Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages. Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse. The current problem, external environment, and emerging risks are highlighted in a recent publication (Building a Resilient and Secure Pharmaceutical Supply Chain: The Role of Geographic Diversification) of the Duke-Margolis ReVamp Drug Supply Chain Consortium, of which Lachman’s Patrick Day is a founding member and White Paper contributor as a participant in the ReVAMP Consortium Advisory Group. This advisory group is an active cross-section composed of stakeholders from manufacturing companies, regulatory observers, academics, and healthcare providers, all striving to fight the ongoing global drug shortage problem.
Much has been written about drug shortages, but this new White Paper provides expert-level analysis of the role of geographic diversification, including significant regulatory actions and legislative activities, as well as key recommendations for the industry. These insights should be used by the industry not only to influence next year’s corporate objectives but be considered in enterprise risk-management plans. This White Paper outlines significant recommendations and is a great reference source for ongoing legal, regulatory, and industry initiatives. Some of the items covered in the White Paper are:
- Advancing regulatory harmonization: This is a critical area where global supply chains span countries and regulatory bodies.
- Vulnerability to geopolitical conflicts and regulatory oversight in certain countries: Emerging risks are identified within the volatile political environment, and the backlog of inspections is highlighted.
- Balancing transparency and protection of confidential information: The White Paper recognizes that balance is ongoing between these sometimes seemingly mutually exclusive elements.
In addition to this information-rich White Paper, real-life examples of investment changes by firms are included in response to the call for onshoring, nearshoring, and implementation of advanced manufacturing technologies. Specific to this White Paper is an outline of global efforts such as:
- France’s €800 million for the development and production of biomedicines through 2030
- The Austrian government and Sandoz’s combined investment of $213 million for production expansion as well as an increase in domestic manufacturing of antibiotics
- UK’s Vaccine Taskforce’s intention to increase domestic supply in support of the vaccine supply chain
- Canada and Brazil’s active initiatives to diversify their supply chains
The White Paper outlines that, despite all of these efforts, as of 2023, the average duration of a drug shortage was more than three years, up from an average of two years in 2020. Many of these issues were reported by Lachman Consultants in previous blogs (including Supply Chain Shortage News). Our work with clients has enabled them to not only “see” risk indicators but also use best practices to enable efficient mitigation. Knowledge is power so engage Lachman Consultants to make sure your teams understand this important publication today! Reach out to us at LCS@LachmanConsultants.com for a consultation.