Agreement 024-2018
- Decree: 16-2006
- Published: June 14, 2018
- Gazette: 34,666
- Category: Health
Summary
This regulation protects pharmaceutical test data (safety and effectiveness studies) for new medicines for 5 years from their approval in Honduras. It prevents other laboratories from using that information without the owner's permission, though it allows generic drug manufacturers to produce medicines if they conduct their own studies. ARSA is responsible for issuing protection certificates and maintaining a public database of protected products.
Considerations
Whereas the Republic of Honduras is a party to the Free Trade Agreement between the Dominican Republic, Central America, and the United States of America, and this legal regulation in its Article No. 15.10: Measures Related to Certain Regulated Products, specifically in its numeral one (1) subsections a), b), c), and d); and numeral two (2) subsections a) and b), make reference to the figure of "Protection of Test Data", which are those referring to the tests and experiments conducted to demonstrate the proper functioning and effectiveness of pharmaceutical products… where this regulation protects the holders of said products during a period of five years.- In this sense, no medication is patented in itself, so any laboratory can produce the same, provided that it demonstrates by its own means that the formula complies with the sanitary requirements established by law. Honduras having through the Sanitary Regulatory Agency the freedom to grant the protection of said data when these are requested as a requirement for the authorization of a new pharmaceutical product that wants to be marketed or to deny the protection of test data in the case that they are already in the public domain or in case of national emergency.
Whereas the State recognizes the right to protection of health and it is the duty of all to participate in the promotion and preservation of personal and population health.
Whereas it corresponds to the State through its agencies and organisms constituted in accordance with the Law, the regulation, supervision, and control of food, chemical, pharmaceutical, and biological products. That the primary purpose of the State is to promote commerce and the health of the population through the control and surveillance of products and establishments of sanitary interest.
Whereas through Legislative Decree No. 16-2006, the Law of Implementation of the Free Trade Agreement, Dominican Republic, Central America, United States is created and in its Title IV. Measures Related to Certain Regulated Products, Single Chapter. On the Protection of Data or Undisclosed Information in its articles 19, 20, 21, 22, 23, and 24, establish the provisions to protect, promote, and strengthen the bases of legal certainty for the protection of test data being this a regulation applicable in the administrative area and at the same time it is the competence of the National Authority as appropriate to maintain the protection of said data.
Whereas by Presidential mandate through Decree PCM-032-2017, dated April 28, 2017 and published in the Official Journal "La Gaceta" on May 19 of the present year, the Sanitary Regulatory Agency (ARSA) is created, as a decentralized entity of the Secretariat of State in the Office of Health (SESAL) assigned to the Sectorial Cabinet of Development and Social Inclusion with functional, technical, financial, and administrative independence, with legal personality, responsible for the supervision, review, verification, control, surveillance, and oversight of compliance with legal, technical, and administrative regulations of establishments, suppliers, products, and services of sanitary interest and of those that carry out activities or practice conduct that may impact or could impact the health of the population; and for the regulation, granting, renewal, modification, suspension, or cancellation of registrations, permits, licenses, certifications, and other sanitary authorizations. The Sanitary Regulatory Agency (ARSA) shall have its domicile in the Municipality of the Central District, with national jurisdiction.
Whereas it is the competence of the Sanitary Regulatory Agency (ARSA) to develop and update the normative framework that regulates establishments, services, and products of sanitary interest, as well as, it is an attribute to establish mechanisms to guarantee the quality of services and products in the market that may impact the health of the population, in the same manner it is the competence of ARSA to design and propose strategies to execute policies, plans, and projects within the framework of its functions. For this reason, since there does not exist in the Sanitary Regulatory Agency a regulation for Protection of Test Data for new pharmaceutical products, we find ourselves under the obligation to create said legal norm.
Whereas the Sanitary Regulatory Agency once having the draft project of the Regulation for Protection of Test Data, this was submitted for public consultation, for a period of thirty (30) days, a process that was published on the Official Page of said Institution, giving a reasonable time to receive consultations or observations, after this period has elapsed, taking into consideration the observations made to said document, it is submitted for legal review for its approval.
