[Ip-health] WTO informal meeting (Feb 12) regarding TRIPS public health amendment: the Canada/Rwanda case

[Richard Elliott]

SOME CONTEXT FOR WTO MEMBERS' UPCOMING "INFORMAL" DISCUSSION ON TRIPS PUBLI=
C HEALTH AMENDMENT (FEBRUARY 12, 2010)

IP-Watch has carried a story today (below) about an "informal" meeting tomo=
rrow of WTO Members to discuss the implementation and use of the August 30,=
 2003 General Council Decision on compulsory licensing of pharmaceuticals f=
or export.  The story reports that at least the U.S. (and quite possibly ot=
her Members?) sought to prevent this discussion by, in part, invoking the e=
xample of the one licence issued to date, pursuant to Canada's legislation =
implementing the WTO Decision, under which one fixed-dose combination ARV w=
as shipped to Rwanda.

It should be noted that, at this time, there is little reason to think that=
 "Canada's Access to Medicines Regime" (CAMR) is going to be used again, ab=
sent some reform.  One generic pharmaceutical manufacturer, Apotex, was per=
suaded to make the commitment to use this legislation soon after it was ena=
cted in May 2004, in order to produce a fixed-dose combination ARV (see htt=
p://www.apotex.com/apotriavir/default.asp).  Other generic manufacturers ha=
d little interest at that time, in part preferring to wait and see what cam=
e of this initial foray, and the experience to date has not engendered any =
further interest on their part.  It took years to get to the point of getti=
ng that medicine out the door to Rwanda (which, it should be noted, was pro=
vided at an internationally competitive price, contrary to suggestions from=
 some quarters.)  The bulk of the delay from the time the law was enacted t=
o the date the medicines first went to Rwanda was the result of the ineffic=
iencies and deterrents built into, and surrounding, the Regime.

The generic manufacturer in question has publicly stated repeatedly that it=
 has little interest in trying to use the Regime again - although it has al=
so publicly committed that, if the Regime is streamlined along the lines pr=
oposed by a bill currently before Parliament, it will make a paediatric for=
mulation of the ARV already exported to Rwanda.  This would be a first, nex=
t step in stimulating further use of a legislative Regime that could, if pr=
operly crafted, make a significant contribution to scaling up access to AID=
S and other treatment.  If a truly user-friendly model were created in one =
country (such as a streamlined Canadian legislative scheme), this could be =
useful for potential application elsewhere in actually turning the moribund=
 August 30th, 2003 Decision into something that delivers on the promise of =
more affordable medicines -- although, of course, just getting the legislat=
ive scheme properly crafted is only one, necessary part of the solution, an=
d is not sufficient by itself.

A broad cross-section of dozens of Canadian civil society groups have calle=
d for reforms to the Canadian legislation.  The text is below, and is also =
found here: http://www.aidslaw.ca/publications/interfaces/downloadDocumentF=
ile.php?ref=3D946.  A recent poll found 80% of Canadians supported reformin=
g the legislation: http://www.aidslaw.ca/publications/interfaces/downloadDo=
cumentFile.php?ref=3D994.

A bill is currently pending before Parliament that would simplify considera=
bly the existing Canadian legislation implementing the Aug 30th, 2003 Decis=
ion and would not contravene Canada's WTO obligations.  (For text of the bi=
ll and other details, see: http://www2.parl.gc.ca/Sites/LOP/LEGISINFO/index=
.asp?Language=3DE&Session=3D22&query=3D5834&List=3Dtoc.)  At the moment, it=
 is an open question whether there is sufficient political support in Parli=
ament to pass it, and Canada's Research-based Pharmaceutical Companies, the=
 industry association for patent-holding pharmaceutical companies, is activ=
ely lobbying against the bill.  The bill is expected to be the subject of p=
arliamentary committee hearings once Parliament reconvenes next month.  A m=
ore detailed update, as of early December 2009, is available here:
http://lists.essential.org/pipermail/ip-health/2009-December/014495.html

More information about the Canadian legislation can be found at www.aidslaw=
.ca/camr.  This includes an article with the history and some analysis of t=
he current Canadian legislation (at http://www.aidslaw.ca/publications/publ=
icationsdocEN.php?ref=3D864) and the short backgrounder entitled "Fixing Ca=
nada's Access to Medicines Regime: 20 Questions & Answers" (at http://www.a=
idslaw.ca/publications/publicationsdocEN.php?ref=3D965).

