[Ip-health] Canada: Patent Act amendment introduced -- Legal Network and
Government of Canada press releases (Nov 6, 2003)
Richard Elliott
relliott@aidslaw.ca
Thu Nov 6 12:08:17 2003
--
[ Picked text/plain from multipart/alternative ]
Dear colleagues:
Today the Canadian introduced its bill to amend the Patent Act to implement
the WTO August 30, 2003 decision on compulsory licensing for the export of
generic pharmaceutical products to countries lacking pharmaceutical
manufacturing capacity. (The bill will eventually be available on-line via
www.parl.gc.ca, but this could take a day or two.) Pasted below is the
text of the Government's press release, and an accompanying backgrounder,
issued this morning. It is also available on the website of Industry
Canada at www.ic.gc.ca.
Pasted below is the text of the press release issued today by the Canadian
HIV/AIDS Legal Network in response to the bill. The release, and other
materials, are also available on-line at www.aidslaw.ca.
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.
____________________________________________________________________
For immediate release -- 6 November 2003
Canada can set global precedent with Patent Act changes,
but flaws in legislation could undermine potential benefit
TORONTO =96 The Canadian HIV/AIDS Legal Network welcomed today=92s introduc=
tion
by the federal government of amendments to the Patent Act that would allow
exports of lower-cost generic pharmaceutical products to developing
countries. But the Legal Network also stressed that the bill is flawed as
it stands, and must be improved in two key ways if it is to actually
achieve the stated objective of improving access to treatment for millions
of people in the developing world.
=93This is an important, historic step by the Government of Canada=94, said
Richard Elliott, Director of Legal Research & Policy. =93We commend the
government for responding quickly to the call to action from Canadian and
international civil society and from Stephen Lewis, the UN Special Envoy on
HIV/AIDS in Africa.=94
Elliott also congratulated the government for heeding the message that the
amendment should not be limited by only allowing exports of pharmaceutical
products for specific diseases or only once a country=92s situation had
become an =93emergency.=94 But the Legal Network also cautioned that the
legislation must not include provisions that undermine its potential
benefit, and highlighted two major concerns.
First, =93the amendment should not be limited to a list of specific
pharmaceutical products,=94 said Elliott. He pointed out that humanitarian
organizations, human rights activists, and developing countries resisted
all such efforts at the World Trade Organization to narrow down the options
for developing countries to just a handful of medicines. =93What is requir=
ed
is a flexible approach. It makes no sense from a public health perspective
to limit the pharmaceutical products that countries could obtain from
generic manufacturers. All countries =96 and developing countries are no
exception =96 should be able to make sovereign decisions in determining whi=
ch
products are needed to respond to public health problems in their setting,
without having to get further approval from the Canadian government.=94
Elliott also pointed to a second major concern with the bill that has been
introduced. He said the legislation would be fatally flawed if it includes
a so-called =93right of first refusal=94 for brand-name drug companies, as =
this
would effectively allow brand-name drug companies to =93freeze out=94 gener=
ic
companies from actually supplying lower-cost products to meet the public
health needs of developing countries.
=93The whole point of this exercise was to ensure that developing countries
can effectively use the process of giving licences to generic companies in
order to get lower medicine prices. If the legislation always gives the
brand-name pharmaceutical company the right to take over a contract that a
generic manufacturer has negotiated with a developing country, and thereby
block the generic manufacturer from getting a licence to produce for
export, then it removes any incentive for generic companies to even bother
negotiating those contracts. As a result, we won=92t actually end up seein=
g
lower prices, from either generic companies or brand-name companies,=94
Elliott explained. He rejected as inaccurate the suggestion that granting
a brand-name company the right of first refusal is required by WTO rules.
The Legal Network expressed its expectation that the government will be
open to further discussion on these important points before the legislation
in finalized and introduced by the government in the next session of
Parliament.
=93We look forward to further consultation with the government on these
issues,=94 said Elliott. =93We fully support action to improve access to
affordable medicines in developing countries, as a matter of fundamental
human rights. Now we need to make sure Canada, as the first country in the
world to take this step, doesn=92t undermine its own initiative and set a b=
ad
global precedent.=94
=96 30 =96
Media contact: Elana Wright, (514) 397-6828, ext. 259
For additional information, including a backgrounder and other materials on
the issue of the Patent Act amendment, see:
<http://www.aidslaw.ca/Maincontent/issues/cts/patent-amend.htm>http://www.a=
idslaw.ca/Maincontent/issues/cts/patent-amend.htm
Advisory: Richard Elliott, the Legal Network=92s Director of Legal Researc=
h
& Policy, will be delivering a public presentation on the subject of the
Patent Act amendment at the University of Toronto, University College (Room
240), 15 King=92s College Circle, later today (Thursday, November 6) from
2:00 =96 3:30 p.m. The event is open to the public and to media.
