As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.
A helicopter view of each stage of the healthcare & life sciences supply chain lifecycle and an overview of the trends that businesses in the sector should consider in 2021 and beyond, including sustainability, digitalization and increased public funding.
On November 15, President Biden signed the more than USD 1 trillion Infrastructure Investment and Jobs Act into law. Despite substantial criticism and various attempts to amend the bill while it was under debate in Congress, the Infrastructure Act includes two changes to provisions of the Internal Revenue Code that deal with reporting obligations for certain digital assets transactions. Although one of these changes received much more attention than the other.
On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.
On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.
On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.
In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
In a recent interview Mr. Anutin Charnvirakul, the Minister of Public Health, lauded the many community enterprises all over Thailand which have been growing cannabis for hospitals to extract for medical purposes and the hundreds of medical cannabis clinics all over the country which have proven to be very popular with the Thai people. The Minister was pleased with how Thai people have embraced cannabis and has again stressed his mission to make cannabis both a cash crop, as well as a medicine, for the nation. He also mentioned intended efforts to continue with liberalizing the laws and regulations on cannabis even further to increase access to cannabis.
In the current narcotics and psychotropic substances regulatory regime, there are numerous laws governing narcotics and psychotropic substances which are enforced by different regulatory bodies. The Thai government aims to modernize certain current provisions and to incorporate these laws into the Narcotics Code for ease of reference and consistency in law enforcement.
The Ministry of Public Health has issued notifications to amend the list of formula of Thai traditional medicine containing cannabis under the Herbal Product Act which is allowed for use to treat a disease or for research, and to amend the information, warnings or precautions required to be displayed on the package inserts of Thai traditional medicine containing cannabis.