COVID-19 Outbreak: Weekly Global Report for Friday, July 31, 2020

AdvaMed recognizes that its members, particularly those with global government affairs responsibilities, are tracking COVID-19 related developments around the world to assess the public health and economic impacts on their businesses. Knowing that companies are consuming information from a variety of sources, AdvaMed’s global team would like to provide members with a weekly snapshot of the key statistics, policy developments and advocacy initiatives underway in our priority markets.  If you have any suggestions, we welcome your feedback.

Global

• Weekly COVID-19 statistics- global cases reached 17.1 million, nearly a 2 million increase over the previous week. Deaths around the world exceeded 668,000. The countries with the most reported cases are the U.S. (4.46 million), Brazil (2.5 million), and India (1.5 million).
• U.S. cases exceeded 4.64 million with deaths increasing to 151,000.
• Staff Contact: Ralph Ives ([email protected]).

China

• Weekly COVID-19 statistics –China reported over a thousand new cases since the previous week due to outbreaks in the Xinjiang region in China’s northwest and Liaoning province in China’s northeast. This represents the greatest increase in reported cases since early March, with total cases now standing at 87,363 and deaths at 4,658.
• Urumqi, the capital of the Xinjiang autonomous region, has reported dozens of new cases each day throughout the past week, with a high of 96 cases reported on July 30. Local authorities have canceled flights to and from the city and have ordered the city’s 3.5 million residents to undergo testing.
• Dalian, the capital of Liaoning province, has reported over 50 cases in the past week. Epidemiologists with China’s CDC have connected the outbreak to contaminated seafood imports. Within a week, Dalian’s 4 million residents have been undergone nucleic acid tests. Local authorities have not yet imposed travel restrictions into and from the city.
• While the Chinese government last week reported better than expected economic figures for the second quarter, high unemployment in urban areas and systemic financial risks pose continuing challenges. Consumption also remains below pre-COVID levels. To tackle rising unemployment particularly among youth, the government is providing thousands of new positions at state-owned enterprises even as the profitability of the state sector plunges.
• As part of its ongoing response to the Covid threat, the government is emphasizing the role of traditional Chinese medicine (TCM) as a therapeutic remedy. TCM clinics are to increase their supply of PPE and carry out nucleic acid tests.
• Hospitals have resumed elective/regular surgeries for a few months now and medical services are back to normal for the most part. Planned hospital admissions appear to be at 80-90% of pre-COVID levels, with this range varying by particular medical condition of the patient and geographical area.
• China is continuing to allow an increased number of inbound flights from overseas. The vast majority of passengers on these flights are returning Chinese nationals, as the Chinese government has not relaxed its entry ban on foreigners.
• While U.S.-China relations remain in a downward trajectory, the Phase One trade deal remains intact and has emerged as a key remaining pillar of cooperation. Chinese state firms have continued to sign several large contracts for U.S. farm products. USTR and the Chinese side continue to check-in regularly to discuss implementation of the agreement.
• Staff Contact: Kyle Churchman ([email protected])

