COVID-19 Outbreak: Weekly Global Report for Friday, December 18, 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 74.4 million, a 4 million increase over the previous week. Deaths around the world surpassed 1.65 million. The countries with the most reported cases continue to be the U.S. (17 million), India (10 million), and Brazil (7 million).
• U.S. cases exceeded 17 million with deaths increasing to 307,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Weekly COVID-19 statistics–China’s total COVID cases now stand at 94,722, an increase of 712 cases over last week. There were 10 new deaths over the previous week, bringing the death count to 4,758. Almost all new cases have been linked to foreign arrivals.
• On December 4, China’s National Health Commission released updated figures on the number of hospital visits and medical consultations by Chinese patients this year. In January through August, the total number of hospital visits/medical consultations reached 3.39 billion, a decrease of 16% over the same period in 2019. It is important to note that this percentage decrease has gotten progressively smaller since June, perhaps indicating Chinese patients have become more comfortable in visiting medical institutions in the second half of 2020.
• China reportedly has five coronavirus vaccine candidates in the third and final stage of clinical trials.
• Deputy head of China’s national vaccine research and development taskforce Wang Junzhi announced that the country will have 600 million doses of a COVID-19 vaccine ready for market by the end of 2020. He further stated that the government will make a major announcement in the next two weeks with regard to China’s development of a vaccine.
• The Chinese government is reportedly considering the establishment of a new disease control agency that will combine the National Health Commission and the China Center for Disease Control and Prevention.
• A World Health Organization (WHO) team of international experts will join Chinese scientists “as soon as possible” in Wuhan to investigate the origins of COVID-19. Phase one of the investigation will work to establish how the virus broke out through research of hospital records, blood samples and interviews with early patients.
• The United Arab Emirates issued the first government approval of a Chinese coronavirus vaccine on Wednesday, citing preliminary data showing that it was 86 percent effective, a move that could bring Chinese vaccines a step closer to widespread use. If results from elsewhere show similar findings, the Chinese vaccines could offer a lifeline to developing countries that cannot afford vaccines from the United States that are likely to be more expensive and more difficult to transport
• Government attention has largely turned towards preventing a second wave outbreak, with imported frozen food now considered the major risk vector. The smattering of recent transmissions linked to frozen food indicate the government is right to be cautious, but scientific experts remain divided over contaminated frozen food in fact causing new transmissions. The State Council issued its Work Plan for the Preventive and Comprehensive Disinfection of Imported Cold Chain Food, mandating that the packaging of all imported cold food must be disinfected before distribution.
• Both Chinese nationals and foreigners traveling to China are now required to present negative nucleic acid and serum IgM antibody tests taken within the 48 hours prior to departure. Passengers transiting through a third country or territory will be required to undergo a second round of the same tests within that country or territory before continuing their journey. All tests must be verified by the local Chinese embassy or consulate, which will then grant passengers a green health code to be presented upon boarding.
• The General Administration of Customs released November trade data indicating a 21 percent year-on-year increase in exports and a 4.5 percent year-on-year growth in imports. While this represented this year’s fastest rate of export growth, third party analysis questioned the longevity of this demand, as a vaccine may revive overseas manufacturing and dampen global demand for protective healthcare equipment.
• U.S.-China relations remain strained. The Phase One trade deal remains intact and has emerged as a key area of cooperation. NEC Director Larry Kudlow said this week that President Trump will not impose any new tariffs on China. China continues to make record buys of U.S. farm products, most notable soybeans and corn.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

