Pharmaceutical & Health
Strengthened IP protection and access to public health procurement
Trade Volume
€ 8.5 Mrd
Tariff Reduction
14% → 0%
Transition Period
10 years (medicines), 7 years (medical devices)
Key Figures
#4 mondial
Brazilian pharma market
6-14%
Current duties on medicines
12-24 mois
ANVISA registration time
20 ans
Protected patents (IP chapter)
Opportunities
Access to public health procurement (Brazil: 4th largest pharma market)
Strengthened patent and clinical trial data protection
Mutual recognition of GMP (Good Manufacturing Practices)
Export of medical devices and hospital equipment
Risks
Generics policy in Brazil (compulsory licenses possible)
Long registration procedures (ANVISA: 12-24 months)
Local production requirements for certain public tenders
Exchange rate fluctuations impacting profitability
Strategic Recommendations
1
File patents in all 4 MERCOSUR countries simultaneously2
Prepare ANVISA dossiers in parallel with EMA3
Explore local manufacturing partnerships (CRO/CMO)4
Participate in public tenders via the Public Procurement chapterSector Inquiry
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