 India

• Weekly COVID-19 statistics – 1,584,219 total cases with 528,242 active cases/34,968 deaths as compared to 426,167 active cases/29,861 deaths reported last week. India recorded biggest daily jump of 52,123 COVID-19 cases on Thursday as recoveries cross 10 lakh (1,000,000).
• Ministry of Home Affairs (MHA) issued new guidelines on Wednesday, July 29, 2020 for opening up of more activities in areas outside the Containment Zones. In Unlock 3, which will come into effect from August 1, 2020, the process of phased re-opening of activities has been extended further. The new guidelines are based on feedback received from States and UTs, and extensive consultations held with related Central Ministries and Departments and will be in force untill August 31, 2020.
• Prime Minister Modi claims that India is the world’s second-largest manufacturer of PPE during a video call with Union Health Minister Dr Harsh Vardhan and the Chief Ministers of Maharashtra, UP and Bengal as they launched several “high throughput” COVID-19 testing facilities at the Indian Council of Medical Research (ICMR) centers in Mumbai, Noida and Kolkata. The Prime Minister praised the nation’s achievement in scaling up production of PPE, needed for healthcare professionals battling the coronavirus outbreak, calling it a “huge success story”. “At one point India didn’t manufacture a single PPE kit. Now it is the world’s second-largest manufacturer. Over 1,200 companies are making PPE kits within six months,” the Prime Minister said, adding, “More than three lakh N95 masks are made each day.”
• Amendments to the export policy of PPE/Masks – DGFT vide notification number 21/2015-2020 dated July 28, 2020 has amended its earlier notification. This notification reads, “Notification no. 20 dated 21st July 2020 read with Notification no. 16 dated June 29, 2020 is amended to the extent that the export policy of 2/3 ply surgical masks, Medical goggles is amended from “Prohibited” to “Restricted” category and the export of Face Shields has been made “Free”. A monthly export quota of 4 crores (40 million) per month has been fixed for 2/3 ply surgical masks and 20 lakh (2 million) per month for medical goggles for issuing export licences to eligible applicants as per the criteria to be separately issued in a Trade notice.”
• Business activity in India improved for the second month in a row in June according to indices compiled by Bloomberg, suggesting that the worst may be over for the country’s economy. GDP is still projected to shrink 20 percent year-on-year in the second quarter.
• The government is preparing a plan to boost pharma R&D. The Department of Pharmaceuticals (DOP) is all set to encourage research and development of novel drugs with a new policy. The government-appointed committee, chaired by DOP Secretary Vaghela, and comprising officials from ICMR and Department of Science and Technology, along with Biocon chairperson Kiran Mazumdar-Shaw and Zydus Cadila chairman Pankaj Patel, will frame the policy.
• In an order dated July 27, 2020, the Ministry of Health & Family Welfare exempted hand sanitizers from the requirement of sale licence for its stocking or sale under the provisions of Drugs and Cosmetics Act and Rules.
• Staff Contact:  Abby Pratt ([email protected]).

Japan

• Weekly COVID-19 statistics – 35,521 reported cases and 1,020 reported deaths compared to 28,963 reported cases and 1,005 reported deaths the previous week.
• After Japan deactivated its virus alert and moved to the third and final stage of its plan to reboot businesses and reopen society, it has experienced a major resurgence of cases.
• The number of new cases has grown by over 60% since the beginning of July. The number of new cases reached a daily record of just over 1,200 on July 29.
• This growth has had a severe impact on Japan’s hospitals. Some hospitals are cutting back or halting elective surgeries in order to deal with the influx of new cases. Nearly 70% of Japan’s hospitals are now operating in the red.
• The majority of new cases are in Tokyo and are affecting people in their 20s and 30s. Tokyo’s governor is now requiring restaurants to close at 10 p.m.
• Japan and Vietnam have agreed to ease bilateral travel restrictions in stages. Vietnam will first accept 440 Japanese business travelers on three charter flights. The travelers will be required to undergo tests upon arrival and be quarantined for two weeks at hotels.  Thailand will likely be next in line for eased restrictions, followed by Australia and New Zealand.
• Japan currently has an entry ban in place for 111 countries and regions, with foreign travelers who have been to any of those areas within the last two weeks being turned away.
• Japan’s Ministry of Health has adopted priority regulatory review procedures for new COVID-related medical devices.
• Japan will ban foreign companies from purchasing advanced medical device companies that are deemed essential to the national security in the fight against Covid-19. This measure is based on concerns about China but applies to companies from all countries.  The government aims to ensure stable supply of essential devices that are vulnerable to contamination by infection, such as implants and dialyzers.
• Staff Contact:  Phil Agress ([email protected]).

