Dealing with Excessive Off-label Drug Use: Liability vs. Patent Prolongation

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use may be the preferred instrument for achieving dynamic efficiency. The liability threat reduces the demand for off-label use, giving manufacturers an appropriate incentive to invest in extended approval. By contrast, patent prolongation does not affect physicians' prescription decisions and increases the likelihood of investments in cases where the induced additional benefit falls short of testing costs.Off-label use, patent protection, exclusivity, liability

Modernisierung des Gesundheitssystems?

Die Bundesregierung hat kürzlich einen Gesetzentwurf zur "Modernisierung des Gesundheitssystems" vorgelegt. Welche Änderungen des Gesundheitswesens sind beabsichtigt? Wie sind sie zu bewerten? Eberhard Wille, Stefan Felder und Anja Olbrich sowie Peter Oberender nehmen Stellung

Modernisierung des Gesundheitssystems?

Die Bundesregierung hat kürzlich einen Gesetzentwurf zur „Modernisierung des Gesundheitssystems“ vorgelegt. Welche Änderungen des Gesundheitswesens sind beabsichtigt? Wie sind sie zu bewerten? Eberhard Wille, Stefan Felder und Anja Olbrich sowie Peter Oberender nehmen Stellung. --

Towards an HPC certification program

The HPC community has always considered the training of new and existing HPC practitioners to be of high importance to its growth. This diversification of HPC practitioners challenges the traditional training approaches, which are not able to satisfy the specific needs of users, often coming from non-traditionally HPC disciplines, and only interested in learning a particular set of competences. Challenges for HPC centres are to identify and overcome the gaps in users’ knowledge, while users struggle to identify relevant skills. We have developed a first version of an HPC certification program that would clearly categorize, define, and examine competences. Making clear what skills are required of or recommended for a competent HPC user would benefit both the HPC service providers and practitioners. Moreover, it would allow centres to bundle together skills that are most beneficial for specific user roles and scientific domains. From the perspective of content providers, existing training material can be mapped to competences allowing users to quickly identify and learn the skills they require. Finally, the certificates recognized by the whole HPC community simplify inter-comparison of independently offered courses and provide additional incentive for participation

Study protocol for a randomised controlled trial of an e-health stepped care approach for the treatment of internet use disorders versus a placebo condition: the SCAPIT study

Introduction Excessive internet use can lead to problems for some individuals. The WHO has introduced Gaming Disorder in the International Classification of Diseases-11 (ICD-11). Previous research has shown that other internet applications can cause serious mental health problems as well. It is important to provide measures of prevention, early intervention and therapy for internet use disorders (IUDs). Methods and analysis The study ‘Stepped Care Approach for Problematic Internet use Treatment’ is a randomised, two-arm, parallel-group, observer-blind trial. The aim of the study is to investigate if a stepped care approach is effective to reduce symptom severity for IUD. The sample is primarily recruited online with a focus on employees in companies with support of health insurances. After screening, the stepped care approach depends on the success of the previous step—that is, the successful reduction of criteria—and comprise: (1) app-intervention with questionnaires and feedback, (2) two telephone counsellings (duration: 50 min) based on motivational interviewing, (3) online therapy over 17 weeks (15 weekly group sessions, eight individual sessions) based on cognitive–behavioural therapy. A follow-up is conducted after 6 months. A total of 860 participants will be randomised. Hierarchical testing procedure is used to test the coprimary endpoints number of Diagnostic and Statistical Manual of Mental Disorders, fifth edition and ICD-11 criteria. Primary analysis will be performed with a sequential logit model. Ethics and dissemination The study has been approved by the Ethics Committees of the Universities of Lübeck (file number: 21-068), Mainz (file number: 2021-15907) and Berlin (file number: 015.2021). Results will be reported in accordance to the CONSORT statement. If the approach is superior to the control condition, it may serve as part of treatment for IUD. Trial registration number DRKS00025994

Dealing with Excessive Off-Label Drug Use: Liability vs. Patent Prolongation

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use may be the preferred instrument for achieving dynamic efficiency. The liability threat reduces the demand for off-label use, giving manufacturers an appropriate incentive to invest in extended approval. By contrast, patent prolongation does not affect physicians' prescription decisions and increases the likelihood of investments in cases where the induced additional benefit falls short of testing costs

The Optimal Negligence Standard ein Health Care under Suply-Side Cost Sharing

This paper elaborates on the optimal negligence standard in a world where physicians choose damage prevention subject to erroneous court judgements and to the degree of supply-side cost sharing. Liability uncertainty in malpractice lawsuits leads some physicians to provide excessive prevention and others to underprovide, which results in a welfare loss compared to the pooled first-best equilibrium under perfect information. The standard that minimizes the welfare loss depends on the cost share: Under traditional, close to full cost reimbursement it is lower than the first-best standard, while under substantial supply-side cost sharing it increases and may exceed the first best

Heterogeneous physicians, lawsuit costs, and the negligence rule

Real-world observations of negligent and defensive medicine challenge malpractice liability. Based on a principal-agent model with two types of physicians I show that lawsuit costs affect the patients' decision to sue and the physicians' level of care under the negligence rule, leading to a separated equilibrium in care. Given these conditions, punitive damages allow for a pooled equilibrium where all physicians exert first-best care. If courts cannot use punitive damages, a second-best solution arises with an optimal negligence standard that deviates from first-best care.