Are companies engaging in voluntary licensing to expand access?
Management of the intellectual property (IP) of large R&D-based pharmaceutical companies impacts the availability and affordability of medicines. Enabling generic medicine manufacturers to develop generic versions of medicines can increase affordability, support supply, foster competition and ultimately improve access. A non-exclusive voluntary licence is an important approach, among many, to making a product accessible.
The 2021 Index highlighted activities relating to companies’ non-assertion declarations and their access-oriented, transparent non-exclusive voluntary licences. The licences negotiated with the Medicines Patent Pool (MPP) contain the most access-enabling terms. To assess the quality of the licences, the Index looks for the presence of specific terms or clauses in the agreement, including licence agreed prior to or shortly after approval of originator product and ability to manufacture and freely source active pharmaceutical ingredient (API).
The 2021 Index has identified 20 marketed compounds from six companies that are covered by non-exclusive voluntary licences or non-assert declarations. Compared to 2018, only two compounds have been added e.g. glecaprevir/ pibrentasvir (Mavyret®) from AbbVie. Some previously licensed compounds are now off patent (e.g. GSK's abacavir (Ziagen®)). During the period of analysis, no new licences for approved products outside viral hepatitis and HIV/AIDS were agreed.
AbbVie, Bristol Myers Squibb and Gilead engage in both HIV/AIDS and hepatitis C licences, while GSK (through ViiV Healthcare), Johnson & Johnson and MSD*** engage solely in HIV/AIDS licences. The pharmaceutical industry remains hesitant in endorsing the rights of national governments to grant compulsory licences or deploy IP systems flexibly as needed. For Pfizer’s investigational compound for TB treatment, sutezolid, a licence was agreed with the Medicines Patent Pool (MPP) during the period of analysis to facilitate its clinical development.
When it comes to endorsing the rights of national governments to grant compulsory licences or deploy IP systems flexibly as needed, the pharmaceutical industry remains hesitant. Just over half of the companies assessed by the Index publicly support the TRIPS Agreement which includes flexibilities for World Trade Organization (WTO) member states to set aside patent rights to protect public health.
Which countries do companies’ licences cover?
The 2021 Index finds that upper middle-income countries (UMICs) are more likely to be excluded from non-exclusive licensing agreements. For instance, Mexico is not covered by any licence; Brazil and China are covered by only one licence for lopinavir/ritonavir (now covered by a non-assert declaration) for HIV/AIDS. Compared to low-income countries (LICs), they have greater purchasing power and thus represent more attractive commercial markets for companies.
Licensing — a tool to address children's needs
It can take years for treatments to be approved for use in children, in part due to the risks and limitations associated with clinical trials that include paediatric patients. Over the years, non-exclusive voluntary licences have played a role in accelerating the development and uptake of adapted formulations of optimal paediatric HIV, TB and hepatitis C medicines. The 2021 Index finds that four compounds have been agreed specifically for paediatric HIV treatments: dolutegravir (Tivicay®) by GSK, lopinavir/ritonavir (Aluvia®/Kaletra®) by AbbVie and raltegravir (Isentress®) by MSD. The uptake of raltegravir (Isentress®) is low as only one sub-licensee has agreed to manufacture the treatment in a licensed territory.
Opportunities still exist to improve licensing coverage and performance
Licensing for marketed products remains confined to just a few diseases: HIV/AIDS, hepatitis C and, as of 2020, coronavirus. Opportunities for increased engagement from companies are prominent, including licensing medicines that are included on the WHO EML, products that received a favourable clinical assessment and are highlighted for future inclusion (e.g. SGLT2 inhibitors for diabetes, oncology medicines with high ESMO clinical benefit score) in order to facilitate affordable access in low- and middle-income countries. In fact, companies can partner with the MPP whose expanded mandate focuses specifically on the coverage of such medicines and newly included COVID-19 treatments. Companies can expand their geographic licence territories to cover these countries and improve access to the poorer population.
Patent holders need to take other steps toward registration and use access strategies (equitable pricing strategies, donations and others) to reach patients in all markets and from all the income pyramid levels.
It should also be pointed out that licensing does not guarantee supply. There are still challenges for generic medicine manufacturers such as registration hurdles in some countries where the originator did not file for registration or smaller markets which can deter generic medicine manufacturers from entering those countries. As a result, availability and affordability can remain barriers for many countries. Patent holders need to take other steps toward registration and use access strategies (equitable pricing strategies, donations and others) to reach patients in all markets and from all the income pyramid levels.
* Remdesivir (Velklury®) approved for emergency use only in the USA and Japan during period of analysis (approved by FDA in October 2020).
** Investigational project, licence to facilitate the clinical development of sutezolid.
*** Merck & Co, Inc (Kenilworth, NJ USA)