COVID-19 Outbreak: Weekly Global Report for Friday, November 20, 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 56.6 million, a 4 million increase over the previous week. Deaths around the world surpassed 1.35 million. The countries with the most reported cases continue to be the U.S. (11.6 million), India (9 million), and Brazil (6 million).
• U.S. cases exceeded 11.6 million with deaths increasing to 251,000.
• Staff Contact: Ralph Ives (rives@advamed.org).

China

• Weekly COVID-19 statistics–China’s total COVID cases now stand at 91,918 (an increase of 143 over the previous week). There were no reported deaths over the previous week, leaving the death count unchanged at 4,742. Almost all new cases have been linked to foreign arrivals.
• Anecdotal evidence suggests that hospitals have been gradually resuming elective/regular surgeries and operations 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 reportedly has four coronavirus vaccine candidates in the third and final stage of clinical trials.
• 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. Last week, 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.
• The State Council announced that China will launch a public health campaign this winter to step up the control of COVID-19 and other infectious diseases. The campaign will involve improving public health facilities, orchestrating sanitation efforts, and creating contingency plans for local outbreaks.
• 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.
• China’s economy expanded 4.9 percent in Q3, falling short of widespread analyst expectations of 5.5-6% growth. Manufacturing output in October reached a 10-year high according to an independent PMI tracker by Caixin, with exports remaining resilient compared to earlier this year. Domestic consumption, while rising in recent months, is subdued relative to the growth in 2019.
• The General Administration of Customs released October import and export data, showing exports increased 11.4 percent year-on-year, the fastest growth rate in 19 months, while imports rose at 4.7 percent. Export growth was in part fueled by continued demand for medical supplies as the pandemic worsens in other parts of the world. Underwhelming growth in imports was largely attributed to decreased demand for key industrial commodities, such as crude oil and coal.
• U.S.-China relations remain strained. The Phase One trade deal remains intact and has emerged as a key area of cooperation. China continues to make record buys of U.S. farm products, most notable soybeans and corn.
• Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India - Diwali Holiday in India this week

Japan

• Weekly COVID-19 statistics – 126,644 reported cases and 1,966 reported deaths compared to 114,537 reported cases and 1,886 reported deaths the previous week.
• Japan is experiencing a surge of cases. It had over 2,000 new cases daily on Wednesday and Thursday for the first time since the pandemic began.
• 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.
• Revenues for clinics continue to decline from a year ago, but the rate of decline is easing. Revenues dipped by 16.5% in May, 6.8% in July, and 4.9% in August.
• The pandemic has had a severe impact on Japan’s hospitals. Nearly 70% of Japan’s hospitals are now operating in the red.
• Japan will 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 will cover 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 will only apply to residents of Japan who are planning to spend no more than seven days at their overseas destinations.
• Under the revised policy, Japan will also relax 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.
• Japan will also lift the rule requiring the submission of a negative test result for travelers who will spend less than 14 days at their destination from any of the 11 regions.
• The pre-arrival PCR test requirement will remain in place for 152 countries and regions still covered by the entry restrictions.
• Japan's Ministry of Health has adopted priority regulatory review procedures for new COVID-related medical devices.
• Japan will ban purchases from foreign companies of 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 (PAgress@AdvaMed.org).

