[Ip-health] McGill Daily: Life-saving meds wrapped in red tape

[Thiru Balasubramaniam]

Thursday, November 29th, 2007 | Volume 97, Number 24

http://www.mcgilldaily.com/view.php?aid=3D6777

Life-saving meds wrapped in red tape
Government stalls in addressing flawed legislation
By Nikki Bozinoff
The McGill Daily
Six months after Industry Canada finished its review of legislation
that allows Canadian drug manufacturers to produce and export generic
medicines, a report of the findings has yet to be completed.

The legislation, known as the Canada Access to Medicines Regime
(CAMR), was passed in 2004 to facilitate access to affordable
essential medicines in developing countries. But the legislation is
widely recognized as flawed =96 so far, not a single pill has left the
country.

Three years of bureaucracy

Shortly after the legislation was passed, M=E9decins Sans Fronti=E8res
(MSF) Canada approached Canadian pharmaceutical company Apotex and
urged them to develop a generic triple fixed-dose combination (FDC)
antiretroviral.

Antiretroviral drugs are used to treat HIV by suppressing the virus,
allowing the immune system to recover, and reducing the emergence of
HIV resistance to drug therapy. While a patient suffering from AIDS in
the developed world will receive an individualized dose and
combination of antiretroviral drugs, the triple FDC antiretroviral is
used in developing countries because it requires patients to take a
single pill each day, facilitating distribution and increasing the
likelihood of adherence to the medical regime.

But MSF Canada President Joanne Liu explained that both negotiating
with Canadian patent holders Glaxo Smith Kline, Shire, and Boehringer
Ingelheim Inc. =96 none of which were prepared to freely grant the
necessary voluntary license =96 and getting the triple FDC drug approved
by Health Canada turned out to be extremely cumbersome.

=93[Apotex] had to go through different steps =96 chemical steps and
bureaucratic steps =96 to be, in the end, qualified. Those processes
were laborious and took a hell of a lot of time,=94 she said.

Two years and $2-million in research and development later, Glaxo
Smith Kline and Boehringer Ingelheim declined to provide voluntary
licenses. Apotex thus was free to approach the Commissioner of
Patents, and request a compulsory license =96 the main aim of CAMR =96
which allows the manufacturer to by-pass the patent holder=92s rights
under exceptional circumstances.

Meanwhile, Apotex had to wait for a developing country to request the
drug. This summer, Rwanda became the first country to ask for Canada=92s
help when it told the World Trade Organization that it wanted to buy
260,000 packages of a triple-drug antiretroviral therapy =96 enough to
treat 21,000 people for one year.

Finally, on September 20 of this year, Apotex was granted a compulsory
license and production of the triple FDC antiretroviral could begin.

=93We=92ve done the homework for them=94

As Richard Elliott, Director of the Canadian HIV/AIDS Legal Network,
explained, CAMR is made much more complicated than it needs be. The
manufacturer is required to apply for a separate compulsory license
for each country it wants to export to, and for each quantity it wants
to export. He suggested that only a single license should be required
under the regime.

=93We suggest allowing the generic manufacturer to export the drug to
any country on the list, without a specific quantity,=94 Elliott said.
=93Then they can negotiate deals with developing countries in order to
maximize economies of scale. You could negotiate multiple contracts
with multiple countries, and you would simply pay the royalties
periodically.=94

Other suggestions for reform include making Health Canada approval
optional if the World Health Organization has pre-qualified the drug,
as well as more clearly defining the =93reasonable terms=94 required in
the pre-license negotiations with patent-holders.

Elliott explained that as December 1 =96 World AIDS Day =96 approaches,
AIDS advocacy organizations were hoping the Canadian government would
table the CAMR report, triggering a discussion about revising the
regime.

=93I would think that, with World AIDS Day just around the corner, the
government should be taking the opportunity to announce what it will
do to fix the regime,=94 he said.

But according to Industry Canada Communications Officer Lisa-Marie
Gagn=E9, the report has yet to be completed.

=93The ensuing report is being finalized,=94 she wrote in an email to The
Daily. =93The report will be tabled within 30 days of completion as
statutorily required.=94

Reasons for the delay in completing the report are unclear, as the
review was completed last May. Elliott, for one, is unimpressed.

=93I don=92t know what is taking so long,=94 he said. =93We=92ve more or le=
ss
done the homework for them.=94

It=92s not over yet

Now that Apotex has begun the manufacture of the triple FDC
antiretroviral, it has only to wait for Rwanda to call for price bids.
But the story doesn=92t end here.

During the three long years that it took for Apotex to arrive at this
point, generic manufacturers in India began producing the same drug
without requiring a compulsory license because the country did not
grant patents on drugs until 2005.

It was around this time that MSF began to focus its priorities
elsewhere.

=93I don=92t think [reform of CAMR] is our role. Our donors are giving us
money to go and intervene in times of crisis. We go beyond our mandate
to give a little push on some issues,=94 Liu said of MSF=92s early
involvement with Apotex.

Some, however, have gone as far as to suggest reform of CAMR is no
longer necessary, as generic drugs can be obtained more easily,
quickly, and cheaply from India.

Apotex, maintains that it can produce the drugs at a competitive
price, and is expected to place a bid, along with the Indian
manufacturer.

Elliott argued that reform is necessary because India is beginning to
comply with international trade regulations, which could require it to
stop producing generics.

=93If the tap from India turns off, it has huge health concerns,=94 said
Elliott, adding that reforming the legislation is also necessary to
initiate competition, which could further reduce costs.

Liu too agreed that reform was still necessary.

=93We think that for the time being, it=92s not something to disregard,
but [CAMR] is not a fast enough track to invest at this time,=94 she
said. =93The bottom line is that 30 per cent of the world population
doesn=92t have access [to essential medicines], and when they do, we=92re
never sure about the quality.=94

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
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