[Ip-health] Globe and Mail: Red tape blocking medicine for Africa

[Thiru Balasubramaniam]

http://www.theglobeandmail.com/servlet/story/RTGAM.20070418.wxafrica18/
BNStory/National/home

Red tape blocking medicine for Africa
Organizations seek amendments to allow production of generic versions
for export

GLORIA GALLOWAY

 From Wednesday's Globe and Mail

OTTAWA =97 Three years after Jean Chr=E9tien said Canada would allow
generic drug makers to send copies of brand-name medicines to poor
countries to combat diseases such as AIDS and malaria, groups that
follow the issue say not a single pill has left Canada.

The roadblock, they say, is red tape and a powerful brand-name
pharmaceutical industry that opposes the generic reproductions.

But the groups argue that Canada's Access to Medicines Regime can be
rewritten to get the drugs moving.

The Canadian HIV/AIDS Legal Network and Doctors Without Borders will
ask the Commons industry, science and technology committee today to
change the law to allow any pharmaceutical firm to produce generic
versions of any drug patented in Canada for export to any eligible
developing country.

"We are giving them concrete amendments that they could enact, if they
wanted to, to simplify the legislation and increase the chances of it
working." Richard Elliott, the deputy director of the HIV/AIDS Legal
Network, said yesterday.

Shortly after Tony Clement took over the federal health portfolio last
year, he said he realized that Mr. Chr=E9tien's so-called Pledge to
Africa was not being fulfilled. The minister attributed this to a lack
of "take-up" by developing countries, where AIDS claims nearly 8,000
lives a day.

But Mr. Elliott said the problem is not that simple.

"There were discussions when the legislation was first being drafted
[by the Liberal government] three years ago where we and a number of
the other [organizations] raised concerns about the complexity of the
process," Mr. Elliott said.

The industry committee is conducting a mandatory review of the drug
regime and must table a report in mid-May. "So now is the time to go
back to the drawing board and say this is too complicated," Mr. Elliott
said.

Apotex, one of Canada's best-known generic drug manufacturers, has
developed a treatment for people with HIV that uses three
patent-protected drugs: AZT, 3TC and Navirapin.

Canada's law requires that the brand-name manufacturers be consulted to
see whether they will let the generic company violate their patents by
selling it to developing countries. If they won't, Apotex must obtain
what is known as a "compulsory licence" that permits the sale of a
specific quantity of the drug to a specific country for two years.

That means that "before there is any guarantee of actually being able
to get that licence and therefore buy the product, the [developing]
country actually has to step forward and be identified," Mr. Elliott
said.

"And we have seen over the last decade that, any time countries
contemplate using compulsory licensing to override patents to get
cheaper medicines from generic producers, there is a great deal of
pressure brought to bear by the big multinational pharmaceutical
industry, which doesn't want to see this happen, and by the U.S.
government, which goes to bat for its pharmaceutical industry."

Typically, he said, if a country says it wants to buy the generic drugs
using the compulsory licence, the United States will threaten to cut
off trade.

On the other hand, Mr. Elliott said, if a generic manufacturer is
permitted to sell any quantity of a drug to any number of countries for
an unlimited period, paying royalties to the brand-name company as is
required, many of the barriers would come down.

"Countries that want to do this will still have to stand up to the
pressure that they are under," he said. "But, at least with the process
that we are describing, you could have any number of countries getting
together and making a joint order for a large quantity of product from
a generic manufacturer. That would bring the price down because it is
achieving economies of scale and there would be a certain degree of
safety in number."

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org