Korea

• South Korea’s numbers are slightly increased again from where they were last week. Korea reported 343 new cases today, 293 were locally transmitted and 50 were from overseas sources. Still, Korea is doing well compared to most countries. Health authorities will raise social distancing requirements if they cannot achieve lower numbers in the next couple of weeks.
• While Korea’s numbers remain low compared to other countries, the government is increasingly concerned about the difficulty to get the numbers back below 100 new cases per day. South Korea ranks 90th in the world in number of cases.
• South Korea has 29,654 total cases, 3,058 active cases, 498 deaths, and reporting 2 deaths per day. The daily case count for new cases has hovered around 100 for several weeks but has now spiked to 343.
• New clusters of infections continue to pop up in connection to everyday spaces such as cafes, restaurants, karaoke rooms, schools, workplaces and indoor sports facilities, as well as hospitals and nursing homes, which complicates health authorities’ efforts to identify and trace sources of infections. One new cluster of infections was traced to a social gathering among students from a prominent university in the Sinchon area.
• Other new clusters were traced to religious facilities in southern and northern Seoul, with 12 and 24 infections reported, respectively. Their respective first cases were reported Monday and Sunday.
• According to the KDCA, the largest portion of locally transmitted infections reported for the past two weeks were from Seoul with 34.9 percent, followed by Gyeonggi Province with 23.9 percent and Gangwon Province with 6.4 percent.        
• The R number -- the average number of secondary infections produced by a single infected person -- is estimated at about 1.5, according to the KDCA. “We are at a critical juncture facing a mass spread of the virus,” said Health Minister Park Neung-hoo at a briefing, citing a spike in virus cases both in the Seoul metropolitan area and outside the region. “Virus infection prevention-related fatigue and insensitivity could make our achievement (in curbing spread of the virus) in vain.”
• With the COVID-19 pandemic weighing on the airline industry, Finance Minister Hong Nam-ki said Thursday that the government would help local airliners launch international flights without landing. “To support the ailing airline industry and fuel the mood for spending, we have decided to pursue adoption of a new type of traveling -- international flights without landing,” Hong, who doubles as deputy prime minister said in a meeting of economic-related ministers. The special flights would allow local carriers to enter airspace above other countries, but return without landing. It would be similar to the “flights to nowhere” programs that the local airlines have been promoting, but with a global destination.
• Chinese Foreign Minister Wang Yi is likely to visit Seoul next week for talks with Foreign Minister Kang Kyung-wha, diplomatic sources said Thursday, a trip likely to stress bilateral cooperation ahead of a leadership change in the United States. The agenda for the ministerial talks is expected to include the countries' efforts to arrange a visit to South Korea by Chinese President Xi Jinping and Seoul's push to host a trilateral summit among the leaders of South Korea, China and Japan.
• South Korea's health agency said Thursday that a total of 107 people, most of whom were elderly, died after receiving seasonal flu vaccines. The deaths had stoked public anxiety over the safety of such vaccines, but the Korea Disease Control and Prevention Agency (KDCA) said 106 of those deaths have very limited relation with the flu shots. The remaining case is under investigation. Of the total, 48 people were aged over 80, followed by 40 in their 70s, 10 under 60 and nine in their 60s, the KDCA said.
• The health authorities have repeatedly said they have found no direct link between flu shots and deaths, urging people to get flu vaccinations before the onset of winter amid the coronavirus pandemic. Public anxiety has heightened over the safety of flu vaccines after some vaccine bottles -- part of the country's free inoculation program -- were exposed to room temperature during distribution. The authorities, however, said there was no safety issue.
• So far, more than 13.05 million South Koreans have received free state flu shots, out of about 19 million people, for 66.7 percent coverage to date.
• 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. We have received word that the 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. 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 1,085,757 reported cases and 25,700 reported deaths compared to 1,027,035 reported cases and 24,563 reported deaths the previous week.
• ASEAN has seen more than 50,000 new cases for each of the past nine weeks, with the vast majority of those accounted for by Indonesia, the Philippines, and more recently Myanmar and Malaysia. Indonesia surpassed 483,000 total cases and the Philippines has reported over 413,000 cases.
• Myanmar continues to experience a surge that started in September. It added nearly 9,000 cases over the past week and is now approaching 73,500 total cases. The number of deaths is 1,650.
• The Philippines and Indonesia account for 91.8% of the deaths from COVID-19 in the region. Indonesia’s total COVID-19 deaths have reached 15,600, the highest level in East Asia.  The Philippines reported 7,998 deaths.
• Cambodia and Laos have each reported zero deaths, while Brunei has reported 3 deaths, and Singapore has reported 28 deaths (despite having over 58,000 cases), and Thailand has reported 60 deaths. All of these are unchanged from the previous week.
• 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.
• Starting November 18, Singapore will require 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 and Japan agreed to launch a Reciprocal Green Lane for essential business and official travel between the two countries.
• Singapore and Hong Kong have agreed to establish a bilateral air travel bubble which will exempt travelers from quarantines or stay-home notices.
• The Philippines has extended the implementation of the general community quarantine (GCQ) in Metro Manila and six other areas for another month.
• 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. The government is considering reducing the quarantine period to 10 days.
• 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 is allowing the resumption of international air routes with six countries – China, Japan, Korea, Taiwan, Cambodia, and Laos. Visitors must test negative three days prior to departure and will be tested again upon arrival in Vietnam.
• 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.
• Staff Contact: Phil Agress (pagress@advamed.org)

