Medicines for Europe is launching a study of market barriers faced by EU generic and biosimilar pharmaceutical companies operating in 11 key third-country markets.

The analysis looks at the barriers that EU-based companies experience in different markets. The findings confirm that major trading partners are pro-actively investing in pharmaceutical manufacturing, with targeted support for the sector. This highlights the need to rapidly introduce an EU Critical Medicines Act.

The analysis found the main barriers to be:
• Public Procurement rules: Prioritising domestic suppliers in tenders, limiting access for EU companies.
• Regulatory Assessments: Complex regulations and lack of harmonisation cause delays and higher costs.
• Local Manufacturing preferences: Local content rules disadvantage EU manufacturers.
• Local rules on pricing and reimbursement: Price controls and reimbursement policies significantly influence patient access.
•   Intellectual property rules: Patent linkage systems and patent extensions delay the timely entry of • generic and biosimilar medicines.

The findings underline the need for strong EU trade and external policies to remove these barriers, which undermine the competitiveness of EU-based pharmaceutical companies and restrict access to more affordable generic and biosimilar medicines....[MedicineForEurope]