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Vaccine Cargo - Customs needs to gird up loins for tricky challenges on card!

TIOL - COB( WEB) - 743
DECEMBER 24, 2020

By Shailendra Kumar, Founder Editor

COVID-19 is just one of grim reminders that human life is fragile. And humanity is destined to go through samsaric cycle of despair and hope! Ravaged by the 'gluttonous' virus, a flicker of hope for loosening of its stranglehold on humanity was born when the global scientific community rifled through its genome sequences and developed efficacious vaccines in a record time. Great Britain was the first to roll out vaccination programmes. But it seems that the virus had better ideas about its vulnerable underbelly! Even before UK could heave a sigh of relief or relish a sense of being an enviable winner, a new variant of the virus was detected and found to be 70% more transmissible. Though the WHO and other health experts are of the view that there is so far not much reason for alarm but no country, in the midst of surging infections, seems to have been left with any appetite for risk and thus, not only UK's neighbours in the EU but even distantly-situated friendly nations shuttered their skies for flights originating from London. Even its Prime Minister Boris Johnson who was earlier on the cusp of saying boo to the 'marauder' virus, did not find better measures than to impose fresh lockdown and messy travel restrictions.

WHO Chief Tedros, like many other experts, says that virus variants are common. But unlike its cousins the Coronavirus RNA (ribonucleic acid) is sneaky and cunningly parasitic. Once it enters human body it behaves like cowardly hijackers of any terrorist outfit in the world. The hijacked cells become its factories, reading the virus's RNA and producing viral protein to compromise the immune system. The virus xeroxes new copies of itself and penetrates into more parts of the human body. It spreads to other humans by way of saliva, sweat and other bodily fluids. The virus, following Swiss Army knife approach, changes and mutates in response to drugs. Theoretically, vaccines are to be created each time a new variant comes to light. In this backdrop, it is indeed too early to conclude that vaccines being administered in many countries may be equally effective for the new strand. The new UK variant has already put its foot on new possible homes for itself - Australia, Denmark and Netherlands. A fortune may be saved if Pfizer and Moderna vaccines are not neutralised by it.

Even as the bitter winter surge continues to crest in many parts of the world, the good news is that shipments of Pfizer vaccine have begun landing in many countries. After Singapore, India is likely to be the second Asian nation to welcome the much-awaited cargo at the IGI Airport. All eyes are agog for the first lot of jabs. AstraZenca vaccine is also about to be approved. Special protocols are being put in place. Since Pfizer vaccine needs ultra cold freezer for its storage and has also short shelf life, a chain of cold storage is being created in many parts of the world. In few weeks as many as 42 more vaccines which are at clinical evaluation stage, would be ready for international shipments and cross-border movement. Over 160 more vaccines are in pre-clinical evaluation stage. In other words, all these vaccines would be corralling the global supply chain in 2021. The global vaccine production capacity is likely to spike to five million doses per month by January 2021. The USA alone is targeting distribution of 300 mn doses in few months. The WHO Covax is eyeing two billion doses distribution by 2021-end. The vaccine distribution through cross-border poses the greatest challenge for multiple agencies engaged in border management across the world.

What adds to the burden of border management agencies are the supplies of key vaccine accompaniments such as needles, vials and syringes apart from other diagnostic equipment. WTO trade data reveals that global exports of some critical raw materials for vaccine production such as amino acid phenols, lecithins, sterols, acyclic amides and others soared by 49% in the first six months of 2020 to reach close to USD 16 billion in value. Given that the pharma industry largely relies on third parties for quality active ingredients, packaging materials, machinery and equipment, ensuring unbroken supply chain is key to targetted vaccine production in the coming years.

Thankfully, multilateral agencies like WCO, WHO, WTO and WIPO have put their heads together to compile several guidance notes for the agencies engaged in international trade and border management on the issues relating to the pandemic. The WTO has also expressed its concerns about export prohibitions and restrictions notified by 43 countries and six non-WTO members on COVID-19 related medical goods or devices. It is a trifling question that Customs authorities need to put in play expeditious clearance for approved vaccines and other materials along with electronic pre-arrival documentation facilities. To ensure quicker clearance of such vaccines the Customs needs to design special procedures with post-clearance audit option so that valuable time is not lost for time-sensitive vaccines with limited shelf life. It also needs to have proper communication framework to involve health regulators and other stakeholders. Cold chain integrity will be an uphill but desirable task. Ideally, all countries should notify import duty exemption for the vaccines and reduced tariff for other necessary medical devices. Since a large number of poor and developing countries may not afford brand new cold chain equipment, trade policy is to be simplified to facilitate import of reusable cold storage containers and boxes. If a country can afford, lesser duty should be charged on them. Licensing regime for COVID-related imports should be eased for a couple of years to expedite production and distribution of vaccines.

One of the stiffest challenges of border management is to deal with counterfeit goods. It would be naive to rule out possibility of fake vaccines. Organised crime groups have been reaping benefits of the pandemic-related heightened demands for medicines, PPE kit and other equipment. INTERPOL has sounded Customs authorities across the world. As soon as a scramble for vaccines begins in poor countries, such criminal syndicates would be joining the bogie of suppliers who would also be counterfeiting trademark of famed vaccine developers. To counter them on border and in domestic market, enforcement agencies will have to pull up socks. Any indication of lacking the belly for a fight would amount to pulling up a boner which would puncture the confidence of the people in the vaccines. In this case international exchange of information about seizures and offences may keep countries well-informed to take combative measures.

Another associated issue linked to the pandemic but is highly likely to escape the attention of Customs authorities, is the cross-border disposal of medical waste. There have already been spikes in the quantum of pandemic-related medical waste. It would leap manifolds once vaccination programmes are rolled out. Given the infectious nature of such waste and also such items which have expired or contaminated or no longer needed, they have to be carefully disposed of as they are equally hazardous for the planet which is also on look out for a vaccine! Since a good number of countries may not have modern incinerators or other infrastructure, there is bound to be international trade for disposal and recycling of such goods. This is where racketeers may resort to misdeclaration and paper manipulation. Trade in waste is regulated by multilateral environment pacts such as Basel Convention. What makes such trade highly profitable is the fact that a major swathe of two billion tonnes of solid waste generated by cities across the world is contracted for disposal outside borders. After the outbreak of the pandemic, some of the cities have registered huge increases. Hubei reported 370% rise in medical waste. Populous cities like Manila and Jakarta produce an extra over 200 tonnes of waste every day! A good amount of global waste goes into recycling and this is where serious hazard lies and Customs will have an important role to play.

So far as India goes, the CBIC has not come out with detailed protocol or guidance note for import or even export of Indian vaccines which may involve land routes for shipments to neighbouring countries in SAARC. The Modi Government is yet to notify exemption to imported vaccines, waiver or reduction in airport or port charges, special cargo clearance procedures, waiver from testing and inspection; waiver from metrological provisions, advance paperwork and coordination of shipment information from production site to vaccination site. Ideally, the COVID Task Force should go for a deeper pivot and set up a dedicated panel of officials from various ministries so that valuable time is not lost and highly perishable vaccine is not wasted. Though India has indeed done well in terms of managing the contagion but in the fog of misunderstanding at the operational level known for gloomier listening habits, vaccination drive may get messed up! Since last-minute decisions are genetically prone to panic, it may further get aggravated as India lacks in world class cold chain and last mile health infrastructure! India also needs to set up market surveillance mechanism to monitor markets to nobble counterfeit COVID-related drugs and vaccines besides protecting IPRs of developers.

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