[Ip-health] UPDATE: Canadian legislation on compulsory licensing of pharmaceuticals for export (May 7, 2008)
Richard Elliott
RElliott@aidslaw.ca
Wed May 7 11:12:03 2008
This is a multi-part message in MIME format.
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UPDATE: CANADIAN LAW ON COMPULSORY LICENSING OF PHARMACEUTICALS FOR EXPORT
May 7, 2008
Today it was announced that the Government of Rwanda has, after a
competitive international tendering process, chosen to purchase a generic
fixed-dose combination AIDS drug from Toronto-based generic pharmaceutical
manufacturer Apotex, Inc., using the provisions of Canada's 2004 law on
compulsory licensing of patented pharmaceuticals for export to eligible
developing countries. This clears the last major hurdle to the first use o=
f
"Canada's Access to Medicines Regime", and the first use anywhere of the
August 30, 2003 decision of the General Council of the World Trade
Organization (WTO).
Last July, the Government of Rwanda filed with the WTO a notification of it=
s
intent to use the mechanism under the 2003 WTO Decision to import generic
medicines (WTO Doc. IP/N/9/RWA/1). Rwanda's notification stated that it
anticipated importing up to 260,000 packs of the Apotex product "ApoTriavir=
"
(AZT/3TC/NVP). This combination is one of those recommended by WHO as a
first-line regimen for treating people living with HIV.
Rwanda's notification was a necessary precondition for Apotex to pursue the
process under Canadian law for obtaining a licence to manufacture the
product legally for export. Efforts to negotiate a voluntary licence with
each of the patent-holders involved were unsuccessful, and the generic
manufacturer applied for a compulsory licence. In September 2007, the
Commissioner of Patents issued a compulsory licence to Apotex, authorizing
the production of the quantity notified by Rwanda, amounting to 15,600,000
tablets. (The treatment regimen consists of 2 tablets daily.) In October,
Canada notified the WTO of this compulsory licence having been issued (WTO
Doc. IP/N/10/CAN/1).
Rwanda subsequently initiated an international tendering process. Apotex
submitted a bid quoting a price of US$0.195/tablet, meaning treatment with
this regimen would cost US$146 per patient per year. This is lower than th=
e
lowest price from a generic source (US$176 per patient per year) reported
publicly in the most recent edition of "Untangling the Web of Price
Reductions", 10th ed. July 2007, last updated March 2008; HYPERLINK
"http://www.accessmed-msf.org/main/hiv-aids/price-guide-to-aids-drugs"
http://www.accessmed-msf.org/main/hiv-aids/price-guide-to-aids-drugs.
Below are the press releases issued today by Apotex and by the Canadian
HIV/AIDS Legal Network. Also below is a list of other background material
about the Canadian legislation and civil society's criticisms of it and
proposed reforms.
_______________________________________________________
Richard Elliott
Executive Director
Canadian HIV/AIDS Legal Network
+1 416 595-1666 ext. 229
www.aidslaw.ca
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Attn: Health and News Editors
For Immediate Release
May 7, 2008
Canadian Company Receives Final Tender Approval
>From Rwanda For Vital AIDS Drug
Toronto, ON. -- Apotex Inc., Canada's largest generic pharmaceutical compan=
y
has successfully bid and been awarded a tender from the Rwandan Government
for the life saving triple combination AIDS drug "Apo Triavir". Apotex is
the first company to provide this medicine to Africa under the provisions o=
f
the Canadian Access to Medicines Regime (CAMR).
The CAMR provides a mechanism for developing countries to address critical
healthcare needs by importing less expensive generic versions of patented
drugs. Following the process it has taken Apotex over three years to get t=
o
this point where a drug can go to thousands in Africa.
Apotex is the only company in Canada to have worked through the complicated
CAMR process. The Generic Pharmaceutical Industry has recommended that the
Federal Government simplify the process of getting urgently needed drugs to
Africa.
Apo Triavir is a combination of 300 mg Zidovudine, 150 mg Lamivudine and 20=
0
mg Nevirapine and was evaluated and approved under the provision of the CAM=
R
by Health Canada. Triavir fully conforms to all Health Canada regulations
and requirements for marketing a drug in the Canadian healthcare system. As
per Canadian regulations, the product can only be exported to eligible
countries under CAMR and cannot be sold in Canada until the relevant patent=
s
expire.
Apotex is producing Apo Triavir at cost, with the price quoted in the Tende=
r
at 19.5 cents per tablet. The three separate AIDS brand products would cos=
t
around $6.00 per dose if bought individually.
"If other critical medicines are to go to Africa in a reasonable timeframe,
the Federal Government must change the CAMR Legislation. CAMR is unworkabl=
e
as it now stands. Apotex decided to do this because it was the right thing
to do for the people dying from AIDS in Africa", stated Jack Kay, Apotex
President and COO.
The Apotex Group has 6,000 employees in Canada and exports close to 300
quality lower cost medicines to 115 countries. It is the No. 1
pharmaceutical company in Canada for R&D with planned expenditures of $2
Billion over the next 10 years.
