[Ip-health] Fwd: House of Commons passes Bill C-9 to permit export of generic drugs

[Richard Elliott]

--
[ Picked text/plain from multipart/alternative ]

Pasted below is a compilation of recent media clippings regarding the
progress of Canada's legislation to implement the WTO General Council
Decision of 30 August 2003 on compulsory licensing of pharmaceuticals for
export.  The bill is expected to pass through the second chamber of
Parliament very soon.

A more detailed update, with substantive commentary on the final text of
the legislation, will follow.

Richard Elliott
Canadian HIV/AIDS Legal Network

***********

KAISER DAILY HIV/AIDS REPORT
A service of kaisernetwork.org
http://www.kaisernetwork.org/dailyreports/hiv

Wednesday, May 5, 2004

DRUG ACCESS

6. Canadian House of Commons Unanimously Approves Bill To Allow
Manufacture of Generic AIDS, Other Drugs for Africa

Access this story and related links online:
http://cme.kff.org/Key=3D2846.D2Y.K.D.L59648

  Canada's House of Commons on Tuesday unanimously approved a
bill (C-9) that would amend the country's patent laws to permit
the government to order the override of patents to allow certain
pharmaceutical manufacturers to produce and export generic drugs
-- including antiretroviral drugs -- for use in developing
countries, AFP/Yahoo! News reports (AFP/Yahoo! News, 5/4). Under
the measure -- which originally was introduced in the House of
Commons in November 2003 -- about 50 countries would be eligible
to receive generic drugs at a fraction of the prices charged in
Canada. The bill also calls for special markings on and
packaging for the generic drugs sold as part of the program to
prevent them from being sold on the black market or reimported
to Canada. In addition, the bill would require the creation of
lists detailing which drugs could be imported by which countries
(Kaiser Daily HIV/AIDS Report, 4/21). Canada's Senate, which is
its upper house of Parliament, is expected to approve the
measure later this week, according to AFP/Miami Herald
(AFP/Miami Herald, 5/5).

Lobbying?

Member of Parliament Brian Masse said that requiring a list of
drugs would delay the inclusion of new therapies in the generic
drug program while regulators "debate the merits of each drug,"
according to the Ottawa Citizen. Masse had fought to include
Bayer's pneumonia drug moxifloxacin in the list of medicines
approved for generic distribution. According to Masse, the drug
may be used to treat patients with AIDS-related pneumonia or
tuberculosis, the Citizen reports. However, the drug list in the
final version of the bill does not include the moxifloxacin.
Masse said that the omission shows that the legislation is
susceptible to lobbying efforts from pharmaceutical companies,
adding, "If they can be this bold about removing a drug in a
bill that's being developed, what's going to happen in the
future? It's basically going to be Big Pharma selecting what
drugs are going to be available." Bayer Canada Vice President
Doug Grant said there was no need for moxifloxacin to included
because the list already contains other effective pneumonia
drugs. In addition, Grant said until the drug is approved by an
expert review panel for the treatment of TB or HIV, "it should
not be included on the list" (McGregor, Ottawa Citizen, 5/4).

**********

>Canada powers ahead on cheap AIDS drugs for poor countries
>
>May 4, 2004, Yahoo!/AFP
>http://story.news.yahoo.com/news?tmpl=3Dstory&cid=3D1508&ncid=3D751&e=3D8&=
u=3D/afp/200
>40504/hl_afp/canada_wto_aids
>
>OTTAWA (AFP) - Canada moved to the verge of becoming the first country to
>honor a WTO pledge to get cheap generic drugs to HIV sufferers in the
>developing world, with a crucial vote in parliament.
>
>The House of Commons voted unanimously to allow the government to order th=
e
>over-riding of patents held by drug companies to allow cheaper generic dru=
gs
>to reach sufferers in the world's poorest nations.
>
>The House voted 229 to 0 in favour of the legislation, leaving just the
>upper house Senate to approve the bill, probably this week.
>
>The swift -- and unopposed -- passage of the bill in the House of Commons =
on
>Tuesday follows a compromise by the government last month.
>
>Under pressure from its own backbenchers as well as the opposition, the
>government agreed to make it easier than previously planned to over-rule
>patents, especially for drugs combatting such diseases as HIV/AIDS and
>tuberculosis, both of which are rampant in many parts of Africa and Asia.
>
>Even U2 frontman Bono intervened with a personal plea to Prime Minister Pa=
ul
>Martin, cashing in political chips won while performing at the Liberal Par=
ty
>convention last November when Martin was elected party leader.
>
>Canada claims to be more advanced than any other country in pushing throug=
h
>a World Trade Organization (news - web sites) (WTO) pact to allow generic
>drug manufacturers to supply cheap versions of medicines patented by major
>pharmaceutical companies.
>
>Despite changes to the bill, some leading international aid groups still
>criticized the legislation as being too friendly to commercial
>pharmaceutical giants.
>
>Nevertheless, parliamentary opposition to the bill melted away Tuesday as
>members from all four political parties cast their votes in favour.
>
>The government anticipates a similarly easy passage for the final step, th=
e
>third reading in the Senate.
>
>The cheap drugs bill is one of a handful that the Martin government is
>pushing through to clear the way for him to call a snap general election.

