COVID-19 Outbreak: Weekly Global Report for Friday, August 28, 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 24.28 million, nearly a 2 million increase over the previous week. Deaths around the world exceeded 827,000 The countries with the most reported cases continue to be the U.S. (5.8 million), Brazil (3.7 million), and India (3.3 million). As a whole, Latin America continues to be one of the worst affected regions, with more than 6 million reported cases to date.
• U.S. cases exceeded 5.8 million with deaths increasing to 180,000.
• Staff Contact: Ralph Ives ([email protected]).

China

• Weekly COVID-19 statistics –localized outbreaks in Xinjiang (in China’s northwest) and Liaoning province (in China’s northeast) have reportedly stabilized. China’s total COVID cases now stand at 89,805 (an increase of 300 over the previous week) and deaths at 4,715 (an increase of 8 over the previous week).
• In light of these recent outbreaks, the State Council has called for urgent preparations to combat the virus during the autumn and winter months. Priority measures include: enhanced customs inspections (notably of “carrier” foods like fresh seafood imports), more efficient and accurate nucleic acid testing platforms, and more rigorous management of quarantined areas.
• Beijing has reported no new cases for several days and has reopened Xinfadi wholesale market, the source of localized outbreak in June. The city has begun a staggered start to the city’s numerous colleges and universities to minimize mass gatherings.
• While the Chinese government reported better than expected economic figures for the second quarter, the steep drop in demand for Chinese exports and financial system risks pose continuing challenges. Consumption also remains below pre-COVID levels. The NDRC has said it would aim to boost consumption in the intelligent retail, online education and home appliance sectors, as well as offer subsidies for new energy vehicle purchases.
• The National Health Commission this week released data showing visits to primary public hospitals for Jan-May declined 24% decline over 2019. 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.
• Last week, China and the United States agreed to double the number of roundtrip flights between the two countries to eight per week.

• While U.S.-China relations remain in a downward trajectory with President Trump signing executive orders targeting Chinese apps WeChat and TikTok. The Phase One trade deal, however, remains intact and has emerged as a key area of cooperation. USTR Lighthizer and Secretary Mnuchin spoke with Vice Premier Liu He on Aug. 25 to discuss Phase One implementation from a high level.
• Staff Contact: Kyle Churchman ([email protected])

 India

• Weekly COVID-19 statistics – 3,307,750 total cases with 725,991 active cases/60,472 deaths as compared to 2,841,337 total cases with 686,395 active cases/53,866 deaths reported last week. The number of total COVID-19 cases in India has surpassed three million as health officials warn about an accelerating infection rate in the country. India first reported a total of two million cases at the beginning of this month. 
• Union Minister of Health and Family Welfare Harsh Vardhan said on Saturday that the country will have a vaccine against the deadly coronavirus by the end of the year. The Ministry of Health and Family Welfare said that one of the three COVID-19 vaccine candidates has entered the third phase of the pre-clinical human trial.
• The Government amended the export policy for 2/3 ply surgical masks and medical coveralls of all classes and categories, including medical coveralls for COVID-19, by moving them from ‘restricted’ to ‘free’ category. The export policy of N-95/FFP2 masks, or their equivalent masks, has also been revised from ‘prohibited’ to ‘restricted’ category and a monthly export quota of 50 lakh units has been fixed, as per a notification from the Directorate General of Foreign Trade (DGFT) published on Tuesday.
• The government has proposed a “Mission COVID Suraksha” to be set up with a corpus of nearly Rs 3,000 crore to accelerate the process of developing and manufacturing safe and effective COVID-19 vaccines that can be easily accessible and affordable for the public.
• The Indian Central Bank noted that upticks in consumption that were witnessed in May and June have grown weaker due to the re-imposition of lockdown measures, indicating that a contraction in domestic economic activity will be sustained in the coming months.
• The much-awaited trial of COVID-19 vaccine developed by the University of Oxford started in India on Wednesday. Pune-based Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 vaccine candidate for India and low-and-middle income countries. Five volunteers have enrolled in the Phase II trial of Covishield vaccine at Bharti Vidyapeeth’s Medical College and Hospital in Pune.
• Indian researchers start trials on saliva-based COVID-19 testing- The Medanta Institute of Education and Research in Gurgaon, Mumbai-based diagnostics company TransAsia Bio, and Pune’s Mylab are among the entities that are trying to get this testing method validated by demonstrating that analysis of saliva samples is as accurate as nasopharyngeal swab collection.
• The Indian Council of Medical Research (ICMR) has approved Delhi-based Oscar Medicare’s indigenous point-of-care (POC) rapid test kits and hoping for a simple finger-prick diagnostic test to detect Covid-19 antibodies in blood samples, will be widely available at nursing homes, hospitals and private laboratories.

