Tutela del Possesso dell’Archivio delle Certificazioni di Autenticità di Opere d’Arte: un Caso di Spoglio Possessorio

Nell’ambito della problematica inerente la protezione del possesso dei beni artistici, si colloca una vicenda giudiziaria di rilevante interesse che ha coinvolto un artista italiano e il suo Archivio di Certificazioni di Autenticità di Opere d’Arte. Questo caso, oltre a sollevare questioni cruciali di diritto sostanziale e processuale, offre uno spunto significativo per riflettere sulla tutela del possesso in campo culturale e artistico.

In particolare, il Tribunale chiamato a pronunciarsi sulla domanda di reintegrazione nel possesso avanzata dall’Artista ne ha affermato la fondatezza, ordinando la reintegra nel possesso dell’Archivio sottratto senza il consenso del legittimo possessore. La decisione costituisce un importante precedente nella giurisprudenza italiana, riconoscendo piena tutela legale al possesso delle attestazioni di autenticità e provenienza di opere d’arte nella persona dell’Artista che li ha realizzati e raccolti minuziosamente nel corso degli anni.

I Fatti Essenziali

L’Artista, figura di spicco nel panorama dell’arte ottico-cinetica italiana, aveva creato e conservato un Archivio cartaceo delle autentiche delle proprie opere all’interno della propria abitazione/casa coniugale, nella libreria personale. Questo Archivio, corredato di riproduzioni fotografiche delle opere (circa 3200), numerate e firmate, era organizzato in diversi raccoglitori e suddiviso per tipologie. Ogni riproduzione fotografica corrisponde numericamente all’opera riprodotta e, anch’essa sottoscritta dall’artista, ne attesta l’autenticità e la provenienza.  Ha, quindi, finalità di memoria futura d’inerenza all’artista e di autenticità verso terzi e costituisce, strumento indispensabile per contrastare le falsificazioni e ai fini della vendita diretta e/o indiretta (per il tramite di gallerie e/o case d’asta) che l’Artista voglia fare delle proprie opere

L’azione possessoria patrocinata da GA, nella persona dell’avv. Maria Francesca Albertini, è stata promossa per riportare l’Artista nel possesso dell’Archivio cartaceo delle autentiche delle proprie opere, che gli era stato illegittimamente sottratto attraverso un’azione che il Tribunale ha ritenuto integrasse gli estremi dello spoglio violento e clandestino.

Il Certificato di Autenticità: Il Passaporto Essenziale per l’Arte Contemporanea

L’art. 64 del Codice dei Beni Culturali (D.lgs. 22 gennaio 2004, n. 42), rubricato “Attestati di autenticità e di provenienza”, prevede unicamente un obbligo, in capo a chi esercita l’attività di vendita abituale di opere di pittura, scultura, grafica o di oggetti di antichità e d’arte o di interesse storico o archeologico di consegnare all’acquirente “la documentazione relativa attestante la autenticità o, almeno, la probabile attribuzione e la provenienza delle opere” o, in mancanza, di rilasciare “una dichiarazione recante tutte le informazioni disponibili sull’autenticità o la probabile attribuzione e la provenienza” dell’opera. Questa norma trova applicazione anche alle opere d’arte contemporanea (cioè, quelle di autore vivente o la cui esecuzione non risalga a oltre 70 anni) che, come è noto, sono - per il resto - escluse dalla normativa codicistica.

Poiché la Legge sul diritto d’autore (L. 22 aprile 1941, n. 633) stabilisce, all’art. 20, che l’autore ha “il diritto di rivendicare la paternità dell’opera”, quando questi è in vita, sarà lui stesso a rilasciare (o negare) le autentiche delle proprie opere.

Il certificato di autenticità è il primo documento che deve essere consegnato al momento dell’acquisto di un’opera d’arte, di cui deve attestare la paternità, incidendo in maniera significativa sulla valutazione della stessa, sia da un punto di vista artistico, sia economico.

L’autentica è il vero e proprio passaporto dell’opera d’arte. Deve contenere una descrizione dettagliata del lavoro, nello specifico: immagine dell’opera, nome dell’artista, titolo, anno di realizzazione, specifiche tecniche (materiali utilizzati e dimensioni), numero di copie (in caso di opera fotografica o scultorea), provenienza, firma e/o timbro del soggetto che rilascia la dichiarazione e deve essere consegnata dal venditore al collezionista al contestualmente all’acquisto.

Se l’artista è vivente, il certificato di autenticità viene rilasciato per legge dal gallerista, o dall’artista stesso in caso di vendita diretta.

In Italia, quindi, il diritto di autenticare un’opera d’arte spetta, in primo luogo, all’artista ai sensi dell’art. 20 della legge sul Diritto d’autore (legge n. 633 del 22 aprile 1941). Alla morte dell’artista tale diritto morale di attribuzione della paternità dell’opera è esercitabile dai suoi eredi (o meglio dai soggetti indicati dall’articolo 23 della legge suddetta) o da archivi, fondazioni, comitati di esperti o associazioni che siano mandatari degli eredi medesimi.

Poiché il certificato di autenticità è finalizzato all’attribuzione della paternità dell’opera, quando non è rilasciato dall’artista può essere facilmente contestato, poiché costituisce una mera opinione degli eredi o dei loro mandatari.

L’esperimento dell’azione possessoria e la decisione del Tribunale

Dopo vani tentativi di ottenere la restituzione del proprio Archivio, l’Artista ha avviato un’azione possessoria ai sensi dell’articolo 1168 del Codice Civile per ottenere la reintegrazione nel possesso del bene sottratto. L’Archivio era stato prelevato senza il consenso del legittimo possessore. Lo spoglio, avvenuto in modo clandestino, ha privato l’Artista della possibilità di esercitare il controllo su un bene essenziale per la propria attività artistica.

Tribunale di Padova, chiamato a decidere, ha ritenuto fondata la domanda di reintegrazione proposta, riconoscendo che il prelievo del bene abbia integrato gli estremi di uno spoglio (inteso come privazione del possesso di un bene) violento (in quanto contrario alla volontà del possessore),e clandestino (realizzato senza l’autorizzazione del possessore), e posto in essere con l’intento di privare l’Autore del possesso (animus spoliandi), in violazione dell’articolo 1168 c.c., condannando, per l’effetto, lo spoliator alla restituzione delle certificazioni di autenticità delle opere.

La dimostrazione che l’artista possedesse l’archivio in epoca antecedente lo spoglio ha determinato l’esito favorevole dell’azione. Le produzioni fotografiche riproducenti la biblioteca presso cui era conservato l’archivio dall’artista prima e dopo lo spoglio, il deposito dell’archivio digitale su supporto informatico a constatazione della risalente data di inizio del lavoro di catalogazione da parte del ricorrente hanno suggellato la certezza del possesso esercitato dal cliente.

