For years, the global economy has undergone a process of technological evolution and accelerated growth in innovation. The pharmaceutical industry has played a transcendental role in this process due to the substantial investments made by this sector in the research and development of innovative, life-saving medicines that improve human health.
To incentivize the creation of new medicines, prevent unfair competition, and mitigate risks to human health, it is essential to safeguard industrial property rights within this domain. This includes trademark rights over signs that identify pharmaceutical products in commerce, as well as patent rights over the outcomes of inventions. Generally, adequate protection of industrial property fosters innovation, promotes legitimate trade, and contributes to preserving health.
Although industrial property rights are harmonized and recognized internationally, they have been undermined by the severe and decades-long problem of medicine counterfeiting. According to the World Health Organization (WHO), counterfeit medicines constitute 10% of the global pharmaceutical market, a figure that rises to 21% in developing countries (and stands at 10% in the Dominican Republic).
APPLICABLE REGULATIONS AND AGENCIES INVOLVED IN THE FIGHT AGAINST THE CRIME OF MEDICINE COUNTERFEITING
General Health Law No. 42-01 is the most significant legal instrument in the fight against counterfeit medicines, as it expressly criminalizes this offense and classifies it as a felony (crimen). This classification was the result of an amendment introduced by Law No. 22-06, which incorporated notable changes regarding medicine counterfeiting, including the following:
- The inclusion of the concept of a counterfeit medicine in Article 170 of Law 42-01, defined as “any medicine whose label or packaging deliberately and fraudulently misleads regarding its identity, origin, or content. Counterfeiting applies to both brand-name and generic medicines, and includes products with the correct ingredients, incorrect ingredients, no active pharmaceutical ingredients (APIs), or inadequate quantities of active ingredients with counterfeit packaging. It also encompasses any medicine that fails to comply with current sanitary registration requirements in the Dominican Republic.”
- The express incorporation of the crime of medicine counterfeiting under paragraph 8 of Article 156, providing that the following shall be considered felonies punishable by two to ten years of imprisonment and fines ranging from twenty-five to fifty times the minimum wage: “the manufacture, compounding, export, distribution, storage, and/or commercialization, in any form, of counterfeit, adulterated, expired, relabeled, smuggled medicines, or those lacking a valid sanitary registration, as well as chemically or physically altered medicines.”
The General Health Law also outlines administrative measures that the Ministry of Public Health and Social Assistance (MISPAS) may apply during a proceeding, such as: a) ordering the temporary or definitive closure of any establishment engaged in the production, manufacturing, storage, refrigeration, packaging, transport, distribution, commercialization, and sale of food products, medicines, or similar items that violate any provisions of the law; and b) confiscating and destroying deteriorated, adulterated, contaminated, expired, counterfeit, or falsely and deceptively described products.
Although medicine counterfeiting under the General Health Law is an offense subject to public criminal prosecution led by the Public Prosecutor’s Office (Ministerio Público), an industrial property right holder affected by the counterfeiting may participate in the public action by filing a formal complaint (querella) with the Prosecutor’s Office. Following the indictment by the Public Prosecutor’s Office, the right holder may join their action or present a separate accusation within the same proceeding.
The Public Prosecutor’s Office operates the Specialized Prosecutor’s Office for Health Crimes and Offenses (PEDECSA), which is tasked, among other things, with investigating and prosecuting those responsible for medicine counterfeiting offenses under Law 42-01 and its regulations.
Concurrently, MISPAS operates the General Directorate of Medicines, Food, and Sanitary Products (DIGEMAPS), whose objective includes the regulation, control, auditing, and surveillance of pharmaceuticals. This directorate, in conjunction with the Inter-institutional Commission for the Prevention and Combat of Illegal Medicines, coordinates and executes actions against medicine counterfeiting and related illicit practices.
Another legal instrument impacting medicine counterfeiting is Law 20-00 on Industrial Property. While this statute does not expressly criminalize medicine counterfeiting per se, it condemns trademark counterfeiting under Article 16.16, establishing prison sentences and fines for trademark infringement, and further provides for civil actions against infringers. Similarly, Article 166.2 of the law provides for civil actions that may be brought against patent infringers, and Article 176 et seq. criminalizes acts of unfair competition.
In this regard, medicine counterfeiting may be prosecuted under the provisions of Law 20-00 in cases where the infringed drug is identified by a registered trademark or protected by a patent. Furthermore, in all instances, medicine counterfeiting inherently constitutes an act of unfair competition.
Law 20-00 establishes a comprehensive legal framework that provides for preliminary injunctions and precautionary measures against infringers, which can be requested prior to initiating legal action, alongside it, or during the proceedings. The measures that may be ordered include, but are not limited to: a) the immediate cessation of the acts alleged to constitute an infringement, and b) the precautionary seizure (embargo preventivo), inventory, or deposition of samples of the infringing objects, as well as the means exclusively used to commit the infringement.
