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This research examines the potential outputs, outcomes, and impacts of the German Act on Corporate Due Diligence Obligations in Supply Chains (LkSG) on the smallholder cocoa farmers in West Africa. The study primarily relies on a literature review and an impact pathway to conduct a systematic analysis to identify the potential effects of the LkSG on smallholder cocoa farmers. The findings indicate that some, but not all of the risks addressed by the LkSG align with those faced by smallholder cocoa farmers and their families. Additionally, the research also reveals weaknesses, particularly in managing environmental risks, which the LkSG does not adequately cover. Our findings show that in the short- and medium-term, the LkSG has no potential effects on smallholder cocoa farmers. Furthermore, the potential positive impacts of the law on smallholder cocoa farmers will take a long time to realize, as the LkSG considers primarily tier-1 suppliers. Companies in Germany might reassess their supply chains to strive for an LkSG-risk-free supply chain, which could in the long term have sustained impacts on smallholder cocoa farmers. However, we recommend a comprehensive risk analysis of the cocoa supply chain to enhance the human rights of cocoa farmers.
This research examines the potential outputs, outcomes, and impacts of the German Act on Corporate Due Diligence Obligations in Supply Chains (LkSG) on the smallholder cocoa farmers in West Africa. The study primarily relies on a literature review and an impact pathway to conduct a systematic analysis to identify the potential effects of the LkSG on smallholder cocoa farmers. The findings indicate that some, but not all of the risks addressed by the LkSG align with those faced by smallholder cocoa farmers and their families. Additionally, the research also reveals weaknesses, particularly in managing environmental risks, which the LkSG does not adequately cover. Our findings show that in the short- and medium-term, the LkSG has no potential effects on smallholder cocoa farmers. Furthermore, the potential positive impacts of the law on smallholder cocoa farmers will take a long time to realize, as the LkSG considers primarily tier-1 suppliers. Companies in Germany might reassess their supply chains to strive for an LkSG-risk-free supply chain, which could in the long term have sustained impacts on smallholder cocoa farmers. However, we recommend a comprehensive risk analysis of the cocoa supply chain to enhance the human rights of cocoa farmers.
Background: Since 2011, pharmaceutical companies have to proof the added benefit of new drugs in Germany. The benefit assessment is in relation to an “appropriate comparator therapy” (ACT) defined by the Federal Joint Committee (FJC). Based on the benefit assessment, a reimbursement price is negotiated. In order to proof added benefit, it is essential to provide evidence on patient-relevant outcomes from direct head-to-head comparisons with the ACT. Indirect treatment comparisons and evidence based on surrogate parameters are usually not sufficient. FJC often splits the indication into different subpopulations.
Objective: The objective was to analyse whether factors beyond the clinical evidence have influence on the benefit assessment of the FJC.
Methods: All benefit assessments between 2011 and 2015 were included in the analysis. The benefit for each drug was calculated by weighting the evidence grade, strength of evidence and size of subpopulations. Drugs were then clustered in high, low or no benefit. Univariate logistic regression was used to identify variables with potential influence (p<0.25). Those variables were included in a multivariate logistic regression model and variables with p>0.1 were excluded in a stepwise approach.
Results: The final multivariate logistic regression identified that following variables increase the chance of getting a higher benefit: pharmacologically innovative drug, drugs in disease areas with high unmet medical need, drugs in oncology or infectious diseases, and drugs for which the FJC can split the assessment into subpopulations.
Conclusions: The analysis identified variables beyond clinical evidence that influence the benefit assessment by the FJC and provided a better understanding of decision making by the FJC.