Di particolare incisività sono state anche le allegazioni a contestazione della difesa avversaria. Controparte faceva perno sulla asserita paternità dell’archivio da parte dell’associazione culturale costituita dal figlio dell’artista, la quale fondava la sua fortuna proprio sull’attività di promozione, pubblicità e commercio delle opere dell’artista.

La dimostrazione dell’operato illegittimo avversario ha riguardato trasversalmente, negli atti, la costituzione della fondazione a totale insaputa dell’artista, l’assenza, nel verbale di modifica della sede della fondazione, dei dettagli tecnici e formali indispensabili, tra i quali l’assenza di tutti i soci fondatori nella delibera di modifica della sede. La Fondazione aveva, insomma, agito senza alcuna legittimazione.

Come affermato dalla giurisprudenza consolidata, cui si è uniformato il Giudice Patavino, lo spoglio può configurarsi anche in assenza di un titolo giuridico formale da parte del possessore. Per ottenere la tutela possessoria, è sufficiente dimostrare di aver esercitato il possesso del bene e che tale possesso sia stato interrotto o compromesso; non è necessario provare la titolarità formale del diritto di proprietà.

Nel caso di specie, l’Artista aveva sempre avuto accesso al proprio Archivio, custodito nella propria abitazione. La perdita del possesso dello stesso non solo gli arrecava un danno diretto, ma avrebbe potuto altresì favorire la realizzazione di falsi mettendo a serio rischio l’autenticità delle opere, in tal modo minando la fiducia del pubblico.

Banking & Finance

The Venezuelan Central Bank (VCB) established the interest rates applicable to obligations derived from employment relationships (59.30% and 47.65% - October 2024) and to transactions with credit cards (60.00% annual maximum lending rate and 17.00% annual minimum lending rate - November 2024). (Official Gazette of 11/18/2024. Official Notice. Entry into force: Upon publication in the Official Gazette).

Tax

The National Integrated Service of Customs and Tax Administration (Servicio Nacional Integrado de Administración Aduanera y Tributaria - SENIAT) legalized the issue and circulation of liquor warranty seals. (Official Gazette of 11/25/2024. Administrative Ruling No. SNAT/2024/000113. Entry into force: Upon publication in the Official Gazette).

Civil Aeronautics

The National Institute of Civil Aeronautics (Instituto Nacional de Aeronáutica Civil - INAC) issued an Administrative Ruling the purpose of which is to establish the General Conditions of Air Transportation, in relation to the rights and obligations of the passengers that contract for air transportation services, as well as the duties, rights and obligations of the operators of the service of air transportation of passengers, cargo, and mail, in national and international, regular and nonregular operations, within, from and towards the Bolivarian Republic of Venezuela and all matters concerning the civil liability for the damages affecting the users’ interests. Administrative Ruling No. PRE-CJU-GDA398-16, published in Official Gazette No. 6.228 Extraordinary of 05/18/2016, which contains the General Conditions of Air Transportation, was repealed. (Official Gazette of 11/05/2024. Administrative Ruling No. PRE-CJU-GDA-308-24. Entry into force: Upon publication in the Official Gazette).

The INAC issued the following Aeronautical Regulations: Venezuelan Aeronautical Regulation 110 (RAV 110) Safe Air Transportation of Hazardous Goods, the purpose of which is to establish the technical aeronautical rules that will govern the safe air transportation of hazardous goods. Administrative Ruling No. PRE-CJU-107-13, published in Official Gazette No. 6.099 Extraordinary of 05/23/2013, called “Air Transportation of Hazardous Goods”, was revoked. 2.- Venezuelan Aeronautical Regulation 39 (RAV 39) Airworthiness Directives, the purpose of which is to establish the requirements related to the Airworthiness Directives. Administrative Ruling No. PRE-CJU-129-23, published in Official Gazette No. 6.753 Extraordinary of 07/28/2023 that contains Venezuelan Aeronautical Regulation 39 (RAV 39), called ‘Airworthiness Directives”, was revoked. 3.- Venezuelan Aeronautical Regulation 277 (RAV 277) “Aeronautical Meteorological Service”, the purpose of which is to establish the use of the Procedures for the Aeronautical Meteorological Service that integrates the Services into Air Navigation.

Administrative Ruling No. PRE-CJU-GDA-182-19, published in Official Gazette No. 6.462 Extraordinary, dated 07/01/2019 that contains Venezuelan Aeronautical Regulation 277 (RAV 277), called “Aeronautical Meteorological Service” was revoked. (Official Gazette of 11/11/2024, 11/20/2024, and 11/21/2024. Administrative Rulings No. PRE-CJU-346-24, No. PRE-CJU-GDA-411- 24, and No. PRE-CJU-GDA-412-24. Entry into force: Upon publication in the Official Gazette).

Miscellaneous

The National Assembly issued the Law that Approves the “Agreement between the government of the Bolivarian Republic of Venezuela and the government of the People’s Republic of China relating to the Promotion and Protection of Investments”, the purpose of which is to establish, maintain, and consolidate a juridical framework that facilitates and promotes direct reciprocal cross-border investments made by investors of the contracting parties, with the purpose of promoting both countries’ productive development. (Official Gazette No. 6.852 Extraordinary of 11/13/2024). The National Assembly issued the Law of Audit, Regularization, Actions and Financing of Non-governmental Organizations and Notfor-Profit Social Organizations. Article 67 of the Law of Registries and Notaries’ Offices is repealed. All provisions that are contrary to this Law are repealed. (Official Gazette No. 6.855 Extraordinary of 11/15/2024. Entry into force: Upon publication in the Official Gazette).

The Ministry of the Popular Power for Transportation established the minimum and maximum rates for urban transportation service. Likewise, it established the maximum official rate for suburban routes nationwide to be charged by the providers of the public service of ground passenger transportation. The Official Request published in Official Gazette of 03/19/2024 and Resolution No. 014, published in Official Gazette of 03/19/2024, were revoked. (Official Gazette of 11/22/2024. Official Request and Resolution No. 049. Entry into force: As from December 1, 2024). The National Assembly issued the Simón Bolívar Organic Law against Imperialist Blockade and for Defense of the Bolivarian Republic of Venezuela. All legal or sublegal rules that conflict with the Law are repealed. (Official Gazette No. 6.859 Extraordinary of 11/29/2014. Entry into force: Upon publication in the Official Gazette).

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Key Highlights of the New Directive:

Expanded Scope:

The Directive now explicitly includes software, digital products, and AI systems, ensuring comprehensive coverage of both traditional goods and innovative technologies.

Enhanced Consumer Protections:

Consumers will benefit from clearer and more accessible claims processes, with reduced evidentiary burdens when proving harm caused by defective products.

