MEDICAL, HEALTH AND LIFE SCIENCES

HEALTH AND LIFE SCIENCES

The Health and Life Sciences practice is divided into 4 sub sectors;

  • Regulatory
  • Medical Research
  • Drug Development
  • Professional liability claims

REGULATORY
The team advises the Government of Uganda, International Organisations, Regulatory Agencies, Pharmaceutical companies, Healthcare providers, Patients, Non-Governmental Organisations and Academic Research Institutions on the policy and legal issues that affect public health, clinical practice, medical research and the development of drugs, biologics and devices.

MEDICAL RESEARCH/ CLINICAL TRIALS
Our team has the distinction of specialised training and extensive knowledge of bio-ethics and the applicable national, regional and international regulatory regimes for the protection of human subjects, with a special focus on the intersections between health law, bioethics and human rights, the application of Good Clinical Practice guidelines, medical malpractice, Intellectual Property
Rights, Bio-ethics, Drug approvals, Product liability, Counterfeit enforcement actions, Data protection and the ethical conduct of clinical trials.
Under this practice sector, we advise academic research institutions, Non-Governmental Organisations, Inter-Governmental Organisations, Pharmaceutical Companies, Sponsors and Contract Research Organisations on bio-medical, behavioural and data collection studies involving human subjects, with specific reference to:

The National and International Regulatory requirements for the conduct of Clinical Trials under FDA, CFR, WHO, EU, NDPA, Belmont and Helsinki Codes;

  • Ethical/legal review of the protocol and authorization by the National Authorities;
  • The appointment and responsibilities of Ethical/ Institutional Review Boards;
  • Protection of the rights and welfare of research participants;
  • 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;
  • Benefit sharing;
  • Dispute Resolution arising out of the Conduct of the trial

DRUGS AND DEVICES APPROVAL
Our Drug and Devices approval practice advises on the acquisition of Pharmaceutical licenses for retail outlets and the approval of drugs for human, veterinary and herbal use. In addition, we advise on the authorization process for the use of medical devices.
In specific terms, we advise on:

  • Market authorization for new and improved drugs;
  • Registration and approval of local licensees and manufacturers of imported drugs after an extensive process of inspection and assessment;
  • Assessment and registration of medical devices;
  • Product recall and liability arising therefrom;
  • Enforcement action relating to counterfeit, fake and substandard drugs;
  • Adherence to regulations for donated drugs, biologics and devices;

MEDICAL LAW AND PROFESSIONAL LIABILITY
The firm has extensive experience in representing Healthcare providers and patients on professional negligence claims relating to the receipt of medical treatment.
Our advice includes:

  • The acquisition of professional indemnity insurance and the settlement of claims under the policy;
  • Commissioning of independent expert medical reports;
  • Preparation of trial bundles for litigation and administrative action before Professional disciplinary bodies;
  • Settlement of arbitral and post-judgment remedies.

PRACTICE HIGHLIGHTS

    • Advised the World Health Organization and the Ministry of Health on amendments to the legal and regulatory framework governing public health in Uganda, with specific reference to the Public Health Act;
    • Advised a leading global health foundation on the establishment of binding dietary and nutritional regulations to be passed across the East African Community;
    • Advised a leading foundation on amendments to the Law and the development of statutory instruments relating to road safety.
    • Acted for a leading research organization in an unprecedented claim
      relating to the conduct of clinical trials;
    • Acted for a Non-Governmental Organization in a precedent setting public interest petition on medical brain-drain;
    • Acting for a leading hospital in a variety of medical malpractice claims;
    • Advising a leading pharmaceutical sponsor in an application of authorization for the conduct of a clinical trial;
    • Advising a leading manufacturer on the procurement of drugs on the essential list by the Government medical procuring entity – National Medical Stores;
    • Advising pharmaceutical clients on registration of intellectual property rights and enforcement mechanisms against counterfeit, dangerous and substandard variants;
    • Advise a leading University on collaborative research agreements with international partners drawn from the academic, pharmaceutical and non-governmental sector.