[Ip-health] PRESS RELEASE: WHO asked to review the Essential Medicines List as it relates to patented products

[Malini Aisola]

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WHO asked to review the Essential Medicines List as it relates to patented
products.
December 2, 2007
Background
On Monday, December 4, the World Health Organization (WHO) convenes the first
meeting of a new Intergovernmental Working Group (IGWG) on public health,
innovation and intellectual property. This letter addresses one of the issues
that will be addressed in this new WHO working group.
*WHO DG asked to add more patented products to the Essential Drug List*
On December 1, CPTech wrote to Dr. Margaret Chan, the new Director-General the
World Health Organization (WHO), requesting a review of the manner in which
the WHO addresses patented medicines in its model "Essential Medicine List,"
known as the EDL.
The EDL is widely seen as the standard for medicines that are needed to treat
the poor. The list is now limited to "cost effective" medicines. According to
a new study by CPTech, the 312 drug EDL only includes 14 patented medicines,
including 11 for the treatment of AIDS, and only three for all other diseases.
"None of the WHO employees would accept a health care plan that only covered
14 patented medicines," said CPTech Director James Love. "Many patented
medicines currently excluded from the EDL would have been on the list were
they available at generic prices," he said.
CPTech proposes that the EDL be expanded to include a category of medicines
that are essential "if available at generic prices," an option increasingly
relevant to developing countries willing to take advantage of the TRIPS
flexibilities, according to the letter sent to new WHO chief Dr. Margaret
Chan.
The EDL list is controversial for several reasons, including the fact that
inclusion of a medicine on the EDL (1) creates certain obligations by
governments to make the drugs available to the poor, and (2) makes it more
likely that governments would consider issuing compulsory licenses for patents
on the medicine.
The letter also notes that some drug companies' lobbyists and researchers have
argued that low patent cover on the EDL is evidence that patents are not an
access barrier for essential drugs -- an argument that several public groups
(including CPTech), say reaches the wrong conclusion -- since it is the high
prices of patented medicines that drive them off the current EDL, and if the
products were available at the cheaper generic prices, they would replace or
supplement the drugs now on the EDL.
For more information contact:
James Love
james.love@cptech.org[1]
+1 202 361 3040 (U.S. mobile)
+41 76 413 6584 (Geneva mobile)
Thiru Balasubramaniam
thiru@cptech.org[2]
+41 76 508 0997 (Geneva mobile)
*THE LETTER FOLLOWS:*
Consumer Project on Technology
http://www.cptech.org[3]
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[4] <mailto:chanm@who.int>[5]
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 a list of
minimum medicine needs for a basic health care system, listing the most
efficacious, safe and cost-effective medicines for priority conditions, 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 especially as reflected under current patent medicine pricing
regimes 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/[6]) 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 no patented medicines are essential 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 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 Essential Medicines List
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 1970s 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 potential for cost-effective treatment 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 Essential 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.
Sincerely,
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 INDICATION
Abacavir Antiretroviral
Didanosine Antiretroviral
Lamivudine Antiretroviral
Stavudine Antiretroviral
Efavirenz Antiretroviral
Nevirapine Antiretroviral
Indinavir Antiretroviral
Ritonavir Antiretroviral
Lopinavir + ritonavir Antiretroviral
Nelfinavir Antiretroviral
Saquinavir Antiretroviral
Proguanil Malaria prophylaxis
COMPLIMENTARY LIST
DRUG INDICATION
Levofloxin Multi-drug resistant tuberculosis
Eflornithine
Antiprotozoal 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=973[7],
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."

===References:===
  1. mailto:james.love@cptech.org
  2. mailto:thiru@cptech.org
  3. http://www.cptech.org
  4. mailto:chanm@who.int
  5. mailto:chanm@who.int
  6. http://www.fda.gov/cder/ob/
  7. http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=973