Korea

• South Korea’s new daily cases have lowered to 18, and this is a marked decline from several weeks in the 50 to 60 range. Authorities are continuing to monitor and do contact tracing. There are 14,269 cases, 925 active with 300 deaths and 0 deaths per day reported.  
• Korea continues to exhibit one of the lowest global death rates from COVID at just 2.4%. 
• However, authorities have expressed concern about a virus increase during the summer based on infections seen to have occurred from families who went camping.
• South Korea this week unveiled a financial package to inject 40 trillion won ($33.8 billion) into 1,000 selected innovative businesses over the next 3 years. The plan is designed as the final piece necessary to finalize and align the so called “Korean New Deal” incentives which are so far worth 160 trillion won and enable those companies to have unlimited loan credit when borrowing from the Korea Development Bank.
• The South Korea economy shrank 3.3% in the second quarter of this year, its worst performance since the Asian financial crisis in 1998.
• South Korea’s legislature has passed revised laws limiting rent increases and giving tenants additional rights, including presumptions for lease extensions.   The changes will go into effect if the Cabinet approves.
• Travelers from “high-risk” countries — Bangladesh, Pakistan, Kazakhstan, and Kyrgyzstan – are to submit certificates issued within 48 hours proving they tested negative for the coronavirus. Those without proof of the negative test result will not be allowed to board flights to Korea and could face deportation when they arrive. Even with the proof, they still need to self-quarantine for two weeks either at home or at designated facilities, depending on their visa status, and seek testing for the virus within three days of their arrival. On Thursday, Korea added Philippines and Uzbekistan to the list of high-risk countries.
• South Korea maintains its 2-week quarantine for all other incoming international travelers and a requirement for all inbound flights to check passengers’ temperatures. Anyone with a temperature over 37.5 degrees Celsius (99.5 Fahrenheit) is denied entry. Korea has not issued any guidance on an exemption that is supposedly available.  Korea has indicated all US inbound travelers will be tested for symptoms prior to being moved to quarantine.
• Korea is considering a proposal that would potentially reduce the price of certain cardiac stents. AdvaMed continues to be in touch with members and the medtech association in Korea and is prepared to engage at the appropriate time if necessary.

• Resources: http://ncov.mohw.go.kr/en/.
• Staff Contact: Joseph Gatewood ([email protected]).

 ASEAN

• Weekly COVID-19 statistics – ASEAN now has 257,111 reported cases and 7,238 reported deaths compared to 230,367 reported cases and 6,664 reported deaths the previous week.
• The Philippines and Indonesia account for 97% of the deaths from COVID-19 in the region. Vietnam, Cambodia, and Laos have each reported zero deaths, while Brunei has reported 3 deaths, Myanmar has reported 6 deaths, Singapore has reported 27 deaths (despite having over 50,000 cases), and Thailand has reported 58 deaths.
• Elective surgeries have resumed in Thailand and Vietnam.
• In Indonesia, provincial hospitals are resuming elective surgery with COVID-19 protocols in place.
• Singapore now allows certain procedures including cancer screening, surgical operations for advanced cataracts, flu vaccinations, and dental procedures.
• Malaysia maintains limits on elective surgery except in emergency cases.
• Indonesia’s total COVID-19 cases topped 100,000 and deaths exceed 5,000, the highest levels for both in East Asia. 
• Indonesia has lifted the ban on export of medical devices for COVID-19 purposes. At the same time, President Jokowi has called for an end to PPE imports as the country is capable of manufacturing them locally. Indonesia has produced its own rapid test called RI-GHA COVID-19. 
• Malaysia and Singapore will partially reopen their border on August 10. Both governments have agreed to implement a Reciprocal Green Lane (RGL) and Periodic Commuting Arrangement (PCA). The RGL will enable cross-border travel for essential business and official purposes between both countries and the PCA will allow residents of Singapore and Malaysia who hold long-term immigration passes for business and work purposes in the other country to enter the country for work.  
• Malaysia is also holding talks to create a “green zone” for travel with Brunei, Thailand, New Zealand, Australia, Japan, and South Korea. 
• With the continuous increase in confirmed COVID-19 cases in the country, Philippine President Rodrigo Duterte has extended the general community quarantine (GCQ) over Metro Manila until July 31. Surgeries will be for emergency cases only.
• The Philippines has resumed domestic flights. International flights remain suspended except repatriation flights to take foreigners home. 
• Singapore now allows small gatherings, and restaurants and shops can reopen. Social distancing requirements will remain, but this measure marks a major easing in COVID-19 restrictions and reflects a decline in worker dormitory cases and a stable level of other cases.
• Singapore and China began a “fast-lane” travel arrangement for official and business purposes between the two countries. Singapore is in discussion with other countries such Japan, New Zealand, and South Korea on similar arrangements. 
• The Thai Government approved the fifth phase of lockdown easing, allowing most daily activities and businesses to resume.  It has lifted the ban on international flights and allows certain categories of individuals from Japan, China, South Korea, Hong Kong, and Singapore to enter the country The Civil Aviation Authority will still apply stringent international travel restrictions preventing the entry of tourists.
• Thailand’s Centre for Covid-19 Situation Administration (CCSA) approved another extension of the state of emergency nationwide until August 31.
• Following Vietnam’s first locally transmitted cases of COVID-19 in 100 days, Prime Minister Phuc instructed the ministries of national defense and public security to continue with strict border controls, and re-imposed strong stay-at-home requirements and non-essential business closures in Da Nang, the city in which the outbreak occurred. The country is evacuating 80,000 tourists from Danang.
• Staff Contact:  Phil Agress ([email protected])

