Drug companies banding together to solve common problems is not a new idea. For example, groups like TransCelerate Biopharma and the Pistoia Alliance have been trying to convince drugmakers to team up and tackle industry bugbears for several years.
However, rivalries usually remain according to TransCelerate CEO Dalvir Gill who told delegates at a conference in Barcelona, Spain last year “it’s not that suddenly everybody has become nice people, it’s that the pain of not collaborating is no longer bearable.”
One organisation for which this does not hold true is RX-360 according to board member Martin Van Trieste, who rejected the suggestion that members are unlikely to help rivals whose products are being targeted by counterfeiters.
“One of Rx-360’s mantras is that patient safety is not a competitive advantage” Van Trieste told in-Pharmatechnologist.com, citing theft prevention standards the organisation developed at the behest of the US FDA in 2010 as an example.
“Rx-360, working with experts in the field from various companies who are competitors, developed and published a points-to-consider document” he said, explaining that the guide is available to members on the organisation’s site.
Weak points
Collaboration is also the key to addressing the remaining supply chain issues according to Van Trieste, who told us stakeholder efforts to improve security are matched only by counterfeiters’ efforts to bypass such measures.
“All stakeholders need to engage with and support organizations like Rx-360 to stay one step ahead of the criminals. I wake up every morning knowing that criminals are out there trying to figure out ways to bypass industry’s security measures.”
One area of concern is the supply of legitimate active pharmaceutical ingredients (APIs) small quantities of which are often used by counterfeiters to help fakes pass basic chemical tests.
In March, Domenico Di Giorgio from Italian regulator AFIA told this publication that fakers often source genuine APIs from online commerce sites.
However, the problem goes beyond such sites according to Van Trieste who told us counterfeiters “will use almost any and all means to acquire what they need for their counterfeits.
“These can be from both legitimate and illegitimate sources via routine business purchase orders, internet sites or even back alleys.”
“For example, a counterfeiter could present themselves to a legitimate API producer as a potential new customer developing a legal product, or they could acquire raw materials from illegitimate sources online.”
In-Pharma technologist's Fiona Barry will lead a discussion of the drug counterfieting problem and what industry is doing to solve it on April 18. To sign up for this free online event click the banner below.