Increased Responsibility for Manufacturers and Operators:

Companies must ensure that their products—whether physical or digital—meet stringent safety standards. Producers, distributors, and even operators of AI systems may now face liability for damages.

Focus on AI and Autonomous Systems:

With the rise of AI-driven products, the Directive introduces specific provisions for algorithmic accountability, addressing potential risks related to AI behavior and decision-making.

Implications for Businesses:

Organizations operating within the EU must take proactive steps to comply with the new Directive. This includes:

• Conducting thorough risk assessments of their products.

• Implementing stronger safety protocols for AI and software.

• Reviewing insurance coverage to address expanded liability risks.

Why This Matters:

The updated Directive is a direct response to the digital transformation of the global economy. It reinforces consumer confidence in the safety and reliability of innovative products, while holding businesses accountable in a fair and transparent manner.

Grimaldi Alliance is closely monitoring these developments. If your business needs guidance on navigating this new regulatory landscape, our team of experts is here to help.

Banking and Finance

The Venezuelan Central Bank (VCB) established the interest rates applicable to obligations derived from employment relationships (59.26% and 47.63% - August 2024; 59.23% and 47.62% - September 2024) and to transactions with credit cards (60.00% annual maximum lending rate and 17.00% annual minimum lending rate - September and October 2024). (Official Gazette of 10/29/2024. Official Notices. Entry into force: Upon publication in the Official Gazette). BANKING AND FINANCE TAX Bonded Warehouse Regime and not used, must be delivered to the Regional Management, Sector or Unit of Internal Taxes of the domicile of the taxpayer for destruction; 4) the liquor warranty seals identified with designation F-07-2015 or years preceding 2015 that are in SENIAT’s custody must be destroyed in accordance with the procedures established in the rules that govern the matter. (Official Gazette of 10/08/2024. Administrative Ruling SNAT/2024/000098. Entry into force: Upon publication in the Official Gazette).

Tax

The National Integrated Service of Customs and Tax Administration (Servicio Nacional Integrado de Administración Aduanera y Tributaria - SENIAT) issued an Administrative Ruling with the purpose of regulating the use and period of effectiveness of the Warranty Seals to be placed on the Taxed Species of National and Imported Production. Said Ruling established: 1) the liquor warranty seals acquired by the producers or importers of taxed species may not be transferred, assigned or sold; 2) the liquor warranty seals the issue and circulation of which is authorized by SENIAT may be used for a period of two years as from the date of acquisition; 3) the liquor warranty seals identified with designation F-07-2015 or years preceding 2015, acquired under the Bonded Warehouse Regime and not used, must be delivered to the Regional Management, Sector or Unit of Internal Taxes of the domicile of the taxpayer for destruction; 4) the liquor warranty seals identified with designation F-07-2015 or years preceding 2015 that are in SENIAT’s custody must be destroyed in accordance with the procedures established in the rules that govern the matter. (Official Gazette of 10/08/2024. Administrative Ruling SNAT/2024/000098. Entry into force: Upon publication in the Official Gazette).

Civil Aeronautics

The Ministries of the Popular Power for Ecosocialism and for Transportation issued the rules to coordinate the environmental management in the civil aeronautics activity carried out at the national and international airfields and airports of the Bolivarian Republic of Venezuela. (Official Gazette of 10/11/2024. Joint Resolution. Entry into force: Upon publication in the Official Gazette).

Miscellaneous

The Autonomous Service of Registries and Notaries’ Offices (Servicio Autónomo de Registros y Notarías - SAREN) issued an Administrative Ruling with the purpose of regulating the implementation of electronic means in the processes carried out by the SAREN, in order to optimize the service of registries and notaries’ offices, in relation to the verification of the identity of the executing parties, through the biometric analysis of the user identification elements, in the framework of the electronic handling of the registry and notary processes carried out by said Service. The implementation of fingerprint biometry electronic means will be progressively applied, starting at the notaries’ offices located in the capital region. (Official Gazette of 10/17/2024. Administrative Ruling No. 525. Entry into force: Upon publication in the Official Gazette).

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IMF RAISES BRAZIL'S GDP GROWTH PROJECTION FOR 2024 TO 3%

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Banking and Finance

Paraguay reaches investment grade for the first time in its history

The risk rating agency Moody's announced that it raised Paraguay's credit rating from Ba1 to Baa3, granting it investment grade for the first time in its history, reported the Ministry of Economy and Finance (MEF) on past July 24, 2024. Paraguay joins a select group of countries in the region to have the sovereign degree, Chile, Colombia, Mexico and Peru.

In a statement, they indicated that this stable outlook is reached after 26 years when the rating agency assigned a rating to Paraguay for the first time and after 9 years since the last upward review. "This unprecedented achievement is based on the country's solid economic fundamentals and its long history of macroeconomic stability," the MEF said.

They claim that it is the result of more than 20 years of responsible, consistent and predictable public policies. Prudent management of macroeconomic policies was able to achieve and preserve the sustainability of public finances and maintain low inflation

Tax

Agreement between Paraguay and Spain to avoid double taxation finally in force

After ratification by Paraguayan Law Nr. 7.271/2024 and publication in the Official bulletin of the Spanish Kingdom on July 29, 2024, said important agreement for the economic relationships between both countries shall be in force starting October 14, 2024, having effect for all tax purposes since January 1, 2025.

The agreement comprehends the Personal Income Tax, Corporate Tax and Non Resident income taxes in both countries (the so called IRP, IRE and IDU, and INR in Paraguay and IRPF, IS and IRNR in Spain) document observes OECD standards and includes measures to prevent tax base erosion and profit shifting (BEPS), affecting to Personal and Company income taxes in both countries (including income taxes for non-residents), which must now be ratified by the respective Congresses for its entry into force. Model Tax Convention on Income and on Capital 2017 shall be applicable for the interpretation of articles 5 (permanent establishment) and 7 (entrepreneurial benefits) of said Agreement.

Energy

Amendment of Law "On the Independent Production and Transmission of Electric Energy (PTIEE)"

On August 20224 Law No. 7299/2024 that amend Law Nr. 3009/2006 was enacted to foster private investments for the generation of renewable electricity through small hydroelectric plants (SHPs), by introducing correction of concepts that blocked the previous legislation to be applicable and improving the legal framework, by extending the threshold to grant licenses up to 50 MW and generation greater than 50MW should be subject to international public tenders, without the requirement of a risk-sharing contract with the national utility company (ANDE) as stated in the previous Law, although it retains a first call right to acquire the energy generated in case it is not exported or it is needed in the internal market.

