We, the undersigned organizations, bring to the attention of Drug Regulatory Authorities, WHO, Member States and other participants of Pre and International Conference on Drug Regulatory Authorities (Pre-ICDRA and ICDRA) and community in general the following concerns with regard to the regulation of biotherapeutic products, particularly biocompetitors, and its impact on access to affordable, safe and efficacious biotherapeutics.
[Lotti Rutter, Treatment Action Campaign, Link (CC-BY)] In 2011, the UN and member states set a goal of reaching 15 million people on AIDS treatment by 2015—a goal many questioned but that will be met next year. Since then, evidence and tools available have changed and it is clear that simply tracking testing and treatment is not good enough. Critically, it is now clear that suppressing the HIV virus with high-quality HIV drugs keeps people living with HIV alive and healthy while also preventing HIV transmission.
[MPP Press Release, Link (CC-BY-NC-ND)] Geneva – 17 July 2014. Three days before the start of the 20th International AIDS Conference in Melbourne, Australia, the Medicines Patent Pool (MPP) announced seven new sub-licensing agreements for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG). The United Nations-backed MPP negotiates licences with key patent holders to speed access of low-cost, generic medicines to developing countries. To date, the MPP has signed agreements with Bristol Myers-Squibb, Gilead Sciences, F. Hoffmann-La Roche, the US National Institutes of Health and ViiV Healthcare for eight antiretrovirals (ARVs) and one medicine for an HIV opportunistic infection.
[International Federation of Library Associations, Link (CC-BY)] Discussions regarding an international copyright instrument for libraries and archives again collapsed inconclusively at the 28th meeting of the Standing Committee on Copyright & Related Rights (SCCR) in Geneva, from Monday 30 June – Friday 4 July. In the early hours of Saturday 5 July, Member States finally “agreed to disagree” on any conclusions on copyright exceptions for libraries and archives, as well as a draft treaty for broadcasting.
[Electronic Information for Libraries, Link (CC-BY)] The 28th session of the WIPO Standing Committee on Copyright and Related Rights (SCCR) – the main body that shapes international copyright law – failed to reach agreement on the conclusions of its session for the second time this year. It also couldn’t agree during the late evening session on the all-important recommendations to WIPO’s General Assemblies that meet in September.
EIFL was represented at SCCR/28 that met in Geneva from 30 June – 4 July 2014 by Inta Miklūna, EIFL-IP coordinator in Latvia, and the Legal Advisor at the Culture Information Systems Centre. Following the breakdown of the last session in April, libraries and archives were hopeful that member states could resolve their political differences so that the work of the Committee can move forward. But it wasn’t to be.
[WIPO Press Release, Link] India has become the first nation to ratify the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled.
So far, more than 75 WIPO member states have signed the Treaty, which was adopted on June 27, 2013 at a diplomatic conference organized by WIPO and hosted by the Kingdom of Morocco in Marrakesh.
The Treaty will take effect after 20 ratifications or accessions are presented to WIPO. India was first after it officially notified WIPO of its ratification.
The Pediatric HIV Treatment Initiative was launched today at an event on Capitol Hill. The initiative plans to foster the development, manufacture, and distribution of pediatric formulations of antiretroviral therapies for the treatment of HIV/AIDS. It will draw on the Medicines Patent Pool’s existing relationships to obtain the necessary intellectual property rights and production know-how from branded firms, and transfer the technology to generic firms. It then plans to coordinate large-scale purchases to ensure the medicines get to children in need. The Pediatric HIV Treatment Initiative is a joint project of the Medicines Patent Pool, the Drugs for Neglected Diseases Initiative, and UNITAID.
World Health Organization, Link
Peter Beyer and Joseph Perriëns
This paper provides information on the prices paid by 20 middle-income countries for adult and paediatric formulations of antiretroviral treatments recommended by WHO. It links this information with an analysis of the intellectual property situation of the selected medicines taking into account existing license agreements as well as compulsory licenses, and includes data and general information on a number of other determinants of prices and availability of ARVs, including tariffs, mark ups and taxes, as well as the regulatory status.
Last December, the Inter-American Commission on Human Rights Office of the Special Rapporteur for Freedom of Expression published the report Freedom of Expression on the Internet.
The report, authored by Rapporteur Catalina Botero Marino, warned that copyright protection “cannot be pursued in a way that chills creativity or the free exchange of information on the Internet.” It specifically warns against intermediary liability, non-judicial processes of notice and termination, disconnection of users from the internet, and unreasonable penalties in cases of civil liability.
[World Health Organization] OVERVIEW: The paper provides information on the prices paid by 20 middle-income countries for adult and paediatric formulations of antiretroviral treatments recommended by WHO. It links this information with an analysis of the intellectual property situation of the selected medicines taking into account existing license agreements as well as compulsory licenses, and includes data and general information on a number of other determinants of prices and availability of ARVs, including tariffs, markups and taxes, as well as the regulatory status.
Dear Dr. Dybul, Dr. Chan, and Executive Directors of Proposed Convening Partners (UNITAID, UNICEF, World Bank, UNDP and GAVI):
Attached is a letter from 220 non-governmental organizations from around the globe opposing the proposed Blue-Ribbon Task Force to Develop a Global Framework on Tiered-Pricing. The letter address a third-draft concept note on this initiative dated March 18, 2014. In this letter, we urge the Global Fund and proposed partners to:
Joint media release by 10 Library and Archivist Associations | Download PDF
[Reposted from EIFL, Link CC-BY)] Discussions by the World Intellectual Property Organisation (WIPO) Standing Committee on Copyright & Related Rights (SCCR) broke down in the early hours of Saturday morning 3 May, after the European Union (EU) attempted to block future discussion of copyright laws to aid libraries and archives fulfill their missions in the digital environment.