Unveiling the WTO August 30 Decision: The Canadian Experience

Rachel Kiddell-MonroePresident, Universities Allied for Essential Medicines; Former Coordinator for MSF’s Access to Essential Medicines Campaign in Canada

Canada’s Pledge to Africa May 2004: Canada implemented the WTO’s August

30 Decision to allow: “…the use of patents for international humanitarian

purposes to address public health problems” Canadian government refers to “Canadian Access

to Medicines Regime” (CAMR) After Stephen Lewis’ call to action in Canada,

Canadian NGOs embarked on making legislation meaningful for patients.

Drugs to Rwanda

25 September is long-awaited moment forRwandans living with AIDS: up to 21,000 can

receive treatment with AZT/3TC/NVP for 1 year (2 pills per day)

Canadian GovernmentApotex http://www.apotex.com/apotriavir/Canadians

But what does it actually mean for global access to medicines ?

Chronicle of a CAMR Drug Order (1) Sept 2003 to May 2005: extensive advocacy

involvement in process of enacting legislation (May 2004) and regulations (May 2005).

May 2004: MSF committed to making an order under the legislation.

August 2004: MSF invited to propose drugs for production under the under legislation. Proposed 3-in-1 antiretroviral (AZT/3TC/NVP).

December 2004: Canadian generic drug producer agreed. Health Canada approval process begins.

Chronicle of a CAMR Drug Order (2) April 2005: Active prototype formulated and clinical

trials begin. May 2005: MSF agrees to purchase if compulsory

licence obtained in Canada and importing country found who willing to import drug.

July 2006: drug passes Health Canada review. Sent to WHO PQP.

August 2006: WHO PQ received, coinciding with Toronto International AIDS Conference.

MSF decides not to continue with the order 20 September 2007: compulsory licence issued

(first in the world under WTO Aug 30, 2003 Decision)

Chronicle of a CAMR Drug Order (3) Late 2007: Rwanda announces competitive tender

process for the 3FDC 7 May 2008: Apotex announces contract with Rwanda to

provide 15.6 million tablets of 3FDC (1 year treatment for around 21,000 patients).

Cheaper than price offered by Indian generic companies with same product (according to the11th edition of MSF “Untangling the Web”, as of July 2008 - pages 64-65)Apotex: US$0.195 cents per tablet (US$0.39/day)

US$143/year per patientAurobindo/Cipla:

US$176/year per patient 25 September 2008: first shipment due to arrive in

Rwanda

CAMR Provisions Required by WTO August 30th Decision Drug by drug, country by country, case by case decision

making ignores- economies of scale - need for stockpiling

Voluntary licence negotiations at discretion of companies Anti-diversionary measures (pill colours, labelling, website

tracking by generic manufacturer) Notification in writing to TRIPS Council Two compulsory licences Resources to administer complex legislation in developing

countries

CAMR Advantages

Clear royalty formula (sliding scale based on country ranking on UN Development Index to max of 4%)

30 day limit on voluntary licence negotiations (but only starting from the date that all of the information is provided to the patent-holder, including the quantity, name of the country, etc).

CAMR Provisions Not Required by WTO August 30th Decision

Limited list of medicines: In practice taken 3-5 months and discretionary process to add drugs to list

Health Canada approval: required extra-ordinary involvement of MSF and others

Two year limit on compulsory licence List of eligible countries Sections limiting price and profit margin of

generic manufacturer and providing basis for patent-holder to litigate to vary or rescind compulsory licence

Regular Drug Order

MSF Faxes order to company

Company confirmsorder and

estimated date ofarrival in project

Project receivesdrugs

Process Chart: JCPA

WTOMember

Yes No

Schedule1

No

30d 15d 15d 15dSeekVoluntaryLicense

Apply toCIPO &

Pay Fees

CIPOProcess

ComplusoryLicenseIssued

CopyContractto CIPO

NotifyHC

of Startof MfrLots M

anuf

actu

re

PostWeb-site

ExportNotice

Ship Royalty

Complieswith Act& Regs

Enters C-9Queue,

StandardReview and

DistinguishingFeatures

(A)NDS for Schedule 1 DrugStatement of Intent forCompulsory LicenseDistinguishing Features

HCNotifiesCIPO

(A)NDSPatentHold inCanada

Manufacturer mayapply for Health

Canada remissionof fees w/in 45

days ofCompulsory

License issue

Gov’t to Gov’tRequest

orAdvisory

Committee

DiplomaticChannels

(Non-TRIPSMember)

PostInfo

(TRIPSMember)

StartProcess

Renewal

Conclusion of Canadian Experience

August 30 Decision is not an expeditious solution to the access to medicines crisis

The outcome…

Up to 21,000 Rwandan patients have access to treatment they need

Another affordable treatment option available One developed country generic company shown to

have capacity and will to provide low cost, high quality medicines

Extra competition on this drug which brought price down

…does not solve the problem7 years after Doha declared access for all

5 years after August 30 Decision promised a mechanism to allow generic drug production for developing countries

And more than 4 years after Canadian legislation enacted 70% of patients needing ART still do not have access to

treatment Limited coverage No other country or company tried to use legislation

either in Canada or in the other countries which have also adopted legislation.

Historically easy access to Indian drugs clearly demonstrates limitations of WTO process.

From Apotex

‘If other critical medicines are to go to Africa in a reasonable timeframe, the Federal Government must change the CAMR Legislation. CAMR is unworkable as it now stands’  Jack Kay, Apotex President and COO

The AIDS crisis has not gone away

People on antiretroviral treatment develop intolerable side effects or start to develop resistance to the first line drugs (MSF in South Africa: 1 in 5 after 5 years)

Switching to second line is 10 to 20 times more expensive

Switching to less-toxic first-line is 5 times more expensive

Need an effective international solution to bring prices down

Next Steps

WTO members must reconsider ratifying the August 30 Decision recognising the conclusions of the Canadian experience

WTO should consider Article 30 alternative once more

WTO members should ask the Canadian government to take a lead and amend its legislation along the lines of Article 30.

On-going work Canadian NGOs, activists, students and Canadian

media. Notable role of Richard Elliott of Canadian HIV/AIDS Legal Network, Stephen Lewis and the Global Treatment Action Group

New network of Grandmothers-for-Africa groups across Canada raising this issue in international fora, in meetings with parliamentarians, keeping it in the media, gathering thousands of signatures on a petition to Parliament

Legal Network have presented Canadian Parliament with detailed proposals for legislative reform.

For more resources go to www.aidslaw.ca/gtag.