The role of epistemic policies in regulatory science: scientific substantiation of health claims in the European Union

This paper presents an analysis of the concept of scientific substantiation in European health claims regulation. It focuses on the controversies about the demand for the establishment of cause-and-effect relationships between food consumption and health outcomes in claim substantiation. Our analysis, on the basis of regulatory and scientific documents, identifies two opposing views about the aims of health claims regulation. Each of these two stances links certain regulatory objectives with specific epistemic policies, that is particular sets of scientific methodology, criteria, and procedure. The regulators, in selecting a demanding evidentiary approach based on a hierarchy of methodologies that requires causal data for substantiation of claims, give priority to preventing the authorization of false claims. The opposing view, espoused by the critics of this approach, opts for less demanding requirements for substantiation, implying the market availability of a wider range of products with health claims that may provide individual as well as public health benefits. We argue that one of the objectives that underlie the European regulators’ demand for causal data is to protect their own credibility, by trying to isolate them from value-laden debates about the limitations of scientific methodologies, as well as the societal and policy implications of regulatory decision-making.     

Land claims and the pursuit of co-management on four protected areas in South Africa

Successful land claims on protected areas by previously disenfranchised communities often result in co-management agreements between claimant communities and state conservation agencies. South Africa, in particular, has pursued co-management as the desired outcome of land claims on its protected areas. We review four cases of co-management on protected areas in South Africa, and reflect on the appropriateness of the pursuit of co-management as the preferred outcome of land claims. Despite promises of pro-poor, democratically informed management, the practical experience of co-management has seen the continuation of the status quo in terms of conservation, with very few material benefits for claimant communities and limited sharing of responsibilities and decision-making functions. The findings underscore two deep challenges facing co-management in cases of land claims worldwide. First, during land claims negotiations in cases involving protected areas, the state cannot be expected to represent the best interests of its citizens (the land claimants), while simultaneously seeking to meet national and international obligations for protected area coverage. Second, the concept of democratic co-management may sit uncomfortably beside the realities of managing loss-making protected areas with ever-shrinking conservation budgets. Where co-management agreements have already been signed, ensuring that new landowners do indeed have a say in management should form the driving focus for co-management practice going forward.     

浅析建设工程企业施工索赔

本文主要介绍了工程施工索赔的特点和涵义,并对其必要性进行了论述。同时还分析了建设工程施工索赔的主要原因以及基本策略。     

Validation of modeled pharmacoeconomic claims in formulary submissions

Abstract

Modeled or simulated claims for costs and outcomes are a key element in formulary submissions and comparative assessments of drug products and devices; however, all too often these claims are presented in a form that is either unverifiable or potentially verifiable but in a time frame that is of no practical use to formulary committees and others who may be committed to ongoing disease-area and therapeutic-class reviews. On the assumption that formulary committees are interested in testable predictions for product performance in target populations and ongoing disease area and therapeutic reviews, the methodological standards that should be applied are those that are accepted in the natural sciences. Claims should be presented in a form that is amenable to falsification. If not, they have no scientific standing. Certainly one can follow ISPOR-SMDM standards for validating the assumptions underpinning a model or simulation. There is clearly an important role for simulations as an input to policy initiatives and developing claims for healthcare interventions and testable hypotheses; however, one would not evaluate such claims on the realism or otherwise of the model. The only standard is one of the model’s ability to predict outcomes successfully in a time frame that is practical and useful. No other standard is acceptable. This sets the stage for an active research agenda.     

The status of modeled claims

Abstract

The only acceptable modeled claims for costs and outcomes are those that are testable and can be validated in a timeframe that is acceptable to a formulary committee. This issue provides four papers which explore the methodological issues in validation, the UK experience with NICE, the questions a formulary committee should ask of modeled claims, and the role of Big Data in validating modeled claims.     

A risk-based approach for pricing American options under a generalized Markov regime-switching model

This paper considers a risk-based approach for pricing an American contingent claim in an incomplete market described by a continuous-time, Markov, regime-switching jump-diffusion model. We formulate the valuation problem as a stochastic differential game and use dynamic programming. Verification theorems for the Hamilton–Jacobi–Bellman–Issacs (HJBI) variational inequalities of the games are used to determine the seller's and buyer's prices and optimal exercise strategies.     

Moment generating functions of compound renewal sums with discounted claims

Léveillé & Garrido (2001a, 2001b) have obtained recursive formulas for the moments of compound renewal sums with discounted claims, which incorporate both, Andersen's (1957) generalization of the classical risk model, where the claim number process is an ordinary renewal process, and Taylor's (1979), where the joint effect of the claims cost inflation and investment income on a compound Poisson risk process is considered.

In this paper, assuming certain regularity conditions, we improve the preceding results by examining more deeply the asymptotic and finite time moment generating functions of the discounted aggregate claims process. Examples are given for claim inter-arrival times and claim severity following phase-type distributions, such as the Erlang case.