Appraising research policy instrument mixes: a multicriteria mapping study in six European countries of diagnostic innovation to manage antimicrobial resistance.

This article provides prospective appraisal of key policy instruments intended to stimulate innovation to combat antimicrobial resistance (AMR). AMR refers to the ability of microbes to evolve resistance to those treatments designed to kill them, and is associated with the overuse or misuse of medicines such as antibiotics. AMR is an emerging global challenge with major implications for healthcare and society as a whole. Diagnostic tests for infectious diseases can guide decision making when prescribing medicines, so reducing inappropriate drug use. In the context of growing international interest in policies to stimulate innovation in AMR diagnostics, this study uses multicriteria mapping (MCM) to appraise a range of policy instruments in order to understand their potential performance while also highlighting the uncertainties that stakeholders hold about such interventions in complex contexts. A contribution of the article is the demonstration of a novel method to analyse and visualise MCM data in order to reveal stakeholder inclinations towards particular options while exploring interviewees' uncertainties about the effectiveness of each instrument's design or implementation. The article reports results from six European countries (Germany, Greece, Italy, the Netherlands, Spain and the UK). The findings reveal which policy instruments are deemed most likely to perform well, and why, across stakeholder groups and national settings, with areas of common ground and difference being identified. Importantly, the conclusions presented here differ from prominent policy discourse, with international implications for the design of mixes of policy instruments to combat AMR. Strategic and practical methodological implications also emerge for general appraisal of innovation policy instrument mixes.

A molecular monopoly? HPV testing, the Pap smear and the molecularisation of cervical cancer screening in the USA.

DNA-based molecular testing for human papillomavirus has emerged as a novel approach to cervical cancer screening in the context of well-entrenched existing technology, the Pap smear. This article seeks to elucidate the process of molecularisation in the context of screening programmes. We illustrate how, although Pap has long been problematised and could be seen as a competing technological option, the existing networks and regime for Pap were important in supporting the entrenchment process for the artefacts, techniques and new diagnostics industry entrant, Digene, associated with the new test. The article provides insights into how the molecularisation of screening unfolds in a mainstream market. We reveal an incremental and accretive, rather than revolutionary, process led by new commercial interests in an era when diagnostic innovation is increasingly privatised. We show Digene's reliance on patents, an international scientific network and their position as an obligatory point of passage in the clinical research field with regard to the new technology's role, as well as on controversial new marketing practices. The article is based on a mixed method approach, drawing on a wide range of contemporary sources (including patents, statutory filings by companies, scientific literature and news sources) as well as interviews.

Supporting the vital role of boundary-spanning physician researchers in the advancement of medical innovation.

A wide range of stakeholders recognise that physicians play a vital role in medical innovation and, in particular, the importance of boundary-spanning engagement between physicians and industry in clinical research. While UK physicians are keen to take part in research, this article draws on a range of literature to identify apparent and anticipated challenges that discourage or prevent cross-sector engagement by physician researchers. To encourage greater interaction and exploration of associated support mechanisms, we present a full spectrum of engagement modes, funding opportunities and illustrative initiatives, showing how different stakeholders (from government institutions, charities, professional bodies and industry) can contribute to improving the engagement of physicians in boundary spanning research. We emphasise the importance of mutual understanding, trust and commonly shared practices, as well as adequate resources, to encourage these vital interactions.

DNA patenting: the end of an era?

Debates on patenting DNA must evolve to reflect the global decline in filings and regional disparities in patenting activity.

A Multinational European Study of Patient Preferences for Novel Diagnostics to Manage Antimicrobial Resistance.

BACKGROUND: Novel diagnostics are needed to manage antimicrobial resistance (AMR). Patient preferences are important in determining whether diagnostic tests are successful in practice, but there are few data describing the test attributes which matter most to patients. We elicited patients' preferences for attributes of diagnostic tests that could be used to reduce unnecessary antibiotic use in primary care across seven European countries. METHODS: We used an online stated preference survey, including a discrete choice experiment (DCE). The DCE explored how patients make trade-offs between three key attributes of diagnostic tests: the speed that results were available, confidence in the test results, and how convenient it is to take the test. Individuals were eligible to complete the survey if they had taken antibiotics within the last 2 years and were resident in Germany, Italy, Spain, France, Greece, the Netherlands or the United Kingdom (UK). RESULTS: In total, 988 respondents completed the survey. The DCE responses illustrated that speed was the least important attribute in most countries. Responses from Germany and the Netherlands indicated that confidence was most important in these countries. Responses from the UK, France, Spain and Italy showed convenience as the most important attribute in these countries. Two attributes, confidence and convenience, were jointly favoured by respondents in Greece. CONCLUSION: Patients in different European countries do not have the same preferences for the attributes of diagnostic tests to manage AMR in primary care. Failure to account for such differences during test development could reduce test uptake, result in continued overuse of antibiotics, and hamper marketisation.