Europe 

There is continued and more aggressive spiking in the case rates across the EU including Central and Western Europe. Cases continue to spike in the EU, with France, Italy Poland and the UK showing the highest numbers of new cases. Germany’s new case rate has also risen to 20,536. The UK has experienced the most deaths, followed by Italy and France (virtually even) and Spain. Italy and the UK have had the most deaths, followed by France. Belgium’s spike is still persistent but not as severe as last week. Belgium has very high case and death rates as expressed in cases per million and deaths per million.   Although not in the EU, Russia's reported numbers on COVID remain problematic with 1,836,960 new cases and just 31,593 reported deaths.  By comparison, Italy, with much fewer (1,028,423) cases, reports 32,960 deaths

• New daily cases, which tend to show which countries are increasing in COVID incidence are as follows:  Spain 11,064 (down from 19,851 last week); Italy 34,283 (up slightly from 32,960 last week); Germany 20,801 (up very slightly from 20,536 last week); France 28,383 (down from 35,879 last week); UK 19,609 (down from 22,950 last week); Belgium 2,734 (down from 4,293 last week); and Russia 20,985 (up slightly from 19,851 reported last week).  France continues to exhibit persistently large numbers of new case, as do most of the major EU countries, but the rate of increase in new cases appears to be slowing. Italy’s new cases remain the highest in the EU. However, in Western Europe, many daily rates are showing slowing increase from last week but remain at significant levels.
• New deaths per day (which tend to lag any increased infection rates) are increasing and are as follows:  Spain 351; Italy 753; Germany 244 (Germany has now seen deaths per day go over 200 for the second reporting period); France 425; UK 529; Belgium 223. Russia is reporting 456 new deaths per day. Belgium seems to be getting a handle on slowing its increase.  
• Most EU countries are strengthening or maintaining lockdown restrictions.
• The European Commission approved a fifth contract with the European pharmaceutical company CureVac, which provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. The contract with CureVac enlarges the already broad portfolio of vaccines to be produced in Europe, including the contracts signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV and BioNtech-Pfizer, and the successful exploratory talks with Moderna.
• A coronavirus vaccine could be distributed in the European Union before the end of the year, according to the director of BioNTech, the German laboratory that has been working with pharmaceutical giant Pfizer to develop a vaccine. Ugur Sahin told AFP news agency it was possible its vaccine could get authorization and be distributed in the US and EU before 2021. "There is a chance that we can still obtain authorization this year in the United States or in Europe or in both regions," said Dr Sahin. He said a request for authorization is going to be filed with the United States Drugs Agency (FDA) on Friday. "We may be able to deliver vaccines in December," he added.
• On Monday, Hungary and Poland vetoed the EU's trillion-euro coronavirus recovery package because they object to linking access to Brussels cash with countries' respect of the rule of law. Hungarian government spokesperson Zoltan Kovacs stated that the recent changes to the rule of law proposal amounted to "political blackmailing". He explained that the Hungarian government had not changed its stance and that the recent proposal did not include "objective criteria". Hungary's prime minister has called the EU's rule of law mechanism for the EU budget a 'political and ideological weapon' designed to punish anti-immigration governments. The EU's Budget Commissioner Johannes Hahn tweeted that he was 'disappointed' and urged member states to 'assume political responsibility' and finalize the package. He stated, “This is not about ideologies but about help for our citizens in the worst crisis since WWII."
• European Union leaders will discuss the Polish and Hungarian veto on Thursday, but officials do not expect a solution this week.
• The WHO’s regional Europe Office stated that European countries under lockdown should ensure "it's not wasted" by preparing their health care systems for when restrictions are lifted.
• One person is dying from coronavirus every 17 seconds in Europe. Europe is "once against the epicenter of the epidemic, together with the United States", Dr Hans Kluge, the director of the WHO's European Office told reporters on Thursday. Since the beginning of the pandemic, the 51 member states of WHO Europe have reported more than 355,000 deaths and 15.7 million infections — which in both cases represent over a quarter of global totals.
