For some SRHR-related diseases, R&D priorities are not being addressed

The Special Report finds that that while companies are taking steps to improve access to SRHR-related products, and to develop new ones, there are concerning gaps related to certain diseases, health needs, and geographies.

Of the 83 diseases and health needs in scope of the Index, 19 (23%) are related to SRHR. Of the total 1,060 projects in the pipeline among the 20 companies in scope, 171 (16%) address SRHR-related diseases and health needs. Here, the Special Report's findings on R&D are briefly outlined.

The importance of SRHR as an access-to-medicine issue

Sexual and reproductive health and eights (SRHR) are human rights for all people. However, the ability to exercise these rights is not accessible for all. SRHR range from having access to safe, effective and affordable forms of contraception, access to skilled healthcare providers and services to support safe pregnancies and births, to access to treatments and products for various sexual and reproductive diseases and health needs.

SRHR are a key component to achieving the Sustainable Development Goals (SDGs) set by the United Nations General Assembly and Universal Health Coverage set by the World Health Organization (WHO). To achieve these by 2030, action needs to focus on ensuring women and girls, no matter where they live, have access to medicines, products and services for sexual and reproductive health. Although addressing SRHR requires global efforts from various stakeholders, pharmaceutical companies have a key role to play.

R&D projects and priorities for SRHR – what are companies doing to fill the gaps? 

Cancers (i.e., breast, ovarian, cervical and uterine) are a well-addressed category within the SRHR-related diseases and health needs in scope of the Index, with 105 (60%) projects in the SRHR pipeline targeting one of these cancer types. This finding mirrors the makeup of the pipeline for all diseases in scope, where companies invest resources into developing products for non-communicable diseases (NCDs), where significant commercial potential is more likely in comparison to other diseases and health needs like contraceptives or maternal health conditions. 

R&D for some SRHR-related diseases and health needs in scope of the Index is particularly under-resourced. For example, five diseases and conditions are not addressed at all by any R&D project. Conditions related to maternal health are especially underrepresented, with just four projects split between maternal haemorrhage and maternal sepsis. 

^{*‘Other’ is defined as projects which follow a different development cycle than R&D projects which target the treatment of a disease, such as a technical lifecycle for devices.} 

Eleven SRHR diseases or health needs in scope have R&D product gaps;¹ HPV-related cervical cancer, pre-eclampsia, postpartum haemorrhage, hepatitis B, herpes simplex virus type 2 (HSV-2), chlamydia, gonorrhoea, syphilis, human T-cell lymphotropic virus type 1 (HTLV-1), HIV/AIDS, and contraceptive methods. The Index defines R&D projects in the pipeline that address product gaps as 'priority projects.’ 

Although HIV/AIDS and hepatitis B comprise 30% of all SRHR projects in the pipeline, there are no projects in development to address two of the identified product gaps – namely, microbicides for HIV and diagnostics for hepatitis B. There are also no R&D projects currently in development targeting product gaps for HSV-2 (commonly referred to as genital herpes), due to the termination of a project to develop a preventative vaccine for the virus. 

Addressing specific R&D gaps for maternal health could reduce mortality in LMICs  

Maternal mortality rates are disproportionately high in low-income countries, with an average of 462 deaths per 100,000 live births, compared with an average of 11 deaths per 100,000 in high-income countries.² Several factors influence this, including distance to hospitals, inadequate healthcare services and a lack of access to existing medicines. 

While addressing health system barriers is an important step in addressing high maternal mortality, R&D investment is also a key element that can help in this regard. One key gap in R&D for maternal health is for diagnostics for pre-eclampsia, yet none of the companies in scope have priority projects addressing this gap. 

Another notable R&D product gap is for products to treat postpartum haemorrhage, the leading cause of maternal deaths. Currently, treatment for this condition requires intravenous or intramuscular administration of oxytocin by a skilled healthcare worker. A new formulation is needed that is both heat stable and can be easily and quickly administered as an alternative. Currently, among the companies in scope, there are no projects in development to address this need. However, through Merck for Mothers, MSD collaborated with Ferring Pharmaceuticals and WHO to support the advancement of Ferring’s proprietary and investigational heat-stable carbetocin, for the prevention of postpartum haemorrhage. 

Next steps: Addressing access to medicine for SRHR-related diseases and health needs via R&D

• R&D investment: Of the SRHR-related diseases and health needs included in this report, cancers, hepatitis B and HIV/AIDS draw the bulk of the R&D focus. The remaining half of the diseases and health needs make up less than 10% of the SRHR pipeline, with some not addressed at all. More R&D investment in these areas is needed, especially to fill product gaps for diseases and health needs that currently remain unaddressed, for example, pre-eclampsia and postpartum haemorrhage. . 

• Clinical trials: Pregnant and lactating women have been historically excluded from clinical trials. As a result, the body of evidence to support clinical decision-making for medicines used during pregnancy is lacking, despite many women still needing and using medically necessary medicines throughout the course of their pregnancy.³ Where appropriate, companies can make additional efforts to include them in clinical research in line with WHO recommendations.

The full version of the Special Report is available via our Resource Centre.

References:

^{1.Chapman N, Doubell A, Goldstein M, et al. G-FINDER | Sexual and Reproductive Health Research and Development: Understanding the Spectrum.; 2020. Accessed July 5, 2022. https://www.policycuresre-search.org/g-finder/} 

^{2. World Health Organization. Maternal mortality. Published 2019. Accessed October 15, 2022. https://www.who. int/news-room/fact-sheets/detail/maternal-mortality}

^{3. van der Graaf R, van der Zande ISE, den Ruijter HM, et al. Fair inclusion of pregnant women in clinical trials: An integrated scientific and ethical approach. Trials. 2018;19(1):1-9. doi:10.1186/S13063-017-2402-9/TABLES/1}