Risk Assessment

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Medicine and Device Suppliers in the UK's National Health Service are being urged to do Supply Chain Coronavirus Risk Assessments

The World Health Organization (WHO) raised its estimate of the global risk posed by the new coronavirus to "extremely high" status at the end of the week that just passed. This comes not long after the first mortality in the United Kingdom was attributed to COVID-19, the disease that was caused by the virus. The epidemic coronavirus has the potential to disrupt international trade and result in shortages of medications and medical devices due to the transnational nature of many supply chains in the life sciences sector.

The United Kingdom Department of Health and Social Care (DHSC) sent a letter on February 11, 2020, to all of the suppliers of medical goods (including pharmaceuticals, medical devices, and clinical consumable products) to the National Health Service (NHS) in England and Wales, requesting that they conduct a full risk assessment of the impact that the situation will have on their supply chains. This was done in anticipation of the possibility that this would come to pass.

 

According to the advice given by the DHSC, this should cover:

How current and future restrictions within China and other affected markets might impact the production and transportation of finished products, active pharmaceutical ingredients, excipients, and other components; Whether or not any third-party suppliers are dependent upon materials or components sourced from China or other affected markets. The impact that the new coronavirus and COVID-19 might have on business activities.

In addition, the Secretary of State for Health and Social Care in the United Kingdom has requested that companies that provide goods to the National Health Service (NHS) continue to store any products that may have been stocked up in anticipation of Brexit. The NHS should continue to receive supplies from its suppliers in the usual manner; however, suppliers have been asked to carefully monitor orders and consider putting demand control strategies into action in the event that ordering patterns deviate significantly from the norm.

The DHSC has requested that enterprises provide it with the results of the risk assessments, and it has also requested that suppliers that have a known "touchpoint" in the supply chain in China get in touch with the DHSC in advance.

The underlying responsibility of marketing authorization holders (MAH) to assure adequate and sustained supplies of their pharmaceutical products is not alleviated or altered in any way by this advice. In the case that a MAH expects or actually experiences a supply shortfall, the matter is to be quickly notified to the Medicine Supply Team of the DHSC in line with the guidance provided by the DHSC. The Department of Health and Human Services (DHSC) will thereafter work to reduce the potential negative effects of the disruption in supply on patients.

Given the increasingly global nature of the coronavirus outbreak, all pharmaceutical and medical device companies, regardless of the markets in which they operate and to which they supply, should consider the possibility of pro-actively mapping out their supply chains in order to identify potential risks that are associated with the coronavirus and put into place measures that will mitigate those risks. Within the past year or two, many businesses that operate in or supply the UK have already carried out a comparable procedure for determining the potential implications that would result from Brexit. When it is feasible to do so, businesses should also communicate with their most important suppliers in order to have a better understanding of the risks those suppliers face and the measures they are doing to reduce the potential impact.

When it comes to risk assessments, nothing can surpass the methods conducted by Sevron. We specialise in business continuity and have a wide range of solutions for different markets. We are happy to offer our services to any UK businesses that may be struggling with this issue. Our experts have significant experience in conducting supply chain risk assessments and can provide you with peace of mind. Visit our website or call us today!

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