[Ip-health] DHHS Listening Session on WHA 2018: Comment on Agenda item 11.5 Addressing the global shortage of, and access to, medicines and vaccines

Andrew Goldman andrew.goldman at keionline.org
Thu May 17 08:09:10 PDT 2018


On Friday May 11, 2018, the Department of Health and Human Services (DHHS)
held its annual listening session in advance of the upcoming World Health
Assembly. Comments were limited to 2 minutes, with no time set aside for a
question and answer session. On behalf of KEI, I offered this intervention
on the topic of transparency:

Comment on Agenda item 11.5 Addressing the global shortage of, and access
to, medicines and vaccines Documents A71/12 and EB142/2018/REC/1, decision

My name is Andrew Goldman, I work with Knowledge Ecology International, an
NGO that works on intellectual property issues including those that impact
drug pricing.

High drug prices are a critical concern both in the United States and
around the world, and the United States should be actively seeking to
facilitate legal measures that would reduce drug prices, rather than
obstruct positive developments at the WHO.

Transparency regarding the costs of research and development would be a
good place to start.

There is a consequential asymmetry of information on drug pricing that is
toxic for governments and payors trying to formulate policies and evaluate

The pharmaceutical and biotech industries cite high costs of developing new
drugs and medical technologies as the primary justification for excessive
prices. We agree — this is the only reason why governments grant monopolies
that lead to high prices. However, to evaluate how robust and durable the
monopoly should be, what constitutes an excessive price, or what
alternatives might exist to stimulate innovation, we need more than a
simple narrative; we need objective and reliable data.

Key to a more informed discussion will be reporting of actual R&D costs by
clinical trial and by year.

The U.S. should encourage efforts at the WHO to create global norms
requiring the disclosure of disaggregated costs of clinical trials per
clinical trial, including numbers of patients per trial; and any tax
credits, grants or other subsidies from public funds that helped pay for
the R&D of every drug, vaccine and new gene or cell-based treatment.

The discussion on this issue is well underway at the WHO, and is also well
underway here in the U.S., with dozens of states advancing bills that
attempt to pull the curtain back on the proffered logic behind high drug
prices, as well as several bills before Congress.

The U.S. should also encourage efforts that would improve transparency
specific to the complex manufacturing process of biologic drugs, which
include some of the most expensive cancer treatments on the market. One of
the challenges of creating more affordable biosimilars — and thus one of
the reasons why there are only nine biosimilars approved by the FDA to date
— is the secrecy regarding the know-how required for manufacturing.

The U.S. should encourage efforts to require that the originator disclose
and provide those materials and know-how as a condition of registration of
the biologic, in order to expedite the development of biosimilars where the
patent is not at issue.

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670 <(202)%20332-2670>

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