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Following years of market domination by the conventional automobile industry, EV technology is now emerging as an environment-friendlier alternative, opening up various new opportunities for businesses as well as consumers all around the world. EV development permeates the whole chain of the present automotive industry, from the manufacturing and distribution sectors to subscription and ride-sharing or ride-hailing businesses. To operate an EV business in Thailand, there are certain legal concerns you need to take into account.

Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.

EFPIA, the European Federation of Pharmaceutical Industries and Associations and IFPMA, the International Federation of Pharmaceutical Manufacturers and Associations, published at the end of September 2022 a long-awaited Note for Guidance to assist their member companies with their use of social media and digital channels. The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code.

Advertising is a great way for business operators to connect with consumers, and advertisers today are able to reach more customers than ever before through the use of various media and channels (e.g., electronic, social media, brochures, newspaper advertising and TV advertising). In response to this, the Office of the Consumer Protection Board has deemed it necessary to step up its efforts to protect consumers. This article discusses the potential regulatory development that business operators should be aware of concerning the use of advertising that presents unsubstantiated claims or statements that are difficult to prove true.

The ACCC has announced two internet sweeps to identify misleading environmental and sustainability marketing claims and fake or misleading online business reviews and a separate sweep to target fake or misleading online reviews and testimonials. The sweeps are being conducted as part of the ACCC’s compliance and enforcement priorities for 2022-23 announced earlier this year, with the broad aim of identifying deceptive advertising and marketing practices related to the environment and sustainability.

The pandemic acted as a catalyst for acceleration of the metaverse, as increased remote working, studying and the need for remote healthcare provision have increased consumer acceptance of online interactions and created demand for those interactions to be more “life-like.” At the same time, rapidly developing technology and infrastructure is creating the opportunity to perform more activities virtually. The exploration of this new realm may not necessarily be smooth sailing. New challenges may arise in relation to data protection and cybersecurity. Familiar considerations like compliance with regulatory regimes or IP protection may give rise to complexities that are otherwise not apparent at first glance. Parallel trade also continues to generate disputes between IP owners and parallel importers, and our report highlights some recent developments. Baker McKenzie’s trends report provides a summary of some of the key issues to consider from a trademark perspective.

Since late 2020 a reimbursement fast-track program for the most innovative oncology and rare disease treatments (defined as highly innovative medicinal technologies (HIMT)). For example, the first ever HIMT has become reimbursed for this new procedure in less than two years since its authorization. We also observe an increasing number of rare disease therapies being reimbursed in a standard procedure and the Minister of Health has recently reported progress in the implementation of the Plan for Rare Disease for 2021-2023.

On 13 September 2022, the Health Sciences Authority (HSA) issued a retail-level recall in respect of a therapeutic product found to contain foreign matter. Earlier this month, the HSA also issued an update on products found and reported by overseas regulators to contain potent ingredients, and briefly explained the possible side effects of the potent ingredients.

On 2 September 2022, the Singapore Ministry of Health announced that additional transitional support will be provided to cancer patients with changes introduced to the financing regime of cancer drugs.
Subsidies of clinically effective and cost effective cancer drugs will, with effect from 1 September 2022, be extended through the Medication Assistance Fund at Public Healthcare Institutions.
Additional transitional support will also be implemented to cushion the impact of cancer drug spending for patients with IPs that currently cover their treatments and patients with MediShield Life only.