- 30 -
For more information:
Elie Betito
Director, Public & Government Affairs
Apotex Inc.
Tel: 416-749-9300
Cell: 416-558-5491
e-mail: ebetito@apotex.com
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CANADIAN HIV/AIDS LEGAL NETWORK
For immediate release
CANADA FINALLY POISED TO DELIVER ON PROMISE OF AFFORDABLE MEDICINES TO
DEVELOPING COUNTRIES?
But law must be streamlined to ensure it will be used again
Toronto, May 7, 2008 - The Canadian HIV/AIDS Legal Network welcomed today's
announcement that Rwanda's government, after a competitive tendering
process, has chosen to purchase a low-cost AIDS drug from Ontario-based
generic pharmaceutical manufacturer Apotex, Inc. - meaning that Canada's
Access to Medicines Regime should soon deliver for the first time on its
promise of affordable medicines for developing countries.
However, this represents the first success in four years since the law on
exporting generic medicines was passed, confirming that the Regime must be
simplified if Canada is to play an ongoing role in helping developing
countries with access to AIDS treatment or other medicines they need.
"This is great news, and we hope supplies will start moving soon. But
Canada's law is riddled with unnecessary hurdles," said Richard Elliott,
Executive Director of the Legal Network. "Getting this far has required an
extraordinary amount of work by one company and various non-governmental
organizations. This is not sustainable. How many lives could have been
saved in the meantime if this law had worked smoothly the way it should and
could?"
Last year, the Legal Network presented the government and Parliament with a
submission containing 13 concrete amendments they could pass immediately in
order to make the law truly workable. But in December of last year, the
Minister of Industry tabled a long-overdue report in Parliament indicating
the government had no plans to make any changes.
"We did their homework for them," said Elliott, "but so far the government
has refused to act. What we need is a straightforward system that is
user-friendly for both developing countries and for generic manufacturers i=
n
Canada. Instead of requiring separate negotiations and a separate licence
for each country and each order of medicines, we need a simple 'one-licence
solution' such as the one we've proposed."
Based on an agreement hammered out at the WTO in 2003, Canada's Access to
Medicines Regime was created by legislation passed unanimously in Parliamen=
t
in May 2004. It is meant to allow compulsory licensing of patented
medicines, so that generic drug companies in Canada can legally produce and
export lower-cost versions of patented, brand-name medicines to developing
countries. The deal between the Rwandan Government and Apotex, Inc. marks
the first use anywhere in the world of this mechanism.
For more information on the Legal Network's proposed amendments to the
legislation, see "Getting the Regime Right", the 2007 brief to Parliament,
available at HYPERLINK "http://www.aidslaw.ca" www.aidslaw.ca.
- 30 -
For more information, please contact:
Vajdon Sohaili
Communications Specialist
Canadian HIV/AIDS Legal Network
Telephone: +1 416 595-1666 ext. 227
E-mail: vsohaili@aidslaw.ca
Website: www.aidslaw.ca
# # #
R=C9SEAU JURIDIQUE CANADIEN VIH/SIDA
Pour diffusion imm=E9diate
LE CANADA ENFIN SUR LE POINT DE FOURNIR DES M=C9DICAMENTS ABORDABLES =C0 DE=
S
PAYS EN D=C9VELOPPEMENT COMME PROMIS?
La loi doit n=E9anmoins =EAtre simplifi=E9e, afin d'=EAtre utilis=E9e =E0 n=
ouveau
Toronto, 7 mai 2008 - Le R=E9seau juridique canadien VIH/sida s'est r=E9jou=
i
d'apprendre aujourd'hui que le R=E9gime canadien d'acc=E8s aux m=E9dicament=
s
semble pr=E8s de remplir une premi=E8re fois sa promesse de m=E9dicaments
abordables pour des pays en d=E9veloppement. En effet, apr=E8s un processus
d'appel d'offres pour l'achat de m=E9dicaments =E0 bas prix contre le sida,=
le
Gouvernement du Rwanda a choisi le produit du fabricant g=E9n=E9rique ontar=
ien
Apotex inc.
Il s'agit cependant d'une toute premi=E8re r=E9ussite depuis qu'a =E9t=E9 a=
dopt=E9e,
il y a quatre ans, la loi canadienne permettant l'exportation de m=E9dicame=
nts
g=E9n=E9riques - ce qui confirme la n=E9cessit=E9 que le Canada simplifie l=
e R=E9gime
s'il veut aider d'autres pays en d=E9veloppement =E0 se procurer les
traitements, anti-sida ou autres, dont ils ont besoin.
