ABSTRACT
BACKGROUND: Lack of transparency around manufacturing costs, who bears the bulk of research and development costs and how total costs relate to the pricing of products, continue to fuel debates. This paper considers the case of olaparib (Lynparza®), recently indicated for use among BRCA-mutant breast cancer patients, and estimates the extent of public and philanthropic R&D funding. METHODS: We know from previous work that attempting to ascertain the amount of public and philanthropic funding using purely bibliographic sources (i.e., authors' declarations of funding sources and amounts traced through funders) is limited. Since we knew that a publically funded research unit was pivotal in developing olaparib, we decided to supplement bibliographic data with a Freedom of Information request for administrative records on research funding data from this research centre. RESEARCH: In terms of stages of product development, work conducted in the pre-clinical research stage was the most likely to report non-industry funding (> 90% of pre-clinical projects received public or philanthropic funding). Clinical trials were least likely to be funded through non-industry sources-although even here, contrary to the popular assertion that this is wholly industry-financed, we found public or philanthropic funding declared by 23% of clinical trials. Using information reported in the publications, we identified approximately £128 million of public and philanthropic funding that may have contributed to the development of olaparib. However, this amount was less than one-third of the total amount received by one research institute playing a pivotal role in product discovery. The Institute of Cancer Research reported receiving 38 funding awards to support olaparib work for BRCA-mutant breast cancer totalling over £400 million. CONCLUSIONS: Government or charitable funding of pharmaceutical product development is difficult to trace using publicly available sources, due to incomplete information provided by authors and/or a lack of consistency in funding information made available by funders. This study has shown that a Freedom of Information request, in countries where such requests are supported, can provide information to help build the picture of financial support. In the example of olaparib, the funding amounts directly reported considerably exceeded amounts that could be ascertained using publically available bibliographic sources.
ABSTRACT
Objectives:In March 30th 2020, a request was raised by the Austrian Ministry of Health (BMASGK) and further Austrian policy stakeholder to set up a Horizon Scanning System (HSS) for medicines and vaccines. The establishment of a HSS/ Horizon Scanning System for Covid-19 interventions has the intention of a. informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and b. monitoring them over the next few months in order to support evidence-based purchasing, if necessary. Methods:To respond to the request by BMASGK, 1. As a first step an inventory, based on international sources, is being built. 2. As a second step, selective searches by means of searches in study registries are carried out for information on clinical studies in humans and the state of research. 3. The information gathered in the first two steps forms the basis for "vignettes" (short descriptions) for those products that are already at an "advanced" stage. 4. Subsequently, the products are being monitored with regard to their status of clinical studies up to approval and are finally evaluated for their benefit and harm. All work steps are conducted in close international (European) cooperation.
ABSTRACT
Objectives:In March 30th 2020, a request was raised by the Austrian Ministry of Health (BMASGK) and further Austrian policy stakeholder to set up a Horizon Scanning System (HSS) for medicines and vaccines. The establishment of a HSS/ Horizon Scanning System for Covid-19 interventions has the intention of a. informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and b. monitoring them over the next few months in order to support evidence-based purchasing, if necessary. Methods:To respond to the request by BMASGK, 1. As a first step an inventory, based on international sources, is being built. 2. As a second step, selective searches by means of searches in study registries are carried out for information on clinical studies in humans and the state of research. 3. The information gathered in the first two steps forms the basis for "vignettes" (short descriptions) for those products that are already at an "advanced" stage. 4. Subsequently, the products are being monitored with regard to their status of clinical studies up to approval and are finally evaluated for their benefit and harm. All work steps are conducted in close international (European) cooperation.
ABSTRACT
BACKGROUND: We considered the extent of the contribution of publicly funded research to the late-stage clinical development of pharmaceuticals and medicinal products, based on the European Commission (EC) FP7 research funding programme. Using two EC FP7-HEALTH case study examples-representing two types of outcomes-we then estimated wider public and charitable research funding contributions. METHODS: Using the publicly available database of FP7-HEALTH funded projects, we identified awards relating to late-stage clinical development according to the systematic application of inclusion and exclusion criteria, classified them according to product type and clinical indication, and calculated total EC funding amounts. We then identified two case studies representing extreme outcomes: failure to proceed with the product (hepatitis C vaccine) and successful market authorisation (Orfadin® for alkaptonuria). Total public and philanthropic research funding contributions to these products were then estimated using publicly available information on funding. RESULTS: 12.3% (120/977) of all EC FP7-HEALTH awards related to the funding of late-stage clinical research, totalling 686,871,399. Pharmaceutical products and vaccines together accounted for 84% of these late-stage clinical development research awards and 70% of its funding. The hepatitis C vaccine received total European Community (FP7 and its predecessor, EC Framework VI) funding of 13,183,813; total public and charitable research funding for this product development was estimated at 77,060,102. The industry sponsor does not consider further development of this product viable; this now represents public risk investment. FP7 funding for the late-stage development of Orfadin® for alkaptonuria was so important that the trials it funded formed the basis for market authorisation, but it is not clear whether the price of the treatment (over 20,000 per patient per year) adequately reflects the substantial public funding contribution. CONCLUSIONS: Public and charitable research funding plays an essential role, not just in early stage basic research, but also in the late-stage clinical development of products prior to market authorisation. In addition, it provides risk capital for failed products. Within this context, we consider further discussions about a public return on investment and its reflection in pricing policies and decisions justified.
ABSTRACT
Objectives:In March 30th 2020, a request was raised by the Austrian Ministry of Health (BMASGK) and further Austrian policy stakeholder to set up a Horizon Scanning System (HSS) for medicines and vaccines. The establishment of a HSS/ Horizon Scanning System for Covid-19 interventions has the intention of a. informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and b. monitoring them over the next few months in order to support evidence-based purchasing, if necessary. Methods:To respond to the request by BMASGK, 1. As a first step an inventory, based on international sources, is being built. 2. As a second step, selective searches by means of searches in study registries are carried out for information on clinical studies in humans and the state of research. 3. The information gathered in the first two steps forms the basis for "vignettes" (short descriptions) for those products that are already at an "advanced" stage. 4. Subsequently, the products are being monitored with regard to their status of clinical studies up to approval and are finally evaluated for their benefit and harm. All work steps are conducted in close international (European) cooperation.