• The Indian Council of Medical Research has begun a trial in which anti-tuberculosis BCG vaccine which is given to babies after birth, will be administered to 60 plus people to find out if the vaccine protects the elderly from COVID-19.
• The Reserve Bank of India (RBI) has prescribed several reforms to get the economy back on the rails after the rollback of various stimulus measures taken to counter the lockdown-induced economic damage. These include a concrete plan to rein in fiscal deficit instead of kicking the can down the road, targeted tax sops to create employment, and sale of assets to improve liquidity. Behavioural changes would make recovery bumpy, and the texture of recovery would be different from the one that followed the 2008 global financial crisis, the RBI said in its FY20 annual report.
• Staff Contact: Abby Pratt ([email protected]).

Japan

• Weekly COVID-19 statistics – 66,481 reported cases and 1,254 reported deaths compared to 60,033 reported cases and 1,173 reported deaths the previous week.
• Despite the growing number of cases, Prime Minister Abe said he will not reinstate emergency measures.
• The growing caseload has had a severe impact on Japan’s hospitals.       Some hospitals are cutting back or halting elective surgeries in order to deal with the influx of new cases. Nearly 70% of Japan’s hospitals are now operating in the red.
• According to a survey conducted by the Japan Public Hospital Federation of 1,481 member hospitals, patient visits in May 2020 were down by 24.9 percent, compared with one year ago.
• The majority of new cases are in Tokyo and are affecting people in their 20s and 30s.
• Japan and Vietnam have agreed 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 has adopted 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]).

