Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

Manufacturing Innovation

(ProQuest: ... denotes non-USASCII text omitted.) The annual Global Innovation Index released in September 2021 ranked China twelfth, surpassing developed economies such as Japan, Israel, and Canada and raising fears in the United States amidst sluggish growth in North America and strong growth in the Asia Pacific region.1 Interestingly, the United States government responded by boycotting the Beijing Olympic Games, citing human rights abuses as the main reason.2 A tech war between China and the United States brewed beneath the diplomatic rancor over the attendance at the Olympic Games. Part I documents how the United States has assisted China's tech and intellectual property domination through President Nixon's historic visit to China, giving China Most Favorite Nation (MFN) status and ascending China to the World Trade Organization (WTO). [...]under Deng Xiaoping's leadership during the reform period, China rapidly developed its special economic zones (SEZs), laying the foundation for subsequent tech innovation and production. [...]broadcasting, telecommunications, office machines, computers, integrated circuits, and cell phones are among China's notable exports to the world.9 China dominates in commodities and raw materials, exporting refined petroleum, cotton, plywood, and tea.10 For agricultural products, China occupies the perch as the world's largest producer. Shenzhen rose as the largest among the four.18 Shenzhen, a small fishing locale in the southern part of China's southern province, Guangdong, served as the pioneer of Deng Xiaoping's embrace of economic reforms.19 A market-oriented economy took root in Shenzhen, allowing foreign companies and entities from Hong Kong and Macau to operate and allowing Chinese talents the freedom to leave their hometowns and move into the SEZs.20 Cheap labor proved to be another significant factor facilitating China's rise as a global manufacturer.21 In the 1980s, multinational corporations from Taiwan, Japan, and South Korea, as well as domestic Chinese companies, opened their factories in the SEZs and other cities in China to take advantage of the cheap and plentiful labor force.22 Indeed, when Deng Xiaoping began his pilot SEZs, China's young workers who wished to lift themselves out of poverty descended into the economic zones in search of better opportunities.23 Shenzhen grew from a population of 59,000 in 1980 to a population of 12,357,000 in 2020.24 The new migrants became the workers, participants, and stakeholders in the global manufacturing frontier.25 Because of the abundance of cheap labor, manufacturers in China have no difficulty keeping production prices low and pleasing consumers and businesses worldwide.26 China's currency manipulation is another factor propelling China to its domination in global manufacturing.27 The United States Congress attempted numerous times to introduce legislation to combat China's currency manipulation.28 China artificially devalued its currency through government control of the exchange rate and refused to let the Chinese Renminbi (RMB) float.29 Despite strong criticisms from the United States, China refuses to allow its currency to freely float.30 China's currency manipulations, according to critics, caused the widening of trade deficits between the United States and China.31 China's currency manipulation allows products to be manufactured at lower prices, hampering competitors and thereafter replacing them.32 In order to cope with China's currency practices, United States manufacturers facing their own existential crises must decide to either outsource jobs overseas or face large risks, including financial ruin.33 The United States lost millions of manufacturing jobs due to massive job outsourcing as the trade deficits between the United States and China continued to persist.34 Geopolitically, in shaping post-Cold-War powers, the United States decided to assist China in its transformation from a poverty-stricken country to a global manufacturer.

Analysis: FDA's COVID-19 Accelerated Pathways

Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.

Strategizing for Strength in EU PharmaN

"Though Europe's response has demonstrated strengths," the strategy document reports, "existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines, or the availability of manufacturing capacities to adapt and support the production of medicines" (2). [...]a lot of the strategy's proposals stem from the European Green Deal, published in late 2019 (4), from which has emanated last year's EU industrial strategy (5). [...]setting up critical medicines production capacity in the EU would have to be compliant with the Union's competition rules and those of the World Trade Organization, the commission warned (2).

Regulating Digital Therapeutics

Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.

Business on Hold? EMA's Full Recovery in Question

The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).