Many expect him to announce a June 14 election. That will mean Governor
General Adrienne Clarkson dissolving parliament, a move which means that an=
y
unfinished legislation automatically falls.

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

Canada to honour pledge for cheap Aids drugs

Wednesday May 05, 2004 11:16 - (SA)
http://www.suntimes.co.za/zones/sundaytimes/newsst/newsst1083748578.asp

OTTAWA - Canada moved to the verge of becoming the first country to honour
a WTO pledge to get cheap generic drugs to HIV/Aids sufferers in the
developing world, with a crucial vote in parliament.

The House of Commons voted unanimously to allow the government to order the
over-riding of patents held by drug companies to allow cheaper generic
drugs to reach sufferers in the world's poorest nations.

The House voted 229 to 0 in favour of the legislation, leaving just the
upper house Senate to approve the bill, probably this week.

The swift, and unopposed, passage of the bill in the House of Commons on
Tuesday follows a compromise by the government last month.

Under pressure from its own backbenchers as well as the opposition, the
government agreed to make it easier than previously planned to over-rule
patents, especially for drugs combating such diseases as HIV/Aids and
tuberculosis, both of which are rampant in many parts of Africa and Asia.

Even U2 frontman Bono intervened with a personal plea to Prime Minister
Paul Martin, cashing in political chips won while performing at the Liberal
Party convention last November when Martin was elected party leader.

Canada claims to be more advanced than any other country in pushing through
a World Trade Organization (WTO) pact to allow generic drug manufacturers
to supply cheap versions of medicines patented by major pharmaceutical
companies.

Despite changes to the bill, some leading international aid groups still
criticized the legislation as being too friendly to commercial
pharmaceutical giants.

Nevertheless, parliamentary opposition to the bill melted away Tuesday as
members from all four political parties cast their votes in favour.

The government anticipates a similarly easy passage for the final step, the
third reading in the Senate.

The cheap drugs bill is one of a handful that the Martin government is
pushing through to clear the way for him to call a snap general election.

Many expect him to announce a June 14 election. That will mean Governor
General Adrienne Clarkson dissolving parliament, a move which means that
any unfinished legislation automatically falls.

AFP

******

PoliticsWatch

May 4, 2004

OTTAWA - In a rare show of unity, the House of Commons this afternoon
unanimously passed the Jean Chretien Pledge to Africa bill, which amends
two existing acts to allow for the importation of cheaper generic versions
of patented drugs to developing nations.

Although MPs from all parties had some reservations about what drugs get
delivered and how they get delivered to developing countries, all decided
to support the overall goal of the amendments and voted in favour of Bill C=
-9.

"We absolutely support the legislation," said NDP MP Brian Masse, who is
also a member of the Industry committee, which examined the bill.

"At this point in time we want to make sure that the drugs that are
currently on the list are available to those who can actually benefit from
them immediately.

"But kind of the real issue is when new drugs are developed and allowed to
be potentially procured, will there be lobbying behind the scenes to ensure
they won't be eligible for the list? Or will it take years of lobbying to
actually have them available to the countries that need them the most? And
that's really where things are problematic with the particular situation of
the bill."

Masse accused the brand-name drug industry of interference in the creation
of a list of drugs eligible to be made generics.

Masse said Health Canada had agreed to a series of drugs the committee was
proposing be on the list, but "behind the scenes there were things that
were happening." Health Canada had two drugs pulled off the list, this
included the drug moxifloxacin, a drug he had lobbied to have added to the
list. This morning the Ottawa Citizen reported Bayer lobbied the government
to have the drug taken off the list.

