End the delay on abortion pill

It’s been more than a year since Health Canada approved use of the abortion pill RU-486, also known as mifepristone.

The drug is known as the “gold standard” of medical abortions and is included in the World Health Organization’s Model List of Essential Medicines. But the 100,000 women who choose to have an abortion each year in Canada still don’t have access to it.

Worse, when the drug does become available later this year or early next under the brand name Mifegymiso, it may not be covered under medicare outside of Quebec, as surgical abortions are. Instead, women in the rest of Canada might have to pay $300 for it.

This is just plain wrong. Women should not face yet another road block in the ongoing saga to give Canadian women access to this safe and effective drug.

It was bad enough that Health Canada took three long years to approve mifepristone after drug manufacturer Linepharma International applied in September 2012. At that point, the drug was already available in more than 60 countries, including France since 1988, Britain since 1991 and the United States since 2000.

Indeed, “millions of women worldwide have used mifepristone safely and effectively,” said a commentary in the Canadian Medical Association Journal in 2013. And the Society of Obstetricians and Gynaecologists of Canada has been urging Health Canada to make the drug available since 2009.

After Health Canada finally did approve it, Linepharma suggested the drug would be on the market by January of this year. Then, manufacturing problems apparently arose that delayed it.

Now Celopharma Inc., the small Canadian-owned pharmaceutical company that is distributing the drug in this country, says it has been unable to pay the $72,000 cost for yet another review. This one is by a committee of experts that advises all provinces and territories, except Quebec, on whether they should publicly fund drugs.

And the expert panel, overseen by the Canadian Agency for Drugs and Technologies in Health, has refused to waive the fee. (Quebec does not charge a fee for the same service so it’s likely the drug will be covered in that province.)

What’s at stake is women’s ability to access the most safe and effective abortion possible. At $300, many women will not be able to afford the drug and will have to undergo a surgical abortion.

At the moment, women living in areas where there aren’t any hospitals or clinics that provide surgical abortions must travel long distances to get one. Even in cities, women may have to delay an abortion while they wait for access to the procedure. And there’s an added benefit to a medical abortion: Studies have shown that women who have access to the drug get an abortion earlier in gestation, when it is less dangerous.

Celopharma argues that it’s a small company that has already taken on substantial cost and risk to make mifepristone available to Canadian women.

But it stands to profit once women do get access to the drug. One in three Canadian women will have an abortion in her lifetime and mifepristone accounts for more than 60 per cent of abortions in some European countries and about 20 per cent in the United States. There’s no reason to think it would be much different here.

Celopharma’s president, Paula Tenenbaum, says she has tried to work out an arrangement to reduce the fee for the final review, or simply to pay it in instalments over two years.

That seems like a reasonable compromise. The health of Canadian women should not be further compromised by a dust-up between one company and the review committee. The committee should work harder to find a solution and bring this drug to market.

Women should not have to face yet another road block in gaining access to this safe and effective drug