• Weekly COVID-19 statistics – 9,762,326 total cases, 372,293 active cases/141,772 deaths as compared to 9,531,295 total cases, 422,943 active cases/138,648 deaths last week. India's Covid-19 caseload crossed 97 lakhs on Wednesday, December 9, while the number of people who have recuperated from the disease crossed 92 lakh, pushing the national recovery rate to 94.66 per cent, according to the Union health ministry.
• The Drugs Controller General of India (DCGI) has given conditional approval for Phase 1 and 2 clinical trials of India's first mRNA Covid-19 vaccine candidate -- HGCO19 -- that is being developed by Gennova Biopharmaceuticals.
• The Union Health Ministry on Tuesday, December 8,  charted out a list of preparatory activities which are being carried out by it in collaboration with states and union territories for the roll-out of Covid-19 vaccine. Addressing the press conference, Health Ministry Secretary Rajesh Bhushan listed out six consultative processes and five key strategies the government is adopting to roll out the most-awaited vaccination for the disease.
• Pfizer India has become the first pharma firm to seek an emergency use authorisation from the DCGI for its Covid vaccine in India after its parent company secured such approval in the UK and Bahrain.
• Bharat Biotech is expected to initiate Phase-1 trials of its intranasal vaccine for Covid-19 next month, chairman and MD Krishna Ella said on Tuesday, December 8. He said his firm is setting up two more facilities for manufacturing vaccines, including for Covaxin.
• Hyderabad-based Bharat Biotech filed an application seeking emergency use authorisation for Covaxin on Monday, December 7, becoming the third company to seek such regulatory approval in India after Pfizer and Serum Institute of India (SII).
• Prime Minister Narendra Modi on December 7 said Indians will not have to wait for a COVID-19 vaccine for "too long” but warned against laxity in the prevention of coronavirus infection.
• The government plans to significantly scale up operations to cover around 80 crore people — 60% of the country’s population — in an exercise aimed at achieving herd immunity In the second phase of vaccination against Covid-19.
• The central government has started preparations to set up a cold storage chain for the COVID-19 vaccine that is likely to be approved soon in the country. It is also working on transportation of the vaccine with leading airlines.
• The Serum Institute of India (SII) on Sunday, December 6, became the first indigenous company to apply to DCGI seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country, citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said.
• Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

• Weekly COVID-19 statistics – 191,647 reported cases and 2,806 reported deaths compared to 173,121 reported cases and 2,526 reported deaths the previous week.
• Japan recorded its highest-ever level of COVID-19 patients in intensive care last week.
• With overall infections in Japan exceeding 2,000 a day, authorities across the country have called for a three-week period of concentrated efforts against the virus. In four hardest hit metropolitan areas (Tokyo, Osaka, Sapporo, and Nagoya), bars and restaurants have been asked to close early.
• Japan announced that it plans to inoculate its entire population with a COVID-19 vaccine by the time the Olympics start in July 2021.
• While Japan has made no final decisions on who will get priority for the vaccine, it has discussed first providing it to healthcare workers taking care of COVID-19 patients, then to those who support the elderly, those with underlying diseases, and disabled people in facilities. The next priority would be pregnant women.
• Japan has contracted with Pfizer to purchase 120 million doses of its COVID-19 vaccine to be delivered in the first half of 2021. Pfizer is currently conducting a small-scale trial of the vaccine in Japan, the results of which will determine when the company applies for regulatory approval there. Japan has also contracted for 50 million doses of the Moderna vaccine and 120 million doses of the Astra Zeneca vaccine.
• Hospital beds are running low in many of the hardest hit regions.
• Japan’s third wave differs from the second wave over the summer in that cases among the elderly are more prevalent now.
• Tokyo set a record for COVID-19 cases in November, reaching a monthly total of 9,857 – far outpacing its last record of 1,700 cases in August.
• The increase in cases in Japan appears to be having some impact on return to procedure as many hospitals are struggling to deal with the increase in COVID patients, but the evidence so far is anecdotal.
• The pandemic has had a severe impact on the financial situation of Japan’s hospitals. Nearly 70% of Japan’s hospitals are now operating in the red.
• Japan decided to conditionally exempt business travelers and returnees from its 14-day quarantine policy, which was imposed on all arrivals from overseas to curb the spread of the novel coronavirus. The change covers both Japanese nationals returning from overseas business trips and foreign residents with valid residence permits in Japan, with no restrictions on their overseas travel destinations. However, the change only applies to residents of Japan who are planning to spend no more than seven days at their overseas destinations.
• Under the revised policy, Japan has also relaxed entry restrictions for travelers from Australia, Brunei, China, Hong Kong, Macau, New Zealand, South Korea, Singapore, Taiwan, Thailand and Vietnam, where the pandemic is considered to be kept relatively under control. Such travelers will be exempted from testing upon arrival as long as they observe a 14-day quarantine and don’t use public transport during that period.
• The pre-arrival PCR test requirement will remain in place for 152 countries and regions still covered by the entry restrictions.
• Japan and China have opened a fast-track business travel lane. Travelers between the countries will be able to forego mandatory quarantine requirements following the submission of itineraries and negative PCR test results.
• Japan's Ministry of Health has adopted priority regulatory review procedures for new COVID-related medical devices.
• Staff Contact:  Phil Agress (PAgress@AdvaMed.org).