Korea

• South Korea’s new daily cases continue to spike upward and are now at their highest levels since March (441 cases per day). This remains low compared to many other countries, but it is very concerning because for Korea, this is a dramatic upswing. South Korea’s health authorities are being forced to seriously consider near lockdown measures.  
• There are 18,706 cases, a dramatic increase to 3,932 in active cases, and 313 deaths. Korea is reporting 1 death per day.  
• Korea’s National Assembly has decided to shut down today after a reporter who covered yesterday’s Democratic Party’s Supreme Council meeting was confirmed to have the virus. Around 30 people including Chairman Lee Hae-chan and floor leader Rep. Kim Tae-nyeon had attended the meeting.
• Health authorities continue to indicate that the COVID crisis in South Korea is at a more critical phase than it was in May due to continued local spikes linked to small gatherings. Authorities are concerned that they have less ability to track these events and that they are seeing signs that cases without symptoms or with mild symptoms are remaining undetected and spreading throughout the local communities. A second wave of infections appears to be occurring and it may be worse than the initial phase.
• President Moon Jae-in met with leaders of Protestant groups on Thursday, asking for their support in the fight against COVID-19, as churches continue to be linked to infection clusters. But church leaders remained uncooperative, reiterating that worship services are the essence of faith and ‘cannot be compromised.’
• The Korean government said Thursday they would report striking junior doctors to police, after they defied back-to-work orders issued the previous day. The Ministry of Health and Welfare said that the doctors’ noncompliance with the administrative orders would result in up to three years in jail or a fine of 30 million won ($25,300). They may be stripped of their licenses to practice as well.
• During a closed-door session of the parliamentary intelligence committee Monday, the Unification Ministry acknowledged that it had scrapped a plan to permit barter transactions with a North Korean trading company after one of the firms involved was found to be subject to international sanctions, according to lawmakers on the committee. The ministry had been considering approving the 150 million-won ($126,450) deal between a South Korean farmers’ group and the North’s Kaesong Koryo Insam Trading to bring in North Korean liquor in return for South Korean sugar.
• The coronavirus that has been spreading in recent outbreaks in South Korea mostly belongs to a variant prevalent in Europe, North America and the Middle East, health authorities said Wednesday, and is believed to be six times as infectious as the forms of the virus that emerged from China.
• Eight people residing in the same apartment building have been confirmed to have contracted the virus since August 23. The five households were living in adjacent apartments as well as above and below the first patient’s apartment. Residents were fearful that the apartment’s ventilation system was transmitting the virus, but health authorities looking into the situation have indicated the virus is unlikely to be transmitted in this manner.
• For visitors from South Korea, Taiwan has strengthened entry restrictions citing the resurgence in the virus outbreak mostly in the greater Seoul area. South Korea was taken off from Taiwan’s list of foreign countries relatively less prone to coronavirus infection, and business travelers arriving in Taiwan from the South should be in self-isolation for 14 days without exception, according to the South Korean Mission in Taipei.
• Korea is providing a financial package to inject 40 trillion won ($33.8 billion) into 1,000 selected innovative businesses over the next 3 years. The plan is designed as the final piece necessary to finalize and align the so called “Korean New Deal” incentives which are so far worth 160 trillion won and enable those companies to have unlimited loan credit when borrowing from the Korea Development Bank.
• The South Korean government has announced it will create at least 50 new job categories in the upcoming years, while providing necessary legal and fiscal support to tide over the worsening employment situation. It also pledged to inject 4.6 trillion won ($3.89 billion) into export-oriented service industries and adjust the government’s fiscal support regulations which have been focused on the manufacturing sector.
• Travelers from “high-risk” countries — Bangladesh, Pakistan, Kazakhstan, and Kyrgyzstan – are to submit certificates issued within 48 hours proving they tested negative for the coronavirus. Those without proof of the negative test result will not be allowed to board flights to Korea and could face deportation when they arrive. Even with the proof, they still need to self-quarantine for two weeks either at home or at designated facilities, depending on their visa status, and seek testing for the virus within three days of their arrival. The Philippines and Uzbekistan have more recently been added to the list of high-risk countries.
• 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.
• Korea appears to be moving toward implementation of a proposal that would potentially reduce the price of certain cardiac stents. AdvaMed is in touch with members and the medtech association in Korea and has had preliminary discussions with the US Government on this topic. Please contact Joseph Gatewood ([email protected]) if you have an interest in this matter and are not already engaged.
• Resources: http://ncov.mohw.go.kr/en/. 
• Staff Contact: Joseph Gatewood ([email protected]).

