James Love's blog
Despite very tough laws on the books in the US for counterfeiting, which include possible life sentences for some offenses, and the very aggressive federal PR campaign against counterfeit drugs, the US is not always that tough on the trade in counterfeit drugs. In this recent case, Curtis Henry was sentenced to three years probation.
MAY 18, 2012
Upstate New York man sentenced for importing counterfeit pharmaceuticals
Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: "Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease." A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html
KEI Statement on WHA resolution on Consultative Expert Working Group on Research and Development: Financing and CoordinationSubmitted by James Love on 26. May 2012 - 4:51
KEI Statement on World Health Assembly resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination
A number of developing countries worked together to push the World Health Assembly to create a member state process to consider the implementation of the CEWG. The most important CEWG recommendations are to begin work on a new WHO Convention on R&D financing, and to de-link R&D costs from drug prices.
Here is the resolution that was adopted.
Among the key parts of the 2 page resolution are the following:
1. WELCOMES the analysis of the CEWG report and expresses its appreciation to the Chair, Vice Chair and all the members of the Working Group for their work;
2. URGES Member States:2
(1) to hold national level consultations among all relevant stakeholders in order to discuss the CEWG report and other relevant analyses resulting in concrete proposals and actions;
Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and healthSubmitted by James Love on 25. May 2012 - 5:58
Open letter to those who collectively produced the May 23, 2012 statement to the WIPO SCP on the topics of patents and health (Copy of US statement available here: http://www.keionline.org/node/1416).
May 25, 2012
To each and everyone who worked on the SCP submission:
This letter outlines our concerns to the May 23, 2012 statement to the 18th Session of the World Intellectual Property Organization (WIPO) Standing Committee on the Law of Patents (SCP), on the agenda for patents and health.
In its opening, the USPTO said the following:
This is a brief note regarding the WHA negotiations on the proposed treaty for medical R&D, and in particular, the elements which deal with financing R&D. I'll skip the history and earlier context of the negotiations, and focus on the main issues in play this week.
On May 23, 2012, the World Health Assembly began discussion of Agenda Item 13.14, the report of the Consultative Expert Working Group (CEWG) on Research and Development Financing and Coordination.
The following is the statement read today by USPTO during a meeting of the WIPO Standing Committee on the Law of Patent, on the agenda item for patents and health. I'll provide more commentary later, but in general, this was seen an aggressive attack on a proposal for work by the Development Agenda Group (DAG), and on the notion that countries should grant compulsory licenses on patents to address concerns over access or affordability of drugs.
[Update: KEI wrote to USPTO about the submission: http://keionline.org/node/1420]
The USPTO statement follows:
The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.
BIO memo opposing transparency of drug development costs, sales, prices, and clinical trial outcomesSubmitted by James Love on 21. May 2012 - 6:49
Senator Sanders has offered an amendment to the Food and Drug Administration Safety and Innovation Act of 2012 that would require drug sponsors to disclose the costs of pre-clinical research, clinical trials and related R&D, as well as grants, economic incentives that subsidize drug development costs, and also report quarterly sales and revenues, register all clinical trials at www.clinicaltrials.gov, and report detailed descriptions of each clinical trial participant’s results.
This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:
- The proposal for a new extended monopoly for antibiotics and antifungal drugs is a "huge giveaway" that will lead to high prices and harm consumers.
Update: the hearing web page is here: http://www.help.senate.gov/hearings/hearing/?id=2d5dda75-5056-9502-5d1a-2a40d8a92d51
On May 15, 2012, the Primary Health and Aging Subcommittee of the Senate HELP Committee will hold hearings on S.1138, the Prize Fund for HIV/AIDS.
COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS
Primary Health and Aging Subcommittee
The WHO's Consultative Expert Working Group (CEWG) on R&D proposal for a new WHO Convention on health R&D has been widely praised by public health groups (See http://www.keionline.org/node/1399). The CEWG proposal for a treaty has also, at least so far, avoided much criticism from the pharmaceutical industry, even though it strongly embraces the notion of delinkage of R&D costs from product prices, open innovation, and technology transfer and capacity building in developing countries.
Senate HELP Committee proposes evaluation of Innovation Inducement Prizes, as alternative to product monopoliesSubmitted by James Love on 25. April 2012 - 2:48
In the United States Senate, the Committee on Health, Education, Labor and Pensions (HELP) is trying to move forward a bill titled the "Food and Drug Administration Safety and Innovation Act." Among other things, the bill would "amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, establish user-fee programs for generic drugs and biosimilars," and address a number of other topics, such as extend the legal monopoly on antibiotic drugs by 5 years.