Europe

Europe continues to improve overall, although France and Spain have seen a spike in new cases. Conditions in some of the worst hit countries, such as Italy and Spain, have continued to improve, with new daily cases and total cases flattening. Belgium, which was having recurrent spikes, seems to be on a solid downward trend. The UK leads the EU in the number of cases and deaths. Italy and France are second and third in the EU in the number of fatalities from COVID. Although not in the EU, Russia’s reported numbers on COVID are continuing to increase, and continue to be the worst in Europe. Russia remains the COVID hot spot in Europe, now reporting 828,990 cases, with just 13,673 reported deaths.  By comparison, Italy, with much fewer (246,776) cases, reports 35,129 deaths. Russia’s response and condition remain a concern for EU countries who are looking to reopen borders.

• New daily cases, which tends to show which countries are increasing in COVID incidence is as follows:  Spain 2031; Italy 289; Germany 860; France 1,392; UK 763; Belgium 234, Russia 5,475.  Spain and Italy are significantly down, UK is stable, Germany and France are significantly up.
• New deaths per day are as follows:  Spain 5; Italy 6; Germany 5; France 15; UK 83; Belgium 11. Overall trends remain positive in the EU, with some concerns in France, Spain and even Germany as re-opening proceeds. France has ruled out a lockdown despite a spike in infections.
• The EU prohibition against inbound travelers from the US, Russia and Brazil based on COVID concerns remains in place. Inbound travel is permitted from any of 15 approved countries and the list will be updated every two weeks.  
• The EU will distribute around $2 trillion of funds across the bloc over the next seven years. The package comprises the $1.3 trillion seven-year EU budget plus a special $858 billion emergency package. It’s designed to help the bloc recover from the Covid-19 pandemic as one, rather than abandoning poorer countries to their fate as wealthier nations surged back.
• The European Parliament had stated it will push for more of the EU recovery package to be spent on research and development, health, and education and for a clearer link between economic aid and observing the rule of law. However, this week it was announced that the Horizon Europe program, a key innovation program, will experience large budget cuts.
• The WHO this week warned that there is growing evidence that young people may experience long term adverse consequences from contracting COVID.
• The European Court of Justice has struck down the EU-US Privacy Shield law based on arguments from an EU plaintiff that the US security laws did not sufficiently protect EU citizens. Commerce Secretary Wilbur Ross expressed ‘deep disappointment’ in the ruling and said he would work with the EU to limit any negative consequences. AdvaMed is considering its members views and potentially adding its voice to those who are expressing dissatisfaction with the impact the decision is likely to have. 
• The negotiating team for the EU stated this week that the UK negotiators have only engaged with issues ‘in the last week or two.’ It was reported that there was a recent attitude shift due to business pressure on No. 10.   One of the negotiators indicated that there were at least ‘five or six’ major issues standing in the way of a deal. The UK government denied this characterization stating that ‘the UK has engaged constructively on all issues throughout the negotiation’ and faulted the EU for its ‘unusual approach.’ Germany has called on the UK to exhibit ‘more realism’ in its Brexit negotiations. Meanwhile, the UK has indicated it is close to securing a post-Brexit ‘continuity deal’ with Japan.
• The UK has extended its mandatory self-isolation period from 7 days to 10 days for those who have tested positive for COVID. 
• A network of coronavirus walk-in testing centers across the UK is being set up to encourage more people to be tested.
• Face masks are now mandatory in the UK in shops, supermarkets, carry out restaurants, post offices and most indoor facilities. Some places, such as hairdressers, gyms, dine-in restaurants and pubs or cinemas, concert halls or theatres are exempted. Scotland has indicated gyms and stadiums there are likely to remain closed until at least September.
• There is backlash from a large UK trade union and many in the public health arena regarding the UK government’s pronouncement that it will be safe for people to return to work on August 1 if they can no longer work from home and certain social distancing measure are in place.  
• The UK’s Department of Health has published the “NHS People Plan” which attempts to set out practical measures to support NHS staff and keep them healthy.
• ABHI is conducting a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
