[Ip-health] Kaisernetwork.org: WHO Gives Endorsement to Canadian Company's Combination HIV/AIDS Drug

[Thiru Balasubramaniam]

*
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=39125

**Monday, August 14, 2006*

*Drug Access*

      *WHO Gives Endorsement to Canadian Company's Combination HIV/AIDS
      Drug; Health Canada Approval Held Up by Negotiations Between GSK,
      Apotex*

      The World Health Organization <http://www.who.int/> on Friday gave
its approval to Apo-triAvir, a generic HIV/AIDS medication made by the
Toronto-based drug company Apotex <http://www.apotex.com/>, a "critical
step" in allowing the drug to be exported to developing countries, the
Toronto Star
<http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1155333028229&call_pageid=968332188492&col=968793972154>
reports. Apo-triAvir contains nevirapine and two other drugs in a
single-pill format. Rachel Kiddell-Monroe -- head of Medecins Sans
Frontieres <http://www.msf.org/>' Campaign for Access to Essential
Medicines, who is scheduled to address the XVI International AIDS
Conference <http://www.aids2006.org/> in Toronto -- said, "Once a drug
is approved by WHO, it can be bought by developing countries who need
it, safe in the knowledge that it is effective and safe for their
people. Since there are so many different drugs around, many of which
are [of] extremely doubtful quality, (developing countries) need
somewhere they can look and be sure drugs are appropriate."

* Obstacles *
Even with WHO's approval, there are "troublesome obstacles to getting
the new drug to Africa and elsewhere, not the least of which is faulty
federal legislation," the Star reports (Westhead, Toronto Star, 8/12). A
nearly two-year-old Canadian law allows drug makers to manufacture and
export less-expensive, generic versions of patented drugs -- including
antiretroviral drugs -- to developing countries, but so far, no drugs
have been exported as a result of the law. The law, which was modeled
after an agreement
<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=8037>
signed by World Trade Organization <http://www.wto.org/> officials in
2001, says that generic manufacturers must charge developing countries
who request low-cost medicines 25% of the Canadian market cost of their
brand-name equivalents. The law was meant to take advantage of a WTO
agreement provision that allows countries signing the agreement to grant
compulsory licensing of drugs during national health emergencies (Kaiser
Daily HIV/AIDS Report
<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=38931>,
8/4). The legislation says that talks between the patent holder of a
medication and the generic drug company should last at least 30 days
before the generic company can seek a compulsory license from Health
Canada <http://www.hc-sc.gc.ca/> to bring the generic drug to market.
However, the legislation does not set a time limit on how long the talks
can last. Discussions between Apotex and GlaxoSmithKline
<http://www.gsk.com/>, the patent holder on nevirapine, have "dragged,"
the Star reports. Lawyers for GSK have said Apotex must show that
Apo-triAvir will not resemble comparable drugs in Canada. MSF, which has
agreed to pay 38 cents per pill for Apo-triAvir, has criticized the
process, according to the Star. Kiddell-Monroe is expected at the
International AIDS Conference to call on Canada to address the obstacles
in the legislation (Toronto Star, 8/12). In addition, U.N. Special Envoy
for AIDS in Africa Stephen Lewis on Wednesday at a press conference in
Toronto ahead of the AIDS conference criticized the Canadian government
for not supplying developing countries with low-cost medications (Kaiser
Daily HIV/AIDS Report
<http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=39076>,
8/11). Canadian Health Minister Tony Clement has said that he is seeking
advice on how to change the legislation with organizations such as MSF
and the Canadian HIV/AIDS Legal Network <http://www.aidslaw.ca/>, as
well as with Lewis (Teotonio, Toronto Star
<http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1155505811686&call_pageid=968332188774&col=968350116467>,
8/14).