Korea

• South Korea’s numbers are again increased from last week. Korea is reporting 1,014 new daily case, including 993 local cases (the remainder of cases originated overseas). Seoul recorded an all-time high of 423 new cases, as Seoul’s Deputy Mayor indicated that the city will not hesitate to raise its social distancing level to Level 3 if the daily case count remains high. Although increased, Korea is nonetheless not seeing the dramatic spikes or infection levels that many other countries are experiencing.
• Still, Korea ranks 90 in the world in cumulative cases and 89^th in the world in number of deaths (663).
• South Korea has 46,453 total cases, 12,209 active cases, with 634 deaths, reporting 22 deaths per day. Total cases per million population have increased significantly, but still remain one of the lowest at just 906, as do deaths per million population at just 12.
• Significant bed shortages are straining hospitals in Seoul, which has long been Korea’s COVID-19 epicenter, as the city counted a record number of 423 new cases on Thursday.
• Public health officials said Thursday a Seoul resident in their 60s had died while waiting to be admitted to a hospital after a COVID-19 diagnosis, marking the first such case to be reported in the capital since the pandemic began. They said the patient died at home Tuesday after having waited three days for a hospital bed since testing positive for the virus on Saturday. The patient did not exhibit severe symptoms initially.
• Authorities can adopt Level 3, the third highest under the five-tier virus restrictions, when locally transmitted cases surge to 800 to 1,000 or the daily tally doubles from the previous day. Health authorities raised social distancing measures to Level 2.5, the second highest, early last week, but they have failed to slow the spread of the virus so far. They have acknowledged that the current level of social distancing has failed to flatten the virus curve and hinted they will not hesitate to adopt Level 3 when necessary. But health authorities remain cautious about doing so, as the move will cause economic damage to shop owners and self-employed people.
• On Thursday, the authorities stated they will ban the operation of poker pubs and dining inside unmanned cafes starting Saturday for the next 10 days.
• Intensive care unit hospitalizations are at an all-time high, even as guidelines have been revised to discharge patients faster. Currently, there are 226 severely or critically ailing patients in ICUs. Only one ICU bed for COVID-19 patients was available in Seoul as of Tuesday afternoon.
• A series of nursing home outbreaks threaten a further surge in hospitalizations. At least 335 residents at nursing homes in Gyeonggi Province, South Chungcheong Province and Ulsan have tested positive for the disease as of Tuesday.
• Prime Minister Chung Sye-kyun hinted at a “near-lockdown” in a government meeting Wednesday morning. “That may be coming and we need to get ready for that beforehand,” he told ministries.
• Yoon Tae-ho, a senior official at the Ministry of Health and Welfare, said in a news briefing held the same day that Korea, having averaged between 800 and 1,000 cases per day over the past week, qualified for the strictest tier of its social distancing system. “Before tightened rules can come into effect, a societywide consensus appears necessary. We are talking about rules that are akin to a lockdown,” he said, citing damage to the economy, especially small businesses.
• The top social distancing tier, if implemented, limits indoor gatherings of more than 10 people, religious services, in-person classes at schools and operations of businesses that are 300 square meters or larger. Wearing face masks becomes mandatory even in outdoor settings where putting a 2-meter distance between people is difficult. Food outlets including pubs and bars can stay open until 9 p.m., after which point only to-go orders are permitted.
• Public health officials are urging against all nonessential activities, asking people to stay home as much as possible, without enforcing orders.
• According to a survey of 1,500 adults by a research team led by psychiatry professor Kim Sung-wan at Chonnam National University Medical School, there was a noticeable decrease in prejudice, fear and anxiety among those who have more knowledge of COVID-19. “The more knowledge people have about the infectious disease the less afraid they were, but the media did not contribute to increasing the level of knowledge among people. Rather, the more people were exposed to news about the coronavirus, the bigger their fear, prejudice and anxiety got,” Kim said in his dissertation, which was published in the Journal of Korean Medical Science on Monday. Despite the need to deliver information about the scale of coronavirus outbreaks, there needs to be cooperation between journalists and medical personnel not to fan excessive fear and anxiety about the coronavirus, he added.
• 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.
• South Korea’s movement toward implementation of a proposal that would potentially reduce the price of certain cardiac and peripheral stents has been at least temporarily postponed. A December meeting that was scheduled to occur to discuss the proposal has been postponed. AdvaMed is in touch with members and the medtech association in Korea and has had several discussions with the US Government on this topic. We have sent a letter to the health ministry expressing opposition to the proposal.
• Last week we submitted a letter in response to a recently issued request for comments on the proposal for potential implementation of pricing controls. Please contact Joseph Gatewood (jgatewood@advamed.org) if you have an interest in this matter and are not already engaged.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

