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New Comparative Law Report — Approval of Medical Devices

November 14, 2014 Comments off

Approval of Medical Devices (PDF)
Source: Law Library of Congress

This report describes the approval process for medical devices in the European Union and fifteen countries, and also indicates whether or not an expedited approval procedure is available. Many of the countries reference EU law, including France, Germany, the Netherlands, and Switzerland. Israel more readily approves devices with a CE mark (indicating approval in the EU) or an indication that they are approved by the US Food and Drug Administration (FDA). In many nations, particularly those influenced by the EU, part of the review process is conducted not by the government but by private, independent organizations called “notified bodies.” These organizations are designated by EU Member States.

In most of the countries in the survey, medical devices are categorized based on the risks associated with their use, and the approval process varies by category. For example, in the United Kingdom, manufacturers of low-risk devices may register with the government agency and simply declare that the devices meet the requirements to be approved. Devices classed as higher risk must undergo more detailed review, by a notified body.

On the question of an expedited approval process, Australia, Canada, China, Japan, Spain, and Switzerland permit some sort of rapid review in particular cases, often when a device is required for an individual patient and no substitute is available. Mexico has provided for more rapid approval of devices if they have already been approved in either Canada or the United States. No such procedure exists at present in Brazil, France, Israel, the Russian Federation, or the United Kingdom. The Russian Federation did have a rapid approval system in place prior to August 2014. Germany provides for temporary approval of devices in limited circumstances. South Africa is now considering draft legislation that would include expedited procedures in specified situations.

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CRS — Political Transition in Tunisia (October 22, 2014)

November 6, 2014 Comments off

Political Transition in Tunisia (PDF)
Source: Congressional Research Service (via U.S. State Department Foreign Press Center)

Tunisia is in its fourth year of transition after the 2011 “Jasmine Revolution,” and it has so far continued to avoid the types of chaos and/or authoritarian resurrections that have affected other “Arab Spring” countries. Legislative and presidential elections scheduled for late 2014 are expected to put an end to a series of transitional governments. On January 26, 2014, Tunisia’s National Constituent Assembly voted overwhelmingly to adopt a new constitution. This is widely viewed as a landmark accomplishment, given the difficulty of achieving political consensus, tensions between Islamists and secularists, and ongoing social and economic unrest. The new constitution asserts Tunisia’s Muslim identity, but its framing—creating a civil state and provisions on civil liberties—is seen as a victory for secularists. The vote followed a political agreement under which Tunisia’s main Islamist party, Al Nahda, agreed to give up its leadership of the government in favor of a technocratic prime minister in the lead-up to the elections.

CRS — U.S. and International Health Responses to the Ebola Outbreak in West Africa (October 29, 2014)

November 6, 2014 Comments off

U.S. and International Health Responses to the Ebola Outbreak in West Africa (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

In March 2014, an Ebola Virus Disease (EVD) outbreak was reported in Guinea, West Africa. The outbreak is the first in West Africa and has caused an unprecedented number of cases and deaths. The outbreak is continuing to spread in Guinea, Sierra Leone, and Liberia (the “affected countries”); it has been contained in Nigeria and Senegal, and has been detected in Mali. As of October 22, 2014, more than 10,000 people have contracted EVD, more than half of whom have died.

In the aggregate, between 1976, when Ebola was first identified, through 2012, there were 2,387 cases, including 1,590 deaths, all in Central and East Africa. The number of Ebola cases in this outbreak is four times higher than the combined total of all prior outbreaks, and the number of cases is doubling monthly. The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have projected an exponential increase in cases. WHO estimated that by the end of November, some 20,000 people may contract Ebola; CDC estimated that “without additional interventions or changes in community behavior,” up to 1.4 million could contract EVD in Liberia and Sierra Leone by January 2015. CDC indicates, however, that the outbreak may not reach such proportions since responses are intensifying. In Liberia, for example, improvements in burial practices have resulted in roughly 85% of all bodies being collected within 24 hours of being reported to national officials.

See also: Increased Department of Defense Role in U.S. Ebola Response – CRS Insights (October 10, 2014) (PDF; via U.S. State Department Foreign Press Center)

CRS — Al Qaeda-Affiliated Groups: Middle East and Africa (October 10, 2014)

November 3, 2014 Comments off

Al Qaeda-Affiliated Groups: Middle East and Africa (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

After more than a decade of combating Al Qaeda in Afghanistan and Pakistan, the United States now faces an increasingly diverse threat from Al Qaeda affiliates in the Middle East and Africa and from emerging groups that have adopted aspects of Al Qaeda’s ideology but operate relatively or completely autonomously from the group’s senior leadership.

