E-DRUG: Canada CL request for export of generic oseltamivir
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[Open letter from Biolyse, posted to E-drug by James Love. WB]
13 February 2006
Honourable Tony Clement
Minister of Health
Health Canada
Brooke Claxton Bldg.
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
Via fax (613) 952-1154 and post
Honourable Maxime Bernier
Minister of Industry
Industry Canada
C.D. Howe Building
235 Queen Street
Ottawa, Ontario
K1A 0H5
Via fax (613) 992-0302 and post
I write on behalf of Biolyse Pharma, a Canadian pharmaceutical
company with extensive experience in the manufacture and
commercialization of pharmaceutical products.
The purpose of this letter is to request the addition of oseltamivir
phosphate: Capsule, 75mg; Powder for oral suspension, 12mg/mL, to the
list of pharmaceutical products eligible for compulsory licensing for
export set out in Schedule 1 of the Patent Act.
Oseltamivir phosphate is a neuraminidase inhibitor (NAI) used as an
oral antiviral preventative and treatment for the influenza virus,
including certain strains more commonly known as "avian flu", and
specifically the highly fatal H5N1 variant. In 1996, the
multinational pharmaceutical company Hoffmann-La Roche, Inc. (Roche)
acquired worldwide licenses to certain patents on oseltamivir
phosphate from Gilead Sciences, Inc. (Gilead). Oseltamivir phosphate
was launched in Canada in 1999, and is marketed in Canada by Roche
under the trade name Tamiflu. The Canadian Patents that will be
affected are patent number 2313638 and patent number 2411153.
As you know, there is considerable concern that a future strain of
avian flu may be transmitted from person to person. Leading public
health authorities say there is a risk of a global pandemic of avian
flu, and that in some scenarios would lead to the death and suffering
of millions. The World Health Organization (WHO) has already released
a report "Responding to the avian influenza pandemic threat.
Recommended Strategic Actions" and the Canadian Government has
recognized the threat in different occasions.
Very few developing countries have stockpiled oseltamivir phosphate
remotely close to the quantities recommended. As a consequence, they
lack one of the tools for treatment or prevention of avian flu,
should such a pandemic occur.
Roche and firms licensed by Roche or Gilead are unable to meet the
current demand for oseltamivir phosphate, having cut off commercial
sales of Tamiflu in many countries, and having rationed and delayed
delivery of government stockpiles in many countries. The high prices
for Tamiflu are also a significant barrier for developing countries
to build needed stockpiles of this medicine.
Biolyse Pharma has developed a generic formulation of oseltamivir
phosphate and intends to apply for a non-exclusive compulsory license
to produce and export oseltamivir phosphate at an affordable cost to
developing countries, under the amendments to the Patent Act
implemented by the Jean Chretien Pledge to Africa Act, enacted
unanimously by Parliament in May 2004 and proclaimed into force in
May 2005. That legislation, which incorporated into Canadian law the
World Trade Organization (WTO) Decision of 30 August 2003 concerning
the Implementation of Paragraph 6 of Doha Declaration on the TRIPS
Agreement and Public Health, allows for compulsory licensing of
patented pharmaceutical products in Canada for the purposes of export
to eligible countries in need of lower-cost medicines to address
public health problems.
The current list of pharmaceutical products eligible for export, set
out in Schedule 1 to the Patent Act, does not include oseltamivir
phosphate. As a result of the amendments enacted in the Jean
Chretien Pledge to Africa Act, Article 21.03 (1) of the Patent Act
regulates the procedure to amend Schedule 1, requiring a Governor in
Council decision following the recommendation of both the Minister of
Industry and the Minister of Health.
Therefore, for the reasons mentioned herein, we ask you, as the
Ministers of Health and Industry respectively, to recommend to the
Governor in Council the amendment of Schedule 1 to include
oseltamivir phosphate in the list of pharmaceutical products eligible
for export under the Patent Act. We note that this request concerns
a response to a potential public health emergency, and there is an
urgent need for countries to prepare for a possible pandemic. We
also note that Schedule 1 has already been amended once since its
enactment to add a product, and that during the process of drafting
and passing the Jean Chretien Pledge to Africa Act, stakeholders were
repeatedly assured that it would be a simple, rapid process for
Governor in Council to add products to Schedule 1.
The Jean Chetien Pledge to Africa Act received the unanimous support
of all parties in Parliament, and of every Member of Parliament and
Senator, as one aspect of Canada's response to the many health
challenges confronting developing countries. It has, however, not yet
been used to produce and export a single medicine. Biolyse Pharma, a
Canadian company, is ready and willing to make use of the law to
respond to an emerging public health need of developing countries.
This is an opportunity for the Government of Canada to follow through
on Parliament's stated commitment to improving access to medicines
and to demonstrate the usefulness of this precedent-setting legislation.
Please do not hesitate to contact us if you would like any additional
information. We look forward to hearing from you at your earliest
convenience.
Sincerely,
John R. Fulton
Executive Vice President
Biolyse Pharma Corporation
59 Welland Vale Road
St. Catharines, Ontario
Canada
L2S 3Y2
Tel:(905)687-8008
Cell:(905)871-9463
Fax:(905)687-4923
fulton@biolyse.ca
www.biolyse.ca