발간보고서
home > 자료실> 발간보고서
- 글자크기
Outlines on Regulatory Harmonization in Latin American and Caribbean Countries
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2015-12-04 | 조회수 | 1,504 |
| 원문 | |||
| 출처 | |||
Outlines on Regulatory Harmonization in
Latin American and Caribbean Countries
- 글 Kozlova Anastasia
(코즐로바 아나스타샤) - KHIDI 해외제약전문가
상임 컨설턴트
컨설팅 분야
- 기술 마케팅
- 중남미지역 의약품 해외수출 전략 및 시장개척
- 파트너링 및 수출계약
- 의약품 전략적 제휴 관리(Alliance Management)
주요 약력
- 2013-2015 엔파마 (에콰도르의약품구매공사) 대외협력/국제협력 팀장
- 2013 엔파마 (에콰도르의약품구매공사) 대외협력/국제협력 연구원
- 2007-2012 에콰도르 제약분야 전문컨설팅
- 2007 베그로드대학 (러시아)/언어학
The pharmaceutical industrialization embarked in Northern Hemisphere in XIX century, however in South and Central America advances in drug manufacturing were still conceiving the idea of creating an industry of production of drugs and other medicinal products. It was in the last decades of the nineteenth century, which made their appearance in this region, and patent medicine and pharmaceutical formulations reached this market. In fact, Mexico’s first Sanitary Registration dates back to 1927th.
In the struggle for the proper health stewardship in sanitary regulations vis-à-vis the protection of the quality of drugs for the population still remained a challenge for this region in the beginning of XX century. The medicinal products represented by the herbal preparation or even chemical formulations could hardly been controlled, being dispensed at the pharmacies or sold by local hawkers. With wide repertoire of ailments of that time, even in Europe, the deficiency of solid regulations oftentimes led to “sentence to death” medical conditions.
Contemporary pharma R&D stepwise breakthrough transformed the reality and imposed the Sanitary Authorities’ agenda a fundamental question, to protect the public from hazardous drugs, control the novel formulations and regulate the forthcoming panacea treatments that haven’t been exploited yet.
Meanwhile, the Latin American countries (LAC) passed through the hard array of undertakings at the forefront of long-running confrontation among the region, persistent political instabilities, economic crisis and which affected tremendously almost all countries of this group and impede the adequate development on the frontier of XX and XXI centuries.
Despite the outbreak of the international financial crisis in 2008, the countries of LAC achieved socioeconomic progress, political stability and international leadership. Today the region faces new challenges of security, employment opportunities and universal coverage, still being middle-income region and combating the heterogeneity and inequality.
Furthermore, these countries were specially imprisoned with patent outburst, being strong market tool and constraining factor, that delayed the proper development of industry and other restrictive practices, among them, discriminatory prices.
Amid the global overarching efforts toward the universal health coverage and regulatory harmonization, Latin American and Caribbean Regulatory Authorities firmly concerted public health measures within the last two decades, prioritizing the safety, quality and efficacy of medicines and medical devices, convergence of legal procedures associated with the drug development, pharmacovigilance and compliance with all enacted by the Constitutional law.
The following recent modifications and achievements have restructured the Regulatory systems from 2000 to 2015, ensuring the quality and optimizing the administrative processes of the Sanitary Registration Application.
- Harmonization of Public Health System in close cooperation with the regional and world regulatory agencies (WHO, PAHO, PANDRH);
- Incremented the State Expenditure to Health Sector, particularly apportioned to drug procurement within the Economical Integrated Allies in Central America and Caribbean states (CELAC, UNASUR, MERCOSUR, ALBA, , ALADI, CAN);
- Implementing time-saving on-line system for Drug Approval (Solicitud de Registro Sanitario);
- Homologation of registration among the region as a mean to impulse the import/ export for generics;
- Bioequivalence studies to guarantee the interchangeability of the drugs.
- Enhancing the protection of Catastrophic, Rare and Orphan diseases;
- Introduction of more rigorous regulatory frameworks related to Good Manufacturing Practices;
- Adoption of new regulations for biological drugs with group differentiating factor (vaccines, biotechnological, biosimilar, blood derivatives);
- Attaining the equilibrium of the market drug price to the public through introduction of the price controlling mechanism.
In the first place, the World Health Organization (WHO) and Pan American Health Organization (PAHO) play an important role in the convergence of the regulatory frameworks of LAC countries today. Due to its’ successful collaboration, in the LAC region raised an urgent need to create the National Drug and Medical Device Regulatory Authority that would put in place the essential foundations for regulations, enabling people to have access to safe, effective and quality medicines and would promote the rational use of drugs.