• Kluge reiterated his stance that national lockdowns should be "a last resort measure". Asked what countries who have opted for this measure should do to prevent a repeat of the summer (when the number of COVID-19 cases quickly rose again following the lifting of lockdowns), Kluge called for the easing to be "gradual and safe". "As we have stated consistently when we anticipated a lifting of the first lockdown, we never anticipated that there would not be a flare-up or a second wave because that was in line with expectations.”
• So far this month, over four million cases have been confirmed across Europe and 80 per cent of the countries now have 14-day incidence rates greater than 100 per 100,000 population. In a third of the countries, the rate stands at more than 700 per 100,000 inhabitants which is putting significant pressure on health care systems, Kluge warned. As a result of the second wave unfurling across Europe, most countries have reintroduced restrictive measures including national lockdowns in Austria, the United Kingdom and France.
• Instead of lockdowns, WHO Europe favors a multi-tiered approach which implies fighting the pandemic at the local level based on the area's epidemiological situation. Both France and the UK introduced such systems early into the autumn, only to then introduce their second national lockdowns.
• Due mainly to austerity cuts, Southern Europe, including countries such as Italy, Spain and Portugal, has experienced an exodus of doctors and nurses over the past decade. The demands of the COVID pandemic on health personnel have exacerbated these shortages. Spain was estimated to have a shortage of 4,000 doctors in 2019, estimated 7,000 in 2020. Italy is said to need an extra 15,000 specialists. In response, these countries have started to take action.
• Italy is pushing medical students onto the frontline and trying to entice retired doctors back to the wards. The southern region of Campania advertised this month for 450 doctors and used state television to broadcast nationwide appeals for help, but it only received 165 applicants. In Spain, the government has allowed regions to temporarily hire some 10,000 additional health workers, mainly graduates and professionals from outside the European Union. But while Barcelona’s Sant Pau Hospital has the budget to open new intensive care wards, it cannot find highly qualified people to staff them all. “There’s not enough trained people and the existing ones are very tired,” said its medical director Xavier Borras. An interview with an intensive care physician in Paris, who had left Spain for these reasons, revealed that his salary was more than double what he was being paid in Spain.
• Even before the virus struck, Europe’s southern nations were short of nurses. In a 2019 report, the Organisation for Economic Co-operation and Development said Italy and Spain had just 5.8 nurses per 1,000 inhabitants and Portugal 6.7 compared with 12.9 in Germany and an average of 8.8 amongst major industrialized nations.
• The Nurses General Council in Madrid estimates that Spain needs as many as 150,000 nurses to come into line with the European Union average. Antonio De Palma, the head of Nursing Up, said Italy needed about 60,000-65,000 nurses. “The optimal ratio between nurses and beds should be 1-to-6. In Italy it has reached peaks of 1-to-17,” he said, denouncing some local health authorities for relying heavily on part-time workers who had no job security and were paid as little as 16 euros an hour. Portugal’s Order of Nurses says some 18,000 Portuguese nurses work abroad, mostly in Britain.
• The importance of Portuguese nurses to the British National Health Service was highlighted in April when Prime Minister Boris Johnson publicly thanked a Portuguese nurse for his care after he was hospitalized for COVID. The Portuguese Order says 30,000 nurses are needed at home to help deal with the coronavirus crisis, but has warned about a spike in requests from other EU nations looking to attract their members, including from the Netherlands, which was offering bigger salaries, accommodation, transport and language courses.
• The Swiss Society for Intensive Care Medicine said that 876 Intensive Care Unit (ICU) beds in Switzerland are practically full. The military has been called in to support efforts in several cantons. Professor Thierry Fumeaux, the society's former President, stated that the system is now dangerously overstretched: "What we call certified beds - visited by certificate commissioners - are all full, but of course we have some in reserve because all hospitals have been able to increase capacity by asking more people from their teams not normally in ICU to work there, but nevertheless the situation is critical." "There's a misconception that all of these people that are dying are old, which is not the case. If people saw what was happening inside the ICU, they would understand.".
• 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.
