Exploring Three Key Trends Shaping EU Pharma Logistics

The pharmaceutical landscape in Europe is dynamic, influenced by unique regulations and evolving trends that impact drug development and distribution across member states and Britain. In this context, Euro American, an affiliate of the life sciences sector in Massachusetts, and third-party logistics center specially designed for pharmaceuticals, biomedical, and other high-quality products, emphasizes the importance of staying informed about ongoing trends in pharmaceutical logistics. Here are three significant trends in Europe, along with the associated regulations, that Euro-American is closely monitoring.

1. Supply Chain Concerns

The European Union (EU) has been grappling with drug shortages, driven by increasing demand and limited production capacity. Various factors such as manufacturing disruptions, geopolitical events like the Russia-Ukraine conflict, raw material shortages, and distribution challenges contribute to this issue. The European Commission (EC) has responded by implementing actions to address critical medicine shortages, including measures to enable member states to redistribute needed medicines and regulatory flexibility to ensure timely patient access. Additionally, recent pharmaceutical legislation revisions underscore the EU’s commitment to securing medicine supply and availability across the region.

2. Temperature-Controlled Shipping

The COVID-19 pandemic has underscored the importance of temperature-controlled shipping, particularly for vaccines requiring stringent temperature management. The growing demand for temperature-sensitive products, driven by increased adoption and spending on biologics and advanced therapeutic medicinal products (ATMPs), is expected to continue. EU agencies are actively promoting the development and approval of ATMPs, necessitating enhanced regulatory support and creating opportunities for logistics providers specializing in temperature-controlled transport. As the reach of ATMPs expands across the EU, there is a corresponding need for infrastructure to ensure uninterrupted stability during storage and distribution.

3. Prefilled Drug Delivery

Prefilled drug delivery systems have gained traction in the European market, offering benefits such as cost savings, dosing accuracy, and improved patient experience. The use of prefilled syringes and autoinjectors enhances patient accessibility and adherence, particularly for injectable medications used in chronic conditions like diabetes and obesity. With the implementation of new EU GMP Annex 1 regulations on aseptic packaging, logistics providers must prioritize sterility and product safety, especially for parenterally administered therapeutics. Integration of GMP-compliant packaging services with the logistics chain ensures efficiency and shorter lead times, aligning with the evolving regulatory landscape.

Conclusion

Pharmaceutical logistics in Europe are influenced by ongoing trends and regulatory changes, requiring adaptability and strategic planning from logistics providers. GMP-certified and integrated value chains play a crucial role in accommodating these trends while ensuring agility, reliability, and efficiency. Euro American, a leader in strategic planning, asset management and logistics planning, stands ready to provide essential logistical support through its strategically positioned facilities, and worldwide through a network of Exclusive Service Level Agreements.

Ensuring Supply Chain Resilience in the Face of Disruptions

Pharmaceutical companies face a myriad of risks and disruptions in their supply chains, including natural disasters, geopolitical tensions, and global health crises. Building resilience in the supply chain is essential for maintaining continuity of operations and ensuring the availability of life-saving medications and treatments.

Challenges

  1. Identifying and assessing potential risks and vulnerabilities in the supply chain.
  2. Developing robust contingency plans and response strategies for various scenarios.
  3. Building redundancy and flexibility into supply chain networks to mitigate disruptions.
  4. Establishing strategic partnerships with reliable suppliers and logistics providers.

