Resisting the Global Crackdown on Civil Society

Civil society is increasingly coming under assault around the world, as authoritarian governments grow more bold and sophisticated in stifling independent groups that monitor elections, expose corruption, or otherwise give citizens a voice in how they are governed. In response, senior U.S. officials have reaffirmed their support for universal rights, including freedom of association, while mid-level officials have criticized specific abuses against civil society. However, only modest U.S. government efforts have dealt systematically with the global nature of the crackdown on civil society. This weak U.S. response to the crackdown hurts U.S. interests and undermines U.S. credibility abroad. The U.S. government needs to respond to the threats against civil society more forcefully.To curb the global crackdown, the United States needs to systematically oppose efforts by authoritarian governments to control civic space, take vigorous political and diplomatic measures to support civil society organizations that come under threat, and get around government restrictions designed to isolate local organizations from the international community. Effective U.S. policy to defend civil society needs to respond comprehensively to the global nature of the crackdown and, at the same time, turn the tide in key countries where repression of civil society has significant regional repercussions. While bipartisan collaboration is critical to make such policy effective, a strong U.S. response to the global crackdown on civil society must begin in the White House

Election Systems Vulnerability to Corruption Assessment: Final Report

Elections in Afghanistan are highly susceptible to corruption, which undermines the credibility of the electoral process, calls into question the legitimacy of election results, and deprives citizens of their right to choose their representatives and President. Despite repeated electoral reform efforts, allegations of widespread fraud have recurred in each recent election cycle. To assess the electoral process’ vulnerability to corruption, the Independent Joint Anti- Corruption Monitoring and Evaluation Committee (MEC) conducted a review of electoral regulations and procedures, extensive interviews with election officials and other key stakeholders, including Wolesi Jirga candidates, field research in 18 Provinces into the experiences of more than 800 voters in the 2018 Wolesi Jirga elections, and direct observations and interviews with over 325 voters in the 2019 presidential election in eight Provinces. The main findings of MEC’s research are as follows: • The independence, accountability, and integrity of the Independent Election Commission (IEC) and the Independent Electoral Complaints Commission (IECC) are open to question. • The election Commissions, particularly the IEC, are fairly lax in maintaining standards of integrity among Secretariat staff. • The voter registration process had serious flaws and produced an inaccurate voter list. • Campaign finance is poorly regulated, and punishment for infractions is weak. Only 12 percent of Wolesi Jirga candidates submitted a complete and consistent report on their campaign contributions and expenditures. • The voting process on election day, particularly at polling centers in insecure areas, is vulnerable to vote buying, intimidation of voters, and election fraud. Poll workers are at times complicit in corruption. • Biometric devices provided no verification of voter identity in 2018 because they were not connected to the voter list. • Allegations of widespread bribery marred the 2018 elections. • The vote tabulation process in 2018 was slow, opaque, and fairly inaccessible. The IEC took more than a month to release preliminary results of the Wolesi Jirga elections for all but five Provinces and took over six months to announce final results for Kabul. • Vote recounts are prone to tampering. The IECC’s expansive decision in 2018 to invalidate all votes in Kabul paved the way for a recount that was riddled with allegations of bribery and was described by a senior IEC official as “doomsday.” • The IECC, contrary to its own procedures, failed to publicly release the decisions of Provincial Complaints Commissions, which make up 94 percent of all IECC decisions related to the Wolesi Jirga elections. 5 • The IECC denied MEC’s requests to view select case files on electoral complaints that arose in the Wolesi Jirga elections. The lack of transparency raises questions about the integrity of the IECC’s adjudication of electoral complaints. • Despite allegations of widespread bribery and electoral fraud in the Wolesi Jirga elections, few senior officials or powerful individuals were punished for electoral crimes, and former IEC and IECC Commissioners were convicted on dubious grounds. • Bribery in elections carries a lighter punishment than bribery in other contexts. MEC offers a series of detailed recommendations at the end of this report to strengthen the integrity of elections in Afghanistan. Highlights of key recommendations include the following: • IEC and IECC Commissioners should be nominated by a committee of elections experts and selected by consensus among elections stakeholders based on nominees’ expertise in election management, independence, impartiality, and integrity. • The IEC and IECC should each develop and implement an anti-corruption policy, create a written procedure for addressing staff misconduct, and write a regulation