Voluntary Licensing Agreement

- December 20, 2020

We need to make sure that everyone gets the drugs they need for HIV and all the diseases for which there is treatment. “While voluntary licenses should improve access to essential medicines, in some cases they can effectively impede access,” said consultation participant Chalermsak Kittitrakul of the Thailand AIDS Access Foundation. “Some voluntary licenses exclude some countries from the agreement. Some of them have clauses such as licensing fees that require generic licensees to pay high fees to the initiator and differentiated prices that allow sublicensing providers to set a certain price for countries based on their income level. Voluntary licenses can also be misused to control the generic pharmaceutical industry and sources of supply of active substances (APIs). This prevents generic drug prices from being as low as they should be. Some documents discuss potential access issues that are relevant to voluntary licensing (Beyer 2013, MSF Access Campaign 2017, 2015). MSF Access Campaign highlighted access problems in middle-income countries that have been excluded from Gilead`s voluntary licensing agreements for HIV and hepatitis C drugs (MSF Access Campaign 2017, 2015). Overall, the agreements cover low- and middle-income countries, where 90.3% of adults and 98.2% of children living with HIV live. Gilead has signed non-exclusive voluntary licensing agreements with generic drug manufacturers based in Egypt, India and Pakistan to further expand the Remdesivir offer. Agreements allow companies – Cipla Ltd; Dr. Reddy`s Laboratories Ltd.

Eva Pharma; Ferozson Laboratories; Hetero Labs Ltd. Jubilant Lifesciences; Mylan; Syngene, a biocon company; and Zydus Cadila Healthcare Ltd. – for the manufacture of remdesivir for distribution in 127 countries. Countries are made up of almost all low- and middle-income countries, as well as several middle- and high-income countries, which face significant barriers to access to health care. Remdesivir`s accreditation status varies by country and the distribution of re-employment in each of the countries listed below is governed by local laws and regulations. In the absence of voluntary licenses, countries that cannot afford to purchase the drug from the original companies could wait more than a decade to access the treatment. If rights holding companies do not exclusively license patented drugs, they allow other manufacturers to develop generic versions of these drugs.