Solutions

  1. Conducting comprehensive risk assessments and scenario planning exercises: Conducting comprehensive risk assessments involves systematically identifying, analyzing, and evaluating potential risks and vulnerabilities throughout the supply chain. This process enables pharmaceutical companies to anticipate and understand the various threats that could disrupt their operations, whether they are related to regulatory changes, natural disasters, geopolitical events, or other factors. Additionally, scenario planning exercises involve simulating different hypothetical situations to assess their potential impact and develop appropriate response strategies. By conducting these exercises, companies can proactively identify areas of weakness, prioritize risk mitigation efforts, and develop contingency plans to mitigate the impact of potential disruptions.
  2. Implementing business continuity plans (BCPs) that outline roles, responsibilities, and communication protocols during disruptions: Business continuity plans (BCPs) are essential documents that outline how an organization will continue its critical operations during and after a disruptive event. These plans typically include predefined roles and responsibilities for key personnel, clearly defined escalation procedures, and communication protocols to ensure effective coordination and decision-making during crises. BCPs also identify critical business processes and resources, establish recovery objectives and timelines, and outline procedures for activating and executing response and recovery activities. By implementing robust BCPs, pharmaceutical companies can minimize the impact of disruptions, maintain essential operations, and expedite the recovery process.
  3. Diversifying supplier and transportation networks to reduce reliance on single sources: Diversifying supplier and transportation networks involves expanding the pool of suppliers, carriers, and logistics partners to reduce reliance on single sources and mitigate the risk of supply chain disruptions. This strategy may include identifying alternative suppliers or transportation routes, establishing redundant inventory locations, or leveraging multiple logistics providers to ensure continuity of supply. By diversifying their networks, pharmaceutical companies can enhance flexibility, resilience, and responsiveness in the face of unforeseen disruptions, such as supplier failures, capacity constraints, or transportation delays.
  4. Collaborating with trusted logistics partners experienced in managing supply chain disruptions: Collaborating with trusted logistics partners who possess expertise in managing supply chain disruptions is crucial for pharmaceutical companies seeking to enhance their resilience and agility. These partners may have specialized knowledge and capabilities in risk management, crisis response, and contingency planning, allowing them to provide valuable insights and support during times of uncertainty. By forging collaborative relationships with experienced logistics partners, pharmaceutical companies can leverage their resources, networks, and best practices to effectively mitigate risks, address disruptions, and maintain continuity of operations across the supply chain.

Conclusion

Ensuring supply chain resilience is paramount for pharmaceutical companies operating in an increasingly complex and volatile global environment. By prioritizing risk management, contingency planning, and strategic partnerships, companies can minimize the impact of disruptions and maintain continuity of operations.

Streamlining Customs Brokerage for International Pharmaceutical Trade

Customs brokerage plays a crucial role in facilitating the smooth flow of pharmaceutical products across international borders. However, navigating the complex landscape of import/export regulations and customs procedures can be challenging for companies in the life sciences sector.

Challenges

  1. Understanding and complying with diverse import/export regulations in different countries.
  2. Managing documentation requirements for customs clearance, including import licenses and permits.
  3. Addressing the risk of delays and disruptions in customs clearance processes.
  4. Ensuring compliance with security and anti-counterfeiting measures for pharmaceutical products.

Solutions

  1. Partnering with a licensed U.S. Customs Brokerage with expertise in pharmaceutical trade compliance: These brokers possess in-depth knowledge of the complex regulatory requirements governing the import and export of pharmaceutical products, including Good Manufacturing Practices (GMP), FDA regulations, and international trade agreements. By leveraging their expertise, pharmaceutical companies can ensure seamless customs clearance while mitigating the risk of compliance violations and associated penalties.
  2. Utilizing advanced customs clearance software for automated document processing and submission: These software solutions automate routine tasks such as document generation, data entry, and submission to customs authorities, reducing the risk of errors and delays associated with manual processing. Additionally, advanced software platforms often incorporate features such as real-time tracking, status updates, and compliance alerts, enabling proactive management of customs clearance processes. By embracing technology-driven solutions, pharmaceutical companies can expedite customs clearance, minimize administrative burdens, and ensure compliance with regulatory requirements.
  3. Maintaining proactive communication with customs authorities to address potential issues and expedite clearance: Establishing regular dialogue with customs officials enables companies to clarify regulatory requirements, address inquiries or discrepancies promptly, and resolve issues before they escalate. By prioritizing open and transparent communication, pharmaceutical companies can build positive relationships with customs authorities and streamline the customs clearance process.
  4. Conducting regular audits of customs compliance processes to identify areas for improvement: These audits may encompass various aspects of customs compliance, including documentation accuracy, tariff classification, valuation, and record-keeping practices. By conducting thorough and systematic audits, companies can proactively identify potential risks, address compliance gaps, and improve overall customs compliance processes. Additionally, audits provide opportunities for continuous improvement, enabling companies to stay abreast of evolving regulatory requirements and industry best practices.

