Episoder
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Nick Beckett talks with Lifesciences Asia-Pacific Network (LAN) members, Alan Adcock of Tilleke & Gibbins in Thailand, Chie Kasahara of Atsumi & Sakai in Japan and Ki Young Kim of Yulchon LLC in Korea.
In this episode, we discuss:
a fragmented situation in APAC in terms of government policy and support for digital health initiativesa lack of a clear definition of “digital health” in most jurisdictions, and a mixed regulatory environment, with a need to update the laws in many jurisdictionshow to deal with privacy concerns with the use of personal data with digital health technologieshow to protect the intellectual property associated with digital health innovationdevelopments in telemedicine in the APAC region and support for remote care and online consultations -
Nick Beckett talks with Jonathan Chu (CMS Hong Kong), Sheena Jacob (CMS Singapore) and Thomas Hirse (CMS Germany).
In this episode, we discuss:
the rationale for compulsory licences and the requirements for granting the samethe rights of patent owners faced with the threat of compulsory licences any requirement for patent owners to also provide know-how and technical support under a compulsory licencelimitations on exploitation under compulsory licences, including labelling requirements and distribution channel restrictionsthe use of compulsory licences to deal with the supply of medical necessities during COVID-19the debate regarding the need for COVID-19 vaccine patent waivers -
Manglende episoder?
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Nick Beckett speaks with Virginie Dor (CMS Belgium), Bernt Elsner (CMS Austria) and Caroline Hobson (CMS UK).
In this episode, we discuss:
the importance of public procurement in the Healthcare sector, representing approximately 10% of GDP in the E.U.the challenges for public procurement in extreme and unforeseen emergencies, including COVID-19the scrutiny of direct awards and potential legal challenges and sanctionsthe joint centralised procurement of vaccines in short timeframes and the benefits and pitfalls of such approachin what circumstances exclusivity, including due to IP rights or technical barriers, can justify derogation from public procurement procedureswhat changes do U.K. companies face in public procurement procedures in the E.U., and vice versa, in light of Brexit -
Nick Beckett discusses telemedicine with Maria González Gordon (CMS Spain), Reemt Matthiesen (CMS Germany) and Valentina Parvu (CMS Romania). In this episode, we discuss:
the significant growth and market opportunities that telemedicine and digital health apps presenthow barriers to the take-up of telemedicine have been broken down during COVID-19exceptional permitted uses of telemedicine in cases of emergency such as pandemicsfragmented regulation of telemedicine and digital health apps in different jurisdictions, with the advent of specific regulation in some jurisdictionsrestrictions on the advertising of telemedicine and remote treatmentshow patient data is protected and confidentiality preserved in use in telemedicine -
Nick Beckett discusses with Laurent Romano (CMS France), Sarah Hanson (CMS UK/Singapore) and Roland Wiring (CMS Germany) commercial collaborations.
In this episode, we discuss:
are old contracting models dead?sophisticated new forms of collaboration emerginga service oriented digital approach – beyond the pill?win-win collaborations with start-upstrends to in-souring in certain critical areasthe development of Centres of Excellence and opportunities for public-private partnerships and consortium -
Nick Beckett talks with Alaina Wadsworth (CMS UK), David Bridge (CMS UK) and Laura Opilio (CMS Italy) on product liability and medical malpractice. In this episode, we discuss:
international perspectives on product liability riskthe liability of Health Care Professionals (HCPs) “playing out of position” during COVID-19the risks for non-Life Sciences manufacturers entering the Life Sciences spacethe “search for a scape goat” – an easy hunting expedition?a double track system in Italy and comparative perspectivespractical advice to companies to minimise riskoff-label use and relevant considerationsLearn more about CMS at cms.law or subscribe to further Life Sciences & Healthcare news and updates at CMS Law-Now.
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Nick Beckett continues to discuss digital health with Rob Flaws (CMS Dubai), Niall McAlister (CMS UK) and Roland Wiring (CMS Germany).
In this second instalment, the team focuses on:
an increasing demand for digital health and increase in tele-consultations and use of chatbotsthe digitalisation of healthcare recordsthe approach of Big Tech and their provision of advanced technical solutionsdata privacy requirements regarding the use of immense data reserves in the provision of digital health servicesthe need to incorporate human insight and oversight into AI system processesLearn more about CMS at cms.law or subscribe to further Life Sciences & Healthcare news and updates at CMS Law-Now.
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Nick Beckett discusses digital health with Rob Flaws (CMS Dubai), Niall McAlister (CMS UK) and Roland Wiring (CMS Germany).
In this episode (Part 1), we discuss:
the need for collaborations and to deal with a potential clash of cultures in bringing the “digital” and “health” sides of the industry togetherthe use of AI in track-and-trace and the search for a vaccine for COVID-19the lack of clarity of the definition of AIwhether the EC White Paper sufficiently provides a comprehensive proposal for regulation of AI, and whether new legislation is requiredwhere liability rests in respect of software -
Nick Beckett discusses with Dora Petranyi (CMS Hungary), Jens Wagner (CMS Germany) and Gabriela Staber (CMS Austria) the advertising of medicines and medical devices providing practical insights and an overview of the applicable laws. In the episode, we consider:
the complicated and fast changing area of regulation of advertisements with different rules in different jurisdictionshow to verify that scientific evidence is sufficient to substantiate claimsthe use of advertising in social media and other promotional campaignsthe approach of the authorities to new entrants to the market including in times of crisisrisks associated with competitors or consumer protection organisations filing claimsthe potential impact of MDR on advertising of medical devices -
Nick Beckett discusses with Laura Opilio (CMS Italy), Ellen Gielen (CMS Netherlands) and Shuna Mason (CMS UK) how the medicinal cannabis industry is developing across Europe, the challenges it faces and what the future might hold. In particular, we discuss in this episode:
potentially the largest cannabis market on the planet;how Moore’s law seems to apply to the legal opening up by authorities in Europe;why there is yet to be significant use in practice;what studies are needed to provide the hard scientific evidence healthcare professionals and authorities need to be comfortable with the efficacy and safety of medicinal cannabis;whether recreational use in coffee shops may be diverted for medical use;whether food supplements, cosmetics, drinks or even cigarettes could be an alternative means for patients to receive cannabis for medical purposes.
