Position Statement of the Max Planck Institute for Innovation and Competition of 25 May 2022 on the Commission's Proposal of 23 February 2022 for a Regulation on Harmonised Rules on Fair Access to and Use of Data (Data Act)

On 23 February 2022, the European Commission issued a Proposal for a Regulation on harmonised rules on fair access to and use of data (Data Act). The overarching objective of the Proposal is to ‘ensure fairness in the digital environment, stimulate a competitive data market, open opportunities for data-driven innovation and make data available for all’. The Institute hereby presents its Position Statement that features a comprehensive analysis of whether and to what extent the proposed rules might reach the envisaged objectives. It comments on all parts of the Proposal, including the new IoT data access and use right. Finally, the Institute offers a set of recommendations as to how the proposed provisions should be amended in the legislative process to align them better with the objectives of the Data Act

Language policy and orthographic harmonization across linguistic, ethnic and national boundaries in Southern Africa

Drawing on online and daily newspapers, speakers' language and writing practices, official government documents and prescribed spelling systems in Southern Africa, the paper explores the challenges and possibilities of orthographic reforms allowing for mobility across language clusters, ethnicity, regional and national borders. I argue that this entails a different theorisation of language, and for orthographies that account for the translocations and diasporic nature of late modern African identities and lifestyles. I suggest an ideological shift from prescriptivism to practice-orientated approaches to harmonisation in which orthographies are based on descriptions of observable writing practices in the mobile linguistic universe. The argument for orthographic reforms is counterbalanced with an expose on current language policies which appear designed for an increasing rare monoglot 'standard' speaker, who speaks only a 'tribal' language. The implications of the philosophical challenges this poses for linguists, language planners and policy makers are thereafter discussed.IS

A compact fluorescence sensor for low-cost non-invasive monitoring of gut permeability in undernutrition

Undernutrition is associated with approximately 45% of deaths among children under the age of 5. Furthermore, in 2020, around 149 million children suffered impaired physical/cognitive development due to lack of adequate nutrition. Environmental enteropathy (EE) is associated with undernutrition and is characterized by a multifaceted breakdown in gut function, including an increase in intestinal permeability that can lead to inflammatory responses. However, the role and mechanisms associated with EE (particularly gut permeability) are not well understood. This is partly because current techniques to assess changes in gut permeability, such as endoscopic biopsies, histopathology and chemical tests such as Lactulose:Mannitol assays, are either highly invasive, unreliable or difficult to perform on specific groups of patients (such as infants and patients with urine retention problems). Therefore, low-cost, non-invasive and reliable diagnostic tools are urgently needed for better evaluation of intestinal permeability. Here, we present a compact transcutaneous fluorescence spectroscopy sensor for non-invasive evaluation of gut permeability and report the first in vivo data collected from volunteers in an undernutrition trial. Using this technique and device, fluorescence signals are detected transcutaneously after oral ingestion of a fluorescent solution. Preliminary results demonstrate the potential use of the presented sensor for clinical assessment of gut permeability in low-income settings

Participatory learning and action cycles with women s groups to prevent neonatal death in low-resource settings: A multi-country comparison of cost-effectiveness and affordability.

WHO recommends participatory learning and action cycles with women's groups as a cost-effective strategy to reduce neonatal deaths. Coverage is a determinant of intervention effectiveness, but little is known about why cost-effectiveness estimates vary significantly. This article reanalyses primary cost data from six trials in India, Nepal, Bangladesh and Malawi to describe resource use, explore reasons for differences in costs and cost-effectiveness ratios, and model the cost of scale-up. Primary cost data were collated, and costing methods harmonized. Effectiveness was extracted from a meta-analysis and converted to neonatal life-years saved. Cost-effectiveness ratios were calculated from the provider perspective compared with current practice. Associations between unit costs and cost-effectiveness ratios with coverage, scale and intensity were explored. Scale-up costs and outcomes were modelled using local unit costs and the meta-analysis effect estimate for neonatal mortality. Results were expressed in 2016 international dollars. The average cost was $203 (range:$61-$537) per live birth. Start-up costs were large, and spending on staff was the main cost component. The cost per neonatal life-year saved ranged from$135 to $1627. The intervention was highly cost-effective when using income-based thresholds. Variation in cost-effectiveness across trials was strongly correlated with costs. Removing discounting of costs and life-years substantially reduced all cost-effectiveness ratios. The cost of rolling out the intervention to rural populations ranges from 1.2% to 6.3% of government health expenditure in the four countries. Our analyses demonstrate the challenges faced by economic evaluations of community-based interventions evaluated using a cluster randomized controlled trial design. Our results confirm that women's groups are a cost-effective and potentially affordable strategy for improving birth outcomes among rural populations

Incomplete Recovery of Pneumococcal CD4 T Cell Immunity after Initiation of Antiretroviral Therapy in HIV-Infected Malawian Adults