Among other changes, the Ministry of Public Works and Communications replaced a Council of several Ministries (MOPC, Environment, Industry and Trade, Foreign Affairs) that made the procedure very bureaucratic. It must be clarified that shall Law is only applicable for the generation of electricity from the use of natural gas and/or minor hydroelectric generation, which also includes cogenerators and self-generators. This Law does not apply to other renewable energies (solar, wind) governed by Law No. 6977/2023, on Non-Conventional Renewable Energies (NCRE).

Public Procurement

Enactment of Decree Nr. 2264/2024, which regulates Law No. 7021 of December 9, 2022, "On Public Supply and Procurement".

This decree imposes a significant advance in what has to do with administrative management in public procurement. It seeks to improve efficiency, transparency and all flexibility in everything that has to do with public procurement processes. There are updates in terms of terminology, structure, facilitating reading and limiting the search for information and providing greater clarity to the management of State procurement, reducing the deadlines that have to do with protests, reconsideration appeals and deadlines for responses from public institutions to the DNCP.

A special type of bidding that he highlighted is joint procurement, which he described as an innovation in public procurement. It consists of public institutions coming together to buy goods or services, in search of efficiency through the implementation of economies of scale and administrative standardization. The annual average of the awards is USD 3.246 million, with 9.513 procedures and 3.266 suppliers.

"Argentina Under Milei: A New Landscape for Investment

12 Questions to Guide Your Opportunities"

Abstract

Javier Milei, elected President of Argentina in November 2023, has embarked on a radical economic reform agenda aimed at addressing decades of economic mismanagement characterized by high inflation, fiscal deficits, and a bloated public sector.

His administration has implemented a series of measures designed to stabilize the economy, reduce inflation, and encourage foreign investment.

Milei's leadership has significantly influenced Argentina's international relations, marking a dramatic shift from previous policies. The country has moved towards a more ideologically driven foreign policy, prioritizing alliances with Western liberal democracies while distancing itself from traditional partners in Latin America and beyond.  Milei advocates for aligning Argentina with what he terms "the free world," emphasizing support for liberal democracies and opposing authoritarian regimes. His administration promotes a doctrine of foreign relations focused on defending liberal values and fostering free trade.

Questions and answers

1. What measures has been already taken by Milei’s administration for controlling inflation and obtaining Fiscal Surplus?

Monthly inflation rates have decreased significantly from approximately 25% at the end of 2023 to about 3.5% by September 2024 (2,5% estimated October 2024). However, comparing with other economies, annual inflation remains extremely high at around 237%.

Milei projects inflation will drop to 104.4% by the end of 2024 and further to 18.3% by December 2025.

In addition, the administration has implemented severe and deep austerity measures, including slashing government spending and eliminating state subsidies. As a result of that, for the first time in years, Argentina has achieved a fiscal surplus.

2. How the currency and international trade barriers imposed by former Argentina government has been modified under Milei's leadership?

The Argentine peso was devalued by 50% shortly after Milei took office. This devaluation is part of a broader strategy to align the currency with market realities while maintaining a controlled depreciation rate.

As of October 2024, Argentina's foreign exchange control regulations remain complex and multifaceted, reflecting ongoing economic challenges and the government's efforts to stabilize the economy. The Central Bank of Argentina (BCRA) continues to enforce stringent measures aimed at controlling capital outflows and managing the value of the Argentine peso amid persistent inflation.

Argentina operates a system with multiple exchange rates for the U.S. dollar, including Official Rate, used for regulated transactions within the banking system and Blue Rate, an unofficial rate used by unlicensed money changers, typically higher than the official rate (currently + 15%)

As of today, certain bureaucracy on access to Foreign Currency still applies. It is mandatory to schedule the access to foreign exchange markets for various transactions, including payments to foreign creditors and suppliers (usually 30 days after the nationalization of the goods or services). It is expected a gradual easing of currency restrictions as the government aims for greater economic stability. A potential unification of exchange rates is planned for the first quarter of 2025, which could simplify the current system.

On the other hand, Javier Milei has implemented a series of transformative policies aimed at revitalizing and enhancing foreign trade, including but not limited to the elimination of Import Licensing.  Milei abolished the previous import licensing regime (SIRA), allowing for greater ease in importing goods. This deregulation is expected to facilitate smoother trade flows and reduce bureaucratic hurdles for foreign businesses looking to export to Argentina.

Also, by reducing Export Duties, which have historically been a barrier to trade. This move is expected to incentivize exports by improving profit margins for exporters, thereby encouraging them to expand their operations internationally.

By adjusting the exchange rate and removing artificial barriers to imports, the government aims to improve the trade balance, which is essential for restoring confidence among foreign investors and trading partners.

3. What is the status of Argentina's relationship with the IMF and other multilateral bodies?

As of October 2024, Argentina's relationship with the International Monetary Fund (IMF) and other multilateral institutions is characterized by ongoing negotiations, fiscal restructuring efforts, and a complex economic environment.

Argentina is currently under a 30-month Extended Fund Facility (EFF) arrangement with the IMF, which was initiated to support the country's economic stabilization efforts. The EFF agreement includes a total commitment of approximately $44 billion, making it one of the largest agreements ever granted by the Fund. As of June 2024, the IMF Executive Board completed its eighth review of this program, indicating that Argentina has met several of the fiscal and monetary targets set forth in the agreement.

Argentina also maintains an ongoing relationship with the World Bank, which provides financial and technical assistance aimed at promoting sustainable development. The World Bank's focus includes enhancing agricultural productivity and supporting social protection programs for vulnerable populations affected by economic instability. The World Bank has been involved in projects aimed at improving infrastructure and promoting renewable energy sources in Argentina, aligning with global sustainability goals.

Argentina also engages with regional development banks such as the **Inter-American Development Bank (IDB). The IDB has committed to financing various infrastructure projects that are crucial for enhancing connectivity and economic growth within Argentina.

4. What significant legal reforms have been enacted under Milei? How do these reforms could impact on foreign investment?

Milei's government has pushed through significant legal reforms aimed at liberalizing the economy.

The administration passed an omnibus reform bill, "Ley de Bases y Puntos de Partida para la Libertad de los Argentinos" (Law of Bases and Starting Points for the Freedom of Argentines), with the primary aim to modernize the Argentine economy by promoting deregulation and reducing public sector involvement in economic activities.

“Ley Bases” was officially promulgated on June 27, 2024, following extensive negotiations in Congress. This comprehensive law includes over 200 articles addressing various aspects of Argentine life, including taxation, labor laws, public spending, and privatization of state-owned enterprises granting broad executive powers for deregulation and privatization initiatives.

5. What are the main goals of “Ley Bases”?

Privatization Initiatives: The law facilitates the privatization of several state-owned companies, although initial proposals were scaled back significantly from a broader plan to privatize dozens of firms. Key companies like YPF (oil & gas) and Aerolíneas Argentinas (airline) were excluded from privatization efforts but could be subject to other specifics regimes allowing the participation of private investors. This move is intended to reduce the fiscal burden on the government and attract foreign investment.

