Durban Reflections #1: The Threat of Big Pharma's Monopoly Unbound

Returning to Durban, South Africa for the International AIDS Conference sixteen years later, the issue of high drug prices remains front and center. First generation antiretroviral medicines remain accessible and affordable in most low- and middle-income countries and some people in some regions have access to low-priced second-generation medicines because of voluntary licenses and discounted prices.  But millions of people with HIV and their governments, especially in middle-income countries in Asia, Latin America, Eastern Europe and Central Asia, and in the Mideast and North Africa, face antiretroviral drug prices that are exclusionary because of drug monopolies.  And yet, people with HIV have better access than most – our brothers and sisters living with cancer, hepatitis, mental illness, and other treatable health conditions face unrelenting intellectual property barriers. Meanwhile, the Indian generic industry - often referred to as "the pharmacy of the developing world" -  is under threat.

Multiple forces conspire to undermine the efficient spending of regrettably restrained funding. Even as we demand that the $7 billion-plus funding gap in the AIDS response be closed so that we can achieve Fast-Track goals of treating 13 million more people with HIV by 2020, we know that those resources can be and will be squandered if we do not promote generic competition of quality assured medicines. Instead of allowing production and sale of generic medicines 99% cheaper than monopoly-protected medicines, multinational pharmaceutical companies located in the U.S., Europe, and Japan use lawsuits to protect and extend their exclusive patent rights. Instead of allowing universal access to lifesaving medicines, these same companies enlist trade representatives and government officials from rich countries, including President Obama, to seek longer, stronger, and broader patent monopolies through trade agreements and backdoor pressures. Threats to access to affordable medicines highlighted at AIDS 2016, are almost too numerous to mention:

#1. Indian Generics in Crisis
In India, the US President and Vice President, Members of Congress, and the US Trade Representative have for a decade challenged India’s adoption of strict standards of patentabilty, its refusal to allow monopolies on regulatory data, and even its issuance of a compulsory license on a grossly overpriced cancer medicine. They have placed India on the Special 301 priority watch list, and sent waves of government officials and industry representatives to India to twist arms and issue threats. As a result of unrelenting pressure, and its own subservience to corporate interests, the new Indian government led by Prime Minister Modi has adopted a moratorium on issuing compulsory licenses, has opened it doors to US consultation on domestic intellectual property policy, and has loosened and even reversed its strict patent examination standards - mostly troublingly with respect to Gilead’s sofosbuvir patent application. Even more recently, India has created a virtually unlimited access for Big Pharma companies to buy out India generic companies without any or only limited government review. Equally troubling, India has threatened the registration of the Lawyers Collective, which not only fights for human rights but also helps lead the fight against patent monopolies in India. As a result of this threat, activists at the International AIDS conference marched on the Indian Consulate on July 21 to protest these developments.

#2. Intellectual Property Policy Incoherence and Delay in South Africa
In South Africa, home to this year’s AIDS conference, activists from the Treatment Action Campaign and now many other health groups have fought a Fix the Patent Act Campaign that demands that South Africa adopts strict patent criteria, examines pharmaceutical patents applications stringently, allows oppositions, and simplifies procedures for issuing compulsory and government use licenses, among other demands. The U.S. government responded with pressure during the African Growth and Opportunity Act (AGOA) negotiations and the US pharmaceutical industry attempted infamously to set up an “indigenous” disinformation campaign. The South African government has procrastinated and has in all likelihood issued over 10,000 pharmaceutical patents over the past five years. Only during this conference it finally issued a revised IP consultative framework on pharmaceutical related patents. Although the framework promises some of the needed reforms, it is unnecessarily cautious and it proposes a needlessly extended consultative process both within government and with external stakeholders during which Pharma will continue to try to shrink proposed policy reforms. At the conference, TAC and other activists has constantly raised demands that South Africa fix its patent laws now, not later.

#3. Pharma lawsuits, trade threats against the use of lawful flexibilities, and Pharma restrictions on access to lifesaving medicines in middle-income countries
Pharmaceutical companies have filed or threatened legal claims to prevent generic competition in Ukraine (based on data exclusivity), Colombia (based on the threat of a compulsory licenses), and Argentina (based on its pharmaceutical patent examination guidelines). Big Pharma companies are also excluding countries from voluntary licenses and affordable prices for hepatitis C and HIV medicines, and are excluding all countries from access to affordable cancer and other life-saving medicines. At the conference in Durban, activists have expressed solidarity on these issues by actions at Gilead’s booth (hepatitis C medicines) and Roche’s booth (breast cancer medicines).

#4. Trade and investment agreements threaten future access to all medicines
The United States, European Union, Japan, and other rich countries are seeking longer, stronger, and broader intellectual property protections and enforcement in the Trans-Pacific Partnership Agreement, the EU/India Free Trade Agreement, the Regional Comprehensive Economic Partnership, and in the Transatlantic Trade and Investment Partnership. They are seeking new rights for foreign pharmaceutical companies to bring private arbitration claims against governments when expectation of monopoly profits from IP are frustrated by government policies or decisions — like Eli Lilly has done in its $.5 billion North American Free Trade Agreement (NAFTA) claim against India.  During the Treatment for All March, activists demanded that these trade agreements and other efforts to impose even more monopoly rights stop immediately.

#5. Rich Countries Oppose Major Reforms to R&D and Access Efforts at the UN Secretary General High Level Panel on Access to Medicine 
Based on years of activist pressure both about the insufficiency of the global intellectual property regime to produce the medicines needed for all people and the appalling lack of affordable access to medicines because of IP monopolies, the Secretary General of the United Nations established a High Level Panel on Access to Medicine (HLP). Because of the HLP’s threat to Big Pharma’s monopoly profits, the US, other rich countries, and industry have attacked the HLP substance and process publicly and privately. Activists have asserted their expectations for the HLP Report directly to Ban Ki Moon and have also requested its prompt release to avoid dilution of its recommendations by opposing governments.


AIDS activists continue to take the lead in highlighting the danger of monopolies on medicines and in trying to save access to affordable generics. Middle-income countries are already feeling the burden of monopolies — they are rationing life-saving medicines or even refusing to purchase them at all. As long as the intellectual property regime remains in its current form, there will be inefficiencies and shortfalls in needed research and development. Likewise, as long as the intellectual property regime remains, there will be high prices that threaten the lives and well-being of millions living with HIV and billions living with other health conditions. This is why Health GAP, the Treatment Action Campaign and other activists at the AIDS conference are calling the entire intellectual property regime into question and mounting multiple campaigns to reverse its perverse impacts.

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