HIV-infected African adults are at a considerably increased risk of life-threatening invasive pneumococcal disease (IPD) which persists despite antiretroviral therapy (ART). Defects in naturally acquired pneumococcal-specific T-cell immunity have been identified in HIV-infected adults. We have therefore determined the extent and nature of pneumococcal antigen-specific immune recovery following ART. HIV-infected adults were followed up at 3, 6 and 12 months after initiating ART. Nasopharyngeal swabs were cultured to determine carriage rates. Pneumococcal-specific CD4 T-cell immunity was assessed by IFN-γ ELISpot, proliferation assay, CD154 expression and intracellular cytokine assay. S. pneumoniae colonization was detected in 27% (13/48) of HIV-infected patients prior to ART. The rates remained elevated after 12 months ART, 41% (16/39) (p = 0.17) and significantly higher than in HIV-uninfected individuals (HIVneg 14%(4/29); p = 0.0147). CD4+ T-cell proliferative responses to pneumococcal antigens increased significantly to levels comparable with HIV-negative individuals at 12 months ART (p = 0.0799). However, recovery of the pneumococcal-specific CD154 expression was incomplete (p = 0.0015) as were IFN-γ ELISpot responses (p = 0.0040) and polyfunctional CD4+ T-cell responses (TNF-α, IL-2 and IFN-γ expression) (p = 0.0040) to a pneumolysin-deficient mutant strain. Impaired control of pneumococcal colonisation and incomplete restoration of pneumococcal-specific immunity may explain the persistently higher risk of IPD amongst HIV-infected adults on ART. Whether vaccination and prolonged ART can overcome this immunological defect and reduce the high levels of pneumococcal colonisation requires further evaluation

Expanding CWD Disease Surveillance Options Using Environmental Contamination at Deer Signposts

1. Environmental surveillance can allow early detection of diseases, which increases management options and can improve disease trajectories. Chronic wasting disease (CWD) in cervids is a significant prion disease that has been spreading across North America since the 1960s, leading to cervid population declines and concern from hunters and state wildlife agencies. White-tailed deer have a unique breeding season behavior called scraping, where they deposit urine and saliva at shared sites. Since both these fluids can contain CWD prions, scrape sites have the potential to serve as sentinel sites for environmental surveillance of CWD.2. To examine this potential, we used camera traps to monitor deer behavior and collected environmental samples from 105 scrape sites. The 48 km2 study site was located at the center of the CWD zone in southwestern Tennessee (United States), where CWD prevalence is ~50%. We also sampled scrapes in northern Mississippi at the leading edge of the same CWD distribution to test the potential for early CWD detection using scrape sampling.3. From camera data, we identified 218 unique bucks visiting 105 scrapes, with a mean of 12.2 ± 7.5 bucks per scrape (mean ± SD, range 1–39) and individual bucks visiting a mean of 5.9 ± 4.6 monitored scrapes each (range 1–23).4. Using real-time quaking-induced conversion (RT-QuIC), we detected prion seeding activity in 20% of the soil and 41% of the licking branches of the scrape sites within the CWD study area, and in 25% of the soil and 11% of the licking branches of scrape sites sampled at the edge of the known CWD distribution.5. Our data show there is environmental prion contamination at scrape sites. This supports the idea that scrapes could serve as early warning sentinel sites for CWD surveillance through testing soil and licking branches for prion seeding ac-tivity, especially in areas with limited access to harvested deer samples

Clinical Performance Validation of 4 Point-of-Care Cervical Cancer Screening Tests in HIV-Infected Women in Zambia

We sought to determine the clinical performance of visual inspection with acetic acid (VIA), digital cervicography (DC), Xpert HPV, and OncoE6 for cervical cancer screening in an HIV-infected population

Genetic determinants of the pharmacokinetic variability of rifampin in Malawian adults with pulmonary tuberculosis

D.J.S. was supported by a Wellcome Trust Clinical PhD Fellowship (086757/Z/08/A to D.J.S.). A.D.M. was supported by a National Institute for Health Research Integrated Clinical Academic Training Fellowship and a Wellcome Trust Clinical PhD Fellowship (105/392/B/14/Z). The Malawi Liverpool Wellcome Trust Clinical Research Programme is supported by a strategic award from the Wellcome Trust.Variable exposure to antituberculosis (TB) drugs, partially driven by genetic factors, may be associated with poor clinical outcomes. Previous studies have suggested an influence of the SLCO1B1 locus on the plasma area under the concentration-time curve (AUC) of rifampin. We evaluated the contribution of single nucleotide polymorphisms (SNPs) in SLCO1B1 and other candidate genes (AADAC and CES-1) to interindividual pharmacokinetic variability in Malawi. A total of 174 adults with pulmonary TB underwent sampling of plasma rifampin concentrations at 2 and 6 h postdose. Data from a prior cohort of 47 intensively sampled, similar patients from the same setting were available to support population pharmacokinetic model development in NONMEM v7.2, using a two-stage strategy to improve information during the absorption phase. In contrast to recent studies in South Africa and Uganda, SNPs in SLCO1B1 did not explain variability in AUC0-∞ of rifampin. No pharmacokinetic associations were identified with AADAC or CES-1 SNPs, which were rare in the Malawian population. Pharmacogenetic determinants of rifampin exposure may vary between African populations. SLCO1B1 and other novel candidate genes, as well as nongenetic sources of interindividual variability, should be further explored in geographically diverse, adequately powered cohorts.Publisher PDFPeer reviewe