Widespread and swift registration of newer products is a critical step towards improved access

New and innovative products typically aim to improve on existing therapies, making it crucial to ensure they are available to every patient who needs them – regardless of where they live. As the patent holders of such products, the companies analysed in the Index can determine where they are made available. To this end, registration serves as a critical step to ensuring the availability of these quality-assured healthcare products for patients.

While high-income markets are commercially lucrative and have established stringent regulatory authorities, registration may be more challenging in LMICs. However, with LMICs being home to nearly 80% of the world’s population,¹ registering their newly approved products swiftly and widely in these countries can help companies ensure equitable access to their much-needed medicines. This is especially vital in LMICs where burdens of disease are high.

Best Practice 

Three companies – Bayer, Novartis and Roche – lead in registering their newer products widely in LMICs in comparison to their peers. The Index categorises newer products as those that have received marketing authorisation within the last five years. Overall, these three companies outperform others analysed in the Index by:

• Registering their products in the most LMICs in scope on average, and;

• Accounting for the largest increase in the number of LMICs in scope where their products are registered, in comparison to the previous Index (2022).

Bayer, which registered its newer products in 21 countries on average, leads in increasing registration of these products since the previous Index, with an increase of 13 countries on average. It registers finerenone (Kerendia®), indicated for chronic kidney disease with albuminuria associated with type 2 diabetes, in 30 countries – an increase of 25 since the previous Index. Finerenone (Kerendia®) is one of the products with the largest increase in registrations in low-income countries for all companies assessed by the Index since 2022.

Novartis registered its newer products in 23 countries on average. Inclisiran (Leqvio®), indicated for patients with high cholesterol, is now registered in 41 countries, compared to only five in the previous Index – an increase of 36 countries, including three low-income countries. Like Roche (see below), Novartis demonstrates good practice by widely registering its biologicals, which are more complex and variable, and which require different regulatory frameworks.²

Roche registered its newer products in 30 countries on average, the most of any company assessed in the 2024 Index. Notably, its product pertuzumab/trastuzumab (Phesgo®), indicated for HER2-positive breast cancer, is registered in more countries in scope (52) than any other product approved within the last five years. Furthermore, Phesgo® has been registered in 28 additional countries (including four low-income countries) since the previous Index, making it one of the largest increases for any product assessed.

Conclusion 

Registering in LMICs can be challenging. Although much more work is needed to improve registration efforts across the 113 LMICs in scope of the Index, Bayer, Novartis and Roche have successfully registered newer products more widely and quickly than other companies assessed. Their regulatory strategies have been effective, showing it is possible to expedite registration in LMICs, even with more complex biologic products. By submitting product dossiers for evaluation, companies can also help to build capacity and expertise in regulatory authorities in lower-income countries.

It must be noted that while registration is a critical step to enabling the availability of quality-assured products, companies must also implement access strategies in tandem to ensure equitable access to their products once they reach the market.

_{1. World Bank Group. Low & middle income. Population, total. Published 2023. Accessed August 27, 2024. https://data.worldbank.org/income-level/low-and-middle-income} 

_{2. International Federation of Pharmaceutical Manufacturers & Associations. Regulation of Biologics. Published online 2023. doi:10.1016/S1470}