U.S. counterterrorism debates have focused on “formal” Al Qaeda affiliates, and policymakers increasingly are considering options for addressing the range of threats posed by the wider spectrum of groups inspired by—or similar in goals and aspirations to—Al Qaeda. An additional challenge is the fluid nature of the threat, given the apparent fragmentation of Al Qaeda, and Ayman al Zawahiri’s struggle to assert leadership of the group in light of challengers such as Islamic State leader Abu Bakr al Baghdadi. Finally, concerns regarding these issues might shape ongoing reevaluations of the federal statutes that underpin current U.S. counterterrorism policy, including the 2001 Authorization for Use of Military Force (AUMF, P.L. 107-40).

Sub-Saharan African Immigrants in the United States

November 2, 2014 Comments off

Sub-Saharan African Immigrants in the United States
Source: Migration Policy Institute

The first migrants from sub-Saharan Africa came to the United States as a result of the trans-Atlantic slave trade. Between 1519 and 1867 approximately 360,000 Africans were forced to migrate to the United States; in total, more than 10 million people were enslaved and brought to the Americas. Significant voluntary migration from sub-Saharan Africa to the United States did not begin until the 1980s. From 1980 to 2013, the sub-Saharan African immigrant population in the United States increased from 130,000 to 1.5 million, roughly doubling each decade between 1980 and 2010. Between 2010 and 2013 the sub-Saharan African-born population increased a further 13 percent, from 1.3 million to 1.5 million. As of 2013, sub-Saharan Africans accounted for a small but growing share (4 percent) of the 41.3 million total immigrants in the United States; they also constituted 82 percent of the 1.8 million immigrants born anywhere on the African continent.

Estimating the Future Number of Cases in the Ebola Epidemic — Liberia and Sierra Leone, 2014–2015

October 24, 2014 Comments off

Estimating the Future Number of Cases in the Ebola Epidemic — Liberia and Sierra Leone, 2014–2015
Source: Morbidity and Mortality Weekly Report (CDC)

The first cases of the current West African epidemic of Ebola virus disease (hereafter referred to as Ebola) were reported on March 22, 2014, with a report of 49 cases in Guinea. By August 31, 2014, a total of 3,685 probable, confirmed, and suspected cases in West Africa had been reported. To aid in planning for additional disease-control efforts, CDC constructed a modeling tool called EbolaResponse to provide estimates of the potential number of future cases. If trends continue without scale-up of effective interventions, by September 30, 2014, Sierra Leone and Liberia will have a total of approximately 8,000 Ebola cases. A potential underreporting correction factor of 2.5 also was calculated. Using this correction factor, the model estimates that approximately 21,000 total cases will have occurred in Liberia and Sierra Leone by September 30, 2014. Reported cases in Liberia are doubling every 15–20 days, and those in Sierra Leone are doubling every 30–40 days. The EbolaResponse modeling tool also was used to estimate how control and prevention interventions can slow and eventually stop the epidemic. In a hypothetical scenario, the epidemic begins to decrease and eventually end if approximately 70% of persons with Ebola are in medical care facilities or Ebola treatment units (ETUs) or, when these settings are at capacity, in a non-ETU setting such that there is a reduced risk for disease transmission (including safe burial when needed). In another hypothetical scenario, every 30-day delay in increasing the percentage of patients in ETUs to 70% was associated with an approximate tripling in the number of daily cases that occur at the peak of the epidemic (however, the epidemic still eventually ends). Officials have developed a plan to rapidly increase ETU capacities and also are developing innovative methods that can be quickly scaled up to isolate patients in non-ETU settings in a way that can help disrupt Ebola transmission in communities. The U.S. government and international organizations recently announced commitments to support these measures. As these measures are rapidly implemented and sustained, the higher projections presented in this report become very unlikely.

See also:
Importation and Containment of Ebola Virus Disease — Senegal, August–September 2014
Control of Ebola Virus Disease — Firestone District, Liberia, 2014
Ebola Virus Disease Outbreak — Nigeria, July–September 2014
Ebola Virus Disease Outbreak — West Africa, September 2014
Frequently Asked Questions About “Alternative” Therapies for Ebola (NCCAM)

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections

October 24, 2014 Comments off

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections
Source: New England Journal of Medicine

As of September 14, 2014, a total of 4507 confirmed and probable cases of Ebola virus disease (EVD), as well as 2296 deaths from the virus, had been reported from five countries in West Africa — Guinea, Liberia, Nigeria, Senegal, and Sierra Leone. In terms of reported morbidity and mortality, the current epidemic of EVD is far larger than all previous epidemics combined. The true numbers of cases and deaths are certainly higher. There are numerous reports of symptomatic persons evading diagnosis and treatment, of laboratory diagnoses that have not been included in national databases, and of persons with suspected EVD who were buried without a diagnosis having been made

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