Comisión Europea Acelera Compra Comunitaria de Medicamentos Esenciales
nueva Ley de Medicamentos Esenciales de la UE: Asegurando el Suministro y la Asequibilidad
Table of Contents
- nueva Ley de Medicamentos Esenciales de la UE: Asegurando el Suministro y la Asequibilidad
- EU Essential medicines Act: Q&A on Supply and Affordability
- What is the EU Essential Medicines Act?
- What are the main objectives of the Essential Medicines act?
- Which medicines are prioritized under this Act?
- Why is the EU introducing this new law?
- How will the Act address medicine shortages?
- How does the Act prioritize European manufacturing?
- What is the “joint procurement” system under the proposed law?
- What are ”strategic projects” as defined in the proposal?
- What are the concerns surrounding the funding for the Essential Medicines Act?
- How does this Act relate to EU security and Defense framework?
- Key Components and Reactions to the EU Essential Medicines Act
La Unión Europea ha propuesto una nueva legislación, la Ley sobre Medicamentos Esenciales, con el objetivo de garantizar un suministro estable y fiable de medicamentos, protegiendo la salud pública y asegurando la disponibilidad de fármacos a precios accesibles.
Según Várhelyi, “La Ley sobre Medicamentos Esenciales garantiza que los pacientes de la UE tengan acceso a los medicamentos que necesitan, cuando y donde los necesiten, a un precio asequible. En el actual contexto geopolítico esto se ha convertido en una prioridad aún mayor”.
Objetivos Estratégicos de la Ley
La propuesta establece como objetivo estratégico la seguridad del suministro y la disponibilidad de medicamentos esenciales. Para lograrlo, se requiere un planteamiento coordinado a nivel nacional y comunitario.
La ley se centra en los medicamentos incluidos en la lista de medicamentos esenciales de la UE elaborada por la Agencia Europea de Medicamentos (EMA) en 2023, priorizando los fármacos utilizados para tratar afecciones graves o con alternativas limitadas.
Abordando la Escasez de Medicamentos
La propuesta busca hacer frente a la grave escasez de medicamentos en la Unión Europea, especialmente de fármacos esenciales como antibióticos, insulina y analgésicos. Esta escasez se debe, en gran medida, a la dependencia de un número limitado de fabricantes o países.
La Comisión Europea reconoce la fuerte dependencia de la UE de proveedores extranjeros de principios activos farmacéuticos y los riesgos que plantean las interrupciones de las exportaciones. La pandemia de COVID-19 puso de manifiesto estas vulnerabilidades, subrayando la necesidad de una cadena de suministro más resistente.
Aunque las empresas farmacéuticas son responsables de garantizar un suministro suficiente de medicamentos, cada Estado miembro de la Unión Europea supervisa la distribución en su territorio. La mayoría de los desabastecimientos se gestionan actualmente a nivel nacional.
Priorizando la Fabricación Europea
La nueva propuesta pretende impulsar la inversión en la fabricación de medicamentos esenciales e ingredientes clave dentro de la UE, reduciendo la dependencia exterior. Una medida clave es una especie de indicación para “comprar productos europeos”, que introduce criterios de adjudicación de contratos públicos que dan prioridad a la seguridad del suministro sobre el precio.
En la práctica, cuando se detecte una vulnerabilidad en las cadenas de suministro y la dependencia de un único tercer país, los poderes adjudicadores de la UE aplicarán, cuando esté justificado, requisitos de contratación que favorezcan a los proveedores que fabriquen una parte significativa de estos medicamentos esenciales dentro de la UE.
Según un funcionario del bloque comunitario, “Se trata de aumentar la capacidad de producción de la UE y diversificar las cadenas de suministro para hacerlas más resistentes, aprovechando al mismo tiempo la demanda”.
Sistema de Contratación Conjunta
La propuesta introduce una categoría de medicamentos sometida a estrecha revisión: los medicamentos de interés común. Se trata de fármacos con escasa disponibilidad y accesibilidad en al menos tres estados miembros de la UE, como los utilizados para el tratamiento de las denominadas ‘enfermedades raras’.
Para estos medicamentos, la Comisión propone mecanismos de adquisición coordinados con los Estados miembros para evitar desigualdades y lagunas en el suministro. Esto podría verse como un intento de poner en práctica la tan esperada adquisición conjunta de fármacos a nivel de la UE, con la participación de la Comisión Europea apoyando a los Estados miembros en el uso de diferentes herramientas de adquisición colaborativa para medicamentos esenciales y otros fármacos de interés común.
Además, la propuesta introduce el concepto de proyectos estratégicos, destinados a reforzar la capacidad de la UE para fabricar y desarrollar medicamentos esenciales. Estos proyectos, ubicados en la UE, se beneficiarán de incentivos tales como permisos acelerados, evaluaciones medioambientales simplificadas, apoyo administrativo y científico y posible financiación de la UE.
Reacciones y Financiamiento
Tilly Metz, eurodiputada luxemburguesa del grupo de Los Verdes, reclamó iniciativas más audaces para deslocalizar la producción de medicamentos en Europa. “No basta con hacer compras conjuntas y acelerar los procesos“, declaró.
Vlad Voiculescu, eurodiputado liberal rumano, celebró la propuesta como un paso positivo hacia un mayor acceso a medicamentos asequibles. “Es un comienzo. Esperamos verla respaldada por financiación, presupuestos y legislación nacional lo antes posible”, señaló.
La financiación sigue siendo motivo de preocupación. Otros temen que el presupuesto indicativo de la propuesta, de 83 millones de euros para el período 2026-2027, principalmente a través del programa EU4Health, sea insuficiente.
