The Right to Health as Impulse for Innovation The Jurisdiction of the Federal Constitutional Court in view of the Incentives of Innovation in the German Healthcare System By Prof. Dr. Astrid Wallrabenstein

Introduction The 2005-Case of the Federal Constitutional Court: Patient Public Health Insurance Duchenne Muscular Dystrophy desires Magnetic Resonance Therapy No appropriate treatment in the catalogue of approved provisions of the public health insurance system Immediate Constitutional Right Social Rights in the German Constitution 2010: Immediate constitutional guarantee of a subsistence minimum that is in line with human dignity

Introduction Proposition: Structure: Right to health is a catalyst for innovation Structure: Innovation in Healthcare Provision Two Types of Innovation Framework: The German Healthcare System Public and Private Health Insurance The Incentives für Innovation in the German Healthcare System Private Health Insurance? Leeways of the Public Health Insurance? Inpatient Care? Innovation as a Function of the Right to Health Federal Constitutional Court Legislature Legal Practice

Innovation in Healthcare Provision Two Types of Innovation Novelty-oriented Risky and inefficient at the beginning Efficiency-oriented Improvement of methods etc. In Healthcare Example: Vaccination Novelty: New Chance of Prevention Efficiency: Wide Distribution Right to Health Article 12 ICESCR Para 2 lit. d) States Parties have to take steps for „the creation of conditions which would assure to all medical service and medical attention in the event of sickness“

The German Healthcare System Public Health Insurance – GKV 90% of the population Financing Members pay income-related contributions to Central Health Fund Fund distributes lump sums for every insured person to 100 health insurance providers Health insurance providers pay healthcare providers for services

The German Healthcare System Public Health Insurance – GKV Insurance provider Diagonsis-related lump sum Hospital Treatment Insured patient Central fund Service provider association Global Payment Score-based Payment FJC catalogue Physician Treatment

The German Healthcare System Public Health Insurance – GKV Outpatient care Individual providers deliver services to insured patients Bill the health insurance providers Services are defined in catalogue of provisions by the Federal Joint Committee New methods of treatment require approval by the Federal Joint Committee Inpatient care Contract between hospital and health insurance provider Diagnosis-related fee-per-case system Individual agreement on unregistered cases No restrictions on new methods of treatment

The German Healthcare System Private Health Insurance – PKV Insurance Service Provider Contract Patient and Insured Reimbursement Statutory fee schedule

The German Healthcare System Private Health Insurance 10% of the population Financing Individual ‚risk-adjusted‘ premiums Interest rates are supposed to cover costs in old age Procedure Individual contract between service provider and patient No restrictions Patient pays for treatment Statutory fee scedule Reimbursement of costs by the private insurer

The Incentives for Innovation in the German Healthcare System Private Health Insurance – an innovation-friendly insurance system? From the perspective of the service providers: non restricted and better paid Critique: two-tier-system Innovation First: available to smaller groups but higher return If successfull: taken over by Public Health Insurance Today: Assimilation of private and public health insurance Loss of innovation-oriented competition between public and private health insurance

The Incentives for Innovation in the German Healthcare System Creative Leeway of the Public Health Insurance – potential of innovation? Selective contracts between health insurance provider and healthcare provider Innovative treatments Programme has to be self-supporting financially Insurance customers sign in to programme Instrument of competition between insurers Innovation Potential More efficieny Better financial results for providers and insurers Benefits for the insured by additional services No novelty-oriented innovation

The Incentives for Innovation in the German Healthcare System Inpatient Care – openness to innovation? Diagnosis-related lump sum Fosters efficiency-oriented innovation No novelty-oriented innovation Conclusion Incentives for innovation still exist But clearly oriented toward efficiency

Innovation as a Function of the Right to Health Federal Constitutional Court In general: public health insurance system is efficiency-oriented Exemption: In case of life-threatening, regularly terminal disease When regular treatment has been of no avail Conclusion: Innovation should be financed by public health insurance when Treatment catalogue lacks sufficient option Objective of the innovation is to save life or to grant palliative relief

Innovation as a Function of the Right to Health Legislature Statute of 2011 Confirmation of the jurisdiction of the Federal Constitutional Court Extention to comparably severe diseases Conclusion Innovation should be financed by public health insurance also when Objective of the innovation is to treat severe diseases

Innovation as a Function of the Right to Health Legal practice / Social Courts Right to extraordinary treatment is a significant claim

Innovation as a Function of the Right to Health Legal practice / Social Courts Right to extraordinary treatment is a significant claim Main criterion: type of illness Example: aggressive and difficult-to-treat tumour Social Court jurisdiction: right to extraordinary treatment in ‚rare‘ cases Due to rarity no approval of specific treatment is possible Off-label and extraordinary treatment is the most efficient way to grant health care Critique: that might help in the individual case but does not help to close the gap in innovation

Innovation as a Function of the Right to Health Conclusion The deeper meaning of the Federal Constitutional Court‘s decision Because of the strictly efficiency-oriented public healthcare system encouraging (some specific) novelty-oriented innovation as well