[Ip-health] US Congressional efforts to control the cost of DoD funded drugs

Kim Treanor kim.treanor at keionline.org
Mon Jul 17 10:54:32 PDT 2017


https://www.keionline.org/node/2832

US Congressional efforts to control the cost of DoD funded drugs
Kim Treanor on 17 July 2017

The report of the Senate Armed Services Committee on the National Defense
Authorization Act of 2018, S. 1519, published July 10, 2017, includes a
directive that links exclusive patent rights to the prices of drugs,
vaccines and other medical technologies that are based upon DoD-funded
inventions.

The text of the directive, approved unanimously by the full Senate Armed
Services Committee, is as follows:

115TH Congress, 1st Session, 2017, Senate Report 115–125. National Defense
Authorization Act for Fiscal Year 2018. Report to accompany S. 1519, page
173.
Licensing of federally owned medical inventions
The committee directs the Department of Defense (DOD) to exercise its
rights under sections 209(d)(1) or 203 of title 35, United States Code, to
authorize third parties to use inventions that benefited from DOD funding
whenever the price of a drug, vaccine, or other medical technology is
higher in the United States than the median price charged in the seven
largest economies that have a per capita income at least half the per
capita income of the United States.

The language in Senate Report 115-125 was originally proposed by Senator
Angus King (I-ME), who serves on the Committee on Armed Services. The
Committee on Armed Services is empowered with legislative oversight over
the Department of Defense and military research. The text in the
committee’s report explains the legislative intent and carries weight as a
directive to the Department of Defense. The Committee on Armed Services
report creates an affirmative obligation to use the aforementioned rights
in the case of a violation.

The two rights cited in the report both fall under the Bayh-Dole Act. The
first is 35 U.S.C. § 209(d)(1), which specifies that in any license of a
federally-owned invention, the license must retain a provision “retaining a
nontransferable, irrevocable, paid-up license for any Federal agency to
practice the invention or have the invention practiced throughout the world
by or on behalf of the Government of the United States.”

The second refers to 35 U.S.C. § 203 “march-in” rights, which allows the
government to force the rights holder of a federally-funded invention “to
grant a nonexclusive, partially exclusive, or exclusive license in any
field of use to a responsible applicant or applicants, upon terms that are
reasonable under the circumstances,” or, if the rights holder refuses, the
government may itself grant the license. Utilizing these march-in rights
requires a determination that at least one of four conditions (section
203(a)(1-4)) are met, but most relevant to the amendment is the requirement
for “practical application” of the invention, which is defined in 35 U.S.C.
§ 201(f) as making benefits of the invention “available to the public on
reasonable terms.”

The royalty-free right can be used by the government or on behalf of itself
at any time, without payment of royalty.

Using existing statutory authority in the Bayh-Dole Act, DoD is directed to
ensure that DoD-funded inventions on drugs, vaccines or medical devices are
not more expensive in the United States than the median price charged
residents in the seven countries with the largest economies that also have
a GNI per capita of at least 50 percent of the U.S.

Because the reference countries are large economies, it will be difficult
for companies to game the system. By limiting the group to countries with
relatively high per capita incomes, the policy does not penalize efforts to
lower prices where incomes are lower. For example, a country like India,
which had a GDP in 2016 of more than $2.2 trillion, but a per capita income
of just $1,680 — less than 3 percent of the US — is excluded from the
reference pricing formula.

Table 1 illustrates which countries would have been included as a reference
for pricing in 2016.

Table 1: Sample of High Income Country Data, in regards to report language

Country

GDP 2016

GNI Per capita 2016 Atlas Method

Qualifies as reference country (per 2016 figures)?

United States

$18,569,100,000,000

$56,180

N/A




Japan

$4,939,383,909,875

$38,000

YES

Germany

$3,466,756,880,461

$43,660

YES

UK

$2,618,885,692,029

$42,390

YES

France

$2,465,453,975,282

$38,950

YES

Italy

$1,849,970,464,192

$31,590

YES

Canada

$1,529,760,492,201

$43,660

YES

South Korea

$1,411,245,589,977

$27,600

NO

Spain

$1,232,088,185,030

$27,520

NO

Australia

$1,204,616,439,828

$54,420

YES




BRICS Countries



China

$11,199,145,157,649

$8,260

NO

India

$2,263,522,518,124

$1,680

NO

Brazil

$1,796,186,586,414

$8,840

NO

Russia

$1,283,162,348,133

$9,720

NO

South Africa

$294,840,648,284

$5,274

NO

Source: World Bank, World DataBank, 2017


The prostate cancer medication Xtandi (enzalutamide) and the Zika vaccine
currently in development and the subject of a proposed exclusive license to
Sanofi were both developed by the Department of Defense using U.S. taxpayer
funds. Both have been the subject of controversy in the United States over
pricing concerns.

In the case of the prostate cancer drug, enzalutamide was originally
created at the University of California Los Angeles Medical Center through
a DoD grant, and is marketed by Astellas, a Japanese pharmaceutical
corporation, and is priced 2-4 times higher in the U.S. than in thirteen
other high-income countries. With a cost of $130,000 per patient per year
as of 2015, insurers have restricted access to this medicine, an important
medication for late stage prostate cancer patients. Medicare expenditures
have also increased dramatically, up from $447 million in 2014 to
approximately $791 million in 2015. (See http://keionline.org/xtandi).

Had DoD enforced this mandate earlier, Medicare would have saved
considerable money. In 2015, the average medicare price was $73.94 per pill
(4 per day are required). In 2016, the median price for the seven reference
prices* was the Japan price of $26.37 per pill, a discount of 64.3 percent
of the 2015 Medicare price. Based upon this calculation, the 2015 savings
to Medicare would have been $791m x .643 = $508m.

------------
* 2016 reference prices for Xtandi were $20.12 CA, $23.45 AU, $26.01 IT,
$26.37 JP, $26.73 FR, $35.65 UK, $36.93 DE.
----------

With regard to the Zika vaccine, the taxpayers (through a combination of
in-house conducted research and grants and contracts from the Army, the NIH
and BARDA) have already funded the pre-clinical research and the Phase 1
trial, and BARDA is paying Sanofi $43 million to conduct phase II trials,
with an option for an additional $130 million for phase III trials as
needed. If Sanofi registered the vaccine for sale, it will likely be
awarded an FDA priority review voucher (PRV), valued at between $100 and
$200 million at recent prices.

Sanofi has reportedly opposed any provision in the license that would
address the pricing of the vaccine to the public, although in the past
week, Sanofi has sent a letter to members of Congress claiming the company
was not presented with a “specific” requirement on pricing by the Army.
(See report in FiercePharma).

For more on this issue: see:
http://keionline.org/zika
http://keionline.org/xtandi
https://www.keionline.org/government-funded-inventions

-- 


Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670



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