Drug companies must make fundamental changes to their core business to address Research and Development (R&D) gaps and access to existing medicines for women’s sexual and reproductive health in lower-income countries, global health equity advocates urge.

Despite progress in women’s health and rights in the last 50 years, stark inequalities remain in access to contraceptives, health services to support safe pregnancy and birth, and treatment of sexual and reproductive diseases, the Access to Medicine Foundation highlights in a special report presented to industry representatives last week.

According to the researchers, in low- and middle-income countries (LMICs), such services often fail to meet minimum medical and human rights standards.

“Our message with this report is that there’s a lot more to do at the company’s core business. Otherwise, we’re leaving a significant gap in the world, and we’re not solving inequity issues at all,” said Jayasree K. Iyer, CEO, Access to Medicine Foundation

World Health Organisation figures show that maternal mortality rates are disproportionately high in low-income countries, with an average of 462 deaths per 100,000 live births, compared with 11 deaths per 100,000 in high-income countries.

Women and girls have been “chronically neglected”, said Iyer, CEO of the Access to Medicine Foundation, which produces an annual report tracking progress made by the pharmaceutical industry on fair access to life-saving drugs.

“The pharmaceutical industry has the products, the means, the market presence to do something about this and to do something faster, at scale,” she told SciDev.Net.

Specific gaps in research and development must be plugged if global goals on women’s rights to reproductive and sexual health care are to be met by 2030, the special report produced alongside the foundation’s 2022 Access to Medicine Index in November says.

The survey of major pharmaceutical companies by the Netherlands-based foundation found R&D notably lacking in products to diagnose and treat maternal haemorrhage – the leading cause of maternal death worldwide – and maternal sepsis, another life-threatening condition. Gaps were also identified in diagnostics for human papilloma virus (HPV), a cause of cervical and other cancers.

The current treatment for post-partum haemorrhage requires intravenous or intramuscular administration of oxytocin by a skilled healthcare worker, not always available in poorer, remote communities.

Access strategies lacking

The report, presented to healthcare suppliers at a workshop by the UN Population Fund in Copenhagen (1-2 December), also highlights a lack of access strategies among many pharmaceutical companies to ensure that existing medicines relating to sexual and reproductive health reach those who need them. Many products, it says, are not even widely filed for registration in LMICs.

“R&D is heavily focused on cancers, especially breast cancer,” said Emma Shiffman, a researcher who worked on the analysis. “There are key gaps in R&D for certain health conditions which are responsible for ending the lives of many women worldwide, especially in LMICs. And at the same time, with all of this R&D investment into cancer, access strategies for these products are still limited.”

Breast cancer is a standout example. The survey looked at 14 breast cancer products and found that for 11 of them, there was no strategy to ensure women in low-income countries could access them.

Iyer noted that R&D on contraceptives is also lacking, adding: “We have quite a few really good contraceptives that are easy to use in the world, but patients need choice.”

According to the report, around 214 million women of reproductive age living in LMICs cannot source modern contraceptives, contributing to 111 million unintended pregnancies a year – a situation exacerbated by the COVID-19 pandemic as the world went into lockdown.

Women with children on their backs listen to a physician at a health facility in Cote d’Ivoire. Copyright: Anouk Delafortrie/ECHO. (CC BY-ND 2.0).

Despite this, drug companies have come a long way in widening access to contraceptives, said Iyer, citing Bayer and Pfizer as examples. “But I think the big step that’s going to come up in the next few years is going to be on some of the cancer products,” she added.

‘Transforming the sector’

She sees voluntary licencing, which allows patented medicines to be made affordably by other manufacturers in different countries, playing an important part in this.

Out of all the sexual and reproductive diseases analysed in the report, non-exclusive voluntary licenses — where a company allows sub-licensees to manufacture and sell generic versions of their products in LMICs — were only in place for HIV, the researchers found.

Companies should be looking to ensure that a licence is available early in the product lifecycle, suggested Iyer, adding: “It’s voluntary licensing that gives that scale of accessibility.”

She believes the industry also has a fundamental role in “changing the profit margin” in the healthcare system: “You can’t expect that someone in the world pays those high-profit margins to subsidise initiatives in the country.”

Companies need to see women and girls as a key source of revenue in lower-income countries and look at making products available in the requisite volumes at a lower price, said Iyer. “I think that’s what’s going to transform the sector,” she projected.

“Our message with this report is that there’s much more to do at the company’s core business. Otherwise, we’re leaving a significant gap in the world, and we’re not solving inequity issues at all.”

Agnimita Giri Sarkar is a consultant paediatrician at the Institute of Child Health in Kolkata, India, where she also raises awareness of cancer and HIV among sex workers. She believes pharma companies have a broader role to play in improving women’s health in LMICs, where malnutrition, early marriage and childbirth, anaemia and maternal haemorrhage contribute to high maternal mortality rates.

“Focus should immediately be made on promoting consciousness about female sexual health, developing targeted vaccination strategies and improving access of females to health care services,” she told SciDev.Net.

“Pharmaceutical companies can not only play a crucial role in R&D, and funding in social health, but also engage their networks in achieving this goal.”

A spokeswoman for the US health care firm Johnson & Johnson said the company was committed to applying science to “solve persistent and emerging global health challenges”.

She said the company worked with the Monash Institute of Pharmaceutical Sciences at Monash University, Australia, to advance the development of an inhaled version of oxytocin to treat post-partum haemorrhage.

“This collaboration has supported Phase 1 clinical trials, and we continue to work closely with Monash to explore further developing this potential innovation to support pregnant people and the health workers who support them.” – Health-e News

This piece was produced by SciDev.Net’s Global desk.

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