[Ip-health] First Shipment of Affordable Medicines Finally En Route to Africa / Un premier lot de médicaments abordables enfin en route vers l'Afrique

[Ethan Guillen]

On behalf of Richard Elliot:

-----Original Message-----
From: Richard Elliott
Sent: Tuesday, September 23, 2008 1:05 PM
Subject: First Shipment of Affordable Medicines Finally En Route to Africa /
Un premier lot de médicaments abordables enfin en route vers l'Afrique

Colleagues:

Please find pasted below the text of two media releases issued this morning,
marking the first shipment, at long last, of generic AIDS drugs produced for
export under Canada's law on compulsory licensing of pharmaceuticals for
export (implementing the WTO's August 30, 2003 decision).

To the best of our knowledge, this represents the first such export under
the terms of the WTO decision.

This development comes in the middle of a federal election in Canada.
Pasted below is the text of a short backgrounder on reforming "Canada's
Access to Medicines Regime" that is being distributed widely to put this
issue on the agenda for federal political parties during the campaign.  See
www.aidslaw.ca/election2008.

More information about "Canada's Access to Medicines Regime", and proposals
to reform it to make it more user-friendly, can be found at
www.aidslaw.ca/gtag.

Richard
___________________________
Richard Elliott
Executive Director
Canadian HIV/AIDS Legal Network
Telephone: +1 416 595-1666 ext. 229
Fax: +1 416 595-0094
Website: www.aidslaw.ca
 
Directeur général
Réseau juridique canadien VIH/sida
Téléphone : +1 416 595-1666 poste 229
Télécopieur : +1 416 595-0094
Site web : www.aidslaw.ca
 
 please don't print this e-mail unless you really need to.
 s.v.p. ne pas imprimer ce courriel à moins d'en avoir vraiment besoin.

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PRESS RELEASE

 Attention: City/International Editors

 For Immediate Release

 September 23, 2008


Canadian-Made Life Saving HIV/AIDS Drug Heading To Africa Under

Canada's Access To Medicines Regime (CAMR)


Toronto, September 23, 2008 - Apotex Inc, the largest Canadian-owned
pharmaceutical company, is pleased to announce that Apo-TriAvir, a triple
combination HIV/AIDS drug, approved under Canada's Access to Medicines
Regime (CAMR), is ready to ship to Rwanda, the only country to make a
request through a program tender process. The first shipment of seven
million tablets, which will help save the lives of 21,000 people, is
scheduled to leave from Toronto on September 24th, 2008. Apotex is doing
this on a humanitarian, not-for-profit basis.

"While we are extremely pleased to be able to make this important and
historic contribution, there is a reason no other company has tried to
provide medicines under this regime. It is too complex and has to be
repeated for every request that comes in from a country. For Canada to truly
be able to provide help, the regime must be changed. Apo-TriAvir will save
lives the moment the patients have access to it but it is now up to the
federal government to fix CAMR ," said Jack Kay, Apotex President.

Canada's Access To Medicines Regime came into force in May 2004 and is meant
to allow Canadian generic drug makers to legally produce patented,
brand-name drugs for export to developing countries. The Canadian regime is
based on a 2003 World Trade Organization (WTO) to allow developing countries
to import lower-cost medicines their populations desperately need. After
almost four and a half years in the CAMR process, Apotex is the only company
to have submitted, received approval, and then negotiated through the very
complex CAMR process.

Apotex competed against pharmaceutical companies from around the world in
the tender to supply this AIDS drug. A second shipment of seven million
doses is scheduled to leave in September 2009.

"This is an important and exciting time for Apotex and all of our employees
who worked so hard for so long with the hope of making a difference. Despite
the many hurdles and setbacks we have suffered due to this ineffective
regime, we have persevered and now we will make a direct impact on the lives
of hundreds of thousands of people who desperately need our help." Kay said.

Apotex has 6,000 employees in Canada and manufactures 300 medicines which
are exported to 115 countries. It has over 600 products under development
with planned R&D expenditures of $2 billion over the next 10 years.

- 30 -

For further information:

Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
Cell: 416-558-5491
ebetito@apotex.com


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CANADIAN HIV/AIDS LEGAL NETWORK

For immediate release

FIRST SHIPMENT OF AFFORDABLE MEDICINES FINALLY EN ROUTE TO AFRICA

But Canada's Access to Medicines Regime could end up being "one-hit wonder"

Toronto, September 23, 2008 - The Canadian HIV/AIDS Legal Network hailed
this morning's announcement that the first batch of a lower-cost, generic
AIDS drug to be exported under Canada's Access to Medicines Regime will
finally be shipped to Rwanda tomorrow.  But it also called on the new
federal government and Parliament to move quickly after the election to fix
the Regime to avoid this first shipment also being the last.

"The delivery of these medicines is way past due," said Executive Director
Richard Elliott.  "It's taken more than four years to get to this point.
People are dying because they can't pay high prices for patented, brand-name
drugs - they can't afford such delays."

Canada's Access to Medicines Regime was created 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.

Earlier this year, after a competitive tendering process, the Government of
Rwanda announced that it had chosen to purchase a low-cost AIDS drug from
Ontario-based generic pharmaceutical manufacturer Apotex, Inc.  The initial
order is for enough medicine to treat more than 21,000 people for a year -
and at US$0.39 per daily dose, it means limited funds can save more lives.

