Probably the most publicly-discussed example of how IP may have adverse social impacts is the possibility of patents to restrict access to pharmaceuticals, especially medicines used to treat HIV/AIDS. Indeed, when it became apparent that patents might be making drugs more expensive and less accessible, widespread public outcry led to political action and reformation of parts of the global IP system. The success or failure of those reforms will be the focus of our lesson on patents and public health. We’ll talk about social justice by critically evaluating Canada’s response to global health crises — the Canadian Access to Medicines Regime — and the recent shipment of generic antiretroviral pills to Rwanda.
The starting point, I suppose, is to read the TRIPS Agreement itself, specifically Articles 27-33 in Section 5 on Patents:
- Agreement on Trade Related Aspects of Intellectual Property (15 April 1994) in Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 United Nations Treaty Series 299 (entry into force 1 January 1995), Articles 27-33.
For reasons you’ll learn about in this lesson, these provisions of the TRIPS Agreement were the source of widespread criticism from various sources. Eventually, the members of the WTO adopted what’s known as the Doha Declaration, intended to mitigate some of the effects of TRIPS’ patent provisions on public health in developing countries. Please read it.
- WTO Ministerial Conference, Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2 (14 November 2001).
Paragraph 6 of the Doha Declaration was implemented through decision of the WTO General Council, which waives the application of Article 31(f) of TRIPS under certain conditions. Take a look:
- WTO General Council, Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, WT/L/540 (30 August 2003).
The General Council Decision was translated into a permanent amendment to TRIPS, Article 31bis, which will take effect if 2/3 of WTO member states ratify the change by a deadline that keeps getting extended (from 2007, to 2009 and lately to even further into the future.
I mentioned that the Doha Declaration was the result of public pressure and criticism, which came mostly from NGOs and some developing countries’ governments. Ellen ‘t Hoen explains how tall his happened much better than I ever could, so I’ve assigned as required reading pages 43-54 of:
- Ellen ?t Hoen, ?TRIPs, Pharmaceutical Patents and Access to Essential Medicines: A Long Way from Seattle to Doha,? (2002) 3:1Chicago Journal of International Law 27-46 at pp. 30-42. Or see here at pp 43-54.
Not everyone agrees, however, that patents are the real problem here. For a critical perspective, please read:
- Amir Attaran & Lee Gilespie-White, “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?,” (2001) 286:15 Journal of the American Medical Association 1886-1892.
Justified or not, some countries have amended their domestic patent laws to permit local drug-makers to produce generic versions of essential medicines for export, usually under strict conditions. The EU, Netherlands, Switzerland, China, India and South Korea are among the jurisdictions that have done so. Canada is another. We’ll spend significant time discussing Canada’s Access to Medicines Regime, so have a look at that site and make sure you’ve skimmed:
- Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act – The Cr?tien Pledge to Africa Act, 2004 Statutes of Canadach. 23 (entry into force 14 May 2005).
Because Canada was the first country to implement Doha domestically, and the first (and only) country whose amended compulsory licensing system has actually been used, it has drawn a lot of attention worldwide. Of all the commentary out there, I’ve chosen to refer you to this recent work from Matt Rimmer:
- Matthew Rimmer, “Race Against Time: The Export of Essential Medicines to Rwanda,” (2008) 1:2 Public Health Ethics 89-103.
Our guest for this lesson will be Amir Attaran, who’ll challenge us by explaining why he’s skeptical that patents are a problem, why he’s critical of the Doha and CAMR and what other options exist to ensure access to essential medicines. I’m going to send via email one his forthcoming articles, which will be required reading for his visit. Sorry for the late notice, but rather than the Rimmer article, we’ll listen to Amir present his most recent work:
- Amir Attaran, “Why Canada’s Access to Medicines Regime Can Never Succeed,” University of New Brunswick Law Journal (2010, forthcoming).
Feel free to browse the Canadian HIV/AIDS Legal Network for another perspective.
There are some commentators who claim that the TRIPS system regarding patents and public health is so broken that we should try something completely different. You can’t ignore the opinions of Nobel prize-winners like Joseph Stiglitz, especially when they’re backed by solid arguments like the ones found in this article I’m asking you to read:
- Tim Hubbard and James Love, “A New Trade Framework for Global Healthcare R&D,” (2004) 2:2 PLoS Biology 147-150.
This kind of thinking is catching on. You can see how and why by skimming this 2008 report from the World Health Organization, the final document I want you to glance through for this lesson:
- World Health Assembly, “Global strategy and plan of action on public health, innovation and intellectual property,” WHA 61.21 (24 May 2008).