Richard
________________________________________________
Richard Elliott

Executive Director | Directeur g=E9n=E9ral
Canadian HIV/AIDS Legal Network | R=E9seau juridique canadien VIH/sida
+1 416 595-1666 ext. 229
relliott@aidslaw.ca | www.aidslaw.ca

Children Can't Wait! Dying for Drugs in Developing Countries - see www.aids=
law.ca/camr
Les enfants ne peuvent attendre! Le manque de m=E9dicaments tue, dans les p=
ays en d=E9veloppement - voir www.aidslaw.ca/rcam

***********************

Statement | =C9nonc=E9

For immediate release |=09=C9galement disponible en fran=E7ais

DYING FOR LACK OF MEDICINES IN DEVELOPING COUNTRIES
43 organizations join in statement on the 5th Anniversary of
Canada's Access to Medicines Regime (CAMR)

May 14, 2009 - Ottawa and Toronto

We represent thousands of Canadians from coast to coast to coast but more i=
mportantly, we write on behalf of the 10 people who will die from treatable=
 disease in the two minutes it will take to read this statement.  Sadly, a =
large proportion of them are children.

Exactly five years ago today, on May 14th, 2004, the legislation that creat=
ed Canada's Access to Medicines Regime (CAMR) passed with unanimous support=
 from all political parties in Parliament and received Royal Assent.

The goal was, and is, worthy: get more affordable, generic medicines to peo=
ple in the developing world. Canada was the first country to respond to cha=
nges in international trade laws which allowed compulsory licensing of life=
-saving medicines.

Unfortunately, that laudable initiative was, and is, seriously flawed.

In five years, CAMR has been used only once, to supply a single order of th=
ree-in-one AIDS medicine to Rwanda.  This one instance required years of ef=
fort by a generic pharmaceutical manufacturer and numerous civil society or=
ganizations, plus the involvement of an international foundation.

These medicines, delivered last September, represented a significant breakt=
hrough for the roughly 21,000 patients in Rwanda with HIV who will now rece=
ive medicine that would otherwise have been unavailable. But they are only =
a fraction of the response needed to scale up AIDS treatment in the develop=
ing world.

Furthermore, CAMR is unlikely to be used again to achieve the stated humani=
tarian objective of increasing access to affordable treatment for people wi=
th HIV or other diseases in poor countries.  It is not the user-friendly me=
chanism developing countries need to ensure a sustainable supply of medicin=
es.

Fortunately, there is hope.  New legislation currently before parliament (B=
ill S-232) proposes streamlining CAMR by moving to a 'one-licence solution,=
' instead of the current country-by-country, order-by-order process of comp=
ulsory licensing.  A 'one-licence solution' would address the key bottlenec=
k impeding use of CAMR by both developing countries and suppliers of generi=
c medicine.

We know from discussions with concerned citizens and civil society organiza=
tions across the country that Canadians are not willing to stand by and see=
 Canada fail to deliver on the promise made by Parliament five years ago to=
day.

Time is of the essence: lives are being lost each day.  CAMR is now five ye=
ars old.  Many of the children that it could help save never made it to tha=
t age.  At the moment, half of all children with HIV in sub-Saharan Africa =
die before the age of two because they don't have access to affordable, pra=
cticable medicines suited for children.  Canada could help address this des=
perate public health and human rights tragedy by streamlining CAMR to make =
it workable.

On this anniversary date, we call upon all Parliamentarians to renew their =
commitment to strengthen Canada's role in responding to the AIDS crisis and=
 other global health needs and to commit to fixing CAMR to deliver on the p=
romise Parliament made on behalf of all Canadians.

We call on Canadian citizens to demand their representatives in Parliament =
remove the current hurdles and inefficiencies in CAMR.

For more information: www.aidslaw.ca/camr.

- 30 -
______________________________________________

Action Canada for Population and Development
Africa Change International
African and Caribbean Council on HIV/AIDS in Ontario
AIDS Committee of Guelph & Wellington County
AIDS Committee of Toronto
AIDS Community Care Montreal
AIDS PEI
Around the Corner Kingston Grandmothers
Black Coalition for AIDS Prevention (Toronto)
Bracelet of Hope Campaign (formerly Masai for Africa)
British Columbia Persons With AIDS Society
Burlington Ubuntu Grandwomen
Canadian AIDS Treatment Information Exchange
Canadian Association of Nurses in AIDS Care
Canadian Crossroads International
Canadian Federation of Medical Students
Canadian Harm Reduction Network
Canadian Hemophilia Society
Canadian HIV/AIDS Legal Network
Canadian Physicians for Aid and Relief
Canadian Treatment Action Council
Canadian Working Group on HIV and Rehabilitation
CAP AIDS
Central Alberta AIDS Network Society
Coalition des organismes communautaires qu=E9b=E9cois de lutte contre le si=
da
G-Moms of Port Perry, Grandmothers to Grandmothers Campaign
Grandmothers to Grandmothers Campaign National Advocacy Committee
HIV & AIDS Legal Clinic (Ontario)
HIV Edmonton
Interagency Coalition on AIDS and Development
Living Positive Resource Centre (Okanagan)
McGill Global AIDS Coalition
OHAfrica
Ontario AIDS Network
Oxfam Canada
People's Health Movement Canada
Positive Living North
RESULTS Canada
Streetworks (Edmonton)
Toronto People With AIDS Foundation
UNICEF Canada
Universities Allied for Essential Medicines
Women For African Grandmothers (Toronto)

