• Regulatory NewsRegulatory News

    Pharma groups slam US decision to support COVID-19 vaccine patent waivers

    Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines, charging that the waiver is a bad idea that would compromise vaccine efficacy and safety. Their views clash with World Health Organization’s (WHO) arguments and other groups that the waiver is necessary to increase access to th...
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    WTO Makes Permanent a Way to Help Poor Countries Gain Access to Generics via Compulsory Licenses

    The World Trade Organization (WTO) on Monday officially amended its Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow developing countries facing public health problems and lacking the capacity to produce generic drugs the ability to obtain such medicines from third country producers under "compulsory licensing" arrangements.  The amendment, which is the first since TRIPS was created in 1995, provides a permanent legal basis for both poten...
  • Feature ArticlesFeature Articles

    Drug Development in Asia: Scattering the Mist

    This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape. Introduction Asia is a huge landmass with contrasting physical and human geographies. The economic panorama within this rich milieu of human geography has become one of Asia's most prominent features, and many major pharmaceutical companies are acquainting themselves with the unique regulatory and medical landscape ...
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    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 ...
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    US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

    Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides. Background Since the initial WTO agreement on Trade-Related Aspects of IPRs (TRIPs) in 1995, least-developed countries (LDCs) have been granted exemptions from implementing intellectual property (IP) rules for pharmaceut...
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    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...
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    European Commission Says Compulsory Licensing can Only Happen at National Level

    After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license. Background In the past two years, drugmakers have launched several drugs to treat hepatitis C (HCV), a disease which left untreated can lead to cirrhosis or liver cancer. The new generation of HCV treatments, led by Gilead's Sovaldi and Harvoni, are highly eff...
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    US, Switzerland Campaign to End 20-Year Moratorium on Non-Violation Complaints to WTO

    At the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting last week, the US and Switzerland called on the Council to end a 20-year moratorium on what are called "non-violation complaints," LiveMint reports. While non-violation complaints were rare even before the moratorium, they could provide a way for countries to challenge controversial intellectual property provisions such as Section 3(d) of India's Patents Act . Background Non-v...
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    Trade Group Wants to See Stricter Limits on Compulsory Licensing

    A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015 , the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need. What is a Compulsory License? Compulsory licensing (CL) is a legal provisi...