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Regulatory Focus™ > News Articles > 2021 > 3 > Global medicinal supply chain examined in EC, US efforts

Global medicinal supply chain examined in EC, US efforts

Posted 01 March 2021 | By Kari Oakes 

Global medicinal supply chain examined in EC, US efforts

The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.
 
By coming to a clearer understanding of how global medical supply chains function, the European Health Union and other players in medical supply chains hope to spot where vulnerabilities lie and how they can be addressed.
 
“The initiative will help to address the resilience of our pharmaceuticals supply chains, in particular to develop production capacity for critical active ingredients, raw materials and medicines in the EU to ensure better preparedness for future health pandemics, in light of the experiences with COVID-19,” wrote the European Health Union in announcing the structured dialog.
 
The launch meeting was moderated by EC vice president Margaritis Schinas, European commissioner Stella Kyriakides, who heads EC health initiatives, and commissioner Thierry Breton, who oversees the EC’s internal markets. As the structured dialog sessions continue through 2021, the year-end goal is to arrive at policy recommendations that will address identified vulnerabilities.
 
Four separate areas of focus are being addressed in the first of two phases of the structured dialog; a written report in each area will be forthcoming at the end of the first phase. The first area of focus centers on the medical supply chain, looking at the dimensions of “agility, flexibility and resilience,” according to the European Commission.
 
Another workstream will identify medicinal products deemed critical to EU public health and look to quantify within-EU capacity for manufacturing these products. The third initiative to be addressed is to identify what links in the supply chain may be vulnerable, recognizing that vulnerabilities may differ for different kinds of medicines. “The discussion should include consideration of disruption challenges most frequently observed/ that pose the greatest threat to supply, to identify the drivers of these vulnerabilities, including dependencies,” according to the EC account of the initiative.
 
Finally, the first stage of the structured dialog will identify where modernization and innovation are needed. Included in this workstream will be an examination of priority areas for research and development, and steps needed to keep EU production capacity high.
 
 
The European Federation of Pharmaceutical Industries and Associations (EFPIA), in a press release after the launch event, declared its endorsement of the structured dialog effort in which it is participating.
 
In the announcement, EFPIA made the point that “The EU is the largest exporter of medicines in the world, with a global market share of 63.8%,” and that over three quarters of the active pharmaceutical ingredients used in pharmaceutical innovations come from within Europe.
 
Nathalie Moll, EFPIA’s director general, pointed to the COVID-19 pandemic as a critical reminder of the importance of a resilient supply chain. “Our recent experience in discovering, developing and delivering COVID-19 vaccines and therapeutics has underlined that resilience begins with our research and development eco-system as well as the paramount importance of resilient global supply chains,” said Moll.
 
The same week the structured dialog was launched in Europe, US President Joe Biden issued an executive order on American supply chains, calling for reports from heads of several agencies within 100 days of the 24 February order.
 
The US Secretary of Health and Human Services (HHS) is tasked in the order with “identifying risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients and policy recommendations to address these risks.”  The HHS report should augment the agency’s ongoing work to identify shortfalls and shore up the resilience of the supply chain for pharmaceuticals and equipment, including personal protective equipment, needed in the ongoing battle against COVID-19, according to the order.
 
The US presidential executive order lays out in detail the factors to be considered in each agency’s report, including “the defense, intelligence, cyber, homeland security, health, climate, environmental, natural, market, economic, geopolitical, human-rights or forced-labor risks or other contingencies that may disrupt, strain, compromise, or eliminate the supply chain.”
 
EC Structured Dialog
US Executive Order
 

 

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