Israel's COVID-19 Diplomacy in Sub-Saharan Africa and Central Europe

Israel's aid initiatives have historically been facilitated through the Agency for International Development Cooperation (MASHAV). However, the COVID-19 pandemic impacted MASHAVs ability to provide assistance due to budget cuts and government instability. As such, Israel's COVID-19 diplomacy initiative took on greater importance in maintaining its presence and reputation internationally. This article analyzes Israel's approach to COVID-19 diplomacy, which involved providing medical teams, PPE, and surplus vaccines to approximately 20 countries, and examines the political and strategic calculations behind Israel's decision to extend assistance to specific countries. The article argues that Israel's COVID-19 diplomacy initiative was more limited in scope and geography compared to other countries with similar economic development levels, and aid efforts were concentrated in regions where Israel has sought to increase its involvement in recent years, particularly sub-Saharan Africa and Central Europe. Finally, the article assesses the impact of Israel's COVID-19 diplomacy initiative on its diplomatic relations with recipient countries and the broader international community.

Time for a Tune Up in America's Healthcare Market: Securing the Right to Repair for Medical Devices

Pursuant to a directive of Congress, the Federal Trade Commission (FTC) issued a report in May of 2021 examining consumer protection and antitrust issues relating to repair restrictions with a focus on the prevailing practices of mobile phone and auto manufacturers.12 In its report, the FTC identified eight primary methods by which OEMs restrict independent repair and repair by consumers: * Product designs that complicate or prevent repair;* Unavailability of parts and repair information;* Designs that make independent repairs less safe;* Policies or statements that steer consumers to manufacturer repair networks;* Application of patent rights and enforcement of trademarks;* Disparagement of non-OEM parts and independent repair;* Software locks and firmware updates;and * End User License Agreements.13 Software locks, often called digital rights management (DRM) tools or technological protection measures (TPMs), are access controls through which OEMs have throttled independent repairs on a wide range of software-enabled products.14 End-user license agreements (EULAs) are "contracts that users must agree to before using a product or service," which are also known as "click-wrap," "shrink-wrap," or "terms of service" agreements, constituting another major way OEMs restrict repairs.15 In the style of adhesion contracts-inundating consumers with virtually every digital service and software-enabled product they utilize-EULAs often impose post-sale usage, repair, and modification restrictions, granting corporations "unprecedented access to monitor, manage, and restrict how consumers use their products, even going so far as to revoke ownership. B.The Right-to-Repair Movement Today Leading the charge for the right-to-repair movement today is the Repair Association, comprised of notable consumer-rights groups and industry organizations such as the U.S. Public Interest Research Group (PIRG),19 the Electronic Frontier Foundation,20 and iFixit,21 along with a variety of other members whose interests align with advancing the right to repair.22 The right-to-repair movement consists of two main, interdependent branches.23 The first is focused on amending the Digital Millennium Copyright Act (DMCA),24 an important facet of the federal intellectual property law regime.25 The second branch of the movement is focused on pushing bills through legislatures, mainly at the state level. The Act Protecting Motor Vehicle Owners and Small Businesses in Repairing Motor Vehicles.28 Although limited to automobile repairs, this landmark state law mapped the core provisions of template legislation advanced by the Repair Association for enshrining the right to repair broadly across industries.29 Pursuant to these provisions, the Massachusetts law gave car owners and independent repair shops access to the same manuals, diagnostic software, and diagnostic repair tools provided to licensed dealerships by their respective automobile manufacturers.30 Specifically, the law required motor vehicle manufacturers to "make available for purchase by owners . . . and by independent repair facilities the same diagnostic and repair information" and "all diagnostic repair tools" provided to dealers by OEMs on "fair and reasonable terms. In 2014, the Alliance of Automobile Manufacturers, the Association of Global Automakers, and two automobile aftermarket industry groups came together to sign a "Memorandum of Understanding" by which the automobile industry nationwide effectively agreed to voluntarily abide by substantively the same provisions of the Massachusetts right-to-repair law.32 Unsurprisingly, the law generated considerable momentum for the right-to-repair movement over the following years, which saw a greatly amplified nationwide effort by advocates pushing for legislation "that would recognize the right to repair consumer electronics-not only smartphones, laptops, and televisions, but also household appliances, wearable technology, farm equipment, and medical devices, to offer just a few examples.