"That's one of the problems that we noted in the legislation that it could
have some kind of politicalization of the new drugs that would go on the
list and that's exactly what happened in this particular situation," said
NDP MP Brian Masse.

"We would have liked to have seen other improvements to the bill, but this
is just one of the things that has a potential underbelly to it that is
exposed to interference."

Liberal MP Dan McTeague, who is a known critic of what he likes to call Big
Pharma, also supported the bill and called it a "step in the right
direction," but he remains a bit skeptical given what has already happened
with moxifloxacin.

"A number of very strategic drugs have not been put on the list," he said.
"I think I'll be one of those in eight months hoping beyond reason that
something positive will come of this.

"My concern will be I will be watching very closely in the next six to
eight months to see if in fact any drugs are sold from Canada to Africa."

McTeague said another potential problem with the legislation is it contains
language that requires governments, and not non-governmental organizations,
to request the drugs and this could make it "practically impossible for any
generic to get their product over to Africa."

But one of McTeague's Liberal colleagues was much more upbeat about the
bill passing.

"I'm ecstatic, I'm euphoric, I think it's a solid bill," said Liberal MP
Marlene Jennings, who is also vice-chair of the Industry committee. "I
think that Canada has shown the way for the Westernized world how to move
forward to ensure that cheaper drugs are available for developing countries
and least developed countries. I'm thrilled."

Conservative MP James Rajotte, vice-chair of the committee, said the
Conservatives supported the bill despite their concerns about how the drugs
are going to be delivered to the people that need them.

"We certainly support the bill," he said. "We would like to actually see
more details from the government in terms of what medical infrastructure
commitments they're going to make through CIDA and other sources.

"The bill, in and of itself, is good bill in our view."

*******

http://www.canada.com/ottawa/ottawacitizen/news/story.html?id=3Dbad871d7-26=
17-4411-8c39-bfeba5a2ea10

Drug bill lets 'Big Pharma' call the shots
Government yields to pressure from Bayer to keep new drug off list of
HIV/AIDS program

Glen McGregor
The Ottawa Citizen

Tuesday, May 04, 2004

As the House of Commons votes today on legislation to allow the export
of low-cost drugs to the developing world, an NDP MP says the
humanitarian effort has been hampered by lobbying from the drug industry
to exclude important new medicines from the program.

Even before the legislation passes, the government has yielded to
pressure by Bayer Inc. and kept the company's pneumonia therapy,
moxifloxacin, off the list of medicines that can be exported in generic
form to impoverished countries.

Bill C-9, as it is known, would allow generic drugmakers to create
low-cost versions of patented drugs on the list and export them to
eligible developing countries. It will make Canada the first country to
pass legislation based on a World Trade Organization agreement to ensure
a supply of affordable medicine to treat HIV/AIDS, malaria and TB in the
developing world.

Brian Masse, the NDP MP who fought to get moxifloxacin (brand name
Avelox) on the list, says the drug's omission shows the legislation is
susceptible to a lobbying effort as the brand-name pharmaceutical
industry tries to protect its commercial interests.

"If they can be this bold about removing a drug in a bill that's being
developed, what's going to happen in the future?" said Mr. Masse.

"It's basically going to be Big Pharma selecting what drugs are going to
be available. We're seeing a politicization of the process."

Mr. Masse, a member of the House industry committee, last month made a
motion to add moxifloxacin to the schedule of medicines covered by the
legislation. Its use in treating pneumonia could make it valuable as an
AIDS drug, he said, and it also shows early promise as a tuberculosis
treatment.

Mr. Masse said he was stunned when Bayer's Canadian director of national
policy, Shona Kinley, called him directly to argue against including
moxifloxacin.

By the time the bill passed through committee and was returned for
today's vote in the House, moxifloxacin had disappeared off the list.

"I'm shocked and outraged that on the twilight on this bill you would
have this kind of interference. It's extremely alarming."

To Mr. Masse, the lobbying effort was confirmation of what humanitarian
groups had warned: that by including a schedule of medicines with the
legislation, new therapies could be delayed while regulators debate the
merits of each drug. He points out that the original WTO agreement on
which the new legislation is based did not require a list of approved
medicines.

Bayer Inc. says it fully supports Bill C-9, but doesn't want its drugs
used "off-label" -- for conditions they're not approved to treat.
Although there are trials under way, nowhere is moxifloxacin approved as
a frontline treatment for TB and the drug is not on the World Health
Organization's list of essential medicines.

