BRACCO

BRACCO

Bracco is an international Group active in the healthcare sector and leader in the diagnostic imaging.

Lobbying Activity

Response to European Critical Raw Materials Act

28 Jun 2023

We are referring to the proposed Regulation on the European Critical Raw Materials Act We agree that critical raw materials (CRMs) are essential inputs for various strategic sectors, amongst which there is also the health sector, and the suppliers of these imports are often concentrated in a small number of third countries during the extraction and processing stages. This concentration can lead to structural supply dependencies for the EU and can affect its strategic autonomy, both in peacetime and during times of crisis. The proposed regulation aims to enhance Europe's resilience and preparedness by addressing vulnerabilities in the supply chain. Not surprisingly, the majority of respondents in the public consultation agreed that the EU's capacities for processing and refining CRMs are insufficient. They emphasized the need to increase re-use and recycling capacities for critical raw materials. One of the strategic sectors for Europe is the healthcare industry, which serves the needs of the European population. A significant part of this sector focuses on diagnostic purposes, particularly through in-vivo imaging techniques. Many of these diagnostic exams rely on the use of contrast agents. European industry holds a leadership position in this sector, with the most commonly used agents originating and developing within the EU. However, there is increasing competition from generic manufacturers in Far East countries. It is important to note that the production of APIs for contrast agents used in in-vivo imaging is fully dependent on two specific raw materials that cannot be substituted. These raw materials are iodine for X-ray contrast agents used in radiology and computed tomography, and gadolinium for contrast agents used in magnetic resonance imaging (MRI) exams. Neither iodine nor gadolinium are available from EU sources, but it is conceivable to implement systems that improve their circularity and sustainability, thus enhancing the availability of these materials as secondary raw materials. The share of iodine available as a secondary raw material is estimated to be already in the double-digit region. Iodine is primarily used for manufacturing X-ray contrast agents and is mainly produced in Chile, Japan, and the United States. It is also produced in Russia, Turkmenistan, Azerbaijan, Indonesia, and China. It is worth mentioning that sudden unavailability of some sources can occur, as demonstrated during the Fukushima nuclear accident when all iodine was allocated for the treatment of the affected population. Strategic iodine stocks are also provided in the United States. Regarding gadolinium, the main mining areas are in China, with lesser quantities found in the US, Brazil, Sri Lanka, India, and Australia. Chinese companies predominantly control the refining capacities, leading to extreme price volatility and limited availability. In conclusion, we believe that the insertion of iodine and gadolinium in the list of Critical raw materials will contribute to enhancing European Unions resilience and to reinforcing its strategic autonomy, by addressing a specific vulnerability in the supply chain of industries of healthcare, one of the most crucial sectors serving the needs of the entire European population.
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Meeting with Carlos Moedas (Commissioner) and

19 Nov 2018 · Research and Innovation in the Life Sciences Sector