Holding Up a Mirror to the World Trade Organization: Lessons from the COVID-19 Pandemic

[...]what of other cognate international institutions that govern the global political economy and thereby facilitate or hamper access to lifesaving medical equipment and drugs, provide a system of enforceable rules to encourage vaccine development and distribution, or ensure that populations already beleaguered by a potentially lethal contagion do not become casualties of new scarcities of essential goods and services? [...]the rapid and global spread of COVID-19 was facilitated by a model of globalization that recognizes merit in the free movement of people across borders. [...]the WTO’s rules on trade-related intellectual property rights (TRIPS) directly impact upon the issue of the accessibility of the vaccine. State-owned enterprises and subsidies in China showed a mixing of public and private power that was an anomaly to the rules-based system of free and fair markets that the liberal order had envisaged;it was, however, a good illustration of the exercise of state power on and via the private sector, along the lines outlined by the model of weaponized interdependence.

Preventing Childhood Vision Loss Through Exploitative Prison Labor: A Call for Action

The California Prison Industry Authority (CALPIA), a semiautonomous prison labor agency under the California Department of Corrections and Rehabilitation, runs two optical laboratories operated by people incarcerated at Valley State Prison and California State Prison, Solano,1 and these laboratories supply ophthalmic lenses to eligible Medicaid recipients, such as this young patient. Documents we obtained through a public records request revealed that our state's public health agency, the California Department of Health Care Services (DHCS), agreed to pay CALPIA up to $37.9 million for the 2021/22 fiscal year for optical services alone. CALPIA wages in prison-based optical shops range between $0.35 and $1.00 per hour,6 up to 55% of which can be deducted by law for restitution and administrative costs, resulting in an effective pay rate as low as $0.16 per hour.7 Courts have routinely rejected legal challenges to these meager wages by concluding that, because the Thirteen Amendment permits the involuntary servitude of incarcerated people, the federal minimum wage law does not apply to prison labor.8 The result is a strange supply chain that is not always transparent or top of mind: medical devices produced by poorly paid imprisoned people are provided to the poorest members of free society, such as the infant who needed sight-saving glasses. Others have called for public health officials, researchers, and physicians to address the sprawling reach of the prison industrial complex.14 Medical providers could use their position of authority to advocate better pay and conditions for incarcerated workers who produce the very devices that providers prescribe.

Medical devices associated adverse events under Materiovigilance Programme of India in a Tertiary Care Hospital of Tribal District of Odisha

For definition, a medical device can be an instrument, apparatus, machine, implant, regent, IVD, software, or assisted material intended to be used alone or in combination, for human beings, for one or more medical purposes of diagnosis, prevention, treatment, and monitoring of an injury or a disease or investigation, replacement, modification, treatment, monitoring, and support of an anatomical or physiological condition for supporting and sustaining life, controlling conception by means of in vitro examination, or intending action by pharmacological, immunological, and metabolic in or on of human body. There was no proper system for the regulation, manufacturing, export, import, sale, and distribution of medical devices. [...]the Government of India, in collaboration with the Drugs Technical Advisory Board, recently brought out the Medical Device Rules 2017. [1] The following medical devices and in vitro diagnostics are currently regulated in India: Cardiac stents, drug-eluting stents, catheters, heart valves, orthopedic implants, intraocular lenses, intravenous cannulae, bone cements, ablation devices, internal prosthetic replacements, intrauterine contraceptive devices, condoms, tubal rings, umbilical tapes, blood sera, scalp vein sets, ligatures, sutures, staplers, surgical dressings, disposables syringes, hypodermic needles, perfusion sets, and in vitro diagnostic tests for human immunodeficiency virus, hepatitis B surface antigen, and hepatitis C virus. [13] As we are all aware, various medical tools are being used during this coronavirus pandemic, which also gives rise to a number of ADRs related to gloves, masks, sanitizer, swap kits, pulse oximeters, and other equipment. [...]the MvPI-IPC has introduced a specific PPE form for accurate data collection)14 Reports received from hospitals, health-care professionals, and manufacturers are documented.

