COVID-19 Regulatory Developments: Update 18
The outbreak of the COVID-19 pandemic has resulted in countries adapting their regulatory landscape to accommodate and mitigate the unprecedented disruptions to companies and individuals. Through regular updates, Compliance & Risks will closely monitor the situation and inform our clients of the latest global regulatory developments in relation to COVID-19 relevant to their topics, along with updates on items which may be of interest outside our topics.
EH&S: Occupational Health and Safety
California has introduced two new bills related to COVID-19. The first bill (AB 685, ‘Imminent COVID-19 Hazard to Employees’) creates an obligation for employers who receive a notice of potential exposure to COVID-19 to inform, within one business day, all employees, including subcontracted employees who were on the premises with the ‘qualifying individual’. Notifications to employees, sub-contracted employees and exclusive representatives shall include information on the disinfection and safety plan that the employer plans to implement in accordance with the guidelines of the Federal Centers for Disease Control. Employers also have a duty to provide information on COVID-related benefits and options available to employees under applicable federal, state, or local laws. The bill would require employers to report and communicate, within 48 hours, the number of cases which meet the definition of a ‘COVID-19 outbreak’ (i.e. three or more cases in the last 14 days) to the competent health authority in the jurisdiction of the workplace. If the number of cases meets the criteria of an outbreak, the employer shall provide the public health authority with the names, number, worksite and occupation of the affected employees. These records shall be kept for a period of three years. The bill enacts section 6409.6 of the California Labor Code, which will take effect on 1 January 2021.
The second Californian bill SB 1159 creates a rebuttable presumption of occupational injuries for COVID-19. It includes COVID-19 in the list of ‘injuries sustained in the course of employment’ thereby giving rise to employees’ compensation until 1 January 2023. This means that any claim relating to COVID-19 is presumptively compensable subject to specific exceptions. In particular, in order to receive compensation employees will need to exhaust their paid sick leave benefits and meet specified certification requirements before receiving any temporary disability benefits. Employees would also have to be tested positive within 14 days after performing labor or services at the employee’s place of employment. Such work or services must have been performed on or after 6 July 2020. Finally, the employee must be tested positive during a period of an outbreak at the employee’s specific place of employment.
A similar bill establishing a presumption of workers’ compensation coverage for COVID-19 cases has been approved for essential workers in New Jersey.
The Californian Occupational Safety and Health Standards Board is considering two new COVID-19 emergency regulations for adoption in November 2020. According to the petition file received by the Board, the first regulation would consist in a ‘temporary emergency standard that would provide specific protections to California employees who may have exposure to COVID-19, but who are not protected by the Aerosol Transmissible Diseases standards’. The second proposed standard would be a permanent rulemaking effort to protect workers from infectious diseases including novel pathogens (e.g. COVID-19). The framework would be established in parallel to the existing Illness and Injury Prevention Program (IIPP) regulation and requires employers to create a written plan for employee protection, together with additional “procedures to identify and evaluate COVID-19 workplace hazards and to identify jobs categories, tasks, and procedures where employees may be exposed to COVID-19”. The OSHSB approved the petition and committed to submit a proposal for consideration no later than the 19 November 2020.
On 25 September 2020, Oregon Occupational Safety and Health released a second draft COVID-19 Temporary Standard after receiving a series of feedback. As discussed in our previous update, the Oregon Occupational Safety and Health Administration issued a first draft COVID-19 Temporary Standard on 17 August 2020 and gave interested parties an opportunity to comment until 7 September 2020. The new draft does not bring any major changes to the original standard. It applies to all workplaces albeit with gradual requirements depending on the level of risks and exposure. The requirements for all workplaces include a mandate for physical distancing, face coverings, sanitation, appointment of a distancing officer as well as posting, information and training requirements for employees. The Agency removed the provisions which obliged employers to provide paid leave to employees who were required to isolate or self-quarantine where reassignment was not possible. A copy of the proposed temporary standard developed by Oregon OSHA can be found here.
The Israeli Ministry of Health has published a similar Temporary Order to restrict activities in the workplace in the wake of COVID-19. The order, which came into force on 10 August 2020, imposes posting and notification requirements on employers and requires the designation of a Coronavirus Officer who will be responsible for ensuring physical distancing and compliance with all regulatory requirements within the workplace.
The Government of Ontario continues to support businesses and employees by extending protection against permanent job losses resulting from temporary layoffs until 2 January 2021.
Mandatory screening requirements came into force in Ontario on 26 September 2020. An amendment to the Ontario Regulation for Stage 3 Areas has been issued and requires employers to carry out employee screening in compliance with the new Screening Tool for Workplaces issued by the Ministry of Health on 5 September 2020. Section 2 of the Regulation introduces new requirements whereby ‘the person responsible for a business or organization that is open shall operate the business or organization in compliance with the advice, recommendations and instructions of public health officials, including any advice, recommendations or instructions on physical distancing, cleaning or disinfecting’. This also includes advice, recommendations and instructions issued by the Office of the Chief Medical Officer of Health with respect to screening individuals. Failure to use the government’s screening tool will give rise to significant fines. A physical distance of at least two meters shall be maintained between individuals in business premises and facilities, unless the exceptions of Schedule 2 allows persons to be closer together.
While not related to health and safety, it is worth mentioning that the maximum allowable length of leave that employees can claim in relation to COVID-19 in Ontario has been extended to 28 weeks. The measure was taken in response to the recent increase in the number of weeks a worker is entitled to receive the Canada Emergency Response Benefit. Employees working in a federally-regulated sector are now entitled to a maximum of 28-weeks unpaid job-protected leave if they were unable to work for reasons related to COVID-19 (e.g. quarantine, self-isolation, infection of dependent individuals).