ASEAN

• Weekly COVID-19 statistics – ASEAN now has 1,353,775 reported cases and 30,983 reported deaths compared to 1,279,458 reported cases and 29,519 reported deaths the previous week.
• ASEAN has seen more than 50,000 new cases for each of the past thirteen weeks, with the vast majority of those accounted for by Indonesia, the Philippines, and more recently Myanmar and Malaysia.  Indonesia surpassed 636,000 total cases and the Philippines has reported over 454,000 cases.
• Myanmar continues to experience a major surge that started in September.       It is now reporting 110,667 total cases. The number of deaths is 2,346. To prevent further spread, the government has extended stay-at-home orders in 74 townships, while grounding all commercial flights until at least December 15.
• The Philippines and Indonesia account for 90.6% of the deaths from COVID-19 in the region. Indonesia’s total COVID-19 deaths have reached 19,248, the highest level in East Asia.  The Philippines reported 8,833 deaths.
• Cambodia and Laos have each reported zero deaths, while Brunei has reported 3 deaths, and Singapore has reported 29 deaths (despite having over 58,000 cases), and Thailand has reported 60 deaths. These numbers are unchanged from the previous week.
• Last week, Indonesia received 1.2 million doses of China's Sinovac vaccine. The first batch of doses will be distributed to medical workers and other high-risk groups.
• Elective surgeries have resumed in Thailand and Vietnam.
• In Indonesia, provincial hospitals are resuming elective surgery with COVID-19 protocols in place.
• Malaysia maintains limits on elective surgery except in emergency cases.
• Singapore restricts most elective surgeries but allows certain procedures including cancer screening, surgical operations for advanced cataracts, flu vaccinations, and dental procedures.  
• The Philippines extended its State of Calamity by a year to counter the pandemic. This extension will give national and local governments latitude to continue utilizing appropriate disaster relief funds and affords the government powers to monitor and control necessities and provide essential services to the affected populations.
• In Malaysia, schools and entertainment venues have been closed in much of the country and a ban on inter-state trave has been reinstituted.
• Malaysia has imposed an entry ban on citizens of countries recording more than 150,000 cases of COVID-19.
• The Malaysian government relaxed its recent entry ban on expatriate and professional visit pass holders from 23 countries, provided they receive approval from the Malaysian Immigration Department and a support letter from the Malaysian Investment Development Authority. 
• Malaysia and Singapore partially reopened 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 considering fully reopening the Malaysia-Singapore border for daily commuters in January 2021 if conditions warrant.
• Myanmar gave clearance for domestic flights to resume. Myanmar had grounded all domestic flights on September 11 after a surge of coronavirus cases. State Counselor Daw Aung San Suu Kyi stated that the government is planning to resume international commercial flights as soon as possible. 
• Singapore will pilot quarantine-free business travel starting in January. Short-term business travelers from all countries will be able to stay, work and meet at dedicated facilities here from mid-January, without the need for prior quarantine, as efforts get under way to draw them back to Singapore.
• Vietnam and Singapore are planning to launch a green lane for business and official travel by the start of next year.
• Singapore and France are working on a travel green lane for short-term business and official trips.
• Singapore is requiring travelers who are not Singaporeans or permanent residents entering Singapore from high-risk countries to take a COVID-19 PCR test within 72 hours before their departure.
• The Singapore Government is looking into phase 3 of reopening by end of 2020 if the number of COVID-19 community cases remain low. Phase 3 is expected to further relax social distancing measures.
• Singapore and Indonesia announced a green lane between the two countries aimed at keeping essential business going. Applications for travel include strict health protocols and controlled itineraries. Singapore also maintains agreements with Australia, Brunei, China, Malaysia, and Korea on fast-lane arrangements for essential travel.
• Singapore is piloting a new business travel pass for senior executives with regional or international responsibilities. Travelers on this pass would need to keep to a strict itinerary while abroad. On returning to Singapore, they would have the option of a COVID-19 test in lieu of a stay-home notice and would need to self-isolate until the results are released.
• Singapore has lifted border restrictions for all visitors from mainland China and Australia’s Victoria State.
• Singapore is lifting border restrictions for visitors from Taiwan beginning December 18. Upon arrival, visitors from Taiwan will undergo COVID-19 testing and if the result is negative, will be allowed to enter Singapore without serving a stay-home notice. 
• Singapore and Japan agreed to launch a Reciprocal Green Lane for essential business and official travel between the two countries.
• Singapore and Hong Kong have postponed the start of their bilateral air travel bubble, which will allow quarantine-free air travel between the two Asian hubs, through at least December due to a spike in cases in Hong Kong.
• The Philippines has extended the implementation of General Community Quarantine (GCQ) in Metro Manila for the entire month of December. Apart from Metro Manila, areas also under GCQ until the end of the year are Batangas, Iloilo City, Tacloban City, Lanao del Sur, Iligan and Davao City. The rest of the country will be under modified GCQ.
• Thailand now allows long-term stay visitors, including business travelers and tourists, who will be able to remain in the country for up to 90 days (with up to two extensions possible). Visitors must be from a designated low-risk country, must undergo testing, and must quarantine for 14 days upon arrival in Thailand.
• Thailand has extended its nationwide state of emergency through January 15 and deferred a proposal to shorten the quarantine period for foreign tourists to 10 days to prevent a COVID-19 resurgence during the peak holiday season.
• The Thai Government adopted a 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.
• Vietnam and Japan have lifted mandatory quarantine for short-term visits for businessman and officials. However, there will be strict testing and medical surveillance protocols in place.
• Vietnam is finalizing an agreement to allow South Korean business travelers to fly in without serving the mandatory 14-day quarantine. The agreement is expected to take effect on January 1, 2021.
• Cambodia recorded its first COVID-19 community transmission from a cluster linked to a prison chief on November 28, after going months without domestic infections. Public gatherings of more than 20 people have been banned for at least two weeks, while schools, museums, and cinemas will also temporarily close. 
• Staff Contact:  Phil Agress (PAgress@AdvaMed.org)

