[Ip-health] WHO asked to review essential drug list for patented products

[James Love]

The following is the text of a letter to Dr. Margaret Chan, Director-
General, World Health Organization (WHO), asking for a review of the
Essential Drugs List (EDL) as it relates to patented products.  Jamie

http://www.cptech.org/blogs/ipdisputesinmedicine/2006/12/letter-
asking-who-review-of-essential.html

Consumer Project on Technology
http://www.cptech.org

December 1, 2006

Dr. Margaret Chan
Director-General Elect
World Health Organization
20 Avenue Appia
1211 Geneva 27
Switzerland

Fax number: 41 22 791 4864
Email: chanm@who.int

Dr. Margaret Chan

We are writing to request a review of the manner in which the WHO
Essential Medicines List is composed.

The intent of the Essential Medicines List (EDL) is to present =93a
list of minimum medicine needs for a basic health care system,
listing the most efficacious, safe and cost-effective medicines for
priority conditions,=94 where priority diseases themselves are
identified in part on the basis of the potential for cost-effective
treatment.  Given that countries are free to use various means, such
as compulsory licenses, to increase access to medical products that
can improve the public health, it is appropriate to reassess the role
that cost =96 especially as reflected under current patent medicine
pricing regimes =96 plays in this evaluation.

Patents on drugs, which are tied to market costs, are clearly a
factor in determining the EDL, as remarkably few patented medicines
are listed.  To examine this, we referenced every medicine that
appears in the most recent WHO List, the 2005 14th edition, to the
U.S. Food and Drug Administration Electronic Orange Book (http://
www.fda.gov/cder/ob/) to check for patent status and the availability
of generics.

The attached Table summarizes the patented drugs on both lists.[1]
Only 14 (12 on the core list and 2 on the complimentary list) of the
total 312 medicines on the EDL are under a U.S. patent that bars
generic competition at the listed dose and route of administration.

While the Orange Book does not include all medicines, and while there
may be some discrepancy between products under patent in the U.S. and
those under patent internationally, this is likely an accurate
representation of the WHO EDL that are under patent worldwide.

Of the 14 "essential" drugs that are patented, 11 are patented
antiretroviral drugs used for the treatment of AIDS.  There are only
three patented drugs on the EDL (one on the core list, and two on the
complementary list) for all other diseases  -- evidence that patents
have distorted prices considerably, and created enormous access
barriers for the poor.

Drug industry representatives have used the WHO EDL to argue that
rigid intellectual property protections are not a barrier to
essential medicines, because =93no=94 patented medicines are =93essential=
=94
according to the WHO.[2]   Of course this is a distortion; many
patented medicines currently not on the EDL would be included were
they available at generic prices =96 for instance the most recent list
includes no patented anti-cancer drugs, and the core list includes no
anti-cancer drugs whatsoever.  The existence of a WHO =93Essential
Medicines List=94 which clearly does not contain many truly essential
medicines may be confusing for public health officials and others and
provide rhetorical fodder to those who oppose intellectual property
flexibilities for health.

Simply put, the traditional intellectual property regime in place
when the EDL was conceived in the 1970=92s is no longer as firmly
entrenched.  The 1999 WHO Revised Drug Strategy, the 2001 WTO Doha
Declaration on TRIPS and Public Health, the 2006 CIPIH report, the
upcoming WHO Intergovernmental Working Group on Public Health,
Innovation and Intellectual Property, and countless initiatives to
address greater flexibility, including mechanisms other than rigid
intellectual property rights for the promotion of medical innovation
and the expanded use of compulsory licenses, are compelling
testimonies to the importance and acceptance of the larger movement
to overcome patent barriers when promoting "access to medicines for
all."

Patented medicines currently available only at prohibitive prices may
nonetheless offer the =93potential for cost-effective treatment=94 as
countries have the opportunity to legally produce or import generic
versions.  More critical to the evaluation of cost effectiveness
under the emerging system is the true marginal cost of production,
which bears little or no relationship to the market price in
developed countries.

