- © 2008 Canadian Medical Association
Four years later, roadblocks to AIDS drugs overcome
In the end, the Commissioner for Patents had to issue a compulsory licence, but at long last, low-cost life-saving AIDS drugs are scheduled to be shipped to Rwanda this fall under legislation Canada passed more than 4 years ago.
Canada received kudos from around the world when in May 2004 it became the first country to implement a World Trade Organization (WTO) agreement designed to get affordable, life-saving drugs to the developing world in a timely fashion.
Next month, Canadian generic drug manufacturer Apotex Inc. expects to ship a supply of a specially manufactured, low-cost, triple-combination AIDS drug that will treat 21 000 Rwandans for a year, says spokesperson Elie Betito.
“It is a victory to see this first use of the legislation,” says Richard Elliott, deputy director of the Canadian HIV/AIDS Legal Network, which was instrumental in lobbying for the new law. “But it will be bittersweet if it turns out to be the only shipment to go out.”
To date, Apotex is the only company in the world that has manufactured drugs for the developing world as a result of the WTO provision.
The legislation, originally the Jean Chrétien Pledge to Africa Act but renamed the Canadian Access to Medicines Regime, has been criticized as unnecessarily cumbersome by the legal network and others.
The WTO agreement provided for generic drug companies to apply for licences to patented drugs in order to manufacture affordable generic versions of drugs for use in developing countries. The compulsory licence was issued in September 2007, after Apotex was unable to obtain voluntary licences from the patent-holders.
The compulsory licence authorizes export only of a designated quantity of medicine to a single country; the whole process will have to be repeated for further drug orders from Rwanda or another country.
Eliott says Canada could easily streamline the process in order to “increase access to affordable drugs for tens or hundreds of thousands of people in the developing world. The unanswered question is whether parliamentarians have the political will to take action to improve access to AIDS drugs,” he wrote in the July 2008 issue of the network's Policy and Law Review. The legal network and the Global Treatment Action Group submitted detailed proposals for amendments to the federal Government's 2007 review of the legislation. However, in its December 2007 report, the Minister of Industry indicated that it would be premature to amend the legislation.
Apotex President Jack Kay has said that unless the process is streamlined, his company won't seek to produce another needed drug. But Elliott pointed to the need for a pediatric formulation of the combination AIDS drug and said he hoped Apotex might be open to working on it. — Ann Silversides, CMAJ
Food allergen labelling
In a bid to increase protection for food allergy sufferers, Health Canada has announced new labelling requirements for food allergens, gluten sources and added sulphites contained in prepackaged foods.
The new requirements will oblige manufacturers to list on their label all:
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proteins derived from “almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts; peanuts; sesame seeds; wheat, kamut, spelt or triticale; eggs; milk; soybeans; crustaceans; shellfish; or fish.”
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gluten sources; in other words, when a food contains a protein produced from barley, oats, rye, triticale or wheat, including kamut or spelt.
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sulphites “when either directly added to a food or when the total amount of sulphites present in the food is 10 parts per million or more.” — Wayne Kondro, CMAJ
Safer water saves lives
Water-related deaths are rare in Canada, but a new World Health Organization (WHO) report indicates a large percentage of deaths in other countries could be prevented by increasing access to safe drinking water, improving sanitation and hygiene, and by better managing water resources to reduce drownings and the spread of infectious diseases.
The report, entiled Safer Water, Better Health, claims 0.2% of deaths in Canada in 2002 were due to drownings. In other countries, however, water supply problems resulted in deaths from diarrhea (1.4 million child deaths), malnutrition (860 000 child deaths) 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 Democratic Republic of the Congo and 24.1% for Angola.
The WHO claims a US$11 billion annual investment to improve water safety and management would save health agencies US$7 billion a year and save individuals US$340 million a year. In addition, it would result in the gain of 320 million work days for adults and 270 million school days for children. The total payback, the WHO estimates, could reach US$84 billion a year. — Roger Collier, CMAJ