Putting pharmacogenetics into practice.

Genetics is slowly explaining variations in drug response, but applying this knowledge depends on implementation of a host of policies that provide long-term support to the field, from translational research and regulation to professional education.

Continental drift? Do European clinical genetic testing laboratories have a patent problem?

Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods that applied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have a relatively low risk of infringing patents on naturally occurring DNA or methods for detecting genomic variants. In Europe, however, such claims remain patentable, and European laboratories risk infringing them. We report the results from a survey that collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportion of European laboratories that have refrained from providing associated testing services owing to patent protection has increased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly strongly affected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sector laboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.

Cost-effectiveness of pharmacogenomics in clinical practice: a case study of thiopurine methyltransferase genotyping in acute lymphoblastic leukemia in Europe.

Only a few studies have addressed the cost-effectiveness of pharmacogenetics interventions in healthcare. Lack of health economics data on aspects of pharmacogenetics is perceived as one of the barriers hindering its implementation for improving drug safety. Thus, a recent Institute for Prospective Technological Studies (IPTS) study, entitled 'Pharmacogenetics and pharmacogenomics: state-of-the-art and potential socio-economic impact in the EU' included an explorative cost-effectiveness review for a pharmacogenetic treatment strategy compared with traditional medical practice. The selected case study examined the cost-effectiveness of thiopurine methyltransferase (TMPT) genotyping prior to thiopurine treatment in children with acute lymphoblastic leukemia (ALL). Information for the cost-effectiveness model parameters was collected from literature surveys and interviews with experts from four European countries (Germany, Ireland, the Netherlands and the UK). The model has established that TPMT testing in ALL patients has a favorable cost-effectiveness ratio. This conclusion was based on parameters collected for TPMT genotyping costs, estimates for frequency of TMPT deficiency, rates of thiopurine-mediated myelosuppression in TPMT-deficient individuals, and myelosuppression-related hospitalization costs in each of the four countries studied. The mean calculated cost per life-year gained by TPMT genotyping in ALL patients in the four study countries was euro 2100 (or euro 4800 after 3% discount) based on genotyping costs of euro 150 per patient. Cost per life-year gained is expected to further improve following the introduction of the wider use of TMPT genotyping and the availability of lower cost genotyping methods. Our analysis indicates that TPMT genotyping should be seriously considered as an integral part of healthcare prior to the initiation of therapy with thiopurine drugs.

Innovation policy instruments (non-price) for medical innovation

Innovation policy instruments are policy interventions with a specific mechanism of action that influences the innovation process. This Oslo Medicines Initiative technical report presents a broad range of such instruments available to national policy-makers in support of innovation for new medicines (excluding those focused on price, which are covered elsewhere in the report series). This report explores various types of policy instrument, based on reviews of the literature on policies for innovation in the medical and other sectors. For each type identified, the report explores the mechanisms of action, the effects these have and where they occur, and the extent to which these instruments have been implemented globally. It also sets out considerations for their effective implementation. The report demonstrates that the long-established push/pull (supply/demand) framing that dominates discourse around medical innovation can be broadened, providing policy-makers with instruments to supplement push/pull approaches, by emphasizing the role of communication, collaboration and coordination in supporting the emergence of medicines to address societal needs.

Инструменты политики (не связанные с ценовыми факторами) в поддержку инноваций в области медицины: Технический доклад Инициативы Осло по лекарственным средствам: основные положения.

Под инструментами инновационной политики имеются в виду вмешательства в сферу политики с особым механизмом действия, который оказывает влияние на процесс нововведений. В техническом докладе Инициативы Осло по лекарственным средствам представлен широкий диапазон таких инструментов для использования национальными органами, отвечающими за формирование политики, в поддержку инноваций в области новых лекарственных препаратов (за исключением тех, которые ориентированы на факторы цены, о чем говорится в других материалах серии докладов). Этот доклад посвящен анализу различных типов инструментов политики, проведенному в результате обзора литературных источников по вопросам инновационной политики в медицинском и других секторах. По каждому из этих типов в отчете дается описание их механизмов действий, характера воздействия и в чем он проявляется, а также уточняется размах внедрения этих инструментов в практику в глобальном масштабе. Здесь также изложены соображения по эффективному осуществлению таких механизмов. Доклад наглядно показывает, что давно сложившуюся пуш/пул-конструкцию (соотношение спроса и предложения), занимающую доминирующее положение в связи с полемикой вокруг нововведений в области медицины, можно расширить, вооружив определяющих политику лиц инструментами в дополнение к пуш/пул-подходам через актуализацию функции коммуникации, сотрудничества и координации в процессе содействия появлению новых лекарственных средств для удовлетворения потребностей населения.