 ASEAN

• Weekly COVID-19 statistics – ASEAN now has 439,797 reported cases and 10,547 reported deaths compared to 395,800 reported cases and 9,545 reported deaths the previous week.
• The Philippines and Indonesia account for 97.6% of the deaths from COVID-19 in the region. Indonesia’s total COVID-19 deaths exceed 7,000, the highest level in East Asia. The Philippines reports 3.234 deaths.
• Cambodia, and Laos have each reported zero deaths, while Brunei has reported 3 deaths, Myanmar has reported 6 deaths, Singapore has reported 27 deaths (despite having over 56,000 cases), and Thailand has reported 58 deaths. All of these totals are unchanged from the previous week.
• The Philippine lifted its two- week lockdown in and around Manila, the center of the outbreak, and most businesses can reopen until at least August 31. Surgeries will be for emergency cases only. The government will intensify pooled testing and contact tracing to detect asymptomatic cases in communities and workplaces while allowing more people to go back to work. 
• Vietnam’s outbreak in Danang following 100 days without any locally transmitted cases has led to its first COVID-19 fatalities (30 reported to date). The government has re-imposed strong stay-at-home requirements and non-essential business closures in Da Nang, and 80,000 tourists have been evacuated from the city. Hanoi and Ho Chi Minh City issued directives requiring people to wear face coverings in public or face a monetary fine.
• Elective surgeries have resumed in Thailand and Vietnam. Thailand has gone over 80 days without a single case of community transmission.
• 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 government has lifted measures requiring doctors and healthcare workers in the public and private sectors to limit their movements across healthcare institutions. 
• Indonesia has lifted the ban on export of medical devices for COVID-19 purposes. At the same time, President Jokowi has called for an end to PPE imports as the country is capable of manufacturing them locally. Indonesia has produced its own rapid test called RI-GHA COVID-19. 
• 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 also holding talks to create a “green zone” for travel with Brunei, Thailand, New Zealand, Australia, Japan, and South Korea. 
• Singapore is in talks with Thailand to facilitate essential business travel through a reciprocal green lane arrangement.
• 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 Japan, New Zealand, and South Korea on similar arrangements. 
• 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.
• Thailand’s Centre for Covid-19 Situation Administration (CCSA) approved another extension of the state of emergency nationwide until September 30.
• Staff Contact:  Phil Agress ([email protected])

Europe 

Europe remains in decent shape, but they have had difficulty suppressing rates below a certain level, and there is now some upward spiking. The UK new cases are down, reflecting their position as lagging by a few weeks behind the continental countries. Italy, France, Spain, and Germany are seeing daily increases in cases, but not yet at extreme rates. However, authorities in those countries are clearly concerned and are looking at stricter measures. Spain leads the EU in cases and the UK leads the EU in deaths, followed by Italy and France. Although not in the EU, Russia’s reported numbers on COVID are problematic. Russia remains the COVID hot spot in Europe, now reporting 975,576 cases, with just 16,804 reported deaths.  By comparison, Italy, with much fewer (262,540) cases, reports 35,458 deaths. Russia recently has claimed its COVID curve is flattening, but there is skepticism of that claim. Russia’s response to COVID and overall rates remain a concern for EU countries who are looking to reopen borders.

