Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

Executive Summary

Portugal’s pharmaceutical market, valued at approximately €2 billion in 2022, demonstrates robust growth driven by aging demographics, healthcare reforms, and policy shifts favoring generic medication utilization. The market comprises a significant segment of both branded (innovative) and generic drugs, with generics accounting for over 50% of prescriptions but only around 30% of expenditures due to lower prices.

Regulatory frameworks established by the Portuguese Medicines Agency (INFARMED) govern market entry, pricing, and reimbursement policies. While these policies foster cost-containment and increase access, they also entail challenges, including complex authorization procedures, price controls, and limited patent protections.

The evolving landscape presents opportunities for innovative entrants, especially in biosimilars and specialty medicines, but hurdles such as market penetration barriers, limited local R&D infrastructure, and rigid pricing policies.

This report provides a comprehensive assessment of Portugal’s market dynamics, regulatory environment, and strategic insights for stakeholders aiming to capitalize on this market.

Market Overview

Market Segmentation

Regulatory Framework and Policies

Authorization & Registration

• INFARMED oversees drug approval via the European Union (EU) Centralized Procedure, or national procedures aligned with EU directives.
• Innovative medicines often require extensive Clinical Trial data; generics leverage bioequivalence data.
• Biosimilars follow specific EMA guidelines, with approval contingent on comparable efficacy, safety, and quality.

Pricing & Reimbursement Policies

• The Pricing Regulation System is based on Reference Pricing, with maximum prices set relative to other EU countries.
• Reimbursement is managed via the National Health Service (SNS), with positive reimbursement decisions tied to cost-effectiveness assessments by INFARMED.
• Price reductions are common, with a statutory 10% rebate on reimbursed medicines.
• Recent reforms aim to incentivize generic prescribing through substitution policies and price discounts.

Intellectual Property and Patent Regulations

• Patent protection lasts 20 years from the filing date, with opportunities for supplementary protection certificates (SPCs).
• Patent expiry typically leads to open competition with generics; however, patent evergreening and data exclusivity can delay generics’ market entry.
• Biosimilar patents are aligned with EMA timelines, emphasizing the importance of early pipeline development.

Opportunities in Portugal’s Pharmaceutical Market

1. Growth of Generics and Biosimilars

• The government’s policies aim to increase generic substitution from 30% to 60% by 2025.
• Generics offer a high-volume, low-margin model, but biosimilars can command higher prices and margins due to fewer competitors.
• The biosimilar market is projected to grow at a CAGR of ~8% through 2026 (European market data), with initial focus on oncology and autoimmune diseases.

2. Specialty and Rare Disease Drugs

• Portugal’s aging population (~20% over 65 by 2025) fuels demand for oncology, neurology, and rare disease therapies.
• Market entry for innovative and orphan drugs requires navigating regulatory pathways but offers high-margin opportunities.

3. E-Health and Digital Therapeutics

• National policies favor digitization, including electronic prescriptions and telemedicine, reducing distribution costs.
• Digital therapeutics targeting chronic diseases present new growth avenues, especially in disease management and adherence.

4. Policy Support for Local Manufacturing

• Incentives encouraging local production, including tax benefits and grants, aim to develop Portugal as a regional manufacturing hub.
• Strategic partnerships with EU manufacturing networks can bolster competitiveness.

Challenges in Portugal’s Drug Markets

1. Price Control and Cost Containment

• Stringent pricing caps hinder profitability, especially for branded innovative drugs.
• The oversupply of generics resulting from aggressive substitution policies compresses margins.

2. Slow Market Penetration and Adoption

• Physicians often display brand loyalty, and generic substitution is not always automatic.
• Patient resistance due to perceptions of lower quality hampers uptake.

3. Regulatory Complexity and Delays

• Lengthy approval timelines for innovative medicines and biosimilars due to administrative procedures.
• Limited local regulatory staff and capacity can cause bottlenecks.

4. Limited R&D Infrastructure

• Portugal’s domestic R&D investment remains below EU averages (approximately 0.7% of GDP; EU average ~2%).
• Dependence on external innovations limits opportunities for local lifecycle management.

5. Intellectual Property Barriers

• Patent litigation and evergreening practices can delay generics and biosimilars entry.
• Data exclusivity periods restrict market access for biosimilars in the initial years post-approval.

Comparison with EU and Global Markets

This comparison indicates Portugal’s market aligns with EU norms but exhibits slower innovation adoption and R&D investment levels.

Strategic Recommendations for Stakeholders

Regulatory Environment: Key Policies & Timeline

Conclusion

Portugal’s pharmaceutical market presents a promising landscape characterized by regulatory support for generics and biosimilars, a growing demand for specialty and orphan medicines, and opportunities driven by healthcare digitization. Challenges such as strict price controls, regulatory delays, and limited local R&D capacity require strategic navigation—but also open avenues for innovative, partnered, and locally tailored approaches.

Stakeholders aiming to succeed must adopt a nuanced understanding of regulatory policies, leverage EU harmonization for faster approval, and align product strategies with Portugal’s evolving healthcare priorities.

Key Takeaways

• Market Growth: Portugal’s pharmaceutical market is expanding modestly, with increasing penetration of generics and biosimilars, and a burgeoning specialty medicines sector.
• Regulatory landscape: INFARMED’s policies incentivize cost-effective prescribing but impose hurdles related to pricing, approval timelines, and patent protections.
• Opportunities: Biosimilars, rare diseases, local manufacturing, and digital therapeutics offer high-growth potential; strategic partnerships can mitigate risks.
• Challenges: Price regulation, slow adoption of generics, and R&D limitations necessitate targeted, collaborative market entry strategies.
• Policy Engagement: Active dialogue with regulators can pave the way for more favorable pathways and faster market access.

FAQs

1. What is the current trend in generic medicine adoption in Portugal?
   The prescription volume of generics exceeds 50%, with policies aiming to increase generic substitution to 60% by 2025, indicating a positive but gradual shift.

2. Are biosimilars widely used in Portugal?
   Biosimilars are emerging, especially in oncology and autoimmune disorders, with regulatory frameworks aligned with EMA, but adoption remains in early stages.

3. What are the primary regulatory hurdles for new drug approvals in Portugal?
   Lengthy approval timelines, administrative delays, and capacity constraints within INFARMED pose challenges. Leveraging EU centralized procedures can mitigate some issues.

4. How does Portugal’s pricing regulation affect market entry for innovative drugs?
   Stringent price caps and reference pricing reduce margins, making it less attractive for high-cost innovations unless supported by reimbursement and risk-sharing agreements.

5. What strategies can companies use to succeed in Portugal’s pharmaceutical market?
   Building local partnerships, focusing on high-value niches like orphan drugs, engaging with regulators early, and investing in local R&D can improve success prospects.

References

[1] IMS Health, 2022. Portuguese Pharmaceutical Market Report.
[2] INFARMED, 2022. Annual Market Data.
[3] OECD, 2022. Health Data: Portugal.
[4] European Medicines Agency, 2023. Guidelines on Biosimilars.
[5] Portugal National Statistics Institute (INE), 2022. Demographic Data.