Conclusion

Streamlining customs brokerage processes is essential for pharmaceutical companies seeking to expand their international presence. By partnering with a trusted customs brokerage provider and implementing best practices, companies can minimize delays and disruptions in customs clearance and ensure compliance with import/export regulations. Apart from being industry experts and long-term professionals with a combined 70 years of brokerage experience, Euro American is committed to continuing education, thorough study, and cultivating their passion for their work. We are deeply committed to increasing your efficiency and consulting throughout the process. By working with shippers on compliance, classification and documentation, we are able to hone your processes and save you precious time and money.

EAWL Storage Facility

Gaining GMP Storage Space Utilizing a 3rd Party Solution in Massachusetts

Intro

Are you a life sciences manufacturer struggling to find enough storage space for supplies and materials? Outsourcing to a 3rd party GMP storage facility is your best solution.

Storage providers in Massachusetts have state-of-the-art facilities and strict adherence to Good Manufacturing Practices (GMP), so that you can trust that your materials will be safe, organized, and easily accessible when you need them.

This article explains how utilizing a 3rd party satellite facility can help maximize your storage space and streamline your materials management process.

Exploring the Benefits of a 3rd Party Satellite Facility for Enhanced Materials Management

Firstly, a validated storage facility is essential for life science manufacturing. Many materials used in this industry require specific temperature and humidity levels to maintain their efficacy and integrity. With a 3rd party provider like Euro American, you can ensure that your materials are stored in validated conditions, minimizing the risk of degradation, and maintaining the quality of your products.

Additionally, managing single-use disposables can be a challenge due to their bulky nature. By utilizing a third-party satellite facility, you can free up valuable space in your own facility and store these disposables in an organized and efficient manner until you need them. This streamlines your production process and eliminates the hassle of finding space for these essential items.

Lastly, cold-chain transportation is often required for temperature-sensitive materials. It is essential to assess the provider’s capabilities in managing cold-chain transportation. A 3rd party storage facility equipped with proper cold-chain management systems, including temperature-controlled vehicles for transporting the goods between your facility and theirs, will maintain the integrity of your materials and ensure on-time availability. This alleviates any logistical challenges of maintaining temperature control and provides peace of mind for quality.

Selecting the Right 3rd Party Provider: Key Considerations

When selecting a 3rd party provider for stockpiling supplies and materials, make sure the provider has the following two things in addition to the normal cGMP requirements: Experience and Guaranteed Same-Day Access.

Experience: First and foremost, it is crucial to ensure that the provider has experience and expertise in handling the specific needs of life science manufacturing. Choose a provider like Euro American that has been specializing in this industry for nearly six decades and understands the unique challenges and requirements involved.

Guaranteed Same-Day Access: The goal when outsourcing is to gain storage space without sacrificing quality or accessibility. Make sure the provider guarantees same-day access to your materials being stored. The provider should be equipped with temperature-controlled vehicles, maintain 24/7 availability, and guarantee same-day delivery from their facility to yours.

Final Thoughts

As a life science manufacturer, you know the struggles of finding adequate storage space for your supplies and materials. Utilizing a third party GMP Storage Solution in Massachusetts provides you with the space you need and ensures that your items are safe, organized, and easily accessible when you need them.