Europe 

• There is continued increase across the EU. Belgium, Spain and France are among the countries with the highest numbers of cases per million. In terms of raw numbers, Germany now has the lead in new cases at 28,969 followed by Russia (26,509) and UK (25,161). Italy, Poland, the Netherlands and Sweden are also on the high end in new cases. Italy has the most deaths, followed by the UK, France, Spain and Russia. Although not in the EU, Russia's reported numbers on COVID remain problematic with perhaps the highest number of total cases of any country at 2,734,454, new cases at 26,509 and 48,564 reported deaths (and reporting one of the lowest death rates in Europe at 333 per million). By comparison, Italy, with much fewer (1,888,144) cases, reports 66,537 deaths.

• New daily cases, which tend to show which countries are increasing in COVID incidence are as follows (last week’s figures are in parentheses for comparison purposes):  Spain 11,079 (up from 4,886; Italy 17,572 (up from 12,756); Germany 28,969 (up from 23,928); France17,615 (up from 14,595); UK 25,161 (up from 16,578); Belgium 2,211 (up from 1,957); and Russia 26,509 (up from 26,190). Daily rates continue to increase across Europe and remain at significant levels.
• New deaths per day (which tend to lag any increased infection rates) are increasing and are as follows:  Spain 195; Italy 680; Germany up again this week to 749; France 289; UK 612; Belgium 124. Russia is reporting 596 new deaths per day. Belgium seems to have slowed the rapid spikes it experienced several weeks ago by imposing additional restrictions.  
• Most EU countries are strengthening or maintaining lockdown restrictions. Brussels has made a festive warning and called on EU countries to remain vigilant against coronavirus until a vaccine is widely available.
• The holiday season’s increase in indoor gatherings and people returning to their families to celebrate have heightened fears infections will increase over the Christmas period. It has prompted the European Commission to call on member states to continue initiatives like social distancing, contact tracing and limiting social contacts.
• With Europe gripped by the second wave of COVID-19, Commission President Ursula von der Leyen offered hope Thursday, announcing that vaccinations will begin on December 27th. The plan is for every EU country to receive vaccine deliveries on the same day, but after that - it will be up to the national governments to determine how fast they can be delivered.
• The World Health Organization does not believe there will be enough supplies of coronavirus vaccines in the next three to six months to prevent a surge in the number of infections.
• Governments across Europe are trying to navigate between avoiding spreading the virus over the holiday season and allowing people to celebrate with family and friends.
• Amid steep increases in daily death rates, Italians will not be able to attend midnight mass or move between regions over the Christmas period. Italy has been reporting more daily Covid-19 fatalities than any other European nation in recent weeks and, while the increase in new cases and hospital admissions is slowing, the government is worried about spiking due to gatherings over Christmas.
• The Spanish government has agreed with regional authorities that a maximum of 10 people per household will be allowed to gather for the Christmas and New Year holidays to avoid spreading the coronavirus. Movement of people between regions will be banned, with some exceptions, between 23 December and 6 January. Spain’s March-May Covid-19 death toll appears to have been nearly 70% above the official count.
• An EU-wide Cyber Shield and Joint Cyber Unit were just some of the plans unveiled on Wednesday as part of Europe's bolstered cybersecurity strategy.
• EU High Representative Josep Borrell, Commission Vice-President Margaritis Schinas and Commissioner Thierry Breton laid out the strategy at a press conference in Brussels, promising it would strengthen the "collective resilience against cyber threats" across the bloc. Among the initiatives is the use of AI-enabled Security Operations Centres established across the EU to create a "Cyber Shield" that detects signs of attack and can launch early preventative action. Another is the creation of a Joint Cyber Unit to ensure better protection from harmful and cross-border cyber attacks.
• A deal was finally agreed between EU leaders at their final summit of the year, on pressing ahead with the bloc's €1.8tn seven-year budget and pandemic recovery fund. It came after Hungary and Poland lifted their veto over concerns at a mechanism MEPs attached to the package linking the receipt of funds to respect for European core values, such as the rule of law. The leaders also reached an agreement over reducing greenhouse gas emissions by at least 55% over the next ten years, compared to 1990 levels.