Does melatonin protect fetal brain during maternal hypothyroidism? An experimental study

Objectives: To study the effects of melatonin in preventing neonatal neuronal apoptosis induced by maternal hypothyroidism. Methods: Twelve healthy female Wistar rats, 12-16 weeks, were divided equally into three groups. Group-A was labelled as control. Group-B was made hypothyroid by giving 15mg/kg of propylthiouracyl (PTU) daily whereas Group-C was given PTU along with melatonin (10mg of melatonin/kg/day) in drinking water. After one week of treatment, the female rats were allowed to mate and conceive. The treatment of all groups continued throughout the period of pregnancy and lactation. After delivery, a total of 30 pups, 10 from each group, were labelled and sacrificed on 22nd day of life. The serum levels of TSH, T3 and T4 of the pups were measured. The brains were extracted from the skull and homogenized for isolation of mitochondria to determine the levels of cytochrome c oxidase and for isolation of RNAs to measure the levels of gene expressions of caspases 3, 9 and 8. Results: Group-B pups showed a significant increase in serum levels of TSH (21 ± 3.7 mg/dl), and gene expression levels of caspase 3 (0.85±0.02) and 9 (0.69±0.02) where as in Group-C, there was visible reduction in concentration of TSH (15 ± 2.4 mg/dl), caspase 3 (0.50±0.02) and 9 (0.25±0.01) expressions. Increase in cytochrome c oxidase enzyme concentration (3.416 ± 0.001) in Group-B was the result of mitochondrial outer membrane rupture, causing decrease in the number of neurons by accelerating apoptosis. A decrease in its level in Group-C (2.100 ± 0.001) indicated inhibition of apoptosis. Conclusion: Intake of melatonin during pregnancy and lactation protected the brains of offspring from extensive apoptosis during maternal hypothyroidism.

Additive manufacturing towards product production: a bibliometric analysis

Additively manufactured products offer extensive variety to consumers than many forms of production. Additive manufacturing (AM) production system allows consumer involvement, which has created a huge but largely untapped market. However, there is a gap between production and the market. Therefore, AM towards product production which focuses on the Commercialization of Additive Manufactured Products (CAMPs) is imperative. Despite the importance of CAMP, specific focus of research on the commercialization of additively manufactured products are scanty. There is also a lack of knowledge about the conceptual structure, intellectual structure, research trends, and the thematic structure of CAMP research. To contribute to this stream of research, this study takes an exploratory dimension by conducting a bibliometric analysis of publications on the CAMP. The R package and its associated biblioshiny were the software used. The study reveals that studies on CAMP started in 2007 with renewed interest starting from 2012. Importantly, it was found that the most cited articles focused on the economic potential of AM products in the home and specific industries. Also, there is an increasing focus on the business models that are necessary for the commercialisation of AM products. Generally, there is a shift in focus from the firm to the market. However, this is a niche area and requires more attention. Themes such as commercialization are just emerging, and researchers need to devote more time and effort to the consumer side of the commercialization of AM products.