=AB La nouvelle d'aujourd'hui est excellente - et nous esp=E9rons que la
marchandise commencera =E0 bouger tr=E8s bient=F4t =BB, commente Richard El=
liott,
directeur g=E9n=E9ral du R=E9seau juridique. =AB Il a fallu, pour arriver j=
usqu'ici,
une somme extraordinaire de travail de la part d'un fabricant et de divers
organismes non gouvernementaux. Ce fonctionnement n'est pas durable. Combie=
n
de vies auraient pu =EAtre sauv=E9es entre-temps, si la loi avait fonctionn=
=E9
sans encombre comme elle le devrait et comme c'est d'ailleurs possible? =BB
L'an dernier, le R=E9seau juridique a pr=E9sent=E9 au gouvernement canadien=
et au
Parlement un m=E9moire contenant 13 amendements concrets pouvant =EAtre ado=
pt=E9s
sur-le-champ afin que la loi devienne utilisable et fructueuse. Mais en
d=E9cembre dernier, le ministre de l'Industrie a d=E9pos=E9 au Parlement un
rapport, tr=E8s en retard, indiquant que le gouvernement n'avait aucune
intention d'y apporter des am=E9liorations.
=AB Nous avons fait le travail pour le gouvernement mais il refuse jusqu'ic=
i
d'agir =BB, r=E9sume Elliott. =AB Il faudrait rendre la d=E9marche moins co=
mpliqu=E9e,
plus conviviale pour les pays en d=E9veloppement et pour les fabricants
g=E9n=E9riques canadiens. Plut=F4t que de requ=E9rir des n=E9gociations dis=
tinctes et
des licences distinctes pour chaque pays et pour chaque commande de
m=E9dicament, il faudrait une "solution =E0 licence unique" comme nous avon=
s
propos=E9. =BB
Comme suite =E0 une entente adopt=E9e en 2003 =E0 l'Organisation mondiale d=
u
commerce, le R=E9gime canadien d'acc=E8s aux m=E9dicaments (RCAM) avait =E9=
t=E9 cr=E9=E9
par une loi que le Parlement a appuy=E9e =E0 l'unanimit=E9 en mai 2004. La =
loi
vise =E0 autoriser l'=E9mission de licences obligatoires sur des m=E9dicame=
nts
brevet=E9s, de sorte que des fabricants canadiens de m=E9dicaments g=E9n=E9=
riques
puissent en produire l=E9galement des versions =E0 prix r=E9duit pour expor=
tation
=E0 des pays en d=E9veloppement. L'entente intervenue entre le Gouvernement=
du
Rwanda et la soci=E9t=E9 Apotex est la toute premi=E8re utilisation du RCAM=
dans
le monde.
Pour information sur les amendements =E0 la loi propos=E9s par le R=E9seau
juridique, voir =AB Rectifier le R=E9gime =BB, le m=E9moire d=E9pos=E9 au P=
arlement en
2007, accessible =E0 HYPERLINK "http://www.aidslaw.ca" www.aidslaw.ca.
- 30 -
Pour information :
Vajdon Sohaili
Sp=E9cialiste des communications
R=E9seau juridique canadien VIH/sida
T=E9l. : +1 416 595-1666 (poste 227)
Courriel : vsohaili@aidslaw.ca
Internet : www.aidslaw.ca
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ADDITIONAL MATERIAL OF INTEREST:
"Getting the Regime Right", Legal Network brief with recommended amendments=
,
submitted to the Parliamentary committee reviewing Canada's Access to
Medicines Regime (April 2007)
HYPERLINK
"http://www.aidslaw.ca/publications/publicationsdocENhttp://www.aidslaw.ca/=
p
ublications/publicationsdocEN.php?ref=3D705
Access to Medicines and Intellectual Property: An International Expert
Meeting on Canada's Access to Medicines Regime, Global Developments, and Ne=
w
Strategies for Improving Access (19-21 April 2007)
HYPERLINK
"http://www.aidslaw.ca/publications/publicationsdocENhttp://www.aidslaw.ca/=
p
ublications/publicationsdocEN.php?ref=3D792
Notifications to WTO by Rwanda and Canada available via: HYPERLINK
"http://www.wto.org/english/tratop_e/trips_e/public_
http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm
"Time to Deliver (or not)" - Commentary by the Canadian HIV/AIDS Legal
Network on needed reforms to Canada's legislation on compulsory licensing
for export (November 2006)
HYPERLINK
"http://www.aidslaw.ca/publications/publicationsdocENhttp://www.aidslaw.ca/=
p
ublications/publicationsdocEN.php?ref=3D610
"Neither Expeditous, Nor a Solution: The WTO August 30th Decision is
Unworkable - An illustration through Canada's Jean Chr=E9tien Pledge to
Africa" (briefing paper by M=E9decins Sans Fronti=E8res)
HYPERLINK
"http://www.msf.ch/fileadmin/user_upload/uploads/communiques/images_2006/pd=
f
/came_Neither_expeditious_nor_a_solution_-_August_30_and_the_JCPA_sinhttp:/=
/
www.msf.ch/fileadmin/user_upload/uploads/communiques/images_2006/pdf/came_N=
e
ither_expeditious_nor_a_solution_-_August_30_and_the_JCPA_single_page.pdf
"Medicines for all? Commitment and compromise in the fight for Canada's law
on compulsory licensing for export", in The Power of Pills: Social, Ethical
& Legal Issues in Drug Development, Marketing and Pricing (Pluto Books,
2006)
HYPERLINK
"http://www.aidslaw.ca/publications/publicationsdocENhttp://www.aidslaw.ca/=
p
ublications/publicationsdocEN.php?ref=3D679
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