From the FDA page on the Orphan Drug Tax Credit. Incentives TAX CREDIT (See Footnote 1 below) FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR CONDITIONS Introduction Section 45C of the Internal Revenue Code of 1954 allows a credit… Continue Reading
From the FDA page on the Orphan Drug Tax Credit.
IncentivesTAX CREDIT
(See Footnote 1 below)
FOR TESTING EXPENSES FOR
DRUGS FOR RARE DISEASES OR CONDITIONSIntroduction
Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.2010 Fabrazyme March-In Request
NIH rejects Fabrazyme March-In Petition
- December 7, 2010. Press release from Fabry patients: DHHS denies patient’s march-in request to end Genzyme’s rationing of treatment for Fabry Disease citing that FDA rules block manufactures from supplying the drug in a timely manner.
- December 7, 2010. Statements by KEI and others on NIH rejection of Fabrazyme March-In Request
1 ACTA briefing by De Gucht in the European Parliament
This week, the European Commission conducted two briefings for members of the European Parliament.
On Monday, July 12, members of the European Parliament’s INTA Committee (Committee on International Trade) were briefed by EU ACTA negotiators Luc Devigne and Pedro Valesco in a private, closed meeting.
Today, July 13, Karel De Gucht, EU Commissioner for Trade held a public briefing in the LIBE Committee (Committee on Civil Liberties, Justice and Home Affairs). The video is now available here
China describes TRIPS Council proposal on ACTA and other plurilateral enforcement agreements.
At a June 28, 2010 Geneva workshop on the Anti-Counterfeiting Trade Agreement. Dr. Zhao Hong, from the Permanent Mission of the People’s Republic of China to the World Trade Organization, distributed a proposal that was prepared for the June 8-9, 2010 meeting of the WTO TRIPS Council:
Decisions to be takenDecision of the TRIPS Council on the Relationship between the TRIPS Agreement and Intellectual Property Provisions of bilateral, plurilteral Trade Agreeements
Members,
4 The EU proposal for increasing access?
The EU position came out in a proposal for a Joint Recommendation with 9 articles in 11 pages. It is hard to believe but it is worst than the US proposal and it is even worst than nothing. It is an outrageous “roll back” recommendation. It does make clear who’s the boss in the commission. The publishers apparently. Their proposal is bold. Here’s a quick read:
1 How Much Time is Necessary to Negotiate the Text of a Multilateral Agreement on Intellectual Property?
There is a negotiation in the WIPO SCCR over the work program on copyright limitations and exceptions for persons with disabilities. Some countries favor a negotiation on a binding treaty. The US government is asking that the SCCR set aside work on the treaty, and focus instead on a non-binding recommendation to address a limited set of issues relating to the import and export of works created under an exception. The US government asserts that treaties would take a very long time to negotiate, ratify and implement. Continue Reading
Anne Marie Worning appointed as new acting head of WHO’s team on public health, innovation and intellectual property
On 4 June 2010, Dr. Margaret Chan (Director General, World Health Organization) announced Dr. Anne Marie Worning as ‘acting Director, Public Health, Innovation and Intellectual Property (PHI)’. According to the WHO website,
Dr Anne Marie Worning, a Danish national, is the Executive Director of the Director-General’s Office since April 2009.
WIPO SCCR: US Proposal for a Consensus Instrument for persons with print disabilities
Today, 27 May 2010, during the WIPO Open-ended Consultations on Copyright Limitations and Exceptions for Persons with Print Disabilities and on the Protection of Audiovisual Performances, the government of the United States of America distributed a draft proposal to WIPO Member States for a Consensus Instrument for persons with print disabilities.
The US proposal is available in pdf format here, in doc format here, and copied below.The Health Impact Fund Proposal
26 September 2011, Sakiko Fukuda-Parr and Proochista Ariana, Health Impact Fund – Raising Issues Of Distribution, IP Rights And Alliances, IP-Watch. Thomas Pogge and Jake Hirsch-Allen published a response on October 3, 2011.
Selected KEI Blogs on the Health Impact Fund
2008 blogs