Regulatory Focus™ > News Articles > Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn

Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn

Posted 30 April 2012 | By

A rash of counterfeit drugs invading the European pharmaceutical supply chain is spurring EU legislators to develop a new anti-counterfeiting directive that has attracted both the praise and scorn of regulated industry, reports Reuters.

The European Commission's planned Directive involves requiring pharmaceutical products "to be sold in tamper-proof packs from 2016, each with a unique identifier allowing them to be tracked through the supply chain," writes Reuters.

Some companies, including Pfizer, GlakoSmithKline and Roche have come out in support of the plan, but the plan has failed to attract the support of the generics industry.

The European Generic medicines Association (EGA) is calling the plan unnecessary, costly and likely to squeeze generics manufacturers too much.

"Anti-falsification technologies and the massive changes required to production lines - if applied to our sector - would place an unjustifiable burden on the sustainability of a part of the EU pharmaceutical industry which is a cornerstone of healthcare provision in Europe," said EGA's Director General, Greg Perry, in a press statement.

Reuters notes the rules could add 4-12 euro cents to each drug pack, which would disproportionately affect low-cost generics medicines.

The EGA is calling for a "risk-based approach" that focuses primarily on branded medications, notes Reuters, but it is unclear if this approach will be palatable to EU legislators.

Read more:

Reuters - EU plans to block fake drugs spark industry row

EGA - Costs of EU Anti-Falsification Technologies Threaten Access to Low-Priced Generic Medicines

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