Antimicrobial resistance (AMR) to drugs is a natural and unavoidable consequence of treating infectious diseases. A growing global public health threat, AMR reduces the chances of successfully treating patients with infectious diseases, thereby increasing the probability of complications, morbidity and mortality. The World Health Organization estimates that infectious diseases are the third leading cause of death in the European Union.
Antimicrobial resistance (AMR) is becoming a major global public health threat and has begun to command attention from European and US policy makers. An initial focus on monitoring AMR and conserving existing treatments by cutting down on misuse has been complemented by moves towards addressing the paucity of new drugs in the R&D pipeline of the pharmaceutical industry.
Mattison, N., Mestre-Ferrandiz, J. and Towse, A. eds.
This publication reports on a seminar intended to encourage further thought about the distinguishing characteristics of the market for biosimilars and the implications of these for potential savings.
Economists and regulatory experts from the US and Europe were invited to describe their research and offer their perspectives about what can be expected in the near- and medium-term. The publication includes updated insights that take account of changes since the seminar, including more recent analyses of potential market impact.
Antimicrobial resistance (AMR) to drugs, a natural and unavoidable consequence of treating infectious diseases, is a growing global public health threat. The EU Commission is to develop comprehensive proposals by the end of 2012 for addressing the situation. This Paper is meant to provide input into those policy discussions.
The paper reviews AMR’s implications for the burden of disease, the causes of AMR, the current state of the antibiotic development pipeline and the reasons antibiotic R&D has been de-emphasised by biopharmaceutical companies.
The authors point out that biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate after patent expiry. Off-patent versions of the originator product, moreover, cannot rely on a simple demonstration of chemical comparability; they are best described as ‘biosimilar’. These differences mean that biosimilar markets will evolve in a more complex way than traditional, small molecule, chemical generics markets.
One of the main characteristics of the pharmaceutical industry, including biotechnology, is the important role played by public institutions. Their role is not only focused on encouraging research and development (R&D), but also on regulation of the final product market. The special characteristics of the pharmaceutical industry and its economic importance for many nations imply that governments have a strong interest in supporting the efficient functioning of the industry.
Improving the health and life expectancy of the populations of the less developed countries of the world requires both better access to medicines and research and development (R&D) of new drugs, vaccines and diagnostics. Achieving the latter is a critical part of a package of steps needed to treat and ultimately eradicate the infectious diseases prevalent predominately in the poorest regions of the developing world.
This study provides a life cycle perspective on cross-national differences in pharmaceutical prices, volumes and expenditures. Most previous studies have focused solely on cross-national differences in drug prices, comparing prices for a small sample of branded products at a single point in time. However, policymakers are increasingly concerned with total drug expenditures, which reflect volume and average prices for all products.