At the Federal level, Bill C-4 has been introduced in second reading to amend the eligibility criteria for the sick leave related to COVID-19 and clarify the number of weeks that an employee is entitled to take for each of these criterion under the Canada Labour Code. Further changes to the COVID-19 Emergency Response Act are proposed to ensure that employees may continue to take COVID-19 related leave until September 25, 2021. The new bill also proposes to increase the amount of the Canada Recovery Benefit to $500 per week.
The Canadian Centre for Occupational Health and Safety has updated its C-19 Resources by adding a new ‘COVID-19 Workplace Health and Safety Guide” which completes a series of tip sheets on screening, face coverings and operating procedures for disinfection. Per the Workplace Health and Safety Guide, employers must:
- Make sure workers know about the virus, and the steps the workplace is taking to minimize its spread
- Communicate COVID-19 information to workers using languages and formats that they clearly understand and can easily access
- Set a clear policy for what is expected of workers if: a) they get sick, b) they have symptoms of COVID-19, c) they may have been exposed to someone with COVID-19 and d) an exposure is reported at the workplace
- Do everything possible, under the circumstances, to protect the health and safety of workers by using control measures, and providing adequate information, training, sanitation, and personal protective equipment
- Make sure workers are trained to work safely, and are trained before replacing the duties of other
The Scottish Government issued short guidance for the technology sector on safe re-opening during the coronavirus pandemic. In summary, the guidance encourages the development of risk-based approaches which identify risks and mitigation measures to be implemented to safeguard the health and safety of employees while maintaining the economic viability of businesses. Risk-based approaches must be developed in close collaboration with employees through trade unions or workforce representatives. The HSE’s short guide on working safely during the coronavirus outbreak may help employers develop robust risk-based approaches.
The Belgian Legislative Assembly introduced a draft law to maintain the income of employees who are unable to work due to quarantine or self-isolation.
In Argentina, the Ministry of Productive Development signed a resolution that suspends the time limits of all legal and contractual guarantees within the meaning of the Consumer Protection Law 24240. The suspension runs for the entire period within which the consumer has been unable to exercise their rights due to social, preventive and mandatory isolation dictated by the decree No. 297/2020. Suppliers of goods and services must inform consumers in a correct, clear and detailed manner about such a suspension prior to payment operations.
Wireless and Telecommunication Equipment
ANATEL, the National Telecommunications Agency of Brazil, has extended until 30 December 2020 the instructions contained in Official Letter No. 134/20, 194/20 and 384/20 which make the process of maintaining the certificates issued by the Agency more flexible in the context of COVID-19. Official Letter 134/20 and 194/20 – 384/20 authorized the maintenance of certificates based on the presentation of the necessary declarations for the conduct of the certification process, photos and test reports.
In Argentina, the validity of energy performance certificates for household electrical appliances has been extended for a second time until 1 October 2020 (Resolution 252/2020). Whether further extension will be granted is yet uncertain. The first deferral of expiry date was already approved by the Ministry of Productive Development in April 2020 under Resolution 119/2020.
British Columbia has enacted a new legislation which confirms financial support for people and businesses. In summary, the Economic Stabilization Act brings the B.C. Emergency Benefit for Workers into law and authorizes a number of filing and payment deferral for employer health tax, provincial sales tax, carbon tax and motor fuel tax to 30 September 2020. Further information may be found here. In conjunction to this, the Government has announced that the state of emergency will once again be extended until 13 October 2020. The extraordinary powers granted to health and emergency management officials under the Emergency Program Act will therefore continue to apply until this date.
Medical Devices and Personal Protective Equipment
Mexico has launched a new electronic appointment system for applicants seeking registration or in-person meeting with COFEPRIS, the division of the Mexican Ministry of Health responsible for approving medical devices and IVD.
The Federal Food and Drug Administration (FDA) has published new guidance in the form of FAQs to support registration, listing and the import medical devices during the pandemic. The first FAQ answers questions about procedures and requirements concerning the registration of facilities and listing of devices. It addresses aspects related to 1) registration and listing of facilities during the COVID-19 pandemic, 2) confirmation of registration and listing information, and 3) registration and listing of certain medical devices for personal use during the emergency. The second FAQ provides information on importing NIOSH and non-NIOSH approved respirators, face masks and PPE. It describes procedures for importing devices subject to Emergency Use Authorizations (EUA) and for devices for which an enforcement discretion policy has been issued by the FDA.
Note that the FDA is currently seeking feedback on proposed changes to the definition of ‘intended use’ in relation to medical devices. The FDA contends that this initiative will ‘amend FDA’s regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations, including whether an approved or cleared medical product is intended for a new use’.
From 1 January 2021 the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market. Earlier in September, the Agency developed Guidance to clarify how the medical devices regulation will apply to the certification, marking and registration of devices placed on the UK market after the end of the Brexit transitional period. In summary, the guidance outlines that the CE marking will continue to be used and recognized in the UK until 30 June 2023. The certificates issued by EEA notified bodies will remain valid until 30 June 2023. A new certification route will apply to devices placed on the UK market with effect from 1 January 2021. From 1 January 2021, all medical devices and in vitro medical devices will need to be registered with the MHRA albeit with certain grace periods depending on the classification of the device. Further details may be found here.
On 22 September 2020, the Russian Federation issued new legislation which regulates the licensing of production and maintenance activities for medical equipment. Production and maintenance of medical devices would be subject to registration with the Federal Service for Surveillance in Healthcare until 31 December 2023.
Additional regulatory developments concerning medical devices and PPE in the United States include the introduction of a new bill to address circumvention of copyright protection systems with respect to the maintenance or repair of critical medical devices.