Nancy Di Salvo: Protecting Access to IVIG and SCIG – A Call for Continued EU Recognition
Nancy Di Salvo, Director of International Affairs at GBS-CIDP Foundation International, reposted from UNITAR on LinkedIn:
“Protecting Access to Essential Treatments: Human Immunoglobulins Must Remain on the EU Critical Medicines List
As the European Union reviews its Union List of Critical Medicines (ULCM), the GBS|CIDP Foundation International strongly supports the continued inclusion of human normal immunoglobulins (IVIG and SCIG) on the list.
Immunoglobulins are indispensable, plasma-derived medicines for millions of patients worldwide, including individuals living with rare and serious neurological conditions.
Their continued availability is essential to protecting patient health, preventing disease progression, and avoiding unnecessary disability.
Maintaining immunoglobulins on the Union List of Critical Medicines is an important measure to strengthen Europe’s pharmaceutical security and supply-chain resilience.
The importance of these medicines extends beyond their use in primary and secondary immunodeficiencies.
They are also essential treatments for patients with autoimmune and immune-mediated neurological disorders, including Guillain-Barré syndrome (GBS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) (GBS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN).
For many of these patients, treatment is not optional or easily postponed. Interruptions, delays, or reductions in therapy can result in clinical deterioration, loss of mobility and independence, increased disability, and, in some circumstances, hospitalization.
For some patients, immunoglobulin therapy is the only effective or clinically appropriate treatment available. Ensuring access to these medicines is therefore not simply a matter of supply and distribution; it is a matter of protecting patients’ health, independence, and quality of life.
The GBS|CIDP Foundation International calls on the European Institutions and Member States to:
- Maintain human normal immunoglobulins on the EU Union List of Critical Medicines.
- Recognize their essential role in treating rare autoimmune and immune-mediated neurological conditions.
- Strengthen supply-chain security and ensure sustainable, equitable, and uninterrupted access across all EU Member States.
- Recognize that immunoglobulin products are not interchangeable, and that treatment decisions must be guided by individual patient needs and clinical judgment.
No patient should experience preventable deterioration or disability because an essential medicine is unavailable.
Access to IVIG and SCIG must be protected. For the patients who depend on these therapies, continuity of treatment is not a privilege; it is a necessity.”
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