Indo-China Trade Relationship in Last Quarter Century: An Empirical Analysis

Purpose: The study tries to find pattern in the bilateral trade and impact of macro happenings like GFC, Chinese meltdown, Galwan conflict, COVID-19 on it over the period of 1995 to 2020. Design/Methodology/Approach: The study has two dimensions. The first one analyses the monthly export and import figures between India and China product wise (based on HS Code at two-digit level) from Jan2016 to Jan 2021 whereas second one focus on annual data of Indo-China Export and Import along with their annual GDP for 26 years starting from 19941995 to 2019-2020. Bilateral trades are analysed by using four tools namelyBilateral Trade Dependence Index (BTDI);Trade Intensity Index (TIT);Herfindahl Hirschmann Market Concentration Index (HHI);and Index of Export market penetration (IEMP). The study has also used Time series analysis to find the relationship between total bilateral trade and GDP of respective countries using Johansen Cointegration Test, Granger Causality Test, and VAR model. Findings: The annual growth rate of import and export for India with China suggest the short-term impact of macro happenings. Research Limitations: The study has several limitations with respect to availability of very recent data, availability of cost components of trade items in respective countries etc. Managerial Implications: Policy makers for India are suggested to work towards import substitution via various programs like Make-in-India with priority of domestic productions of HS Code 85, 84, 29 which are increasing the trade deficit continuously. Originality/Value: This study is an original effort to highlight the dynamic bilateral trade relationships between India and China in last twenty-five years.

Regulating Environmental Impact of Medical Devices in the United Kingdom—A Scoping Review

Medical devices are highly regulated to ensure safety and efficacy of the products and minimize the risk of harm to users and patients. However, the broader impacts of these devices on the environment have scarcely been questioned until recently. The United Kingdom National Health Service intends to achieve a “net zero” emissions service by 2040 and has identified specific targets to achieve through this process. However, medical device manufacturers do not see sufficient incentives to invest in reducing greenhouse gas emissions unless enforced by legislation. Furthermore, there is little evidence on the legislation required to reduce emissions from medical devices. This study addresses the relationship of medical device regulations and the environmental impact of the devices throughout their lifecycle. A scoping review was conducted on academic literature on the topic, followed by a critical review of the current medical device regulations and associated guidelines in the United Kingdom. The challenges to regulating environmental impact of medical devices were identified under seven themes. These challenges were contextualized with the National Health Service target of achieving zero emissions by 2040. The review indicates that current guidelines support single-use disposal of devices and equipment as the best approach to prevent pathogen transmission and landfilling and incineration are the most used waste management strategies. Manufacturers need to be guided and educated on reducing their emissions while ensuring the development of safe and effective devices.

Effects of the 3DP process parameters on mechanical properties of polylactic acid part used for medical purposes

PurposeThis paper aims to investigate effect of infill density, fabricated built orientation and dose of gamma radiation to mechanical tensile and compressive properties of polylactic acid (PLA) part fabricated by fused deposit modelling (FDM) technique for medical applications.Design/methodology/approachPLA specimens for tensile and compressive tests were fabricated using FDM machine. The specimens geometry and test method were referred to ASTM D638 and ASTM D695, respectively. Three orientations under consideration were flat, edge and upright, whereas the infill density ranged from 0 to 100%. The gamma radiation dose used to expose to specimens was 25 kGy. The collected data included stress and strain, which was used to find mechanical properties, i.e. yield strength, ultimate tensile strength (UTS), fracture strength, elongation at yield, elongation at UTS and elongation at break. The t-test was used to access the difference in mechanical properties.FindingsCompressive mechanical properties is greater than tensile mechanical properties. Increasing number of layer parallel to loading direction and infill density, it enhances the material property. Upright presents the lowest mechanical property in tensile test, but greatest in compressive test. Upright orientation should not be used for part subjecting to tensile load. FDM is more proper for part subjecting to compressive load. FDM part requires undergoing gamma ray for sterilisation, the infill density no less than 70 and 60% should be selected for part subjecting to tensile and compressive load, respectively.Originality/valueThis study investigated all mechanical properties in both tension and compression as well as exposure to gamma radiation. The results can be applied in selection of FDM parameters for medical device manufacturing.