The need for better access to medicines is highest in low- and middle-income countries
There are many countries where very few of the products included in this analysis have been registered
Filing for registration is a vital first step towards introducing a medical product into a country, as successful registration means that a product is now allowed to be imported and sold.
Companies can register their products with the national regulatory authorities of each country, by filing dossiers of technical, medical, and scientific information. Alternatively, in some cases they can make use of special import processes that can waive registration for certain essential medicines, such as tuberculosis medicines.
Typically, pharmaceutical companies first file for registration in higher-income countries with larger markets. However, considering that less wealthy countries often have the highest need for new products, pharmaceutical companies should register their products widely in low and middle-income countries (LMICs).
Which products were included in this analysis?
Across the 17 companies, the Benchmark examined 166 medicines and vaccines to assess how widely companies are filing for registration:
18 on-patent antibacterial vaccines, marketed by four companies – GSK, MSD, Pfizer, and Sanofi.
17 on-patent antibacterial and antifungal medicines, marketed by seven companies – Cipla, Johnson & Johnson, MSD, Otsuka, Pfizer, Shionogi and Viatris.
131 off-patent/generic medicines, marketed by 16 companies – all companies in scope except for Otsuka.
As in the 2020 AMR Benchmark, in 2021 the products in this analysis are generally not widely filed for registration across the 102 LMICs in scope. Only six on-patent medicines have been filed in ten or more of these countries.
Vaccines are filed much more widely than patented medicines, reflecting high international demand as well as the impact of supranational pooled procurement agencies such as Gavi, The Vaccine Alliance.
Which LMICs account for the most registration filings?
The five countries within the scope of this analysis where the most registrations have been registered are South Africa, the Philippines, India, Brazil, and Thailand. More than 45 filings were reported in those countries during the period of analysis, with South Africa benefitting from the highest number of filings (56 in total, across the 166 products). Compared to other LMICs, these countries provide greater revenue opportunities for pharma companies due to their large patient populations in need, as well as mixed payments from private insurances, public health systems or out-of-pocket expenditure
Which LMICs account for the least registration filings?
There are 14 countries in which none of the products in scope are known to have been registered. These countries include Somalia and South Sudan, which face political instability, as well as small countries like Tuvalu and Vanuatu, which are hard-to-reach countries that rely on imports for most of their medicines.
While the Benchmark identifies little forward movement on registering antimicrobials and antifungals in low- and middle-income countries (LMICs), there are tangible steps that companies can take, namely: to prioritise the registration of medicines and vaccines more widely, or, when applicable, to use an alternative option of special import waivers in order to facilitate access; and to focus on registering products in countries where the number of registered products is the lowest, and where the burden of diseases is highest, in order to reach those who are most in need.
In expanding product registrations, pharmaceutical companies will need to navigate a range of challenges that can act as a barrier to registration:
There are various reasons why a company may or may not file a product for registration in a specific country, including:
- Competing products already on the market in that country;
- Market size and financial opportunities;
- Policies on pricing transparency;
- Political instability, conflict, or economic sanctions;
- Unclear local regulatory requirements, and long processing times for registration.
An increasing number of LMICs now require marketing authorisation to license and manufacture a product. Yet, the submission of dossiers can be lengthy and burdensome for companies. Some regulatory authorities may also lack the technical expertise to assess the dossier, resulting in long waiting times before regulatory approval..
Few online regulatory databases yet track the registration of medicines in smaller LMICs. Because regulatory agencies in these countries may lack the capacity for building and updating such databases, companies can play a role in being more transparent on where they file their medicines for registration. For example, Johnson & Johnson is the only company in scope to publicly disclose where it filed its multidrug-resistant (MDR-TB) medicine bedaquiline (Sirturo®) for registration.
In response to some of these challenges, a number of bodies and
programmes have been established, and are already providing companies with support for product registration:
- The WHO Collaborative Registration Procedure
- The African Medicines Regulatory Harmonization (AMRH) programme
- The African Medicines Agency (AMA)