[Ip-health] KEI statement: 21st meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines

Thiru Balasubramaniam thiru at keionline.org
Mon Mar 27 05:35:31 PDT 2017


http://keionline.org/node/2752

Submitted by thiru <http://keionline.org/user/6> on 27. March 2017 - 14:17

On Monday, 27 March 2017, Knowledge Ecology International (KEI) delivered
the following oral statement to the Open Session of the 21st Meeting of the
WHO Expert Committee on the Selection and Use of Essential Medicines. The
program for the open session can be found here
<http://www.who.int/selection_medicines/committees/expert/21/OpenSession_EXPCOM21_Agenda_ENG.pdf?ua=1>
.

KEI submitted two applications to the 21st WHO Expert Committee on the
Selection and Use of Essential Medicines - 1) a proposal for the inclusion
of enzalutamide on the WHO Model List of Essential Medicines for the
Treatment of Metastatic Castration Resistant Prostate Cancer
<http://www.who.int/selection_medicines/committees/expert/21/applications/s8_enzalutamide_add.pdf?ua=1>
and
2) a proposal for the inclusion of trastuzumab emtansine (T-DM1) on the WHO
Model List of Essential Medicines for the Treatment of HER-2 Positive
Locally Advanced or Metastatic Breast Cancer
<http://www.who.int/selection_medicines/committees/expert/21/applications/trastuzumab_emtansine_ad/en/>
.

Statement of Knowledge Ecology International: WHO 21st Expert Committee on
the Selection and Use of Essential Medicines

27 March 2017

Dear members of the Expert Committee,

Traditionally, the World Health Organization (WHO) has defined essential
medicines as those that “satisfy the health care needs of the
population...and are intended to be available within the context of
functioning health systems at all times...and *at a price the individual
and the community can afford* [Emphasis added].”

In 2015, the WHO announced the inclusion of costly treatments for hepatitis
C, cancer (including trastuzumab and imatinib) and tuberculosis (including
bedaquiline and delamanid) on the WHO Model List of Essential Medicines
(EML), reflecting the importance of their clinical benefits, even though in
many countries, the prices were high, due to patent and other IPR
protections.

As the Committee once again deliberates the inclusion of medically
effective but costly medicines, it is time to more explicitly acknowledge
the need to address the practical issues that governments face. Resources
are limited, and expensive drugs can divert resources from more cost
effective products. It is not surprising that many dedicated public health
professionals are opposed to including expensive patented drugs on the EML.
It is also not surprising that many patients and patient advocates chafe at
the paucity of newer drugs on the EML.

The WHO Expert Committee ask been asked, several times, to create a
category in the EML for products that would be essential, if available at
affordable prices.

New medicines are expensive due to policies, not physics, chemistry or
biology. A policy to grant an IPR monopoly, through patents, data
exclusivity or other IPR mechanisms, is designed solely to induce
investments in R&D. Countries can regulate or eliminate monopolies, and
some do. India broke the monopoly for sorafenib, for example, because of
excessive pricing. As countries wrestle with affordability issues, they can
seek technical assistance from the WHO or other entities in order to use
lawful pathways to ensure treatments are affordable and widely available —
including through the granting of compulsory licences.

If drugs are medically effective, but expensive, they should be placed in
an EML category for drugs that are medically essential but face challenges
regarding affordability. Governments and patients would take this as a
signal to implement policies to make these medically effective drugs
affordable.

KEI is completing a review of 56 new anti-cancer drugs approved by the US
FDA from 2010 to 2016. 45 of the new drugs received a priority review
status by the US FDA. None of the 56 new drugs are on the WHO EML.

In a different analysis, KEI looked at the 28 drugs with unique active
ingredients the US National Cancer Institute (NCI) identified that as
approved by the FDA to treat breast cancer. Of the 28, 18 were registered
from 1953 to 1998, and of these, 12 are included in the current 2015
version of the WHO EML. Ten were registered from 1999 to 2016, and of
these, none are included in the WHO EML.

A system of medical guidance that is consistently ignoring or excluding new
drugs for cancer needs to be reformed, and new options for dealing with
affordability and access are needed if we are serious about achieving
equality of health outcomes.

In conclusion, we suggest that the Expert Committee create a working group
to address the complex and rapidly evolving challenges posed by cancer;
this standing group could help identify treatable tumours of public health
relevance and prioritize and identify the medicines used to treat these
tumours, and also begin to evaluate and contribute to proposals to delink
R&D incentives from drug prices, because this is the fundamental policy
change that is needed.



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