[Ip-health] Canadian Government's press release on pharmaceutical law admendment
mhbonin
mhbonin@clc-ctc.ca
Thu Nov 6 12:08:02 2003
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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 =97 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 said
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 worked
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 global
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 Nations
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
powerful 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
market.
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.
Source: Government of Canada's website
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