We believe that it is more appropriate that the Essential Medicines
List reflect the opportunity that many countries have to obtain
currently patented drugs at generic prices by assessing cost-
effectiveness not only on the basis of current market prices, but
also on the basis of potential generic prices if countries were to
avail themselves of their right to exercise TRIPS flexibilities,
including the granting of compulsory licenses.  Developing countries
in particular might stand to benefit from a model WHO Essential
Medicines List that does not exclude essential patented medicines by
ignoring the potential that those drugs could be obtained more
cheaply.  A welcome side-effect of this change would be an =93Essential
Medicines List" that more fully reflects the range of truly essential
medicines, where essential reflects both the need for treatments and
the costs of meeting those needs unburdened by patent rents.

We recognize that the current WHO Essential Medicines List (EDL) is
designed to avoid high priced (less cost effective) patented
medicines, that some national laws that reference the EDL create
obligations for public outlays, and that these outlays may not be
justified at the higher prices for patented medicines.   The WHO
could easily address this problem by creating a category within the
EDL for medicines that are essential "if available at generic
prices," an option that is clearly relevant for many developing
countries.

We therefore propose a review of the policies and considerations that
shape the WHO Essential Medicines List, to examine how the list
should address medicines that are current under patent but could be
manufactured or imported at generic prices.

Thank you for your consideration of this request.

=09Sincerely,



James Love
Director
CPTech
1621 Connecticut Avenue
Suite 500
Washington, DC 20009

CC:  Bill Kean, Howard Zucker, Hans Hogerzeil, Malebona Matsoso

Attachment
ESSENTIAL DRUGS LIST PRODUCTS UNDER PATENT

CORE LIST
DRUG=09INDICATION
Abacavir=09Antiretroviral
Didanosine=09Antiretroviral
Lamivudine=09Antiretroviral
Stavudine=09Antiretroviral
Efavirenz=09Antiretroviral
Nevirapine=09Antiretroviral
Indinavir=09Antiretroviral
Ritonavir=09Antiretroviral
Lopinavir + ritonavir=09Antiretroviral
Nelfinavir=09Antiretroviral
Saquinavir=09Antiretroviral
Proguanil=09Malaria prophylaxis

COMPLIMENTARY LIST
DRUG=09INDICATION
Levofloxin=09Multi-drug resistant tuberculosis
Eflornithine=09Antiprotozoal for trypanosomiasis

FOOTNOTES

[1] Background information on the actual U.S. patents is available on
request.

[2] The first comprehensive analysis of the patent status of the WHO
essential drugs list was a August 2001 PhRMA survey on patents in
Africa, presented by Tom Bombelles on September 30, 2001, at the
American Society of Law, Medicine & Ethics (ASLME) conference on Law
and Human Rights, in Philadelphia.  This data was later updated, and
presented in a 2004 article in Health Affairs, by Amir Attaran. "How
Do Patents And Economic Policies Affect Access To Essential Medicines
In Developing Countries?,"  Health Affairs, 23, no. 3 (2004):
155-166.   Our letter to Health Affairs addressed logical fallacies
in the Attaran article.  James Love, "Drug Patents In Poor
Countries," Health Affairs, 23, no. 5 (2004): 279.  An example of the
pharmaceutical industry use of the data on low patent coverage for
the WHO essential drugs list is the May 4, 2004 IFPMA Press Release,
"New Peer-Reviewed Study Shows That Patents on Essential Drugs Are
Rare in Low-to Mid-Income Developing Countries," available on the web
at http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=3D973, which
reads in part: " 'By showing that the actual patenting of essential
medicines in low- to mid-income developing countries is, in reality,
quite rare, he gives policy-makers the opportunity to move away from
a debate overly focusing on intellectual property rights and public
health', notes Dr. Bale."


---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton"