Helle Håkonsen, Isabel Emmerick, Zaheer Ud Din Babar

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

1 Citation (Scopus)


All across the globe, pharmaceutical policies have undergone significant changes in recent decades to improve availability, access and quality of drugs. This chapter provides examples of policies of low-income, middle-income, and highincome countries that are at different stages of development with regard to their health system. It includes policies implemented in the wake of the Universal Declaration of Human Rightsfollowed by a description of national efforts to increase pharmaceutical production and supply, and measures to harmonize national regulations with international standards. Finally, increased access to affordable drugs is explored with an emphasis on the wider availability of generic drugs. The lowincome and lower middle-income countries included are Pakistan, the Philippines, Vietnam, and the East African Community; the upper middle-income examples included are Argentina, Brazil, Bulgaria, Colombia, China, Ecuador, Jordan, Russia and South Africa. Poland, Saudi Arabia, Trinidad and Tobago, and UAE are then presented as examples of high-income countries with developing healthcare systems. The chapter concludes that pharmaceutical policies have played a central role to make drugs more available and accessible and thereby improve social conditions and decrease poverty. Still, there are structural developments that present considerable challenges in providing equitable access to drugs. Pharmaceutical policy deals with the development, provision, and use of drugs within a healthcare system. The need for pharmaceutical policies became urgent after the thalidomide scandal in the 1960s [1] and was reinforced by an overall increase in drug utilization and the establishment of health insurance systems [2]. The World Health Organization (WHO) recommends that all countries formulate and implement a comprehensive national pharmaceutical policy in order to address pharmaceutical sector issues under a common framework [3]. The policy should embrace all drugs which should be available in a market, including original brands and generic drugs, biologics (products derived from living sources, as opposed to chemical compositions), vaccines, and natural health products [3]. It should ensure that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient’s illness. In four decades, the concept of national pharmaceutical policy has become broadly recognized and implemented in more than 100 countries [4]. Key components of a national pharmaceutical policy are regulation of access (e.g., essential drugs), control of quality, safety and efficacy, economic accessibility (e.g., price regulation and reimbursement systems), publicly available information, and strategies for rational drug use. All across the globe, pharmaceutical policies have undergone significant changes in recent decades, resulting in improved availability, access, and quality of drugs by better systems for surveillance and support to national industry. This book provides examples of regulatory policies in pharmaceutical markets in a selection of countries that show a great deal of variety in the construction of their healthcare systems. Yet, there are common features in agreement with international treaties on human rights and implementation of national drug policies within a framework of combined public and private healthcare systems.

Original languageEnglish
Title of host publicationPharmaceutical Policy in Countries with Developing Healthcare Systems
PublisherSpringer International Publishing AG
Number of pages9
ISBN (Electronic)9783319516738
ISBN (Print)9783319516721
Publication statusPublished - 1 Jan 2017


Dive into the research topics of 'Introduction'. Together they form a unique fingerprint.

Cite this