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  • Regulatory NewsRegulatory News

    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
  • Regulatory NewsRegulatory News

    EC Calls for Indefinite Exemption from Pharma IP Rules for Least-Developed Countries

    The European Commission on Thursday agreed to support a proposal that would allow the least-developed countries (LDCs) to have easier access to generic drugs via an indefinite exemption from World Trade Organization (WTO) intellectual property rules for pharmaceuticals. The exemption, which must also be approved by the European Council, would allow generic drugs to be imported and manufactured locally, regardless of patents. More simply, the proposal means that manufactu...
  • Feature ArticlesFeature Articles

    Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in Developing Countries

    This article discusses how the regulatory profession in developing countries can benefit from global regulatory harmonization. Advances in science and technology in the global healthcare industry continue to impact millions of people by providing them—often for the first time—with medication necessary to prevent early death, serious illnesses or irreversible disabilities. Scientific discoveries of new therapies and inventions, particularly in drug delivery (e.g., ...
  • PLoS: Pressures on Doha Declaration Signatories Preventing Overuse of Compulsory Licenses

    • 12 January 2012
    A recent study in the Public Library of Science's (PLoS) Medicine journal provides a review of the Doha Declaration , and finds that the issuance of compulsory licenses (CLs) dropped significantly after 2006, and that upper-middle-income countries (UMICs) face barriers to utilizing CL's excessively. Compulsory licenses are used by countries to override patents when the country deems that a health crisis warrants such action. When the Doha Declaration was first sig...