Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance.

Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company's position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products' CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.

The non-market benefits of early and partial gains in managing threatened salmon.

Threatened species are increasingly dependent on conservation investments for persistence and recovery. Information that resource managers could use to evaluate investments-such as the public benefits arising from alternative conservation designs-is typically scarce because conservation benefits arise outside of conventional markets. Moreover, existing studies that measure the public benefits of conserving threatened species often do not measure the benefits from partial gains in species abundance that fall short of official recovery, or the benefits from achieving gains in species abundance that happen earlier in time. We report on a stated preference choice experiment designed to quantify the non-market benefits for conservation investments aimed at threatened Pacific Coho salmon (Oncorhynchus kisutch) along the Oregon Coast (OC). Our results show that a program aimed at increasing numbers of returning salmon can generate sizable benefits of up to $518 million/y for an extra 100,000 returning fish, even if the species is not officially declared recovered. Moreover, while conservation investment strategies expected to achieve relatively rapid results are likely to have higher up-front costs, our results show that the public attaches substantial additional value of up to $277 million/y for achieving conservation goals quickly. Our results and approach can be used to price natural capital investments that lead to gains in returning salmon, and as inputs to evaluations of the benefits and costs from alternative conservation strategies.

Anticipating policy considerations for a future HIV vaccine: a preliminary study.

BACKGROUND: New human immunodeficiency virus (HIV) infections continue to occur worldwide. Despite previous failures, there is renewed optimism about developing an efficacious HIV prophylactic vaccine following the 31.2% vaccine efficacy (modified intention to treat analysis) achieved in the RV-144 trial. Intense efforts at characterising the immune responses in the trial participants who appeared to gain some protection from the candidate vaccine are ongoing to delineate correlates of protection. However, the characteristics of a vaccine suitable for programmatic introduction in high prevalence areas remain undefined. AIMS: We set out to ascertain the vaccination policies and strategies that policy makers involved in vaccine introductions would advise were a candidate HIV vaccine to become available. METHODS: Structured questionnaires in both English and French were self-administered to consenting policy makers such as members of National Immunisation Technical Advisory Groups. Members from three out of the six WHO regional groups were purposively reached for their responses. RESULTS: Thirty-seven key opinion leaders were approached through self-administered questionnaires delivered by e-mail or in person. Nine responses were received, representing a 24.3% response rate. The responses received were from three [Africa (6), Americas (1) and Europe (2)] out of the six WHO regions. All respondents would prioritise the vaccination of commercial sex workers over other risk groups if there was an efficacious HIV vaccine. Vaccine efficacy was considered to be the most important factor, ahead of vaccine safety and cost, in determining the acceptability of a new prophylactic HIV vaccine. CONCLUSIONS: It is expected that the first generation HIV vaccines may be modestly efficacious. However, even a modestly efficacious vaccine might curtail the spread of HIV if universal or near-universal coverage is achieved. It is important to anticipate policy discussions which would influence how rapidly an HIV vaccine would be rolled-out programmatically to achieve maximum impact.

Projected land-use change impacts on ecosystem services in the United States.

Providing food, timber, energy, housing, and other goods and services, while maintaining ecosystem functions and biodiversity that underpin their sustainable supply, is one of the great challenges of our time. Understanding the drivers of land-use change and how policies can alter land-use change will be critical to meeting this challenge. Here we project land-use change in the contiguous United States to 2051 under two plausible baseline trajectories of economic conditions to illustrate how differences in underlying market forces can have large impacts on land-use with cascading effects on ecosystem services and wildlife habitat. We project a large increase in croplands (28.2 million ha) under a scenario with high crop demand mirroring conditions starting in 2007, compared with a loss of cropland (11.2 million ha) mirroring conditions in the 1990s. Projected land-use changes result in increases in carbon storage, timber production, food production from increased yields, and >10% decreases in habitat for 25% of modeled species. We also analyze policy alternatives designed to encourage forest cover and natural landscapes and reduce urban expansion. Although these policy scenarios modify baseline land-use patterns, they do not reverse powerful underlying trends. Policy interventions need to be aggressive to significantly alter underlying land-use change trends and shift the trajectory of ecosystem service provision.

Implementing the optimal provision of ecosystem services.

Many ecosystem services are public goods whose provision depends on the spatial pattern of land use. The pattern of land use is often determined by the decisions of multiple private landowners. Increasing the provision of ecosystem services, though beneficial for society as a whole, may be costly to private landowners. A regulator interested in providing incentives to landowners for increased provision of ecosystem services often lacks complete information on landowners' costs. The combination of spatially dependent benefits and asymmetric cost information means that the optimal provision of ecosystem services cannot be achieved using standard regulatory or payment for ecosystem services approaches. Here we show that an auction that sets payments between landowners and the regulator for the increased value of ecosystem services with conservation provides incentives for landowners to truthfully reveal cost information, and allows the regulator to implement the optimal provision of ecosystem services, even in the case with spatially dependent benefits and asymmetric information.

