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January 8, 2021

The weekly global report provides brief updates on COVID-19 related activity and policy development in AdvaMed’s priority markets. For additional information, please contact Ralph Ives at Rives@AdvaMed.org.

COVID-19 Outbreak: Weekly Global Report for Friday, January 8, 2021

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 87.7 million. Deaths around the world surpassed 1.9 million. The countries with the most reported cases continue to be the U.S. (21.4 million), India (10.4 million), and Brazil (7.8 million).
U.S. cases exceeded 21.4 million with deaths increasing to 363,000.
Staff Contact: Ralph Ives (rives@advamed.org).

China

Overview: several important developments have occurred since our last newsletter three weeks ago. Hebei province is grappling with China’s largest outbreak in months. China approved its first COVID vaccine, with the national goal of vaccinating 50 million people ahead of the Spring Festival holiday in early February. The Chinese government continues to create challenges for the WHO team investigating the origins of the virus, leading to criticism by senior WHO officials.
Weekly COVID-19 statistics: China’s total COVID cases now stand at 96,432, an increase of around 1,700 cases compared to our last report on Dec. 18. Deaths now stand at 4,788, an increase of 30 compared to three weeks ago. So far in January, most new cases have been locally transmitted.
Hebei outbreak: with 92 confirmed infections and 149 asymptomatic cases as of Wednesday, the Hebei outbreak marks China’s biggest rise in COVID-19 infections in recent months. Among the new positive cases, 50 were discovered in the province’s capital city Shijiazhuang, whose Gaocheng district has been designated as China’s only “high-risk” area. Shijiazhuang has mobilized some 3,000 medical workers to support the mass testing of its entire 11 million population within four days. As of Wednesday afternoon, about 2 million samples had been collected. In addition to barring people from leaving the city, people and vehicles in Gaocheng are not even allowed to leave their district for other areas of Shijiazhuang.
New cases in neighboring Beijing: Beijing sealed off ten areas in the city’s Shunyi district and stepped-up testing after the discovery of 16 new cases imported, perhaps, from nearby Hebei. The city also temporarily banned large scale gatherings, increased the frequency of trains to ensure sufficient commuter spread, and cancelled events to contain the outbreak.
Vaccine roll-out: On December 31, China approved the Sinopharm coronavirus vaccine, the country’s first for general use. Results from ongoing Phase 3 clinical trials showed an efficacy rate of 79 percent. However, the lack of details by Chinese regulators and Sinopharm has raised concerns in some circles. Current estimates show that nearly 4 million Chinese citizens have received the vaccine so far.
Second vaccine: Officials in the Brazilian state of São Paulo, where a prominent medical research institute carried out a large study of the vaccine developed by Beijing-based Sinovac, said the inoculation had an efficacy rate of 78 percent. The vaccine reportedly prevented all trial participants from developing serious and mild complications from the virus, the officials said.
Updated estimates on 2020 hospital visits: according to the National Health Commission, the total number of hospital visits/medical consultations in January through September 2020 reached 3.9 billion, a decrease of 15.3% 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.
New NHC advisory body: The National Health Commission established an advisory panel of 67 experts to provide recommendations on how to prevent coronavirus infections in Chinese hospitals and clinics.
WHO team investigating COVID: China has blocked the arrival of a team from the World Health Organization investigating the origins of the coronavirus pandemic, claiming that their visas had not yet been approved even as some members of the group were on their way. The WHO’s director general, Tedros Adhanom Ghebreyesus, expressed his dismay and said he had called on China to allow the team in.
New requirement for foreigners travelling to Beijing: at a press conference Tuesday, Beijing city officials said people entering the Chinese capital from abroad must quarantine for 21 days — seven days longer than the city’s previous policy. While the first 14 days must be spent at a government-designated facility, the remaining week can be completed at a private residence with approval from local authorities.
S.-China relations remain strained, with the Trump administration considering a series of tough executive actions targeting China in its final weeks. On a positive note, the Phase One trade deal remains intact and has emerged as a key area of cooperation. On December 28, USTR extended tariff exclusions for several COVID-related medical devices. USTR even granted some new exclusions for a smaller batch of medical devices. All of these exclusions are set to expire on March 31, 2021.
Staff Contact: Kyle Churchman (kchurchman@advamed.org)

