Excerpt from Executive Summary: This is the first-ever global report on treatment access to hepatitis C medicines. The report provides the information that countries and health authorities need to identify the appropriate HCV treatment, and procure it at affordable prices. The report uses the experience of several pioneering countries to demonstrate how barriers to treatment access can be overcome. It also provides information on the production of new hepatitis C drugs and generic versions worldwide, including where the drugs are registered, where the drugs are patented and where not, and what opportunities countries have under the license agreements that were signed by some companies as well as current pricing of all recommended DAAs, including by generic companies all over the world.
Joint submission authored by Yousuf Vawda, Andrew Rens, Andrew Rens, Brook Baker, Tobias Schonwetter, and Achal Prabhala; and co-submitted by 44 other academics, experts, scholars and advocates. The full submission is available here as a printable PDF.
The introduction follows.
The Department of Trade and Industry’s (the dti) Intellectual Property Consultative Framework (the Framework) identifies the intersection between intellectual property (IP) and public health as a priority area that requires immediate domestic review. Thus, the focus of this submission is on this priority area.
Joint statement by Fundación Grupo Efecto Positivo and the ABIA Grupo de Trabalho sobre Propriedade Intelectual
Buenos Aires, Rio de Janeiro, September 15th, 2016 – The United Nation’s High Level Panel (UN HLP) on Access to Medicines released yesterday its final report. The Panel was mandated in November 2015 by UN’s Secretary-General Mr. Ban-Ki Moon to find solutions for the “incoherence” between human rights and public health and rules on intellectual property that hinders innovation and access to medicines. Although the recommendations of the report could have been stronger, it clearly recommends the use of pro public health safeguards to promote the human right to health. The report describes some of the challenges faced by countries to make use of those safeguards, however it fails on addressing the responsibility of pharmaceutical companies.
Executive Summary and Recommendations are below,
Click here for the full report
In September 2015, 193 Member States of the United Nations adopted the 2030 Agenda for Sustainable Development (2030 Agenda). This agenda includes Sustainable Development Goal (SDG) 3 that aims to ensure healthy lives and promote the wellbeing of all people of all ages. SDG 3 is an important vehicle for realizing the right to health and the right to share in the benefits of scientific advancements, whose affirmation dates back to the Charter of the United Nations (1945), the Universal Declaration of Human Rights (1948) and the Constitution of the World Health Organization (WHO) (1948). These rights are also enshrined in the International Covenant on Economic, Social and Cultural Rights (1966) and various other international treaties, declarations and national laws, including at least 115 constitutions.
Abstract: The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia.
Letter from 56 Non-profit Organizations and Academic Experts to Secretary Kerry Regarding State Department Pressure Against Access to Medicines Efforts [PDF]
July 20, 2016
Dear Secretary Kerry: We are writing to express our concern about recent statements made by representatives of the State Department on issues regarding intellectual property (IP) and access to medicines in various settings, including proceedings in Colombia, several important United Nations fora, and in India.
Presented by the Colombian civil society organizations:
CIMUN, Ifarma, Foundation, and Misión Salud (Link)
[Bogotá, Colombia 30th June, 2016 ] .. It is important for us to offer for your consideration, and for the consideration of the UN Secretary-General and UN Member States, a brief report on the specific situation we are currently facing in Colombia with regard to access to affordable medicines. This situation reflects both the urgent need for global governmental action that favors the human right to health as well as the need for strategies to address the pressure interests preventing governments and civil society from increasing access to affordable medicines using well-recognized and established legal flexibilities.
[Médecins Sans Frontières, Link] New York/New Delhi, June 2, 2016—As Indian Prime Minister Narendra Modi prepares to address US Congress next week, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is urging India—often called the “pharmacy of the developing world“—to resist pressure from US lawmakers and the pharmaceutical industry and protect access to affordable medicines. Millions of people across the globe who rely on Indian low-cost quality generics are at risk of having their lifelines cut as pharmaceutical lobbying groups and US lawmakers aim to change India’s intellectual property (IP) policies to favor excessive pharmaceutical monopolies.
[Joint Letter Signed by 122 Experts – PDF in English and Spanish, with Signatures] Dear President Santos: We are lawyers, academics and other experts specializing in fields including intellectual property, trade and health, writing to affirm that international law and policy support Colombia´s right to issue compulsory licenses on patents in order to promote public interests including access to affordable medicines.
[Médecins Sans Frontières, Link] Gilead Sciences has been seeking patents in India for the hepatitis C drug sofosbuvir. The patent applications have been challenged by groups of people living with hepatitis C and HIV through ‘pre-grant oppositions.’ The patent just granted by India’s patent office was initially rejected in January 2015, just before President Obama’s visit to India, which was seen as vexing the US. Gilead appealed the rejection and the patent has now been granted.
[Joint civil society letter, Link] Dear Member of Congress: As organizations concerned with public health in the United States and across the world, we are alarmed by the implications for access to medicines of the Trans-Pacific Partnership (TPP), signed by the U.S. and 11 other countries on February 4th, 2016. The intellectual property (IP), investment, and pharmaceutical and medical device reimbursement listing provisions included in the TPP would do more to undermine access to affordable medicines than any previous U.S. trade agreement. We therefore urge you to reject the TPP in its current form.
Authors: Andrew Hill, Dzintars Gotham, Joseph Fortunak, Jonathan Meldrum, Isabelle Erbacher, Manuel Martin, Haitham Shoman, Jacob Levi, William G Powderly, Mark Bower.
Objective: To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs).
Background: TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production.