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Pricing and Reimbursement Issues for Generics and BiosimilarsPublished by: Frost & Sullivan Published: Dec. 28, 2006 - 51 Pages Table of Contents 1. Executive Summary
Chapter 5
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AbstractResearch OverviewThis Frost & Sullivan research service titled Pricing and Reimbursement Issues for Generics & Biosimilars Markets in Europe provides a detailed analysis of various issues affecting pricing and reimbursement decisions of generics in Europe. The study includes an overview of cost-containment measures such as reference pricing, parallel trade, generic substitution, patient co-payments and reimbursement. Certain key issues such as the EU accession, the Roche/Bolar provision, data exclusivity and marketing authorisation applications are also discussed. Market Sectors Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:
Ageing Population and Spiralling Healthcare Costs to Drive Increased Uptake of Generic Drugs With expensive drugs increasing healthcare costs, generic medicines have a critical role in the European market. Generics are widely regarded as the best method to allow access to safe, effective and high-quality drugs at affordable prices to a vast majority of patients. They also play a vital role in the development of sustainable healthcare models by imposing a direct influence on pharmaceutical spending. In most European countries, the generics industry is highly competitive, thereby increasing pressure on the pharmaceutical sector to develop innovative drugs. Consequently, the cost savings achieved from generics enable governments to reimburse these innovative drugs. "An ageing population, increasing healthcare expenditure and the need for cheap, effective medicines are the key factors driving growth in the European generics market", notes the analyst of this research service. "Various studies have indicated the cost savings derived from generics and several governments in Europe are actively promoting it." Moreover, given the rapid increase in healthcare expenditure, pricing and reimbursement systems are essential to set conditions that regulate the demand and supply of drugs. However, there is great variation in the generics markets across Europe due to different country-wise policies. Hence, the biggest challenge faced by several European countries is to establish a sustainable healthcare model, through which generics can provide savings to payers and innovative drugs continue to offer a fair rate of return to manufacturers, thus making medicines affordable for all. Standardisation of Generics Policies Crucial for Market Expansion In view of the escalating pharmaceutical expenditure, European governments are under immense pressure to implement corrective measures. Several countries have resorted to methods such as generic substitution and reference pricing to lower pharmaceutical pricing. In addition, with certain countries offering incentives to pharmacists and physicians for prescribing generics, the generics markets are likely to witness significant growth. Finally, the advent of biosimilars is expected to be another crucial factor in reducing drug prices. Despite these positive trends, the EU expansion is likely to bring in standardisation problems with respect to policies concerning the generics market. "Although the EU accession is believed to provide long-term benefits to generics manufacturers, harmonisation of policies is expected to take a few years," states the analyst. "In addition, the lack of provisions such as the Roche/Bolar provision, which allows for research to be carried out before the loss of patent exclusivity, is likely to delay generic approvals in Europe." Apart from this, delays in the marketing authorisation application process will need to be overcome. Besides, participants in the generics market must focus on low-cost contract manufacturing markets such as India and China to speed up their time-to-market. Strategic agreements between participants operating in different countries are also likely to yield synergistic benefits. Lastly, market participants will need to optimise their product portfolio and devise long-term R&D strategies to ensure success in the competitive environment. Get Full Details About This Report >> |
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