The authors contribute to the development of empirical methods for measuring the impacts of place-based local development strategies by introducing the adjusted interrupted time-series (AITS) approach. It estimates a more precise counterfactual scenario, thus offering a stronger basis for drawing causal inferences about impacts. The authors applied the AITS approach to three community development initiatives using single-family home prices as the outcome indicator and found that it could measure impacts on both the base level of prices and the rate of price appreciation. The authors also found a situation in which the method appears unreliable, however. The AITS approach benefits from more recurrent data on outcomes during the pre-and post-intervention periods, with an intertemporal pattern that avoids great volatility. The AITS approach to measuring effects of community development initiatives holds strong promise, with caveats.

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Orphan legislation provides incentives to industry to investigate rare conditions that otherwise would be unlikely to be investigated. These incentives include, free access to scientific advice during the development of their clinical programs ('protocol assistance'); reduction in fees payable to EMA for review of the marketing authorisation and subsequent licence maintenance fees; sustained market protection in the form of market exclusivity in addition to a range of national incentives. To qualify for these incentives companies must apply for orphan designation confirming the seriousness of the condition which has inadequate alternative therapeutic options (for the diagnosis, prevention or treatment) and that the condition qualifies in terms of low prevalence in the European community. The company must also provide evidence of medical plausibility including likely significant medical benefit for patients to be treated with the product for the proposed orphan indication. If an application for orphan designation is not accepted then a company is able to appeal providing detailed grounds for reassessment and will receive a second opinion from the PDCO. The period of market exclusivity awarded by orphan designation will require that future applications received by the EMA for the same condition have to undergo an assessment of similarity to ensure that no variations or new applications for 'similar' medicinal products are granted licences during this ten year period. Products gaining orphan designation provide regular/annual reports regarding their development status, status of global regulatory submissions and any change likely financial returns predicted for the indication.

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