Therefore, the first autonomous Regulatory Agencies and Organizations started in Peru-DIGEMID (1990), Argentina- ANMAT (1992), Colombia- INVIMA (1994), Brazil- ANVISA (1999), Mexico- COFEPRIS (2001), El Salvador- DNM (2012), and in Ecuador-ARCSA (2012).
Aiming the same perspective these Regulatory Authorities founded a Pan American Network on Drug Regulatory Harmonization (PANDRH) that favorably resulted on the harmozation of the regulations among the Latin American and Caribbean region. Committed to the single outcome, PANDRH members succeeded to shorten and simplify the process of drug approval application, introducing the on-line application, with its’ equivalents: in Ecuador (VUE-Ventanilla Única Ecuatoriana), Peru (VUCE- Ventanilla Única de Comercio Exterior).
By the same token, with the need to boost the regional trade expansion, the following economic integration organizations were founded within the Latin America and Caribbean, generating potential economic ties, with the special tax exemptions and import tariffs benefits.
- CAN - Andean Community (Bolivia, Colombia, Ecuador, and Peru);
- MERCOSUR- Southern Common Market (Argentina, Bolivia, Brazil, Paraguay, Uruguay and Venezuela);
- UNASUR- Union of South American Nations, USAN (Bolivia, Colombia, Ecuador, Peru, Argentina, Brazil, Paraguay, Uruguay, Venezuela, Chile, Guyana, Suriname;
- ALBA -Bolivarian Alliance for the Peoples of Our America (Antigua and Barbuda, Bolivia, Cuba, Dominica, Ecuador, Grenada, Nicaragua, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines,Venezuela)
- ALADI-Latin American Integration Association (Argentina, Bolivia, Brazil, Chile, Colombia, Cuba, Ecuador, Mexico, Paraguay, Panama, Peru, Uruguay, Venezuela)
- CELAC- Community of Latin American and Caribbean States (33 member states)
From 2010, the SUCRE (in Spanish: Sistema Unitario de Compensación Regional, English: Unified System for Regional Compensation) is a regional virtual currency proposed for commercial exchanges between members of the regional trade bloc Bolivarian Alliance for the Americas (ALBA), as an alternative to the Free Trade Agreement of the Americas. The present financial initiative represents a shield to safeguard and increment the stability of regional markets, as a medium of exchange in order to decrease US influence and control of Latin American economies.
Over the last two years, the LAC countries considerably increased the public spending on safe and effective healthcare products. The statistical evidence corroborates that in 2015 Peru’s pharmaceutical products’ expenditure increased 85% that ascended significantly within the past years. By analogy, Ecuador’s state health expenditure went up to 4% of GDP with the 30% projected for the drugs.
The important regional augmentation in health expenditure is, likewise, the outcome of a consolidating regulations pertaining the catastrophic and rare diseases, which endeavor to meet the national demand in orphan drugs and satisfy the necessary expensive treatments for the patients in the region, in case of daily Food Supplements for children affected by Propionic Acidemia, Antiphospholipid syndrome or Tirosinemia Type I.
Another milestone achieved by LAC countries, when the government partly reduces or completely assumes the expenses incurred in the most costly illnesses: cancer, heart problems, stroke, and diabetes. A worthy example for such encouragement is “Ricarte Soto’s Law” in Chile, “Remediar” in Argentina.
Conversely, the ongoing efforts had reasonably balanced the market price of the drugs to the public in El Salvador in 2012, approving a new regulatory solution, as a Price Regulation (Reglamento para Determinación de Precio de Venta Máximo al Público de los Medicamentos y su Verificación, PVMP) that resulted in 35% cost reduction of the prescribed pharmaceutical products for this country. While in early 90’ Brazil was the first in Latin America to incorporate international price referencing instrument to control monopolistic products.
Analogically, the price controlling regulatory mechanisms in Brazil, Colombia, Chile, Ecuador and Peru promulgated the access to the affordable medicinal products, considered as strategic, promoting the generic products and targeted for the innovative products with the therapeutic advantage. And the Colombian National Commission for Medicines and Medical Devices Prices is a vivid illustration of it permitting stimulate competition of different suppliers and at the same time preventing abuses of monopoly and oligopoly segments.
The other noteworthy breakthrough in sanitary regulations is the recognition of Argentina, Brazil, Colombia, Cuba and Mexico as the National Regulatory Authorities of Regional Reference. PAHO qualifies these countries as Level 4 after a rigorous evaluation system where all mentioned integrates proved to be a competent national regulatory authority and with efficient performance, as it is recommended by PAHO/WHO in pursuit to guarantee the quality, safety and efficacy of medicinal products and medical devices.
- 끝 -
- 이전글 이전글이 없습니다.
- 다음글 다음글이 없습니다.