"It's not a drug that's indicated for tuberculosis or HIV, and until it
goes through expert panel review, it should not be included on the
list," said Doug Grant, vice-president of Bayer Canada.

"Our pushback on this is that all of a sudden, after all the
negotiations, this motion comes out of blue."

Mr. Grant says there's no need to list moxifloxacin for treating
pneumonia because there are other effective pneumonia drugs already on
the list, including Bayer's broad-spectrum antibiotic, Cipro.

He says the effectiveness of moxifloxacin for treating TB is still an
unknown.

Indeed, while some early studies suggest moxifloxacin could be
effective, even Medecins Sans Frontieres warns that it might not be
appropriate in developing countries. The group's medical adviser, Dr.
Richard Bedell, says while the drug can "potentially be quite useful,"
it is not always the right choice for treating pneumonias because it can
mask TB symptoms.

Still, the U.S. Centers for Disease Control in Atlanta was encouraged
enough by its effectiveness in mice that it began conducting its own
phase II trials to assess how well it works in humans with TB.

"It's shown a lot of promise and there's a lot of folks interested in
it," said Dr. Philip Spradling, the medical officer with the CDC who is
running the study. "But in terms of betting the farm, we're not there yet.

"Realistically it's going to be many years before we know if this is the
drug, or if there's another drug out that may be better."

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

Sylvain Larocque (Presse canadienne)
http://www2.canoe.com/techno/nouvelles/archives/2004/05/20040505-120022.htm=
l

Dans une rare unanimit=E9, les d=E9put=E9s de la Chambre des communes ont a=
dopt=E9
mardi un projet de loi qui facilite l'exportation de m=E9dicaments brevet=
=E9s
vers les pays les plus pauvres.

Les 229 d=E9put=E9s pr=E9sents en Chambre ont tous vot=E9 en faveur de la m=
esure.

Le Canada est ainsi l'un des premiers pays =E0 mettre en oeuvre une d=E9cis=
ion
de l'Organisation mondiale du commerce (OMC) rendue en ao=FBt dernier.

En vertu de la nouvelle loi, Ottawa pourra accorder des licences afin de
permettre =E0 des firmes de fabriquer des m=E9dicaments brevet=E9s, m=EAme =
si elles
ne d=E9tiennent pas elles-m=EAmes le brevet. Des fabricants canadiens de
m=E9dicaments dits g=E9n=E9riques (copies des originaux) pourront ainsi r=
=E9pondre
aux besoins des pays en d=E9veloppement qui ne disposent pas d'une capacit=
=E9
suffisante de production pharmaceutique, et ce =E0 tr=E8s faible co=FBt.

La mesure sera particuli=E8rement utile aux pays pauvres qui sont aux prise=
s
avec des =E9pid=E9mies de maladies requ=E9rant des m=E9dicaments co=FBteux,=
 comme le
VIH/sida, le paludisme et la tuberculose.

Une disposition de la loi demande aux compagnies participantes d'utiliser l=
e
r=E9gime de bonne foi dans le but de r=E9gler des probl=E8mes de sant=E9 pu=
blique,
et non pour des motifs commerciaux.

Le texte porte le nom officiel de =ABLoi de l'engagement de Jean Chr=E9tien
envers l'Afrique=BB, en raison des efforts consentis par l'ancien premier
ministre pour cette cause. Le projet de loi doit encore recevoir
l'approbation du S=E9nat avant d'entrer en vigueur, ce qui devrait =EAtre f=
ait
avant le d=E9clenchement des =E9lections f=E9d=E9rales, d'ici la fin du moi=
s.

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


Richard Elliott
Director, Legal Research & Policy / Directeur, politiques et recherche
juridique
Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien VIH/sida
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4
Tel : +1 (416) 595-1666                 Fax +1 (416) 595-0094
E-mail: relliott@aidslaw.ca     Web: www.aidslaw.ca

The Canadian HIV/AIDS Legal Network is a partner organisation of the
AIDS Law Project of South Africa, and a non-governmental organization in
Special Consultative Status with the Economic and Social Council of the
United Nations. //
Le R=E9seau juridique canadien VIH/sida est un organisme partenaire  du AID=
S
Law Project
de l'Afrique du Sud et ONG dot=E9 de statut consultatif sp=E9cial aupr=E8s =
du
Conseil =E9conomique
et social des Nations Unies.
____________________________________________________________________
--