Carbon Border Adjustment Mechanism: Response to EC Public Consultation on the Extension of CBAM to Downstream Products, Anti-Circumvention Measures and Rules for the Electricity Sector

Global carbon pricing next to boosting more renewable energies and energy efficiency is key for combating climate change. It levels the playing field, rewards innovation and drives emission reductions cost effectively. 

MedTech Europe shares the general motivation of preventing carbon leakage in support of fair carbon pricing as long as global climate ambitions differ. At the same time, we have seen several instances where well-intentioned horizontal legislation, such as the Carbon Border Adjustment Mechanism, introduce significant data collection and reporting requirements with associated costs for medical technology manufacturers, which make us challenge the robustness of CBAM for the medical technology sector from an economic, environmental and social sustainability perspective. We are also concerned with conflicts with the sector specific regulatory system established by Regulations (EU) 2017/745 on Medical Devices (MDR) and 2017/746 on in-vitro Diagnostic Medical Devices (IVDR) as CBAM related supplier switches trigger certain MDR/IVDR requalification and regulatory re-approval obligations. 

At this stage, MedTech Europe has no evidence of carbon leakage in the MedTech Sector in Europe due to difference in global carbon cost that would in our view justify the inclusion of medical technologies or components used in the manufacturing and assembly of medical technologies in Europe, in the scope of an extended CBAM. We very much appreciate the current efforts towards simplification, which should be maintained and strengthened, including the de minimis threshold and use of default values for emission calculation. However, we still observe significant challenges regarding the technical feasibility of implementing CBAM on highly complex products, such as medical technologies and their supply chains that can be up to 30 tiers from materials to the final device. It is not uncommon for routinely used devices to have hundreds and thousands of different components, including iron-, steel and aluminium intense components. 

We specify our considerations on the CBAM and health interface in the MedTech Europe’s response to the EC public consultation on CBAM.