India

Weekly COVID-19 statistics – 10,395,938 total cases, 228,083 active cases/150,336 deaths as compared to 9,762,326 total cases, 372,293 active cases/141,772 deaths last week. The trajectory of contraction in India's total Covid-19 active cases continues unabated. The share of active cases in the total cases has further shrunk to 2.19 per cent, the ministry said.
Two vaccines Oxford Institute's Covishield, which is being developed by the Pune-based Serum Institute, and Bharat Biotech's Covaxin received emergency approval from the country's drug regulator on Sunday, January 3, 2021. Experts have raised concerns over India's emergency approval of a locally-produced coronavirus vaccine before the completion of trials. The regulator also granted permission to conduct Phase-III Clinical Trial Protocol to M/s Cadila Healthcare Ltd, Ahmedabad on Sunday, January 3, 2021.
The Health Ministry on Tuesday, January 5, 2021 said it is prepared to roll out the Covid-19 vaccinewithin 10 days from date of emergency use authorisation, which was issued on January 3.
After nearly 10 months, AIIMS has resumed non-emergencysurgeries. It has also allowed pre-booking of appointments for OPD consultation directly from the counter or online.
Health activists and patient groups have raised concerns about the “abrupt” manner in which the health ministry’s expert panel appeared to have changed its position in recommending approval of Bharat Biotech’s Covaxin.
The union ministry had earlier said the country has 28,932 cold chain points and 85,622 cold chain equipment, however, state-wise data accessed by a leading media house shows that just six states with only a third of India’s population have more than 52% of the cold chain points and nearly 40% of all the equipment.
To address the logistical challenges in moving Covid-19 vaccines, Hyderabad International Airport Ltd, GMR Hyderabad Air Cargo (GMR-HYD), and Dubai Airports have teamed up to build a Hyderabad to Dubai global vaccine corridor called ‘HYDXB-VAXCOR.’
India is gearing up to supply hundreds of thousands of healthcare workers needed across nine countries including the US, UK, Germany and Canada among others till 2022 to help them better prepare for any future pandemic.
India will not allow the export of the Oxford University-AstraZeneca coronavirus vaccine for several months, the head of Serum Institute of India, which has been contracted to make 1 billion doses of the vaccine for developing nations, said Sunday.
Staff Contact: Abby Pratt (apratt@advamed.org).