• Britain announced its biggest military spending increase since the Cold War on Thursday, pledging to end the “era of retreat” as it seeks a post-Brexit role in a world Prime Minister Boris Johnson warned was more perilous than for decades. Johnson said the extra spending reflected the need to upgrade military capabilities even as the COVID-19 pandemic pummels the economy and strains public finances. He outlined plans for a new space command, an artificial intelligence agency and said the navy would be restored as Europe’s most powerful.
• In Brexit news, top-level talks over a post-Brexit trade deal were suspended on Thursday after an EU negotiator tested positive for COVID-19. It added uncertainty to discussions that were already under pressure amid a looming deadline. EU chief negotiator Michel Barnier announced the suspension on Twitter but said lower-ranking officials would continue discussions in the interim. Any long suspension of talks will make it tougher for a deal to be reached ahead of January 1, when the existing trade agreements between the EU and Britain expire. “We are discussing with them the implications for the negotiations. We have been, and will continue to, act in line with public health guidelines and to ensure the health and welfare of our teams,” the British government said in a statement. London and Brussels are still divided over three key issues: fisheries, how to check compliance of the deal and standards the UK must meet to export into the EU.
• Northern Ireland businesses have called for an extension of the Brexit transition period in the region, warning they “simply will not be ready” for the mandatory border checks on 1 January. They say they are the “rope in a tug of war” between the UK and the EU and warned of a “huge black hole” in information and a “disconnect” with Westminster and Brussels over the reality of Brexit checks kicking in 43 days’ time. “There is a responsibility on the EU as well as the UK” to make sure the Northern Ireland protocol works, Stephen Kelly, the chief executive of Manufacturing Northern Ireland, told MPs.
• The UK’s Department for International Trade has announced that a post-Brexit trade deal with Canada will likely be concluded before the end of the year.
• Phase 2 trials of Oxford University's COVID-19 vaccine in healthy older adults have found it is safe and provokes an immune response. The university confirmed that the candidate vaccine it is developing with AstraZeneca showed similar safety and immunogenicity results in healthy older people (aged 56 and over) to those seen in adults aged 18-55 years. Older people are at a disproportionate risk of severe COVID-19 disease, so it is essential that any vaccine adopted for use is effective in this group. The early-stage results, which they described as "promising" were published Thursday in The Lancet medical journal.
• An Imperial College London expert in modeling disease outbreaks contends that “There is evidence that infection rates are plateauing and may be starting to go down slowly.” However, he also noted that “It is too early to assess what the overall impact by 2 December will be, though we should not expect too much, given schools are still open,” he said. “A halving of infection prevalence over the four weeks would be a positive result.”
• Leading scientists have expressed concern at government plans to allow UK residents to visit extended family members at Christmas, with one saying that with vaccinations seemingly imminent, it would be tragic to throw away gains in suppressing the virus. Andrew Hayward, a professor of infectious disease epidemiology at University College London and a member of the Scientific Advisory Group for Emergencies (Sage), questioned the idea of allowing older people to mix with relatives at a time of year when respiratory diseases are most prevalent.
• Gabriel Scally, an epidemiologist at Bristol University, and a member of the unofficial Independent Sage group of scientists, was even more blunt: “There is no point in having a very merry Christmas and then burying friends and relations in January and February. We need to think very seriously about Christmas and how we’re going to spend it,” he told ITV.
• Downing Street has yet to fully decide either the regional tiers or restrictions that will replace the England-wide lockdown from 2 December or what will happen at Christmas, but it is understood the default choice for the festive period is to allow several households to mix indoors.
• 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 continues on its ‘lockdown lite’ until the end of November 2020. Restaurants, bars, entertainment and sports facilities will have to close while stores, schools, and daycare centers will remain open. In public spaces only people from two households may meet, with a maximum of 10 people.
