[Ip-health] "Red tape blocking medicine for Africa" (The Globe & Mail, April 18, 2007) -- Canada reviewing legislation on compulsory licensing for export

[Richard Elliott]

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UPDATE =96 18 April 2007

Canada=92s legislation on compulsory licensing of pharmaceuticals for expor=
t



In 2004, Canada=92s Parliament unanimously enacted legislation to implement
the WTO Decision of August 30, 2003 on compulsory licensing of
pharmaceuticals for export.  It was one of the first countries =96 of which
there have been but a handful =96 to do so.  To date, not a single pill has
been exported under Canada=92s regime or that of any other country with
fundamentally similar regimes based on the same WTO Decision =96 and more t=
han
3 years later, no country has yet notified the WTO that it intends to use
the August 30, 2003 decision to import generics manufactured under
compulsory licence.



As mandated by law, Canada is currently reviewing its legislative regime,
and within a few weeks, the government must table a report in Parliament
with its conclusions about the lack of action and, perhaps, some proposals
about amending the regime to improve it.  In addition, Parliamentary
hearings into the failure of the legislation to deliver on its humanitarian
pledge are underway this week.  Today, Stephen Lewis (former UN Special
Envoy on HIV/AIDS in Africa), and representatives of Canadian NGOs that hav=
e
been active on advocating for global treatment access =96 including the
Canadian HIV/AIDS Legal Network, M=E9decins Sans Fronti=E8res, Oxfam, and t=
he
Interagency Coalition on AIDS and Development =96 will appear before the
Parliamentary committee.  (Those committee hearings will be webcast live as
of 3:30 p.m. Ottawa-time: to watch, go to www.aidslaw.ca
<http://www.aidslaw.ca/> .)



At the Committee hearings, and at a press conference shortly before, MSF
will highlight its experience of having tried to use the legislation to
obtain a novel generic combination of three existing patented
antiretrovirals for treating people living with HIV, and the Legal Network
will present a series of key legislative amendments that would considerably
streamline Canada=92s regime for exporting generic medicines under compulso=
ry
licence =96 and that would go beyond the cumbersome, failed mechanism of th=
e
2003 WTO Decision by legislating instead a process that is simple and
straightforward for both developing countries and generic manufacturers to
use.  Such a streamlined regime would take advantage of other
=93flexibilities=94 in the WTO=92s patent rules in the TRIPS Agreement that=
 exist,
and that have been expressly affirmed and reaffirmed by WTO Members in both
the 2001 Doha Declaration on the TRIPS Agreement and Public Health and agai=
n
in the 2003 WTO Decision itself as being available to WTO Members.



Below is an article from today=92s Globe & Mail, Canada=92s national newspa=
per,
that may be of interest.  The full text of the Legal Network=92s submission=
 to
the Parliamentary Committee, including the text of proposed legislative
amendments, will be available later today at www.aidslaw.ca
<http://www.aidslaw.ca/> .



Later this week, the Legal Network and the North-South Institute are
convening an international group of experts =96 including representatives o=
f
developing countries, policy experts, treatment advocates, generic
manufacturers, and Canadian government representatives =96 to discuss, amon=
g
other measures needed to help improve access to generics, the barriers to
the use of Canada=92s current legislative regime on compulsory licensing fo=
r
export, as well as various options for reform that are being proposed.
Those discussions should help inform possible changes to Canada=92s regime.



Finally, a public forum in Ottawa this Thursday evening, April 19th, will
hear from representatives from Thailand, India, Canada and MSF=92s Campaign
for Access to Essential Medicines about current developments related to
patents and treatment access.  The event is free and open to the public and
the media, and all parliamentarians have been invited to attend.  Additiona=
l
details below =96 and for more information, go to www.aidslaw.ca/events.



Richard Elliott

Deputy Director

Canadian HIV/AIDS Legal Network

+1 (416) 595-1666 ext. 229



For media inquiries: Leon Mar, Director of Communications, +1 (416) 595-166=
6
ext. 228, lmar@aidslaw.ca, www.aidslaw.ca <http://www.aidslaw.ca/>



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



http://www.theglobeandmail.com/servlet/story/RTGAM.20070418.wxafrica18/BNSt=
o
ry/National/home



The Globe & Mail

Wednesday, April 18, 2007

Page A4 (Ottawa edition)


Red tape blocking medicine for Africa


Organizations seek amendments to allow production of generic versions for
export


GLORIA GALLOWAY

>From Wednesday's Globe and Mail

OTTAWA =97 Three years after Jean Chr=E9tien said Canada would allow generi=
c
drug makers to send copies of brand-name medicines to poor countries to
combat diseases such as AIDS and malaria, groups that follow the issue say
not a single pill has left Canada.

The roadblock, they say, is red tape and a powerful brand-name
pharmaceutical industry that opposes the generic reproductions.

But the groups argue that Canada's Access to Medicines Regime can be
rewritten to get the drugs moving.

The Canadian HIV/AIDS Legal Network and Doctors Without Borders will ask th=
e
Commons industry, science and technology committee today to change the law
to allow any pharmaceutical firm to produce generic versions of any drug
patented in Canada for export to any eligible developing country.

"We are giving them concrete amendments that they could enact, if they
wanted to, to simplify the legislation and increase the chances of it
working." Richard Elliott, the deputy director of the HIV/AIDS Legal
Network, said yesterday.

Shortly after Tony Clement took over the federal health portfolio last year=
,
he said he realized that Mr. Chr=E9tien's so-called Pledge to Africa was no=
t
being fulfilled. The minister attributed this to a lack of "take-up" by
developing countries, where AIDS claims nearly 8,000 lives a day.

