Five Reasons the U.S. Should Not Review Its Dealings With South Africa
[Sean Flynn and Jonathan Band] On November 13, 2019, BusinessTech published an article listing the International Intellectual Property Alliance’s five primary concerns with the Copyright Amendment Bill awaiting President Ramaphosa’s signature. These concerns have led the U.S. Trade Representative to review the eligibility of South Africa for trade preferences. An examination of these five concerns reveals that they have no merit. Click here for more.
The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the Untied States?
[Simone A. Rose and Tracea Rice] Abstract: The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. Click here for more.
Access to Knowledge? WIPO Not Ready to Decide
[Electronic Information for Libraries] … During the SCCR/39 session, and at the International Conference, three core issues emerged from the discussions: 1) there was clear recognition that L&Es are intrinsic to a balanced copyright system; 2) there was wide acknowledgement that copyright laws in many countries are falling behind in the digital age, and 3) there was emerging consensus on the urgent need to support preservation and access to cultural heritage, a core public interest activity of libraries, archives and museums. Click here for more.
What Can We Learn from the Open Education Movement About Attaining Educational SDG in the Digital Age?
[Andressa Barp Seufert and Dominik Theis] The United Nations Sustainable Development Goal on Quality Education (SDG 4), aims to “ensure inclusive and quality education for all and promote lifelong learning”. The open movement is trying to break down the social, political, and technical barriers preventing people from accessing and contributing to education and free knowledge. Open Educational Resources can be an instrument to bridge knowledge gaps and promote educational equity as well as to contribute to the achievement of the SDG 4. Click here for more.
The Importance of Intellectual Property (IP) Law When It Comes to Access to Medicines, Particularly in South Africa, Cannot Be Overstated.
[Zukiswa Pikoli] … There is a growing urgency for South Africa to revise its intellectual property framework in order to ensure that those seeking to access healthcare (particularly in the public health system) are not denied lifesaving medication… While it is true that patents drive innovation in medications, in South Africa our liberal patent laws lead to the excessive granting of licences, further fuelling big pharmaceutical monopolies. Click here for more on the Daily Maverick.
Safeguarding User Freedoms in Implementing Article 17 of the Copyright in the Digital Single Market Directive
[Sign on document circulated by IViR, University of Amsterdam] On 17 May 2019 the new Directive (EU) 2019/790 on copyright and related rights in the Digital Single Market was officially published (DSM Directive). Article 17 (ex-Article 13) is one of its most controversial provisions. Article 17(10) tasks the Commission with organising stakeholder dialogues to ensure uniform application of the obligation of cooperation between online content-sharing service providers (OCSSPs) and rightholders, and to establish best practices with regard to appropriate industry standards of professional diligence. This document offers recommendations on user freedoms and safeguards included in Article 17 of the DSM Directive – namely in its paragraphs (7) and (9) – and should be read in the context of the stakeholder dialogue mentioned in paragraph (10). Click here for more.
