Treatment safety

The safety and supply of treatment products is a key concern for the bleeding disorders community. In the years since many people in our community were infected with HIV and hepatitis C (HCV) by clotting factor concentrates in the 1970s and 1980s, the WFH has closely monitored product safety, efficacy, availability, and supply. We work in close cooperation with government agencies, industry, clinicians, and patient groups to achieve both the quality and desired quantity of treatment products. These critical issues remain a central theme of our work, and we continue to foster debate and dialogue on them. We also closely monitor and promote scientific and technological developments that can lead to safer, more efficacious treatment or a cure.

WFH advisories, letters, and statements

Panel discussion: Expanding Access to Hemophilia Treatment Products, what will be the game changer?
While the WFH vision is “Treatment for All,” the majority of the world’s population has little to no access to hemophilia care. Patient advocates and WFH Humanitarian Aid and Public Policy representatives debate what might be the game changer in improving access to clotting factor products beyond its current limitations.

Panel: Brian O’Mahony, Mark Brooker, Assad Haffar, Albert Farrugia, chaired by David Page.

The opinions expressed in this video are those of the individual panelists and not the official position of the World Federation of Hemophilia.

Monitoring safety and supply 

Through its Coagulation Products Safety, Supply and Access Committee (CPSSAC), the WFH monitors developments in product safety and supply and takes proactive action as required. When important issues related to either safety or supply emerge, the CPSSAC posts informative, accurate, and useful information on our website as soon as possible. 

The WFH has made statements to the World Health Organization, U.S. Food and Drug Administration, the European Commission, national governments, and to our members on safety and supply issues. Recent policy statements have addressed: 

  • The selection of safe and efficacious treatment products, 
  • The global supply of safe affordable high quality clotting factor concentrates from voluntary and compensated plasma donations, and 
  • Deferral of blood donations from men who have sex with men (MSM)

To view these and other recent WFH advisories, letters, and statements, click here.

The WFH monitors recalls of treatment products – both voluntary and imposed by health authorities - and reports to our community in the case of serious adverse events or threats to patients. We do not report on recalls of a minor or local nature. Manufacturers are obligated to report recalls on their websites and to notify treatment centres and regulators directly.

Product recalls in the U.S.A. can be seen here
For European recalls, click here

Fostering debate and information exchange

Critical issues affecting the global hemophilia community – such as product safety standards, regulatory criteria, and supply shortages – are too often debated only at the national or regional level. The WFH is in a unique position to raise the discussion to a global level, and bring together representatives from around the world who have a direct impact on or interest in the issues. 

The WFH organizes the Global Forum on Research and Treatment Products for Bleeding Disorders. Each Global Forum focuses on current issues and concerns. Click here (PDF) to view proceedings of the previous WFH Global Forum.

Educating on the selection of safe products

Ensuring that decision makers have the knowledge and expertise to select safe treatment products to treat people with bleeding disorders is a key concern. The WFH has developed a Guide for the Assessment of Clotting Factor Concentrates (PDF) and organizes regulators’ workshops to educate regulators and public health authorities on choosing safe treatment products. 

Advocating for patient involvement

Ensuring that patients have a voice and a place at the table when decisions about their care are being made is a WFH priority. Through various publications such as the Guide to National Tenders for the Purchase of Clotting Factor Concentrates (PDF), the WFH encourages patient organizations to play a key role in the procurement of safe treatment products.

The WFH publishes several documents related to the safety and supply of treatment products for bleeding disorders, including:

Search the WFH’s publications library for a complete list of resources.

Updated March 2016