While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.
The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
President Donald Trump’s penchant for tariffs as a negotiating tool was on full display when he slapped a 25% tariff on products coming from Mexico and Canada – which may already been suspended in the case of Mexico. The actual impact of the tariffs on med tech is nonetheless tough to gauge due in no small part to the prospect that manufacturers will simply pass on at least part of the tariff to its customers in the U.S.
Beijing’s policy of favoring domestic medical technology is a matter of record, but the European Commission apparently heard enough from EU med tech firms to take action. The Commission posted notice that it may take steps to retaliate by restricting bids from China for EU government contracts in retaliation, a move certain to draw cheers from European device makers.
Medtronic plc and Irvine, Calif.-based Axonics Inc. have been locked in a struggle over several patents in the past few years, but now Medtronic has shifted some of its effort from the U.S. courts to the executive branch.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
A threat is currently hanging over the Swiss medical device industry, which is heavily reliant on trade with the EU. Upcoming changes to the CE marking regime will have the effect of making the mutual recognition agreement (MRA) obsolete. This currently allows Switzerland to enjoy unrestricted access to the medical device market in the 27 member states. Up until now, this bilateral agreement has regulated trade between Switzerland and the EU.
The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently.
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