• 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 is updated every two weeks. The EU recommended member states gradually lift the travel restrictions for the following countries: Japan, Canada, Georgia, Australia, Montenegro, New Zealand, Rwanda, South Korea, Thailand, Tunisia and Uruguay.
• European fishermen would lose the right to fish in British waters if there is no EU-UK agreement. But Belgium could turn to a 17th-century charter in an attempt to keep at least some of its access. The charter, known as The Privilege, allows up to 50 fishermen from the Flemish city of Bruges access to British waters in perpetuity. It was issued by Charles II following his exile to Europe after his father, Charles I, was executed in 1649. The UK has said, however, other more recent treaties override this old Belgian document, like the United Nations Convention on the Law of the Sea, which grants countries rights to their surrounding waters by up to 12 nautical miles.
• The EU's chief Brexit negotiator Michel Barnier has said he still has the firm belief that a post-Brexit trade agreement is possible, as talks between the EU and the UK resumed in Brussels. It comes a day after the UK and the EU kicked the latest deadline into touch to keep the seemingly interminable saga on life support -- and just two and a half weeks before the end of the transition period. Speaking as he arrived to brief EU ambassadors on the state of play, Barnier implied the number of key issues blocking a deal had been reduced from three to two: fair competition rules and fishing rights. "Two conditions are not met yet," he said. "This deal, it is still possible," he added. He did not mention legal mechanisms for resolving future disputes, another subject that has dogged the talks.
• The tone from the British government was also more positive, in contrast to last week's message from Boris Johnson who said a no-deal outcome was a "strong possibility". "The fact that we’re continuing to have these discussions shows that there is an opportunity to try and make some progress," said UK Business Secretary Alok Sharma. "Our intention is not to walk away. We will continue to talk as long as there is the possibility of reaching a deal."
• Prime Minister Boris Johnson and Commission President Ursula von der Leyen had dinner for two in Brussels on Wednesday, in what many hoped would break the deadlock, but only served to extend the negotiation deadline (again) to the end of the week. And so both sides began turning up the volume on a no-deal Brexit being more likely. "We would like a free trade deal with the EU," Dominic Raab, the UK's foreign minister said. "But we're not going to sacrifice the basic points of democratic principles on fisheries on control over our laws as we leave the transition period."
• The UK’s cabinet office minister Michael Gove has said there will be no negotiations with the EU on a trade deal in 2021 if one is not agreed by the end of this year. Taking questions from MPs, he confirmed "the most likely outcome is we will leave on WTO terms" - meaning no deal - as he was quizzed on the ongoing Brexit negotiations. Negotiations between the UK and the EU are coming to a head, with the transition period set to end on December 31 - less than two weeks' time.
• The UK government has published the ninth European Union (Withdrawal) Act and Common Framework report, which gives details into the progress of developing Commons framework.
• Waiting times in the UK for patients requiring hospital care is now one hundred times higher than before Covid-19. Four hospital trusts have cancelled all non-urgent elective operations for two weeks, as Covid-19 hospital admission rates rise.
• A hospital in London has cancelled elective procedures after an increase in Covid-19 infection rates.
• The Medical and Medical Devices Bill will enter the House of Lords report stage on the 12th January 2021.
• England has implemented a three tier system to determine appropriate limits of social activity based on local COVID conditions. Under 2 percent of the population will be in Tier 1, most will face tougher restrictions than are currently in place and be in the Tier 2 and Tier 3 categories.
• The Health Secretary has announced that more areas of the UK will be moving into Tier 3, following a rise in Covid-19 infection rates in the South of England.
• The UK and EU have agreed to continue allowing visitors to have access to routine medical treatment, even if the UK leave the EU with no deal.
• In a sign of dramatic COVID impact in the UK, for the first time in its 70-year history, UNICEF has launched an emergency response to help feed children in the UK impacted by the COVID-19 crisis. The United Nation's agency for children is to award grants to 30 local organizations through its "Food Power for Generation COVID" initiative. One of those organisations is School Food Matters which will deliver 18,000 nutritious breakfasts to 25 schools in the south London district of Southwark for the Christmas holidays and a further 6,500 during the February half-term. This will support 1,800 families.
