| 1. |
- Bouchard, Ron A., et al.
(författare)
-
Structure-Function Analysis of Global Pharmaceutical Linkage Regulations
- 2011
-
Ingår i: Minnesota Journal of Law, Science & Technology. - Minneapolis : University of Minnesota. - 1552-9533. ; 12:2, s. 391-456
-
Tidskriftsartikel (refereegranskat)abstract
- Prompt and affordable access to essential medicines is a component of almost all domestic and global public health models. As is now well known, the availability and costs of both brand and generic drugs is a function of traditional patent law incentives. What is less known, however, is that generic entry is controlled increasingly through an emerging form of intellectual property law referred to as "linkage regulations". Linkage regulations tie generic drug approval, and thus access to essential medications, to existing drug patents through potentially long and costly litigation. The linkage regime is in the process of rapidly spreading worldwide through international free trade agreements. Even so, very little is known about how the regulations work in developed nations let alone how they impact on public health systems across international borders. The authors constitute a new consortium of eleven health policy experts and practicing lawyers in nine countries including those with mature linkage regulations, those with new regulations, those without regulations but with practices that parallel linkage, and those where regulations are currently subject to intense public debate and litigation. Here, we propose a novel framework to conduct a comparative legal analysis of global pharmaceutical linkage, with the aim of obtaining critical information about the costs and benefits of tying pharmaceutical innovation and generic drug availability to drug patenting. A major goal of the research is to investigate the structural and functional aspects of global linkage regulations as they relate to drug availability, costs and expenditures on the one hand and incentives for innovation and protection of rights on the other. The structural and functional aspects we discuss here include: assessment in each jurisdiction of the original policy intent underpinning linkage; the manner in which public health policy and economic policy is perceived by governments and the courts to converge or diverge through linkage; the specific legal checks and balances designed specifically to maintain balance between the interests of brand and generic firms; the growing expansion of linkage beyond the drug approval-drug patenting nexus to encompass drug pricing and reimbursement; and the role of empirical studies to establish the legal legitimacy of linkage regulations. A second major goal of our work is to assist domestic and global governments and legal systems working with linkage regimes to stimulate the production of new and innovative drugs while at the same time lowering public health costs and increasing access to essential medicines.
|
|
| 2. |
- Morel, Chantal M., et al.
(författare)
-
Industry incentives and antibiotic resistance : an introduction to the antibiotic susceptibility bonus
- 2020
-
Ingår i: Journal of antibiotics (Tokyo. 1968). - : NATURE PUBLISHING GROUP. - 0021-8820 .- 1881-1469. ; 73:7, s. 421-428
-
Forskningsöversikt (refereegranskat)abstract
- The scarcity of novel antibiotic compounds in a time of increasing resistance rates has begun to ring alarm bells at the highest echelons of government. Large new financial incentives to accelerate antibiotic research and development, such as market entry rewards (MERs), are being considered. However, there is little focus on how to sustain the efficacy of new, promising antibiotics reaching the market. Currently, inappropriate use of antibiotics is commonplace, which has accelerated resistance development. In an attempt to halt this trend, antibiotic stewardship policies are being implemented in many resource-rich settings. Unfortunately, this has not yet had an impact on the amount of antibiotics being prescribed globally. One important hurdle is misalignment of incentives. While governments and health services are incentivized to promote prudent use of this common good, pharmaceutical companies are incentivized to increase volume of sales to maximize profits. This problem must be addressed or else the major efforts going into developing new antibiotics will be in vain. In this paper we outline an approach to realign the incentives of pharmaceutical companies with wider antibiotic conservation efforts by making a staged bonus a component of an MER for antibiotic developers when resistance to their drug remains low over time. This bonus could address the lack of stewardship focus in any innovation-geared incentive.
|
|
| 3. |
- Rahman, Sakib, et al.
(författare)
-
Market concentration of new antibiotic sales
- 2021
-
Ingår i: Journal of Antibiotics. - : Springer Nature. - 0021-8820 .- 1881-1469. ; 74:6, s. 421-423
-
Tidskriftsartikel (refereegranskat)abstract
- We calculate the average sales of new antibiotics during their first 8 years on the market. The discounted net present value is only $240 m in total per antibiotic, well below costs of supplying these products. The reliance on the US for sales is striking: the US market accounts for 84% of sales during the first 8 years. These facts clarify the need for additional revenues, especially from other countries, to support incentives for the development of new antibiotics. Market entry rewards may be of particular value.
|
|