Labor Law Reforms: The reforms include significant changes to labor laws intended to make it easier for employers to hire and fire employees. In detail:

Impact on workers' Rights, easier dismissals and employment elexibility, makes it easier for employers, including banks and corporations, to dismiss full-time workers at will. This change is expected to lead to a rise in the use of contingent labor, such as gig workers and temporary employees, effectively undermining job security for many workers. Limitations on collective bargaining, by including provisions that limit the right to strike, potentially weakening the bargaining power of unions. It abolishes penalties for irregular contracts and allows for longer working hours (up to 12 hours per day), which could lead to increased workloads without corresponding compensation. The law facilitates mechanisms that can suppress union activities, including restrictions on automatic dues payments from non-members (solidarity dues). This change threatens the financial stability of unions, making it harder for them to operate effectively and represent their members' interests Reprisals against strikers, including reprisals against public sector strikers, such as non-payment of wages, suspensions, and layoffs. Tax Burdens on low-income workers: The introduction of new income taxes for low-wage earners (e.g., single workers earning $2,000 annually) places additional financial pressure on already struggling workers, potentially exacerbating economic hardship and reducing their ability to organize or resist unfavorable labor conditions. Promotion of registered employment: The law encourages formal employment registration by providing incentives for businesses that comply with labor regulations.

Fiscal Package: Accompanying the Ley de Bases is a fiscal package that reinstates income taxes while lowering the taxable income floor. This measure is expected to generate additional revenue for the government amidst a backdrop of soaring inflation. Also, a new framework for taxation is established, including the modifications in personal property and internal taxes, and regularization programs for tax obligations to encourage compliance and investment.

Emergency powers: The law grants Milei special emergency powers for one year, allowing him to govern by decree in various sectors including economic and social matters. This has raised concerns about potential overreach and lack of legislative oversight.   - The law declares a state of emergency in economic, financial, fiscal, administrative, social security, tariff, health, and social matters for one year. This allows the executive branch to govern by decree until December 31, 2025, facilitating rapid implementation of reforms without extensive legislative approval.

Deregulation measures: The reforms aim to reduce bureaucratic hurdles across various sectors, particularly in oil and gas, where previous strict export quotas are being lifted. This is intended to attract foreign investment into key industries, for instance, by lifting export quotas in agriculture and simplifying regulations for businesses to foster a more favorable investment climate.

Investment Incentives: The law creates an Incentive Regime for Large Investments (RIGI for its acronymous in Spanish), which includes tax breaks and legal protections for qualifying projects deemed to be in national interest. This aims to stimulate foreign direct investment in key sectors (specifically described in next questions).

6. Which are the eligibility conditions for applying to RIGI?

RIGI has the primary objective of provide long-term legal guarantees necessary for attracting multi-million-dollar investments, by stimulating economic development and enhancing competitiveness across various sectors, as well as to promote job creation and increase exports of goods and services.

RIGI is open to both Argentine and foreign companies that commit to investing a minimum of USD 200 million in qualifying projects. The RIGI was officially published on July 8, 2024, and companies have a two-year window to apply for its benefits, with a potential one-year extension. The regime is designed to be operational immediately upon publication at the Official Gazette. Specific sectors eligible for these incentives are described below:

- Forestry

- Tourism

- Infrastructure

- Mining

- Technology

- Steel

- Energy

- Oil and Gas

- For offshore oil and gas exploration, the minimum investment requirement is set at USD 600 million.

Recent updates to the RIGI have expanded its scope to include electric and hybrid vehicle production within the technology sector. This inclusion reflects Argentina's strategic focus on sustainable industries and aligns with global trends toward electrification.

7. How RIGI protects investors?

Under the RIGI several legal protections are offered to investors (local or foreign). These protections aim to create a stable and secure environment for investment, addressing concerns that international investors may have regarding regulatory changes and potential risks associated with investing in Argentina.  The main measures are:

Regulatory Stability: 30-Year Stability Guarantee: The RIGI guarantees that the rights, protections, and incentives provided under the regime will remain stable for 30 years. This means that any newly imposed taxes or increases in existing ones will not apply to projects under RIGI, ensuring long-term predictability for investors.

Tax and Customs Incentives - secured rights over incentives: Investors have secured rights akin to ownership over tax and customs incentives. This protection ensures that these benefits cannot be altered by future regulations, providing a layer of security for financial planning.

Dispute Resolution mechanisms - International Arbitration. Choice of law and jurisdiction: In addition to the Treaties to Protect FDI already executed by Argentina, The RIGI allows disputes between Argentina and companies participating in the regime to be resolved through international arbitration freely agreed by the Parties. If a legal dispute cannot be settled within 60 days, companies can bypass national courts and go directly to independent arbitration bodies. This provision is crucial for investors who may fear biased treatment in local courts.

Protection against expropriation - guarantee against confiscation: The regime provides assurances that investments will not be subject to confiscatory or expropriation acts. This protection is vital for foreign investors who may be concerned about the security of their assets in Argentina.

Rights to repatriate profits. Free availability of funds: Investors have the right to repatriate profits, dividends, and interest without facing restrictions, if the funds have been settled through the foreign exchange market. This ensures that investors can access their returns without bureaucratic hurdles.

Legal protections for assets - Full availability of assets: The RIGI guarantees that all assets allocated to the execution of investment projects will remain fully available without restrictions, enhancing investor confidence regarding asset management.

Special provisions for Long-Term Strategic Export Projects: For projects classified as "Long-Term Strategic Export Projects," additional legal protections may apply, extending stability guarantees based on project timelines and milestones.

8 Which are other RIGI’s key benefits for investors?

Eased Currency Liquidation Requirements: Under the RIGI, foreign investors are granted flexibility regarding the liquidation of foreign currency earnings. For the first two years, projects under RIGI are required to liquidate only 80% of their dollar income in the official exchange market. This is a significant reduction compared to standard requirements, allowing investors to retain a larger portion of their earnings. After the initial period, the liquidation requirement decreases to 60% after three years and ultimately to 0% after four years. This means that after four years, projects will not need to bring any new U.S. dollars into the official exchange market, providing investors with greater control over their foreign currency.

Exempt from standard foreign currency obligation: Single Purpose Vehicles (SPVs) entities adhering to the RIGI are exempt from the obligation to enter and settle foreign currency through the foreign exchange market for specific percentages based on their operational timeline. For instance, they can retain a higher percentage of their foreign currency earnings as they progress through different stages of their investment.

Advance Collections and Financing: Advance export collections and pre-financings are also exempt from the obligation to enter and settle through the FX Market, allowing for more straightforward financial operations without stringent currency conversion requirements.

