Patent law + self-interest = double standard

Kristen Vernon

The Canadian government wants to have its cake and eat it too.

It acts one way when the health needs of Canadians are at stake but responds another way when developing countries want to safeguard their citizens’ health.

No cases of anthrax were found in Canada. But fear of anthrax attacks such as those in the United States prompted Health Canada to stockpile the anti-anthrax drug, ciprofloxacin hydrochloride, sold by Bayer under the brand name Cipro.

Health Canada says it tried to get a stockpile of Cipro from Bayer last month but was told only a limited supply was available. As a result, Health Canada ordered one million tablets from Apotex, a Canadian-owned generic drug company.

Bayer, a German-owned drug company, owns the exclusive right to make and sell Cipro.

A patent gives the owner a 20-year exclusive right to make and sell the patented product.

The government could have sidestepped Bayer’s patent by asking permission of the patent commissioner, but it chose not to. According to the Patent Act, the government can use a patented product in the case of a national emergency or where the product is for public, non-commercial use.

While under attack in Parliament for his department’s failure to follow the law, Health Minister Allan Rock said: “The bottom line for us is to make sure the health of Canadians is protected, and that is exactly what we did. If big drug companies want to play shell games with us, we will not stand for it. We will do what is required to get the drugs in hand to protect the health of Canadians.”

The Cipro fiasco demonstrated the government’s willingness to do whatever it considers necessary to safeguard Canadians’ health security.

Given this response, it seems hypocritical that the government didn’t support developing countries which demanded a pro-health interpretation of the international agreement on trade-related aspects of intellectual property rights (TRIPS).

The agreement is an international treaty governing intellectual property rights, including patent protection for medicines. TRIPS is enforced by the World Trade Organization, of which Canada is a member.

The agreement tries to strike a balance between patent protection and a government’s ability to safeguard public health. In theory, the agreement provides some flexibility for countries to override patents when faced with a public health crisis.

But when countries such as South Africa and Brazil tried to use that flexibility to provide affordable AIDS drugs, they were challenged by multinational pharmaceutical companies and the United States.

In 1997, South Africa introduced laws to make affordable medicines available to its 4.2 million citizens who have HIV and AIDS. Thirty-nine pharmaceutical companies took the government to court and the U.S threatened trade sanctions.

To eliminate ambiguity about whether governments have the ability to bypass patents to protect public health, developing countries from Africa, Asia and Latin America wanted TRIPS clarified at the WTO ministerial meeting which took place last week in Doha, Qatar.

They wanted a declaration saying that nothing restricts governments from taking action to protect public health, including allowing governments to issue licences to generic drug producers so they could produce cheaper drugs for export.

Currently, WTO-member governments, except for some less-developed countries who don’t have to align their laws to TRIPS until 2006, are restricted in their ability to issue licences to generic drug companies. And when they can issue a licence, it’s to serve the domestic market. But many developing countries can’t afford to produce generic drugs themselves.

In September, responding to developing countries’ demands, the U.S., Canada and other countries reaffirmed the TRIPS agreement. They said there must be protection for intellectual property rights as an incentive for research, and the existing agreement gives countries flexibility in treating epidemics that cross borders, such as AIDS.

According to the World Health Organization and UNAIDS, three million people died from HIV and AIDS, two million died from tuberculosis and between one and two million died from malaria last year. The developing world is most affected by these diseases.

Developing countries need access to the life-saving drugs to prevent deaths, but many can’t afford the medicine.

Even in Canada, the Mulroney government’s amendments to the Patent Act in favour of multinational drug companies, have contributed to skyrocketing drug costs.

The Canadian Drug Manufacturers Association says generic drugs cost about 50 per cent less than their brand-name equivalents.

Despite the Canadian government’s recent encounter with Bayer and Apotex, the government didn’t support the developing world in its quest for affordable medicines to protect the health of its citizens.

The WTO issued a political statement on the TRIPS agreement last week, encouraging developing countries to take measures to protect public health and promote access to medicines for all. But the statement left licencing the production of generic drugs for export to the TRIPS Council, the body that administers the agreement.