Andrew Goldman's blog

WHA 69: Colombian Minister of Health Calls on WHO to Support the Regulation of Drug Monopolies

(More on Colombia here:

On May 24, 2016, Colombia's Minister of Health, Alejandro Gaviria, made an intervention at the World Health Assembly that referred to the pressure Colombia has been facing with regard to the potential compulsory license for imatinib and called for the WHO to support members to ensure sustainable development through the regulation of pharmaceutical monopolies and promoting competition, transparency, and the rational use of drugs.

KEI Comments to DHHS on WHA 69 re CEWG, Nocommunicable Diseases

Today the Department of Health and Human Services held their annual WHA listening session. This year HHS sent an email the day prior announcing that the usual 3 minute allotment would be cut in half to 90 seconds. This decision caused several NGOs to not attend.

Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi

KEI submitted the attached letter to Secretary Burwell and Director Collins in support of the KEI/UACT petition that asked the NIH (or the Army) to use the federal government rights in the patents on the prostate cancer drug Xtandi, to remedy the excessive and discriminatory price in the United States. The letter calls attention to findings of an article from the the Journal of Oncology Pharmacy Practice, in which the authors conclude that a reduction in price would make Xtandi the most-cost effective option.

The text of the letter follows:

KEI Comments to U.S. Copyright Office on Section 1201

On March 3, 2016, KEI filed a comment with the U.S. Copyright Office in Docket No. 2015-8, regarding 17 U.S.C. § 1201.

The comment made specific recommendations regarding changes to the rulemaking procedure, the anti-trafficking provisions, and permanent exemptions, and also suggested requiring a registration and application process, as well as payment of a fee, for the DRM/TPM seeking legal protection under the law.

Colombia Technical Committee Recommends Declaration that a Compulsory License on Imatinib (Gleevec) Would Be in Public Interest

(More on Colombia here:

In Colombia, a technical committee has issued a recommendation that a declaration be made that a compulsory license on imatinib (Gleevec) would be in the public interest. Under Colombian law, this is an important intermediary step prior to the actual grant of a compulsory license.

Industry USTR filings refer to Indian Government agreement to block compulsory licenses

The dearth of recent compulsory licenses out of India has led to speculation that the Government has made an agreement not to issue such licenses.

On reviewing submissions for the Office of the United States Trade Representative's upcoming 2016 Special 301 Review, several industry documents confirm that such an agreement exists.

The submission by the United States Chamber of Commerce's Global Intellectual Property Center states:

Rep. Eshoo (D-CA) Sends Letter to USTR Requesting Clarification Regarding Conflicts in TPP Language on Damages and BPCIA, ISDS

On Tuesday October 20, 2015, Representative Anna Eshoo (D-CA), one of the principal authors of the Biologic Price Competition and Innovation Act (BPCIA), sent a letter to the United States Trade Representative requesting timely clarification regarding the Trans-Pacific Partnership's impact "on existing U.S. laws that limit damages for infringement of intellectual property (IP) rights, and on the potential ISDS ramifications for those conflicts."

Seven Members of House of Representatives Send Letter to USTR Calling For Waiver of WTO Patent Rules for LDCs

October 2, 2015
CONTACT: Zack Struver
+1 (202) 332-2670

Seven House Members Push U.S. Trade Representative to Support Indefinite Waiver on Pharmaceutical Patents for Least Developed Countries (LDCs)

Bucharest: KEI Europe Hosts Side Event on Access to Affordable HCV Medicines Saturday 30 May 10:00

For any of you in Bucharest this weekend at the EASL conference on liver disease, KEI Europe will host a side event on access to affordable HCV medicines on Saturday morning.

Pathways to Widespread Access: Affordable HCV Medicines in Romania
Date: 10:00-12:00 Saturday, 30 May 2015
Venue: Novotel Bucharest City Centre, Conference Room Lyon (Mezzanine Floor)

A Panel Discussion:

Peter Beyer, World Health Organization (WHO). Access to Medicines and Intellectual Property Rights

California AB 463 (Pharmacetical Cost Transparency Act of 2015) Held Over as Two-Year Bill

Yesterday, under intense pressure from the powerful pharmaceutical industry lobby, California Assembly Member Dan Chiu withheld bill AB 463, the Pharmaceutical Cost Transparency Act of 2015. A vote on the bill had already been postponed for a week in order to allow Assembly Member Chiu more time to address various concerns raised by colleagues in the Health Committee.

Public Citizen, National Physicians Alliance, Other Civil Society Groups Write Letters in Support of California AB 463

In addition to the numerous groups and institutions that stood in support of AB 463 (Pharmaceutical Cost Transparency Act of 2015) at the California Assembly Health Committee hearing on April 21st, six civil society groups that we are aware of have submitted letters or statements in support of the bill.

In alphabetical order, these include:

1. American Medical Students Association (AMSA)
2. National Council of Asian Pacific Islander Physicians (NCAPIP)
3. National Physicians Alliance (NPA)
4. Public Citizen
5. Universities Allied for Essential Medicines (UAEM)

KEI Notes on California Assembly Health Committee Markup on AB 463 Pharmaceutical Cost Transparency Act of 2015

Yesterday (April 21,2015) the California Assembly held a Health Committee hearing to discuss various bills being offered, including Assembly Member Dan Chiu's AB 463, titled the Pharmaceutical Cost Transparency Act of 2015.

AB 463 calls for the pharmaceutical industry to annually report its costs for developing and manufacturing a drug (for any course of treatment over $10k). The bill seeks to provide audited information on R&D costs, a topic for which the industry often makes unsupported and exaggerated claims.

KEI comments at February 24, 2015 USTR Special 301 Hearing

On February 24, 2015, the USTR convened the Special 301 Review, taking testimony almost exclusively from witnesses representing large corporate rights holders. Over the course of the three-and-a-half hour hearing, groups such as Phrma, NAM, IPO, and the misleadingly-named Alliance for Fair Trade with India (an alliance comprised of groups such as Phrma, NAM, MPAA and many other similar groups) as well as foreign-owned multinational Bridgestone, pushed for the watch-listing of countries that fail to implement TRIPS+ measures.

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