À propos de la propriété intellectuelle Formation en propriété intellectuelle Respect de la propriété intellectuelle Sensibilisation à la propriété intellectuelle La propriété intellectuelle pour… Propriété intellectuelle et… Propriété intellectuelle et… Information relative aux brevets et à la technologie Information en matière de marques Information en matière de dessins et modèles industriels Information en matière d’indications géographiques Information en matière de protection des obtentions végétales (UPOV) Lois, traités et jugements dans le domaine de la propriété intellectuelle Ressources relatives à la propriété intellectuelle Rapports sur la propriété intellectuelle Protection des brevets Protection des marques Protection des dessins et modèles industriels Protection des indications géographiques Protection des obtentions végétales (UPOV) Règlement extrajudiciaire des litiges Solutions opérationnelles à l’intention des offices de propriété intellectuelle Paiement de services de propriété intellectuelle Décisions et négociations Coopération en matière de développement Appui à l’innovation Partenariats public-privé Outils et services en matière d’intelligence artificielle L’Organisation Travailler avec nous Responsabilité Brevets Marques Dessins et modèles industriels Indications géographiques Droit d’auteur Secrets d’affaires Académie de l’OMPI Ateliers et séminaires Application des droits de propriété intellectuelle WIPO ALERT Sensibilisation Journée mondiale de la propriété intellectuelle Magazine de l’OMPI Études de cas et exemples de réussite Actualités dans le domaine de la propriété intellectuelle Prix de l’OMPI Entreprises Universités Peuples autochtones Instances judiciaires Ressources génétiques, savoirs traditionnels et expressions culturelles traditionnelles Économie Égalité des genres Santé mondiale Changement climatique Politique en matière de concurrence Objectifs de développement durable Technologies de pointe Applications mobiles Sport Tourisme PATENTSCOPE Analyse de brevets Classification internationale des brevets Programme ARDI – Recherche pour l’innovation Programme ASPI – Information spécialisée en matière de brevets Base de données mondiale sur les marques Madrid Monitor Base de données Article 6ter Express Classification de Nice Classification de Vienne Base de données mondiale sur les dessins et modèles Bulletin des dessins et modèles internationaux Base de données Hague Express Classification de Locarno Base de données Lisbon Express Base de données mondiale sur les marques relative aux indications géographiques Base de données PLUTO sur les variétés végétales Base de données GENIE Traités administrés par l’OMPI WIPO Lex – lois, traités et jugements en matière de propriété intellectuelle Normes de l’OMPI Statistiques de propriété intellectuelle WIPO Pearl (Terminologie) Publications de l’OMPI Profils nationaux Centre de connaissances de l’OMPI Série de rapports de l’OMPI consacrés aux tendances technologiques Indice mondial de l’innovation Rapport sur la propriété intellectuelle dans le monde PCT – Le système international des brevets ePCT Budapest – Le système international de dépôt des micro-organismes Madrid – Le système international des marques eMadrid Article 6ter (armoiries, drapeaux, emblèmes nationaux) La Haye – Le système international des dessins et modèles industriels eHague Lisbonne – Le système d’enregistrement international des indications géographiques eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange Médiation Arbitrage Procédure d’expertise Litiges relatifs aux noms de domaine Accès centralisé aux résultats de la recherche et de l’examen (WIPO CASE) Service d’accès numérique aux documents de priorité (DAS) WIPO Pay Compte courant auprès de l’OMPI Assemblées de l’OMPI Comités permanents Calendrier des réunions WIPO Webcast Documents officiels de l’OMPI Plan d’action de l’OMPI pour le développement Assistance technique Institutions de formation en matière de propriété intellectuelle Mesures d’appui concernant la COVID-19 Stratégies nationales de propriété intellectuelle Assistance en matière d’élaboration des politiques et de formulation de la législation Pôle de coopération Centres d’appui à la technologie et à l’innovation (CATI) Transfert de technologie Programme d’aide aux inventeurs WIPO GREEN Initiative PAT-INFORMED de l’OMPI Consortium pour des livres accessibles L’OMPI pour les créateurs WIPO Translate Speech-to-Text Assistant de classification États membres Observateurs Directeur général Activités par unité administrative Bureaux extérieurs Avis de vacance d’emploi Achats Résultats et budget Rapports financiers Audit et supervision
Arabic English Spanish French Russian Chinese
Lois Traités Jugements Parcourir par ressort juridique

Bolivie (État plurinational de)

BO030

Retour

Supreme Decree No. 29004 of January 9, 2007, Introducing a Prior Consent Step in Procedures for Patent Application for Pharmaceutical Products and/or Processes

 SUPREME DECREE No. 29004

1.

OFFICIAL GAZETTE OF BOLIVIA

SUPREME DECREE No. 29004

Courtesy translation provided by WIPO, © 2011

EVO MORALES AYMA CONSTITUTIONAL PRESIDENT OF THE REPUBLIC

WHEREAS:

Subparagraph (a) of Article 7 of the Political Constitution of the State states that any person has the fundamental right to life, health and safety; Articles 158 and 164 also stipulate that the State has the obligation to defend human capital by protecting the health of the population, and that the rules on public health are binding and compulsory.

