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Editorial

MAURITIUS PROVIDING AN ATTRACTIVE LEGAL FRAMEWORK FOR CLINICAL TRIALS

The development of Life Sciences has been one of Mauritius’s long time ambitions. It is an industry which meshes well the island’s ambitions in the pharmaceutical industry and bio-technological research. However, the testing of drugs on human subjects is an issue which has sparked ethical controversies worldwide. Prior to the enactment of the Clinical Trials Act 2011 (the “Act”) in September 2011, projects for conducting clinical research on human beings were prohibited in Mauritius.

Clinical trial is defined by the World Health Organisation as any research study that prospectively assigns human participants to health-related interventions to evaluate the effects on health outcomes. Intervention include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes and preventive care.

The Act enables Mauritius to have a legal framework conducive for the conduct of clinical trials comparable to those related legislations in Europe. It also sets out a regulatory framework for the safe and ethical conduct of trial on human beings in Mauritius. It caters for the setting up of independent qualified bodies which are compliant with “The International Council for Harmonisation (ICH), European Guidelines namely the ICH E6: Good Clinical Practice: Consolidated Guideline” which oversee and regulate the process from the application for a trial licence to the successful completion of the clinical trial in scrupulous observance of international norms. These institutions are: (1) the Clinical Research Regulatory Council (CRRC); (2) the Ethics Committee (EC); and (3) the Pharmacovigilance Committee (PC).

A sponsor who seeks to conduct clinical tests in Mauritius shall apply for a trial licence with the CRRC. The application is reviewed by the CRRC for an initial evaluation and subsequently the application is submitted to the EC. Upon being satisfied that the proposal meet ethical standards, the application is referred back to the CRRC which issues the licence to the sponsor. The CRRC takes into consideration the following criteria before granting a trial licence:

The EC has ensured that ethical values and international scientific standards are complied with and that local community values and customs are respected;

2 The EC has advised the CRRC on the physical and health conditions of the subjects involved in clinical trials; and

3 The PC has made an analysis of the adverse effects on subjects involved in clinical trials.

The clinical trials are conducted on two (2) categories of individuals namely: (1) volunteers, healthy individuals and (2) patients, individuals suffering from a pathology and are conducted in four (4) phases:

1 Phase I is conducted on a small group (20-100) of healthy volunteers to assess drug safety and tolerability

(2 Phase II is conducted on a larger group (100-1,000) to assess the effectiveness of the drug

3 Phase III consists of randomised multicentre trials on large groups (3,000-10,000)

4 Phase IV focuses on post-marketing surveillance about the safety of the drug once on the market (Pharmacovigilance).

The Act also affords a high degree of protection to the subjects and makes provision for any subject undergoing a clinical trial to be appropriately compensated in the event of any clinical trial-related injury. It is mandatory under the Act for any sponsor to enter into an insurance contract to cover its liability and the liability of every person participating in the clinical trial.

Mauritius as a centre of excellence for clinical trials

The availability of skilled professionals in the health sector, a highly developed medical infrastructure coupled with an appropriate regulatory framework are the main elements favoring the conduct of clinical trials in Mauritius. Clinical Research Organisations (CRO) such as Centre International de Développement Pharmaceutique (CIDP) and more recently CAP Research, both located in the first regional hub dedicated to biotechnologies in Mauritius have started to develop clinical research in the country. The Board of Investment (BOI) has positioned itself as a catalyst in the development of the conduct of clinical trials in Mauritius to potential foreign investors in the field of clinical research in Mauritius through the different services it offers free of charge including inter alia counselling on investment opportunities in Mauritius, assistance with the occupation permits, licences and clearances and assisting with the identification of joint venture partners.

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