Amendments
- Modified by: Acuerdo Ejecutivo No. 087-2015 — Suspensión de modalidades de asignación de contingentes arancelarios para maíz y arroz conforme RD-CAFTA (Amendment) — articles 13, 15
Articles
For purposes of the following regulation, the following shall be defined:
Competent Health Authority: The Health Regulatory Agency (ARSA), as the authority responsible for the application of this regulation. Test Data Protection Certificate: Certificate issued by the Health Authority that certifies the granting of rights provided for in this Regulation. Test data: Information containing the results of pre-clinical and clinical studies of Phase I, II and III, through which the safety and efficacy of a pharmaceutical product is demonstrated. Chemical Entity: Active ingredient, that is, a molecule endowed with pharmacological activity, that has not been previously used for any pathological indication of a pharmaceutical product. New Pharmaceutical Product: Pharmaceutical product that contains a new active ingredient and whose commercialization has not been authorized for commercialization in Honduras. Other Undisclosed Data: That information that has not been published, by any means, in a form sufficient for a person to have knowledge of the same. Such as the safety and efficacy of a pharmaceutical product that is not found in clinical trials phases I, II and III. Pharmaceutical Products: They are synthetic chemical medicines, biological medicines, vaccines, blood derivatives, biotechnological medicines, orphan medicines, radiopharmaceuticals. Holder: Natural or legal person, owner or to whom it designates, who has in his name a legal document that grants him a right to protection of test data or undisclosed information, related to the requirements for authorization of commercialization of pharmaceutical products.
For purposes of the application of this regulation, the protection conferred shall not extend to modifications or innovations made in the following aspects: 1. Uses or therapeutic indications different from those authorized in other registers or previous health authorizations of the same chemical entity. 2. Changes in the route of administration or forms of dosage from those authorized in other registers or previous health authorizations of the same chemical entity. 3. Changes in pharmaceutical forms, formulations or combinations of already authorized or registered chemical entities. 4. Salts, complexes, crystalline forms or those chemical structures that are based on a chemical entity with prior registration or health authorizations. 5. Those that involve new commercial presentations.
Whoever requests approval in the country for commercialization of a new pharmaceutical product must take into account that they must present to the Competent Health Authority complete undisclosed test data, to the satisfaction of the health authority, on the safety and efficacy of the product; the application shall be submitted within twelve (12) months from the date of the first commercialization approval granted in the world for a product containing the same chemical entity that was first registered. TERM OF VALIDITY OF PROTECTION
Test data or other undisclosed information that the product holder requests shall be protected against all unfair commercial use for a period of five (5) years, counted from the date of approval for commercialization in the country.
The holder of the innovative product or third-party applicants authorized by it or who present their own clinical studies, may require from the Competent Health Authority a Certificate of Protection of Test Data. REQUIREMENTS FOR APPLICANT HOLDERS
The applicant may request the test data protection certificate jointly with the request for authorization of the sanitary registration of the innovative product, having to present the detailed requirements
below, in addition to those established in the current regulations.
- a)
Test data or other undisclosed information or, a certificate of the authorization obtained in another country, where the respective test data or other undisclosed information on the safety and efficacy of the new pharmaceutical product were presented.
- b)
Sworn declaration before a notary stating that it is a new pharmaceutical product and that there is no valid patent covering the product in question.
- c)
An authentic document when applicable, indicating all national and foreign patents covering the new pharmaceutical product or its approved use, in order to prevent the authorization of commercialization of products covered by patents without the consent of the patent holder. This list shall include information on the sanitary registration number, trade name, date on which the validity period expires and the identification of the holder. In the event that there is no patent covering the product or its approved use, this situation must be stated in writing. REQUIREMENTS FOR THIRD-PARTY APPLICANTS
When a third party requests authorization for commercialization of the innovative pharmaceutical product, they must present consent in writing, signed and sealed by the natural or legal person who initially generated the information and obtained approval for commercialization, as well as comply with the requirements b) and c) set forth in the previous article. REGARDING RESPONSIBILITY AND CONFIDENTIALITY
The holder of a protection certificate may request from the competent courts, within the non-extendable period of five (5) years counted from the date of approval of the new product in the country, the suspension of commercialization by a third party of the protected product, provided that: a) The third party did not have the consent of the holder of said certificate to obtain approval for its commercialization, b) The third-party applicant had not presented to the competent Health Authority test data generated independently from that of the certificate holder. The holder of the protection certificate may request from the competent Health Authority the provisional measures provided for in applicable legislation in order to prevent the infringement of the rights conferred in accordance with this regulation.
When the Competent Health Authority receives undisclosed test data, it shall preserve under confidentiality for a period of five (5) years, counted from the date of obtaining the Test Data Protection Certificate, those data that the applicant for the protection certificate specifically declares have not been disclosed and with respect to which it has taken reasonable measures to prevent its disclosure, on the condition that they are presented jointly with the request for approval for commercialization of the new product.
The Competent Health Authority must take necessary measures to prevent unauthorized disclosure of undisclosed data, except when disclosure is necessary in order to protect the public, such as to prevent consumer error or to protect human life, health or safety.
Whoever, without being the holder of test data or undisclosed information, has used, acquired or disclosed information without authorization from its holder, shall be liable to administrative sanctions for economic damages and losses caused by their willful action, without prejudice to civil and criminal sanctions.
