PBI40 TENDER APPROACHES IN THE OFF-PATENT BIOLOGICAL MEDICINES MARKET: A EUROPEAN COMPARATIVE ANALYSIS

Abstract

Tendering has become an important strategy to contain spending when purchasing pharmaceuticals. However, tender approaches, such as awarding total market volume to a sole competitor, may threaten the sustainability of the off-patent biological medicines market. This study aims to (i) map the organisation and implementation of tendering across Europe, (ii) investigate tender frameworks and award criteria, (iii) identify best tender practices and (iv) formulate recommendations. First, to gather information on tender implementation and applied frameworks, a quantitative web survey was completed by hospital pharmacists and procurers across Europe. Second, to explore insights and derive learnings, semi-structured interviews were performed with hospital pharmacists, procurers and industry from countries representing different healthcare systems: Norway, Denmark, Italy, UK, France and Belgium. A hundred survey participants representing 26 countries were included for descriptive analysis. Although the implementation and experience with tendering for off-patent biologicals was heterogeneous among participants, similar selection and award criteria were often applied. The majority of participants indicated the use of selection criteria beyond price. Twelve interviews were conducted. Interviewees mentioned the complex trade-off between benefits and risks of national and regional/hospital tendering systems. National systems, representing a larger purchasing capacity, may result in larger discounts, but may also push other competitors out of the market. Regional/hospital systems may be advantageous for long-term competition by providing an opportunity for multiple players, however they may also result in less competitive prices. Some interviewees were apprehensive about the risk of competitors withdrawing from the market due to unexpected high price pressure. Due to variations between regions, national healthcare systems and product classes, it may not be possible to create a ‘one-size-fits-all’ tendering framework. However, overarching best practices towards sustainable tendering for off-patent biologicals were identified, including: (i) multiple winner tenders, (ii) differentiation beyond price and (iii) re-opening of contracts upon biosimilar market entry.