The 30-Billion-Dollar Distribution Markups and Taxes of Pharmaceuticals in Latin American Countries: Impact, Options, and Trade-Offs.

OBJECTIVES: The World Health Organization provides 10 specific guidelines for managing the prices of pharmaceutical products. Many of those are widely known and used such as reference pricing, value-based pricing, price transparency, and tendering. Less attention and knowledge is concentrated in markup regulation across the pharmaceutical supply chain and distribution and in tax exemptions or reductions. This article quantifies the impact of these price components in the Latin American (LatAm) region and places the findings in the context of economic theory and international policy experiences. METHODS: 2020 retail pharmaceutical sales data from 8 major LatAm markets covered in the IQVIA database were decomposed into ex-factory, distributor markups, and taxes using price build up information and the Price Decipher Methodology developed by the Novartis Global Pricing Governance and Negotiation team. The findings were reviewed by an international panel representing academia, health policy, health economics, patient, and industry. RESULTS: The ex-factory market value of the analyzed markets was $49 billion. Distribution markups added $20 billion and taxes a further $10.5 billion. This represented a 63% increase over ex-factory prices, considered high if compared with 24% for an international benchmark of 35 ex-LatAm countries. Reducing markups for these LatAm countries to 24% would represent up to $19 billion in savings for payers and patients. CONCLUSIONS: There is potential for significant cost reductions associated with tax and distribution markup refinements in the LatAm retail pharmaceutical market. National policies should be informed by additional context-specific research for effective implementation.

A civil society view of rare disease public policy in six Latin American countries.

Patients with rare diseases across the world struggle to access timely diagnosis and state-of-the-art treatment and management of their conditions. Several recently published reviews highlight the importance of country efforts to address rare diseases and orphan drugs policy comprehensively. However, many of these reviews lack depth and detail at the local level, which we believe is necessary for rare disease advocates to identify and prioritize opportunities for strengthening each country's policy framework.We asked leading patient advocates from civil society organizations their views on rare disease public policy in Argentina, Brazil, Chile, Colombia, Mexico, and Peru with a focus on whether specific laws and regulations in these six Latin American countries have been promulgated. From December 2018 to March 2019 we supplemented their perspectives with evidence from accessible literature using key search terms. For each country, we prepared a detailed analysis on how laws or other policy initiatives took shape and the steps taken since to implement them. This allowed us to identify five broad policy categories for subsequent analysis: national laws, national regulations, health system incorporation of rare disease treatments, care delivery, and patient engagement.By describing the different approaches, challenges and timelines across six countries, our research demonstrates that strengthening rare disease policy first requires a common understanding and local consensus of each country's recent past and current situation. Subsequent analysis based on a set of common policy dimensions led us to where we believe salient opportunities lie for each of these countries to strengthen their overall policy framework for rare disease patients.

HTA Implementation in Latin American Countries: Comparison of Current and Preferred Status.

OBJECTIVES: To provide an overview about the current status of health technology assessment (HTA) implementation in Latin American countries and to identify long-term objectives considering regional commonalities. METHODS: We conducted a survey among participants of the 5th Latin American Future Trends Conference in October 2015. Thirty-seven respondents from eight Latin American countries provided insights about the current and preferred future status of HTA implementation related to human capacity building, HTA financing, process and organizational structure for HTA, scope of mandatory HTA, decision criteria, standardization of HTA methodology, mandating the use of local data, and international collaboration in HTA. RESULTS: Survey respondents reported insufficient human resources and public investment for HTA implementation. Organizational structure and legislation framework of HTA differ considerably across countries. According to survey respondents, in the future policymakers should rely more on the assessment of therapeutic value, cost-effectiveness, and budget impact criteria by applying explicit thresholds, potentially in a multicriteria decision analysis framework. HTA should not be restricted to policy decisions of new technologies but it should also be used for the revision of previous decisions. In addition, the quality and transparency of HTA have to be strengthened. CONCLUSIONS: HTA plays an increasingly important role in Latin American countries. Each country needs to record its current implementation status and identify components for improvement. Duplication of efforts can be reduced if international collaboration is integrated into national HTA implementation.