Access To Generic Reproductive Health Supplies Decades Behind Medicines?

Despite a massive worldwide push to improve access to contraceptives, generic manufacturers say they’re not yet getting a good share of the pie.

Fatou Hane speaks with a group of mothers about family planning and contraception at the Croix Rouge health post in Pikine, Dakar, Senegal on April 26, 2013.

The use of family-planning products has rocketed in recent years, as more women around the world – especially in low and middle-income countries – choose to have smaller families. In 2017, a whopping 671 million women in developing countries are currently using modern methods.

And a global initiative, launched in 2012 by donors including the Bill and Melinda Gates Foundation and the United Kingdom government, is trying to increase the number of women accessing modern contraceptives, yet more. Around 214 million women, however, who want to use contraception do not have access.

Indeed, the initiative, called FP2020, set an ambitious target to halve the unmet need for contraceptives in 69 countries where there are the most acute problems by 2020. It’s doing that by encouraging both donors and countries themselves to commit more funds to family planning, tackle stock-outs, increase the choice of contraceptives, and increase the number of health workers able to distribute contraceptives or provide counselling services to help parents understand what choices are on offer. Although off target, initiative has produced a drop in the unmet needs (in 2014 those without access were 225 million).

The thinking behind improving access to family-planning products for the women who want them is that spacing between babies reduces the chance that many women will die in childbirth, mums are healthier and so are their children, as well as better educated. The Guttmacher Institute, a research organisation focused on sexual and reproductive rights, reckons if all unmet need for modern contraception were satisfied in developing regions, millions of unplanned pregnancies and unsafe abortions and the resulting maternal and newborn deaths would plummet.

So, spending on contraceptives has dramatically increased, said Heather Boonstra, director of public policy at Guttmacher Institute. “In fact, over the last several years we’ve seen an increase in the number of countries that include family-planning programs in their budgets and this itself is an illustration of how countries recognise the benefits of investing in these programs,” she added.

And there is also a wide range of generic reproductive health products to choose from too. In almost every class of contraceptives, there is a generic equivalent now, said Lester Chinery, of NGO Concept Foundation, which tracks the use of such products.

The problem is, countries and international agencies such as US’s aid agency USAID and the United Nations Population Fund (UNFPA), which procure a range of contraceptives for use within developing countries. are not buying quality-assured generics, he said.

“Why is it that while the whole world has moved towards generics because of the cost benefits. But in reproductive health the same suppliers are supplying the market – purchased by UNFPA and other international agencies – as they were purchasing from 30 years ago?” said Chinery.

He chairs a group of generic manufacturers, the generic manufacturers caucus of the Reproductive Health Supplies Coalition, which got together to improve supplies of quality generic products some years ago. Members include India’s Cipla and Mylan. In a webinar posted by this group in June, they stated that in the six years to 2015, UNFPA had bought 99 percent of hormonal products (including implants, pills and injectables), in terms of value, from just three innovator companies.

After a brief increase in 2016, they said, the figures will probably look the same in 2017, indicating that at an international level currently most family-planning purchasing is still primarily restricted to three or four historical innovator companies.

For example, data shared by the caucus at the webinar suggests that 45 percent of all spending on hormonal products by UNFPA in 2015 come from Bayer Pharma AG Germany, while Pfizer and MSD from the Netherlands are 27 percent each.

The problem is different in low and middle-income countries. Here, they are buying plenty of generics, just not necessarily the ones that have gone through the WHO’s prequalification system, an assessment process that guarantees the qualities of products for buyers – whether they are international donors or governments.

“Paradoxically, at country-level local purchasing by governments of generics has increased much quicker than it has at the international level,” said Chinery. “However, they lack the information required to make a distinction between a quality-assured generic product and one that isn’t.”

A recently prequalified reproductive project was Levonoplant, an implant produced by Chinese manufacturer Shanghai Duhua, a member of the caucus (Levonoplant received prequalification on 30 June and will be available at a lower price to FP2020 countries, it said, at this year’s family-planning summit in London). By June, 26 generic finished reproductive products had been prequalified (14 from caucus members), they said.

But it is an expensive business, and these companies have invested significant sums of money to ensure that their products can pass the stringent quality tests.

“Donors supported some of these companies, but companies have made substantial investments themselves,” he said. “The caucus realised pretty soon that they have their products prequalified but they weren’t seeing the return on their investment in terms of orders from international procurers.”

Getting countries to buy better contraceptives – and not just the cheapest – has been a real challenge, agrees Steve Davis of CEO of PATH, which helps design and market new kinds of contraceptives for LMICs. He said that countries often plump for the cheapest ones, because they can get the biggest volumes – say condoms – rather than others, such as hormonal contraceptives, that may be more expensive but prevent pregnancies over months or even years.

Chinery, for his part, said international agencies are starting to change, in part because of the webinar. However, it is unclear if or when that might translate into a meaningful shift towards prequalified generics.

[Update] Seloi Mogatle, a technical specialist at the procurement branch of the UNFPA, said that on the contrary the organisation shifting towards generics and the numbers have started to rise in recent years. “Generic hormonal contraceptives are important for UNFPA to achieve universal access to quality assured medicines,” she said. “Within UNFPA, there has been a lot of advocacy for the use of generics and as an organisation we promote the use of generics.” In fact, last year hormonal contraceptives were identified by the international non-proprietary names in the UNFPA catalogue for the first time.

She reckons that the proportion of contraceptives (by value) bought from innovative companies has dropped to 86.6 percent from 99.1 percent in 2014 for the combined pill. And from 100 percent to 98.4 percent for the progesterone-only pill. The emergency contraceptive pill dropped from  63.9 percent to 53.8 percent in 2016. Figures for injectables and implants were not supplied. [end update]

Ultimately, getting cheaper quality products is more important than ever, because funding for family planning is being slashed and existing funds must go further, say observers.

Funds are disappearing because the US Trump administration is bringing back the so-called global gag rule, a ban on funding family-planning services run by foreign organisations that provide abortion services, refer women to other organisations for abortions, or campaign for liberalised policies on abortion – even these activities are paid for by funds from other donors (it is usually repealed by Democrat administrations and reinstated by Republican ones). Additionally, funding to UNFPA is also being slashed, and Trump has also proposed the total elimination of family funding for family-planning and reproductive health programs in developing countries in its budget request the next fiscal year.

Should these proposals go ahead, the massive shortfall is unlikely to be filled by donors elsewhere in the world, say family planning advocates (although they have formed an initiative, called She Decides, to do just that).

But the effects on women could be tragic, says Guttmacher’s Boonstra. “At the end of the day, the combination of the expanded gag rule, expected cuts to UNFPA and the international family-planning account threatened to erase the important benefits of US investment in developing countries,” she said. “And potentially millions of women will lose out on health care resulting in more unintended pregnancies and quite likely more abortions, many of which are unsafe, and more maternal deaths and disability.”


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