Lakeshore zoning has heterogeneous ecological effects: an application of a coupled economic-ecological model.

Housing growth has been widely shown to be negatively correlated with wildlife populations, avian richness, anadromous fish, and exotic invasion. Zoning is the most frequently used public policy to manage housing development and is often motivated by a desire to protect the environment. Zoning is also pervasive, taking place in all 50 states. One relevant question that has received little research concerns the effectiveness of zoning to meet ecological goals. In this paper, we examined whether minimum frontage zoning policies have made a positive impact on the lakes they were aimed to protect in Vilas County, Wisconsin, U.S.A. We used an economic model that estimated when a given lot will be subdivided and how many new lots will be created as a function of zoning. Using the economic model, we simulated the effects of multiple zoning scenarios on lakeshore development. The simulated development patterns were then input to ecological models that predicted the amount of coarse woody debris (CWD) and the growth rate of bluegills as a function of residential density. Comparison of the ecological outcomes under different simulated zoning scenarios quantified the effect of zoning policies on residential density, CWD, and bluegill growth rates. Our results showed that zoning significantly affected residential density, CWD counts, and bluegill growth rates across our study area, although the effect was less clear at the scale of individual lake. Our results suggest that homogeneous zoning (i.e., for a county) is likely to have mixed results when applied to a heterogeneous landscape. Further, our results suggest that zoning regimes with a higher minimum shoreline frontage are likely to have larger ecological effects when applied to lakes that are less developed.

Providing formative feedback from a summative computer-aided assessment.

OBJECTIVES: To examine the effectiveness of providing formative feedback for summative computer-aided assessment. DESIGN: Two groups of first-year undergraduate life science students in pharmacy and neuroscience who were studying an e-learning package in a common pharmacology module were presented with a computer-based summative assessment. A sheet with individualized feedback derived from each of the 5 results sections of the assessment was provided to each student. Students were asked via a questionnaire to evaluate the form and method of feedback. ASSESSMENT: The students were able to reflect on their performance and use the feedback provided to guide their future study or revision. There was no significant difference between the responses from pharmacy and neuroscience students. Students' responses on the questionnaire indicated a generally positive reaction to this form of feedback. CONCLUSIONS: Findings suggest that additional formative assessment conveyed by this style and method would be appreciated and valued by students.

Novel human vaccine strategies and the 5th Framework Programme: pushing the envelope.

Mucosal vaccines could result in a great scientific and practical achievement. More than three decades of research in experimental models have shown promising results in stimulating mucosal immune responses, thus, it was expected that within a short time mucosal vaccines for human use could be achieved. Indeed this is not being the case. In the last few years, the most important oral vaccine, the anti-polio developed by Sabin in the fifties, has been progressively abandoned in developed countries to avoid the few cases of disease caused by the vaccine. Furthermore, two recently developed mucosal vaccines for human use against rotavirus diarrhoea and influenza were withdrawn after a short period in the market because of adverse reactions among the vaccinees. This controversial situation has created a difficult future for research on mucosal vaccine at the industrial level. A great help and encouragement for believers in mucosal vaccines has been given by the EU Commission through the 5th Framework Programme (5FP). At the end of the first projects of the 5FP, it is quite clear that mucosal vaccines are experiencing a real renaissance. The Euroconference/Workshop "Novel Strategies of Mucosal Immunisation through Exploitation of Mechanisms of Innate Immunity in Pathogen-Host Interaction", organised under the sponsorship of the EU Commission and reported in this special issue of Vaccine, witnesses a very creative moment of European groups involved in mucosal immunology. This conclusive paper of the issue is intended to describe a positive experience of some European scientists that have been working together in organised fashion within two EU projects. The first, defined by the acronym MUCIMM, was aimed to pave the way to tackle mucosal vaccines with different approaches, mainly that of new delivery systems and adjuvants, that of dissecting the fine mechanisms of basic mucosal responses and that of obtaining meaningful assays to measure human immune responses to mucosal vaccines. The second, the MUCADJ project, was aimed to prove that an intranasally delivered influenza vaccine induces protective levels of immunity in human adult volunteers. The results obtained demonstrate that mucosal vaccines for humans are feasible. It is interesting to note how this model of making biomedical research is flourishing, becoming an example for work organisation. At the same time it is important to underline some of the limits of this cooperative approach and it is also mandatory to spend a word of consciousness regarding the impact that the new European regulations could exert on mucosal vaccines, particularly for those based on live delivery systems. In a world where the damages caused by syringe needles are still largely visible, mucosal vaccines could represent an extremely important tool to fight infections, particularly in the large population of the most impoverished. The EU Commission will still encourage and support mucosal vaccines in the 6FP. The scientific community must decide in which direction has to proceed to avoid regulatory problems that could halt a promising tool to improve human health. The envelope has been pushed, the trip begins.