The History
Patents became part of the World Trade Organization (WTO) agreement first in 1995 – called the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Developed countries had one year to ensure their patent laws were consistent with TRIPS. Developing countries had to introduce TRIPS by 2000 but had until 01 January 2005 to have patents in place. Least developed countries were given more time, initially 11 years, extended to 2016, and now again until 2021.
The Doha Declaration
In introducing patents on pharmaceuticals, there was concern about the possible effect on access to essential medicines in developing countries. Therefore, flexibilities were built into the TRIPS agreement that would allow developing countries access to such medicines, but these were not clear, and many governments were unsure how to use them. In November 2001, WTO ministers agreed that TRIPS does not and should not prevent members from taking measures to protect public health; they underscored countries’ ability to use built-in flexibilities and agreed to extend exemptions on pharmaceutical patent protection for least-developed countries until 2016 (now further extended to 2021). Hence, the Doha Declaration was born.
Compulsory licensing (CL) is at the center of the TRIPS flexibilities allowed. Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. This was originally envisaged only for domestic use, but after 2003, it allowed countries to issue CLs to import generics when they had no production themselves.
Indian Patent Law
India introduced its patent law, as required, on 01 January 2005. It has very high criteria for patentability. That is, it is harder to get a patent granted due to strict interpretations, for example, of what is new and innovative and what is not. With tight patentability criteria combined with a strong pharmaceutical industry and the willingness of Indian generic manufacturers to get involved (led by Yusuf Hamied of Cipla), India became the center of production, supplying up to 90% of generic antiretrovirals (ARVs) to the developing world. This made possible a huge price reduction and enabled us to get as many people on HIV treatment as we have.
The Problem
Many of the older drugs are off-patent anyway. However, newer first-line and second and third-line drugs, diagnostics, and HCV treatment are still largely on patent. There have also been aggressive patenting campaigns by manufacturers worldwide, including in developing countries. Since 2001, the spirit of TRIPS flexibilities and the Doha Declaration have been undermined by a raft of Free Trade Agreements (FTAs); many have already negotiated, and a huge lot are still under negotiations. These agreements contain TRIPS+ clauses, which provide more protection than that required by the TRIPS agreement of the WTO. Despite declarations and agreements, the US, EU, and some other countries continue to break their undertakings by including TRIPS+ clauses in FTAs, which restrict the ability of countries to use TRIPS+ flexibilities. This has allowed Pharma to continue to dominate and manipulate the market with a move towards voluntary licenses and negotiated ‘deals’.
The NGO Report – Why did we choose this subject?
This year, the annual report of the NGO Delegation to the UNAIDS Programme Coordinating Board (PCB) will be on “Intellectual Property (IP) Barriers to Treatment Access,” to be delivered in December 2014 in Geneva at the 35th PCB meeting. This subject is critical to the HIV response and affects all regions. If we don’t get affordable access to diagnostics and good ARVs (including second and third-line drugs), we will fail. IP is one of the biggest barriers, and yet not much is done about it. The Member States will not bring this up, and neither will UNAIDS. As such, through its report, the NGO Delegation wants to create awareness of these issues and initiate action to address them.