Self-care: Regulatory standards and processes of SRH products

Delivering sexual and reproductive health (SRH) through self-care and remote care enables and empowers women and girls to take control of the management of their SRH. As a health intervention, self-care and remote care can also improve the quality of care and offers a more cost-effective approach to provision of essential SRH services such as contraception, emergency contraception and diagnostic tests for pregnancy, fertility and ovulation.

Photo Credit: Paul Joseph Brown Photography

In 2020, with funding from WHO, Concept Foundation undertook research and reported on the regulatory situation and availability of self-care products with a focus on contraceptives, emergency contraception and selected fertility products.

In June 2020, a 3-month pilot project was initiated focusing on five countries from the Eastern Mediterranean Region: Egypt, Jordan, Morocco, Lebanon and Tunisia.

A follow-on project to the initial pilot project began in September 2020 and will be completed in February 2021. It includes the remaining five WHO regions; Africa: Burkina Faso, Ethiopia, Kenya, Nigeria, Senegal, Uganda, Zambia and Zimbabwe, Americas: Argentina, Brazil, Canada, Panama and Uruguay, Europe: France, Georgia, Kazakhstan and United Kingdom, South East Asia: Bangladesh, India and Thailand, and Western Pacific: Australia, China, Laos, Philippines and Papua New Guinea.

In this project, the scope of products included in the research was expanded to include diagnostic tests (pregnancy, ovulation & HPV) in selected countries.

Research methodology:

i) Research the current regulatory procedures related to over-the-counter (OTC)/self-care products

ii) Prepare an overview of products available in the selected countries and where available, investigate any licensed for OTC/self-care use

iii) Use local experts to validate the above information and provide ‘real life’ situation related to sexual and reproductive health medication

iv) Compile a report and/or manuscript highlighting findings and potential recommendations to improve the regulatory standards and processes of self-care interventions.

This research is being undertaken through a combined effort by Concept Foundation’s Country Support and R&I teams.

Pilot study in five countries in the Eastern Mediterranean Region

In November 2020, the manuscript with our findings ‘Regulatory standards and processes for over‑the‑counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region’ was accepted in Health Research Policy and Systems.

The main conclusions indicate that none of the investigated countries had an official regulatory procedure to facilitate moving products requiring a prescription to being available OTC. Across the five countries, three had publicly available lists of products which were legally available as OTC, of these three countries only one relevant product in one country (EllaOne in Lebanon) was listed.

Despite the above-mentioned facts, multiple sources suggested that sexual and reproductive medication was available in these countries without a prescription. Overall, our study emphasises that the need for transparent and consistent regulatory guidance, procedures and processes across the EMR was evident.

This would facilitate increased interest by marketing authorisation holders to support products being made available OTC and enable simpler and reliable access to SRH for users.

In February 2021, a report will be submitted to WHO with our findings for the other five WHO regions and overall general recommendations. In addition to this report, a manuscript will be prepared.