• Germany has done comparatively well in navigating economic impact from COVID. This is due in large part to an unprecedented $868 billion aid package that sought to prevent insolvencies, mass layoffs and poverty. However, Germany also saw its economy shrink by a record 10.1% in the April to June period. The German government has expressed concerns that if they were hit by a second wave of COVID, it would occur just as its stimulus packages is set to expire.
• Germany has seen a rise in cases and has expressed concern after footage emerged of young partygoers on vacation overseas in crowded areas not following guidelines. The German Health Minister has publicly stated he wants mandatory testing for those coming back from overseas vacations.
• Germany’s Research Minister has said it does not see a COVID vaccine becoming available before mid-2021.
• Germany’s Economy Minister spoke positively about the EU’s stimulus plan, stating that it would increase the likelihood of a gradual economic recovery in the second half of 2020.
• France has issued a decree making masks compulsory in enclosed public places as of Monday with offenders subject to a €135 fine. This is in response to an uptick in cases. France now has its highest daily totals since May and is also concerned about a spike in cases attributable to young people congregating for summer activities at beach resorts. The French Health Minister has stated observing social distancing is essential to avoiding another lockdown.      
• The French government has mailed out 40 million masks to 7 million people it has deemed are the most in need of them. There continue to be logistical and financial burdens in obtaining enough masks.
• France has indicated the government would commit an envelope of €7.5 billion to raise the wages of staff at hospitals badly strained by the coronavirus pandemic.
• The French government under Macron is enjoying a surge in popularity with the passage of the EU stimulus package and his actions to reshuffle his Cabinet.
• If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
• The proposed one-year suspension of implementation of the EU’s MDR is now final.  The measure extends until May 26, 2021 the date of application of the current regulation but does not extend every target deadline referenced in the law.  It also creates the possibility of EU-wide derogations for specific medical devices.
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718;
• https://www.medtecheurope.org/news-and-events/press/medtech-europe-welcomes-the-amendment-of-the-medical-devices-regulation-and-urges-similar-action-for-the-ivd-regulation/.
• AdvaMed’s joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation. We recently hosted joint webinars and working group calls with ABHI to give members the latest information.  
• Resources: https://www.ecdc.europa.eu/enlll;
• https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
• https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
• https://www.ecdc.europa.eu/en;
• https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
• https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
• https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
• https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
• https://www.medtecheurope.org/covid-19-information-hub;
• https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
• https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
• https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
• Med Tech Europe White Paper on Companion Diagnostics under the IVDR:       https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
• Staff Contact:  Joe Gatewood ([email protected]

Latin America

Regional

• Total COVID-19 cases up 14% and deaths up 10% over the previous week.

Weekly Highlights –COVID 19

• Argentina: Expectation rises as President Fernandez announces economic reactivation plan.
• Bolivia: As elections are postponed, tensions between opposition and the interim government are likely to increase.
• Brazil: Bolsonaro polls at 30% approval, as tax reform looms in Congress.
• Chile: President Piñera reaches record low approval since start of pandemic.
• Colombia: Ministry of Health updates testing protocols amidst rising cases.
• Ecuador: Ecuador seeks to join the “Covax Facility” initiative.
• Mexico: Mexico and China co-chaired a virtual meeting with foreign ministers of the Latam region on vaccine access and financing.
• Paraguay: Government moves forward in ensuring access to a vaccine when it becomes available.
• Peru: Ministry of Health announces creation of sanitary macro-regions in order to fight spread of virus.
• Uruguay: Cases rise during the week as government insists the compliance of sanitary measures.
• Staff Contact: Steven Bipes ([email protected])