but it's for watches, jewels, Nike runners - it's an economic issue, but it doesn't focus on public health, it doesn't focus on the patient."
Mr Bonner has been involved at European level to draw up legislation that would penalise drug counterfeiting. He said the Council of Europe was compiling a feasibility report which was likely to recommend a European directive on the matter.
The big issue, according to Mr Bonner, is whether the EU will support it, because [ to date] they have not seen counterfeiting as a public health issue. He said counterfeit medicines affected patients, manufacturers and distributors, but were also undermining the credibility of the healthcare system.
"Once it is discredited, will the patient continue to work within the healthcare system?" Mr Bonner asked. "Once the credibility goes down, people will move to the other side of the fence, to buying on the internet. They think it's cheaper - it's not. They think it's guaranteed - it's not."
He suggested technology applied to the supply chain to provide tracking and tracing of all drugs and medical devices in the European market would be a significant improvement. "At least then we can have some idea where it has been with track and trace."
He said he had encountered products that had been in the legitimate market but then crossed into the black market before being sold through legitimate channels again. While various technical solutions are being proposed for the tracking and tracing of medications, technologists are doing themselves no favours by fighting over which standard to introduce. "There's no track and trace system in place today because technologists won't agree on one system," said Mr Bonner. "But a regulator can't go around with 10 different scanners hanging off them."
Mr Bonner was speaking at a conference in Dublin entitled Securing the European Healthcare Supply Chain. He suggested that the focus on certifying medical devices solely when they were launched on the market was a potential target for counterfeiters.
Rather than seeing each other as being on opposite sides of the "fence", Mr Bonner said distributors and regulators should be working together to tackle problems such as counterfeiting.
He cited an informal European survey which found there were 27 counterfeit drugs being sold through legitimate sources and 171 different medicines being sold on the black market.