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 as we ramp up this work stream, we welcome your feedback.
- Weekly COVID-19 statistics- global cases reached 9.56 million—a one million increase over the previous week. Deaths exceeded 489,000—a 40,000 increase over the previous week. The countries with the most reported cases are the U.S. (2.4 million), Brazil (1.3 million), Russia (613,000) and India (473,000).
- U.S. cases exceeded 2.45 million, with deaths increasing to 117,832.
- 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 only a few cases each day and are mostly linked to foreign arrivals. Total cases stand at 84,687 and deaths at about 4,641.
- The outbreak in Beijing appears to be under control. Authorities there claim to have conducted 2 million nucleic acid tests over the past two weeks, with the capacity to test 300,000 people per day. Unlike in the U.S., China takes some “shortcuts” when testing. For example, five samples will be tested together, on presumption all are negative. If results come back positive, testing authorities will then test each of the five individuals separately.
- China’s customs authority is undertaking checks of all cold-stored fresh produce imported from “high-risk countries” given the suspected link of such products to the recent Beijing outbreak. China has also halted some U.S. poultry imports due to a Covid outbreak at a large Arkansas processing plant of Tyson foods.
- 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 is gradually allowing an increased number of inbound flights from overseas. Foreign airlines are allowed to conduct one commercial passenger flight per week to the Chinese mainland, with the possibility of increasing to two per week if no passengers test positive for COVID-19. Last Monday, the U.S. and China announced that weekly flights between the two countries will increase from two to four.
- 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 Phase One trade agreement is proceeding with implementation. China’s purchases of U.S. farm products are picking up on account of contracts the Chinese signed in recent months and the U.S. harvest season. China is lagging in its additional purchases of energy products and manufactured goods (including medical devices), however.
- Staff Contact: Ralph Ives ([email protected]).
- Weekly COVID-19 statistics –186,514 active cases/14,894 deaths as compared to 160,384 active cases/12,237 deaths reported last week. India’s total number of infections has surpassed 450,000 – the fourth-highest in the world behind the United States, Brazil, and Russia.
- News reports of hospitals in New Delhi growing overwhelmed by the number of cases have picked up.
- Prime Minister Narendra Modi on Saturday met with the ministers and top officials from infrastructure and commerce ministries, to discuss ways to boost local manufacturing and exports amid continuing tensions with China.
- The government decided to tighten the regulatory restrictions on pharmaceuticals imports from China through stricter scrutiny of APIs key starting materials for medicines and medical equipment.
- The Director General of Foreign Trade on June 22 decided to continue its export ban only on specific personal protection equipment (PPE) such as medical coveralls of all classes and goggles. The Government is likely to soon allow exports of PPE kits and ventilators, two crucial components in the battle against coronavirus.
- Government has permitted pharmaceutical companies to launch generic versions of Remdesivir and Favipiravir — the two anti-viral drugs that have shown promising results in treating patients suffering from COVID-19.
- The government lifted its ban on the export of hydroxychloroquine after ensuring surplus stock in domestic market.
- The Indian Council of Medical Research (ICMR) on Tuesday recommended additional strategies for Covid-19 testing, as it allowed the use of an antigen tests to fast-track testing and tracing of positive cases and ease the burden on the current RT-PCR test.
- ICMR says COVID-19 testing should be widely available to all symptomatic individuals.
- Staff Contact: Abby Pratt ([email protected]).
- Weekly COVID-19 statistics – 18,924 reported cases and 984 reported deaths compared to 18,471 reported cases and 950 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 a decrease in new coronavirus cases to 28 (down from 59 per day at highest point last week). Authorities are continuing to monitor and do contact tracing. There are 12,563 cases, 1,307 active with 282 deaths. The current daily death totals remains very low at just 1.
- 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.
- The country’s third supplemental budget was slated for passage in June, but has hit a political snag with opposition from the minority party. The legislation is projected to provide 35.3 trillion won (29.2 billion US) to mitigate economic damage from COVID. It is unclear when this will be passed.
- 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 slightly over 136,000 reported cases and 3,973 reported deaths compared to 121,434 reported cases and 3,669 reported deaths he previous week.
- The bulk of infections are in Singapore, Indonesia, and the Philippines. The overwhelming preponderance of deaths are in Indonesia and the Philippines.
- 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. A few 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.
- Singapore and China began a “fast-lane” travel arrangement for official and business purposes between the two countries. Singapore is in discussion with other countries such as Malaysia, New Zealand, and South Korea on similar arrangements.
- Malaysia continues to ease its COVID-19 restrictions and will permit weddings and social gatherings of up to 250 people. U.S. businesses in Malaysia have largely resumed operations and made adjustments to the COVID-19 environment.
- 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’s health ministry announced that, beginning June 19, small gatherings will be permitted, and restaurants and shops can reopen. Social distancing requirements will remain, but the announcement marks a major easing in COVID-19 restrictions and reflects a decline in worker dormitory cases and a stable level of other cases.
- Thailand is planning to partially reopen to international visitors, with a quota of 1,000 per day consisting of business people and those in need of medical treatment. None of those who gain entry would need to undergo the 14-day quarantine that has been mandatory for returnees. The move to admit limited numbers of foreign visitors would be part of the “travel bubble” plan being put forward by the Ministry of Public Health for ‘zero risk’ or very ‘low-risk’ countries.
- Vietnam has gone over two 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.