One of the fundamental principles is the Right to Health, in accordance with international agreements such as the International Covenant on Economic, Social and Cultural Rights; the Agreement on Trade-Related Aspects of Intellectual Property Rights – TRIPS; and the Doha Declaration on the TRIPS Agreement and Public Health of the World Trade Organization – WTO, which states that the TRIPS Agreement must be interpreted and applied in a way that protects public health and promotes access to all medicines.

The World Health Organization – WHO reaffirms the right of its member countries, which include Bolivia, to make full use of the flexibilities included in the TRIPS Agreement to protect public health and boost access to medicines.

It is necessary to protect Public Health and access to medicines for all Bolivians and foreigners living or staying in the national territory, reaffirming the obligations established in the Political Constitution of the State.

Article 2 of the Health Code, approved by Decree Law No. 15629 of July 18, 1978, states that health is a public interest good, and that it is the duty of the State to protect the health of the individual, the family and the population as a whole.

Article 4 of Law No. 3351 of February 21, 2006 – Organization of the Executive Branch Act, establishes the responsibilities of the Ministry of Health and Sport as including the regulation, planning, control and leadership of the National Health System and the private and public subsectors of Social Security.

Law No. 1737 of December 17, 1996, Medicines Act establishes, in Articles 1 and 3, mechanisms for the regulation and control of medicines, in accordance with the Medicines Policy established in Articles 1 and 3 of Supreme Decree No. 25235 of November 30, 1998, Regulations under the Medicines Act.

The Ministry of Health and Sport, subject to Ministerial Resolution No. 580 of August 29, 2006, approves the Organizational Structure of the Unit of Medicines – UNIMED, so that it complies with the obligations stipulated in the Medicines Act and the Regulations thereunder.

Supreme Decree No. 27938 of December 20, 2004, amended by Supreme Decree No. 28152 of May 16, 2005, establishes the jurisdiction of the National Intellectual Property Service – SENAPI, as the competent national office to administer the intellectual property regime, and for the monitoring and effective protection of the rights of exclusivity in relation to industrial property.

OFFICIAL GAZETTE OF BOLIVIA

The State must protect the public interest, guaranteeing the social function that must be fulfilled by private ownership; in this sense, it is necessary to establish a special procedure for the treatment of pharmaceutical products, as differentiated social goods.

IN COUNCIL OF MINISTERS,

D E C R E E S:

ARTICLE 1. (OBJECTIVE). The objective of this Supreme Decree is to establish a prior consent procedure in a product patent application and/or pharmaceutical invention process.

ARTICLE 2. (PRIOR CONSENT). For the purposes of this Supreme Decree, Prior Consent shall mean the concrete mechanism to determine whether the content and scope for which protection is sought in the patent application do not interfere with the right to health and access to medicines.

ARTICLE 3. (GRANTING OF PATENTS). The granting of pharmaceutical invention patents for products and procedures shall depend on the Prior Consent given by the Unit of Medicines and Health Technology – UNIMED.

ARTICLE 4. (COMPETENT ENTITIES). The Competent Entities are as follows:

(a) the National Intellectual Property Service – SENAPI, which is responsible for analyzing the requirements for the award of patents and the registration procedure.

(b) The Unit of Medicines and Health Technology – UNIMED, of which the main responsibility is to issue Prior Consent in response to a patent application for a pharmaceutical invention.

ARTICLE 5. (RESPONSIBILITY). Responsibilities of competent entities:

(a) SENAPI, following the award of an invention patent in the pharmaceutical area, shall refer the relevant procedure to UNIMED.

(b) when the result of the Prior Consent is positive, UNIMED shall refer to SENAPI the pharmaceutical invention patent application, giving the grounds for the result of the Prior Consent. If the result of the Prior Consent is negative, UNIMED shall refer the patent application to SENAPI, giving the grounds for the refusal and supporting it with documentation.

ARTICLE 6. (TECHNICAL COMMISSION FOR PRIOR CONSENT). In accordance with Article 1 of this Supreme Decree, UNIMED will form a Technical Commission for Prior Consent, to enable objective decisions to be made to analyze the pharmaceutical invention patent application referred by SENAPI.

TRANSITIONAL PROVISIONS

SINGLE TRANSITIONAL PROVISION. The Ministry of Health and Sport shall draft and approve, 90 (ninety) days from the publication of this Supreme Decree, the supplementary regulations needed to apply this rule.

All the provisions that contradict the present Supreme Decree are repealed and abolished.

The Ministers of State for the Offices of Production and Micro-enterprise and Health and Sport shall be responsible for the implementation and enforcement of the present Supreme Decree.

Done at the Palace of Government in the city of La Paz, on the ninth day of the month of January of the year two thousand and seven.

OFFICIAL GAZETTE OF BOLIVIA

SIGNED BY EVO MORALES AYMA, David Choquehuanca Céspedes, Juan Ramón Quintana Taborga, Alicia Muñoz Alá, Walker San Miguel Rodríguez, Casimira Rodríguez Romero, Hernando Larrazábal Córdova, Luís Alberto Arce Catacora, Abel Mamani Marca, Celinda Sosa Lunda, Salvador Ric Riera, Hugo Salvatierra Gutiérrez, Carlos Villegas Quiroga, José Guillermo Dalence Salinas, Santiago Alex Gálvez Mamani, Félix Patzi Paco, Nila Heredia Miranda.