Lydia Wakulowsky  

Partner

Executive Summary

Lydia is a Partner in the Toronto office of Borden Ladner Gervais LLP. Lydia practises corporate and commercial law, focusing on the health sector. She is Certified by the Law Society of Upper Canada as a Specialist in Health Law.

Lydia has considerable experience in acting for drug, medical device and natural health product manufacturers, private sector medical supplies and service providers, laboratories and pharmacies. She is regularly called upon to provide advice on the Canadian legislative landscape for health regulatory matters; the acquisition of product and establishment licences; provincial funding programs; labelling, advertising and promotion; Health Canada inspections; crisis management and recalls; interactions with health professionals under provincial laws and industry codes of conduct; public procurement with hospitals and hospital group purchasing organizations; freedom of information issues; private sector privacy and data protection; and health privacy.

Lydia also has extensive experience in providing advice, counsel and direction to Ontario hospitals, community care access centres, long-term care facilities, mental health institutions, health care agencies, professional medical colleges, health-related charities and other public health care organizations.

Lydia frequently negotiates and drafts complex contracts, participates in briefings with various stakeholders and assists in the development and review of policy for health sector clients.

Representative Work

Pharmaceutical, Medical Device and Natural Health Product Practice

  • Acted on several mergers and acquisitions.
  • Advising on market access issues, including product and establishment licensing, and obtaining registered vendor status with provincially funded assistive device programs and on matters concerning manufacturing, distribution, packaging and labeling of drugs, medical devices, natural health products and consumer health products.
  • Advising on research ethics matters, clinical trial agreements, including associated agreements for monitors and investigators, conflict of interest, consent and privacy guidelines and REB terms of reference and policies.
  • Advising on the development of global policies and Canadian corporate compliance policies concerning interactions with health professionals, reflecting the requirements of federal and provincial laws and regulations and 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 and regulations, advertising laws and government requirements arising from registered vendor agreements.
  • Reviewing advertising material, both television, on-line and print, before it is disseminated.
  • Advising on proposed sponsorship arrangements.
  • Advising on regulatory matters relating to Health Canada inspections and enforcement actions, crisis management and recalls, adverse events and public advisories.

Health Law

  • Acted for the Ministry of Health and 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, and numerous public hospitals and other health care providers, and 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 and 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 and professional staff by­laws, (common) credentialing and mid-term revocation policies, clinical inter-professional policies and professional staff rules and regulations to ensure they are clear, concise and up-to-date with legal and regulatory requirements and leading practices.
  • Served as lead legal counsel for the voluntary merger of two hospitals on two separate files (one by way of asset transfer and the other by way of amalgamation), both projects involving governance renewal and education.
  • Developed complex agreements for the hospital sector, including various memoranda of understanding, management services, affiliation, funding and accountability, physician and health care provider services, alternate payment plan, drug and medical equipment supply, shared services, cost sharing, laboratory, rehabilitation and other service agreements. 
  • One of the principal authors of the 2008 LHIN/Health Service Provider Governance Resource and Toolkit for Voluntary Integration Initiatives.

Privacy

  • Advising and delivering presentations on federal and provincial privacy requirements, document management and retention matters, and the impact of health privacy laws on clients.
  • Developing submissions in response to access to information requests and freedom of information requests made federally and provincially.
  • Developed privacy compliance checklists, policies, codes and notices, outsourcing and privacy agreements with third parties, data sharing agreements with hospitals and researchers, employee pledges, consent forms, access request forms, job description for a privacy officer and terms of reference for a privacy team.
  • Developed the Hospital Privacy Toolkit for Ontario hospitals and physicians for the OHA, OMA, IPC and MOHLTC.

Publications & Presentations

  • Author, "Managing the Privacy Side Effects of Rx (and other) Customer Loyalty Programs," McMillan's Health Law Bulletin, May 2014.
  • Author, "The Supreme Court of Canada Upholds the Ban on Private Label Generic Drugs – Katz Group Canada Inc. v Ontario (Health and Long-Term Care), 2013 SCC 64," McMillan's Health Law Bulletin, December 2013.
  • Author, "The Canadian Special Access Programs for Medical Devices," McMillan's Health Law Bulletin, July 2013.
  • Author, "From Tooth-Brushes to Insulin Pumps, The Regulation of Medical Devices in Canada," McMillan's Health Law Bulletin, July 2013.
  • Author, "Navigating Health Law in Canada – The Legal Framework," McMillan's Health Law Bulletin, June 2013.
  • Speaker, "Accountability in Health Care: The Legal Framework," Osgoode Certificate in Health Law, 2010-16.
  • Speaker, "Consent in Clinical Trials," Osgoode Certificate in Health Law, 2016.
  • Speaker, "Long Term Care and Seniors Care," Insight Information Conference, 2007.
  • Speaker, "The Board's Role in Patient Safety," Ontario Hospital Association, 2007. 
  • Speaker, "Governance of Family Health Teams," MOHLTC/OMA, 2006.
  • Speaker, "Privacy in the Maternity Ward," Insight Information Conference, 2006.
  • Speaker, "Local Health Integration Networks," Insight Information Conference, 2005. 
  • Speaker, "Governance of Family Health Teams," Ontario Medical Association, 2005. 
  • Speaker, "Health Information Management," CHIMA/OHA, 2005.
  • Speaker, "Health Information Management," OHIMA/OHA, 2005.
  • Speaker, "Emergency Care," Insight Information Conference, 2005.

Rankings & Recognitions

  • ​Certified by the Law Society of Upper Canada as a Specialist in Health Law.
  • Martindale-Hubbell® AV® Preeminent™ 4.9 out of 5 Peer Review Rated, 2015 and 2016. "Lydia is an exceptional lawyer who cares deeply about her clients, and works tirelessly on their behalf".