The Copenhagen Centre for Regulatory Science (CORS) Annual conference took place in November 2018, and gathered more than a hundred experts from academia, regulatory authorities, industry and patient organisations. This year, the conference explored the theme ‘Impact of drug regulation on health and society’, and focused on three question under this topic:
• How does innovation impact on drug regulation? Introducing perspectives from biosimilars and emerging digital health innovations.
• How and why to measure the impact of regulation on society and public health?
• How do policy instruments affect society and public health?
Speakers included David Martin from the Office of Medical Policy FDA, Professor Bert G. Leufkens from the Utrecht Institute for Pharmaceutical Sciences and Associate Professor Mette Gørtz from the Department of Economics at University of Copenhagen.
The conference provided a unique platform for discussion and debate about the role of drug regulations on the approval of medicines and medical devices. On the one hand, if the drug regulations are overly strict, then there is a risk that it can impede innovations and state-of-the-art medical treatments. On the other hand, if the drug regulation shifts towards a more loose approach, then it might endanger the health and well-being of the patients.