How companies perform on ensuring access to their SRHR-related products for women and girls in LMICs

Sexual and reproductive health and rights (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 improving SRHR requires global efforts from various stakeholders, pharmaceutical companies have a key role to play.  

Despite standout examples, many SRHR-related products are not widely filed for registration in LMICs 

Filing for registration with a national regulatory authority is the first step required to gain 'approval' before a product is launched on the market. Despite a high burden of disease and unmet healthcare needs for SRHR-related products in LMICs, some products may never receive regulatory approval in countries in scope. When a product is not registered in a country, it limits choice and potentially leaves women and girls without essential and lifesaving SRHR-related products. 

Of the 190 products analysed in the Index in terms of registration data, 39 were indicated for SRHR-related diseases and health needs.* In general, older products such as Bayer’s levonorgestrel-releasing intrauterine system (Mirena®), which received its first global regulatory approval in 1990, are most widely registered in LMICs. The levonorgestrel-releasing intrauterine system is a form of long-term contraception, and is the most filed product within the SRHR-related scope of the Index, with a total of 64 filings in LMICs. 

Data analysed by the Index on which products have been registered, and where, suggests that – of the countries in scope – companies are most likely to register their products in middle-income countries. Only 18 (46%) out of the 39 products have been filed for registration in any low-income countries. For example, Uganda has 11 products filed, while Mozambique has 5 and both Ethiopia and Rwanda have 4.  

^{*A maximum of ten recently launched products were included in the Index for analysis of product registration. As some newer products are not indicated for SRHR-related diseases and health needs, information is not available for all 176 products in scope of this special report. For Eli Lilly and MSD the exact registration status of their latest products within LMICs could not be reported as no data was provided/verified or available in the public domain during the period of analysis.} 

Supporting access through supranational procurement 

Supranational procurement agreements are pooled procurement mechanisms whereby large volumes of health products are purchased by an organisation for supply in multiple countries. This is an important mechanism to ensure a sufficient supply of affordable SRHR-related products are available in LMICs, especially in countries with limited health budgets.

Eight of the companies in scope – AbbVie, Bayer, Bristol Myers Squibb, Pfizer, GSK, MSD, Roche and Johnson & Johnson – engage in international agreements for the procurement of SRHR products. However, currently, pooled procurement via supranational agreements is focused on HIV medicines and diagnostics, HPV vaccines, and contraceptives.  

Lack of access strategies for oncology products, especially in low-income countries 

Through mechanisms like pricing strategies, non-exclusive voluntary licensing, product donations and technology transfers, companies can create access strategies to make their products available and affordable locally in LMICs.

Although the quality of access strategies varies across products and countries, the Index finds that in low-income countries, companies consistently do not have access strategies in place for some SRHR products. Weak health systems, lack of regulatory capacity and inadequate funding pose challenges to reaching patients in low-income countries.

This gap in access is particularly pronounced for oncology products, especially breast cancer. The Index analysed access strategies for 14 breast cancer products, of these 11 (78%) did not have an access strategy in any low-income country in scope. Products for HIV/AIDS and hepatitis B are more likely to be covered by access strategies in low-income countries. Of the combined total of six products for these indications that are included in this analysis, five products were covered by an access strategy in at least one low-income country.  

Reaching low-income women and girls through inclusive business models  

Inclusive business models are scalable, commercially viable models that provide goods, services and livelihood opportunities to low-income populations and other vulnerable groups that may face additional barriers to access. Several constraints prevent companies from including women and girls as consumers, employees or producers in their value chain, such as gender-based expectations, limited literacy, and lack of rights and agency. Where some access strategies may fall short in addressing SRHR access barriers facing women and girls, companies can engage in inclusive business models to improve access to their products.

Nine of the twenty companies in scope of the Index show evidence of their engagement in inclusive business models that address SRHR-related diseases and health needs (AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Johnson & Johnson, MSD, Novartis, Pfizer and Roche), despite 19 companies having products in their portfolio that cover SRHR diseases or health needs. These models cover SRHR health needs such as maternal health, cancers, HIV/AIDS, and contraceptives. 

Addressing barriers to access and availability in LMIC health systems 

Companies have an additional role to play beyond researching and supplying products. Higher levels of company engagement in health systems strengthening are needed and efforts can be made to scale up initiatives and inclusive business models to more countries where there are women and girls with unmet access needs. 

Companies can engage with partners, such as the United Nations Population Fund, to build supply chain capacity for SRHR products in specific areas including demand forecasting and improving infrastructure for storage and delivery of medicines.  

Supply chain issues like a lack of trained staff and weak information systems pose a threat to the continuous supply of contraceptives in LMICs. Several agencies like UNFPA are actively working in LMICs and low-income countries to support supply of contraceptives in addition to other SRHR products. However, such agencies rely on partnerships with pharmaceutical companies, who supply the necessary products and greatly impact product availability, affordability, and uninterrupted supply. Four companies engaged in supply chain capacity building specifically targeting SRHR-related diseases and health needs, three of which report working directly with the UNFPA. 

What can companies do to ensure women and girls in LMICs have access to the SRHR-related products they need?

• Access strategies for more products, in more countries: For key products in their portfolios, and particularly for NCDs like ovarian cancer, endometriosis and uterine cancer, companies must implement country-specific access strategies to ensure equitable access, reaching all income tiers, including low-income countries.  

• Approaches to national and supranational procurement: Companies can expand access a wider variety of their products via supranational procurement agreements. In addition, when countries are not eligible to benefit from supranational procurement, companies should develop access strategies for these countries to ensure that women and girls can access medicines at a similar price.

• Registering products more widely: Although several barriers may make registration in some countries more challenging, companies should now ensure more SRHR products are filed consistently across low-income countries, with a particular focus on the countries with a high burden of the disease targeted by their particular product. 

• Investment in capacity building and tailoring inclusive business models: Companies can help expand access to their products by investing in initiatives to strengthen health systems and expand supply in LMICs. They can increasing their use of inclusive business models to address the specific needs of women and girls.

• Non-exclusive voluntary licensing (NEVL) for key breast cancer products: NEVL is a mechanism whereby, under certain terms and conditions, a company agrees to allow particular generic medicine manufacturers to manufacture and sell generic versions of their products in particular LMICs. Breast cancer treatments that have been identified by the Medicines Patent Pool as priorities for NEVL include ribociclib (Kisqali®) from Novartis, abemaciclib (Verzenio®) from Eli Lilly and palbociclib (Ibrance®) from Pfizer.

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