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Globe and Mail public health reporter Andre Picard (John Morstad for The Globe and Mail)
Globe and Mail public health reporter Andre Picard (John Morstad for The Globe and Mail)

Access to abortion drug would give Canadians a needed alternative Add to ...

In 57 countries around the world, women can have an abortion at home using a drug prescribed by their doctor – no surgery required.

But not in Canada.

The drug, mifepristone (brand name Mifeprex), has never been approved here. Yet it has been available in France since 1988 and in the United States since 2000.

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The reason, on the surface, is largely bureaucratic. The manufacturer has never applied for approval in Canada.

Two reasons are commonly cited: The small market, and Health Canada’s onerous approval process. But those are speculation, because the manufacturer has never said.

However, according to an article published in the Canadian Medical Association Journal on Monday – there is now a formal request. (Health Canada would not confirm or deny the report, saying that is proprietary information.)

“It is important that this submission not be allowed to fail,” said Sheila Dunn, research director of the Family Practice Health Centre at Women’s College Hospital in Toronto and a co-author of the CMAJ piece.

She makes several compelling arguments.

Abortion is legal in Canada. Timeliness is particularly important, for obvious reasons. Yet access to surgical abortion is spotty and often non-existent outside big cities.

Having an alternative – essentially a pill – would allow better, quicker access to care for women who choose to have an abortion.

A family physician or even a nurse practitioner could prescribe mifepristone. That is the norm in most of Europe, where about 60 per cent of abortions are drug-induced.

Mifepristone blockes production of the hormone progesterone, which nourishes the fetus and is required to sustain a pregnancy. It is taken in conjunction with misoprostol, a drug that induces contractions.

An abortion results; physically, the process is the same as a miscarriage.

(Mifepristone is not to be confused with the morning-after pill, levonorgestrel, commonly known as Plan B, which prevents a fertilized egg from latching onto the uterus. It is a contraceptive, not an abortion pill.)

Mifepristone is usually used in the first 50 days of pregnancy – when most surgical abortions are done. It has a good safety profile, with serious complications in 0.4 per cent of users. A cluster of rare bacterial infections was associated with the drug in the early 2000s, but that does not seem to have persisted. (It should be noted that abortion, miscarriage, menstruation, tampon use and childbirth all create conditions that increase the risk of infection.)

It goes without saying that abortion is a controversial topic, and that is reflected in the history of mifepristone. Anti-abortion groups particularly dislike it because it makes abortion easier, cheaper and more discreet.

When the drug was developed in France, the company, Roussel-Uclaf, decided not to market it as an abortion pill unless invited to do so. The French government took them up on the offer.

In the United States, president Bill Clinton facilitated the drug getting to market, including creation of a small manufacturing company, Danco Laboratories LLC, because large pharmaceutical companies fear attacks by anti-abortion zealots. (Danco has an unlisted number and keeps its address secret.)

Political leaders in this country – Conservative and Liberal alike – have never invited the manufacturer to apply for a Canadian license. Now, it looks like it is going to happen in spite of that spinelessness. Let’s just hope politicians stay out of the way.

More than 100,000 women a year opt for abortion. In exercising choice, they should also have choices, including the gold standard for treatment, mifepristone.

Follow on Twitter: @picardonhealth

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