Japan

Weekly COVID-19 statistics – 267,716 reported cases and 3,899 reported deaths compared to 191,647 reported cases and 2,806 reported deaths three weeks ago.
Japan has adopted a state of emergency in Tokyo and three surrounding prefectures through at least February 7 due to a surge in cases over the past several weeks. Under this declaration, the relevant prefectural governors will ask people to stay at home after 8 p.m., while restaurants, pubs and cafes that serve alcoholic beverages are requested to serve them only from 11 a.m. to 7 p.m. and close by 8 p.m.
The central government will also ask companies to reduce the number of workers going to the office by 70% and facilitate telecommuting and staggered commuting hours.
Japan confirmed that the UK variant of the virus has been found in the country and has banned all foreign tourists from entering Japan as a result.
Japan has contracted with Pfizer to purchase 120 million doses of its COVID-19 vaccine to be delivered in the first half of 2021. Approval of the Pfizer vaccine is expected around February 2021. Pfizer is currently conducting a small-scale trial of the vaccine in Japan. Japan has also contracted for 50 million doses of the Moderna vaccine and 120 million doses of the Astra Zeneca vaccine.
Vaccinations are not expected to begin in Japan until late February.
Japan announced that it plans to inoculate its entire population with a COVID-19 vaccine by the time the Olympics start in July 2021.
It has asked local governments to make arrangements to allow 30-40 million elderly citizens to be vaccinated by the end of March. About 10,000 healthcare workers who work with COVID-19 patients should receive the vaccine by the end of February, and around 3 million other healthcare workers will receive it by mid-March.
Hospital beds are running low in many of the hardest hit regions.
Kanagawa Prefecture’s Governor requested nearly 60 hospitals to postpone non-essential surgeries for one month on January 5 in order to free up beds for Covid-19 patients.
According to a recent survey, 44% of advanced medical care hospitals are experiencing significant postponements of procedures due to patients’ concerns about COVID-19.
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 have moved up and down over the holiday season but currently seem to be on a slightly downward trend. They currently are at 870 new daily case, including 833 local cases (the remainder of cases originated overseas), with 19 deaths per day. This is the third consecutive day that the new cases have been below 1,000. South Korea continues to avoid the dramatic spikes that many other countries are experiencing.
Korea ranks 90 in the world in cumulative cases and 89^th in the world in number of deaths (663).
South Korea has 66,686 total cases, 17,991 active cases, with 1,045 deaths, reporting 19 deaths per day. Total cases per million population have increased significantly, but remains low compared to most of the world at just 1,300. Deaths per million remain comparatively low as well at just 20.
South Korea is revising its social distancing guidelines to allow certain businesses to operate, as strict virus control measures have wreaked havoc on the lives of small merchants. Prime Minister Chung Sye-kyun said in a meeting Thursday that the government would take steps to assure fairness and address the financial difficulties facing small businesses, with details to be announced in the coming days. “As frustration continues and seems endless, people have questioned the virus control standards and there were movements from some sectors opposing them in groups,” Chung said. “The threat from this third virus wave is getting longer from the seasonal effect and cumulated social fatigue. The government will do better.”
A number of businesses have staged demonstrations and collective actions to protest government restrictions they deem unfair, as well as the lack of compensation from the government.
The government earlier extended Level 2.5 social distancing rules in Seoul, Incheon and Gyeonggi Province and Level 2 rules for the rest of the country until Jan. 17. An additional ban on private gatherings of five or more people has also been extended to the same date. Level 2.5 rules categorically disallow the operation of indoor sports facilities, but the government made exceptions allowing small cram schools and ballet and taekwondo schools in the capital region to hold classes for up to nine children at a time.
The Greater Seoul area will also allow high-risk entertainment businesses like bars, clubs and karaoke places to operate when the current social distancing rules expire on Jan. 17.
The country added three new cases of the new COVID-19 strain first reported in Britain, raising the total to 15, including one case from South Africa.
To block the more transmissible coronavirus variant, South Korea has extended the suspension of direct flights from Britain for two more weeks until Jan. 21.
Starting Friday, foreigners arriving at South Korean airports must present a negative polymerase chain reaction (PCR) coronavirus test taken within 72 hours of their departure to the nation.
Foreigners from Britain and South Africa who fail to present negative PCR test results will be banned from entering the nation, and incoming Korean nationals without test results will be isolated in temporary living facilities for two weeks upon their arrival in the nation, the KDCA said.
Health authorities will continue to conduct further tests, known as next-generation sequencing, on infected people from Britain and South Africa to detect the mutant virus and are set to implement strengthened measures on those from abroad, it said.
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.
We have 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 1,597,647 reported cases and 36,092 reported deaths compared to 1,353,775 reported cases and 30,983 reported deaths three weeks ago.
The vast majority of cases are in Indonesia, the Philippines, and more recently Myanmar and Malaysia. Indonesia surpassed 788,000 total cases and the Philippines has reported over 482,000 cases.
Myanmar continues to experience a major surge that started in September. It is now reporting 128,465 total cases. The number of deaths is 2,785.
The Philippines and Indonesia account for 90.4% of the deaths from COVID-19 in the region. Indonesia’s total COVID-19 deaths have reached 23,296, the highest level in East Asia. The Philippines reported 9,356 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). These numbers are unchanged from three weeks ago. Thailand has reported 67 deaths.
Thailand, which in mid-December had just over 4,000 cases of COVID-19, experienced a major surge that originated in a shrimp market southeast of Bangkok. It is now reporting over 9,600 cases.
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.
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.
As of January 1, Indonesia has closed its border to foreign nationals to mitigate the increased spread of COVID-19. The border will remain closed until January 14. The new policy provides exemptions for holders of diplomatic visas and official visas related to foreign officials at the ministerial level, holders of limited stay permits, and permanent resident permits.
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.
The Philippines has imposed restrictions on travelers from the United States and 20 other countries where cases of the new COVID-19 variant were reported.
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 from mid-January, without the need for prior quarantine, as efforts get under way to draw them back to Singapore.
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.
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 has liftied border restrictions for visitors from Taiwan. Upon arrival, visitors from Taiwan must undergo COVID-19 testing and if the result is negative, are 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.
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.
Thailand 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.
Staff Contact: Phil Agress (PAgress@AdvaMed.org)

