Cases
Representative Work: Pharmaceutical, Medical Device
Natural Health Product Practice
Acted on several mergers
acquisitions.
Advising on market access issues, including product
establishment licensing,
obtaining registered vendor status with provincially funded assistive device programs
on matters concerning manufacturing, distribution, packaging
labeling of drugs, medical devices, natural health products
consumer health products.
Advising on research ethics matters, clinical trial agreements, including associated agreements for monitors
investigators, conflict of interest, consent
privacy guidelines
REB terms of reference
policies.
Advising on the development of global policies
Canadian corporate compliance policies concerning interactions with health professionals, reflecting the requirements of federal
provincial laws
regulations
industry codes of conduct, including the Innovative Medicines Canada Code of Ethical Practices, MEDEC Code of Conduct on Interactions with Health Professionals, provincial health profession laws
regulations, advertising laws
government requirements arising from registered vendor agreements.
Reviewing advertising material, both television, on-line
print, before it is disseminated.
Advising on proposed sponsorship arrangements.
Advising on regulatory matters relating to Health Canada inspections
enforcement actions, crisis management
recalls, adverse events
public advisories.
Health Law
Acted for the Ministry of Health
Long-Term Care ( MOHLTC ), several Local Health Integration Networks ( LHIN ), the Ontario Hospital Association ( OHA ), the Ontario Medical Association ( OMA ), the Ontario Association of Community Care Access Centres,
numerous public hospitals
other health care providers,
their associations, to provide advice on corporate governance issues in the health care sector.
Developed comprehensive governance policy frameworks as a result of the amalgamation of several Ontario hospital corporations
participated in comprehensive governance policy framework renewal processes for many Ontario public hospitals that have undertaken this initiative voluntarily or as a result of the appointment of a hospital supervisor.
Developed or revised corporate
professional staff by-laws, (common) credentialing
mid-term revocation policies, clinical inter-professional policies
professional staff rules
regulations to ensure they are clear, concise
up-to-date with legal
regulatory requirements
leading practices.
Served as lead legal counsel for the voluntary merger of two hospitals on two separate files (one by way of asset transfer
the other by way of amalgamation), both projects involving governance renewal
education.
Developed complex agreements for the hospital sector, including various memor
a of underst
ing, management services, affiliation, funding
accountability, physician
health care provider services, alternate payment plan, drug
medical equipment supply, shared services, cost sharing, laboratory, rehabilitation
other service agreements.
One of the principal authors of the 2008 LHIN/Health Service Provider Governance Resource
Toolkit for Voluntary Integration Initiatives.
Privacy
Advising
delivering presentations on federal
provincial privacy requirements, document management
retention matters,
the impact of health privacy laws on clients.
Developing submissions in response to access to information requests
freedom of information requests made federally
provincially.
Developed privacy compliance checklists, policies, codes
notices, outsourcing
privacy agreements with third parties, data sharing agreements with hospitals
researchers, employee pledges, consent forms, access request forms, job description for a privacy officer
terms of reference for a privacy team.
Developed the Hospital Privacy Toolkit for Ontario hospitals
physicians for the OHA, OMA, IPC
MOHLTC.
