Anne-Sophie Bricca

Anne-Sophie Bricca is Deputy General Counsel at Terumo BCT, a global leader in blood components and cellular technologies, member of the Terumo group. With her team, she provides legal and compliance support to Terumo BCT sales entities in EMEA. She is a member of Terumo BCT Executive Leadership Team. She represents Terumo group at MedTech Europe (the European association of the medical devices and diagnostic industry) and since January 2019, she assumes the Chair of the Ethics and Compliance Group and seats at the Code Committee. S is also member of the Board and Co-Chair of the Strategic Committee of ETHICS (International Society of Healthcare Ethics and Compliance).

Before joining Terumo BCT in 2009, Anne-Sophie Bricca worked as in-house counsel for the IT industry during 10 years (HP, CPG International, Ingram Micro). She also worked as a general counsel for Franco Dragone Entertainment Group for the design and making of the Macao show “The House of Dancing Water”.

Anne-Sophie holds two post graduates degrees in European Laws from the University Robert Schuman (Strasbourg) and in International Laws from the Université Libre de Bruxelles (Brussels). She was the laureate of the international Rousseau Competition in International Laws chaired by Boutros Boutros-Ghali in 1997.

 

Artificial intelligence (AI) has enormous potential to improve patient outcomes and reduce their variability, making health systems more efficient. But we must take an ethical approach to ensure sustainable implementation and public trust. As leaders in the medical technology sector, we are playing our part in ensuring that our industry develops advanced data-driven technologies in the interest of patients. For us, this is not new: it is in line with our approach to innovation. We begin from an ethical perspective, seeking to improve the lives of people who benefit from the medical technologies we develop. This is a crucial moment in the history of AI in healthcare. Policymakers are looking closely at how to maximise the positive impact of computational science in the age of data while safeguarding privacy and security. We have set out our thinking in two key documents: a paper on Trustworthy Artificial Intelligence in healthcare , in response to the Ethics Guidelines for Trustworthy AI of the European Commission High-Level Expert Group on AI (HLEG AI), and a recently-published MedTech Europe position paper on AI in medtech , addressing the Policy and Investment recommendations of the HLEG AI. These documents set the foundation for our contribution to the upcoming communication of the European Commission on artificial intelligence. Game-changing potential Let’s remind ourselves why this is worth getting right. AI can improve the speed and accuracy of diagnostics and medical imaging; support real-time monitoring and preventative healthcare – intercepting disease in very early stages, sometimes even before it happens. It can also bring a new approach to the delivery of care, optimising the use of healthcare resources, including health professionals’ time; supporting doctors to be at their best and treat patients in better ways than ever before; and empowering patients to manage their well-being. But there is...
This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities , the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes are not just a set of rules and policies drafted by an army of lawyers. On the contrary! A compliance programme will only be effective if it’s designed strategically by taking into account how the business is structured and what are the areas of risk. To be successful compliance must be embedded in the business activities. By adopting this common agenda, the medical device industry is leading by example, which is the right thing to do. Actually, the real surprise would have been if the industry had taken any other approach. This year, again, there were several scandals involving our industry. First of all, the Implant Files. This investigation conducted by a consortium of independent journalists around the world tried to denounce the fact that some medical devices (implants in particular) were improperly put on the market and abusively prescribed by certain HCP. The investigation received a lot of media attention but none of these allegations finally revealed illegal behaviours from the medical device companies. The healthcare system is certainly not perfect and further transparency shall be encouraged, in particular in the system of complaints reporting. It will be the case with the implementation of the Medical Device Regulation as from May 2020. But it should not be forgotten that the medical device industry is not the sole player in the health system and healthcare professionals and healthcare organizations have some responsibilities as well. In the future, the main risk in terms of compliance...