The Canadian HIV/AIDS Legal Network
(<http://www.aidslaw.ca/>www.aidslaw.ca) is a national organization engaged
in education, legal and ethical analysis, and policy development. Founded
in 1992, the Network=92s promotes responses to HIV/AIDS that respect human
rights; facilitate prevention efforts and access to care, treatment and
support; minimize the adverse impact of HIV/AIDS on individuals and
communities; and address the social and economic factors that increase
vbulnerability to HIV/AIDS and to human rights abuses. The Network is an
NGO in Special Consultative Status with the Economic and Social Council of
the United Nations. Its work has received national and international
recognition, and the United Nations Joint Programme on HIV/AIDS has
included the Network=92s activities in UNAIDS=92 collection of "best practi=
ces."
[end]
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Government of Canada Introduces Legislative Changes to Enable Export of
Much-Needed, Low-Cost Pharmaceutical Products to Developing Countries
OTTAWA, November 6, 2003 =AD The Government of Canada is leading the global
movement to address public health problems, especially human
immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS),
tuberculosis, malaria and other epidemics, by introducing today legislative
changes that will help give developing and least-developed countries
greater access to much-needed, low-cost pharmaceutical products.
The proposed changes to the Patent Act and the Food and Drugs Act make
Canada the first country to take concrete measures to implement the World
Trade Organization's (WTO) recent Declaration on the Trade-Related Aspects
of Intellectual Property Rights Agreement and Public Health (Doha
Declaration). The legislative changes will make it easier for Canadian
pharmaceutical companies to export their products to countries in need.
Under the WTO agreement, member countries may allow patented products to be
manufactured under licence by someone other than the patent holder for a
limited period of time and in response to a public demand by a country with
insufficient pharmaceutical manufacturing capacity.
=93These proposed legislative changes are broad, flexible and faithful to
what WTO members have spent so long negotiating. We hope that our leading
role encourages developed countries around the world to follow suit,=94 sai=
d
Pierre Pettigrew, Minister for International Trade. =93These actions
demonstrate Canada's strong commitment to the development objectives set
out in the WTO Doha Development Agenda.=94
=93Our goal is to address a pressing humanitarian problem, and we have work=
ed
with the two pharmaceutical associations and with non-governmental
organizations who provide on-the-ground public health assistance to develop
legislation that will be part of the solution,=94 said Allan Rock, Minister
of Industry. =93At the same time, we recognize the need to respect
intellectual property rights, which are critical to the development of new
products and therapies in Canada. The input of the industry and
non-governmental organizations has been invaluable, and I thank all who
have participated in these consultations.=94
=93Canada has one of the most rigorous drug approval systems in place, and =
as
Minister of Health, I am committed to ensuring that the system is used to
ensure that the pharmaceutical products sent to less-developed countries
meet Canadian safety standards,=94 said Anne McLellan, Minister of Health.
=93This is an important step in helping other countries fight HIV/AIDS,
malaria, tuberculosis and other diseases.=94
=93This is one of the most important steps Canada can take to advance globa=
l
health and human rights, and we hope to see other G-8 countries following
suit,=94 said Bill Graham, Minister of Foreign Affairs. =93As United Nation=
s
Secretary-General Kofi Annan said last week, our action today could save
millions of lives. This is a major breakthrough in the international
community's capacity to address not just the prevention of AIDS and other
diseases in the developing world, but also the provision of treatment and
access to pharmaceutical products for those in need.=94
=93Nothing disrupts development like the burden of disease,=94 said Susan
Whelan, Minister for International Cooperation. =93Some of the most powerfu=
l
things we can do to improve the well-being of people overseas involve
changes to how we do things right here in our own country, such as changing
our patent and drug legislation.=94
With legislation now introduced, the Government of Canada will put in place
the complementary regulatory frameworks as soon as possible. As the
government proceeds, it will continue to actively consult with and engage
those who will contribute to the ultimate success of this initiative.
