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.
- Weekly COVID-19 statistics- global cases reached 10.7 million, representing a 1.1 million increase over the previous week. Deaths exceeded 517,000. The countries with the most reported cases are the U.S. (2.7 million), Brazil (1.44 million), Russia (660,000), and India (604,000).
- U.S. cases exceeded 2.7 million with deaths increasing to 128,421.
- Staff Contact: Ralph Ives ([email protected]).
- Weekly COVID-19 statistics – aside from the recent outbreak in Beijing that saw over 200 locally transmitted cases, all other areas of China continue to report very few to no new cases each day and are mostly linked to foreign arrivals. Total cases now stand at 84,825 and deaths remain unchanged over the previous week at 4,641.
- The outbreak in Beijing appears to be under control. There have been 18 new cases reported in neighboring Hebei province, however. Authorities in in Anxin—a city 90 miles south of Beijing—ordered the quarantine of the city’s 400,000 residents due to a cluster outbreak.
- 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.
- China’s economy continues to face some challenges. While production levels have returned to pre-Covid levels, consumption continues to lag. For instance, tourism revenues during last week’s Dragon Boat festival dropped nearly 70 percent compared to last year. The Finance Ministry further released data indicating that state-owned enterprise profits fell 52.7 percent year on year across January to May. Analysts suggest that slow income growth and social distancing have severely hampered the recovery of consumption.
- China is continuing to allow an increased number of inbound flights from overseas. United Airlines and Delta Airlines will resume services to Shanghai from San Francisco and Seattle, respectively. However, routes discovered to have transported new cases of COVID-19 will be suspended.
- Elective/regular surgeries and other medical services are back to normal. Beijing is admitting all Covid patients to Ditan Hospital in the city’s northeast. To our understanding, Beijing’s other hospitals have not paused elective surgeries as of now.
- The WHO is to send a team to China next week to investigate the origins of COVID-19.
- The U.S. government has postponed the return of several of its diplomats to China—initially scheduled for next week–for reasons that are not clear, but may be related to tensions in the U.S.-China relationship.
- Staff Contact: Ralph Ives ([email protected]).
- Weekly COVID-19 statistics –226,947 active cases/17,834 deaths as compared to 186,514 active cases/14,894 deaths reported last week.
- Daily confirmed cases of the coronavirus in India remain close to 20,000, leading a number of cities to remain cautious about easing health restrictions. While India announced its second phase of reopening “Unlock 2.0,” 19 states including New Delhi, Tamil Nadu, West Bengal, Karnataka, and Maharashtra have already extended lockdown measures for at least an additional month.
- The Modi government is scrambling to set up makeshift health centers in the hardest-hit geographies, such as in the capital of New Delhi, amid a growing shortage of hospital beds. Meanwhile, Prime Minister Modi outlined economic reforms, said several sectors ‘unlocked’.
- On Tuesday, Prime Minister Modi chaired a high-level meeting to review the planning and preparations for vaccination against COVID-19, as and when the vaccine is available. The PM directed officials to evaluate in a broad manner available technology options that can form the backbone of the national endeavor to vaccinate all in the most efficient and timely manner.
- Union Ministry of Home Affairs (MHA) on Monday issued new guidelines for “Unlock 2” to open up of more activities in areas outside the Containment Zones. The new guidelines will come into effect from July 1, 2020. Detailed standard operating procedures (SOPs) have also been issued. The guidelines can be accessed here.
- The Health Ministry added the steroid Dexamethasone to its COVID-19 treatment protocol in revised guidelines issued on Saturday. The Union Health Ministry said that Dexamethasone can be given to severe COVID-19 patients as an alternative to another steroid methylprednisolone — which was included in earlier protocols.
- In a move to support “Make in India” exports, the government eased restrictions on the export of PPE to allow for the export of 5 million medical coveralls per month.
- The World Bank approves $750 million emergency response fund for India’s MSME sector.
- Staff Contact: Abby Pratt ([email protected]).
- Weekly COVID-19 statistics – 19,802 reported cases and 990 reported deaths compared to 18,924 reported cases and 984 reported deaths the previous week.
- Japan lifted all domestic travel restrictions. Residents are free to visit any prefecture across the nation. The government says it removed the final barriers because it believes that coronavirus spread has been successfully halted in Japan.
- The government released a national contact tracing app but was immediately confronted with bugs that forced the Ministry of Health, Labor, and Welfare (MHLW) to hastily pause the app’s operations.
- Tokyo deactivated its virus alert and moved to the third and final stage of its plan to reboot businesses and reopen society. Under Phase 3, nearly all business closures are being lifted. Restaurants and bars can stay open until midnight, and public events will be limited to one thousand people.
- Japan and Vietnam announced an agreement 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 announced that it will adopt 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]).
- Weekly COVID-19 statistics – South Korea reported an increase in new coronavirus cases to 54 (almost double the number from last week). Authorities are continuing to monitor and do contact tracing, but the recent spike appears to be localized in Gwangju, 170 miles from Seoul. There are 12,850 cases, 955 active with 282 deaths. Korea is not reporting any daily deaths so far for the latter part of this week.
