How to make mobility a compliance reality

1. How to make mobility a compliance reality • BRIAN KELLY • Regulatory Lawyer • Covington & Burling Presentation >

2. Mobility: Making mobile compliance a reality Brian Kelly bkelly@cov.com ThinkDigital 2013

3. Overview • Introduction • Challenges • promotional issues • pharmacovigilance • classification • data privacy/e-commerce • EU Enforcement • Making compliance a reality

4. Introduction • Increased use of mobile technology in the life science/healthcare sectors • Intended for: • healthcare professionals • members of the general public • Wide range of media: • dedicated websites • social networks, blogs, discussion forums • mobile applications/tablets • Regulatory framework slow to catch up

5. Challenges (1): Promotional issues • EU Directive 2001/83/EC regulates promotion of medicinal products • prohibits direct-to-consumer advertising • prohibits off-label/unlicensed promotion • permits disease awareness information • permits exchange of scientific information • Promotion versus non-promotion? • Interference with doctor-patient relationship? • Damgaard • Codes of practice often stricter

6. Promotion cont. • General rule: liable for content unless there is a genuine arm’s length relationship with no control or use of the relevant material • Vicarious liability? • DTC issues • disclaimers, access restrictions • Off-label promotion • links to independent websites • blogs, discussion forums • Online meetings • acceptable, but set ground rules

7. Challenges (2): Pharmacovigilance • Marketing authorisation holders under global adverse event reporting obligations • Consumer reports • Follow-up obligations • When are the obligations triggered? • must report ARs of which MAH is “can reasonably be expected to have knowledge”(Art. 104, Dir. 2001/83) • company-sponsored activities? • what about information on independent websites? • blogs etc?

8. Challenges (3): Classification • Does software itself become a medical device • EU Directive 93/42/EC: • “Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of…diagnosis, prevention, monitoring, treatment or alleviation of disease” • Mobile applications, e.g. • dose calculators • blood glucose monitors • European Commission guidance

9. Challenge (4) Data privacy/e-commerce • Platform must conform to legislation governing the privacy, security and confidentiality of personal information • EU Data Protection Directive 95/46/EC • E-Privacy Directive 2002/58/EC • Health information regulations/policies? • Consider jurisdictional issues • Scope to “forum shop” • Country-of-origin/country-of-destination principles • E-Commerce Directive 2001/31/EC

10. Enforcement in the EU • Traditionally self-regulated • Industry codes of practice • Different sanctions apply, e.g., administrative fines in Spain, public reprimands in the UK • Private unfair trade practices litigation, e.g. under German UVG • Criminal enforcement historically rare • UK prosecution of Roussel Laboratories in 1980s • Increased enforcement activity • See Damgaard • Criminal penalties vary widely • e.g., France, max. €150,000 fine and 2 years imprisonment

11. Compliance • A number of regulatory challenges BUT • compliance with regulations can be worked through and managed • resource and budget issues • plan ahead and involve cross-functional team • Demonstrate “added value” business case • Consider government engagement/support • “…towards a paperless NHS” • Respect wishes of prescribers and patients • mobility is not always for everyone

12. Thank You