For more information, please contact:
S=E9bastien Th=E9berge
Office of Pierre Pettigrew
Minister for International Trade
(613) 992-7332
Media Relations
Department of Foreign Affairs and
International Trade
(613) 995-1874
Linda Kristal
Office of Allan Rock
Minister of Industry
(613) 995-9001
Media Relations
Industry Canada
(613) 943-2502
Isabelle Savard
Office of Bill Graham
Minister of Foreign Affairs
(613) 995-1851
Farah Mohamed
Office of Anne McLellan
Minister of Health
(613) 957-0200
Media Relations
Health Canada
(613) 941-8189
Media Relations
Canadian International Development
Agency
(819) 953-6534
Marta Anderson
Office of Susan Whelan
Minister for International Cooperation
(819) 953-6238
----------
Backgrounder
The World Trade Organization and access to pharmaceutical products
In the November 2001 Doha Ministerial Declaration, World Trade Organization
(WTO) members recognized the gravity of the public health problems
afflicting many developing and least-developed countries, especially those
resulting from human immunodeficiency virus and acquired immune deficiency
syndrome (HIV/AIDS), tuberculosis, malaria and other epidemics.
On August 30, 2003, negotiations among WTO members resulted in a decision
waiving certain provisions of the Agreement on Trade-Related Intellectual
Property Rights (TRIPS), which appeared to prevent nations in need from
importing less-expensive versions of pharmaceutical products.
As the first WTO member to announce its intention to domestically implement
this decision, Canada's challenge is to demonstrate leadership in the
promotion of an effective international system that will remove barriers to
the quick delivery of affordable pharmaceutical products to developing and
least-developed countries. Canada's proposed regime fully reflects the
outcome negotiated among WTO members.
The agreement stipulates that the decision must be used in good faith to
deal with public health problems, and not for industrial or commercial
objectives, and that it is important to ensure that these products are not
diverted from their intended beneficiaries.
Canada's approach, when implemented, will allow for vital health and
development goals to be advanced, while also respecting the intellectual
property rights that promote the development of new pharmaceutical products=
.
The proposed amendments to the Patent Act and the Food and Drugs Act, once
approved by Parliament, won't result in better health for the developing
world overnight, however, this is a move in the right direction. It
complements the work Canada is doing in a broad range of international
programs, exemplified by the commitments made in the Africa Action Plan
introduced at the G-8 Summit in Kananaskis, Alberta.
Canada will continue to work with the WTO, the World Health Organization
(WHO) and the World Intellectual Property Organization (WIPO) to develop
effective international means of implementing the WTO decision on access to
pharmaceutical products.
In November 2003, the WTO will implement a notification system for
countries that wish to import drugs using compulsory licences. The TRIPS
Council will discuss this when it meets from November 16-18.
In Geneva, Canada is working closely with the WTO, the WHO, the WIPO and
other international bodies to advance this issue.
Amendments to the Patent Act
The Government of Canada is proposing amendments to the Patent Act in order
to add a new section authorizing third party use of patented inventions to
address public health problems afflicting developing and least-developed
countries especially those resulting from HIV/AIDS, TB, malaria and other
epidemics. The new section in question will allow for the issuance of
compulsory licences to Canadian firms, typically generic drug companies,
authorizing them to manufacture in Canada specific patented pharmaceutical
products for the sole purpose of exporting them to least-developed and
developing countries that are unable to produce domestically the
pharmaceuticals needed to respond to their public health problems.
The proposed amendments to the Patent Act, developed in consultation with
Canada's pharmaceutical industry and non-governmental organizations (NGOs),
are designed to implement the provisions of a waiver to certain obligations
in the WTO Agreement on Trade Related Aspects of Intellectual Property
Rights (TRIPS) which had until now prevented developed countries like
Canada from issuing licences to pharmaceutical companies to produce
patented brand name pharmaceutical products for export to least-developed
and developing countries. In conceiving the amendments, the Government of
Canada was mindful of the importance of continuing to protect the
intellectual property rights of domestic patent holders and of respecting
its other international trade obligations in this regard.
Once amended, the Patent Act will include Schedules which identify the
specific pharmaceutical products and importing countries which are eligible
under this new regime. The Schedules setting out the eligible importing
countries consist of the WTO member countries which qualify under the terms
of the Waiver but also includes non-WTO members that have been identified
as least-developed-countries by the United Nations. The Schedules will not
include the 23 WTO members that have self-identified as non-importing
countries under the regime.