• "The coronavirus crisis is having an unprecedented impact on children's lives — their support systems ripped apart, their education lost, their access to food impacted," Anna Kettley, director of programmes at UNICEF UK, said.
• The UK government announced its post-Brexit tariff with duty suspensions for COVID goods on the WHO list (matching the existing EU duty suspensions). https://www.gov.uk/government/news/legislation-for-the-uks-independent-tariff-policy.
• A wide range of waiting times data has been released by the British government as part of its return to treatment initiative. The number of people waiting for over a year for treatment in England has reached its highest levels since 2008. The official and detailed data from NHS England on waiting times can be found here: https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/.
• 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 shattered its record for Covid-19 deaths in 24 hours on Tuesday with 952 patients dying compared to a previous record of 598 on December 11, according to the country's center for disease control. The nation tallied 27,728 new coronavirus cases, the Robert-Koch-Institute (RKI) reported, as it enters a hard national lockdown on Wednesday in an effort to bring the situation under control. The head of the RKI said Tuesday that the situation was "as serious as it has ever been during this pandemic."
• Few Germans had expected to enjoy all the trappings of a traditional Christmas this year but new countrywide restrictions, which come into force on Wednesday, will limit festivities to the smallest of family gatherings. No caroling, no parties and even Germany's much loved Glühwein stalls will close, as drinking outdoors is banned.
• Beginning this week until at least January 10, schools and non-essential shops will close; people must, where possible, work from home; private gatherings will be limited to a maximum of five people from two households - with an additional four close family members allowed over Christmas; some German states are going further with night-time curfews and a ban on going out for anything other than essential reasons imposed in some areas.
• There'll be no let-up over New Year either. No gatherings on the streets will be allowed, and the sale of fireworks is prohibited (it is common in Germany to set off fireworks for New Year celebration).
• A lawmaker from Germany's far-right AfD party, who sparked furor for wearing a mask with holes to a Bundestag sitting, has been hospitalized because of the coronavirus, German media reported Thursday. The far-right party has in recent months vocally opposed measures including mask-wearing or social contact limits put in place by Chancellor Angela Merkel's government to halt transmission of the virus.
• Germany’s CureVac is working on a COVID-19 vaccine. While they admit they are behind other manufacturers, they believe their approach, which involves a vaccine that is more stable, is easier to store and mass produce, and requires significantly lower dosage, will be a winning formula. Final phase three trials are now underway.
• During a recent webinar hosted by BVMed, experts discussed the problems for manufacturers of medical devices and their Notified Bodies that are currently ongoing. These issues remain despite the postponement of the EU Medical Device Regulation (MDR) until May 2021. There are still too few Notified Bodies: Of 48 certifications so far, only 17 have been notified for the MDR. In addition, MDR audits have to take place on site, which is not possible in COVID-19 times. Dr. Nada Alkhayat from the European Commission sees the availability of Notified Bodies as a "critical issue", but points out the complex designation process, which takes about one and a half years. Despite the bottlenecks, the Commission is currently not considering postponing the start of the MDR's validity again, Dr. Alkhayat said.
• According to the head of Germany’s vaccine panel, it will take until 2022 to vaccinate all of Germany's population. "If you can administer shots on 150,000 to 200,000 people a day, so on five or six days a week – assuming vaccines are available and people are willing to be vaccinated – then you can calculate how long it will take," Thomas Mertens, head of STIKO, Germany's expert panel on vaccine use, told the Rheinische Post. "Then you would need 100 days to vaccinate 15 million people."
• Germany is currently preparing vaccination centers across the country so it can start offering the shots as soon as a vaccine is approved in Europe.
• In France, President Emmanuel Macron has tested positive for the coronavirus and will self-isolate for seven days, the Elysée Palace has announced. The diagnosis was established following a RT-PCR test carried out as soon as the first symptoms appeared. He will self-isolate for 7 days but continue to work. Macron has recently been in meetings with many key EU leaders, including at the EU summit on December 10 – 11, so there could be additional repercussions from his positive test. Some EU leaders are already self-isolating.
