Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.
From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Dr. Natz has also worked in the field of competition law with the European Commission and in the pharmaceutical industry.
Patients with rare diseases often have limited licensed treatment options, leading to the use of off-label therapies that may be considered as comparators in value assessment. However, clinical use alone does not necessarily make an off-label treatment an appropriate comparator, and comparator choice can materially influence the assessment of licensed treatments and subsequent patient access. Drawing on expert perspectives and the example of primary biliary cholangitis, this panel will explore the key considerations that should guide comparator selection in rare diseases, including regulatory status, evidence quality, clinical relevance, legal and ethical safeguards, and longer-term access implications. It will also consider potential ways forward to support fair assessment and patient access.
- How can joint clinical assessments reshape patient access across Europe?
- How can joint scientific consultations influence global evidence strategies?
- Strategic implications of EUHTA for global clinical development
- Lessons for orphan medical products (OMPs), practical implications and decision-maker learnings