🔍 Outdated assumptions by policymakers can have unintended consequences on biosimilars and biologic medicines.
🔍 Patents incentivize innovation by restricting competition, but they also hinder the entry of biosimilars.
🔍 European policy-makers entrust tender decision-making to public bodies, considering factors like price and quality.
🔍 Competitive tendering processes in Europe can lead to price reductions of 20-40%.
🔍 However, tendering may not necessarily deliver long-term value or foster market dynamics.
🔍 Manufacturing innovations like QTL technology may require recalibration of the European tender system for lower prices.
🔍 A new era of manufacturing capability may provide opportunities for lower-cost biosimilars and enhanced public access.
Introduction:
The article discusses the impact of tendering processes on biosimilar policymaking in Europe. It highlights the importance of procurement policy in shaping the decisions made in the pharmaceutical industry, particularly regarding biologic medicines and their generic equivalents, biosimilars. The article raises concerns about outdated assumptions and the strategies used by biotechnology and pharmaceutical companies to restrict competition and extend their monopolies. It also examines the European tender system and its role in assessing the value of biosimilars.
- Procurement policy and assumptions made by policy-makers can have unintended consequences on the pharmaceutical industry, especially on biologic medicines and their generic equivalents, biosimilars.
- Patents incentivize innovation by restricting competition, but strategies employed by companies, such as filing multiple patents and retaining key know-how, make it difficult for biosimilars to enter the market and drive down prices.
- European policy-makers have implemented a variation of the tender system, entrusting decision-making to public bodies like the National Institute for Clinical Excellence (NICE). Biosimilar suppliers bid on various factors, and sophisticated cost and benefit analysis by experts determines the overall value.
- While tenders may result in price reductions, concerns are raised about security of supply and lack of transparency in the tendering process, which can hinder competition and market dynamics.
- The article suggests that the European tender system may need to be recalibrated to accommodate manufacturing innovations, such as Quantitative Trait Loci (QTL) technology, which could potentially lower prices and eliminate tactics like ever-greening and patent thickets.
Conclusion:
The tendering process in Europe has significant implications for biosimilar policymaking and the pharmaceutical industry. While it can result in price reductions, concerns are raised about barriers to competition, lack of transparency, and the need to adapt to emerging manufacturing technologies. Recalibrating the tender system may be necessary to ensure that innovative technologies like QTL can translate into lower prices and increased accessibility for the public.