- Vietnam is looking to allow international flights to China, Hong Kong, Taiwan, Japan, Korea and ASEAN countries in 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. The weekly cases in Europe have risen for the first time in months affecting more than two dozen countries in Europe. However, in some of the previously hardest hit countries, like Italy and Spain, new daily cases and total cases are stabilizing or decreasing. The UK now leads in the number of cases and deaths. Italy and France are second and third in the EU in the number of fatalities from COVID. Mortality rates and deaths per day in most EU countries still appear to remain on a downward trend. Italy which was in such dire straits not so long ago, has succeeded in flattening its case and deaths. Although not in the EU, Russia’s reported numbers on COVID are continuing to get dramatically worse each week, and continue to be the worst in Europe. (Russia remains the COVID hot spot in Europe, now reporting 613,994 cases, with just 8,605 reported deaths). This remains a concern for EU countries who are looking to reopen borders.
- New daily cases, which tends to show which countries are increasing in COVID incidence is as follows: Spain 334; Italy 190; Germany 476; France 81; UK 652; Belgium 88, Russia 7,176. (Some of these rates have increased from last week despite progress being shown). Germany continues to show a higher number of new cases than several weeks ago. Italy, France, Spain and Belgium appear to be flattened. UK is showing resistance to further decreases in its daily case numbers.
- New deaths per day are as follows: Spain 2; Italy 30; Germany 17; France 11; UK 154; Belgium 9. Overall trends remain positive.
- The EU’s coronavirus recovery package is now on track to be supported by all member states. Called Next Generation EU, the package consists of 500 billion Euro in grants and another 250 billion Euro in loans. Initially suggested by France and Germany, the package contains linkages to innovation, digitalization and green technology development. The EU Commission will raise the necessary funds on international markets leveraging its AAA rating and then allocate to member states that are hardest hit by COVID. EU leaders, including Angela Merkel, have urged the EU to adopt the recovery package in July.
- The European Medicines Agency recommended a conditional marketing authorization for remdesivir as a Covid treatment. The drug is produced by Gilead and will be used to treat patients over the age of 12 who are in need of oxygen therapy.
- Brexit talks between the UK and the EU continue to show little progress. The EU has recently made several public statements about the unwillingness of the UK to offer any compromise in their position. The UK has maintained its position that it will not seek an extension of the December 31 deadline.
- The EU is planning on re-opening its borders on July 1, but is also considering barring American travelers from the EU because of the large number of cases that are still occurring in the US. Travelers from Brazil and Russia would be banned as well. The policy has not been finalized so it remains to be seen what will occur. Any travel ban policy that is implemented would be re-evaluated every two weeks.
- The UK will be one of the hardest hit countries in the EU from COVID. Britain’s slump is likely to manifest as an 11.5% decline, which would outstrip similarly gloomy forecasts for other larger EU economies such as Spain, Italy, France and Germany. Half of the UK workforce is still working remotely.
- 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.
- In the UK tens of thousands (in one estimate 500,000) flocked to various UK beaches leading to emergency response from authorities. The beaches exhibited high vacation peak conditions without people observing social distancing. Police have advised travelers to stay away from these areas and beaches.
- The NHS is warning about severe backlogs in treatment as hospitals re-open, in one instance forecasting that 10 million people could be encountering long delays in access to treatment by the end of the year. A recent proposal to route capacity through private hospitals appears to be stalled.
- National statistics show that almost ½ of UK businesses have either stopped investing or cut back capital spending since COVID struck.
- German Chancellor Merkel indicated measures to fight COVID related economic decline will address both short and longer term economic issues, combining for 130 billion euro. She also extended social distancing rules to June 29.
- German hospitals are re-opening and there is a large backlog for elective procedures. Patients are being reassured through public affairs messages of the measures that are in place to ensure safety from COVID. But there remains hesitancy for patients to undertake elective procedures at pre-Covid levels.
- The recent outbreak of cases at German meat packing plants points to air filtration/cooling systems in those plants as potentially the key culprit for spreading the disease. One city in western Germany went into lockdown after about 1,500 of the employees at a meat packing plant were infected with the virus. The same conditions and air recirculation exist in many meat packing plants globally
- Three states in northern Germany will not allow tourists from the affected districts where the meat packing plants are located, to vacation in their regions.
- Germany and France have publicly committed to political and financial backing for the WHO in its fight against the coronavirus.
- 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. The Eiffel Tower has re-opened as of June 25, with stair access only, no elevators. France’s major southern airport reopened just this week but with only about 10 percent of normal capacity.
- The Bank of France indicated the French economy will shrink by about 10 percent this year due to COVID and will take until mid-2022 to recover. Unemployment is expected to reach as high as 11.5 percent in mid-2021 and then improve.
- Local elections in France are set to occur on June 28 and are not expected to show favorable results for the Macron led government. Voter polling shows Macron’s popularity has slipped significantly over the last several months, with not all the dissatisfaction attributable to coronavirus.
- 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 still increasing in Latin America; cases up 30% an deaths up 100% 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 for the past month.
- Concern rising regarding a draft bill for government procurement at odds with the USMCA.
Other Highlights (Source: Prospectiva):
- Argentina: Authorities set up a united front for the Metropolitan Area of Buenos Aires despite tensions.
- Bolivia: Congress pressures the executive to enact election law
- Brazil: Imprisonment of close Bolsonaro ally increase the president’s isolation
- Chile: Government extends the State of Catastrophe by 90 days
- Colombia: Worst economic downturn since 2005 recorded.
- Ecuador: The health emergency was extended for an additional 60 days.
- Mexico: Mexico leaves Kearny’s ranking of most attractive countries for foreign investment.
- Paraguay: Government delivers an overall positive balance of response measures.
- Peru: Phase 3 of economic reactivation expected to start on July 1st.
- Uruguay: As pandemic control remains successful, new sectors prepare to reopen
- Staff Contact: Steven Bipes [email protected]