In signing on to the WTO Waiver, Canada, as well as stakeholders,
recognized that it was not conceived to apply to all pharmaceutical
products but rather is targeted at the medicines needed to treat grave
public health problems. The World Health Organization (WHO) List of
Essential Medicines (which lists the most efficacious, safe, and
cost-effective medicines for priority conditions in a basic health care
system) provides a sound guide for establishing the initial schedule of 46
eligible products that are currently subject to a patent in Canada.
The amendments retain flexibility by providing a regulatory mechanism to
add to or delete from these Schedules as the need arises or as
international consensus emerges. They also enable the creation of an expert
advisory committee by the Ministers of Health and Industry, composed of
medical health practitioners and other experts in relevant fields, which
may be asked to provide advice on amending the Schedule of pharmaceutical
products.
Consistent with Canada's TRIPS obligations, and in keeping with the
underlying objective to expedite the provision of pharmaceutical products
to countries in need, under the amended Patent Act, patent-holding brand
name companies will be given the opportunity to be the first supplier of a
requested pharmaceutical product. Following a notice of intent by a
pharmaceutical company seeking a compulsory licence, the patent holder will
have 30 days in which to decide whether to fulfill the supply opportunity.
If the patent-holder decides not to do so, the other company may proceed
with its application for a compulsory licence. Such a licence will be
subject to the following terms and conditions:
* Use of the patented pharmaceutical product must be limited to a
specific quantity and for use in a specific country;
* A website must be established disclosing the information relating to
the licence;
* The licencee must pay a royalty of two percent of the value to the
importing country of the exported pharmaceutical product;
* The licence shall have an effective period of two years from date of
grant; and
* Health Canada must notify the Commissioner that the pharmaceutical
product meets the requirements of the Food and Drug Regulations including
that it be distinguishable from the domestic brand product (eg. by
labelling, packaging, marking, embossing etc.) in order to discourage
re-importation and diversion.
Subject to Parliament's approval, the legislative amendments and their
subordinate regulations will come into force on the same day. In the
absence of an international infrastructure for implementing the WTO Waiver,
the development of which is unlikely for some time, the proposed amendments
contain a clause stipulating that the legislation be reviewed by the
Minister of Industry three years after its coming into force, following
which a report is to be tabled before both Houses of Parliament.
Evaluating the drugs and medical devices exported under the WTO agreement
The Government of Canada's objective is to improve access to less-expensive
pharmaceutical products that are urgently needed by the world's
least-developed countries to fight these public health issues. This will
not affect Canadians' access to drugs.
Health Canada to review drugs so they meet Canadian standards
The countries eligible under this regime are particularly vulnerable, and
may have limited capacity to conduct their own evaluations. Health Canada
will therefore conduct a regulatory review to ensure that the drugs and
medical devices destined for these countries are manufactured in compliance
with Canadian standards.
Amending the Food and Drugs Act and Food and Drug Regulations
The bill will amend Section 37 of the Food and Drugs Act (relating to
exportation), so that products intended for export under this program come
under the same scientific assessment as those intended for the Canadian mar=
ket.
Subsequent changes to the Food and Drug Regulations will make necessary new
regulations to implement the WTO decision. These deal with the requirement
for Health Canada to notify the Commissioner of Patents that the products
comply with the Regulations (i.e., they meet Canadian standards) and that
they carry distinguishing markings as compared to those available on the
Canadian market.
Canadian efforts to fight infectious diseases in developing countries
Canada recognizes that people in developing countries suffer from a lack of
basic medical supplies and has responded with wide-ranging initiatives to
help fight the spread of infectious diseases.
Canadian funding for HIV/AIDS initiatives in developing countries will
increase to $80 million per year by 2005, representing a five-year
commitment of $270 million. In addition, Canada is also contributing $50
million over five years to the International AIDS Vaccine Initiative and to
the African AIDS Vaccine Programme.
Canada also supports multilateral initiatives that manage and disburse
resources through public-private partnerships to mitigate the impact of
infectious diseases. For example, a total of US$100 million is being
provided over four years to the Global Fund for AIDS, Tuberculosis and
Malaria. Canada is also a founding member and strong supporter of the
Global Tuberculosis Drug Facility, having earmarked $80 million to help
eradicate this disease. Canada also provides immunization and vitamin A
capsules to vulnerable children in more than 40 countries in Africa, Asia
and Latin America, saving more than 1.5 million lives.
Regarding polio, Canada has been a substantial supporter of eradication
efforts around the world, funding a total of $95 million to the Global
Polio Eradication Initiative over the last five years.
[end]
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