PHA-Exchange> 1 year later, no cheap drugs for Africa

[abraham]

1 year later, no cheap drugs for Africa

"We're still in a waiting game," said Tony Parmar of Doctors Without 
Borders, which had hoped the bill would be a lifeline for countries 
devastated by AIDS, malaria and other treatable diseases. OTTAWA (CP) -- 
Almost a year after Canada won global praise for passing legislation to 
provide cheap drugs for poor countries, the law hasn't resulted in a 
single pill being exported. Government officials say the Jean Chrétien 
Pledge to Africa Act has been stalled by technicalities. Critics say it 
is fatally flawed and will never have any real impact. "The conclusion 
we can draw is that one year later, not a single drug has been exported. 
"We're hopeful we can do that in the future but there's no guarantees at 
this point. To be honest, there hasn't been a whole lot of interest for 
the generic drug makers to use this legislation." The bill, introduced 
during the dying days of the Chrétien administration, won praise from 
champions of international development such as Bono of the rock band U2 
and South Africa President Thabo Mbeki. It took advantage of a new (at 
the time) World Trade Organization policy permitting generic drug firms 
to produce cheap versions of patented drugs, provided the products were 
sold only in poor countries. Canada was the first country to take 
advantage of the policy, and generic firms initially were strong 
backers, but stepped back in dismay when they saw the actual provisions 
of the bill. "There are many, many restrictions on it (the legislation) 
that are actually not necessary according to the World Trade 
Organization," says Jim Keon, president of the Canadian Generic 
Pharmaceutical Association. He suggests the legislation was strongly 
influenced by brand-name pharmaceutical manufacturers worried about 
giving an advantage to their arch rivals. The bill allows generic drug 
firms to charge the cost of manufacturing plus 15 per cent. If they 
charge more than 25 per cent of what the drug sells for in Canada they 
are open to challenge by the patent-holder. Doug Clark, a senior 
official at Industry Canada, said the bill perhaps mistakenly assumed 
drug makers will seek to export drugs for humanitarian reasons. "There 
is room there to make some money but it definitely does not accommodate 
lucrative transactions." The problem, he conceded, is that generic drug 
makers are not charities. "That's the unspoken issue with this bill that 
no one has really talked about. The incentives are simply not 
significant because the money is not there. There was really no 
discussion of that at any point." Any serious attempt to explore the 
bill's potential has been impossible because its regulations -- the 
detailed rules on what is and isn't allowed -- have not yet been 
published. Clark says the regulations have been delayed because a Senate 
committee studying the bill discovered a serious flaw which had been 
missed in the Commons. A new bill had to be drawn up to fix the flaw, 
and it is expected to get consideration this week and to be passed soon, 
unless of course the government falls. "There is no excuse for this kind 
of delay," says Stephen Lewis, UN Special Envoy for HIV/Aids in Africa. 
"I think that the delay on issuing the regulations is just absolutely 
absurd, and frankly intolerable. But the far more important point is, 
will the bill become a reality? "If in fact there's been no significant 
initiative for drug production and export thus far under the bill, then 
I think the bill is in danger of becoming a non-entity because it will 
be lost in the politics of Canada." While the bill has crawled through 
Parliament at a snail's pace, the international drug market has changed. 
Tim Gilbert, a Toronto lawyer who does work for both generic and 
brand-name manufacturers, recently visited Ghana to assess needs, and 
found that most AIDS drugs are already available. The drugs are being 
supplied by companies in India, China and Brazil at prices that Canadian 
firms can't match. What the Ghanaians really want, says Gilbert, are the 
latest, most sophisticated drugs, and also the technology to make the 
drugs themselves. Canadian firms are reluctant to transfer technology 
because they'd be planting the seeds for future competition. "Is the 
social conscience alive and well in Canada?" asks Gilbert. "Yes it is, 
but it's got to make sense economically too." Doctors Without Borders 
has approached Toronto-based Apotex about producing a new 
triple-combination AIDS therapy that definitely is wanted in Africa, but 
it's a drug not available now even in Canada. That raises the question 
of how a generic manufacturer could obtain approval, since the current 
Health Canada process requires proof that a generic product is 
equivalent to the original brand-name product. Since the 
triple-combination drug isn't available even from brand-name 
manufacturers, how could a generic drug firm prove equivalence? Apotex 
spokesman Elie Batito said discussions are still at an early stage. Keon 
of the generic pharmaceutical association says discussions continue "but 
there are no products waiting to be shipped." He says Ottawa should 
provide research funding to develop the products needed. Liberal Senator 
Jim Munson, who once served as Chrétien's press spokesman, hopes the 
bill bearing his former boss's name will yet prove its worth. "It's a 
shame that it's taken this long to go through this political labyrinth 
to get it to this point. Let's get on with it. Tens of thousands of 
people are dying and it's a shame that it's taken this long to get this 
far."


--Clau
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