Explore the International Coalition for Safe Plasma Proteins (ICSPP)

This WHO Initiative calls on its Member States to:

1. improve quality and safety of blood and blood products (including plasma)

2. avoid wastage of plasma and use it for fractionation of PDMPs
and also to use stepwise in LMICs untransfused plasma for local preparation of safe plasma protein products (PPPs) in existing blood establishments, e.g. with pathogenreduction technologies (PR)

The document outlines an "Action Framework" designed to advance universal access to safe, effective, and quality-assured blood products. Acknowledging the crucial role of blood products in healthcare, the framework highlights the necessity of a coordinated national blood system. Blood products—including whole blood, blood components for transfusion, and plasma-derived medicinal products (PDMPs)—are vital for various medical treatments and procedures.

The framework addresses the challenges in establishing and strengthening national blood systems, particularly in regions where progress has been slow. Major challenges include gaps in policy, regulations, governance, and financing; insufficient blood collection and availability; low levels of voluntary non-remunerated donations; and deficiencies in ensuring blood safety and quality.

 

This new edition of the World Federation of Hemophilia (WFH) guidelines for the management of hemophilia comes at an exciting time in the evolution of the diagnosis and treatment of this condition. Since the publication of the second edition in 2012, tremendous advances have been made in several aspects of the management of hemophilia. These include genetic assessment as well as therapy with many innovative therapeutic products including extended half-­life factor VIII (FVIII) and factor IX (FIX) products, a bi-­specific antibody, and hemostasis rebalancing drugs now in clinical development. All of these allow for more effective hemostasis than was possible in the past. Laboratory monitoring of therapies is better defined and prophylaxis is accepted as the only way to change the natural history of bleeding. There are highly effective therapies for patients with inhibitors. Outcome assessment with validated clinimetric instruments is widely advocated and practiced. All these advances are reflected in this third edition of the WFH guidelines, with new chapters devoted to several of these topics along with a new chapter on principles of care that aims to provide a framework for development of a comprehensive healthcare system for hemophilia including advocacy and empowerment for people with hemophilia (PWH). The recommendations in this edition were all developed through a formal evidence-­informed and consensus-­based methodology involving multidisciplinary healthcare professionals (HCPs) and well-­informed PWH. While directed primarily at HCPs, these guidelines should also be very useful for PWH as well as advocacy organizations.

 

Several plasma-derived medicinal products (PDMPs) are included in the WHO Model List of Essential Medicines, highlighting them as medications considered to be the most effective and safe to address the major needs in a health system. However, PDMPs are in shortage at global level, most severely affecting patients in LMIC. Inadequacy of PDMPs in those countries also results from an insufficient domestic supply of plasma of a quality suitable for non-domestic fractionation and from a lack of technical and financial capacity to implement a domestic plasma fractionation programme.

Supporting access to quality and safe PDMPs at global level aligns with the objectives of World Health Assembly (WHA) resolution 63.12 (2010) on availability, safety and quality of blood products, addressing a major unmet public health need that has steadily increased with expanded use of these medically important products.  This white paper was developed within the scope of the World Health Organization (WHO) Action Framework to Advance Universal Access to Safe, Effective and Quality-Assured Blood Products 2020–2023, consistent with WHA resolutions and WHO documents that are relevant to global advancement of blood systems.  It is intended to provide a high-level overview and recommendations for actions that can be taken by policy-makers, national regulatory authorities, blood collection organizations, blood donors and their associations, clinicians and patients as a roadmap toward reducing wastage of plasma that could be fractionated to make the PDMPs and thus increase access to PDMPs in low- and middle-income countries (LMIC).  The document highlights the steps that can be taken to increase the production of quality and safe plasma from voluntary non-remunerated donors in LMIC and to enable its use in fractionation.

 

The workshop identified pragmatic technical options for stepwise access to safe plasma protein therapies in resource-constrained countries to support the implementation of the recent WHO guidance on “Increasing Supplies of Plasma-derived Medicinal Products in Low- and Middle-income Countries through Fractionation of Domestic Plasma” and “Centralization of Blood Donation Testing and Processing.”

WS organised by ISBT WP on GBS with participation of: 

• WHO (international authority)
• FIODS (blood donors)
• ISBT (producers of blood products and specialists in TM) 
• IPOPI (advocacy group for patients with PID) 
• WFH (organisation of patients with IBD) 
• Industry (plasma fractionators, medical device manufacturers, pathogen-reduction technology providers,…) 
• Regulators
• Researchers

Continuation of the momentum:

1. Setting up the “International Coalition for safe plasma protein products in low- and middle- income countries” 
2. Pilot Project PP “NBTC Dakar&Cryo-PR” (extendable to IG-PR)
3. Additional projects in LMICs in Africa, South-East Asia and in Latin America

are under consideration

 

October 3 2022

Launch of the International Coalition for Safe Plasma Proteins (ICSPP) 
Organizations join with ISBT to advance global access to safe plasma proteins

The ISBT Working Party on Global Blood Safety initiated the ICSPP as a global coalition to advance access to safe plasma proteins in Low- and Middle- Income Countries. In cooperation with the World Health Organization, this coalition was established to address the global insufficiency of plasma-derived medicinal products that are unavailable or unaffordable in many low- and middle- income countries (LMIC) and the consequent suffering and early mortality of patients with bleeding disorders and immune deficiencies who lack adequate treatments.

Through its projects in LMIC, the ICSPP seeks to reverse the tragic wastage of domestic plasma that could be used, when meeting appropriate quality standards, either in industrial fractionation, or else, initially locally to prepare safe intermediary protein therapies.