By granting the Test Data Protection Certificate, the Competent Health Authority grants the holder the essential right of exclusive protection of the commercialization of the protected product, therefore, the Competent Health Authority shall not reject any request for approval for commercialization, but rather shall not grant the right thereof, during the exclusivity period, this in order not to delay the process that would imply initiating or completing the approval process after that date.
GRANTING OF PROTECTION
The Test Data Protection Certificate shall be issued by the Competent Health Authority, shall indicate the name and address of its holder, the protected product and the duration of the protection. Likewise, it shall contain a reference to the undisclosed data presented to the Competent Health Authority.
The issuance of the Certificate, as well as its transmission, shall be registered with the Competent Health Authority to have effect against third parties, and shall be subject to payment thereof. The granting of the certificate and, if applicable, its transmission, shall be published in written, digital or electronic media that the Competent Health Authority deems appropriate. SUSPENSION AND CANCELLATION OF THE TEST DATA PROTECTION CERTIFICATE
Intellectual property rights are not absolute, but rather are subject to the public interest, therefore, in situations such as public health or national emergency, among others, they can justify the termination of protection exclusivity of the product. Likewise, in the event that the holder of the Test Data Protection Certificate incurs in abuses or practices declared as anti-competitive, the Competent Health Authority must terminate the exclusivity period.
The competent Health Authority may declare the cancellation of the Certificate in the following cases:
- a)
At the request of the holder or a natural or legal person authorized by said holder;
- b)
For reasons of public interest such as public health, national security, emergency or circumstances of extreme urgency that justify the termination of the exclusivity period;
- c)
When the competent Health Authority determines, as a result of an administrative or judicial proceeding ordered by the corresponding authority, that the holder of the Protection Certificate has incurred in abuses of its rights, for example, through practices declared as anticompetitive;
- d)
When the competent Health Authority determines, as a result of an administrative or judicial proceeding ordered by the corresponding authority, that the Protection Certificate has been granted in contradiction with some provision of this regulation and other applicable legal standards, its revocation shall be warranted. The act by which the Certificate is cancelled may be appealed before the competent Health Authority. DATABASE AND NOTIFICATION OF CHEMICAL-PHARMACEUTICAL SPECIALTIES WITH TEST DATA PROTECTION
The competent Health Authority shall develop a database on its website, which it shall keep updated and available for any citizen to consult, it shall include a list and the corresponding information referred to in letter c) of Article 6, likewise, a copy shall be sent to the Institute of Property, to the General Directorate of Intellectual Property within fifteen (15) business days following the admission of the request. The aforementioned database shall contain the general data of the product such as the trade name, active ingredient, name of the holder of the pharmaceutical product, whose test data enjoy protection and the expiration date of said protection. EFFECTIVE DATE
This Regulation is of general use for the institution and shall not contravene the provisions of the legal standards currently in force regarding this matter in our country and shall take effect as of its date of publication in the Official Gazette "La Gaceta". COMMUNICATE AND PUBLISH. - Given in the city of Comayagüela, municipality of the Central District on the eleventh (11) day of the month of June of the year two thousand eighteen (2018). _________________________________ DR. FRANCIS RAFAEL CONTRERAS COMMISSIONER PRESIDENT ______________________________ ATTY. DILCIA ANABEL MEDINA GENERAL SECRETARY
Related laws
- Regulation on Protection of Test Data (Agreement No. 24-2018) — This regulation protects scientific data of new medications against unfair commercial use for 5 years from their approval in Honduras. It applies to pharmaceutical companies seeking to sell innovative drugs, allowing them to be the sole sellers during the protection period, unless there is a national emergency or abuse of rights. (Decree 16-2006, 2018)
- Reglamento — Reglamento del Consejo Nacional de Protección — This regulation organizes how the National Protection Council works, a body that oversees and advises the system protecting human rights defenders, journalists, and social communicators in Honduras. It establishes who comprises it (government and civil organization representatives), what they can do, their rights and duties, and how they make decisions in their meetings.
- Acuerdo No. 024-2018 — Reglamento de Protección de Datos de Prueba de Nuevos Productos Farmacéuticos — This regulation protects test data for new medications with never-before-used chemical molecules from unfair copying for 5 years from their approval in Honduras. It benefits pharmaceutical companies that invest in developing innovative medicines, allowing them to prevent competitors from using their clinical studies to market the same product without authorization. (Decree 024-2018, 2018)
- Reglamento — Reglamento para la Protección de Zonas Especiales (Zonas de Recarga y los Acuíferos) en San Pedro Sula
- Reglamento — Reglamento Especial para la Protección y Mantenimiento de Obras contra Inundaciones — This regulation establishes mandatory standards for protecting and maintaining flood control works (embankments, culverts, gabions, and channels) in the Sula Valley. It requires municipalities, communities, and authorities to regularly inspect these structures, prohibit their misuse, prevent vandalism, and enforce penalties against those who damage them, thereby protecting lives, property, and the environment in the region.