Free Availability of Foreign Currency: for local or external financing and repatriation of profits.

Reduced Corporate Tax Rate: Investors participating in projects under the RIGI will benefit from a reduced corporate income tax rate of 25%, down from the standard rate of 35%. This reduced rate is locked in for a period of 30 years, providing long-term stability for investors.

Exemptions from New Taxes. Tax Stability**: Projects under RIGI are exempt from any new taxes that may be introduced over the next 30 years. This provision ensures that investors will not face unexpected tax increases during their investment period.

Import Duty Exemptions: Capital Assets and Machinery**: Projects under RIGI are exempt from import duties on capital assets, machinery, and spare parts necessary for their operations. This exemption significantly lowers the initial costs for foreign investors.

Export Duty Exemption: Initial Period: Projects will be exempt from paying export duties for a period of 3 years, or two years for specially qualifying “strategic exports.” This exemption encourages export-driven businesses by enhancing profit margins.

Dividend Tax Reductions: The tax rate on dividends is reduced to 7% during the first three years of the project, further decreasing to 3.5% after seven years. This reduction enhances returns for investors on their profits distributed as dividends.

Accelerated Amortization and Depreciation: Depreciation Schedules: The regime allows for accelerated amortization and depreciation schedules, enabling investors to recover costs more quickly and reduce taxable income in the early years of operation.

Transfer of Net Operating Losses. Loss Transferability: Investors can transfer (sell) any remaining Net Operating Losses (NOLs) after the conventional five-year period from accrual, providing additional financial flexibility.

9. What sectors are taking advantage of RIGI?

The agriculture sector stands to gain significantly from the RIGI through enhanced export capabilities and reduced operational costs due to tax exemptions and duty-free imports of necessary equipment.

The energy sector, with Argentina's vast natural resources, particularly in oil and gas, is expected to attract substantial investments aimed at exploration and production. The special provisions for offshore projects signal a commitment to fostering growth in this critical sector. In this sense, TGS, Argentine energy company TGS presented a project seeking to invest USD 700 million in expanding a pipeline connecting Vaca Muerta with Buenos Aires, marking it as one of the first major investments under the new regime.  Also Petrona’s representatives from Malaysian oil and gas company Petronas met with Argentine officials regarding potential investments aligned with the RIGI framework.

The mining sector, particularly lithium extraction crucial for battery production, is poised for growth under the RIGI. The incentives provided can enhance competitiveness and attract foreign investment.

The inclusion of technology-related projects under the RIGI presents opportunities for innovation-driven investments in areas like biotechnology, software development, artificial intelligence, and more.

10. What can be expected in terms of deregulation of the Economy?

Minister Sturzenegger, in charge of the deregulation minister, has outlined further reforms that are anticipated to complement Milei's initial legislative agenda:

Expansion of Deregulation: Proposed measures include further deregulation across multiple sectors such as energy, finance, transport, infrastructure and agriculture, aiming to enhance competitiveness and attract international investors.

Tax Incentives for Investment: New tax incentives are being discussed to encourage both domestic and foreign investments in strategic sectors like technology and renewable energy.

Social Security Reforms: Plans are underway to reform social security systems with an emphasis on sustainability while potentially reducing benefits for future retirees as part of broader austerity measures.

Continued Labor Market Flexibility: Additional proposals may include further amendments to labor laws that would enhance flexibility for businesses in workforce management while potentially facing pushback from labor unions.

Infrastructure Investment Initiatives: To address critical infrastructure gaps, there may be initiatives aimed at public-private partnerships (PPPs) to leverage private capital for public projects.

11. What the market expects from Argentina in the coming years?

The market expects Argentina to experience a challenging economic landscape in the short term, followed by a significant recovery, with growth projections indicating a rebound of 5% in 2025 after a contraction of approximately 3.5% in 2024. This outlook is supported by various sources, including the IMF, which anticipates that structural reforms and stabilization efforts under President Milei will lay the groundwork for future growth, driven by improved agricultural production and investments in the energy sector.

The OECD also echoes this sentiment, highlighting an upturn for the Argentine economy post-2024, contingent on successful implementation of fiscal adjustments and inflation control measures.

The World Bank also forecasts a contraction of 3.5% in 2024, similar to the IMF's assessment. They predict that economic recovery will begin in 2025, with growth projected at 5% driven by better weather conditions for agriculture and normalization in production levels after a challenging year.

BBVA Research predicts that Argentina will experience an average decline of 4% in GDP for 2024 but expects a rebound starting in the second half of the year. Their outlook suggests that after the initial phase of economic adjustments, Argentina could see significant recovery as fiscal policies stabilize and inflation begins to ease.

According to Trading Economics, the GDP growth rate for Argentina is expected to be around -1% by the end of 2024, with projections indicating a gradual recovery to approximately 0.8% in 2025 and 1% in 2026. These estimates reflect cautious optimism about Argentina's long-term economic prospects following necessary reforms.

In the same understanding, several articles were already published by international media, as Financial Times and Bloomberg,[1]

In addition, significant backing has emerged from influential tech billionaires, including Elon Musk and Mark Zuckerberg. Their support is crucial for promoting investment in Argentina, particularly in sectors like technology and renewable energy.

Elon Musk, the CEO of Tesla and SpaceX, has publicly expressed interest in Argentina's potential as a hub for lithium production, essential for electric vehicle batteries. His endorsement is seen as a critical signal to other investors about the viability of investing in Argentina's burgeoning lithium sector, which is rich in natural resources.

Mark Zuckerberg co-founder of Facebook (now Meta) has also shown interest in expanding technology investments in Latin America. His company’s initiatives to enhance internet connectivity and digital services align with Milei’s goals of fostering a more robust digital economy.

Despite short-term contractions, analysts remain optimistic about Argentina's long-term growth potential due to its vast natural resources, educated workforce, and strategic position within Latin America. The country’s rich agricultural base and emerging technologies are viewed as key drivers for future economic expansion.

12. What opportunities can Argentina offers to EU countries within the framework of the EU-MERCOSUR Agreement?

MERCOSUR, or the Southern Common Market, is a regional trade bloc established in 1991, comprising Argentina, Brazil, Paraguay, and Uruguay as its founding members. Venezuela's membership was suspended in 2017, while Bolivia is in the process of ratification. MERCOSUR aims to promote free trade and the fluid movement of goods, people, and services among member countries, enhancing economic integration and cooperation.

Within MERCOSUR, Common External Tariff (CET), applies to imports from non-member countries and ranges from 0% to 35%, depending on the product category. For most products traded within MERCOSUR, tariffs are significantly lower or non-existent. Approximately 80% of products traded between MERCOSUR members are exempt from tariffs due to the CET's implementation since 1995. Sensitive products, such as textiles and automobiles, may still face higher tariffs.

