[e-drug] Expanding the WHO Model Essential Medicines List (4)

e-drug
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E-DRUG: Expanding the WHO Model Essential Medicines List (4)
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Dear Friends:

Implementing the suggestion on e-drug that the WHO Model List of
Essential Medicines adds a category of products labeled "if available
at generic prices" would be potentially misleading at this time.

Either a drug is essential because it meets an otherwise unmet need
or it is not. The principal issue with respect to inclusion on the
Model List is substantial evidence of usefulness, not price. When
alternative therapies exist, cost-effectiveness (1) is considered
when selecting the prototype medicine to list as the example from the
class.

As the proposers of this new category point out, there are
currently a number of patented medicines on the Model List because
the Expert Committee determined that they were essential. All
medicines added within the past few years are considered essential
for specific uses that have been validated by a careful review of the
data supporting the use of the medicine.

Proposals by anyone to add additional medicines to the Model List are welcome provided the application includes the data to support the determination that the proposed drug is essential for its proposed indication. It would be most helpful if individuals who identify medicines they perceive as essential and are not on the current Model List submit full applications for them for Committee consideration.

1. Weinstein MC, Stason WB. Foundations of cost-effectiveness
analysis for health and medical practices. N Engl J Med 1977; 296: 716-21.

Marcus M. Reidenberg, MD, FACP
Chairman, 2007 WHO Expert Committee on the Selection and Use of
Essential Medicines
Professor of Pharmacology, Medicine, and Public Health
Head, Division of Clinical Pharmacology
Weill Medical College of Cornell University
1300 York Ave., Box 70
New York, NY 10021
phone (212) 746-6227
fax (212) 746-8835
e-mail mmreid@med.cornell.edu

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E-DRUG: Expanding the WHO Model Essential Medicines List (5)
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Dear all,

   Marcus raises a good point in respect to process. I am not sure what
   resources WHO has to provide responses to each proposal presented to
   it, but I gather proposers would welcome such.

   Nonetheless, I would suggest that the onus is on governments to
   firstly firm their treatment needs, and are encouraged to do so,
   with reference to the WHO's recommendations (that is, "Model List").

   I think that has always been the position of WHO, which is, to make
   recommendation and provide guidance to governments, specially in this
   critical area? Institutions supporting government health programme are
   often in a position to assist governments formulate their needs, but
   they too are expected to make reference to the WHO Model List. Those
   governmetns and institutions with a full package of resources, can
   include other commodities that are not on the WHO Model List.
   But first and foremost, there has to be strong evidence of usefulness.

   Regards,

   Dr Bonnie Fundafunda
Drug Supply Budget Line,
Ministry of Health,
Lusaka,
Zambia
"BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>

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E-DRUG: Expanding the WHO Model Essential Medicines List (7)
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Dr. Reidenberg, the Chair of the 2007 WHO Expert Committee on the
Selection and Use of Essential Medicines, has responded to our
proposal to expand the WHO EML with the odd comment that this "would
be potentially misleading at this time," and defending the new model
EML as having "a number of patented medicines."

The WHO EML has very few patented drugs outside of one disease --
AIDS. AIDS drugs were only added to the EML when it was clear that
countries could obtain generic products at much lower prices.

The dearth of patented medicines on the EML for cancer, heart
disease, diabetes, and other non-communicable diseases is a political
decision to not recognize that many products would be cost-effective
if available at generic prices.

Critics of the use of compulsory licensing point to the WHO model
EML, claiming that the lack of patented medicines undermines the case
for compulsory licensing, a modern Catch-22 which is defended by the
Expert Committee.

What is misleading and harmful to the poor is the suggestion that
patent protection is not related to "cost-effectiveness," or that
countries cannot choose to override exclusive rights and obtain
access to cheaper generic copies, which changes the cost-
effectiveness calculations. More candor on this issue is long overdue.

  James Love

ANNEX

Ben Krohmal's review of the 2007 model EML against the U.S. FDA
Orange Book finds only three patented medicines outside of many
products listed for AIDS.

Proguanil Malaria prophylaxis
Levofloxin Multi-drug resistant tuberculosis (complementary list)
Eflornithine Antiprotozoal for trypanosomiasis (complementary list)

HIV/AIDS
Abacavir, Antiretroviral
Didanosine, Antiretroviral
Lamivudine, Antiretroviral
Stavudine, Antiretroviral
Efavirenz, Antiretroviral
Nevirapine, Antiretroviral
Indinavir, Antiretroviral
Ritonavir, Antiretroviral
Lopinavir + ritonavir, Antiretroviral
Nelfinavir, Antiretroviral
Saquinavir, Antiretroviral
tenofovir disoproxil fumarate, Antoretroviral
emtricitabine/tenofovir, Antiretroviral
efavirenz/emtricitabine/tenofovir, Antiretroviral

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James Packard Love
Knowledge Ecology International
http://www.keionline.org
Washington, DC +1.202.332.2670
james.love@keionline.org