The PSCI is pleased to announce the publication of its updated Principles. The Principles underpin the work of PSCI, and form the basis of our mission. As such, we encourage all members, suppliers, and auditors to ensure they understand and are familiar with them.

The Principles have been in place, in their original form, since they were agreed by PSCI’s founding members in 2006. They were updated for the first time in December 2019. As part of our three-year periodic review, the PSCI has spent the last year in consultation with members, suppliers, partners, advisory panellists, and external stakeholders to refresh our foundational document.

Following this consultative process, all members were invited to vote to approve the new version of the Principles, which was formally adopted at the PSCI Spring Meeting on 23 May 2023.

The refreshed Principles take effect for members immediately. To ensure proper implementation, all members are now invited to start reflecting the changes in their policies, codes, processes, and practices. The first check-in will take place during the annual member calls in March 2024. All PSCI member companies are expected to have integrated the revised PSCI Principles by November 2024.

Significant changes to the Principles are:

• ‘Governance and Management Systems’ is now the first Principle, reflecting its foundational nature and impacting the other four sections (Ethics, Human Rights, Health & Safety, and Environment)
• Broader scope of the human rights section, now covering the rights of local communities and the commitment to conduct regular human rights risk assessments
• New clauses on establishing a culture of responsible practices, providing remediation, setting up grievance mechanisms, protecting products and quality, upholding the right to collection bargaining, supporting the wellbeing of workers, and conserving biodiversity
• Strengthened clauses on resource efficiency and climate change (covering suppliers' scope 3 emissions)

As ever, the Principles are made available freely and publicly to anyone with an interest in responsible supply chains for our sector. To view the Principles, visit them in our Resources library.

Any comments to the refreshed Principles, or their implementation, should be submitted to the Secretariat.

The Pharmaceutical Supply Chain Initiative (PSCI) Releases Position Paper on Sector’s Use of Horseshoe Crabs

• The PSCI - representing 75 of the world’s largest pharmaceutical companies - launches progressive position paper on the use of Horseshoe Crab blood in the industry
• Position paper addresses a range of issues to ensure sustainability and welfare of the Horseshoe Crab populations

22nd May 2023 – The Pharmaceutical Supply Chain Initiative (PSCI) just released a position paper on the use of Horseshoe Crabs in the pharmaceutical sector. The paper takes a progressive stance, noting the potential animal welfare and sustainability impacts of the use of Horseshoe Crab blood within the industry, and aims to encourage its member companies to minimize their use and seek out safe alternatives for their supply chains.

Horseshoe Crabs are an ancient group of crab species who have been around for more than 400 million years. Their blood has the remarkable property of indicating certain types of endotoxins. For this reason, it has been harvested by the medical and pharma industries to use as a test for these harmful compounds. Endotoxin testing using approved methods is a key demand of the regulators who authorize pharmaceutical development and manufacturing.

While this process does not require the death of the animal, there are still questions over possible animal welfare, biodiversity, and sustainability impacts from the collection of these materials from populations of wild crabs. Of the three affected species of Horseshoe Crabs across the US and Asia, one Asian species is listed as endangered, with concerns over the other Asian species where data is deficient.

The connection between the Horseshoe Crab species and the pharmaceutical sector highlights the importance of biodiversity for human health and acts an excellent example of interdependence between medicine and biodiversity. It also illustrates the complexity of biodiversity-related sourcing in a regulated industry.

However, it also emphasizes the need for the industry to take an active position, and so the PSCI has launched its progressive position paper on what it believes to be good practice for the use of Horseshoe Crab blood within the pharmaceutical industry.

“The PSCI is releasing this position paper to encourage our members to protect the endangered species, seek out alternatives to these materials, and to adopt an intentional approach to sourcing where it is remains necessary.

Our commitment is to work together now, to drive this transition towards a long-term sustainable position and to play our part in protecting these remarkable species.”
 
– A spokesperson for the PSCI
 
Representing 75 of the world’s largest pharmaceutical companies, the PSCI will encourage its members to commit to no further collection from endangered species, minimising the use of these materials, and sharing information to understand the animal welfare and conservation questions.

While this paper is not a membership requirement for the PSCI, it does outline the organisation’s views on good practice as it continues its commitment to the protection of all endangered species. It is important the industry has a strategy for reducing its dependence on Horseshoe Crab-derived products, and the PSCI is committed to working with its members to facilitate their progress and report the position across the whole industry.

Click here for the full position paper.

Please contact the PSCI at info@pscinitiative.org, or our Communications Manager, emma.wilkins@carnstone.com, if you have any questions or would like to learn more. 
 
About The PSCI 
Helping suppliers meet industry expectations. The PSCI was formed as a project between the 6 founding members in 2006 and was legally established in the United States as a non-profit membership organization in 2013. 
 
Our vision is for excellence in safety, environmental, and social outcomes for the whole of the global pharmaceutical and healthcare supply chain. Our purpose is to bring together members to define, establish, and promote responsible supply chain practices, human rights, environmental sustainability, and responsible business.
 
We achieve this through the PSCI Principles for Responsible Supply Chain Management. They are the blueprint for responsible practice, setting our expectations for five relevant topics: Ethics, Labor, Health & Safety, Environment, and Management Systems. 
 
Our strategy is based on the 6 strategic themes of: Leadership, Audit Partnering, Regional Presence, Supplier Learning, Innovation. 
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A position paper from the PSCI

Context and background

Blood products derived from Horseshoe Crabs are used in the process of pharmaceutical development and manufacturing as endotoxin testing reagents; materials which indicate the presence of certain bacterial toxins when applied to a sample. Testing for contaminants is a crucial part of ensuring safety in drug products.