• There are signs that the country’s “lockdown lite” is working and could reduce numbers soon, health officials said on Thursday.  “It is a fact that the measures are working,” Lothar Wieler, head of the Robert Koch Institute for infectious diseases (RKI), told a news conference, referring to Germany’s partial lockdown in place since Nov. 2. Bars and restaurants are closed, while schools and shops remain open. Private gatherings are limited to a maximum of 10 people from two households. After an exponential increase in the number of infections over the past weeks, Wieler said a plateau had now been reached.
• Even before a vaccine has been approved, Germany is doing its best to be prepared. Federal and state authorities are developing a nationwide plan for delivery and storage. The states are responsible for setting up 60 vaccinating centers around the country. The federal authorities will pay for the vaccine and the armed forces are being drafted in to help with distribution. There are also plans to establish teams of professionals to vaccinate staff and residents of institutions such as care homes.
• The German Hospital Federation (DKG) expects that the standard care in the hospitals could remain massively limited. "If the number of new infections remains at the current level, we will have massive restrictions in the number of procedures that can be planned by next spring," said DKG President Gerald Gaß to the newspapers of the Funke Media Group. "At least every third plannable intervention will not be able to take place. If the number of new infections stabilizes at the current level in the coming weeks, the number of corona patients on normal wards is likely to exceed 20,000 patients. Gaß warned that hospitals can just about cope with such a situation - but only on condition that the number of planned interventions is significantly reduced.
• BVMed’s autumn survey shows COVID-19 has had a dramatic impact on medtech industry sales. The survey indicated reductions of 4.9 percent for their members this year. The weighted average sales decline was reported as 2.1 percent. One third of companies surveyed indicated sales declines in the double-digit range. 188 member companies participated in the survey.
• France became the first European country on Tuesday to record more than 2 million COVID-19 infections.
• With 2,036,755 cases confirmed since the beginning of the pandemic, France has the fourth-highest tally in the world after the US (11.2 million), India (8.8 million) and Brazil (5.8 million). France passed the one million cases mark on October 23 but officials have stressed that the second wave of the pandemic unfurling over the country has been "brutal". The French Health Minister has been emphasizing this week that "the efforts of the French are paying off" — the country has been under a second four-week national lockdown since October 30. He also said the country has "passed an epidemic peak".
• France’s national lockdown will last until December 1. 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.
• President Emmanuel Macron and top ministers discussed the crisis, including whether to ease some restrictions from December 1 "if conditions allow it", spokesman Gabriel Attal said. But Attal insisted: "We're not at all near ending the lockdown, we're still far from it even."
• At a press conference today, the French Health Minister said the mental health of people in France was deteriorating during the second COVID lockdown due to anxiety and uncertainty caused by the pandemic.
• There were signs, however, that the country's lockdown was working with the latest figures showing the number of Covid-19 patients in hospital having decreased for the third consecutive day, along with the number of patients in intensive care, as reported by the country’s top public health official. On Thursday, France had 32,345 coronavirus hospitalizations of which 4,653 were in intensive care. On Wednesday, there were 32,842 in hospital of which 4,775 were in intensive care.
• According to France24, a recent survey showed that a significant proportion of French people say they will refuse to be vaccinated against Covid-19. The cause has been attributed to misinformation and conspiracy theories.
• 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 November 17, 2020

WEEKLY HIGHLIGHTS –COVID 19

• Argentina: Government advances political and economic agenda.
• Bolivia: President Luis Arce announced new cabinet ministers .
• Brazil: First round of local elections takes place.
• Colombia: President Duque announces that COVID-19 vaccines will be free for Colombians.
• Chile: Sebastian Piñera met with President Duque to discuss the Prosur transition.
• Ecuador: An agreement with AstraZeneca for 5 million doses of the COVID-19 vaccine was closed.
• Mexico: Janssen was authorized to carry out phase 3 tests of the COVID-19 vaccine in Mexico.
• Paraguay: Ministry of Health recommends the compliance of sanitary measures as concerns over a second COVID-19 wave rise.
• Peru: Political crisis takes over the agenda.
• Uruguay: Concerns rise after slight increase of Covidcases in Montevideo and Canelones
• Staff Contact: Steven Bipes (sbipes@advamed.org)