ABSTRACT
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.
Subject(s)
Health Policy , Pharmaceutical Preparations , MedicineABSTRACT
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.
Subject(s)
Policy Making , Medicine , Communication , Pharmacy AdministrationABSTRACT
Can disruption happen when no one notices? Disruptive technologies and processes are fundamentally starting to up-end how medicines and health systems benefit patients but the question is whether health systems are ready for them. This paper will briefly review the business strategy and management literature on topics such as disruption and "black swan" theories of change, before turning to discuss some of the areas where change is affecting medicine and healthcare. Such areas include the emergence of cell and gene therapies, the economics of cures, digital technologies, mobile apps, social media, supply chain technologies such as drones and online distribution, universal health coverage and funding, and consumerisation of healthcare. The question to be asked is whether these sorts of changes are "disruptive" or whether they were coming for a long time and it is just that health systems are slow to change. It could be argued that while perhaps unexpected by day-to-day practitioners in healthcare, in fact, many of the changes now starting to affect the health and medicines sector have been affecting other sectors such as technology, finance and communications for decades.
ABSTRACT
At the 2019 World Health Assembly, a significant new resolution was agreed by most countries to start publicly sharing information on the real net prices they pay for medicines in their health systems. The resolution also includes provisions for countries to support other transparency activities. However, an additional proposal to require pharmaceutical companies to submit information on their internal sales figures, internal research and development costs, clinical trial costs and marketing costs for each individual medicine as a condition of registration, and for governments to publish this, was not agreed. Pressure for coordinated international action to increase the transparency of medicine prices and costs has been building for some time, as confidential discounts and rebates on prices of medicines are common. We argue that while it is possible that stakeholders may benefit to some extent from greater transparency on prices, several important policy and economic issues need to be carefully considered. Such transparency, combined with widespread use of international reference pricing, might undermine companies' differential pricing strategies, which are important in fostering wider access to medicines in low- and middle-income countries in particular, noting that access to medicines issues can occur in high-income countries as well. Moreover, there is a further risk that these types of proposals will lead to price fixing, less competition and higher prices than might otherwise be the case. The lack of any commitments in the resolution to greater transparency in payer decision-making processes also risks undermining the credibility of the resolution. The resolution and further transparency measures could have the potential to undermine patient access to medicines in the developing world, lead to higher prices in some markets and compromise long-term development of new medicines for future generations.
