The scope of this guideline focuses on three overarching policy questions, each with a series of more detailed sub-questions:
Should countries use price control measures to manage medicine prices? If so:
Can ERP be an effective pricing strategy in low- and middle-income countries?
Should HTA be considered as part of (i) decision-making and/or (ii) price setting in low- and middle-income countries?
Can cost-plus price setting be an effective pricing strategy in low- and middle-income countries?
Should countries adopt measures to control add-on costs in the supply chain? If so:
Should countries promote the use of quality assured generic medicines as a strategy to manage medicine prices? If so:
What prerequisites are needed to promote increased use of generic medicines?
Should strategies be used to facilitate/accelerate market entry of generics (e.g. trade-related aspects of intellectual property rights (TRIPS) flexibilities and compulsory licensing; facilitated regulatory approval; fast-tracking and/or reduced fees)?
Should optional/mandatory generic substitution by dispensers be used to promote increased use of generic medicines?
What is the role of generic competition in the pharmaceutical market as part of a strategy for managing prices?
Should internal reference pricing (IRP), by product or therapeutic group, be used to promote increased use of generic medicines?
Should strategies be adopted to encourage the use of generic/lower-cost products among prescribers and dispensers?
Should strategies be adopted to encourage the use of generic/lower-cost products among consumers?
Although pharmaceutical procurement by governments, hospitals, and other organizations is relevant to pricing, this topic is extensively elsewhere and is not addressed in this guideline. Similarly, marketing and promotion practices by the pharmaceutical industry, which can have strong influences on prices, are outside the scope of this guideline.
