[Ip-health] YCEMP statement to WHO 20th Expert Committee on the Selection and Use of Essential Medicines

Melissa Barber melissajoybarber at gmail.com
Mon Apr 20 06:45:47 PDT 2015


http://www.who.int/selection_medicines/committees/expert/20/reviews/open-session_YCEMP-statement_18-apr-15.pdf?ua=1

*​​*The Lancet Youth Commission on Essential Medicines Policies (YCEMP) to
WHO 20th Expert Committee on the Selection and Use of Essential Medicines**

Dear Members of the WHO Expert Committee,

The WHO Model List of Essential Medicines (EML) has been used as a public
health and advocacy tool to lower medicine prices at global and national
levels. The decision to remove medicine price as a criterion for exclusion
from the EML was a significant factor in enabling the generic competition
that lowered the price of antiretrovirals by ninety-nine percent.[1] We are
concerned, however, that some of the proposed medicines may nevertheless be
excluded from the EML on the basis of current prices, despite demonstrated
efficacy, safety, public health need, and expected prices of generic
versions that favour their inclusion.

Reviews for sofosbuvir and simeprevir, as well as commentary by the media,
academia, and civil society, emphasize the difference between the prices
charged for medicines under monopoly and the manufacturing cost: sofosbuvir
is estimated to cost between US$68 to US$136 to produce, yet the prices
charged by the originator company range from US$900 to US$84,000.[2] We
urge the committee to take into account various measures that can, and
regularly do, secure generic competition, such as compulsory or voluntary
licenses, and accordingly define relative cost-effectiveness in relation to
existing or estimated generic prices rather than the exorbitant prices
protected by monopolies and segmented markets.

Similarly, for several new anti-cancer medicines proposed, peer-reviewers
comment that these are “hardly affordable in general and even more so in
disadvantaged settings”, and that medicines be considered for the EML based
on “how far the WHO considers affordable costs as a requisite for the
selection of essential medicines.”[3] Concerns justly arise on the
affordability of medicines such as trastuzumab, currently priced between
US$23,000 to US$78,000 per patient per year, when a potential alternate
supplier has suggested that it could be available for US$248 per patient
per year— 1% of the lowest Roche price.[4] We do not believe that it is
ethically justifiable to determine how essential a medicine is based upon
the level of resources that a particular country may have. We urge this
committee to ask why medicines are so expensive in the first instance and
what these discoveries mean if patients cannot afford them.

This Expert Committee meeting marks a milestone with the proposed inclusion
of bedaquiline and delamanid, the first new tuberculosis drugs developed
since the 1977 introduction of the EML. Healthcare providers’ advice should
be based on which medicines would be best for their patients, rather than
medicines’ registration status, the existence of compassionate use
programs, and prohibitive prices. The inclusion of bedaquiline, delamanid,
and linezolid would be a progressive step in addressing these barriers, as
the EML influences national essential medicines lists (NEMLs), drug
procurement, generic manufacturers, and is an eligibility criterion for
enrolment in the WHO Prequalification of Medicines Programme (PQP).

While the decisions of this committee will declare certain medicines
essential to public health, we should also reflect upon conspicuous
absences. Entire categories of diseases lack serious research and
development efforts, such as antibiotics and neglected diseases.

When we consider those drugs undiscovered that are absent from this list,
cost-effectiveness takes on a new meaning.  As long as drug research and
development is governed by a logic of profit rather than public health,
pharmaceutical companies will continue to focus their investments on drugs
that can be sold at high prices rather than those which are most needed to
alleviate human suffering. We emphasize the need for new, collaborative,
and needs-driven mechanisms of drug research and development, predicated
upon the principle of de-linkage, and implore the Expert Committee to lead
in highlighting this issue, as addressing these mechanisms is a crucial
part of achieving the Expert Committee’s goals.


________________________________

[1] MSF Access campaign. Untangling the web of antiretroviral price
reductions, 17th edition [Internet]. 2014. [cited 2015 Apr 15]. Available
from:
http://msfaccess.org/content/untangling-web-antiretroviral-price-reductions-17th-edition-%E2%80%93-july-2014

[2] Hill A, Khoo S, Fortunak J, Simmons B, Ford N. Minimum costs for
producing hepatitis C direct-acting antivirals for use in large-scale
treatment access programs in developing countries. Clin Infect Dis
[Internet].2014 [cited 2015 Apr 15]; 58(7):928–36. Available from:
http://cid.oxfordjournals.org/content/early/2014/02/13/cid.ciu012.full

[3] WHO peer review group. Metastatic Breast Cancer [Internet]. 2015 Mar
[cited 2015 Apr 15]. Available from:
http://www.who.int/selection_medicines/committees/expert/20/reviews/MetastaticBreastCancer_PeerReviewReport2_EXPCOM20_3-Apr-15.pdf?ua=1

[4] Knowledge Ecology International, University of California San
Francisco, Universities Allied for Essential Medicines, Young Professionals
Chronic Disease Network. Proposal for the inclusion of trastuzumab in the
WHO Model List of Essential Medicines for the treatment of HER2-positive
breast cancer. 2013 Jan [cited 2015 April 15]. Available from:
http://www.who.int/selection_medicines/committees/expert/20/reviews/MetastaticBreastCancer_PeerReviewReport2_EXPCOM20_3-Apr-15.pdf?ua=1



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