• Italy, France and the UK are showing increases in new cases. France’s increase is most significant.
• New daily cases, which tends to show which countries are increasing in COVID incidence is as follows:  Spain 3,594 (down from 3,715 last week); Italy 1,367 (up from 642 last week) Germany 1,428 (down from 1,595 last week)); France 5,429 (up from 3,776 last week); UK 1,048 (up from 812 last week); Belgium 355 (down from 363 last week), Russia 4,676 (down from 4,828 last week).  Most countries are experiencing spikes in new cases. France’s level is its highest since emerging from lockdown.
• New deaths per day (which tend to lag any increased infection rates) remain low and are as follows:  Spain 47; Italy 13; Germany 7; France 16; UK 16; Belgium 1.  
• 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 is recommending member states gradually lift the travel restrictions for the following countries: Japan, Canada, Georgia, Australia, New Zealand, Rwanda, South Korea, Thailand, Tunisia and Uruguay. There has also been a recommendation to ease restrictions on China, subject to confirmation of reciprocity measures by China’s government.
• Across the EU, Belgium has banned travel to Paris due to COVID concerns. Spain has implemented stay at home orders to four million residents of Catalonia and is fighting back a second wave of the coronavirus — with no consensus on the way forward. The spread of the virus has accelerated in Spain this summer, with 3,594 new cases on Thursday. Germany is scheduled to ban large events until the end of the year amid fears of resurgence.
• The Commission continues to have exploratory talks with a number of vaccine companies to purchase a potential vaccine when it becomes ready. To date the Commission has reported positive talks with Sanofi-GSK, Johnson and Johnson, CureVac and AstraZeneca.
• The first contract the European Commission has negotiated on behalf of the EU Member States with a pharmaceutical company has entered into force following the formal signature between AstraZeneca and the Commission. The contract will allow the purchase of a vaccine against COVID-19 for all the Member States of the EU as well as the donation to lower and middle income countries or the re-direction to other European countries.
• Reporting on the (pan) EU initial response found that in late February, with its numbers tripling every 48 hours, Italy’s prime minister sent an appeal to fellow EU member states and the EU Commission for help. Italy’s hospitals were overwhelmed and its doctors and nurses had run out of the masks, gloves and aprons they needed to keep themselves safe. Hospitals were being forced to make life and death choices for patients due to an acute lack of ventilators. But Italy’s distress call was met with virtual silence and they did not receive the assistance it requested This appears to be related more to lack of overall preparedness among member states than indifference to Italy’s request.  
• European Commission Vice-President Valdis Dombrovskis will take over the trade portfolio temporarily after the resignation of Phil Hogan, Commission President Ursula von der Leyen said today. Hogan resigned Wednesday, a week after he breached Ireland’s coronavirus restrictions by attending an indoor golf society event with 80 other people. Hogan said he deeply regretted his trip to Ireland and conceded the “controversy” was becoming too distracting and “would undermine” his work in the coming Brexit negotiations. Hogan had initially resisted pressure to resign but some initial missteps in his handling of the fallout have taken their toll. Hogan was known as an experienced, effective negotiator. 
• The European Court of Justice has struck down the EU-US Privacy Shield law based on arguments from an EU plaintiff that the US security laws did not sufficiently protect EU citizens. Commerce Secretary Wilbur Ross expressed ‘deep disappointment’ in the ruling and said he would work with the EU to limit any negative consequences. AdvaMed had a virtual meeting/discussion with the Dept. of Commerce to obtain the latest information on the situation. We are enabling our members to provide details of problems they are experiencing directly to Commerce. There are discussions ongoing between the US and the EU Commission to try to find a solution to address the ECJ decision’s dictates. We are continuing to discuss these issues in the DSPWG and looking for ways to assist members. We will be scheduling an informational webinar soon as EU Member States and regional authorities struggle to issue guidance.
• In the UK, the NHS is preparing to spend up to £10 billion in private hospitals over four years in an effort to bring waiting lists down. The outsourced work aims to cut waiting lists, which are forecast “to increase as a result of Covid-19 interrupting and reducing NHS capacity”. It will include testing and imaging and inpatient and outpatient treatment for urgent planned care and cancer treatment.
• Unions have warned Care Quality Commission inspectors “could become covid-19 super-spreaders” after they were not included in plans for regular asymptomatic testing, despite experts’ assurances risk is minimal.
• The NHS’ reliance on Microsoft could be putting the organization’s computer systems at risk of another major cyber security attack, according Chair of the Royal College of GP’s Health Informatics Group.
• Covid-19 death tolls at individual care homes are being kept secret by regulators in part to protect providers’ commercial interests ahead of a possible second coronavirus spike. England’s Care Quality Commission (CQC) and the Care Inspectorate in Scotland are refusing to make public which homes or providers suffered the most fatalities amid fears it could undermine the UK’s care system, which relies on private operators.
• The UK has added Jamaica, Switzerland and Czech Republic to its quarantine list for incoming travelers.
• A leading Trust has said that NHS England’s ambitions for ‘near normal’ service levels this autumn are unlikely to be achieved, with current poor performance for waiting times for elective surgery, diagnostics and cancer treatment all expected to continue.  
• At least 350 people and their households will have to self-isolate after 75 staff tested positive for coronavirus at a poultry plant in Norfolk. Boris Johnson was urged to do more to get a grip on factory outbreaks.
• 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 has scrapped plans to discuss Brexit at a high-level diplomatic meeting next week. The message was fairly straightforward, stating “Since there hasn’t been any tangible progress in EU-UK negotiations, the Brexit item was taken off the agenda.” The move takes on greater significance given that Angela Merkel has been seen as a potential dealmaker in the talks. Both Germany and France have made recent public statements calling for ‘concrete answers’ from the UK.
• Germany’s use of mandatory testing for travelers arriving from high-risk areas (including the US) has triggered concerns regarding who will pay for the testing. Some are arguing the persons being tested should pay.
• Chancellor Angela Merkel and Germany’s 16 regional leaders have agreed to ban major public gatherings and impose a national fine for mask shirkers, as the country grapples with an increase in infections. There The minimum fine of €50 applies to anyone caught without a face mask in places where wearing one is compulsory, such as in shops and on public transport. Merkel also called for Germans to avoid travel to areas where the risk of exposure to coronavirus is high, citing both the US and India as examples. 
• There has been an unprecedented (80%) increase in the number of people in Germany without health insurance. More than 140,000 people living in Germany have no health cover. The rise comes despite the coronavirus pandemic and that it is compulsory in Germany to take out a health insurance policy.
• France is expected to announce details of a 100 billion euro recovery plan on September 3. This would come on top of existing measures that currently amount to around 460 billion euro.
• French Prime Minister Jean Castex has responded to a steep increase in infections with a series of measures including increased testing and compulsory face-coverings in Paris beginning August 28.
• A French company, Plaxtil, has developed a recycling process for COVID face masks. The masks are turned into a compound that is then used to make other products that can be used for a variety of purposes but are currently being put to use in the fight against COVID. Plaxtil says it has already recycled more than 50,000 masks, producing between 2,000 and 3,000 recycled products since the end of June.
• The 2020 Tour de France, scheduled to start in Nice on Saturday, is edging closer to collapse after the Alpes-Maritimes region, site of the opening stages of the race, was placed on red alert owing to the spread of the Covid-19 pandemic.
• France will announce coronavirus restrictions for British travelers in the coming days, Europe Minister Clément Beaune announced. He stated that the measures are designed for France to “. . . have a reciprocity measure so that our British friends do not close the border in one direction only.”
• 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 ([email protected]).  