But Elliott said today's good news doesn't let politicians off the hook.
"The Regime risks becoming a 'one-hit wonder' if Parliament doesn't cut
through the unnecessary red tape.  Canadian generic drug makers and people
who do drug procurement in developing countries are saying it's unlikely
that they will try to use it again because it's too cumbersome."

Last year, the Legal Network submitted a brief to Parliament proposing 13
concrete amendments that could be passed immediately to make the Regime
truly workable.  Chief among these amendments was a simple "one-licence
solution" eliminating the need for separate negotiations and separate
licences for each country and each order of medicines.

"We did their homework for them," said Elliott.  "But so far the government
has done nothing but table a report in Parliament saying that 'more time' is
needed to assess whether to make changes."

The Legal Network called on the leaders of all federal parties to make a
commitment during this election to fix Canada's unnecessarily complicated
process and make it more user-friendly for both developing countries and
Canadian generic manufacturers.

"Anything less would be breaking a promise to help the developing world,"
concluded Elliott.

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 www.aidslaw.ca/treatment.

- 30 -
Disponible en français

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

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Canadian HIV/AIDS Legal Network

Election 2008
Vote for action on AIDS

At issue: Global access to life-saving medicines

Millions of people in developing countries die every year from diseases that
can be treated.  Many developing countries can't afford expensive brand-name
medicines. Without the capacity to make lower-cost, generic versions, they
need to import them.

Canada passed a law four years ago that was supposed to help supply these
medicines, but it has delivered little so far and needs to be fixed.

The need

The World Health Organization estimates that over the last three years more
than 25 million people died because they did not have access to medicines
and vaccines.

Companies that hold patents on brand-name medicines have a monopoly over
them.  Prices for these are often much higher than what poor patients and
health systems in developing countries can afford.

Yet over the past decade, the price of treating people with AIDS has
decreased dramatically, making it possible to get more people the medicines
they need to stay alive, work, and support their families and communities.

This has happened thanks to AIDS activists and leadership by some
governments - and because the law in some countries has limited patent
monopolies on medicines, which means that competition from generic drug
makers has brought prices down.

Canada has a law that is supposed to do just this - in theory.  But in
practice, it could end up being a "one-hit wonder".

The situation

Four years ago, all parties in Parliament voted for the law that created
"Canada's Access to Medicines Regime".  The law is supposed to let generic
drug companies in Canada get licences to export less expensive medicines to
developing countries, in exchange for paying low royalties to the
patent-holders.

Finally, this year, the law has been used for the first time.  Apotex, Inc.
- the largest generic-medicine manufacturer in Canada - announced it had
reached an agreement to supply Rwanda with a simple, 3-in-1 AIDS drug,
enough to treat roughly 21,000 people with HIV for one year.  The selling
price is 39 U.S. cents per daily dose (2 tablets a day at 19.5 cents per
tablet) - about one-third of what it would cost if the brand-name drugs were
bought separately.  The first shipment is expected to arrive in Rwanda by
October 2008.

But unless it's simplified, this could be the last time Canada's Access to
Medicines Regime gets used.  So far, Canadian generic drug makers are saying
it's unlikely that they will try to use it again. Why?  The process is too
cumbersome and complicated.  People handling drug purchasing in developing
countries have raised the same concerns.

When this system doesn't work, it's patients in developing countries that
suffer and die.

The debate

Humanitarian and health organizations agree that Canada's Access to
Medicines Regime has unnecessary hurdles.

It only covers certain medicines.  It does not automatically include
medicines that the World Health Organization has approved, including
simplified versions which combine multiple AIDS drugs into a single tablet
and make treatment easier for patients.

To buy medicines for the clinics they operate to treat patients,
humanitarian organizations have to jump through extra hoops.

Canada's system discriminates against developing countries if they don't
belong to the World Trade Organization and sign its restrictive rules on
drug patents.

Too much red tape makes the process of getting licences to make and export
lower-cost, generic medicines to developing countries inefficient and
inflexible.  Non-governmental organizations have called upon the federal
government to adopt a simpler, more straightforward approach to licensing.

The federal government has heard from developing countries that the system
doesn't fit with how they need to purchase and distribute medicines, and
from non-governmental organizations about potential solutions.  It took four
years to get just one drug order through the system, and there's a very good
chance it might be the last.

But last year, in a report to Parliament, the federal Industry Minister
concluded that "more time" is needed before deciding whether to make any
amendments.

The decision you need to make

Cast your vote for a federal government that will:

Streamline Canada's Access to Medicines Regime into a "one-licence
solution".  Instead of the current country-by-country, order-by-order
process, a better law would require just one licence on a patented medicine.
That one licence would allow exports to any of the developing countries
covered by the law without restricting the quantity in advance.  As a
condition of the licence, the generic drug manufacturer would still pay
royalties to the company with the patent on the drug based on the sales of
the generic product.

One process, one licence - easier and more flexible for developing countries
and for suppliers of generic medicine, and therefore better for patients who
need life-saving medicines.

For more information

www.aidslaw.ca/elect2008
www.aidslaw.ca/treatment

[END]


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