Canada passes law to allow generic HIV drug exports

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The Canadian Senate has passed a bill that will allow generic drug manufacturers in Canada to produce copies of patented treatments for HIV, AIDS, tuberculosis and malaria and export them to resource-limited countries.

The Jean Chretien Pledge to Africa Act, named after Canada’s outgoing prime minister, was drafted last year following a challenge to his home country by UN Special Envoy Stephen Lewis.

Lewis called on Canada to take the lead in lowering the cost of medications after nations reached agreement at the World Trade Organisation talks in Mexico on August 30th 2003 on a deal that would permit developing world countries to import cheaper generic copies of branded medicines to deal with public health emergencies.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

capacity

In discussions of consent for medical treatment, the ability of a person to make a decision for themselves and understand its implications. Young children, people who are unconscious and some people with mental health problems may lack capacity. In the context of health services, the staff and resources that are available for patient care.

malaria

A serious disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. 

diabetes

A group of diseases characterized by high levels of blood sugar (glucose). Type 1 diabetes occurs when the body fails to produce insulin, which is a hormone that regulates blood sugar. Type 2 diabetes occurs when the body either does not produce enough insulin or does not use insulin normally (insulin resistance). Common symptoms of diabetes include frequent urination, unusual thirst and extreme hunger. Some antiretroviral drugs may increase the risk of type 2 diabetes.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

The WTO decision allows developed countries, such as Canada, to authorise someone other than the patent holder to manufacture a lower-cost version of a patented medicine in order to export it to a developing country that has insufficient or no pharmaceutical manufacturing capacity.

The Pledge to Africa Act will allow Canadian generic manufacturers to obtain licenses for patented products and export them to countries lacking their own manufacturing capacity. However, the Canadian HIV/AIDS Legal Network said that the bill does not make it clear whether companies will be able to manufacture three-drug fixed-dose combinations of existing drugs.

The bill also restricts the export of medicines to a list of 57 named products and does not include medicines for diseases such as diabetes.

“Canada is very proud to be the first country to take concrete action to

implement this important decision, which will go a long way toward improving

global health,” said the Honourable Bill Graham, Minister of Foreign Affairs.

“We encourage other countries to follow suit by taking steps to address the

public health problems facing developing countries.”

“We are showing our WTO partners that a novel WTO decision can

effectively be implemented,” said the Honourable Jim Peterson, Minister of

International Trade. “We remain dedicated to ensuring that the multilateral

trading system works to improve the lives of people in developing countries,

who need it most.”

The legislation is part of a strong Canadian response to the need for HIV treatment in developing countries. This week the Canadian government also gave US$72 million to the World Health Organisation to support the 3 x 5 target of 3 million on antiretroviral therapy by the end of 2005, and announced an additional CA$70 million for the Global Fund to Fight AIDS, Tuberculosis and Malaria in 2005.

Further information

Canada doubles WHO's 3x5 funds with £41m pledge - news story, May 11 2004

Canada to use compulsory licensing to produce HIV drugs for developing world - news story, September 29 2003

Canadian government announcement backgrounder