There are three affected species of Horseshoe Crabs: Limulus polyphemus found on the East Coast of the US, and the Indo-Pacific and Tri-spine Horseshoe crabs (Tachypleus gigas and Tachypleus tridentatus) found in Asia. These are used to produce Limulus Amebocyte Lysate (LAL) and Tachypleus Amebocyte Lysate (TAL) respectively, both being extracted from the animals’ blood. This does not require the death of the animal; they are typically collected, a measured amount of blood extracted, and released back into the wild.

Nonetheless, there are potentially animal welfare and sustainability impacts from the collection of these materials from populations of wild crabs, with concerns that the process may increase mortality and lead to population decline among the crabs and related species (birds and sport fish). Tachypleus tridentatus is listed as endangered[1] (with concerns over the other Asian species, where the data is deficient).

Change within the pharmaceutical industry must be carefully managed to ensure products are safe and to secure regulatory approval, however there are opportunities for progress. Good laboratory practices (automation, sample grouping, waste management) provide ways to reduce consumption. Microfluidics test technology offers accurate, reproducible tests using only a tiny fraction (as little as 5%) of the volume of LAL when compared to the traditional LAL test, dramatically reducing the demand for animal-derived product.

There are alternative technologies available in certain applications which do not require LAL or TAL at all. Recombinant Factor C (rFC) assay is an alternative to endotoxin testing using LAL/TAL. Regulators have approved rFC in some contexts; the FDA guidelines in 2012 allow for the consideration of rFC “if appropriately validated” and there is a guidance compendial test chapter in Europe. First regulatory approval using rFC for the approval of a medicine was in 2018 and this product has been approved in over 60 markets. At least seven products to date have global regulatory approvals using an alternative test reagent. Other LAL-like reagents, including a recombinant LAL, are also being introduced to the market.

The PSCI’s Position

Against this backdrop, the PSCI – representing 74 of the world’s largest pharmaceutical companies and their suppliers – is pleased to affirm the following elements of good practice, and to encourage their adoption by all members:

Protect all endangered species – no further collection of TAL. The PSCI’s members will end commercial pressure on the populations of Tachypleus gigas and Tachypleus tridentatus, by committing to no further collections from these species. PSCI members and first tier suppliers will no longer use TAL after existing supplies have been exhausted.

Minimise the requirements for naturally-derived testing materials. The PSCI recognises that members will potentially require a range of endotoxin testing techniques, and the availability of rFC, other recombinant reagents, and microfluidics offers members a route to dramatically reduce the demand for LAL. Members are encouraged to explore and adopt alternatives, setting themselves internal goals to minimize the volume of LAL used in their own operations and first tier suppliers.

Understand the animal welfare and conservation position. For the residual use of LAL, members are encouraged to take an active and intentional approach to sourcing, to understand where the material derives from and the animal welfare and biodiversity considerations that may result. Members are encouraged to co-operate and share data on traceability, populations and conservation status of Limulus polyphemus.

Governance and monitoring

This is a PSCI position paper, but it is not a formal membership requirement of PSCI; the organisation believes it to be good practice and a progressive approach to be widely adopted.

Members are encouraged to adopt positions as set out in this paper and to promote their adoption throughout the supply chain.

PSCI in turn commits to:

• monitor and review our members’ approach on this and report it on an anonymized basis
• engage with others to learn and develop, particularly on the US conservation position
• prepare guidance, materials, and support to members and suppliers to implement the good practice elements of this statement

The PSCI is delighted to welcome Energize as an official PSCI partner to support the acceleration of renewable energy adoption and enable bold climate action within the pharmaceutical sector supply chain.

In 2021, ten PSCI member companies launched a potentially game-changing collaboration to increase access to renewable energy for the pharma supply chain via the Energize Program. This first-of-its-kind industry program will enable suppliers – who may not otherwise have the internal resources or expertise available – to both learn more about and participate in the market for power purchase agreements (PPAs). The program will help pharmaceutical and healthcare suppliers to address their own operational Scope 2 greenhouse gas emissions through green power procurement, which in turn will reduce the participating companies’ Scope 3 emissions.

Renewable energy procurement can be challenging for companies of all sizes for a variety of reasons. The Energize program is designed to overcome typical market barriers such as inadequate knowledge about renewable energy transactions, load size, lack of credit, and the need for guidance throughout a complex and protracted contracting process. Participating suppliers will learn about the renewable energy market, receive guidance on PPAs, and have the opportunity to access and contract for renewable energy on their own or as part of a collaborative buyers’ cohort.

Speaking on the partnership, Rob Williams, Director - Procurement Sustainability at Astrazeneca and Co-lead of the PSCI Decarbonization Team says,

"Decarbonizing the pharma supply chain is a huge undertaking that requires partnership and collaboration. I’m delighted that the PSCI and Energize are working together to support the whole of the pharma sector supply chain through a shared value approach. By raising awareness about the world of renewable energy and providing a platform and solution for the pharma companies and their suppliers to decarbonize, we are making the transition to net zero a reality for the sector.”

John Powers, VP, Renewable Energy & Cleantech, Schneider Electric Sustainability Business says,

"We’re delighted to work together with PSCI and its member companies to accelerate the path to decarbonization through Energize – our unique, first-of-its-kind program designed for pharmaceutical and healthcare suppliers. Together, we’re enabling a more collaborative approach to Scope 3 decarbonization by helping suppliers engage renewable energy via power purchase agreements (PPAs) and meaningfully impacting the total pharma value chain.”

You can find out more about the partnership in this webinar recording presented by the PSCI and Energize teams (available to those registered with the PSCI).

About Energize
The Energize program is designed and delivered by Schneider Electric; the pharmaceutical companies promote the program collectively, and individually invite their suppliers to participate. Current corporate members include Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Takeda, Teva Pharmaceuticals, and UCB.