In calendar year 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This is a large number of approvals.
Attached here is a KEI submission to the US ITC for the January hearing of the
UNITED STATES INTERNATIONAL TRADE COMMISSION
Investigation No. TPA-105-001
Trans-Pacific Partnership Agreement: Likely Impact on the U.S. Economy and on Specific Industry Sectors
Our earlier, related testimony on trade agreements was here: http://keionline.org/node/2370
Under the UK's Pharmaceutical Price Regulation Scheme (PPRS), drug companies will make rebates of about £550 million in 2016, according to this story.
SAVE THE DATE - 16 December 2015 - KEI breakout session on A WTO Agreement on the Supply of Social GoodsSubmitted by thiru on 15. December 2015 - 6:45
On Wednesday, 16 December 2015, at the Fourth Global Congress on Intellectual Property and the Public Interest (National Law University, Delhi, India), Knowledge Ecology International (KEI) will convene a breakout session (led by Jamie Love, Director, KEI) on a WTO Agreement on the Supply of Social Goods.
MICHELE WOODS: Standing Committee on Copyright and Related Rights, 31st session, Geneva, December 7 to 11, 2015. Summary by the Chair.
Agenda item 1. Opening of the session. The 31st session of the Standing Committee on Copyright and Related Rights SCCR or Committee was opened by Mr. Francis Gurry, Director General who welcomed the participants and opened agenda item 2.
Ms. Michele Woods, WIPO, acted as secretary.
The Chair proposed an intersessional on broadcasting and regional meetings regarding Libraries and Archives. This was supported by Asia, Grulac and Africa (but Africa wanted to include education and research institution) and rejected by Group B. The decision will be made at the next SCCR, SCCR 32 possibly May 9-13 2016.
Day 5 of SCCR 31, December 11, 2015
We welcome the proposal tabled by Senegal and the Congo to include the droit de suite, the artist resale right, in this Committee’s agenda for future work.
I would like to refer to the Directive mentioned by the Commission, Directive 2001/84/EC which came into force on 1 January 2006:
SCCR 31 KEI Statement on the GRULAC Proposal for Analysis of Copyright Related to the Digital EnvironmentSubmitted by Manon Ress on 11. December 2015 - 9:16
SCCR 31 Day 5, December 11, 2015
Topic 3 is Legal Deposit.
KEI ‘s question is the following: should these designated deposit systems --national archives or libraries-- be mandated or encouraged as I believe it is described in the US principles)?
We're not even sure this is a copyright issue and to what extent this is essential for libraries.
However, as the IFLA Statement underlined, Legal deposit was the original limitation on copyright, embedded in the Statute of Anne and we believe it could be discussed in the form of a model law intended to ensure the preservation of works at a national level.
Statement of SAA Representative to WIPO Standing Committee on Copyright and Related Rights 31 December 2015 by
William J. Maher (w-maher at illinois.edu)
TOPIC TWO: Reproduction and Safeguarding Copies
SAVE THE DATE - 16 December 2015 - KEI workshop on a WTO Declaration on the TRIPS Agreement and the copyright 3-step testSubmitted by thiru on 10. December 2015 - 9:30
On Wednesday, 16 December 2015, at the Fourth Global Congress on Intellectual Property and the Public Interest (National Law University, Delhi, India), Knowledge Ecology International (KEI) will convene a workshop entitled a "WTO Declaration on the TRIPS Agreement and the Three-Step Test for Copyright and Related Rights."
IFLA represented by Winston Tabb
Knowledge Ecology International (KEI) is and has been supportive of the Committee's work on access and preservation of knowledge which is important for everyone and every country.
Preservation and safeguarding copies of works is to some degree a global public good. We all want and need works to be preserved, and copyright and reproduction rights coupled with limitations and exceptions are essential.
On Thursday, 10 December 2015 South Africa made the following general intervention on copyright limitations and exceptions at WIPO's 31st session of the Standing Committee on Copyright Right and Related Rights (SCCR).