I’m in a two day meeting in Geneva on new approaches to affordable monoclonal antibodies (mAbs), and it made me think of a provision found in some bills that have been proposed or introduced in the U.S. Congress to force technology transfer for biologic drugs. One example is Section 6 from HR 4811, 117th Congress. The section is titled “Manufacturer Provision of Information.”
The bill was introduced by Representative Loyd Doggett (D-Texas), and had 79 cosponsors. The bill text is 50 pages, and the section on technology transfer, which appears on pages 37-38, has not received enough attention, so I wanted to highlight it for the meeting participants.
I will also note that in considering the technology transfer obligations, legislators were unsure when such an obligation should become effective, for example, after a set number of years or amount of sales revenue, or when a price is abusive, etc, and what the enforcement measures should be. Here the fines are not that significant for a blockbuster drug.
HR 4811, 117th Congress
https://www.congress.gov/bill/117th-congress/house-bill/4811
SEC. 6. MANUFACTURER PROVISION OF INFORMATION.
(a) In General.—In the case of a manufacturer of a drug or biological subject to a competitive licensing agreement under section 1860D–11(i)(5) of the Social Security Act, as added by this Act, such manufacturer shall, upon request from an entity electing to manufacture such drug or biological, provide to such entity materials, data, and information relating to the manufacture or supply of such drug or biological, including—
(1) cellular clones and hybridoma stocks;
(2) plasmids, plasmid maps, and sequences of antibody complementarity determining regions;
(3) physicochemical and biophysical characterization;
(4) growth conditions and protocols;
(5) attenuation or inactivation protocols;
(6) extraction and purification protocols;
(7) synthetic work-up and schemes;
(8) sufficient quantities of the drug or biological for testing;
(9) the protocols and methods used for testing the drug or biological; and
(10) the expected outcomes from those protocols.
(b) Enforcement.—The Secretary of Health and Human Services may impose a civil monetary penalty on a manufacturer of not more than $10,000 per day for a violation of subsection (a).