on contacts with candidates. • The IEC should create a new voter registration list after 2019 based on e-Tazkiras, require e-Tazkiras for voter identification, preload biometric voter verification devices with biometric data of voters at their assigned polling station, and ensure that all devices are properly preloaded with biometric data. • The Election Law should be amended to substantially increase the penalties for campaign finance violations, disqualify candidates who fail to submit campaign finance reports, and make false reporting a criminal offense. • The IEC should add training material for poll workers on how to respond to voter intimidation, ballot stuffing, and electoral fraud. • The IEC should provide polling station managers with the technology to transmit initial results electronically, collect initial results as vote counts are completed, and post initial results on the IEC’s website within 48 hours after the polls close. • The IECC should post all Provincial Complaints Commissions’ decisions on its website by the end of the next business day. • The IECC should introduce an electronic Case Management System for electoral complaints, with an audit trail to document every modification made to case files. • During vote recounts, the IEC should release partial results at the end of each day. • Penal Code Article 423 should be amended to increase the punishment for bribery in elections and to require candidates and election officials to report demands, offers, or facilitating of bribes to relevant authorities within 48 hours. 6 • Election Law Article 97 should be amended to require the IECC to refer cases of suspected electoral crimes to the Attorney General’s Office as they arise. • The Attorney General’s Office should fulfill its legal mandate to secure convictions of candidates, senior election officials, and other powerful individuals guilty of electoral crimes and publicly report each month on the status of its elections-related investigations and prosecutions. • The Supreme Court should amend the Law on Jurisdiction and Authority of the Judiciary to establish a permanent, special court to exercise jurisdiction over electoral crimes. MEC presented these recommendations in two interim Election Systems VCA reports, circulated to stakeholders in March and in August 2019, and in briefings to IEC and IECC Commissioners and senior Secretariat officials, presidential campaign representatives, investigators at the Attorney General’s Office, international donors, and senior officials of the United Nations Assistance Mission in Afghanistan. The interim reports were not released publicly, to avoid any appearance of interference in the electoral process, but MEC encouraged stakeholders to adopt its recommendations, particularly the recommendations that could be implemented in time for the 2019 presidential election. This final report aims to support the long-term improvement of electoral institutions for future elections in Afghanistan. The IEC took some measures in line with MEC’s recommendations to strengthen the integrity of the September 2019 presidential election. These measures included selecting Provincial Election Officer competitively, pre-loading voter registration lists onto biometric voter verification devices, and instructing polling center managers to take photos of result sheets after the vote count and send the photos right away to IEC headquarters. While many more safeguards are needed to protect electoral integrity, these initial IEC anti-corruption measures show that when electoral integrity is prioritized, progress can be made in reducing the risks of corruption in Afghanistan’s elections. Elections require maximum transparency. When the electoral process is transparent from start to finish and is actively observed by stakeholders, it is inoculated to at least a significant degree against corruption. At the same time, fair and honest elections require the institutions that administer and oversee elections to act with integrity. The fight against corruption in elections is not a purely technical exercise. Strong internal controls at the IEC and IECC may reduce the election system’s vulnerability to corruption, but they are no substitute for effective leadership committed to a culture of integrity. Without such commitment, election officials probably will seek ways around the internal controls, once again become complicit in gaming the system, and avoid punishment for misconduct. While the IEC and IECC remain central to any effort to rid Afghanistan’s elections of corruption, the integrity of Afghanistan’s elections is not their responsibility alone. Candidates share the responsibility to ensure the integrity of elections, including to adhere to the Election Law and refrain from bribery. Responsibility also falls to the Government, National Assembly, political 7 parties, civil society, and Afghan citizens, who each need to do their part to uphold integrity in elections, demand it of other stakeholders, and hold corrupt individuals to account. The determination of voters to turn out for the Wolesi Jirga elections in 2018, despite pervasive security threats and lives lost, reflects their commitment to a fair and honest process to choose their representatives. With improvements in electoral institutions and commitment by stakeholders, Afghanistan can strengthen the integrity of its elections, curb the corruption that marred elections in the past, and give citizens genuine confidence in the electoral process

Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

INTRODUCTION: At the time of dapagliflozin\u27s approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns regarding acute liver injury and severe complications of urinary tract infection (sUTI) led to two post-authorization safety (PAS) studies of these outcomes to monitor the safety of dapagliflozin in real-world use. OBJECTIVE: To investigate the incidence of hospitalization for acute liver injury (hALI) or sUTI (pyelonephritis or urosepsis) among patients initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). METHODS: These two noninterventional cohort studies identified initiators of dapagliflozin and comparator GLDs in November 2012-February 2019 using data from three longitudinal, population-based data sources: Clinical Practice Research Datalink (UK), the HealthCore Integrated Research Database (USA), and the Medicare database (USA). Outcomes (hALI and sUTI) were identified with electronic algorithms. Incidence rates were estimated by exposure group. Incidence rate ratios (IRRs) were calculated comparing dapagliflozin to comparator GLDs, using propensity score trimming and stratification to address confounding. The sUTI analyses were conducted separately by sex. RESULTS: In all data sources, hALI and sUTI incidence rates were generally lower in dapagliflozin initiators than comparator GLD initiators. The adjusted IRR (95% confidence interval) pooled across data sources for hALI was 0.85 (0.59-1.24) and for sUTI was 0.76 (0.60-0.96) in females and 0.74 (0.56-1.00) in males. Findings from sensitivity analyses were largely consistent with the primary analyses. CONCLUSIONS: These real-world studies do not suggest increased risks of hALI or sUTI, and they suggest a potential decreased risk of sUTI with dapagliflozin exposure compared with other GLDs

Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting

INTRODUCTION: Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), among other conditions. When dapagliflozin was approved in Europe for treating T2DM (2012), potential safety concerns regarding its effect on kidney function resulted in this post-authorization safety study to assess hospitalization for acute kidney injury (hAKI) among dapagliflozin initiators in a real-world setting. OBJECTIVE: The aim of this study was to evaluate the incidence of hAKI in adults with T2DM initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). METHODS: This noninterventional cohort study identified new users of dapagliflozin and comparator GLDs from November 2012 to February 2019 from three longitudinal, population-based data sources: Clinical Practice Research Datalink (CPRD; United Kingdom), the HealthCore Integrated Research Database (HIRD; United States [US]), and Medicare (US). Electronic algorithms identified occurrences of hAKI, from which a sample underwent validation. Incidence rates for hAKI were calculated, and incidence rate ratios (IRRs) compared hAKI in dapagliflozin with comparator GLDs. Propensity score trimming and stratification were conducted for confounding adjustment. RESULTS: In all data sources, dapagliflozin initiators had a lower hAKI incidence rate than comparator GLD initiators (adjusted IRRs: CPRD, 0.44 [95% confidence interval (CI), 0.22-0.86]; HIRD, 0.76 [95% CI, 0.62-0.93]; Medicare, 0.69 [95% CI, 0.59-0.79]). The adjusted IRR pooled across the data sources was 0.70 (95% CI, 0.62-0.78). Results from sensitivity and stratified analyses were consistent with the primary analysis. CONCLUSIONS: This study, with \u3e 34,000 person-years of real-world dapagliflozin exposure, suggests a decreased risk of hAKI in patients with T2DM exposed to dapagliflozin, aligning with results from dapagliflozin clinical trials. STUDY REGISTRATION: European Union Post-Authorisation Studies Register, EUPAS 11684; ClinicalTrials.gov, NCT02695082

Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus : Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)

Purpose: Evidence is insufficient to infer whether topical calcineurin inhibitors (TCIs; tacrolimus and pimecrolimus) cause malignancy. The study objective was to estimate the long-term risk of skin cancer and lymphoma associated with topical TCI use in adults and children, separately. Patients and Methods: A cohort study in Denmark, Sweden, UK, and the Netherlands was conducted. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated for nonmelanoma skin cancer (NMSC), melanoma, cutaneous T-cell lymphoma (CTCL), non-Hodgkin lymphoma (NHL) excluding CTCL, and Hodgkin lymphoma (HL) in new users of TCIs versus users of moderate/high-potency topical corticosteroids. Results: The study included 126,908/61,841 adults and 32,605/27,961 children initiating treatment with tacrolimus/pimecrolimus, respectively. Follow-up was ≥10 years for 19% of adults and 32% of children. Incidence rate ratios and (95% confidence intervals) for tacrolimus versus corticosteroid users in adults were <1 for melanoma, non-Hodgkin lymphoma, and Hodgkin lymphoma; and 1.80 (1.25-2.58) for cutaneous T-cell lymphoma. For pimecrolimus, IRRs in adults were <1 for non-Hodgkin lymphoma, cutaneous T-cell lymphoma, and Hodgkin's lymphoma; and 1.21 (1.03-1.41) for melanoma; and 1.28 (1.20-1.35) for nonmelanoma skin cancer. In children, results were inconclusive due to few events. In adults, incidence rate ratios ≥5 years after first topical calcineurin inhibitor exposure were not higher than in overall analyses. Conclusion: Overall, we found little evidence associating use of topical calcineurin inhibitors with skin cancer and lymphoma; confounding by indication, surveillance bias, and reverse causation may have influenced these results. Even if causal, the public health impact of these excess risks would be low and confined to the first years of exposure