Patents and the Health Sector: IP strategies that might help alleviate the Global Health Crisis in the Colombian Context
Hello, everyone:
One of the questions of my final exam y the Patent X Course, was to reccomend IP strategies that might help alleviate the Global Health Crisis in my country (Colombia). For providing a context, the strategies studied in this course included the following:
1) Improve the procedures in low and middle-income countries [LMICs] for processing applications for marketing authorization;
2) Deploy better systems for detecting and eliminating substandard and falsified medical products [SFMPs];
3) Enable and encourage pharmaceutical firms to employ both international and intra-national differential pricing more often;
4) Facilitate increased use of voluntary licenses;
5) Employ apprenticeship, procurement policies, and limits on clinical trials to increase local production of vaccines and medicines in LMICs;
6) Impose compulsory licenses on the patents pertaining to crucial medical products;
7) Tighten the inventive-step and enablement requirements of patent law in LMICs;
8) Avoid or repeal extensions of the duration of patents on pharmaceutical products;
9) Advise judges in LMICs to minimize the use of injunctions in patent-infringement suits involving pharmaceutical products;
10) Extend the duration of patent protection and/or data-exclusivity protection in upper-income countries [UICs] for (a) vaccines; (b) neglected diseases; and (c) breakthrough drugs of all sorts;
11) Adjust the doctrines of claim construction, equivalents, and remedies in the patent laws of UICs to augment incentives to produce (a) vaccines; (b) neglected diseases; and (c) breakthrough drugs of all sorts;
12) Increase the use of governmental and philanthropic grants to support research and development for vaccines and medicines pertaining to neglected diseases;
13) Impose stricter conditions upon governmental and philanthropic grants of all sorts to increase the availability of their fruits in LMICs;
14) Increase the use of governmental and philanthropic prizes to support research and development for vaccines and medicines pertaining to neglected diseases;
15) Require pharmaceutical firms to achieve each year a social-responsibility index.
Which of them I consider more promising? My response for the Colombian case (that I want to shere with all of you) was as follows:
One of the lessons learned from the COVID-19
crisis, is that our country needs to recover its ability to produce vaccines.
For more than a century, Colombia was an avid vaccine producer and exporter
(yellow fever, cholera, rabies, diphtheria, tetanus, whooping cough, typhoid
fever and tuberculosis), but as a result of several factors (the economic
crisis of 1990s, deterioration of the labs belonging to the National Institute
of Health – INS) it stopped production in 2002 (of yellow fever vaccines)
Only as of 2022, the Ministry of Health, the
Ministry of Science, Technology & Innovation, in alliance with local
authorities of Bogotá and Antioquia, and the private sector (the Colombian Sura
Group, and the Chinese pharmaceutical giant Sinovac), started preparations to operate
their plants of production by 2027, in order to become self-sufficient
On the other side, the Colombian pharmaceutical
sector faces a challenging year 2024, characterized by the uncertainty about
the future of the Social Security System in Health, the need to strengthen
regulatory institutions, and the search of solutions for drug shortages. All of
it in a rising inflation scenario, with effect on prices and production costs
Our National Pharma sector is composed of
almost 1200 companies, affiliated to three Associations (ANDI, AFIDRO and
ASINFAR). With a balance of Imports and Exports (year 2022) of US$3.951 million
and US$418 million respectively (with exports to Ecuador, 28.7%; Perú, 11.3%;
Panama, 9.3%; and Chile, 6.9%), the combined growth of the sector was 7.6% between
2014 and 2018
Our National Health System (which has almost
universal coverage of 51.7 million of affiliates, 98.46% of the population),
functions as a managed free competition model of two regimes (contributory,
with 23 million of users, for affiliated with formal employment or
self-employed; and subsidized, for the rest of population, 26.5 million),
financed by the ADRES as the public administrator of resources (originating
from taxes and subsidies), managed by the EPS, and operated by a web of (public
and private) Health Providers of Service (IPS), being possible to use a private
Health Insurance, without resign to the affiliation to an EPS
The system faces serious difficulties of
financial sustainability, with the pressure of an increased demand, the need to
remove entry barriers for users and to guarantee access to health as a
fundamental right, and difficulty on access to new technology with heavy costs
Since October 2022, we are experiencing drug
shortages in more than 1200 active principles like acetaminophen, amoxicillin,
calcium and dexamethasone, caused by the increase of the demand for health
prevention against COVID-19; rising conversion rate, collapse of supply chains
and increase in the cost of supplies (90% of active principles and excipients
are imported); and delays on administrative approval procedures by the National
Institute of Vigilance on Food and Drugs – INVIMA, among others