El ministro belga de Sanidad, Frank Vandenbroucke, instó a la Comisión Europea a integrar la nueva ley en el marco europeo de Seguridad y Defensa. “La seguridad de los medicamentos es tan importante como la defensa o la seguridad energética. Nuestra seguridad colectiva depende de ella”, señaló.
EU Essential medicines Act: Q&A on Supply and Affordability
This article addresses frequently asked questions about the European Union’s new Essential Medicines Act, designed to ensure a stable and reliable supply of affordable medicines for its citizens.
What is the EU Essential Medicines Act?
The EU Essential Medicines Act is a proposed piece of legislation by the European Union aimed at guaranteeing a consistent and dependable supply of essential medicines. Its primary goals are to protect public health and ensure that medications are available at affordable prices for all EU patients. According to Commissioner Várhelyi,the Act seeks to ensure that EU patients have access to the medicines they need,when and where they need them,at an affordable price,especially considering the current geopolitical context.
What are the main objectives of the Essential Medicines act?
The strategic objectives of the Act are centered around:
Ensuring Security of Supply: guaranteeing a stable and reliable supply of essential medicines within the EU.
Improving Availability: Making sure essential medicines are readily accessible to patients across all member states.
affordability: Making medicines available at affordable prices for all EU citizens.
Thes objectives require a coordinated approach at both the national and EU levels.
Which medicines are prioritized under this Act?
The law prioritizes medicines included in the EU list of essential medicines, which was developed by the European Medicines Agency (EMA) in 2023.These are primarily drugs used to treat:
Serious conditions
Conditions where there are limited or no alternative treatments
Why is the EU introducing this new law?
The EU is introducing this law to tackle the significant shortages of essential medicines, such as antibiotics, insulin, and analgesics, within the Union. This shortage is largely attributed to the EU’s over-reliance on a limited number of manufacturers and countries for these critical drugs. The COVID-19 pandemic highlighted vulnerabilities in the global supply chain,underscoring the urgent need for a more resilient and secure system within the EU.
How will the Act address medicine shortages?
The Essential Medicines Act aims to combat medicine shortages by:
Reducing External Dependence: Encouraging investment in the manufacturing of essential medicines and key ingredients within the EU to decrease reliance on foreign suppliers.
Diversifying Supply Chains: Broadening the sources of supply to minimize the risk of shortages due to disruptions in any single location.
Monitoring Distribution: Ensuring that each EU member state monitors the distribution of medicines within its territory to manage and prevent shortages at the national level.
How does the Act prioritize European manufacturing?
The Act promotes investment in local pharmaceutical production by:
“Buy European” Preference: Introducing public contract award criteria that prioritize security of supply over price, favoring suppliers that manufacture a significant portion of essential medicines within the EU.
Strategic Projects: Establishing “strategic projects” within the EU to boost the capacity to manufacture and develop essential medicines. These projects will benefit from incentives like fast-tracked permits, simplified environmental assessments, administrative and scientific support, and potential EU funding.
What is the “joint procurement” system under the proposed law?
The Act introduces a category of medicines called “medicines of common interest,” which are drugs with limited availability and accessibility in at least three EU member states. For these medicines, the european Commission proposes coordinated procurement mechanisms with member states to avoid inequalities and supply gaps. This involves the Commission supporting member states in using collaborative procurement tools for essential medicines and other drugs of common interest.
What are ”strategic projects” as defined in the proposal?
“strategic projects” are initiatives located within the EU aimed at strengthening the bloc’s capacity to manufacture and develop essential medicines. These projects can benefit from:
Accelerated permit processes
Simplified environmental assessments
Administrative and scientific support
Potential EU funding
What are the concerns surrounding the funding for the Essential Medicines Act?
One concern is the proposed budget of 83 million euros for the period 2026-2027, mainly through the EU4Health program, which some believe is insufficient to achieve the Act’s ambitious goals.
How does this Act relate to EU security and Defense framework?
The Belgian Minister of health, Frank Vandenbroucke, has urged the European Commission to integrate the new law into the European Security and Defense framework.his reasoning is that the security of medicines is as critical as defense or energy security, and the collective security of the EU depends on it.
Key Components and Reactions to the EU Essential Medicines Act
| Component | Description | Reaction/Concern |
| :————————– | :—————————————————————————————————————————————– | :—————————————————————————————————————————————————————————————————————————————————————————————————————— |
| Strategic Goal | Ensure the security and availability of essential medicines at an affordable price within the EU. | Generally supported, but some argue for more aggressive measures to reshore pharmaceutical production. |
| Essential Medicines List | Focuses on drugs identified by the EMA in 2023, crucial for treating serious conditions with limited alternatives.| Aims to prioritize the most critical medications, but the list will need regular updates to remain relevant. |
| Addressing Shortages | Aims to reduce dependence on a limited number of manufacturers and countries. | Focuses on diversification of supply chains. |
| European Manufacturing | Prioritizes investment in EU-based manufacturing and introduces “Buy European” criteria in public procurement. | Encourages local production, but needs effective implementation to avoid protectionism and ensure competitiveness. |
| Joint Procurement | Establishes coordinated procurement mechanisms for medicines of common interest to avoid supply inequalities. | Seen as a positive step towards EU-level coordination,but effectiveness depends on member states’ participation. |
| Strategic Projects | Provides incentives for EU-based projects focused on manufacturing and developing essential medicines, including accelerated permits. | Aims to boost local production capabilities, but the selection process must be transparent and efficient. |
| Funding | Initial budget of 83 million euros for 2026-2027 primarily through the EU4Health program. | Considered insufficient by some, raising concerns about the long-term viability and impact of the Act. |
| Security Integration | Calls for integration with the EU’s Security and Defense framework. | Recognizes the critical role of medicine security, but practical implementation needs careful consideration to avoid overlaps with other security priorities. |