Regulatory compliance and trends in life sciences in Paraguay

Viviana Cervieri
Cervieri Monsuárez, Montevideo
vivianacervieri@cmlawyers.com.uy  

Romina González
Cervieri Monsuárez, Asunción
rgonzalez@cmlawyers.com.py 

Lucía Arimón
Cervieri Monsuárez, Asunción
larimon@cmlawyers.com.py

The Paraguayan context and regulatory trends

In recent years, Paraguay has been undergoing a process of institutional strengthening in the areas of health control and consumer protection. The competent authorities, mainly the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA) and the Secretariat for Consumer and User Protection (La Secretaría de Defensa del Consumidor y el Usuario or SEDECO), have intensified sanitary monitoring and post-marketing enforcement action, emphasising safety, traceability and proper compliance with the current regulations.

A key milestone was the enactment of Law No. 6788/2021, which granted the DINAVISA regulatory autonomy and a central role as the national regulatory authority. Among its main functions, Article 5 requires the DINAVISA to regulate, control and supervise health-related products, including medicines, medical devices, cosmetics, perfumes, personal hygiene products and household sanitation products, as well as the activities carried out by individuals and legal entities across the entire value chain, from manufacturing and quality control to import, distribution, commercialisation and representation. More recently, as a result of the incorporation of functions from the National Institute of Food and Nutrition (Instituto Nacional de Alimentación y Nutrición or INAN), the DINAVISA has expanded its scope of powers to the control and oversight of food products, establishing itself as Paraguay’s comprehensive health authority.

It is also important to highlight the inter-institutional agreements have been signed between the relevant oversight bodies and the Public Prosecutor’s Office, which aim to strengthen investigations and sanctions for violations related to the commercialisation of products that may endanger consumer health (Public Prosecutor’s Office, 2023). This collaboration enhances the public sector’s enforcement capacity and creates an environment wherein administrative complaints can escalate into formal legal proceedings, increasing companies’ accountability in regard to transparency and regulatory compliance.

At the same time, there is a clear trend towards integrating local regulations with Southern Common Market or Mercosur guidelines, prompting companies to adapt their internal processes and ensure regulatory harmonisation. This process is accompanied by a greater emphasis on transparency, product traceability and the accuracy of advertising claims, issues that have become central to government oversight efforts.

Administrative complaints and anti-fraud legislation

Within an increasingly demanding regulatory environment, administrative complaints have become a key tool to ensure transparency, protect public health and preserve fair competition in the Paraguayan market.

In the life sciences sector, complaints allow the relevant authorities to detect, investigate and sanction behaviours that violate consumer rights or compromise market integrity. The strengthening of oversight mechanisms in Paraguay has led to the growing use of administrative complaints, filed not only by consumers, but also by companies, sector associations and internal corporate control bodies. In this context, the DINAVISA and SEDECO have emerged as key actors, with the responsibility for detecting irregularities, conducting inspections, issuing health alerts and applying sanctions.

In recent months, there has been a sustained increase in complaints related to importers and distributors of perfumes and cosmetics who allegedly do not comply with the regulatory requirements. These complaints reveal possible technical discrepancies in product registrations and indicate that some companies may be operating without the necessary permits.

Of particular concern is the suspected use of false sworn statements submitted by importers and/or distributors who are not authorised by the manufacturer or the original product owner. This fraudulent practice not only violates the regulatory framework, but also severely undermines confidence in the health control system.

In this context, Law No. 1334/1998 on consumer protection is especially relevant. Article 6 recognises basic consumer rights, including proper education and disclosure about the product’s characteristics; access to clear information regarding the product’s composition, quality, price and risks; and protection against misleading advertising and unfair commercial practices.

Therefore, any irregularities or a lack of transparency during the relevant registration processes in regard to identifying the responsible technical personnel or in regard to the information provided to consumers not only affects their fundamental rights, but also compromises public safety and weakens the credibility of the regulatory system, which has a significant negative impact on the commercial sector and the country’s reputation.

Consequently, it is essential that the competent authorities adopt all appropriate administrative, preventive and enforcement measures available pursuant to the law to protect consumer health, ensure market transparency and strengthen the integrity of Paraguay’s health control system.

The regulatory team as a strategic actor in the life sciences sector

Due diligence carried out by regulatory teams as a strategic actor in the life sciences sector is crucial to ensuring that products entering and distributed in the Paraguayan market are safe, effective and suitable for human use and/or consumption. It also serves as an essential tool to protect consumers’ fundamental rights, strengthen public trust and ensure the sustainability of the sector.

Emerging regulatory trends are driving  an increase in interactions between companies and the relevant oversight authorities, which are requiring companies to take further and more adaptable corporate actions, as well as provide continuous guidance and consultancy, particularly in an environment where mergers and acquisitions present additional challenges in regard to regulatory compliance.

In regard to its role as a strategic actor, the regulatory team within life sciences firms has the capacity to promote the implementation of regulatory changes, anticipate situations that could place the company at a disadvantage and prevent unnecessary expenses, while always prioritising consumer health protection. Moreover, the coordination of the in-house regulatory team with the authorities and the promotion of responsible business practices not only help to reduce risks, but also create opportunities to position Paraguay as a regional leader in health management within the life sciences sector.

Conclusions and recommendations

The life sciences sector in Paraguay is subject to an increasingly demanding regulatory environment, marked by stronger health-related surveillance mechanisms, consumer protection-related requirements and regional regulatory harmonisation, with a growing trend towards reliance as a key practice in regard to regulatory decision-making. In this context, companies must adopt a proactive approach based on regulatory compliance, transparency and cooperation in order to prevent risks.

The strategic role of in-house regulatory teams is essential to ensure compliance, product safety and traceability within the life sciences sector, by integrating internal compliance policies and mechanisms, such as reporting channels. Likewise, coordination between the private sector, the relevant regulatory authorities and consumers is crucial to building a safer, more competitive and reliable market that can effectively respond to regulatory and industry challenges.

This comprehensive approach not only protects public health and consumer rights, but also creates strategic opportunities for Paraguay to position itself as a regional leader in health management within the life sciences sector, fostering transparency, quality and innovation throughout the value chain.