Worst of all, as of today, the Colombian Health
System is passing through a critical moment, with some Health Promoting
Enterprises (EPS) considering their voluntary retirement or liquidation
(Compensar EPS, with 2 million of affiliates), while others (Sanitas EPS and
Nueva EPS, the last one with 10 million of affiliates) are facing imminent
State interventions
In such a difficult context, for recovering its
sanitary sovereignty while fighting to avoid the collapse of the Health System,
Colombia needs to work heavily on the following two strategies
(a) To create an adequate infrastructure
(vaccine production plants); and
(b) To train workers to fill/finish Pharma
manufacturing (the integrated process, from sterilizing and filling vials with
vaccines, biological and other pharmaceutical drug substances, to finishing the
packaging process for distribution)
Accordingly, I recommend three strategies for their relevance
in the current Colombian scenario:
(a) Improve the procedures for processing
applications for marketing authorization. It is widely recognized that the
filing process for the approval of Health Registration before the INVIMA is far
much longer
(b) Enable and encourage pharmaceutical firms
to employ both international and intra-national differential pricing more often;
in order to reduce the gap between brand-name and generic drugs in the
Colombian market, which during the period 2010 – 2015 was the second more
expensive in Latin America, after Brazil
This is important, because the price difference
between a brand-name drug and a generic one (with denomination of origin) is
about 70%. The difference between the final price of an imported drug and an
equivalent nationally produced is at least 8,1 to 1, making clear that
strengthening local production of generic drugs with denomination of origin is
a key strategy for generating more sanitary sovereignty, leveling trade balance
and mitigating drug shortages
(c) Facilitate increased use of voluntary
licenses. It is the logical proposal, considering the subjacent dependency of
the Colombian market on imports, for drugs, active principles and other inputs
for local production. So, in spite of being laid down by the Andean Decision
486, 2000, our Communitarian law
This measure has been adopted in Colombia, only
as of October 2023, over Dolutegravir, an HIV drug, whose current price is
COP$4.818.894, against a potential price of COP$173.893 for the generic version
Finally, it’s interesting to point out that
Colombia (whose IP legislation has adopted the statutory and case law of the
Andean Community of Nations), in spite of adopting the general rule that direct
infringement is demonstrated by a literal interpretation of the claims
(peripheral claiming), has not excluded infringement by equivalence (a doctrine
not expressly contemplated by the Andean Decision 486, 2000, but also not
expressly excluded). In a recent case (Telemetrik vs. Excelec), the Andean
Court set the first precedent with respect to the applicability of the doctrine
of equivalents in the Andean Community
Referencias
Aguirre Vargas, V. (12 de December de 2019). ¿Registro
sanitario de medicamentos en 180 días? Asuntos Legales:
https://www.asuntoslegales.com.co/analisis/viviana-aguirre-vargas-2943274/registro-sanitario-de-medicamentos-en-180-dias-2943273
Álvarez, R., &
González, A. (April de 2020). Análisis comparativo de los precios de los
medicamentos en América Latina. Revista de la CEPAL(130), 29 - 43.
https://repositorio.cepal.org/server/api/core/bitstreams/0ecc4046-2e6a-4d68-b0c1-e2a9a2d043ee/content
Amaya Rodríguez, C. F.
(June de 2021). El régimen de licencias obligatorias en la decisión 486 de
2000. Superintendencia de Industria y Comercio - SIC:
https://www.sic.gov.co/ruta-pi/junio-2021/jurisprudencia/el-regimen-de-licencias-obligatorias-en-la-decision-486-de-2000
Ángel, D. (6 de October
de 2023). Declaración de interés público y licencias obligatorias a medicamentos
en Colombia y Latinoamérica. Consultorsalud:
https://consultorsalud.com/licencias-obligatorias-medicamentos-colombia/
Ángel, D. (5 de October
de 2023). Dolutegravir a licencia obligatoria, declara el Minsalud ¿Un
parteaguas para las patentes en Colombia? Consultorsalud:
https://consultorsalud.com/dolutegravir-a-licencia-obligatoria-minsalud/
Asociación Nacional de
Industriales - ANDI. (1 de July de 2021). Cuando Colombia hacía vacunas.
Asociación Nacional de Industriales - ANDI: https://www.andi.com.co/Home/Noticia/16011-cuando-colombia-hacia-vacunas
Cambio. (30 de January
de 2024). ¿Qué le espera a la industria farmacéutica en 2024? Cambio:
https://cambiocolombia.com/contenido-especial/que-le-espera-la-industria-farmaceutica-en-2024
Canal Capital. (6 de
September de 2023). ¿Cuáles son los retos de producir vacunas en Bogotá?
Canal Capital:
https://www.canalcapital.gov.co/bogota-region/produccion-vacunas-bogota-retos
Canal Capital. (8 de
September de 2023). Historia de la producción de vacunas en Colombia.
Canal Capital:
https://www.canalcapital.gov.co/ahora-vote/historia-la-produccion-vacunas-colombia#:~:text=El%20Ministerio%20de%20Salud%20anunci%C3%B3,a%20finales%20de%20este%20a%C3%B1o.
Chemtech International.
(2 de February de 2022). Fill/Finish Pharma manufacturing explained.
Chemtech International:
https://chemtech-us.com/fill-finish-pharma-manufacturing-explained/
Contreras Ríos, J. P.