But Mr. Elliott said the problem is not that simple.

"There were discussions when the legislation was first being drafted [by th=
e
Liberal government] three years ago where we and a number of the other
[organizations] raised concerns about the complexity of the process," Mr.
Elliott said.

The industry committee is conducting a mandatory review of the drug regime
and must table a report in mid-May. "So now is the time to go back to the
drawing board and say this is too complicated," Mr. Elliott said.

Apotex, one of Canada's best-known generic drug manufacturers, has develope=
d
a treatment for people with HIV that uses three patent-protected drugs: AZT=
,
3TC and Navirapin.

Canada's law requires that the brand-name manufacturers be consulted to see
whether they will let the generic company violate their patents by selling
it to developing countries. If they won't, Apotex must obtain what is known
as a "compulsory licence" that permits the sale of a specific quantity of
the drug to a specific country for two years.

That means that "before there is any guarantee of actually being able to ge=
t
that licence and therefore buy the product, the [developing] country
actually has to step forward and be identified," Mr. Elliott said.

"And we have seen over the last decade that, any time countries contemplate
using compulsory licensing to override patents to get cheaper medicines fro=
m
generic producers, there is a great deal of pressure brought to bear by the
big multinational pharmaceutical industry, which doesn't want to see this
happen, and by the U.S. government, which goes to bat for its pharmaceutica=
l
industry."

Typically, he said, if a country says it wants to buy the generic drugs
using the compulsory licence, the United States will threaten to cut off
trade.

On the other hand, Mr. Elliott said, if a generic manufacturer is permitted
to sell any quantity of a drug to any number of countries for an unlimited
period, paying royalties to the brand-name company as is required, many of
the barriers would come down.

"Countries that want to do this will still have to stand up to the pressure
that they are under," he said. "But, at least with the process that we are
describing, you could have any number of countries getting together and
making a joint order for a large quantity of product from a generic
manufacturer. That would bring the price down because it is achieving
economies of scale and there would be a certain degree of safety in number.=
"

[end]



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



(Voir plus bas pour la version fran=E7aise.)



The Other War on Drugs: Access to Medicines in Developing Countries



*=09A court case by a multinational pharmaceutical company threatens to
undermine India=92s role as the pharmacy of the developing world.



*=09A company threatens to withhold medicines from registration in
Thailand to retaliate against government measures to produce lower-cost
drugs.



*=09And in Canada, a law meant to permit exports of cheaper medicines to
developing countries approaches the third anniversary of its passage =97 bu=
t
not a single pill has yet been shipped.



As the federal government reviews Canada=92s Access to Medicines Regime, an=
d a
House of Commons committee holds hearings on what should be done to fix it,
health advocates from India, Thailand, Canada and M=E9decins Sans Fronti=E8=
res /
Doctors Without Borders will give updates from the front lines on the
struggle for access to affordable medicines for millions of people in
developing countries.



WHEN:          Thursday, April 19, 2007

7:00 p.m.



WHERE:        National Press Club =97 Library

165 Sparks Street, 2nd floor

Ottawa



Attendance is free and open to all. This event will be held in English, but
questions in French will be welcomed.



For more information, see www.aidslaw.ca/events.



* * * * * * * * * *



The Other War on Drugs: Access to Medicines in Developing Countries [L=92au=
tre
combat : l=92acc=E8s aux m=E9dicaments dans les pays en d=E9veloppement]



Une affaire judiciaire intent=E9e par une multinationale pharmaceutique ris=
que
de compromettre le r=F4le de l=92Inde en tant que pharmacie du monde en
d=E9veloppement.



Une soci=E9t=E9 pharmaceutique menace de ne pas faire homologuer ses m=E9di=
caments
en Tha=EFlande, pour protester contre les mesures de ce pays pour produire =
des
m=E9dicaments =E0 moindre co=FBt.



Au Canada, une loi autorisant l=92exportation de m=E9dicaments plus abordab=
les
vers des pays en d=E9veloppement aura bient=F4t trois ans =97 et aucun m=E9=
dicament
n=92a encore =E9t=E9 export=E9.



=C0 l=92heure o=F9 le gouvernement canadien examine le R=E9gime canadien d=
=92acc=E8s aux
m=E9dicaments et o=F9 un comit=E9 de la Chambre des communes tient des audi=
ences
sur les correctifs souhaitables, des militants pour la sant=E9 qui =9Cuvren=
t en
Inde, en Tha=EFlande, au Canada et au sein de M=E9decins Sans Fronti=E8res =
feront
=E9tat de la situation aux premi=E8res lignes de la lutte pour l=92acc=E8s =
=E0 des
m=E9dicaments abordables pour des millions d=92habitants de pays en
d=E9veloppement.



QUAND :        le jeudi 19 avril 2007

19 h 00



O=D9 :                Cercle national des journalistes =97 Biblioth=E8que

165, rue Sparks, 2e =E9tage

Ottawa



Entr=E9e gratuite et ouverte =E0 tous. L=92=E9v=E9nement se d=E9roulera en =
anglais, mais
les questions en fran=E7ais seront les bienvenues.



Pour plus d=92information, voir www.aidslaw.ca/evenements.



__________________________________
Richard Elliott
Deputy Director

Canadian HIV/AIDS Legal Network

+1 416 595-1666 ext. 229

 <http://www.aidslaw.ca> www.aidslaw.ca



Directeur adjoint

R=E9seau juridique canadien VIH/sida

+1 416 595-1666 (poste 229)

 <http://www.aidslaw.ca> www.aidslaw.ca

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