EU Generic and Biosimilar Firms Face Major Hurdles in Global Markets

Key Takeaways for Stakeholders

The report offers several critical insights for stakeholders:

• Public procurement rules in key markets heavily favor domestic suppliers.
• Complex and unharmonized regulations inflate costs and delay market entry.
• Local content policies challenge EU firms’ competitive edge.
• Strict pricing controls hinder patient access to essential medications.
• Patent linkage and extensions cause delays for generics and biosimilars.

EU generic and biosimilar pharmaceutical companies find themselves navigating a challenging landscape in third-country markets, as revealed by a recent Medicines for Europe report. While these companies have the potential to play a crucial role in global healthcare by providing affordable medicines, they face a multitude of barriers that hinder their competitiveness and patient access. These obstacles, spanning public procurement, regulatory frameworks, local manufacturing preferences, and intellectual property laws, demand immediate attention and action from EU policymakers. The report underscores the necessity for a strong EU Critical Medicines Act to foster market access and highlight the significance of crafting strategic trade policies.

Public Procurement and Regulatory Challenges

One of the main challenges outlined in the report is the restrictive public procurement rules that favor domestic suppliers in the countries studied. This limitation significantly curtails opportunities for EU companies, impeding their ability to compete on a level playing field. Additionally, the regulatory assessments in these markets are often complex and lack harmonization, leading to increased costs and delayed market entry for EU manufacturers. These regulatory hurdles not only burden companies financially but also slow down the availability of vital generic and biosimilar medications to patients in need.

Local Preferences and Pricing Pressures

Another significant barrier involves the preference for local manufacturing, where policies favor companies that incorporate local content. This puts EU manufacturers at a clear disadvantage, as they struggle to meet these criteria while maintaining competitive pricing and quality. Furthermore, stringent pricing and reimbursement rules in these markets exacerbate the situation. Such controls can severely restrict patient access to essential medicines, undermining the EU companies’ efforts to provide affordable healthcare solutions.

To mitigate these challenges, Medicines for Europe advocates for robust EU trade and external policies that dismantle such barriers. The organization stresses the urgency of implementing an EU Critical Medicines Act to elevate the global standing of EU pharmaceutical companies. By doing so, they aim to ensure a sustainable supply of high-quality, affordable medicines and create growth opportunities for EU firms. Aligning with this vision, future trade agreements should facilitate better market access and ensure compliance with international trade commitments, ultimately benefiting both EU companies and global healthcare systems.

The insights from this report highlight the need for a proactive approach in addressing the challenges faced by EU generic and biosimilar companies. By fostering strategic trade relationships and adapting to the evolving global market dynamics, the EU can enhance the competitiveness of its pharmaceutical sector. This not only benefits EU companies but also serves the global community by improving access to affordable, high-quality medicines. A concerted effort to remove market access barriers will pave the way for a more equitable pharmaceutical landscape, ensuring that patients worldwide receive the healthcare they require.

Source

Sophia Miller