Within the framework of a civil action under the aforementioned Law 20-00, the judge may order the following remedies:
- a) The cessation of the infringing acts;
- b) The payment of damages/indemnification;
- c) The seizure of the allegedly infringing products, any related materials or implements, and documentary evidence relevant to the infringement;
- d) The destruction of goods determined to be counterfeit;
- e) The necessary measures to prevent the continuation or recurrence of the infringement, including the destruction of materials and implements used in the production of the seized infringing objects pursuant to paragraph c), without any compensation. It may also be ordered that such materials and implements be disposed of outside of commercial channels to minimize the risk of future infringements.
When criminal actions are pursued, the court may order:
- a) The seizure of allegedly counterfeit goods and the materials and accessories used to commit the offense;
- b) The seizure of all assets related to the infringing activity and all relevant documentary evidence;
- c) The forfeiture (decomiso) of all assets connected to the illicit activity; and
- d) The forfeiture and destruction of all counterfeit merchandise, without any compensation to the defendant.
Regarding criminal prosecution, the offense of medicine counterfeiting arising from trademark infringement may be pursued via public criminal action or private criminal action. The Attorney General’s Office of the Dominican Republic (Procuraduría General de la República) has established specialized industrial property crime units across various jurisdictions to investigate trademark violations ex officio (internally) or at the request of an aggrieved party.
Another highly relevant aspect is that, pursuant to Law 20-00 on Industrial Property, customs authorities may—either ex officio or at the request of an interested party—detain imports and exports of counterfeit medicines bearing registered trademarks, applying the border measures provided by law. The General Directorate of Customs (DGA) operates an Intellectual Property Department tasked with executing these border enforcement measures.
OTHER REGULATIONS
Other statutes that may be invoked within the scope of an action against medicine counterfeiting include Law 358-05 on Consumer or User Protection, which criminalizes health and safety offenses as well as infractions involving alteration, adulteration, or fraud; and Law No. 42-08 on the Defense of Competition, which explicitly lists acts of deception and confusion within its non-exhaustive catalog of unfair competition.
Furthermore, the Constitution of the Republic must be considered, as Articles 61 and 52 recognize the right to comprehensive health and intellectual property, respectively. Additionally, the Medication Regulation (Decree No. 246-06) governs, among other aspects, the manufacturing, processing, quality control, supply, circulation, distribution, commercialization, information, advertising, importation, storage, dispensing, evaluation, registration, and donation of pharmaceuticals.
Finally, Article 2, paragraph 11 of Law 155-17 against Money Laundering and Terrorist Financing classifies medicine counterfeiting as a predicate offense—meaning an infraction that generates illicit assets susceptible to money laundering.
PRECAUTIONARY MEASURES (MEDIDAS DE COERCIÓN)
In cases where medicine counterfeiting is pursued through criminal channels, precautionary or coercive measures may be requested against the defendants pursuant to the Criminal Procedure Code, including:
- The posting of a sufficient economic guarantee (bail);
- A travel ban restricting departure from the country, the locality of residence, or the territorial boundaries set by the judge;
- An obligation to submit to the care or surveillance of a designated individual or institution, which must report regularly to the judge;
- An obligation to appear periodically before the judge or a designated authority;
- The placement of electronic monitoring devices, provided this involves no violence or injury to the defendant’s dignity or physical integrity;
- House arrest, either at their own residence or under the custody of another person, with or without surveillance as determined by the judge; and
- Pre-trial detention (prisión preventiva).
Additionally, in rem or property-based precautionary measures may be ordered against the infringers’ assets.
CONCLUSION
Dominican legislation provides a robust and sufficient legal framework to combat pharmaceutical counterfeiting, offering industrial property right holders numerous cutting-edge regulations that establish penalties, fines, and preliminary injunctions against defendants accused of this punishable act. Furthermore, specialized agencies have been established nationwide to investigate and prosecute this crime effectively.
In certain scenarios, industrial property right holders may invoke multiple statutes cited herein within a single proceeding, requesting the courts to impose a combination of various measures anchored across different laws. In other cases, it will be up to the right holder to determine which legal avenue and statute to deploy based on their specific objectives and strategy.
Pursuing medicine counterfeiting through criminal actions offers a distinct advantage, as it enables right holders to request coercive measures against perpetrators and secure punitive fines and prison sentences.
While combating medicine counterfeiting inherently safeguards industrial property rights, the joint efforts of public authorities and right holders in fighting this crime ultimately contribute to global health welfare and the development of fair commercial competition.
