Pascale Schmidt

Since 01.2015, I am Head of Compliance EMEA-LATAM (+6700 employees, +155 countries) & RDI (Rotkreuz Site, +2600 employees), Member of the EMEA-LATAM Operating Committee and Member of the Roche Group Healthcare Compliance Council. In my role, I coordinate a compliance network of +40 Compliance Officers, set compliance targets for the Region and supervise & coordinate compliance activities within the Region to ensure its adherence to high ethical standards and embedding of the compliance mindset at all levels of the organization.
I have been a member of the Ethics and Compliance Committee since 2015, and of its Steering Committee since April 2017, and have actively participated in the drafting and adoption process of the Code of ethical business practice, in the elaboration of guidance and tools to support its implementation and in promotion and education activities of external stakeholders and national associations.

From 2003 to 12.2014, I was Head of the Legal Department and Compliance Officer in the French Affiliate of Roche Diagnostics (including the management centre for francophone Africa). In this role, I participated actively in the group discussions within the 2 French trade associations SFRL/SIDIV and SNITEM, notably during the examination process of the French Sunshine Act, trained the members of SIDIV on the French Sunshine Act, participated in the animation of professional trainings (eg. IFIS, September 2014).
I hold a Master's degree in EU and Business Law from the University Paris Sud, France, a university diploma in Competition Law from the University Konstanz, Germany, and the Roche Diploma on Compliance.

 
In an era where transparency is expected, the healthcare industry has been at the centre of attention from the public and from authorities. We can see this in how governments around the world – notably the US and France – have developed ‘Sunshine Acts’ to mandate disclosure of industry support for healthcare institutions and professionals. These transparency laws can take differing approaches, posing challenges to companies. On the other hand, Europe’s medtech industry is committed to self-regulation as means of building public trust. We believe that by notably setting a high and common standard for transparency, we can meet public expectations. So, what have we achieved so far? We are pleased to report that our industry has taken several steps forward to improve transparency and enhance our reputation as an ethical business. We have embraced a Code of Ethical Business. A key element of the Code is the ban on direct sponsorship of health professionals. We have shifted towards a model of educational grants, which reinforces our commitment to supporting medical education, whilst providing transparency, as these educational grants are subject to disclosure on a Europe-wide platform . In devising this approach, we learned some lessons from the experience of the pharmaceutical industry which discloses all transfers of value to healthcare professionals on companies’ own websites. Under the pharma model, companies are required to secure health professionals’ consent to disclose information and, in the absence of a European-wide platform, it can be cumbersome for the public to access information on transfers of value. In medtech, we have removed the burden of handling consent management and reduced the burden for the public by making information available in one place. But the lack of convergence between these two approaches poses challenges. For a start, it is difficult to explain to the public...