EU commission Consultation on GDP – Counterfeits

The reasons given for the present consultation on GDP across Europe are: that it has been a long time since European GDP had been reviewed and that the situation regarding Counterfeit medicines needs to be reviewed.

Reason 1. Ok, it has been a long time and a review is probably overdue. More harmonisation of best practice across Europe would also be a good thing, if it were an objective, but it seems not to be. (see point about Belgium below)

Reason 2. Also OK, BUT then when you read it, the consultation has precious little to say on the subject of Suspected falsified Medicinal products (Counterfeits to you and I) and only makes 3 suggestions in 3 short paragraphs totalling less than 100 words. None of the proposals urge medicines manufacturers to do more on product integrity such as for example individual pack sealing and individual pack identity coding, which has been a legal requirement in Belgium for all prescription medicines for years already.

The EU proposals if implemented place all the responsibility with distributors to detect, quarantine and inform the authorities if counterfeits are suspected. If this is all there is, then in my opinion an opportunity has been lost to improve the situation, as all those involved in medicines distribution know how hard it is to detect counterfeits from visual inspection alone. The quality of the counterfeits is often as good as the original

There is a clear cut case in my view for requiring at least branded manufacturers to uniquely code every pack, to at least allow distributors and pharmacies to use technology that already exists and works to help detect counterfeits. (see Aegate Ltd)

If there was also a requirement that all branded packs be sealed at manufacture, deliberate contamination as happened recently with Nurofen plus, or fraudulent re-use of original packs would be close to stamped out at a stroke. The cost of my suggestions, well I don’t know, but it is pence not pounds per pack and the margins on branded patent protected medicines are not that thin that such valuable measures could not be afforded, if branded manufacturers really wanted to do something significant to make the counterfeiters job hard. In fairness some manufacturers already individually seal some packs, but to my knowledge no UK manufacturer is yet individually coding packs to make counterfeit detection more probable.