Negative Effects of the Inflation Reduction Act on the Life Sciences Manufacturing Industry

US Launches Attack on Drug Developers

The Life Science Manufacturing industry has long been hailed as the bedrock of groundbreaking medical research and innovation, particularly in the realm of drug development. With the United States leading the charge, accounting for 55% of approved drugs globally, the mutualistic relationship between public and private sectors has undeniably set a global standard. However, the recently introduced Inflation Reduction Act (IRA) threatens to destabilize this fine balance, sending shockwaves through the industry.

Public-Private Symbiosis Underpins Drug Development Success

The National Institutes of Health (NIH) plays a pivotal role in facilitating biotech advancements. Dr. Hans Sauer of the Biotechnology Innovation Organization (BIO) emphasizes that the existing alliance between NIH and private biotech firms is the cornerstone of American leadership in drug development. In 2020, U.S. investment in biomedical R&D stood at a staggering $245 billion, with the federal government contributing $61.5 billion (25%). Meanwhile, the private sector bore the lion’s share with $161.8 billion (66%).

While a significant portion of NIH funding aids drug development, most of its resources are channeled into basic research. This foundational research subsequently propels private entities to invest in the next stages of drug development, fostering an environment of innovation and risk-taking.

The Price Debate: More Than Meets the Eye

Recent discussions around NIH-supported drug development have steered towards potential price controls. Detractors argue that NIH backing should correlate with reduced drug prices. However, Dr. Sauer refutes this notion, pointing out that private sector contributions significantly outweigh public investments. Moreover, the private sector predominantly shoulders the risk of potential drug failures, emphasizing the peril in introducing arbitrary price caps.

Echoing these concerns, Rachel King, CEO of BIO, warns that the IRA’s price controls are detrimental to the biotech industry’s intricate innovation ecosystem. The disincentives introduced by the IRA, particularly regarding orphan drugs that treat rare diseases, could stymie critical research endeavors. By limiting orphan drugs to a single indication for pricing exemptions, the Act inadvertently hampers the exploration of these drugs’ wider potential applications.

Bridging the Policy Gap: The Way Forward

The backlash against the IRA isn’t just limited to industry stakeholders. Legislative voices have also begun acknowledging the Act’s potential pitfalls. As King articulates, there’s a pressing need for bipartisan efforts to rectify problematic facets of the IRA, ensuring that it doesn’t stifle innovation.

Highlighting the crux of the issue, Christina Hochul of Alexion Pharmaceuticals underscores the unintended challenges presented by the IRA’s orphan drug exclusion. Following the Act’s implementation, various entities, from patient advocates to biotech investors, have spotlighted this legislative blind spot, advocating for prompt amendments.

Amy Rick, Chair of the IRA Orphan Task Force, elucidates the long-term ramifications of the current legislation. Decisions influenced by the IRA today could adversely affect the industry for the next decade. With some companies already halting orphan drug research and venture capitalists growing hesitant, the repercussions are palpable.

As discussions intensify, the Centers for Medicare and Medicaid Services (CMS) emerges as a key player. Over the past year, organizations have actively engaged with CMS, emphasizing the need to reevaluate the IRA’s ramifications, especially concerning orphan drug exclusions.

Conclusion

While the Inflation Reduction Act was designed with commendable intentions, its inadvertent consequences on the life science manufacturing sector cannot be ignored. Collaboration between industry stakeholders, patient advocates, and policymakers is paramount. As the industry continues to navigate these challenging waters, it’s essential to strike a balance that upholds both patient welfare and innovation. Only with mutual understanding and comprehensive legislative revisions can the life science manufacturing industry continue its legacy of pioneering drug development.

Sources:

Inflation Reduction Act: Unintended consequences for rare disease, orphan drugs
BIO Vice Chair John Crowley to Congress: IRA reduces access to innovative drugs
Why drug price controls ‘risk the future of investment’ in R&D
BIO’s Rachel King weighs in on IRA and the biotech industry in new podcasts
BIO expert lauds beautiful relationship between NIH and biotech