Plasma, Italy still far from self-sufficiency

The demand for plasma-derived drugs is growing faster than the capacity to produce them, and Italy, despite having reached an all-time record of 900,000 kilos of plasma collected in 2024, remains far from self-sufficient. Today, only 59% of the immunoglobulins used in the country comes from Italian donations, while the remaining 41% must be purchased on the international market, an increasingly fragile balance in a global context marked by logistical, regulatory and geopolitical tensions. Over the last ten years, immunoglobulin consumption has increased by 57%, with an average increase of 5% per year, driven mainly by the use of subcutaneous formulations (+245%).

The European Commission has included immunoglobulins and albumin in the list of critical medicines in the Critical Medicines Act, while the recent tax and customs policies of the United States - from where more than 30% of the plasma-derived products used in Europe arrive - risk further complicating supply. Despite the generosity of Italian donors and technological progress in plasma processing, the distance to self-sufficiency remains wide and regional inequalities weigh heavily: some regions exceed 20 kg of plasma collected per thousand inhabitants, others do not reach 6.

For patients, this uncertainty is not an abstract fact but a concrete condition. 'During Covid,' says Massimo Marra, president of Cidp Italia Onlus, 'we experienced the decrease in dosages and the lengthening of the intervals between administrations. This resulted in the loss of autonomy: no longer being able to climb stairs, walk, pick up a glass'. Alternative therapies exist, but have more side effects: 'Immunoglobulins are the only chronic therapy that is sustainable over the long term. Taking them away means regressing the patients' quality of life'.

Today there are no widespread shortages, but the problem is not solved. 'Our fear,' Marra emphasises, 'is that what happened during the pandemic could happen again. The global market decides where to send the product and Italy is not always the most convenient country'. This is why the associations are calling for rigorous planning: 'We cannot be satisfied with 1% increases when demand is growing by 5%. Planning means guaranteeing that in a year's time the drug will be there'.

In the same vein, Alessandro Segato, president of Aip Aps, points out the need for a structured intervention in the next Budget Law: 'We need timely action to avoid shortages and ensure appropriateness. For our patients immunoglobulins are life-saving therapies'. Segato also highlights the vulnerability of the international framework: 'The new US rules and the inclusion of plasma derivatives in the list of critical medicines in Europe show how exposed the system is. Without a strengthening of internal collection, we risk not being able to ensure therapeutic continuity'.