Compulsory licensing is a vital public policy tool to combat the high prices of medicines and anti-competitive practices.
This was the position of the ’Developing Countries’ delegation during the 30th session of the Standing Committee of the World Intellectual Property Organization (WIPO), held in Geneva, Switzerland (24-27 June 2019).
In the meeting’s reference document, the use of compulsory licenses (CLs)s to: balance rights; act as an instrument to safeguard public interest; and prevent abuses of the patent rights, were repeatedly referred to, including a reference to Brazil where “a compulsory license may be granted if the patentee exercises his right in an abusive manner, or if the patentee engages in abuse of economic power by means of exploiting the patent.”
The right to health IS compulsory
A week after the WIPO session, Brazil’s Health Minister Luiz Henrique Mandetta contradicted the views expressed by many countries saying: “Brazil should never break medicine patents.” His statement was made during the opening of the Seminar Interfama – Technological Innovation in Health and Value for the Patient, in Brasília.
A compulsory license (CL) is an authorization issued by governments, allowing the manufacture or import of generic versions of a patented medicine. All countries, regardless of income classification, have a legitimate right to issue a CL, for example when faced with the over-pricing of essential medicines and a public interest.
The rights of World Trade Organization (WTO) member countries to issue CLs is recognized in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and has been reaffirmed by the Doha Declaration on TRIPS and Public Health.
Mandetta’s speech signalled his position in defending the interests of the pharmaceutical industry, protecting profits before public health. He said: “It harms the inventiveness and the time spent by private initiative with research and researchers … it is the private sector that produces, and the government has the role of stimulating production initiatives.”
Mandetta’s statement, and inaccurate justification, is in stark contrast with other movements around the world to challenge abuse of the patent system, including advocating for the more routine use of CLs, for example:
- In 2019 in the United States, Republicans and Democrats came together to seek clarification from seven pharmacy executives about the level of prescription medicine prices, in several hearings of the Senate Finance Committee.
- In February 2019, at the World Health Organization, Italy proposed a transparency resolution which requires medicine manufacturers to disclose their production and research and development costs, as well as prices charged for medicines and vaccines.
- In Switzerland, the activist group Public Eye requested a CL for the medicine Perjeta, a so-called ‘blockbuster drug’ of the Swiss Roche laboratory used in the treatment of breast cancer.
- In September 2017, the Malaysian government approved a CL under its Patent Act 1983, on sofosbuvir to procure access to affordable generic treatment for people with Hepatitis C.
- At the 10th International HIV Conference on Science (IAS 2019), we urged 12 countries to issue a CL on HIV drug, dolutegravir, in order to achieve the World Health Organization recommendation for all countries to immediately adopt dolutegravir-based regimens as the preferred first-line treatment for HIV.
- The #Science4All protest that ended IAS 2019, highlighted where CLs would increase access to essential treatment for HIV, Hepatitis and multi-drug resistant TB.