Helen Michaelis a Director in the Healthcare & Life Sciences practice area and has been practicing in healthcare regulatory law for 10 years. She also forms part of the Dispute Resolution, General Regulatory and Environmental Law Practice Group Areas. Helen advises the South African private healthcare sector extensively on all matters pertaining to healthcare regulatory law including medical schemes, professional practice, medicines, foodstuffs, medical devices and national health insurance. Helen, however, also advises, inter alia, on administrative law, consumer protection law, privacy and the protection of personal information as well as environmental law. Helen holds an LLB (with distinction) and an LLM in Environmental Law (with distinction), both from the University of the Witwatersrand.
Years of Experience: 10years
Disputes
Environmental
Healthcare & Life Sciences
Environmental law
Healthcare law
Administrative law
Constitutional law
Due diligence investigations on the above
Consumer protection law
Restitution of land rights and land claims.
Provisions of the Promotion of Access to Information Act and the Promotion of Administrative Justice Act.
Compliance with healthcare legislation including the National Health Act and the Medicines & Related Substances Act.
Compliance with the National Environmental Management Act.
Consumer law, and in particular, the Consumer Protection Act and related legislation.
Advised / Represented / Acted on behalf of:
Advises extensively on matters pertaining to the proposed National Health Insurance.
Advises a number of medical schemes in respect of the application of the provisions of the Medical Schemes Act No. 131 of 1998, as amended, in respect of both the design of benefits, complaints to the Registrar of Medical Schemes and the application of the Rules of various medical schemes to various third parties, including members.
Assisted in team that advised Omegalabs Proprietary Limited in respect of the classification of its product Dermalex as a medical device, the decision by the North Gauteng High Court being seminal in the application of the provisions of the Medicines and Related Substances Act No. 101 of 1965, as amended, to medical devices.
Advised on numerous matters pertaining to the licensing of private health establishments, the regulations dealing with private health establishments both provisionally and nationally and the challenges faced by private health establishments in respect of the licensing application for purposes of operating and running a hospital in the private sector.
Advising and representing the South African Reserve Bank in various matters, which includes PAIA and PAJA related matters and court applications and advice and court proceedings pertaining to the contravention of Exchange Control Regulations.
Various clients on regulatory environmental issues, including Lanxess Proprietary Limited, Bayer Proprietary Limited and Active Foundry Proprietary Limited.
Assisted with various environmental due diligences, including for Cheetah Chrome South Africa Proprietary Limited and Izimbiwa Coal Proprietary Limited.
LLM (Environmental Law) (cum laude), University of the Witwatersrand, 2015
Admitted as an Attorney, 2013
LLB (cum laude), University of the Witwatersrand, 2011
Certificate in Data Protection and Privacy, University of Cape Town, 2023
Authorships
Author of numerous articles in her various fields of specialisation
Johannesburg 
+27 11 535 8424 
+27 11 535 8724 
