A Male Birth Control is Coming to Market. But Not for Americans and Europeans?

A researcher in India has developed a highly effective, inexpensive, long-acting, reversible form of birth control, with minimal side effects.  For men.

In fact, it was developed a decade ago and it’s been in clinical trials since then. Now it’s ready for market. This would seem like a world-changing innovation, but there isn’t a single drug company outside India that’s interested in developing it.

The technique, called “reversible inhibition of sperm under guidance,” involves injecting a gel into the tubes in a man’s scrotum that carry sperm. The gel acts on the sperm – damaging their membranes and making them infertile. It’s 98% effective at preventing pregnancy, and it can be reversed with a second injection. If not reversed, the contraceptive effect seems to last indefinitely; there are men who underwent RISUG in its earliest trial 13 years ago who are still infertile. The procedure takes about 15 minutes, and the recovery time is between 24 and 48 hours.

Aside from the innovation factor of safe, effective, male birth control, there are two interesting angles to the RISUG story.

First of all, RISUG has been tested in human studies for the last ten years in India. It’s about to go on the market, and it’s expected to actually expand the national demand for contraceptives by as much as 17%. It’s not, however, going to go on the market anywhere else any time soon. Not a single pharmaceutical company in the United States or Europe has expressed interest in bringing the drug to market.

In the United States, RISUG is being developed by a non-profit, the Parsemus Foundation, which is devoted to neglected medical research. They’re accepting donations to get RISUG to market, in a slightly different formulation called Vasagel. So far, the foundation has started testing Vasagel in animal trials; they’re doing research in monkeys right now. If they get enough funding, human trials could start in 2018.

It’s a mystery why RISUG isn’t being developed commercially in the US or Europe. One theory is sexism – pharmaceutical companies are run by men who may find the idea of male birth control uncomfortable. They may be uninterested in male birth control themselves, and therefore believe that other man won’t use it. Another theory is that contraceptives have a low profit margin, and the cost of bringing a new form to market would be slow to earn a profit. In the case of RISUG, however, so much development has taken place that additional costs would be minimal.

The mystery is especially confusing when you consider the potential market for male birth control. A lot of couples want to control their family size, but won’t use the options available to them. Cross-cultural studies have found that a large percentage of men – as many as 75% of new fathers – would consider a male contraceptive pill. The United Nations has reported that, “In 2015, less than half of total demand for family planning was being met with modern methods in 54 countries (34 of which are in Africa). In an additional 76 countries, less than 75 per cent of total demand was met by use of modern methods.  A male contraceptive could be a game changer for those couples.

Secondly, this is a sign of the maturing pharmaceutical sector in India. The initial growth of the Indian pharmaceutical industry came from the manufacture of generic drugs. Indian drug companies do novel drug discovery; they produced inexpensive generic versions of drugs developed in other countries. Antibodies and anti-HIV drugs were big moneymakers (and a big reason why HIV drugs are so inexpensive in the developing world.) India actually had the highest number of FDA-approved manufacturing centers outside the United States.

RISUG is part of a more sophisticated Indian pharmaceutical sector. The technique was invented and tested in India, and it’s now being brought to market in India. Sector analysts warn that the transition to a pharmaceutical industry based on novel drugs will be slow, but it’s clearly happening. The last five years have also brought a novel diabetes drug developed in India, Saroglitzar, and a new kind of malaria combination pill that is already being sold in African countries. Size is on the sector’s side. The Indian market alone is big enough to incentivize drug development; licensing and production outside India is just bonus profit.

India is already a global health powerhouse – affordable Indian-made antiretroviral drugs saved the lives of hundreds of thousands of people living with HIV. Novel drug development in India could take that impact to the next level.