• A European Union official said that the French authorities had considered Mr. Macron contagious as of Monday, but that protection measures were observed during the European Council meeting. There have as yet been no reports of other leaders or staff members testing positive.
• Among those going into self-isolation are European Council chief Charles Michel, Spanish Prime Minister Pedro Sánchez and OECD Secretary-General Angel Gurría, all of whom met President Macron this week. Mr. Sanchez has tested negative but, like Mr. Macron, will work remotely from quarantine.
• Portuguese Prime Minister António Costa, 59, has cancelled all official trips, and is isolating and awaiting test results, after a working lunch in Paris with President Macron on Wednesday. Belgian Prime Minister Alexander De Croo and Luxembourg's Prime Minister Xavier Bettel too are self-isolating following contact with the French president.
• Only slightly more than a third of French respondents would take a low-cost COVID-19 vaccine, a recent survey has revealed. France is among the worst-hit countries in Europe from the disease, with more than 33,000 deaths as of October 16. But just 37% of French people questioned would take a low-cost vaccine if it came available in the next year. This compares starkly to several of France's neighbors, where a majority say they would get vaccinated.         Respondents in the United Kingdom were keenest, with 63% backing vaccination, followed by Germany (57%) and Italy (55%).
• There was also contrast between the four countries when it came to rating their government's handling of the COVID-19 crisis. In the UK — the worst-hit country in Europe in terms of deaths — and France, a majority of respondents thought their governments were not taking the right measures to properly address the crisis. Germany's government got the best feedback of the four, with 62% approving of its management of the epidemic. In Italy, 54% of respondents backed their government's approach.
• France's government will delay unwinding some Covid-19 lockdown restrictions amid signs that the downward trend in new infections had flattened out. Prime Minister Jean Castex said the government would lift a restriction on people's movement from December 15 but replace it with an 8pm curfew, including on New Year's Eve. Castex said families would be allowed to travel to celebrate Christmas together but said that museums, theatres and cinemas would remain closed for an extra three weeks as the number of new Covid-19 infections begins to slowly rise again.
• People in France could start receiving the Covid-19 vaccine developed by Pfizer/BioNTech in the last week of December if European Union authorities approve it next week, French Prime Minister Jean Castex said on Wednesday. Castex told parliament that the vaccination campaign in France would be stepped up in January and he confirmed that the elderly would come first in the queue.
• Phase I: The first stage involves vaccinating the estimated 650,000 elderly residents living in care homes; Phase II: Stage two involves vaccinating people over 75 followed by those older than 65 with comorbidities and finally all other people between 65 and 74 years of age; Phase III: All people over 50 years of age will be vaccinated in the third stage, followed by people under 50 who have comorbidities; Phase IV: People who have been in high-risk contact with known coronavirus cases will be offered the vaccine during the fourth stage; and Phase V: All other people over 18 years of age will be granted access to the vaccine in the fifth and final stage of the roll-out, although vaccination will not be compulsory in France.
• France’s national lockdown remains extended. All non-essential shops are closed. People are required to fill in a form to justify getting out of their houses but schools, factories and building works will continue. Some medical experts have said that the lockdown needs to be stricter.
• 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 (jgatewood@advamed.org)

Latin America

COVID 19 Prospectiva/LATAM Weekly Update for December 14, 2020

COUNTRY HIGHLIGHTS –COVID 19

Argentina: Government signs purchase contract for Sputnik vaccine.

Bolivia: New measures announced in Santa Cruz as cases surge in the last weeks.

Brazil: Rising pressure on national government on vaccination plans.

Colombia: Government enacts Law on Vaccines.

Chile: Metropolitan Region returns to stricter lockdown phase.

Ecuador: Government defines COVID-19 vaccination phases as well as the priority population groups.

Mexico: COFEPRIS approved emergency use of Pfizer’s coronavirus vaccine.

Paraguay: As cases continue to rise in Asunción, intensive care units' overload.

Peru: The government suspended clinical trials of Chinese COVID-19 vaccine from Sinopharm.

Uruguay: Positivity rate surges amid concerns from health authorities.

Staff Contact: Steven Bipes (sbipes@advamed.org)