,,ii #aaith ,,congress #b;d ,session ,s4 #ecaf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #f1 #bjbf,mr4 ,ricketts 7for himself and ,ms4 ,slotkin7 introduced the following bill2 which was read twice and referred to the ,committee on ,banking1 ,housing1 and ,urban ,affairs ,a ,,bill ,to amend title ,,viii of the ,defense ,production ,act of #aiej to include biotechnology in the definitions of prohibited technology and notifiable technology1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,biotech ,investment ,national ,security ,act of #bjbf or the ,,binsa ,act4 #b4 ,findings2 sense of ,congress 7a7 ,findings ,congress finds the following3 7#a7 ,the ,people's ,republic of ,china has pursued a deliberate1 state-directed strategy to dominate global biotechnology1 including pharmaceutical development1 biologics manufacturing1 and clinical research and development capabilities4 7#b7 ,united ,states capital flowing to ,chinese biotechnology companies through licensing agreements1 joint ventures1 and equity investments is accelerating the acquisition by the ,people's ,republic of ,china of pharmaceutical intellectual property and clinical development capabilities in a manner that creates strategic dependency risks for the ,united ,states4 7#c7 ,cross-border out-licensing transactions between ,united ,states and ,european pharmaceutical companies and ,chinese biotechnology firms totaled approximately #acf1jjj1jjj1jjj in #bjbe1 representing a rapid and accelerating transfer of pharmaceutical innovation capacity to entities subject to the direction and control of the ,people's ,republic of ,china4 7#d7 ,biotechnology1 including pharmaceutical development and biologics manufacturing1 has civil-military dual-use applications and presents strategic dependency risks for the ,united ,states comparable to those presented by semiconductors1 artificial intelligence1 and other technologies already covered by title ,,viii of the ,defense ,production ,act of #aiej 7#ej ,u4,s4,c4 #deha et seq474 7#e7 ,section #hea of the ,national ,defense ,authorization ,act for ,fiscal ,year #bjbf 7,public ,law #aai-fj2 #da ,u4,s4,c4 #cija note prec47 7commonly referred to as the ,,biosecure ,act71 recognized that biotechnology is both a national security asset and a strategic vulnerability1 and that the ,people's ,republic of ,china seeks to dominate biotechnology as an industry of the future4 7b7 ,sense of ,congress ,it is the sense of ,congress that consistent application of outbound investment screening to biotechnology is necessary to prevent ,united ,states capital and intellectual property from accelerating the dominance by the ,people's ,republic of ,china of the pharmaceutical innovation supply chain in a manner that will create long-term strategic dependency risks analogous to those the ,united ,states now faces with respect to rare earth elements and semiconductors4 #c4 ,inclusion of biotechnology and licensing of technologies in prohibited and notifiable transactions ,section #hji of the ,defense ,production ,act of #aiej 7#ej ,u4,s4,c4 #dehi7 is amended-- 7#a7 in paragraph 7#d77;,a7-- 7,a7 in clause 7vii71 by striking 2 or and inserting a semicolon2 7,b7 by redesignating clause 7viii7 as clause 7ix72 and 7,c7 by inserting after clause 7viii7 the following3 7viii7 licensing of a prohibited technology from a covered foreign person2 or 2 7#b7 in paragraph 7#g77;,a71 by adding at the end the following3 7vi7 ,biotechnology1 meaning the research1 development1 manufacturing1 or commercialization of-- 7,i7 pharmaceutical products 7which has the meaning given the term drug in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7772 7,,ii7 biological products 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7772 and 7,,iii7 therapeutic compounds1 including drug discovery platforms1 clinical research and development capabilities1 biologics manufacturing1 and intellectual property and know-how relating to therapeutic compounds4 2 and 7#c7 in paragraph 7#aj77;,a71 by adding at the end the following3 7vi7 ,biotechnology1 meaning the research1 development1 manufacturing1 or commercialization of-- 7,i7 pharmaceutical products 7which has the meaning given the term drug in section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7772 7,,ii7 biological products 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7772 and 7,,iii7 therapeutic compounds1 including drug discovery platforms1 clinical research and development capabilities1 biologics manufacturing1 and intellectual property and know-how relating to therapeutic compounds4 4 #d4 ,rulemaking 7a7 ,in general ,the ,secretary of the ,treasury shall1 not later than #a year after the date of the enactment of this ,act1 issue a rule to further define the parameters of the area of biotechnology1 as used in paragraphs 7#g77;,a7 and 7#aj77;,a7 of section #hji of the ,defense ,production ,act of #aiej1 as amended by section #c4 7b7 ,requirements ,when defining the parameters of the area of biotechnology pursuant to subsection 7a71 the ,secretary of the ,treasury shall-- 7#a7 consult with the ,secretary of ,health and ,human ,services1 the ,secretary of ,defense1 and the ,director of ,national ,intelligence2 7#b7 give particular consideration to transactions involving the licensing of intellectual property1 drug discovery platforms1 clinical research and development capabilities1 and biologics manufacturing know-how to covered foreign persons 7as defined in section #hji of the ,defense ,production ,act of #aiej72 7#c7 give particular consideration to licensing transactions1 joint ventures1 and equity investments involving drug discovery platforms1 clinical development capabilities1 and biologics manufacturing as priority categories for both the prohibited and notifiable technology tiers within the biotechnology sector2 7#d7 consider the degree to which a transaction would transfer pharmaceutical innovation capacity1 clinical development capabilities1 or manufacturing know-how to entities subject to the direction or control of the ,people's ,republic of ,china2 and 7#e7 not define the biotechnology sector in a manner that includes or could be construed to include agricultural biotechnology1 industrial fermentation unrelated to pharmaceutical or therapeutic production1 or basic academic research with no direct pharmaceutical or therapeutic application4 #e4 ,report required 7a7 ,in general ,not later than #fj days after the date of the enactment of this ,act1 the ,secretary of ,defense shall submit to the appropriate congressional committees a report assessing whether flows of the ,united ,states capital into the biotechnology sector of the ,people's ,republic of ,china1 including through licensing transactions with ,chinese biotechnology firms1 negatively affect the ,united ,states national security and military readiness4 7b7 ,form ,the report required by subsection 7a7 shall be submitted in unclassified form but may include a classified annex4 7c7 ,appropriate congressional committees defined ,in this section1 the term appropriate congressional committees means-- 7#a7 the ,committee on ,armed ,services of the ,house of ,representatives2 7#b7 the ,committee on ,financial ,services of the ,house of ,representatives2 7#c7 the ,permanent ,select ,committee on ,intelligence of the ,house of ,representatives2 7#d7 the ,select ,committee on the ,strategic ,competition between the ,united ,states and the ,chinese ,communist ,party of the ,house of ,representatives2 7#e7 the ,committee on ,armed ,services of the ,senate2 7#f7 the ,committee on ,banking1 ,housing1 and ,urban ,affairs of the ,senate2 and 7#g7 the ,select ,committee on ,intelligence of the ,senate4