Date: 29 June 2011
Source: Intellectual Property Watch
Link:
http://www.ip-watch.org/weblog/2011/06/28/amending-canada%E2%80%99s-access-to-medicines-regime-camr-the-new-fate-of-bill-c-393/
A
Canadian bill to improve global access to medicines might get another shot in
the new Parliament.
The
newly elected Canadian Parliament resumed on 2 June amidst pleas for the
attention of majority Conservative government. But Bill C-393 is quite
different matter than a plea. Determining whether or not to reintroduce and
pass this bill is a crucial humanitarian issue that transcends partisan
interests while posing a bet on Canada`s credibility. Bill C-393 would actually
play as a working way of effectively getting medicines to those still dying in
the developing countries.
Just
under 5 billion people (43 percent relying on less than US$2 daily) live in the
resource-limited countries where communicable diseases, including HIV, malaria
and tuberculosis, are most prevalent, according to the WHO Global
Strategy and Plan of Action on Public Health, Innovation and Intellectual
Property.
Patent
protection, by permitting the application of monopoly prices for brand
medicines, keeps the poorest people, mainly in Sub-Saharan Africa, from
non-discriminatory access to life-saving treatments. Such is the case
notwithstanding the World Trade Organization (WTO) Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which encompasses
flexibilities (including compulsory licenses, or CLs) to help
income-constrained populations equitably access low-priced medicines. (A CL is
a government provision that allows a generic manufacturer to produce and bring
out less expensive, generic – i.e., not brand-name – copies of a medicine
without the consent of the patent holder.)
The WTO
in November 2001 recognised that TRIPS Article 31(f) limited the use of CLs
“predominantly” for the purpose of supplying the domestic market of the country
where the licence was issued (see the Doha Declaration on
TRIPS and Public Health [pdf]). Permission for export under CL was then
agreed upon through a WTO 2003 temporary waiver (the “August 30th Decision”,
voted as permanent amendment on 6 December 2005 and still awaiting ratification
by members).
CAMR,
the Flawed Canadian Way
As a
federal law aimed at helping get medicines for public health needs to the
developing countries, Canada`s
Access to Medicines Regime (CAMR) came into force in 2005 as an
implementation of the WTO 2003 waiver. While a few other countries also have
introduced laws to implement the waiver, Canada is the only country till now
that has really translated legislation into action. Unfortunately, CAMR is a
lengthy and cumbersome process with restrictions going beyond the minimum
standards in WTO 2003 waiver. Presently, developing countries interested in
accessing, under CAMR, affordable copies of brand-name medicines from Canada
must wait until a Canadian generic firm can get a CL on a country-by-country
and order-by-order basis, for a specific quantity of medicines (additional drug
shipping is not permitted) and for a limited period (two years, extendable up
to another two years only to finish delivery of the original order). As such,
CAMR has been used only once for two shipments of medicines for HIV infection
from Canada`s largest generic firm Apotex Inc.(Toronto) to Rwanda in 2008 and
2009, after three years were spent conforming to all regulatory requirements
and the over 100 riders the law is enmeshed with (see IP-Watch,
October 29, 2010).
Calls
by developing countries and public interest groups in Canada and elsewhere are
steadily being renewed to streamline the barely-used regime into a “one-license
solution” that would authorise a company to produce the same medicine for
export to any country that submits
notifications to WTO, regardless of the quantity of medicine. Should CAMR
be amended, Apotex
has publicly pledged to work to develop and deliver a generic three-in-one
fixed-dose medication for treating children with HIV in developing countries,
where half of all children born with HIV die before their second birthday
because they don`t have access to appropriate medicines.
Betting
on Bill C-393
In May
2009, proposed legislation Bill C-393, which aims to make CAMR expeditious and
easier to use while complying with obligations under WTO`s trade rules, was
introduced in the Canadian House of Commons.
In
addition to the “one-licence
solution”, its contents include the removal of unnecessary limits on
medicines that can be supplied under CAMR, and the transformation of a motion
of four-year duration limit for CAMR reforms into a four-year review, instead
of an automatic repeal of them.
Irrespective
of strong opposition, reportedly
from Big Pharma lobbies and some Conservative government members, broad-range,
steadily growing support is currently backing the Canadian campaign for CAMR
reform (see here,
here,
here,
and here).
On 9
March, the majority of MPs in the House of Commons voted in favor of Bill C-393
and passed it on to the Senate of Canada. Unexpectedly, however, the bill
stalled there and died, being prevented from coming to a vote and becoming law,
with the dissolution of Parliament on 25 March.
.http://thevarsity.ca/articles/45372
The New
Parliament: Still a Chance for Bill C-393?
Ballot
box results
from the 2 May Canada`s parliamentary elections ratified the victory of the
Conservative Party, which remains in power (167seats out of 308: 155 needed to
form majority). The New Democratic Party (NDP) gained the second largest number
of seats of any party (102) and became the official opposition, signalling a
key change in Canadian politics. The Green Party won its first election for a
seat, whereas the Liberal Party (LP) collapsed (34 seats) and the Bloc
Québécois was decimated (4 seats down from 48).
Is
there room for hope that Bill C-393 might survive now and pass into law in
Canada`s new 41st Parliament? Answering this question must consider, aside from
the new balance of power inside the 41st Parliament composition, also the fact
that many MPs of the dissolved Parliament already agreed that CAMR needs
reforming.
Interestingly,
four out of five party leaders (from Bloc Québécois, Green Party, LP, NDP; no
response from Conservative Party) replied affirmatively to an 11 April question
posed by the Canadian HIV/AIDS Legal Network whether, if elected, they and
their party would support legislation to fix Canada`s Access to Medicines
Regime by creating a simple one-licence process, without additional and
unnecessary restrictions, in order to improve access to affordable medicines
for people in need in developing countries.
As
regards the fate of Bill C-393, the election results, with significantly more
power assigned to NDP added to the information above, means that Conservatives
now have to face a firmly united opposition. Indeed, the NDP, LP and the Green
Party fought for healthcare and shared similar values during the election
campaign. Besides, it can mean a lot that strong supporters of the bill, such
as its official sponsor, Paul Dewar (NDP), NDP leader Jack Layton, and Green
Party leader Elizabeth May, have a seat in the new Parliament.
On
these grounds, coupled with consideration that amending CAMR is a non-partisan
humanitarian issue, there is hope that Bill C-393 will attract new support from
members of all Parties in the House of Commons, and that the Conservative
government will allow its backbenchers freedom of conscience on it. But, if
Bill C-393 is to be passed, civil society organisations must continue campaigning
and mobilising political will in Parliament.
Keywords: Canada / Medicines / Bill C-393
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