Europe

There is continued increase across the EU. The UK has moved to second in terms of deaths per million. In terms of new cases, the UK has skyrocketed to 62,322, more than double the next highest country, which is surprisingly Germany, with 26,651. Of the larger European countries, France is 3^rd with 25,379, followed by Russia (24,217), Italy (20,331), and Spain (16,588). The UK now also leads in deaths, followed by Italy, France, Russia, Spain, Germany and Belgium (see chart below). (There is a significant gap between Germany at #6 in Europe in terms of total cases, and Belgium (#12). That gap is filled by Poland, Ukraine, Netherlands, Czech Republic and Romania in that order. Russia's reported numbers on COVID remain problematic with perhaps the highest number of total cases of any country at 3,308,601 and new cases at 24,217 and 59,951 reported deaths (and reporting one of the lowest death rates in Europe at 411 per million).  By comparison, Italy, with much fewer (1,888,144) cases, reports 66,537 death.

New daily cases, which tend to show which countries are increasing in COVID incidence are as follows (the pre-Christmas report figures are in parentheses for comparison purposes): Spain 16,588 (up from 11,079); Italy 20,331 (up from 17,572); Germany 26,651 (down from 28,969); France 25,379 (up from 17,615); UK 62,322 (dramatically up from 25,161); Belgium 1,848 (down from 2,211); and Russia 24,217 (down from 26,509). Daily rates continue to increase across most of Europe and the UK and remain at significant levels.
New deaths per day (which tend to lag any increased infection rates) are increasing and are as follows: Spain 122; Italy 548; Germany 1,019; France 283; UK 1,041; Belgium 77. Russia is reporting 445 new deaths per day.
European countries are at a "tipping point" of the pandemic, the World Health Organization's regional director said, as infections rise rapidly and the threat of a mutated version of the virus spreading looms. "We remain in the grip of COVID-19 as cases surge across Europe and we tackle new challenges brought by the mutating virus. This moment represents a tipping point in the course of the pandemic," Hans Kluge said. The more transmissible variant has already been detected in 22 countries in the WHO's European region, he said, emphasizing that countries needed to "intensify" measures to prevent further spread.
"The virus is getting better...and we need to do that too," said Catherine Smallwood with WHO's emergencies programme, explaining that bringing down transmission should be a priority for countries. Health officials also expect that infections could continue to rise following the holidays, with Kluge stating that there is currently an "incomplete picture of the current epidemiological situation" with lower testing around Christmas and New Year.
The EU's medicines regulator on Wednesday recommended authorizing a second coronavirus vaccine developed by biotechnology company Moderna. The European Commission now needs to approve the vaccine to make it available to member states. Many hope that with multiple vaccines authorized in the EU, those who are vulnerable to the disease will be vaccinated more quickly. Vaccinations began in the EU on December 27 after the bloc authorized the Pfizer/BioNTech vaccine.
Across the EU, national governments are being criticized for what citizens believe are too slow of rollouts of vaccines. Many of the countries, including Belgium, are modifying their vaccination roll-out plans to move more quickly.
The EU's health chief has defended the bloc's COVID vaccine rollout amid criticism it was too slow and not enough jabs were ordered. Vaccinations programs in the 27 nation-bloc got off to a slow start and some EU members have been quick to blame the EU’s executive arm for a perceived failure of delivering the right amount of doses. In Finland, health authorities are reportedly unhappy that the country only received about 40,000 doses in December, instead of the 300,000 that were expected.
Stella Kyriakides, EU commissioner for health, said the vaccine strategy had been supported by all 27 member states. "In June when the strategy was launched together with the member states, it was extremely uncertain whether we would have a successful vaccine and which vaccines would be successful," she said. "We have since then, in six months, built a portfolio of six vaccine candidates. "We have approved already the BioNTech/Pfizer one and we have started vaccinations in all 27 member states and the EMA (European Medicines Agency) is in the process of assessing the vaccine of Moderna. "This is not about a blame game. This is about fighting the pandemic. We are not in competition with any other country in the whole world. The only competition is against the virus." The EU has sealed six vaccines contracts, with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But as of Wednesday morning, only the Pfizer-BioNTech one has been approved. Kyriakides told Euronews additional vaccines could be approved within the next two months. This week, the Moderna vaccine was approved.
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.
The EU has also recommended to Member States several actions to address the new UK variant of the virus. These measures include discouraging all non-essential travel to and from the UK should be discouraged until further notice. These measures were issued before the formal Brexit, so are likely to be updated again shortly. Currently, these additional measures are in place:

