Canada’s Paragraph 6 Legislation: What next?

Rachel Kiddell-MonroeCoordinator for Access to Essential Medicines Campaign, MSF Canada

The Jean Chrétien Pledge to Africa

May 2004: Canada implemented the August 30th Decision to allow: “the use of patents for international humanitarian

purposes to address public health problems” Canadian government refers to a Canadian

Access to Medicines Regime

Chronicle of a JCPA drug order (1) Sept 2003 to May 2005: extensive advocacy

involvement in legislative process. May 2004: committed to making an order under

the legislation. August 2004: invited to propose drugs for

production under the under legislation. Proposed 3-in 1 antiretroviral (AZT/3TC/NVP).

December 2004: Canadian generic agreed. April 2005: Active prototype formulated.

Chronicle of a JCPA drug order (2)

April 2005: clinical trials begin December 2005: Health Canada approval process begins May 2005: MSF agrees to purchase if compulsory licence

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

July 2005: drug passes Health Canada review. Sent to WHO PQP.

No compulsory licence application filed – JCPA not yet kicked in.

No importing country confirmed and no notification to WTO.

JCPA Provisions required by WTO August 30th Decision Voluntary licence negotiations at discretion of companies Anti-diversionary measures (pill colours, labelling, website tracking by

generic manufacturer) Drug by drug, country by country, case by case decision making

ignores- economies of scale - need for stockpiling

Notification in writing to TRIPS Council Two compulsory licences Resources to administer complex legislation in developing countries

JCPA 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

List of eligible countries Health Canada approval: required extra-ordinary

involvement of MSF Two year limit on compulsory licence Other…

•Process Chart

WTOMember

Yes No

Schedule1

No

30d 15d 15d 15dSeek

VoluntaryLicense

Apply toCIPO &

Pay Fees

CIPOProcess

ComplusoryLicense

Issued

CopyContractto CIPO

NotifyHC

of Startof Mfr

LotsManufacture

PostWeb-

site

ExportNotice

Ship Royalty

Complieswith Act& Regs

Enters C-9Queue,

Standard

Review andDistinguishing

Features

(A)NDS for Schedule 1 DrugStatement of Intent forCompulsory License

Distinguishing Features

HCNotifies

CIPO

(A)NDS

PatentHold in

Canada

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

Regular Drug Order

MSF Faxes order to company

Company confirmsorder and

estimated date ofarrival in project

Project receivesdrugs

JCPA: Compromise legislation: corporate vs. humanitarian Lack of interest from generics: the special case of Apotex Lack of interest from importing countries Complexity of Canadian legislation and lack of clarity around

many provisions Extra-ordinary involvement from MSF Over 2 years after JCPA implemented, only one drug

produced under legislation by one company and this not yet ready for export.

…And the JCPA mechanism itself has not even kicked in yet so impact of anti-diversionary measures not yet tested

Indian generics to the rescue

Meanwhile…

in June 2006: WHO PQP and USFDA approve Indian versions of same 3-in-1: both reasonably priced and freely available for export immediately.

The Crisis

Where will new HIV/AIDS

drugs come from?

Post 2005 world

The Issue

August 30th has not provided an expedient or practical solution to access to medicines for countries with little or no manufacturing capacity: clearly shown in Canada

Canadian legislation has additional barriers to access built into it.

The ease of access to Indian products clearly demonstrated the limits of the WTO “solution”.

However, as patent protection kicks in in India and other countries, generic manufacturers will no longer be able to respond to needs

MSF Demands

That WTO members urgently revisit their decision in December 2005 to make the August 30th Decision permanent

That Canada remove the barriers to export included in the JCPA