Challenges of Cool Chain Logistics in Russia

With Russia and the Commonwealth of Independent States (CIS) becoming emerging markets in the pharmaceutical industry, as well as on a global level, cool chain logistics have become more of a concern for leading players as it can not only cut costs and reduce waste, but is also important to maintain regulatory compliance.

Cool chain solutions are essential for many organisations, but particularly the pharmaceutical industry, to transport goods in a refrigerated or temperature controlled environment in order to prevent fluctuations that result in unnecessary wastage – and the increased costs that accompany it. For some medications, like vaccines, even a brief period at incorrect temperatures can irreparably damage goods, with many organisations even advised to take steps to prevent the repeated opening and closing of refrigerator doors as this can risk the integrity of some goods.

The World Health Organization (WHO) recently published guidelines to new and emerging states in how to put processes in place for safe vaccine handling, what to do to enable a successful cold chain system and help nations develop immunisation policies. The body claimed that it is vital to ensure that every conceivable measure is put in place to prevent problems in the cool chain but conceded that sometimes emergencies do happen.
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"Emergencies in the cold chain occur mainly due to technical faults in the refrigerator, or to power failures, but whatever the cause, they can seriously disrupt planned immunisation activities. The risks can be minimised however, if emergencies are anticipated and backup plans prepared in advance," WHO stated. It advised that if a refrigerator is not working, doors must be closed as far as possible to prevent unnecessary warming of vaccines, adding that vaccines will usually be safe for between 24 to 48 hours provided doors are kept closed.

Pharmaceutical firms in Russia in particular will have additional difficulties as the country has recently introduced a swathe of new regulations which were created as a direct result of the increasing costs of drugs and drug development, as well as the impact of the swine flu epidemic. Much of the new legislation is concerned with regulating prices on all the drugs available in the Russian market and a ban on foreign producers participating in the state tenders for the procurement of drugs has also been proposed. This is likely to have a huge impact on pharmaceutical organisations as the added cost of compliance with these new rules will make any additional costs from cool chain failures and wastage even more damaging.

The proposals have been criticised by those in the pharmaceutical industry, as well as commentators, as it is believed that not only will their adoption add the burden of additional regulation, but it could even result in major losses for firms in the country. It is suggested that the only people impacted by price fixing are global pharmaceutical firms, with many claiming that they could even result in closures in the country and an exodus of foreign companies out of the nation.

However, other experts believe that the Russian pharmaceutical market could be preparing for a period of substantial growth. Contract Research Organisation (CRO) spokeswoman Laura Wilson told Outsourcing-Pharma.com that the launch of the government's Pharma 20/20 plan could give the industry a boost.

"Pharma 20/20 is another signal that the Russian market is being primed for a substantial growth phase. Going forward, locally developed assets will undoubtedly need a provider of clinical and downstream commercial services at levels of quality and stewardship that are focused on addressing the unmet needs of the patient," she told the source. However, she conceded that to be successful, organisations need to introduce global strategies that adapt to Russian market requirements.