On the Pulse CMS

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 initiatives
a 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 jurisdictions
how to deal with privacy concerns with the use of personal data with digital health technologies
how to protect the intellectual property associated with digital health innovation
developments 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 same
the 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 licence
limitations on exploitation under compulsory licences, including labelling requirements and distribution channel restrictions
the use of compulsory licences to deal with the supply of medical necessities during COVID-19
the debate regarding the need for COVID-19 vaccine patent waivers

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-19
the scrutiny of direct awards and potential legal challenges and sanctions
the joint centralised procurement of vaccines in short timeframes and the benefits and pitfalls of such approach
in what circumstances exclusivity, including due to IP rights or technical barriers, can justify derogation from public procurement procedures
what 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 present
how barriers to the take-up of telemedicine have been broken down during COVID-19
exceptional permitted uses of telemedicine in cases of emergency such as pandemics
fragmented regulation of telemedicine and digital health apps in different jurisdictions, with the advent of specific regulation in some jurisdictions
restrictions on the advertising of telemedicine and remote treatments
how 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 emerging
a service oriented digital approach – beyond the pill?
win-win collaborations with start-ups
trends to in-souring in certain critical areas
the 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 risk
the liability of Health Care Professionals (HCPs) “playing out of position” during COVID-19
the risks for non-Life Sciences manufacturers entering the Life Sciences space
the “search for a scape goat” – an easy hunting expedition?
a double track system in Italy and comparative perspectives
practical advice to companies to minimise risk
off-label use and relevant considerations 
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