The Import Taxes for products with Certificate of Origin, has Preferential Tariffs: Products originating from MERCOSUR member countries benefit from reduced or zero tariffs when imported into another member country, provided they have a valid Certificate of Origin. This certificate confirms that the goods are produced within the bloc. While many goods may be exempt from import duties under the CET, additional charges such as Value Added Tax (VAT) and statistical fees may still apply. Products exported with a Certificate of Origin to other MERCOSUR countries typically do not face additional export duties beyond national regulations.

Negotiations between MERCOSUR and the European Union (EU) for a comprehensive free trade agreement began in 2000. The agreement aims to establish a bi-regional free trade area that encompasses three main components: (i) Political Dialogue: Strengthening political ties and cooperation on global issues, (ii) Trade and Economic Issues, reducing tariffs and barriers to facilitate trade, and (iii) Cooperation: Enhancing collaboration in various sectors, including technology, agriculture, and sustainable development.

The Key Benefits of the MERCOSUR-EU Agreement are so far:

Market Access: The agreement is expected to provide MERCOSUR countries with preferential access to the EU market, which is one of the largest economies globally. This access will enhance export opportunities for agricultural products, industrial goods, and services.

Economic Growth: By reducing tariffs on goods traded between MERCOSUR and the EU, the agreement could stimulate economic growth in both regions. For MERCOSUR countries, this means increased exports of key products such as beef, soybeans, and other agricultural commodities.

Investment Opportunities: The agreement is likely to attract foreign direct investment (FDI) from EU companies looking to establish operations in MERCOSUR countries. This investment can lead to job creation and technology transfer, further bolstering local economies.

Sustainable Development: a significant component of the negotiations includes commitments to sustainable development practices. The agreement incorporates environmental standards that align with international commitments, promoting responsible production methods.

Strengthening Ties: The agreement aims to deepen political and economic ties between two major regions, fostering cooperation on global challenges such as climate change, trade disputes, and social issues.

Diversification of Trade: For EU countries, engaging with MERCOSUR allows for diversification of supply sources and reduces reliance on single markets or regions. This is particularly relevant as geopolitical dynamics shift globally.

 Status of the negotiations:

As of October 2024, negotiations between the European Union (EU) and the MERCOSUR are progressing with renewed momentum. Here are the key developments and challenges surrounding the negotiations.

Spanish Prime Minister Pedro Sánchez has indicated that the EU is "very close to closing" the long-delayed free trade agreement with MERCOSUR. He emphasized the importance of two upcoming events: the G20 summit in Rio de Janeiro on November 18-19, 2024, and a MERCOSUR summit in December 2024, as critical opportunities to finalize the agreement.  The European Commission has expressed its determination to proceed with the negotiations, highlighting the economic and geopolitical significance of sealing the deal. Olof Gill, a spokesperson for trade issues, reiterated that the agreement is crucial for both regions.

Brazilian officials remain optimistic about concluding an agreement this year, reflecting a commitment to enhancing trade relations with Europe. The Brazilian Ministry of Industry and Trade has indicated that progress is being made in discussions. While some officials suggest that a signing during the G20 in Brazil in November 2024 summit is possible, others view it as "very hypothetical" given ongoing disagreements among EU member states regarding environmental protections and agricultural impacts.

[1] https://www.bloomberglinea.com/latinoamerica/argentina/que-necesita-vaca-muerta-para-superar-el-millon-de-barriles-segun-el-presidente-de-shell-argentina

La Ley de Conciencia y Acción Climática Comunitaria en Honduras:

La Ley de Conciencia y Acción Climática Comunitaria (Decreto 61-2024) busca enfrentar los desafíos derivados del cambio climático mediante la participación de las comunidades hondureñas. Esta ley establece un marco legal para que los ciudadanos, junto con las autoridades locales, adopten medidas concretas de mitigación y adaptación al cambio climático y se enfoca en integrar el conocimiento local con estrategias nacionales para crear un impacto significativo y sostenible en el medio ambiente.

Uno de los aspectos más importantes de la ley es la promoción de prácticas agrícolas- sector clave para la economía hondureña- sostenibles y la conservación de los recursos naturales. La ley incentiva a los pequeños productores, agricultores, ganaderos, entre otros a adoptar técnicas que reduzcan las emisiones de gases de efecto invernadero y mejoren la resiliencia frente a eventos climáticos extremos, como sequías e inundaciones que tanto afectan al país. Estas acciones se acompañan de programas de capacitación y apoyo técnico para garantizar su implementación efectiva.

La Ley también fomenta la reforestación y la protección de áreas naturales vulnerables. A través de esta normativa, las comunidades locales son incentivadas a participar en proyectos de reforestación que no solo contribuyen a la captura de carbono, sino que también fortalecen la biodiversidad y protegen las fuentes de agua. Las autoridades locales están obligadas a diseñar y ejecutar planes de manejo forestal en conjunto con las comunidades, asegurando un enfoque participativo en la conservación del medio ambiente.

Además, el Decreto 61-2024 establece un sistema de financiamiento para proyectos comunitarios relacionados con la acción climática. El Fondo de Acción Climática Comunitaria canalizará recursos para apoyar iniciativas locales que busquen reducir los impactos del cambio climático. Esto incluye desde proyectos de infraestructura verde, hasta programas de educación ambiental con especial atención en las zonas rurales y aquellas más afectadas por los efectos climáticos.

Al integrar a las comunidades en el proceso de toma de decisiones y acción, la ley no solo promueve una mayor conciencia ambiental, sino que también garantiza una mayor equidad y sostenibilidad en los esfuerzos nacionales para proteger el medio ambiente y mitigar los efectos del cambio climático en Honduras.

Escrito por: Marcela Barralaga, Asociada

Ley para el Control y Regulación de Bebidas Energizantes en Honduras:

La Ley para el Control y Regulación de Bebidas Energizantes (Decreto 46-2024) tiene como objetivo principal proteger la salud de los consumidores, especialmente de los jóvenes, al establecer controles más estrictos sobre la venta y consumo de estas bebidas. La preocupación por los efectos adversos de las bebidas energizantes, como el aumento de la presión arterial, problemas cardíacos y adicción a la cafeína, llevó a la creación de este decreto que busca mitigar estos riesgos a través de regulaciones claras.

Una de las principales disposiciones de la ley es la prohibición de la venta de bebidas energizantes a menores de 18 años. Esto responde a estudios que han mostrado los peligros del consumo de altos niveles de cafeína y otros estimulantes en adolescentes, cuyo sistema nervioso es más vulnerable. Además, esta ley establece que las bebidas energizantes no podrán ser comercializadas en instituciones educativas o deportivas donde asisten menores, con el fin de reducir su acceso y prevenir problemas de salud debido a la gran demanda actual en estos centros.

