These are the notes from my intervention today at the UN’s High Level Meeting on HIV/AIDS in New York. The persons making statements from the floor were asked to keep their comments to two minutes, so the actual intervention was somewhat shorter. Jamie
NYC, 7 PM Wed, June 8, 2011.
This is a report from the FDA on 2011 new molecular entities (NMEs) approvals, through June 6, 2011. The total number of FDA approvals during that same period was 150. So far, 16 NMEs have been approved in five months, a sharp increase in approvals over the same period 2010.
6 NMEs NDAs were considered priorities
8 NDAs that were considered standard approvals
2 BLA (biologic products) that were not classified.
On Wednesday, 25 May 2011, the 129th session of the World Health Organization’s Executive Board approved Decision, EB129(8) on “WHO reform for a healthy future”. Reproduced below is the text of the Decision which is yet to be published on the WHO website in all 6 UN languages.
EB129(8) WHO reform for a healthy futureThe Executive Board,
Karl De Gucht writes Andris Piebalgs on topic of European Union IPR demands on India and other developing countries
KEI has received a copy of a May 16, 2011 letter from Karl De Gucht to Andris Piebalgs, which discusses (1) the EU-India FTA, and (2) Relations between IPR and development policies. Continue Reading
Senator Sanders introduces two medical innovation prize bills in U.S. Senate to de-link R&D costs from drug prices
On Thursday, May 26, 2011, Senator Bernie Sanders (I-VT) introduced two bills in the United States Senate that would de-link R&D costs from drug prices. The bill names and numbers are as follows:
KEI Technical Meeting to Discuss Innovation Inducement Prizes, June 3, 2011
There is a growing interest in the use of innovation inducement prizes to stimulate investments in medical research and development.
- The Obama Administration and the European Commission are exploring the role of innovation inducement prizes.
- On May 31, 2011, the European Parliament is holding one of several meetings on innovation inducement prizes for medical technologies.
Draft WHO Executive Board resolution on WHO reform
At 18:30 Geneva time on 25 May 2011, during the 129th session of the WHO Executive Board, the EB is considering the following draft decision on WHO reform.
Chair’s text, based on draft proposed by EcuadorThe 29th [sic] Executive Board,
(OP.1) DECIDES to establish an incremental, transparent, Member-State driven and inclusive consultative process comprising of the following elements:
Letter to the 129th WHO Executive Board on conflicts of interest, WHO reform and the future of financing
24 May 2011
NGO letter on Conflicts of Interest, Future Financing, Reform and governance of the WHO.
Dear Members of the Executive Board,
SCP 16: Summary by the Chair
WIPO
World Intellectual Property OrganizationSCP/16/8 PROV.
ORIGINAL: ENGLISH
DATE: MAY 20, 2011Standing Committee on the Law of Patents
Sixteenth Session
Geneva, May 16 to 20, 2011SUMMARY BY THE CHAIR
Agenda Item 1: Opening of the session
1. The sixteenth of the Standing Committee on the Law of Patents (SCP) was opened by Mr. James Pooley, Deputy Director General, who welcomed the participants. Mr. Philippe Baechtold (WIPO) acted as Secretary.
Continue Reading