- Union citizens and UK citizens travelling to their Member State or country of residence as well as third-country nationals that enjoy EU free movement rights should be exempted from further temporary restrictions provided that they undergo a test or quarantine.
- Travelers with an essential function, for instance medical staff, should be required to undergo a test (RT-PCR test or a rapid antigen test within 72 hours prior to departure), but should not be required to undergo quarantine while exercising this essential function.
- Facilitate transport staff and transit of passengers, especially for essential travel.
- Cargo flows need to continue uninterrupted, for example to ensure the timely distribution of COVID-19 vaccines.
- The public health authorities of the Member States should increase sequencing efforts to swiftly identify cases of the new variant. They should also immediately identify cases involving persons who travelled to or from the UK in the past 14 days or who are close contacts of confirmed cases in order to ensure the appropriate follow.

In Brexit news, customers in Europe buying products ranging from furniture to pet food from UK companies are receiving unexpected bills for VAT and customs declarations or finding household names have stopped shipping to the continent, as post-Brexit trading rules come into play.
Farmers in the UK’s devolved administrations are facing substantial cuts to their income as a result of Brexit, which could imperil their ability to protect the countryside, ministers were warned on Thursday. Fergus Ewing, Scotland’s cabinet secretary for the rural economy, told the Oxford Farming Conference that Scottish farmers would lose out to the tune of £170m between now and 2025, compared with the subsidies they could have expected under the EU’s common agricultural policy, which provided roughly £3bn a year across the UK. “Major cuts have been imposed on all the devolved administrations without consultation,” he said. “This is not what farmers and crofters in Scotland were promised if they were to vote for Brexit.”
Northern Ireland is facing disruptions to its food supply because suppliers in Great Britain are unaware of the Brexit-related paperwork needed to send goods to the region, business leaders have said. Trucks are arriving at GB ports with incorrect or absent documentation that delays their passage across the Irish Sea, they told MPs on Wednesday.
The United Kingdom and the European Union have agreed to a Trade and Cooperation Agreement, an Agreement on Nuclear Cooperation and an Agreement on Security Procedures for Exchanging and Protecting Classified Information. The Trade and Cooperation agreement itself sets forth many objectives and principals and leaves many key details to be determined. https://www.gov.uk/government/publications/agreements-reached-between-the-united-kingdom-of-great-britain-and-northern-ireland-and-the-european-union#history; https://www.gov.uk/government/publications/agreements-reached-between-the-united-kingdom-of-great-britain-and-northern-ireland-and-the-european-union/summary-explainer#heading-five--fisheries; We expect further details will be forthcoming and will of course be updating members accordingly as information becomes available.
The UK remains generally under lockdown, with slightly different rules depending on location. In England, citizens are not to leave their homes except where necessary. You may leave home to:

