[Ip-health] Amending Canada's law on compulsory licensing for export -- update and media coverage

Sat Apr 28 12:58:02 2007

Canada=92s legislation on compulsory licensing of pharmaceuticals for expor=
t
UPDATE =96 28 April 2007

BACKGROUND

In 2004, Canada=92s Parliament unanimously enacted legislation to implement
the WTO Decision of August 30, 2003 on compulsory licensing of
pharmaceuticals for export.=A0 It was one of the first countries =96 of whi=
ch
there have been but a handful =96 to do so.=A0 To date, not a single pill h=
as
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.
=A0
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 were held last week. Last week, 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 appeared before the
Parliamentary committee.

REFORMS PROPOSED

At the Committee hearings, and at a press conference shortly before, MSF
highlighted 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 Canadian HIV/AIDS Legal Network
released 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.=A0 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.

For the full text of the Legal Network's submission to the Parliamentary
committee, including the text of specific amendments that should be made to
Canada's existing legislation, see:

http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=3D705 (English=
)
http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=3D706 (fran=E7=
ais)

MEDIA COVERAGE
=A0
Pasted below is a compilation of some media coverage (radio, print and
television) in recent days of efforts to press for legislative reforms to
Canada=92s law on compulsory licensing of pharmaceuticals for export
(implementing the WTO General Council Decision of August 30, 2003).

For additional information, see: www.aidslaw.ca/gtag.

Richard Elliott
Deputy director
Canadian HIV/AIDS Legal Network
+1 (416) 595-1666 ext. 229
www.aidslaw.ca

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

Access to Medicines
The Current
CBC Radio One, Tue 24 Apr 2007

This 20-minute segment dealt specifically with Canada=92s Access to Medicin=
es
Regime.
Listen > Past Shows > 2007 > April 24 > Part 1

http://www.cbc.ca/thecurrent/2007/200704/20070424.html

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

R=E9gime canadien d'acc=E8s aux m=E9dicaments
Jamais trop de l=E8ve-t=F4t
Radio-Canada (Premi=E8re Cha=EEne)
19 avril 2007

Trois ans apr=E8s l'adoption d'une loi, le Canada n'a pas encore envoy=E9 d=
e
m=E9dicaments =E0 prix abordable en Afrique. Le R=E9seau juridique canadien
VIH/Sida demande entre autres =E0 Ottawa de simplifier les modalit=E9s
d'exportation et de modifier certains aspects du R=E9gime canadien d'acc=E8=
s aux
m=E9dicaments. Avec: RICHARD ELLIOTT, dir. adjoint R=E9seau juridique canad=
ien
VIH/sida

=C9coutez > 19 avril 2007 > Sujet: R=E9gime canadien d'acc=E8s aux m=E9dica=
ments

http://www.radio-canada.ca/util/zapmedia/version10/frame.asp?menuFlash=3D&d=
ire
ctLink=3D/Medianet/2007/CBKF/0093DBF4_20070419_133501.asx&promo=3D&duree=3D

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

Ottawa urged to provide low-cost drugs for developing world
CanWest News Service

Thu 19 Apr 2007
Byline: Juliet O'Neill
Dateline: OTTAWA
Source: CanWest News Service; Ottawa Citizen
Story Type: News
Length: 445 words

OTTAWA - Front-line international health workers
appealed to MPs Wednesday to fix the fact that not a
single pill has left Canada under a three-year-old
regime to provide cheap generic drugs to needy
countries in Africa and elsewhere.

They said the plan is unnecessarily complex and
cumbersome, and does nothing to quell the
intimidation of potential importing countries by
brand name pharmaceutical companies and the U.S.
government.

They noted some developing countries are pressured
by threats of legal suits, trade sanctions, threats to
withhold medicines and other retaliatory measures
meant to protect patents and defend intellectual
property rights.

"I worked in Rwanda, Sudan, East Timor and Peru
and I've seen first hand, and it's been painful to see,
the effect of monopoly pricing of medicines," said
Carol Devine, 39, of Medecins Sans Frontieres
(Doctors Without Borders). "I've watched women
younger than me dying in their living rooms with
their children around them because they lacked
access to medicine that is widely available in
Western countries."

She and Richard Elliott of the Canadian HIV/AIDS
Legal Network, proposed amendments to the regime
- "a gift in red tape" - at a news conference before
testifying at a Commons committee.

The committee is reviewing the 'Access to Medicines
Regime' under which then Liberal prime minister
Jean Chretien made Canada the first country to sign
onto a World Trade Organization agreement to
provide generic drugs to save the lives of people with
HIV/AIDS, tuberculosis, malaria and other illnesses
in poorer developing countries.

Devine and Elliott said Canada is not alone in failing
to deliver lower-cost drugs through the international
agreement.

No other country has either.

Nevertheless they said Canada could be the first to
deliver if the Canadian regime is simplified, and that
changes could take place without amending the WTO
agreement.

Chief among their recommendations is any
pharmaceutical firm be authorized to produce generic
versions of any drug patented in Canada for export to
any eligible developing country. The law now
requires a separate licence for every drug order, even
if it's the same drug, and sets a maximum of two
years on the licence.

They proposed manufacturers be allowed to negotiate
exports with groups of countries so that a single
country won't be afraid of stepping forward.

"One of the beauties of what we propose is that it
avoids requiring any one particular country to be
disclosed at the beginning of the process just to get a
very limited quantity of a generic drug," Elliott said.

"There will likely be a certain safety in numbers if
developing countries can actually join together."

They also proposed removal of restrictions on which
medicines are eligible for export.

