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  1. Legal news
    02 July 2019
    Transfer of value: amendments to the French “anti-gift” provisions by the draft Health Act
    www.twobirds.com/en/news/articles/2019/global/transfer-of-value-amendments-to-the-french-anti-gift-provisions-by-the-draft-health-act

    The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”)

  2. Legal news
    08 May 2019
    Patents: obviousness in relation to patent for dosage regime
    www.twobirds.com/en/news/articles/2019/global/patents-obviousness-in-relation-to-patent-for-dosage-regime

    The Supreme Court has confirmed that a patent for a dosage regime of a drug used to treat erectile dysfunction (ED) was obvious over the prior art.

  3. Legal news
    03 September 2019
    China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
    www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

    On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

  4. Legal news
    04 September 2019
    Patents: meaning of enablement in anticipation by prior art
    www.twobirds.com/en/news/articles/2019/global/patents-meaning-of-enablement-in-anticipation-by-prior-art

    The Patents Court has considered enablement in relation to anticipation of a claimed monoclonal antibody invention by prior art, and held the patent was invalid for lack of novelty; it was also obvious for lack of ...

  5. Legal news
    06 September 2019
    China passed new amendments to the Drug Administration Law
    www.twobirds.com/en/news/articles/2019/global/china-passed-new-amendments-to-the-drug-administration-law

    On 26 August 2019, China's National People's Congress passed the final amendments to the Drug Administration Law ("DAL"), which will take effect on 1 December 2019. The DAL was first enacted in 1984, then substantively ...

  6. Legal news
    11 July 2019
    French healthcare system reform: The final steps of the legislative process are expected soon
    www.twobirds.com/en/news/articles/2019/france/french-healthcare-system-reform-the-final-steps-of-the-legislative-process-are-expected-soon

    The Bill of the Law on the organization and transformation of the French healthcare system at the French parliament, adoption of the final version is expected for the end of July.

  7. Legal news
    02 December 2019
    The French Health Data Hub becomes reality
    www.twobirds.com/en/news/articles/2019/france/the-french-health-data-hub-becomes-reality

    The French Health Data Hub was born officially with the publication on 30 November 2019 of a ministerial decision (arrêté).

  8. Legal news
    18 March 2019
    French Legal Framework for the exchange of health data by secured health messaging systems
    www.twobirds.com/en/news/articles/2019/france/french-legal-framework-for-the-exchange-of-health-data-by-secured-health-messaging-systems

    Before the entry into force of the GDPR on May 25th 2018, healthcare professionals and facilities and professionals in medico-social sectors empowered by law in France had to comply with the provisions stated in the ...