Branding & Regulatory challenges for apps and webbased. connected? PTMG 92nd Spring Conference. London, 15 March 2016

Transcription

1 Branding & Regulatory challenges for apps and webbased platforms are you connected? PTMG 92nd Spring Conference London, 15 March 2016

2 What is this presentation about? A few definitions and examples Internet of things, ehealth, mhealth, connected devices, 3D printing all you ever wanted to know about them but never dared to ask From sport apps to ingestible drugs and 3D human skin Legal implications What is the legal nature of apps and connected devices in the pharma industry? How to handle health data? Whose trade mark will protect them? How to contractualise schemes between pharma companies and IT developers? Conclusion Towards personalized care 2 / L_LIVE_EMEA2: v2

3 A few definitions E-health / M-health Internet of things / Connected devices / Quantified-self 3D printing 3 / L_LIVE_EMEA2: v2

4 E-health According to the World Health Organization, E-health can be defined as the transfer of health resources and health care by electronic means. It encompasses three main areas: The delivery of health information, for health professionals and health consumers, via the Internet and telecommunications networks. Using the power of IT and e-commerce to improve public health services, e.g. through the education and training of health workers. The use of e-commerce and e-business practices in health system management. 4 / L_LIVE_EMEA2: v2

5 M-health The World Health Organization defined m-health as a practice of medicine and public health supported by mobile devices, i.e. using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information (Source: WTP Report New Horizons for Health and Mobile technologies, 2011). M-health applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patients vital signs, and direct provision of care (via mobile telemedicine) 5 / L_LIVE_EMEA2: v2

6 Internet of things and Connected device Internet of things is an expression which links two different worlds: the Internet, a world made of immaterial, applied to things, i.e. objects 6 / L_LIVE_EMEA2: v2

7 Quantified-self The quantified-self refers to a number of practices which enable individuals to measure and compare information relating to their life habits with that of others e.g. number of steps per day, physical activities, quality of sleep etc. Use of bracelets, watches, pedometers, apps for mobile phones. 7 / L_LIVE_EMEA2: v2

8 3D Printing 3D printing is a process which enables the reproduction of an object by binding successive layers of materials. Objects are produced using an electronic data file and a specific software The raw material can be of multiple sorts: plastic, metal, ceramic, organic Can be used to reproduce human organs, such as implants or to prepare surgery and to manufacture drugs (e.g. SPRITAM, first pills manufactured using 3D printing, authorized by the FDA in August 2015) 8 / L_LIVE_EMEA2: v2

9 A few stories : ABILIFY & PROTEUS When the drug with the embedded ingestible sensor is taken, the sensor sends a signal to a patch after it reaches the stomach The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals. 9 / L_LIVE_EMEA2: v2

10 A few stories : MEDISSIMO Creation of a connected pills dispenser to avoid mistakes and overconsumption issues The pharmacist places the relevant pills in the connected dispenser The patient connects the dispenser to a specific box using GPRS technology. The Medissimo e-health platform records each time the patient takes a pill 10 / L_LIVE_EMEA2: v2

11 Legal implications Medical device qualification Data protection issues Trade mark issues Contractual schemes 11 / L_LIVE_EMEA2: v2

12 Medical device - Qualification Criteria to qualify as a medical device: intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific medical purposes Classification of connected devices: Device for well-being purposes: measure parameters + use of connected apps Device with medical purpose: certified measure of parameters + use of connected apps + diagnosis, recommendations and monitoring Classification of software: Referred to in the definition of medical device (Draft Regulation on Medical device) Use of MEDDEV graphic chart 12 / L_LIVE_EMEA2: v2

13 13 / L_LIVE_EMEA2: v2

14 Quizz Is it a medical device? [images withdrawn] 14 / L_LIVE_EMEA2: v2

15 Data protection Sensitive Data Digital health necessarily implies access, use, processing and storage of personal data Data relating to the identity of the user (name, address, mobile phone number) for communication purposes Data relating to the health of the user = sensitive data An extensive definition of data concerning health all data pertaining to the health status of a data subject which reveal information relating to the past, current or future physical or mental health status of the data subject; including information about the individual collected in the course of the registration for and the provision of health care (New EU Regulation Recital 26 + Definition) The processing of sensitive data is prohibited subject to specific exceptions 15 / L_LIVE_EMEA2: v2

16 Data Protection Issues Possibility to process health-related data in limited circumstances, in the context of M-health: Consent of the data subject Processing is in the direct interest of the patient or in the public interest (e.g. for the purpose of providing remote medical services) Implementation of security measures to avoid unauthorized access and use of the data Information of the patient/user on the processing of their data and of the categories of persons having access to their data 16 / L_LIVE_EMEA2: v2

17 Trade marks Pharma companies filing for Class 9, 10 and 38? Extension of clearance searches to new classes Extension of trade mark protection Costly? IT companies filing for Class 5 and 10? Organize contractual arrangements Obtain guarantees that relevant clearance was conducted 17 / L_LIVE_EMEA2: v2

18 Example: ABILIFY by Otsuka New CTM application ABILIFY MIVU in 2014 covering: 9: Computer application software for mobile phones, tablets, portable electronic devices and handheld computers for use in collecting and storing patient data and medical information including drug ingestion information, pulse, heart rate, respiratory rate, body temperature, electric pressure in the body, human motion, human position or sleeping condition from a sensor attached to the patient's body. 10: Sensor patches attached to the patient's body for use in measuring, collecting and storing patient data and medical information including drug ingestion information, pulse, heart rate, respiratory rate, body temperature, electric pressure in the body, human motion, human position or sleeping condition. 18 / L_LIVE_EMEA2: v2

19 Example: VERILY by Google, Inc Recent CTM application for VERILY by Google, Inc., covering: 5: Pharmaceutical preparations. 7: Incubators for medical purposes. 9: Wearable computing devices; wearable computing devices for the detection and treatment of diseases; computer software and computer programs for use in the medical, scientific and pharmaceutical fields; clinical trial software; computer hardware and software for medical imaging apparatus; clinical trial data collection, storage and analysis software; data processing equipment; computer software for surgical equipment; health data security and privacy software; computer software and computer programs for transmission of medical and scientific data and information; contact lenses. 10: Surgical, medical, dental and veterinary instruments and apparatus; scientific instruments and apparatus; surgical tools and instruments; instruments and apparatus systems for medical diagnostic uses; medical imaging apparatus; surgical robotics; drug delivery systems; medical devices; intraocular lenses; medical devices for the prevention, diagnosis and treatment of diseases. 38: Electronic transmission and reception of messages and data; electronic transmission and reception of information in the medical, scientific, healthcare and pharmaceutical fields. 19 / L_LIVE_EMEA2: v2

20 Contractual issues Implementation of contracts to cover relationships between IT developers and the pharma industry Development agreements Confidentiality provisions Ownership of IP rights on the device or software Liability issues Services agreement for hosting of health data, anonymisation processes, analyzes of big data 20 / L_LIVE_EMEA2: v2

21 Conclusion Apps and connected devices are the necessary tools for personalised care 3D printing will enable individuals to manufacture or have their drugs manufactured next door For pharma companies, this may mean adopting new internal processes involving individuals who belong to different teams/worlds at the outset of the project: trade mark lawyers, IT engineers, patent lawyers, compliance and regulatory teams 21 / L_LIVE_EMEA2: v2

22 The Perfect Match? [image withdrawn] 22 / L_LIVE_EMEA2: v2

23 Thank you for your attention. Any questions? Frédérique Potin Senior Associate, Simmons & Simmons LLP Paris T E frederique.potin@simmons-simmons.com