Innovation

Dec 9, 2009 Wikileaks documents related to the WHO EWG

On December 9, 2009, Wikileaks posted five sensitive documents related to the WHO Expert Working Group (EWG) on R&D Financing:

  • a non-public draft report of the WHO EWG
  • a non-public Comparative Analysis done by the EWG
  • the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Overview of the EWG Comparative Analysis
  • an IFPMA summary slide on the EWG Draft Report
  • The Bayh-Dole Act of 1980

    The Bayh-Dole Act (or University and Small Business Patent Procedures Act) is a U.S. law that allows for the transfer of exclusive control over many U.S. government funded inventions to universities, non-profit and businesses operating with federal contracts for the purpose of further development and commercialization. The contracting universities, non-profits and businesses are then permitted to exclusively license the inventions to other parties.

    WHO at a crossroads on a mandate for an R&D Treaty

    21 May 2009

    Today at the World Health Assembly (WHA) the US and EU are opposing that the WHO have a mandate on global research and development norms, including the possibility for Member States to negotiate at WHO a global biomedical R&D treaty.

    Developing countries governments made very strong interventions this morning on this issue (among them India, Bolivia, Barbados, Suriname, Bangladesh, Ghana, Argentina, Venezuela, Nicaragua, Ecuador, Cuba and Jamaica) and are wondering where are the promises of multilateralism made by the new Obama administration.

    WHA: Draft resolution to finish Plan of Action on Public Health, Innovation and Intellectual Property

    This morning a draft Resolution proposed by the Delegations of Canada, Chile, Iran (Islamic Republic), Japan, Libyan Arab Jamahiriya, Norway and Switzerland was distributed to the 62nd WHA as document A62/A/Conf.Paper No.4

    If approved in its current form, the resolution will conclude the Plan of Action with the stakeholders, time frames and progress indicators proposed by the documents distributed by the WHO PHI secretariat this week.

    WHA: Civil Society letter to WHO Member States

    May 18, 2009

    Open Letter to WHO Member States on outstanding components of Plan of Action on Public Health, Innovation and Intellectual Property

    Dear WHO Member States,

    During the 2008 World Heath Assembly WHO Member States reached unanimous consensus on resolution WHA 61.21 that adopted a Global Strategy and unfinished Plan of Action on Public Health, Innovation and Intellectual property.

    Novartis games the FDA Priority Review Voucher

    On April 8, 2009, the FDA announced it had awarded Novartis a one-time priority review voucher (PRV) to use towards a future new drug application, for Coartem, a malaria drug. While the PRV was designed as an incentive to develop new drugs, Coartem was developed and put on the market outside the United States years before the PRV legislation was proposed.

    $2 billion and $147 billion: WHO releases detailed costing estimates for implementing WHO IGWG plan of action

    On 21 January 2009, WHO released a document (EB124/16 Add.2) relating to the global strategy and plan of action of the public health, innovation and intellectual strand of its work entitled “Proposed time frames and estimated funding needs“. This document is a costing exercise to “estimate funding needs for the implementation of the plan”.

    HIF proposes $600 million annual budget to evaluate health impacts

    One feature of the HIF that is raising eyebrows is their proposal to
    spend $600 million *per year* on assessing health impacts. This is
    apparently more than an order of magnitude greater than the entire
    budget of NICE. The reference to the $600 million from the HIF book
    follows:

    Aidan Hollis and Thomas Pogge, The Health Impact Fund, Making New
    Medicines Accessible for All, A Report of Incentives for Global Health,
    2008

    Page 30-32

    THE COST OF HEALTH IMPACT ASSESSMENT

    Trade-off between access and incentives

    This is a comment on the references to compulsory licensing in the Hollis/Pogge HIF book that are quoted below.

    http://www.keionline.org/blogs/2008/11/18/excerpts-from-hif-compulsory-licensing/
    Aidan Hollis and Thomas Pogge, The Health Impact Fund, Making New Medicines Accessible for All, A Report of Incentives for Global Health, 2008.

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