[Ip-health] March-in rights aren't a drug price control tool, a final Department of Commerce Report is expected to declare this week. Many patient advocacy groups aren't happy.

James Love james.love at keionline.org
Fri Apr 19 09:19:44 PDT 2019


Nice story by Politico on NIST, although it would have been nice to mention
that KEI has filed comments on the Green Paper (
https://www.keionline.org/29555), and at least mentioned us as a signature
of the NGO letter they quote.  Or the earlier UACT letter which was hand
delivered on the hill.

https://cancerunion.org/2019/02/26/uact-letter-to-congress-regarding-nist-recommendations-to-limit-bayh-dole-act-safeguards/

Jamie

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https://www.politico.com/newsletters/prescription-pulse/2019/04/19/commerce-department-expected-to-slash-march-in-rights-for-drugs-426742


04/19/2019 12:00 PM EDT
By SARAH KARLIN-SMITH (skarlin at politico.com; @SarahKarlin) , SARAH
OWERMOHLE (sowermohle at politico.com; @owermohle)

— March-in rights aren't a drug price control tool, a final Department of
Commerce Report is expected to declare this week. Many patient advocacy
groups aren't happy.

. . .

DRUG PRICING

COMMERCE REPORT: MARCH-IN RIGHTS SHOULDN'T BE USED AS DRUG PRICE CONTROL
TOOL — Advocates of lower drug costs are concerned that the Department of
Commerce's National Institute of Standards and Technology will finalize a
little-noticed green paper that recommends against the government
exercising its "march-in" rights to help lower the cost of medicines. NIST
said the final paper should be released next week. It will be reviewed by
an interagency panel, and regulatory changes could follow. Many Democrats
in Congress have raised the possibility of using march-in rights or similar
authority to revoke patent rights or marketing exclusivity on certain
drugs. They've tried to use the idea as a stick to encourage companies to
cooperate on drug price negotiations.

The background: The 1980 Bayh-Dole Act laid out a pathway to freely
transfer inventions and patent rights resulting from federally funded
research to non-government organizations, so they could be commercialized.
But the law outlined limited circumstances where the government could
"march in" and let other parties produce the patented invention, including
when health and safety needs were not being satisfied in a reasonable way.
Groups like Doctors Without Borders and Knowledge Ecology International
have petitioned NIH to claim that the the high cost of a medication can
satisfy the definition of an unmet need. So far, NIH has never agreed with
this argument.

Now, NIST is recommending changes to Bayh-Dole Act regulations to ensure
march-in rights are never used to control the price of a good, specifically
pharmaceuticals.

Advocates push back: Doctors Without Borders has strongly objected to the
idea. "Agencies relying on public funds to develop life-saving medicines
should not seek to curtail the public's right to appropriate, affordable
access to products developed with public support by this proposed
unilateral regulatory action," the group wrote in comments on the green
paper. The change it proposes "goes against the stated goals of the
administration to lower drug prices and calls by more than 50 members of
Congress to use march-in rights to address 'soaring' pharmaceutical
prices." The group notes that a March 2018 study found NIH funding
contributed to each of the 210 new drugs approved by FDA from 2010 through
2016.

Eleven groups including Doctors Without Borders, Public Citizen, Social
Security Works and the Yale Global Health Justice Partnership wrote
Congress earlier this month urging lawmakers to oppose the change. They
also raised concerns that another suggestion in the report could harm
access to affordable medicines. This change would narrow the government's
royalty-free rights to inventions whose development it funded, to exclude
situations where the government isn't directly using or consuming the
patented good. This would prevent the government from using royalty-free
rights to provide affordable drugs in Medicare or other government programs.

"At a time when drug prices have become increasingly unaffordable for
American patients, the administration's proposals in the NIST paper outline
provisions designed to protect pharmaceutical companies that sell expensive
treatments, and exempt them from obligations to ensure that treatments are
affordable and accessible," the letter says.


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