Professional liability.

The Health and Life Sciences practice at H&G Advocates is divided into 3 sub-sectors namely;
(1) Clinical Trials
(2) Drug development; and
(3) Medical Malpractice Claims.
The Firm advises Regulatory Agencies, Pharmaceutical companies, Healthcare Providers, Patients, Non-Governmental Organisations and Academic Research Institutions on the policy and legal issues that affect clinical practice, research and the development of drugs, biologics and devices in Uganda. The team has specialized training and extensive knowledge of applicable national,
regional and international regulatory regimes for the protection of human subjects in research involving humans as participants, with a special focus on the nexus between health and human rights, the application of Good Clinical Practice guidelines, medical malpractice, Intellectual Property Rights, Bioethics, Drug approvals, Product liability, Counterfeit enforcement actions, Data protection and the ethical conduct of clinical trials.

Under the Clinical trials practice sector, the Firm advises academic research institutions, Pharmaceutical Companies, Sponsors and Contract Research Organisations on;
• The specific National and International Regulatory requirements for the conduct of Clinical Trials under FDA, WHO, EL’, NDPA, Belmont and Helsinki Codes
• Protocol review and authorization by the National Authorities
• The appointment of Ethical/ Institutional Review Boards
• Collaborative agreements with National Research Institutions
• Clinical trial and Site Agreements
• Material Transfer Agreements and licensing of compounds, processes and technology platforms
• Drafting of Informed Consent Agreements, review of applicability to social, cultural and personal circumstances of participants and continuous monitoring for compliance
• Data and Patient Confidentiality
• Dispute Resolution of conflicts arising out of the Conduct of the trials

The Firm’s Drug and Devices approval advisory practice advises on the acquisition of Pharmaceutical licenses for retail outlets and the approval of drugs for human, veterinary and herbal use. In addition, the Firm advises on the authorization process for the use of medical devices. Market authorization for new and improved drugs Registration and approval of local licensee and manufacturer of imported drugs after extensive process of inspection and assessment and registration of medical devices Product recall and liability Enforcement action relating to counterfeit, fake and substandard drugs- Adherence to regulations for donated drugs, biologics and
devices

The team has extensive experience in representing Healthcare providers and patients on claims relating to the receipt of medical treatment. The team advises clients on; The acquisition of professional indemnity insurance and the settlement of claims under the policy Commissioning of expert medical reports Preparation of trial bundles for Court actions and before Professional disciplinary bodies Dispute Resolution from mediation, trial and the settlement of post judgment remedies. Our Practice Highlights
• Successfully defended Organizations and Hospitals respectively in litigation claims of approximately US $ 12,000,000 relating to the conduct of clinical trials and medical malpractice.
• Representing and successfully defended a Statutory body in a claim over licensing and compliance issues relating to Statutory requirements.

• Advising Clients on the requirements for obtaining necessary approvals and authorizations for conducting clinical trials in Uganda.
• Advising Clients on the legal requirements of Informed Consent in respect to clinical trials of Covid-19 vaccines relating to humans as participants of the same.
• Advising Clients on the Legal framework in Uganda relating to vaccination of Employees against Covid-19 and the legal implications of the mandatory requirement of Covid-19 vaccination cards at the work place.

• Advising Pharmaceutical clients on registration of Industrial Property Rights and enforcement mechanisms against counterfeit, dangerous and substandard variants.

John F. Kanyemibwa, Dennis Wamala

John F. Kanyemibwa, Dennis Wamala

• Uganda Virus Research Institute
• Medical Research Council
• Makerere University
• Mengo Hospital
• Uganda National Council for Science and Technology