Ottawa Citizen

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

Lewis tells MPs to fix drugs to Africa
law
by Romeo St. Martin

[PoliticsWatch updated 7:00 p.m. April 18, 2007]

OTTAWA =97 The former UN special envoy for HIV/AIDS in Africa told
a committee of MPs Wednesday that Canada's legislation designed
to send cheaper, generic copies of patented drugs to developing
countries is failing and needs to be fixed.

Stephen Lewis made the comments to the MPs via video conference and his
plea was later echoed by representatives from six other non-governmental
organizations.

"It's clear to everyone that the legislation is deeply flawed," he bluntly
told the
committee.

"I think everything is essentially in place in Canada except we have lousy
legislation that doesn't work."

The Commons industry committee has been holding hearings this week into
the law which have been watched closely by foreign aid groups and Canadian
drug companies.

Canada's Access to Medicines Regime, a program that allows generic drug
companies in Canada to sell drugs currently under patent protection to
developing nations, has failed to send a single drug to a developing nation
since it became law in 2004.

Wednesday's testimony by Lewis and representatives from aid groups
appeared to contradict Monday's testimony from officials from four
government
departments who had a difficult time explaining exactly why developing
countries have not been taking advantage of the law and who denied that the
bill contained roadblocks.

In its submission to the committee, the Canadian HIV/AIDS Legal Network
made a number of recommendations to streamline what it describes as a
complex set of rules that act as a deterrent to the developing nations
seeking to
use the program.

Among those is one that compels the generic drug company to reveal what
country is seeking delivery of the cheaper generic version of the drug. The
group wants the generic companies to be able to keep that information
confidential to protect the country seeking assistance.

Lewis agreed that was a major problem with the law.

"No African country I think wants to be the first to go forward if their
names are
not protected," he said. "There is a tendency to retaliation. Both threats
from
often the United States and explicit threats from pharmaceutical companies.=
"

Representatives from the NGOs that appeared before the committee also
placed a large amount of the blame on brand-name drug companies who they
say lobbied effectively to place the roadblocks in the legislation when it
was
being drafted in 2004.

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

Getting AIDS drugs to poor countries needs to be simpler
CTV News and Current Affairs
Thu 19 Apr 2007
Byline:
Source:
Time: 07:48:35 ET
Network: CTV
Length: 602 words
Guest: Richard Elliott, Canadian HIV/AIDS Legal Network

JEAN CHRETIEN (Former Prime Minister of
Canada): So our quick response will encourage other
countries to follow our example.
[Taped segment ends]

THOMSON: Well, that was former Prime Minister
Jean Chretien, pledging in 2003 that Canada would
lead the way in making AIDS drugs available and
affordable in developing countries. Well, more than
three years later, not a single pill has been sent.
Joining me now from Ottawa is Richard Elliott, the
deputy director of the Canadian HIV/AIDS Legal
Network.
Thank you for taking time to talk to us this morning.

ELLIOTT: Good morning.

THOMSON: Mr. Elliott, let me ask you, what is the
problem? Is the problem the law itself? Or is the
problem that it's just not being used?

ELLIOTT: The problem fundamentally is the law
itself. It's too complicated. And what we've proposed
to the government and to a Parliamentary committee
yesterday is a number of changes that could be made
to the law that would actually make it very simple
and therefore much more likely to be actually used by
developing countries and by generic-drug makers.

THOMSON: And for generic-drug makers and to get
these pills out there, what is, I guess, chief among
them, the problems with the current legislation?

ELLIOTT: As I said, the current legislation is quite
complicated. What is requires is a
drug-order-by-drug-order, country-by-country,
case-by-case process for getting a licence, the legal
authorization, that lets the generic-drug maker make
the cheaper version of the patented drug and export it
to those countries.

For every single order of a particular quantity of a
particular drug that one particular country might want
to place, you need to go through a rather complicated
process with lots of opportunities for it to be derailed.
And so, what we're proposing actually is a simple,
one-licence solution that would actually make the
whole thing much simpler.

THOMSON: Right. Ultimately these companies I
guess essentially wouldn't want to necessarily jump
through all those hoops, take all that time, which is
money, to do that.

ELLIOTT: That's right. And there's actually two
parties that need to jump through all those hoops.
There's the generic-drug makers who can make the
product that the developing countries need to buy at
lower prices, and there's the developing countries
who need to buy the products. They both need to
jump through any number of hoops for every single
time that they want to order a particular drug.
And that to us doesn't make much sense. What we
should be doing is streamlining this legislation and
we should give one licence to the generic-drug maker
here in Canada at the beginning of the process, and
then, given that they'll have that legal authorization to
make the drug, let them negotiate multiple contracts
with multiple developing countries, at the same time
achieve economies of scale and you won't have to go
through the very complicated process the whole time.

THOMSON: Right.

ELLIOTT: And that, to us, would be a much simpler,
straightforward way of doing it.

THOMSON: Well, you've been talking to Ottawa,
pushing Ottawa, on this. Is anybody listening?

ELLIOTT: Well, we were in front of a standing
committee of Parliament yesterday afternoon. We
have given them very specific, concrete amendments
that they can make to the legislation. I think that now
the ball is really in the government's court and in the
court of all the parties in Parliament, because this was
a unanimous piece of legislation back in 2004. So I
think all parties ought to have a stake in actually
fixing it and making it work.

THOMSON: Mr. Elliott, thank you.

ELLIOTT: Thank you.

* * * * * *

The Globe and Mail, Wed 18 April 2007

Red tape blocking medicine for Africa
Organizations seek amendments to allow production of generic versions for
export
GLORIA GALLOWAY

OTTAWA -- Three years after Jean Chr=E9tien said Canada would allow generic
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]