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  • 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...
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    Asia Regulatory Roundup: AHWP to Harmonize Device Submissions in Asia (10 November 2015)

    AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...
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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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    WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

    The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week. To coincide with the review, the WTO Secretariat has released a report on India's trade and related policies, which highlights areas of many areas of progress, while noting some areas of concern related to India's policies on drug patents. Background The WTO routinely reviews its members' trade-related policies in order to track developments that may affect global ...
  • Reaffirming Earlier Ruling, WTO Orders Obama Administration to Drop Flavored Cigarette Ban

    The World Trade Organization, a powerful global body focused on facilitating trade and acting as an intermediary in disputes, ruled the Obama Administration must overturn legislation banning flavored cigarettes. The legislation was originally enacted in 2009 in a bipartisan move aimed at stemming the uptake of cigarette habits amongst children. WTO's 4 April 2012 ruling claims the law is discriminatory as a result of the law specifically exempting menthol cigarettes to ...