- The South Korea Center for Disease Control (KCDC) has warned of a summer wave of COVID that will be triggered by greater travel within the country for summer vacations. They are currently working on guidance for Korea beaches and more detailed guidances for outdoor gatherings. They also noted they could impose stricter travel measures if they see a spike in infection rates during the vacation season.
- Korea continues to exhibit one of the lowest global death rates from COVID at just 2.4%.
- South Korea now requires QR code entry logs at facilities deemed to pose a high risk of creating COVID-19 clusters. It is a step intended to bolster the country’s contact-tracing capabilities and study virus transmission routes. Around 80,000 facilities across the nation — including bars, nightclubs and singing rooms — are now required to install QR code readers. Anyone who wishes to enter first needs to scan a QR code using a smartphone app. KCDC indicated the personal data associated with the QR codes will be encrypted and destroyed after four weeks. The digital information will only be used for contact tracing if someone tests positive. Facilities without QR code logs and written visitor lists face potentially large fines.
- South Korea has eased the standards for releasing COVID-19 patients from hospitals amid growing concerns about a possible lack of beds for critically ill patients. Asymptomatic patients may be released from quarantine although they show an initial positive test result, if they have no symptoms associated with the coronavirus, such as a fever, for 10 days from the day of the initial COVID-19 diagnosis. Patients with symptoms may be released from isolation under two conditions ― 10 days have passed since the diagnosis, and they have shown no symptoms ― and no fever shown without taking a fever-reduction medication for three days in a row. Previously, patients were released from quarantine only when they were symptom-free and had two negative test results on two consecutive days.
- Korean biotech and pharmaceutical firms working to develop COVID-19 treatments are contemplating how to price their drugs with attention to the debates surrounding the pricing of Remdesivir (Gilead). Gilead set a price of $390 per vial for governments in developed countries.
- Korea is seeking to bolster its intellectual property financial investment market to 1.3 trillion won ($1.08 billion) by 2024 to help firms deal with liquidity issues triggered by the coronavirus pandemic.
- 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 still 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]).
- Weekly COVID-19 statistics – ASEAN now has 155,290 reported cases and 4,449 reported deaths compared to over 136,000 reported cases and 3,973 reported deaths the previous week.
- Nearly all the new cases were driven by a sharp increase in the Philippines and Indonesia.
- Elective surgeries have resumed in Thailand and in most hospitals in Vietnam. Singapore now allows certain procedures including cancer screening, surgical operations for advanced cataracts, flu vaccinations, and dental procedures. Malaysia and the Philippines are beginning to plan for the resumption of elective surgery once recovery milestones are met. Provincial hospitals in Indonesia have resumed elective procedures.
- Indonesia has lifted the ban on export of medical devices for COVID-19 purposes.
- Indonesia’s government is drawing up plans to permit limited international travel to China, Japan, South Korea, and Australia. Negotiations with those countries have yet to begin and could face significant hurdles given that Indonesia’s COVID-19 transmission rates remain high.
- Malaysia is in discussions to begin the first phase of reopening the country’s borders. It has agreed with Singapore to allow cross-border travel for certain groups of people, including residents who hold long-term immigration passes for business and work purposes. It plans to hold talks to create a “green zone” for travel with Brunei, Thailand, New Zealand, Australia, Japan, and South Korea.
- The Philippines resumed domestic flights as Metro Manila transitions to a more relaxed general community quarantine (GCQ). 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 and Malaysia have agreed to allow cross-border travel for certain groups of people, including residents who hold long-term immigration passes for business and work purposes. Singapore is in discussion with other countries such 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.
- Meanwhile, the Thai government has decided to keep the kingdom under a state of emergency until July 31 despite having recorded no local transmission for over a month,
- Vietnam has gone nearly three months without any newly reported cases of community-spread COVID-19. It has allowed remaining businesses to reopen and is developing a plan for the gradual reopening of international flights. It is one of the few countries in the world whose economy grew in the second quarter.
- Vietnam is looking to allow international flights to China, Hong Kong, Taiwan, Japan, Korea, and those ASEAN countries that have contained the pandemic in late July 2020 at the earliest.International flights to the EU and U.S. are projected to resume in late 2020 and early 2021.
- Staff Contact: Phil Agress ([email protected])
Europe continues to improve overall. However, The WHO regional director for Europe indicated that Europe has seen a surge of COVID cases since countries began easing restrictions last week. However, in some of the previously hardest hit countries, like Italy and Spain, new daily cases and total cases are very much flattening. However, there appears to be some resistance at getting it below the current levels as restrictions are being lifted. The transformation in Spain and Italy has been particularly impressive with both countries now very close to flat in both new cases and deaths. The UK now 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 spike, and continue to be the worst in Europe. (Russia remains the COVID hot spot in Europe, now reporting 654,495 cases, with just 9,536 reported deaths). This remains a concern for EU countries who are looking to reopen borders.
