On the Pulse

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 

Learn more about CMS at cms.law or subscribe to further Life Sciences & Healthcare news and updates at CMS Law-Now.   

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 chatbots
• the digitalisation of healthcare records
• the approach of Big Tech and their provision of advanced technical solutions
• data privacy requirements regarding the use of immense data reserves in the provision of digital health services
• the need to incorporate human insight and oversight into AI system processes

Learn more about CMS at cms.law or subscribe to further Life Sciences & Healthcare news and updates at CMS Law-Now.    

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 together
• the use of AI in track-and-trace and the search for a vaccine for COVID-19
• the lack of clarity of the definition of AI
• whether the EC White Paper sufficiently provides a comprehensive proposal for regulation of AI, and whether new legislation is required
• where 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 jurisdictions
• how to verify that scientific evidence is sufficient to substantiate claims
• the use of advertising in social media and other promotional campaigns
• the approach of the authorities to new entrants to the market including in times of crisis
• risks associated with competitors or consumer protection organisations filing claims
• the 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.