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Product Regulation & Liability

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As the world prepares for the rollout of the COVID-19 vaccine, manufacturers, governments, and clients in the logistics sector are looking into various structures and arrangements that will help bring the vaccine to the public as soon as possible.

Our Primer focuses on key legal issues and high-level considerations on topics such as the procurement framework, regulatory approvals, and contractual stipulations relating to the supply and distribution of the COVID-19 vaccine across 14 Asia Pacific jurisdictions.

Join Baker McKenzie regulatory and enforcement practitioners as we navigate this uncertain time and work together through the challenges ahead. We offer practical advice and real-time analysis of the changing landscape across the United States, Europe and Asia. Webinar Series: The New Framework for Investment Adviser Marketing In this 4-part…

Even though the term “cosmeceutical” is not new from the global market perspective, such products are considered relatively new from the Thai legal perspective. The Thai Food and Drug Administration (FDA) has been working on finding a new product category for herbal-based/herbal-related products with health claims for quite some time and has recently introduced the Herbal Product Act B.E. 2562 (HPA). The HPA will, generally speaking, regulate and manage the herbal drugs and herbal products which cosmeceutical is part of.

After having rejected initially any possibility in this regard, the Federal Ministry of Health (“MoH”) issued a Decree, published in the Official Gazette on 25 January 20211 establishing the conditions under which the local (State) governments and the private sector, can participate in the National Vaccination Program for COVID-19. Although it does not eliminate many uncertainties, it opens certain possibilities of action.

The increase in legal and regulatory measures arising out of COVID-19 is truly proportional to the growth of the pandemic itself. Although the measures affect all industries, many of these have direct implications and relevance on the healthcare and life sciences sectors. While some industries and services are forced to shut down, companies in the healthcare and life sciences ambit are pushed to work even harder, innovate faster, collaborate and be resilient at an unprecedented pace.

Such measures aim to assure supplies of medicines and medical devices at home as well as to accelerate R&D through incentives. While the pandemic has put some clinical trials in jeopardy, many jurisdictions are now passing special regulations to protect patients while ensuring that ongoing trials can continue. Industry peers are “sharing” IP, be it through compulsory licensing or forced collaborative manufacturing arrangements. Many countries have adopted specific measures to broaden access to telemedicine, a trend expected to survive and grow well beyond the pandemic.