shop for basic necessities, for you or a vulnerable person

go to work, or provide voluntary or charitable services, if you cannot reasonably do so from home

exercise with your household (or support bubble) or one other person, this should be limited to once per day, and you should not travel outside your local area.

meet your support bubble or childcare bubble where necessary, but only if you are legally permitted to form one

seek medical assistance or avoid injury, illness or risk of harm (including domestic abuse)

attend education or childcare - for those eligible.

Prime Minister Boris Johnson announced s national vaccine administration booking scheme in England amid more grim COVID figures. A national booking service for vaccine appointments in England will be launched to help hit ambitious targets, Boris Johnson has said, as he pledged to immunize every elderly care home resident by the end of the month. The prime minister said everyone would be able to get a vaccination within 10 miles of their home and that GP-led vaccine sites providing jabs would increase to more than 1,000 by the end of next week, and hospital sites to 223, delivering hundreds of thousands of vaccines a day by 15 January. “This is a national challenge on a scale, like nothing we’ve seen before. And it will require an unprecedented national effort,” Johnson told a No 10 press conference. “Of course, we are in a race against time. But I can assure you that we are doing everything we can to vaccinate as many people as possible across our whole UK.”
The announcement followed grim new figures for COVID in the UK, including 1,162 further COVID-related deaths. The only day with a higher death toll by this measure on the government’s dashboard was 21 April, when 1,224 deaths were reported. 1.3m people in the UK had received a first vaccine dose by 3 January.
The NHS has announced that COVID-19 patients in the UK are to be prescribed tocilizumab and sarilumab after clinical trials revealed they reduce the risk of death by 24%.
The UK health system remains under stress. As evidence, a hospital in the South East of England has declared it may need to refuse or withdraw critical care due to resource limitation. The UK this week recorded more than 1,000 coronavirus related deaths in one day, for the first time since April 2020.
The UK will extend a ban on travelers entering England from southern African countries in a measure to prevent the spread of a new Covid-19 variant identified in South Africa. The restriction will go into effect on Saturday and remain in place for two weeks, the government said.
The Medical and Medical Devices Bill will enter the House of Lords report stage on the 12th January 2021.
England.
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’s health minister defended the slow start of the country’s coronavirus vaccine campaign on Wednesday amid soaring infection numbers and a tighter lockdown. “The problem is the shortage of production capacity with global demand,” Health Minister Jens Spahn told reporters in Berlin, adding that he understood the desire for a faster rollout.
Germany has faced criticism that it has failed to procure enough vaccine doses to speed up the nationwide campaign amid the high infections and hospitalizations. “We’re in a much worse position than other countries,” said Lars Klingbeil, the general secretary of the Social Democratic Party. “It can’t be that the country where the vaccine is created has too few doses.” On Tuesday, Germany’s disease control agency said 11,897 more coronavirus cases were confirmed in the past 24 hours, up from 9,847 registered on Monday. German Chancellor Angela Merkel announced an extension and tightening of coronavirus lockdown restrictions on Tuesday.
Prime Minister Merkel made the announcement on prolonged restrictions after meeting with the country's 16 state governors to decide on the length of a possible continuation and to what extent schools will reopen. The state and federal governments agreed most non-food shops, bars, restaurants, cultural and leisure facilities and schools will remain closed, as well as new rules being brought in, Merkel said. "We must further reduce our social contacts in order to fight" the pandemic, the Chancellor added. The lockdown measures currently in place initially took effect on December 16, after a partial lockdown failed to calm case numbers, and were set to expire on January 10.
