Pharmaceutical policy in Ecuador

Ecuador has a heterogeneous health system. The 2008 Constitution signaled the start of a process that aims at attaining universal, publicly financed healthcare, including medicines. This has lead to a systematic increase in the use and expenditure on medicines. Between 2008 and 2015, the total Ministry of Health pharmaceutical budget more than doubled, from USD 106.9 million to USD 235.6 million. The National Agency for Regulation, Control and Surveillance of Health (ARCSA), the new medicines regulatory agency, shows several shortcomings in its capacity to ensure the efficacy, safety, and quality of the drugs marketed in Ecuador. The National Essential Medicines List is being updated every second year; however, the introduction of new medicines by means of ad hoc tracks has become a norm during the last years in order to introduced publicly funded high-cost drugs. Price regulation of new drugs is trying to move from the traditional cost of production criterion to more updated mechanisms, based on international price referencing and value-based pricing, but there is still a long way ahead, as there is still not enough technical capacity in health technology assessment and economic evaluation analysis. The local pharmaceutical industry only has a small share of the domestic market, and exports are not substantial, which might be partly caused by the concerns on the quality of locally manufactured medicines. Moreover, local production is highly dependent on the importation of active pharmaceutical ingredients and other inputs, that is, it has a rather low added value. In conclusion, there is a dire need to design and implement a pharmaceutical policy that primarily aims at public health goals but also takes into account the industrial and economic objectives and constraints.