*****************

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http://www.ip-watch.org/weblog/2010/02/11/wto-members-to-consider-review-of=
-trips-public-health-amendment/

IP-WATCH

11 February 2010

WTO Members To Consider Review Of TRIPS Public Health Amendment
By Kaitlin Mara @ 1:57 am

A waiver to World Trade Organization rules intended to aid people in poor c=
ountries in gaining access to medicines has remained essentially unused in =
the over six-and-a-half years since it was put in place. On Friday, member =
states of the WTO will in an informal meeting discuss this situation and se=
e what, if anything, needs be done.
The 2003 waiver was made an amendment in 2005 within the WTO Trade-Related =
Aspects of Intellectual Property Rights (TRIPS) agreement to allow for incr=
eased export of medicines made under compulsory licences. This was intended=
 to give a helping hand to nations without a domestic pharmaceutical indust=
ry, who might have public health needs for a patented and unaffordable medi=
cine they are unable to produce themselves.

Under TRIPS, compulsory licences are meant to primarily serve a national ma=
rket, but the TRIPS public health amendment (often referred to as the "para=
graph 6" solution referring to the Doha Declaration on TRIPS and Public Hea=
lth) allows countries with pharmaceutical industries to manufacture and exp=
ort more medicines under a compulsory licence to countries without them, pr=
ovided certain conditions are met.

The system has been used exactly once since implementation, to make two shi=
pments of AIDS medicines to Rwanda in 2008 and 2009. The Canadian generic d=
rug company involved has said it will not use it again (IPW, IP Burble, 17 =
September 2009). The majority of WTO member states have yet to accept the p=
rotocol.

This was "supposed to be an expeditious solution for public health needs," =
one developing country representative told Intellectual Property Watch. But=
 the "general feeling is that this is neither expeditious nor is it a solut=
ion."

At a TRIPS Council meeting on 27-28 October, members of the African Group, =
the Least-Developed Country Group and several other developing nations incl=
uding Brazil, Ecuador, India, and Pakistan, said that the lack of use and t=
he lack of acceptance of the decision was an indication that there are prob=
lems, and asked for a review to figure out ways to solve those problems (IP=
W, WTO/TRIPS, 30 October 2009).

But the United States argued that the limited use of the system indicated c=
ountries with no domestic manufacturing capacity were getting access to med=
icines via aid, according to the TRIPS Council report to the WTO General Co=
uncil in December.

The US objected to a review on grounds that the example of the Canada/Rwand=
a shipment indicated the system is usable, but in the end allowed consensus=
 to go through on the condition that there be only a single meeting on the =
issue and that it would have no outcome document except "possibly" reportin=
g to the TRIPS Council what had been said, according to the General Council=
 report.

The 12 February gathering is that one informal meeting.

Developing countries are hoping to see a solution as some think public heal=
th is heading in a "very scary" direction in which it is more exposed to th=
e "whims and fancies of the pharmaceutical industry." There are strong gene=
ric versions of many drugs on the market now, but the worry is that future =
drugs - such as much-needed paediatric formulations or second-line medicine=
s to treat HIV/AIDS - come along there may be no one with the freedom to ma=
nufacture them, said a developing country delegate.

In a past interview with Intellectual Property Watch, IP and health expert =
Ellen 't Hoen called the paragraph 6 solution an agreement "gone wrong," as=
 it is "based on a case-by-case, drug-by-drug, country-by-country process,"=
 conditions under a sustainable generics drug industry cannot be supported.

Meanwhile, there was another informal meeting of the TRIPS Special Sessions=
, dedicated to the creation of a mandated international register for geogra=
phical indications (product names associated with specific places) on wines=
 and spirits on 5 February. This meeting was a chance for new chair of the =
Special Sessions, Amb Karen Tan of Singapore, to meet member states in her =
new role. She is temporarily taking over for the previous chair Trevor Clar=
ke of Barbados, who has joined the World Intellectual Property Organization=
 as an assistant director general. The General Council of the WTO will elec=
t a new chair in February.

Kaitlin Mara may be reached at kmara@ip-watch.ch.

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