Germans in areas that are considered hotspots for the virus will not be allowed to travel over 15 km from their homes without a good reason. Those arriving in the country that have come from a destination deemed to be high risk will have to provide two negative test results, with a mandatory five-day quarantine even in cases where the first test is negative. The restrictions in meetings in private will be limited to one other person from outside the household.
On Tuesday, Germany’s disease control agency said 11,897 more coronavirus cases were confirmed in the past 24 hours, up from 9,847 registered on Monday. This puts the country fifth in a tally of COVID-19 infections in Western Europe, behind the UK, France, Italy, and Spain. At least 944 deaths were reported on Tuesday, taking the official coronavirus death toll to 35,518, according to the Robert Koch Institute (RKI).
However, the agency said delays in reporting over the festive period could have affected the figures. Vaccinations against COVID-19 kicked off in Germany on December 26 and, in the nation of 83 million, nearly 265,000 vaccinations had been reported by Monday, RKI said.
Germany’s CureVac is in final stage 3 trials with its vaccine. The vaccine is said to be more stable, easier to store and mass produce, and requires significantly lower dosage.
BVMed hosted a webinar in the fall in which 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."
France continues to struggle with COVID. France’s bars, restaurants and ski lifts are now scheduled to remain closed until at least February.
France’s border with the UK has been closed for the ‘foreseeable future’ according to Jean Castex. So far 19 cases of the new fast-moving variant of the coronavirus, identified by scientists in the UK and called the “English variant” in France, have been identified.
French wine producers are calling on the government to take "tough decisions" as they say new US tariffs could see them losing nearly a billion euros in exports this year. The US and the European Union have been locked in a dispute over aircraft subsidies for years which escalated in October 2019 when Washington slapped 25% tariffs on a number of European products. Brussels swiftly announced retaliatory tariffs. French still — non-sparkling — wine with an alcohol level of up to 14 degrees and in bottles of under two litres were included in the US list. According to the French Federation of Wine and Spirit Exporters (FEVS), the tariffs cost French producers more than €600 million in 2020, with exports to the US falling by 50% compared to the previous year. France's share of the still wine market in the US fell by 22%, they said, adding that US imports of similar wines from countries not affected by the tariffs "remained level, showing that the drop in French imports is exclusively linked to the impact of the 'Airbus sanctions'".
France will extend and speed up its Covid-19 vaccination rollout, Health Minister Olivier Véran said on Tuesday, following outrage over the government’s slow start in one of the world’s most vaccine-sceptical countries. "We are going to amplify, accelerate and simplify our vaccination strategy," Véran told French radio station RTL. France will also extend vaccinations to people aged above 75 who are not in care homes and 500 to 600 vaccination centers will be set up in France by end-January, Véran promised. The announcement came as France recorded about a dozen cases of the more contagious variant of the coronavirus first identified in the UK, making an easing of lockdown restrictions unlikely across the country.
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

COUNTRY HIGHLIGHTS –COVID 19

Brazil:

Mexico: Health workers have protested for corruption cases in the vaccine application process.

Other Latin America

Argentina: As the vaccination campaign begins, ANMAT grants an emergency approval to the Oxford-AstraZeneca vaccine.
Bolivia: Government signed agreement to receive the Sputnik V vaccine.
Colombia: Ministry of Health approved emergency use for COVID-19 medicines.
Chile: Second Pfizer-BioNtech vaccine package arrived at the country.
Ecuador: Government asked Pfizer for two million doses of its COVID-19 vaccine to start the vaccination plan in January.
Paraguay: Ministry of Health authorizes vaccines that have been approved by the regulatory bodies of the US, the EU and regional reference authorities.
Peru: Ministry of Health transferred USD 4 million to PAHO to purchase rapid coronavirus antigen tests and protection gear.
Uruguay: Lacalle Poude fines the last details to close the deal for Pfizer vaccine.
Staff Contact: Steven Bipes (sbipes@advamed.org)