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CMAJ • AUGUST 26, 2008 • 179(5)© 2008 Canadian Medical Association or its licensors

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Four years later, roadblocks

to AIDS drugs overcome

In the end, the Commissioner forPatents had to issue a compulsorylicence, but at long last, low-cost

life-saving AIDS drugs are scheduledto be shipped to Rwanda this fall un-der legislation Canada passed morethan 4 years ago.

Canada received kudos from aroundthe world when in May 2004 it becamethe first country to implement a WorldTrade Organization (WTO) agreementdesigned to get affordable, life-savingdrugs to the developing world in atimely fashion.

Next month, Canadian generic drugmanufacturer Apotex Inc. expects toship a supply of a specially manufac-tured, low-cost, triple-combinationAIDS drug that will treat 21 000 Rwan-dans for a year, says spokesperson ElieBetito.

“It is a victory to see this first useof the legislation,” says Richard El-liott, deputy director of the CanadianHIV/AIDS Legal Network, which wasinstrumental in lobbying for the newlaw. “But it will be bittersweet if itturns out to be the only shipment togo out.”

To date, Apotex is the only com-pany in the world that has manufac-tured drugs for the developing world asa result of the WTO provision.

The legislation, originally the JeanChrétien Pledge to Africa Act but re-named the Canadian Access to Medi-cines Regime, has been criticized asunnecessarily cumbersome by the legalnetwork and others.

The WTO agreement provided forgeneric drug companies to apply for li-cences to patented drugs in order tomanufacture affordable generic ver-sions of drugs for use in developingcountries. The compulsory licence wasissued in September 2007, after Apotexwas unable to obtain voluntary licencesfrom the patent-holders.

The compulsory licence authorizesexport only of a designated quantity ofmedicine to a single country; the wholeprocess will have to be repeated for fur-

Food allergen labelling

In a bid to increase protection forfood allergy sufferers, HealthCanada has announced new la-

belling requirements for food aller-gens, gluten sources and added sul-phites contained in prepackaged foods.

The new requirements will obligemanufacturers to list on their label all: • proteins derived from “almonds,

Brazil nuts, cashews, hazelnuts,macadamia nuts, pecans, pine nuts,pistachios or walnuts; peanuts;sesame seeds; wheat, kamut, spelt ortriticale; eggs; milk; soybeans; crus-taceans; shellfish; or fish.”

• gluten sources; in other words, whena food contains a protein producedfrom barley, oats, rye, triticale orwheat, including kamut or spelt.

• sulphites “when either directlyadded to a food or when the totalamount of sulphites present in thefood is 10 parts per million ormore.” — Wayne Kondro, CMAJ

DOI:10.1503/cmaj.081146

ther drug orders from Rwanda or an-other country.

Eliott says Canada could easilystreamline the process in order to “in-crease access to affordable drugs fortens or hundreds of thousands of peoplein the developing world. The unan-swered question is whether parliamen-tarians have the political will to takeaction to improve access to AIDSdrugs,” he wrote in the July 2008 issueof the network’s Policy and Law Re-view. The legal network and the GlobalTreatment Action Group submitted de-tailed proposals for amendments to thefederal Government’s 2007 review ofthe legislation. However, in its Decem-ber 2007 report, the Minister of Indus-try indicated that it would be prematureto amend the legislation.

Apotex President Jack Kay has saidthat unless the process is streamlined,his company won't seek to produce an-other needed drug. But Elliott pointed tothe need for a pediatric formulation ofthe combination AIDS drug and said hehoped Apotex might be open to work-ing on it. — Ann Silversides, CMAJ

For the record

Safer water saves lives

Water-related deaths are rare inCanada, but a new World HealthOrganization (WHO) report indi-

cates a large percentage of deaths in othercountries could be prevented by increasing ac-cess to safe drinking water, improving sanita-tion and hygiene, and by better managing wa-ter resources to reduce drownings and thespread of infectious diseases.

The report, entiled Safer Water, BetterHealth, claims 0.2% of deaths in Canada in2002 were due to drownings. In other countries,however, water supply problems resulted indeaths from diarrhea (1.4 million child deaths), malnutrition (860 000 childdeaths) and malaria (500 000 deaths).

Developing countries were hit particularly hard. In Burkina Faso, 19.9%of deaths in 2002 were water-related, while the rate was 20.4% for the Demo-cratic Republic of the Congo and 24.1% for Angola.

The WHO claims a US$11 billion annual investment to improve watersafety and management would save health agencies US$7 billion a year andsave individuals US$340 million a year. In addition, it would result in thegain of 320 million work days for adults and 270 million school days for chil-dren. The total payback, the WHO estimates, could reach US$84 billion ayear. — Roger Collier, CMAJ

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