Regulatory Framework for Biotechnology in Paraguay

Introduction

The regulation of biotechnology products is crucial for ensuring safety and promoting innovation. In recent years, Paraguay has made efforts to improve its regulatory framework; however, there are still challenges to be addressed.

Key Aspects of the Regulatory Framework

Patents

• Law No. 1630/2000 regulates patents in Paraguay, excluding plants and animals (except microorganisms) from patent protection.
• The National Directorate of Intellectual Property (DNPI) is responsible for intellectual property policy execution.

Regulatory Agencies

• SENAVE handles biotechnology and biosecurity-related matters.
• While there are some regulatory agencies in place, the lack of public consultation and participation in the regulatory process remains a challenge.

Risk Assessment

• A science-based approach is used to assess risks related to GMOs.
• However, there’s a lack of public consultation and participation in the regulatory process.

Challenges

The regulatory framework has some unclear provisions, such as:

• Article 10 of Law No. 3283/2007 on validation of sanitary registrations from specific countries
• Articles 4 and 5 of Decree No. 6611/2016 on biologics with sanitary registry

These challenges have significant ramifications for a range of stakeholders, including researchers, industry experts, and policymakers.

Conclusion

While Paraguay has made efforts to improve its regulatory framework, there are still challenges to be addressed, including a lack of public consultation and participation in the regulatory process, as well as unclear provisions in some laws and decrees. The evaluation of current scientific and technical capacity in Paraguay is necessary to facilitate the development of a more fit-for-purpose system.