[Ip-health] UACT asks US Congress to authorize Medicare price negotiations, backed up by compulsory licensing authority

Kim Treanor kim.treanor at keionline.org
Mon Nov 6 09:39:15 PST 2017


https://cancerunion.org/2017/11/06/uact-asks-us-congress-to-authorize-medicare-price-negotiations-backed-up-by-compulsory-licensing-authority/

UACT asks US Congress to authorize Medicare price negotiations, backed up
by compulsory licensing authority.
James Love on 6 November 2017

On November 6, 2017, UACT sent a letter to the US Congress, supporting
legislation to permit the United States to negotiation prices for drugs
reimbursed by the Medicare program, but also ask the Congress to include
language on compulsory licensing of patents, in order to ensure that when
there is a dispute over the price, the monopoly is put at risk, rather than
the patient.   The letter also asks Congress to enact measures to enhance
the transparency of R&D costs and drug manufacturing know-how, and under
feasibility studies of delinkage.

A copy of the letter is available as a PDF, here, and reads as follows:

November 6, 2017

Dear Member of Congress,

Regarding Medicare negotiations and drug prices

The Union for Affordable Cancer Treatment (UACT) is a union of people
affected by cancer who are committed to increasing access to effective
cancer treatment and care. We are particularly concerned about the rapidly
escalating cost of cancer medication and we believe that cancer medicines
and other essential medical technologies such as diagnostic tools should be
affordable.

UACT is a patient group that does not receive funding from drug companies.

UACT strongly supports repealing the current restriction on the federal
government’s ability to negotiate drug prices for Medicare.

The lack of price negotiations by Medicare has distorted the prices of
cancer drugs worldwide. Companies know that Medicare will reimburse
extremely high prices. The problems in the Medicare program influence
prices in the non-Medicare market in the United States, as well as in other
countries.

While UACT strongly supports the notion of price negotiations for Medicare,
we are also concerned that such negotiations may result in barriers to
access for cancer patients, unless the government has sufficient leverage
on prices. Without sufficient leverage, UACT is concerned that the
government may then resort to access-limiting restrictions on
reimbursements.

Congress should ensure that the Department of Health and Human Services has
a good statutory framework for allowing the non-voluntary use of drug
patents, and has sufficient exceptions to any non-patent intellectual
property or regulatory exclusivities, when negotiations over reasonable
prices reach an impasse.

The existing legal framework for compulsory licensing of patents are
inadequate and the U.S. lacks sufficient exceptions to regulatory
monopolies such as test data exclusivity or orphan drug exclusivity, for
cases when prices are excessive.

We recommend that any legislation to authorize Medicare price negotiations
include language that would ensure that when there is a dispute over the
price, the monopoly is put at risk, rather than the patient.

The following is an example of language that would enhance the negotiating
power of the federal government and protect patient access during price
negotiations.[1]

-----
Remedy for excessive prices
The Secretary of the Department of Health and Human Services or a designee
authorized by the Secretary may limit the remedies for infringement of any
patent to payment of a reasonable royalty, and create an exception for any
regulatory exclusivity, when such action is necessary in order to enable
the competitive supply of any drug, vaccine, medical procedure or
diagnostic test that is not available at a reasonable price. The Secretary
shall adopt the appropriate rules and procedures to carry out this section.
-----

Other measures that will enhance the ability to negotiate reasonable prices
include those that would ensure greater transparency, including in
particular the costs of each clinical trial used to support the FDA
registration or expanded approval of a product, and the value of public
sector and charitable funding and subsidies for the development of a
product, including the value of the orphan drug tax credit. It would also
be helpful to require companies to disclose the know-how to manufacture
approved products, so when legal monopolies expire, there will be more
robust and timely competition from suppliers of safe and affordable generic
and biosimilar versions.

Finally, Congress should act favorably on proposals to undertake
feasibility studies of more radical changes in the business model for drug
development that fully delink research and development costs from product
prices. With delinkage, price-based formularies for drugs and vaccines can
become a thing of the past, and the relationship between a doctor and
patient can be focused on the treatments that are medically appropriate,
and not be distorted by monopoly prices.

Sincerely,

Manon Anne Ress, PhD. Cancer patient, and Co-founder and acting Director,
Union for Affordable Cancer Treatment

Kirsten Myhr, MScPharm, Cancer patient, and member of the Board of
Directors, UACT

Ruth Lopert, MD, MMedSc,  FAFPHM, Member of Expert Advisory Board, UACT

Clare Love, Cancer patient, and member of UACT

Michael Davis, Cancer patient, and member of UACT

Tido von Schoen-Angerer, MD, Cancer patient, and member of UACT

Megan Ciarfalia , Cancer patient, and member of UACT

Coralie DeTomassi, Cancer patient, and member of UACT



Endnote

[1] The language proposed is consistent with the US obligations under the
WTO TRIPS agreement, and in particular, Article 44.2, which allows a
remedies for infringement to be limited to compensation for using patents,
and also Articles 7, 8 and 40, which acknowledge the need to control
anticompetitive practices, such as excessive prices, and the 2001 WTO Doha
Declaration on TRIPS and public health, which obligates governments to
implement patent laws “in a manner supportive of WTO members’ right to
protect public health and, in particular, to promote access to medicines
for all.”

-- 


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



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