(15 de Septiember de 2023). Medicamentos con registro Invima tendrán
cambio en tiempos de vigencia: será indefinida. El Tiempo:
https://www.eltiempo.com/salud/medicamentos-con-registro-invima-tendran-cambio-en-tiempos-de-vigencia-sera-indefinida-806589
Cueto, J. C. (5 de
April de 2024). Cómo funciona el sistema de salud de Colombia que Petro no
logra reformar (y cómo se diferencia de otros países de América Latina).
BBC News: https://www.bbc.com/mundo/articles/cxrz3prg06wo
Forbes. (15 de April de
2024). Gobierno instalará mesas de trabajo con las EPS para buscar salida
a crisis del sector salud. Forbes: https://forbes.co/2024/04/15/actualidad/gobierno-instalara-mesas-de-trabajo-con-las-eps-para-buscar-salida-a-crisis-del-sector-salud
Ministerio de Ciencia,
Tecnología e Innovación - MinCiencias. (6 de April de 2022). Minciencias
traza la hoja de ruta para la producción de Vacunas en Colombia.
Ministerio de Ciencia, Tecnología e Innovación - MinCiencias:
https://www.minciencias.gov.co/sala_de_prensa/minciencias-traza-la-hoja-ruta-para-la-produccion-vacunas-en-colombia
Moreno Mattar, O. (1 de
March de 2024). Contexto para la inversión en el sector Farmacéutico en
Colombia. NeuroEconomix:
https://neuroeconomix.com/es/contexto-para-la-inversion-en-el-sector-farmaceutico-en-colombia/
Muñoz, C. F. (5 de
April de 2024). El futuro del aseguramiento y de las EPS en Colombia: colapso,
emergencia y posibilidades en el horizonte del sistema de salud.
Consultorsalud:
https://consultorsalud.com/el-futuro-del-aseguramiento-y-de-las-eps-en-colombia-colapso-emergencia-y-posibilidades-en-el-horizonte-del-sistema-de-salud/
Ortiz Álvarez, D. V. (7
de April de 2024). Así es la crisis del sistema de salud de Colombia: ¿qué
salidas sugieren los expertos? El Tiempo:
https://www.eltiempo.com/salud/la-reforma-ideal-del-sistema-de-salud-3331095
Portafolio. (10 de
April de 2023). Cuándo empezaría la producción de vacunas en primera
fábrica del país. Portafolio:
https://www.portafolio.co/negocios/empresas/fabrica-de-vacunas-en-colombia-cuando-empezaria-la-produccion-581206
Restrepo Zea, J. H. (25
de February de 2024). ¿Viene un colapso del sistema de salud? Razón
Pública: https://razonpublica.com/viene-colapso-del-sistema-salud/
Rincón, A., &
Portilla, E. (24 de November de 2023). Colombia: Why a Robust Patent
System is Leading to Litigation Wins. IAM:
https://www.iam-media.com/review/the-patent-litigation-review/2024/article/colombia-why-robust-patent-system-leading-litigation-wins
Roa Ortiz, C. C.
(January - July de 2021). Utilidad de las licencias obligatorias para el
acceso a los medicamentos: Lecciones de Suramérica y análisis del caso
colombiano. Revista de la propiedad inmaterial(31), 65 - 112.
https://revistas.uexternado.edu.co/index.php/propin/article/view/7269/10182
Rodríguez, D. P. (20 de
Junio de 2023). El país aumentó su productividad en el sector farmacéutico
a 35% de su capacidad. La República:
https://www.larepublica.co/economia/el-pais-aumento-su-productividad-en-el-sector-farmaceutico-a-35-de-su-capacidad-3640294
Rodriguez, D. P. (24 de
April de 2023). Estas son cuatro razones que explican el fenómeno de la
escasez de medicamentos. La República:
https://www.larepublica.co/economia/estas-son-cuatro-razones-que-explican-el-fenomeno-de-la-escasez-de-medicamentos-3598286
Sánchez Romero, J. (6
de April de 2024). Con la crisis de las EPS, el Gobierno quedaría
responsable de más de la mitad de los afiliados a la salud en Colombia.
Infobae:
https://www.infobae.com/colombia/2024/04/06/con-la-crisis-de-las-eps-el-gobierno-quedaria-responsable-de-mas-de-la-mitad-de-los-afiliados-a-la-salud-en-colombia/
Solano Betancourt, J.
(8 de May de 2023). El sector farmacéutico se expandirá más de 2% este año
liderado por Tecnoquímicas. La República:
https://www.larepublica.co/empresas/el-sector-farmaceutico-se-expandira-mas-de-2-este-ano-liderado-por-tecnoquimicas-3609969
Vanegas, G. (24 de
April de 2023). Por primera vez, el Invima reconoce el represamiento de
los trámites de medicamentos en medio de los problemas de escasez. El
País:
https://elpais.com/america-colombia/2023-04-24/por-primera-vez-el-invima-reconoce-el-represamiento-de-los-tramites-de-medicamentos-en-medio-de-los-problemas-de-escasez.html
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