SME Chamber

GRTU’s response to parallel trading and the EU Counterfeit proposal

 Earlier this year the European Commission had opened a consultation with stakeholders, amongst which GRTU, on the issue of combating counterfeit medicines for human use. Parallel traders have hit back at some of the EU Commission's anti-counterfeiting measures and big pharma's support for them.


GRTU's Pharmaceutical and trade sector  compiled GRTU's formal response and attended a number of meetings with Government on the issue. The International press have commented on the responses from the European Association of Euro-Pharmaceutical Companies (EAEPC)and the GRTU focus on the repackaging  ban and implementation of tamper evident seals. If the proposals come to pass, repackaging in Malta would be prevented, which GRTU regards as essential for providing the Maltese population with affordable medicines. GRTU's response is particularly strong, according to the pharmaceutical press,  accusing the Commission of pandering to economic interests instead of focusing on patient safety.

 The impassioned nature of GRTU's response can be felt in this statement  "This is an assault on one of the basic tenets of the very pillars of our treasured set of beliefs and freedoms, that is, the free movement of goods across the whole borderless market of the EU. That anyone or anything should attack this basic tenet is shocking. That the attack should be coming from within the Commission is wrong, and we say this with the greatest responsibility and concern. EAEPC's response is somewhat more restrained but it does regard the Commissions proposals as focusing only "on the already well regulated legal supply chain" believing this approach is "neither evidence nor risk based, and ignores the larger threat to public health". It argues that parallel traders and repackagers have an "exemplary safety record", with only one counterfeiter known to have got fake medicines into the legitimate supply chain via parallel trade in the last 35 years.

Both GRTU and EAEPC argued that repackaging  actually provides an extra layer of security in the supply chain, as traders visually inspect the product which results in the removal of defective products from the supply chain.

From the big pharma responses Pfizer was particularly vociferous in its criticisms of parallel trade and the impact it has upon the complexity of the supply chain, regarding it as facilitating the entry of counterfeits into the legitimate supply chain. Recent developments have highlighted the level of support Pfizer has on this issue, with the EFPIA regarding a ban on repackaging as the "most powerful tool to prevent counterfeiting in Europe".
EAEPC and GRTU  seem determined to fight their  corner though, believing that parallel trade and repackaging do not facilitate counterfeiting. The grouping  believes that clamping down on internet pharmacies and securing Europe's borders are important areas which the Commissions proposals failed to adequately cover.

The focus on repackaging at the expense of these issues is concerning to EAEPC, with the body stating: "Nothing presented thus far justifies radical reforms to the parallel distribution system, as implied by several of the Commission's possible legislative proposals." 

GRTU feels that Malta's MEP's and the Maltese representative to the EU should be fully aware of the drastic effect a ban on repackaging will have on Malta. It will have a disastrous effect on the availability of medicines in Malta besides putting at risk the 100 jobs that the local fledgling repackaging industry sustains.  GRTU does note, however, that Government shares its concern on this issue and has taken a similar stand to that of the GRTU on this issue.



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