Counterfeiting, undefended brands, million-dollar fines, lost tenders, and unactivated innovation rights: how the pharmaceutical industry in the Dominican Republic can lose money without seeing it.
I. MILLIONS OF ILLEGAL PHARMACEUTICAL PRODUCTS SEIZED IN ESPAILLAT PROVINCE: HOW MANY COULD HAVE AFFECTED LEGITIMATE BRANDS?
On May 2, 2026, DIGEMAPS reported that it participated alongside MICM and CECCOM in two search operations in San Víctor, Espaillat province. The result: 1.5 million units of pharmaceutical products without sanitary registration, stored in 55 industrial plastic bags inside a structure with no visible identification. Estimated value: RD$31 million. Products presented for illegal commercialization, with a pharmaceutical appearance sufficient to enter the informal channel and confuse consumers. Law 17-19 on Illicit Trade, Law 168-21 General Customs Act, and the Tax Code were invoked.
Six months earlier, the National Police dismantled a network allegedly led by Luis Ezequiel Then Martínez in Santiago and Espaillat: 2,431 grams of tablets stamped XANAX, 411 pills with WUBBA stamp, a clandestine laboratory with sustained production capacity. DIGEMAPS maintains active alerts for counterfeiting of Elatrip, Inqueta, Zolosert, Sadelit, and Evital from batch 161026 attributed to Ethical Pharmaceutical, S.R.L. For years, industry representatives have warned that the illicit pharmaceutical market is not marginal in the Dominican Republic.
The problem does not end with the seizure. When illegal pharmaceutical products manage to enter the market, they not only compete against legitimate medicines: they displace sales, confuse consumers, and erode the trust built by formal laboratories and distributors. And if one of those products causes an adverse event, the reputational damage does not always stay in the informal channel. It can reach the brand the patient believes they consumed, even if the laboratory did not manufacture, import, or authorize that product.
⚠️ In the pharmaceutical industry, losing control over your brand is the start of losing control over the market. Do you have active brand surveillance in the Dominican channel? Are your brands registered or identified with DGA to activate customs protection? If the answer is no, your brand may be losing value.
II. WHILE YOU ARE NOT WATCHING, SOMEONE IS REGISTERING A CONFUSINGLY SIMILAR BRAND WITH ONAPI
Periodically, the National Industrial Property Office publishes trademark applications in its Official Bulletin. The deadline to oppose is forty-five days, according to article 80, numeral 2, of Law 20-00. If someone files a trademark that sounds like yours, is spelled similarly, or evokes the same concept, and you do not oppose in time, you lose that administrative avenue. What follows is no longer prevention: it is cancellation, nullity, reivindication, or trademark litigation actions, typically more expensive, slower, and not guaranteed to succeed.
In medicines, a confusingly similar brand is not just a commercial problem. It is a health risk. A patient who confuses one product for another due to name similarity may ingest the wrong substance. Liability may fall on the laboratory whose brand was imitated. If a third party in bad faith registers a brand that belongs to you, you need a reivindication action. Who monitors ONAPI's Bulletin for you? Preventive opposition is the lowest-cost, highest-return investment in the Dominican industrial property system.
III. RD$14.1 MILLION IN FINES TO GLAXOSMITHKLINE DISTRIBUTORS: DO YOUR DISTRIBUTION AGREEMENTS PROTECT OR EXPOSE YOU?
On June 14, 2021, the National Commission for the Defense of Competition issued Resolution 010-2021. The sanctioned parties: Profarma Internacional, S.R.L. (315 salaries), Sued & Fargesa, S.R.L. (281 salaries), Mercantil Farmacéutica, S.A. (167 salaries), and J. Gassó Gassó, S.A.S. (38 salaries). Total: RD$14,106,090.60. The sanctioned conduct: collusion to fix prices of GSK Winasorb medicines, through identical maximum discount percentages. Violation of article 5 of Law 42-08.
Practices that for decades were assumed to be commercial custom (communication among distributors about price lists, alignment of maximum discounts) are now sanctionable conduct. If your distributors do any of these things, and you do not have a compliance program to document it, the risk is real. Review your distribution agreements and implement a competition compliance program.
IV. THE TENDER YOU LOST FOR A MISSING DOCUMENT: CEDED MARKET, STRENGTHENED COMPETITOR
A significant part of the pharmaceutical business in the Dominican Republic goes through public procurement: PROMESE/CAL, the National Health Service, hospitals, special programs such as DAMAC. As of January 28, 2026, these purchases are governed by Law 47-25 on Public Procurement, which replaced Law 340-06 and introduced stricter modalities. Its Implementing Regulation was approved by Decree 52-26.
In a pharmaceutical tender, sanitary registration, trademark, ownership, representation letters, technical data sheets, traceability, and prices all intersect. An expired sanitary registration or an incomplete representation letter can disqualify your bid. The real harm is not the disqualification itself: the winning competitor becomes a supplier to the public program, gains track record, and you lose market share. Who reviews your bid documents, technical data sheets, and records before you bid?
V. WHAT WORKS: A BRIEF RESPONSE, BECAUSE YOU ALREADY UNDERSTAND THE PROBLEM
The four risks described have answers in the Dominican legal system. They are not dead-end risks. They are risks with activatable mechanisms that require coordinated professional action:
- Trademark defense and anti-counterfeiting: ONAPI surveillance, customs protection, civil measures, and criminal enforcement.
- Competition compliance: Program with manual, training, contract review, whistleblower channel, and documentary audit.
- Pharmaceutical public tenders: Monitoring of processes under Law 47-25, comprehensive review of bid documents, technical data sheets, registrations, trademark ownership.
- Innovation assets: Evaluation of patent portfolio for term compensation (article 27, Law 20-00) and 5-year test data protection (data exclusivity).
The difference lies in arriving before the damage becomes a seizure, a lawsuit, or a reputational crisis.
How much value is my pharmaceutical portfolio losing in the Dominican Republic due to mechanisms that exist, that are activatable, and that no one is activating for me?
That question has an answer. It is called the Diagnostic Pharmaceutical Risk Audit. It cross-references your trademark portfolio, customs registration, DIGEMAPS files, distribution agreements, exposure to Pro-Competencia, participation in tenders under Law 47-25, and the status of your patents and test data.
Deliverable: Executive matrix with prioritized risks, missing documents, processes to monitor, urgent actions, and a 30-, 60-, and 90-day action plan.
Request an Audit → info@legalhubrd.comLic. Carlos Romero Polanco · LegalHub RD
Santo Domingo, Dominican Republic · Industrial property · Public procurement · Strategic litigation · Compliance
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