Since the early ‘70s, European countries have adopted a comprehensive legal framework on personal data protection that aims to balance the free flow of information for market purposes with an adequate level of protection for the right of privacy. Continue Reading
Beginning in 1985, the United States government (USG) diplomatic and trade officials have engaged in wide ranging activities aimed at changing global norms for the protection of intellectual property rights, with a particular emphasis on the IPR protections for pharmaceutical products.
This note reports on U.S. Department of State cables sent in 1986 and 1987, that discussed the U.S. government efforts to change policies in Brazil on the intellectual property protection for pharmaceutical products. The cables have been obtained by KEI with a FOIA request.
USTR will host the next round of ACTA negotiations that will take place all of next week, August 16-20, in Washington DC. According to USTR yesterday, the negotiators “expect to cover all issues” and the agenda would be made available in a day or so.
Here is a proposed agenda that we have obtained from another source.
ANTI-COUNTERFEITING TRADE AGREEMENT (ACTA)
PROPOSED AGENDA
10th Round of Negotiations
August 16th-20th, 2010, Washington, DCACTA’s Washington DC conclave: Is this Round 10?
According to an informed source, USTR intimated that next week’s ACTA meeting in Washington DC will be attended by all the negotiating parties and that discussions would include all issues under consideration in ACTA. We are still awaiting a response from USTR regarding the attendees, scope and purpose of the meeting but this new information seems to be indicative of nothing short of the next ACTA round.
Earlier, US government officials had informed that the an intersessional meeting would be held the week of 16 August in Washington DC.
Continue ReadingWHO releases names of experts and advisor to the Emergency Committee concerning Influenza Pandemic (H1N1) 2009
WHO has released the ‘List of Members of, and Advisor to, the International Health Regulations (2005) Emergency Committee concerning Influenza Pandemic (H1N1) 2009‘ at the following site: http://www.who.int/ihr/emerg_comm_members_2009/en/. Of the 15 members and one advisor, 6 had declaration of interests. On this matter, WHO had the following statement:
Letter to President of Mexico regarding ACTA
The following is an August 10, 2010 letter written by Alberto Cerda Silva, a Research Associate of Knowledge Ecology International, to Felipe Calderón Hinojosa, Presidente Constitucional de los Estados Unidos Mexicanos, regarding the position of the Mexican government in the ACTA negotiations.
The US Orphan Drug Tax Credit
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
Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)
(Cite as Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs), KEI Research Note 2010:3) A PDF version of this document is available here. Notes on the 2004… Continue Reading
Notes and data points for prices of orphan products
February 22, 2010., Matthew Herper, “The World’s Most Expensive Drugs,” Forbes. Genzyme’s web page on the cost of treatment. Some data points on Fabrazyme prices. 2004 prices for Replagal 2001 prices for Cerezyme. Myozyme/Lumizyme A 2007 Canadian analysis of (50… Continue Reading
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures
Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures, On the topic of Direct funding, subsidies and incentives for the development… Continue Reading