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  • Regulatory NewsRegulatory News

    BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries

    Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection. Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s he...
  • Regulatory NewsRegulatory News

    Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

    Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access. Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus. Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepati...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday, with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. The call for more compulsory license...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Looks to Protect Clinical Data Integrity (5 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Introduces Draft Clinical Trial Data Verification Procedures The China Food and Drug Administration (CFDA) has released a provisional document regarding the validation of clinical trial data. Under the model, CFDA’s audit team will conduct on-site assessments of the records kept by clinical trials to verify the authenticity and integrity of data purporting to show the ...
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    Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

    An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports. Background Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent. The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available a...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

    • 03 May 2013
    India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...
  • India's Top Regulator Prepares for a Future Without Branded Medicines

    • 16 October 2012
    The Times of India reports that India's top regulatory official, the drug controller general of India, Dr. G N Singh, eventually wishes to do away with branded or patented medicines in favor of a generics-only system he says will benefit the public before all others. "We want to gradually move towards a future where we will not issue any brand or trade names," The Times reported Singh as saying. "Gradually" may come faster than some pharmaceutical companies may ...
  • Landmark Ruling Clears Way for Use of Compulsory License in India

    In a decision upholding a landmark ruling, India's Intellectual Property Appellate Board (IPAB) has upheld a compulsory license granted by the controller of patents earlier in 2012, clearing the way for generics manufacturers to introduce low-cost versions of German pharmaceutical manufacturer Bayer's cancer drug Nexavar (sorafenib). At issue for Bayer was the country's use of the compulsory license-a concept first established under the Trade-Related Aspects of Intelle...