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.
In this guide, our experts from jurisdictions in Asia Pacific; Europe, Middle East and Africa; Latin America; and North America provide high-level insights to commonly asked questions around market access, clinical trials, IP risks and telemedicine. It answers the following questions:
• How has the regulator in charge been addressing the urgent needs for medicines, medical devices and medical supplies?
• What are the opportunities for market access in terms of regulatory approval?
• What are the challenges for market access in terms of regulatory approval?
• Are there any state emergency supply measures for medicines, medical devices and biocides and what are the implications on IP protection?
• Are there any issued or discussions on likely issuance in response to the COVID-19 outbreak?
• What have been the major impacts on the management of clinical trials?
• Have there been regulatory measures to assist with clinical trial management?
• Are there any general tips and recommended solutions under the local regulatory framework?
• How has the COVID-19 outbreak changed the use and provision of telemedicine services?