In January 2023, a number of cystic-fibrosis patient organisations asked the governments of Brazil, India, South Africa and Ukraine to invoke compulsory licensing and to allow the supply of generic versions of cystic fibrosis treatments. These cases are now documented in our newly updated TRIPS Flexibilities Database, and we will continue to monitor the outcome of the requests.
The TRIPS Flexibilities Database tracks the use of certain provisions of the World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPS) Agreement for the purpose of promoting and protecting public health and in particular access to medicine. The TRIPS provisions we track include compulsory licensing (Article 31 and Article 31 bis), the use of transition provisions for least developed country members of the WTO that allows them not to grant or enforce pharmaceutical patents until 1 January 2033 (Doha Declaration par. 7), and exceptions to patents (Art. 30). The flexibility that TRIPS offers is broader than these articles but the provisions we track are the ones that can and are being used in the procurement of medicines.
The new cystic fibrosis compulsory licences requests are not the first time TRIPS flexibilities have been invoked to circumvent sky-high prices for treatments of the disease, which affects the lungs. In 2019 UK cystic fibrosis patients groups started a campaign to persuade the government of the United Kingdom (UK) to invoke Crown Use of patents for the purpose of accessing more affordable lumacaftor-ivacaftor (brand name Orkambi) for the treatment of cystic fibrosis. The list price in the UK for Orkambi is £104,000 per patient per year. A price too high for the National Health Service (NHS). NHS England offered a £500 million payment for a five-year period for Vertex’s cystic fibrosis medicines. But Vertex, which holds the monopoly over cystic-fibrosis medicines, refused the NHS offer. Parents of children suffering from the disease then asked the government to use compulsory licensing (Crown use) to enable the importation of lower-priced treatments. The Crown use did not happen but it did prompt Vertex to offer a better price and lumacaftor-ivacaftor is now available through NHS England.
But this is not the case in most developing countries that are also dependent on Vertex’s cystic fibrosis treatments and Vertex’s pricing policy, and as a result, many children with cystic fibrosis do not have access to this crucial treatment. It is this that prompted UK-based public health advocacy group Just Treatment in cooperation with the parents of children suffering from cystic fibrosis to launch this new initiative.
TRIPS flexibilities have been successfully used in the past for the importation and supply of generic HIV medicines. For an overview see this article in the WHO Bulletin from 2018 which offered the first report on the TRIPS Flexibilities database. In more recent years, we have seen the TRIPS flexibilities being proposed and used for cancer medication and treatments for Covid-19.
TRIPS flexibilities remain important and form the core of the June 17 2022 WTO Ministerial Decision on the TRIPS Agreement which focussed on access to Covid-19 vaccines and the ongoing debate on whether the decision should be extended to Covid-19 therapeutics. On 11 April, the WHO, together with UNITAID published a guide for countries on how to use the TRIPS flexibilities when they are excluded from the territory of Medicines Patent Pool licences for Covid-19 therapeutics.