Latin America

Regional

• Total COVID-19 cases up 8% and deaths up 7% over the previous week.

Mexico

• The AMLO administration working with the Mexican Congress recently pushed through changes to the Law of Acquisitions, Leases and Services of the Public Sector (LASSP) to allow the government (via the Mexican Institute of Health for Wellbeing – INSABI) to acquire pharmaceutical goods and medical devices through intergovernmental international organizations, specifically the United Nations Office for Project Services (UNOPS). Although this INSABI-UNOPS agreement runs from 2021-2024 and was established in the emergency context of COVID-19, the legislative change is consistent with AMLO’s long-time desire for more centralized purchasing and now defines the new GOM procurement model as it applies to drugs and medical devices.
• https://mexicobusiness.news/health/news/medicine-acquisitions-through-unops
• AdvaMed is working with its Mexican partner association AMID to inform the U.S. and Mexican governments of the expected negative impact of this legislative change and agreement.

WEEKLY HIGHLIGHTS –COVID 19

• Argentina: Ministry signs agreement for COVID-19 vaccine trials.
• Bolivia: Agro sector plan launched amid sanitary crisis.
• Brazil: Congress takes the lead with focus on mandatory spending block.
• Chile: Reopening plan moves forward as COVID-19 cases rose last week in Santiago.
• Colombia: Congress’ role in vaccine procurement and distribution discussions grows.
• Ecuador: The requisition of sedative drugs to be transferred to UCIs was announced.
• Mexico: Key changes took place in the public health system and sanitary regulation agencies.
• Paraguay: Government confirms fund allocation to procure COVID-19 vaccine through COVAX.
• Peru: President Vizcarra announced they seek to purchase the vaccine from five laboratories.
• Uruguay: As active cases declined government reopened borders to European tourists.
• Staff Contact: Steven Bipes ([email protected])