What the Barbados Medical Products Act says about clinical trials
The Barbados Medical Products Act, 2026 (Act 2026-12), which takes effect by Proclamation, brings clinical trials under statute for the first time1. It defines a clinical trial as "an investigation in respect of a medical product for use in humans that involves human subjects" to discover or verify its effects, identify adverse events, study its pharmacokinetics or ascertain its safety or efficacy (section 2)1. The key rules1:
- "No person shall conduct a clinical trial of a medical product on humans without the clearance of the National Ethics Committee appointed pursuant to section 15 and the authorisation of the Authority" (section 55(1)).
- The Board of the Barbados Medical Products Authority must appoint that National Ethics Committee, with membership set by the Board and approved by the Minister (section 15(5)–(6)).
- Trials must follow regulations on Good Clinical Practice and Good Laboratory Practice; the Authority keeps a register of authorised trials; running a trial without approval carries a $5,000 administrative penalty (section 55(3), (5), (6)).
- No one may sell, dispense, supply or manufacture a product "for the purpose of a clinical trial or medical research" without authorisation or a written exemption (section 55(4)).
- The National Pharmacovigilance Programme must cover "identifying and reporting adverse events relating to clinical trials" (section 51(2)(b)), and a National Quality Control Laboratory is created (section 56).
Draft regulations are under way. PAHO reported that a stakeholder consultation in Bridgetown on 20 October 2026 reviewed draft rules on market authorisation, licensing, pharmacovigilance and the conduct of clinical trials11; Barbados aims to reach WHO Global Benchmarking Tool Maturity Level 3 by 202912.
How ethics review works in Barbados today
Until the National Ethics Committee exists, a key existing body sits at the University of the West Indies (UWI). Its Cave Hill campus says the Institutional Review Board "is the primary mechanism of ethics review on the Cave Hill Campus" and that it "also serves the Barbados Ministry of Health (MoH)"; membership includes each Cave Hill faculty, senior Ministry staff and at least one community member unaffiliated with either2. The Act does not say how the new committee will relate to the existing board1.
The evidence gap: Black and Caribbean patients in GLP-1 trials
Black patients, who make up most Barbadians with type 2 diabetes10, are under-represented in the trials behind these drugs. A 2024 systematic review in BMJ Global Health of 27 randomised GLP-1 obesity trials found that participants were 79% white and 9% Black, and that 84.2% of 1,859 trial sites were in high-income countries, "in sharp contrast to the global prevalence of obesity"6. In cardiovascular outcome trials of GLP-1 receptor agonists and SGLT2 inhibitors, Black participants made up 2.4% to 8.3% of enrolment8. A meta-analysis in the Journal of the Royal Society of Medicine found consistent benefits in white and Asian participants but no observed effects in Black populations, and said it was unclear whether this reflected "under-representation of Black populations and low statistical power" or real differences8. A US review concluded that minority enrolment must improve "if clinicians are to have an accurate picture of the benefits and potential pitfalls" of these drugs7.
Barbados is a case in point. The national Health of the Nation survey found obesity in 33.8%, hypertension in 40.6% and diabetes in 18.7% of adults aged 25 and over9. In a population-based Barbadian sample of people with type 2 diabetes, 90% were Black10. WHO's own GLP-1 guideline is conditional partly because of "limited data on their long-term efficacy and safety"13.
Barbados can run trials
Local capacity exists. UWI researchers ran a feasibility study of a low-calorie liquid diet for type 2 diabetes remission in Barbados: 25 participants lost a mean 10.1 kg at 8 weeks, and the authors reported feasibility "in a predominantly black population in Barbados"5; UWI then registered a community implementation study of the same approach (NCT03536377)4. On ClinicalTrials.gov, UWI is also the sponsor of HEADWATERS, a phase 2 trial comparing two chemotherapy drugs in metastatic triple-negative breast cancer "in women of African ancestry", with the Queen Elizabeth Hospital listed as a site alongside Ghana and Jamaica, a target of 750 participants and a planned start in June 20273. When we searched the registry on 7 November 2026, no semaglutide, tirzepatide or other GLP-1 drug trial listed a site in Barbados.
What physicians in Barbados should know
Once the Act is in force, any study that gives a medical product to people in Barbados to test its effects falls under section 55, whether sponsored by industry, a university or a clinic, and supplying a product for "medical research" also needs authorisation1. For peptide drugs, that means a product cannot be supplied in Barbados simply by calling it research material, and it also gives local investigators a formal path to produce the Caribbean data that today's trials lack16.
Sources
- Parliament of Barbados. Barbados Medical Products Act, 2026 (Act 2026-12), sections 2, 15, 51, 55 and 56. The Official Gazette, Part A, Vol. CLXI, No. 73, 22 June 2026. barbadosparliament.com ↗
- The University of the West Indies, Cave Hill Campus. Research Ethics: About the Institutional Review Board. cavehill.uwi.edu ↗
- ClinicalTrials.gov. HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry (NCT07528768). clinicaltrials.gov ↗
- ClinicalTrials.gov. Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community (NCT03536377). clinicaltrials.gov ↗
- Bynoe K, Unwin N, Taylor C, et al. Inducing remission of Type 2 diabetes in the Caribbean: findings from a mixed methods feasibility study of a low-calorie liquid diet-based intervention in Barbados. Diabet Med. 2020;37(11):1816-1824. PubMed 31365159 ↗
- Jeyakumar Y, Richardson L, Sarma S, et al. Representation of racialised and ethnically diverse populations in multicentre randomised controlled trials of GLP-1 medicines for obesity: a systematic review and meta-analysis of gaps. BMJ Glob Health. 2024;9(11):e017177. PubMed 39608857 ↗
- Sinclair MR, Ardehali M, Diamantidis CJ, Corsino L. The diabetes cardiovascular outcomes trials and racial and ethnic minority enrollment: impact, barriers, and potential solutions. Front Public Health. 2024;12:1412874. PubMed 39525461 ↗
- Kunutsor SK, Khunti K, Seidu S. Racial, ethnic and regional differences in the effect of SGLT2 inhibitors and GLP-1 receptor agonists on cardiovascular and renal outcomes: a systematic review and meta-analysis of cardiovascular outcome trials. J R Soc Med. 2024;117:267-283. PubMed 37734450 ↗
- Howitt C, Hambleton IR, Rose AM, et al. Social distribution of diabetes, hypertension and related risk factors in Barbados: a cross-sectional study. BMJ Open. 2015;5(12):e008869. PubMed 26685026 ↗
- Taylor CG Jr, Taylor G, Atherley A, et al. The Barbados Insulin Matters (BIM) study: Barriers to insulin therapy among a population-based sample of people with type 2 diabetes in the Caribbean island of Barbados. J Clin Transl Endocrinol. 2017;8:49-53. PubMed 29067259 ↗
- Pan American Health Organization (PAHO). Barbados advances the development of the BMPA regulations through stakeholder consultations. 23 October 2026. paho.org ↗
- Pan American Health Organization (PAHO). Barbados approves the creation of the Barbados Medical Products Authority with support of PAHO. 1 July 2026. paho.org ↗
- World Health Organization. WHO issues global guideline on the use of GLP-1 medicines in treating obesity. 1 December 2025. who.int ↗
Informational article. It summarizes news, official statements and published studies; it is not medical or legal advice. Sources were checked on the publication date.