PHARMACEUTICALS
Shore thing
Is ‘ reshoring ’ the whole pharmaceutical supply chain to the West practical ? We report from the CPhI Discover event
The pharmaceutical supply chain has been thrown into the spotlight in the past year , thanks to “ a very stunning shock to the global economy ”, according to Brandon Boyd , director of life sciences strategy at analytics firm Clarivate . Boyd was one of the panel members at a CPhI Discover webinar entitled ‘ The API Landscape : Reshoring , Trading & Sourcing Dynamics ’. “ Some critical components have gone into short supply or lack of supply at times over the past year ,” Boyd said . “ The knock-on effect is uncertainty over sourcing and timings , and the fragility of the supply chain , particularly for APIs and some finished dosage forms , has meant some critical shortages at times .” This shortage has been driven by two factors : a labour shortage , as workers were unable to come into some factories at specific times , either because of illness or government mandates ; and , politically imposed constraints on parts of global trade . Labour shortages have not been such a major issue in Europe as other regions , noted Stefan Schmidinger , head of markets and business development at Swiss-based Kemiex , a trade and intelligence platform for the pharmaceutical industry and others . However , Europe has seen the impact of what is happening elsewhere , particularly now in India .
Whenever any medicine was mentioned as a possible treatment for COVID , Schmidinger said , demand and prices soared . Moreover , “ in most countries there are about 50 to 300 drugs that are always short for different reasons and that has only got worse during COVID ”. Matt Hicks , COO of the US-based chemical and pharmaceutical equipment manufacturer and dealer Federal Equipment Company , agreed that there is now a widespread awareness that supply chains “ are not understood at a global level ”. As recently as October 2019 , he said , Dr Janet Woodcock of the
FDA told Congress that , although the agency knew that a lot of manufacturing had moved overseas , it did not really understand how the market worked or where many APIs are made . Once the pandemic hit in Q1 2020 , much more came to light and the company has seen a scramble for equipment to manufacture in the US . However , its lead times are long and the equipment shortage , particularly of new equipment , makes ongoing attempting to reshore production difficult .
Insight issues
Why is the supply chain so opaque ? In Boyd ’ s view , this has a lot to do with the lack of a political mandate to reveal proprietary information . At individual firm level , there actually is good visibility into the supply chain and Clarivate expects to see a greater focus on this and that disclosing more information might become seen as good public policy . “ We ’ ve already seen some legislation driving traceability in the supply chain and API will be a significant part of that in the next couple of years as that legislation comes into effect ,” he added . The question will remain of a government body having supply chain insight into ways that it did not before , Boyd continued . This will require greater engagement with industry . For some years , though , policymakers will continue to struggle with a level of uncertainty . The issue to be resolved is very different for them as opposed to the companies in the industry . Reshoring has been the solution proposed in most major markets , at least by politicians . Clarivate tracks about 400 US API facilities . Of these , about 25 % are owned by Big Pharma and manufacture for captive use ; 33-40 % lack a quality or regulatory track record ; and about 25 % have not been FDA-inspected in the last four years .
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JUL / AUG 2021 SPECCHEMONLINE . COM
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