Legal aspects of Personal Protective Equipment
More than masks and gloves – PPE in Thailand
Personal Protective Equipment is worn or held for protection against one or more safety hazards. This covers face masks, sunglasses and other eye protection, gloves and gowns, earplugs, helmets, certain items of clothing and safety footwear, but also gold standard PPE suits. The design, manufacturing, and distribution of such safety products have been a relevant industry for decades. The coronavirus outbreak has skyrocketed the significance and popularity of PPE. Personal protective equipment derived to a strategic commodity and is increasingly under the pressure of regulatory limitations. Hoarding and profiteering on essential medical equipment and PPE has become a serious global problem since the start of the global pandemic. #CoronaAlliance
Thailand promotes itself as a manufacturing hub for medical and personal protection equipment as part of its financial strategy amid the pandemic crisis, as industries like tourism and hospitality struggle. The Ministry of Public Health has joined forces with related agencies to develop reusable PPEs that are domestically manufactured. The “PPE Innovation Platform” has been concluded between the Food and Drugs Administration, the Government Pharmaceutical Organization, the Department of Medical Sciences, the Department of Science Service, the Thailand Textile Institute, and 13 certified manufacturers. This is part of a more holistic strategy to increase the promotion of health-related industries such as rubber gloves, food supplements, cosmetics, and medical supplies like masks to boost the national economy.
PPE and international supply chains
Sourcing and pricing challenges: COVID-19 has forced healthcare workers and first responders to rapidly adapt to new safety protocols and use large volumes of PPE. Europe and the USA have limited means of actually producing PPE domestically. Reportedly, more than 60% of the world’s PPE is made in Malaysia, with the majority of the remaining supply coming from Thailand and China. Being heavily dependent on Asian manufacturing, first-world countries find themself in a drastically insecure sourcing situation. Sourcing and pricing challenges are combined with high regulatory standards for medical products.
Thailand’s regulatory framework: The design, production, marketing, export and import of personal protective equipment is in Thailand subject to a complex regulatory framework including the Medical Devices Act and the Cosmetics Act. It is governed by various government agencies including the Internal Trade Department and Thailand’s Food and Drug Administration. Rules are currently strictly enforced by the Department of Special Investigation, the “Thai FBI”. The Thai Industrial Standards Institute (TISI) has set-up 1,600 standards for local products, including standard guidelines for cloth face masks on July 14, 2020.
The European Regulation 2016/425 classifies all PPE into one of three risk categories. For simple products, manufacturers can accomplish a self-certification process. For more safety-relevant PPE, manufacturers require an EU Type Examination, that can be done by independent testing. Complex products require an ongoing assessment of compliance under EU rules annual factory audits. The import and distribution into the European Union require an EU Declaration of Conformity (DoC) to prove that the PPE meets the Essential Health and Safety Requirements (EHSR) listed and described in the PPE Regulation.
US OSHA: In the United States of America, personal protective equipment is addressed in specific standards under the Occupational Safety and Health Administration for the general industry, maritime, and construction. OSHA requires that many categories of personal protective equipment meet or be equivalent to standards developed by the American National Standards Institute (ANSI). There are 28 OSHA-approved State Plans, operating state-wide occupational safety and health programs. State Plans are required to have standards and enforcement programs that are at least as effective as OSHA’s and may have different or more stringent requirements.
Legal advice and transactions support from the investment law firm in Bangkok
PUGNATORIUS Ltd. is the specialist provider of transactional legal and tax advice on foreign investments in Thailand’s manufacturing and service industries as well as property developments and acquisitions. The Bangkok law firm represents the legal interests of parties involved in the supply chain in legal and tax matters, from the drafting of contractual agreements, through negotiations, to assistance in the conclusion of contracts and the management of disruptions in the execution of contracts.
Cross-border PPE supply chain: The law firm advises regarding the regulatory environment and legal requirements for products, facilities, vehicles, and routes of the PPE cross-border supply chain and assists in applying for the necessary permits and licenses. It represents the client’s interests in communicating with the foreign parties involved in the transit and distribution countries.