- The EU announced it will not permit inbound travelers from the US, Russia or Brazil based on COVID concerns when it reopens borders on July 1. They will permit inbound travel from any of 15 approved countries and will update the list every two weeks.
- New daily cases, which tends to show which countries are increasing in COVID incidence is as follows: Spain 388; Italy 182; Germany 492; France 918; UK 820; Belgium 88, Russia 6,760. (Germany continues to show a higher number of new cases than several weeks ago.
- New deaths per day are as follows: Spain 8; Italy 21; Germany 9; France 18; UK 176; Belgium 7. Overall trends remain positive.
- European Union negotiators will propose a slightly smaller seven-year budget to EU government leaders but stick to the goal of a 750-billion-euro ($846.30 billion) coronavirus recovery fund. European Council President Charles Michel will propose a total budget of between 1.05 trillion and 1.094 trillion euros. The Commission had proposed 1.1 trillion euros. EU leaders will meet on July 17 and 18th to discuss and attempt to agree on a final budget.
- Unemployment in the euro zone edged up only slightly and by less than expected in May as lockdowns gradually eased, although the rise was more pronounced for women and youths. The seasonally adjusted rate increased to 7.4% in May from 7.3% in April and 7.1% in March, the lowest level since records began in 1998. May brought the second consecutive monthly rise, but it was less than the market expectation of 7.7%. The only modest increase suggests furlough schemes providing temporary layoff are keeping many of those laid off during the COVID-19 pandemic out of the main unemployment records, although a number of these schemes will start to taper.
- The latest negotiations in Brussels on an EU-UK trade and security deal have broken up early, with the EU’s chief negotiator, Michel Barnier, complaining of a lack of respect and engagement by the British government.
- England is showing a high degree of geographic variation in COVID, with only 8 of the 50 worst hit areas being in the south.
- The UK will implement further relaxed distancing measures as of July 4. However, leaked documents from the UK’s public health agency seem to indicate that the infection rate may be higher than the government is indicating, which would not favor furtherance of relaxed measures.
- The UK Transportation Secretary announced a crackdown on people refusing to wear masks on mass transportation. As many as one in seven people are not complying with the requirement and there is now an initiative underway for tougher enforcement and potential fines.
- In a press conference with the EU Commission, German Chancellor Merkel warned that Europe was facing its toughest situation and warned the pandemic has not yet disappeared. Prior remarks by Merkel emphasized that the EU should focus on rebuilding its economic and social strength as it moves out of COVID. Germany assumed the EU Presidency in July and will be followed by Portugal on January 2021 and Slovenia on July 2021.
- The German region of North Rhine Westphalia, where the meat plant outbreak occurred, has conducted over 28,000 tests via six new walk in test centers. There is debate ongoing in Germany about whether local lockdowns are too blunt and over-reactive and need to be better refined and targeted.
- France proceeded to phase 2 of its re-opening, including an end to the 100km travel limit. Paris, however, remains one step behind the rest of the country as it has heightened concerns.
- Local elections in France had very low turnout but resulted in big gains for France’s environmental party. It appears, however, that over 60 percent of voters did not vote in large part due to COVID concerns. President Macron has pledged 15 Billion Euros to speed up the move to a greener economy.
- We have heard one instance of a potential issue with products being blocked by the EU’s export restriction on PPE. If you are experiencing difficulties with this restriction, please let us know immediately.
- 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.
- AdvaMed’s joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation.
- Resources: https://www.ecdc.europa.eu/enlll;
- https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
- 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])
- COVID-19 cases up 19% and deaths up 15% over the previous week.
- The majority of the 300+ COVID-19 measures that the Brazilian government has implemented have been deemed positive for the medtech sector response.
- Concern remains regarding new proposals on the economic regulation of medical technology.
- AdvaMed member and supplier production in the Mexico border states has remained uninterrupted.
- Concern rising regarding a draft bill for government procurement at odds with the USMCA, now in effect.
- Criticisms and concerns over Covid-19 persist.
Other Highlights (Source: Prospectiva):
- Argentina: Metropolitan Area of Buenos Aires returns to phase 1 with strict lockdown protocols.
- Bolivia: Electoral calendar resumed amid pandemic.
- Brazil: Local elections on the political agenda as testing increases across the country.
- Chile: Santiago remains the virus’ epicenter, cases rise in other regions.
- Colombia: National lockdown extended, but pilot plans for reopening specific sectors are drafted.
- Ecuador: President Moreno receives the first part of medical supplies acquired through the PAHO Supply Portal.
- Mexico: A meeting between Trump and AMLO to mark the start of the USCMA will take place.
- Paraguay: Economic reactivations plans delivered and underway as phase 3 of quarantine is extended.
- Peru: Government orders targeted quarantine until July 31.
- Uruguay: As cases decrease in the Brazilian border, Treinta y Tres becomes the country hotspot.
- Staff Contact: Steven Bipes [email protected]