El decreto también regula por medio de la Agencia de Regulación Sanitaria (ARSA) el etiquetado de las bebidas energizantes. Las empresas deben incluir advertencias visibles sobre los posibles riesgos para la salud, indicando de forma clara los efectos que el consumo excesivo puede tener en el organismo. Esto incluye advertencias sobre los niveles elevados de cafeína y otros ingredientes estimulantes, con el propósito de que los consumidores tomen decisiones informadas sobre su consumo.

Otro aspecto importante e innovador para Honduras de esta ley es la limitación de la publicidad de bebidas energizantes. El decreto prohíbe que estas bebidas se promocionen como productos saludables o que mejoren el rendimiento físico o mental, ya que estas afirmaciones suelen ser engañosas. Además, las campañas publicitarias no podrán estar dirigidas a menores de edad, y se restringirá el uso de figuras públicas que promuevan el consumo irresponsable de estos productos.

En resumen, la Ley para el Control y Regulación de Bebidas Energizantes (Decreto 46-2024) en Honduras representa un esfuerzo significativo para proteger la salud pública. Al regular el acceso, la publicidad y el etiquetado de estas bebidas, el gobierno hondureño busca reducir los riesgos asociados con su consumo y fomentar una mayor conciencia sobre sus posibles efectos negativos, especialmente entre los grupos más vulnerables, como los jóvenes.

Escrito por: Marcela Barralaga, Asociada

Ley para la Regularización de las Aportaciones y Cotizaciones del IHSS: Fortaleciendo la Seguridad Social en Honduras

La Ley para la Regularización de las Aportaciones y Cotizaciones del Instituto Hondureño de Seguridad Social (Decreto 48-2024) tiene como propósito central la mejora y sostenibilidad del sistema de seguridad social en Honduras. Ante los desafíos financieros y operativos que enfrenta el Instituto Hondureño de Seguridad Social (IHSS), este decreto busca garantizar que tanto empleadores como trabajadores cumplan con sus obligaciones de manera transparente y oportuna, asegurando la protección social de los ciudadanos.

Uno de los puntos clave de la ley es la regularización de las cotizaciones atrasadas. Se establece un mecanismo para que las empresas y los trabajadores puedan ponerse al día con sus aportaciones pendientes sin enfrentar sanciones severas, siempre y cuando se adhieran a los plazos establecidos para la regularización. Esta disposición ofrece incentivos para que los empleadores se pongan al día con sus pagos, lo que contribuye a estabilizar financieramente al IHSS.

Además, el Decreto 48-2024 establece medidas más estrictas para el control y la fiscalización de las aportaciones. El IHSS ahora tiene mayor autoridad para supervisar y auditar las contribuciones de los empleadores, con el objetivo de evitar la evasión de las obligaciones de seguridad social. Este control también incluye sanciones más severas para aquellos que no cumplan con la ley, lo que se espera que aumente la transparencia y garantice el acceso de los trabajadores a los beneficios del seguro social.

Otro aspecto importante de la ley es la ampliación de la base de cotizantes. Con el fin de asegurar la viabilidad a largo plazo del sistema de seguridad social, la ley busca incorporar a más trabajadores al IHSS, incluyendo a aquellos en sectores informales o independientes. Esto no solo permitirá que más personas accedan a beneficios como atención médica y pensiones, sino que también fortalecerá el financiamiento del sistema al aumentar el número de cotizantes.

En conclusión, la Ley es un paso crucial para fortalecer y modernizar el sistema de seguridad social en Honduras. Al mejorar la fiscalización, facilitar la regularización de aportaciones y expandir la cobertura, esta ley asegura que más hondureños puedan acceder a la protección que ofrece el IHSS, contribuyendo así al bienestar general, ofrecerle a la ciudadanía una mejor calidad en el servicio para el goce del derecho humano de la salud y contribuyendo a la estabilidad social del país.

Escrito por: Marcela Barralaga, Asociada

Reglamento para El Control Sanitario de Dispositivos Médicos

La Agencia de Regulación Sanitaria de Honduras (ARSA), siendo la autoridad encargada de la regulación, supervisión y control sanitario de productos de interés sanitario dentro de los cuales se incluye los Dispositivos Médicos, ha aprobado el “Reglamento Para El Control Sanitario De Dispositivos Médicos Y Otros Dispositivos De Interés Sanitario”, mediante acuerdo No. 0631-ARSA-2023, publicado en el diario oficial la Gaceta el pasado 21 de septiembre de 2024.

El reglamento es aplicable para todas las empresas y personas naturales que se dedican a las actividades de fabricación, repotenciación, reparación, acondicionamiento, importación, exportación, almacenamiento, transporte, distribución, alquiler, comodato, comercialización, investigación, publicidad, servicios de mantenimiento y/o cualquier otra actividad relacionada con los dispositivos médicos y otros dispositivos de interés sanitario, así como también a las actividades de tecnovigilancia desarrolladas por la Agencia de Regulación Sanitaria. La Coalición Interamericana de Convergencia Regulatoria define dispositivo medico como cualquier instrumento, aparato, implemento, maquina, implante, reactivo para uso in vitro, software, material u otro artículo similar o relacionado, destinado por el fabricante a ser utilizado, solo o en combinación, en seres humanos, para uno o varios fines médicos[1].

Los puntos principales de este reglamento son la autorización de fabricación, importación, exportación de dispositivos médicos, mecanismos de control, y responsabilidad de fabricante. Entre los mecanismos de control se incluyen Licencias Sanitarias, Clasificación de Dispositivos por Riesgo, Registro Sanitario, y Certificaciones de Buenas Prácticas en fin de afirmar la calidad y seguridad de los productos. Los fabricantes deben cumplir con estándares de calidad, seguridad y eficacia, en fin de mitigar riesgos y garantizando la buena función de los dispositivos.

Con este reglamento las autoridades tienen como principal objetivo asegurar la calidad, seguridad y eficacia establecidos por la Organización Mundial de la Salud (OMS). Así mismo, busca la mejora continua de las condiciones sanitarias y salud de la población hondureña, estableciendo las directrices, disposiciones y requisitos necesarios para obtener autorización de Exoneraciones, Informe por Riesgo, Registro Sanitario y Licencia Sanitaria en todas sus modalidades. Dichas autorizaciones son de carácter obligatorio para el desarrollo de actividades anteriormente citadas y su incumplimiento es motivo de sanciones por parte de la autoridad sanitaria.

[1] https://www.interamericancoalition-medtech.org/regulatory-convergence/wp-content/uploads/sites/4/2021/06/Def.Disp_.Med_.-ESPANOL-1.pdf