NPA urges MHRA to rethink stance on scanners following counterfeit generics seizures across Europe
Counterfeits The NPA has issued renewed calls for the MHRA to reassess how it plans to implement EU anti-counterfeiting plans, following the seizure of counterfeit versions of generic medicines across Europe.
The NPA has issued renewed calls for the MHRA to reassess how it plans to implement EU anti-counterfeiting plans, following the seizure of counterfeit versions of generic medicines across Europe.
The NPA hoped the recent discovery of 1.2 million doses of fake aspirin in France and 20mg and 40mg packs of the heartburn medicine omeprazole in Germany would trigger a decision for all prescription medicines to be scanned as part of the European Commission's falsified medicines directive, NPA public affairs manager Gareth Jones told C+D.
The MHRA's position is that scanning all prescription medicines is disproportionate and scanners in pharmacies should only be used for specific drugs on a risk-assessed basis to avoid unnecessary costs, when the directive comes into force in 2017.
Recent seizures of counterfeit omeprazole and aspirin go against the established wisdom that generics would not be counterfeited, the NPA's Gareth Jones said |
More on counterfeits MHRA seizes record £12m haul of unlicensed and counterfeit drugs Wholesalers challenge pharmacies to develop medicine scanners MHRA must end stalemate to avoid lagging behind EU on counterfeits |
The drugs regulator told C+D this week that the government was working closely with stakeholders and other member states to agree on a "proportionate implementation" of the directive and that discussions were ongoing. However, the NPA has argued that every prescription medicine needs to be scanned if the system was going to work "simply and efficiently" within a pharmacy. |
"If you protect a certain group of medicines, what the counterfeiters will probably do is look for the next most lucrative group of medicines and target those," Mr Jones told C+D last week. His comments followed the annual meeting of the Pharmaceutical Group of the European Union (PGEU) in Rome last month, where the issue had been discussed.
In April, the Financial Times reported that counterfeit versions of omeprazole had been discovered in Germany. The following month, the French press reported that counterfeit aspirin had been seized, believed to be hidden in a cargo of tea from China.
These examples went against the established wisdom that generics would not be counterfeited, Mr Jones said.
"In this case, cheap drugs were counterfeited. It does make it much more difficult to argue that we should leave generic medicines outside of the falsified medicines directive," he added.
Every pharmacy in the UK could be required to have a barcode scanner to identify individual packs of prescription-only medicines by 2017, as part of the European Commission's falsified medicines directive to prevent counterfeit drugs entering the supply chain.
In March, the NPA warned that the continued disagreement between the European Commission and the MHRA over how the directive should be implemented in the UK could result in a "rushed and disorderly implementation" in pharmacies.
The PGEU has said that the cost of introducing anti-counterfeiting plans would be minimal. Buying scanners at a cost of around £212 (€250) would be the main expense for pharmacists, it said at a meeting in May.
Are scanners the solution to stopping counterfeit medicines from entering the supply chain? And who should foot the bill for their implementation? Comment below or email us at [email protected] You can also find C+D on Twitter, LinkedIn and Facebook |