A human rights-based approach to the reimbursement of expensive medicines.

Abstract

In recent years, pharmaceutical companies have introduced new expensive medicines, some of which target only small patient populations. For example, trastuzumab (Herceptin*), imatinib (Glivec[R]) and sofosbuvir (Sovaldi[R]) are high-priced medicines that have been shown to be effective and safe for treating cancer or hepatitis C, diseases for which no effective treatment existed previously. In 2015, World Health Organization included several such expensive medicines in their model list of essential medicines, (1) despite current prices of 60000-100 000 United States dollars per treatment. The initial public enthusiasm for these medicines' therapeutic value is now tempered by practical concerns about how patients and health systems can afford them. Even in high-income countries affordability is a concern. Ethical and economic dilemmas arise when decision-makers must ration an expensive, life-saving or life-extending medicine. We contend that not funding an effective essential medicine contradicts Article 12 in International Covenant on Economic, Social and Cultural Rights, which declares the States Parties to present Covenant recognize right of everyone to enjoyment of highest attainable standard of physical and mental By September 2016, over 160 countries have ratified or acceded to Covenant. (2) In many countries, such as Argentina, Brazil, Latvia, New Zealand and Uruguay, patients have used Article 12 to litigate through domestic courts for reimbursement of expensive medicines. (3) In Netherlands, advocates of patients with Pompes disease --a rare muscle disease--based part of their arguments on fact that it was patients' right to receive continued reimbursement of an expensive treatment with marginal health benefits. Decision-makers decided to continue reimbursement, despite fact that many other patients in country were not reimbursed for more cost-effective treatments. How can governments with finite public health budgets ensure fair access to expensive, new and essential medicines as part of right to health? Is right to health equally important for all patients? Governments' efforts to prioritize access to essential medicines could be supported by a human rights approach and specifically by principle of progressive realization of right to health. The United Nations Committee on Economic, Social and Cultural Rights describes progressive realization as States Parties' obligation to use maximum of its available resources to move as expeditiously and effectively as possible towards achieving highest attainable standard of health for everyone. (2,4) The approach does not necessarily create an immediate right for everyone to receive treatment at any cost. Instead, progressive realization means that access to health care is gradually fulfilled for all patients. All Parties have an immediate obligation to take deliberate, concrete and targeted steps towards progressive realization. (3) However, providing immediate universal health care with all possible treatments for all people is not a legal obligation. (5) For prioritization, a transparent and independent reimbursement ranking process of medical treatments, largely based on estimates of comparative cost-effectiveness, presents a concrete and practical tool for decision-makers. Progressive realization justifies such ranking of treatments by ensuring that governments use available resources as effectively as possible and thereby progressively realizing right to health for largest number of people at lowest possible cost and without discrimination against patients. This duty of efficiency is also in line with authoritative interpretation by Committee on Economic, Social and Cultural Rights of governments' legal obligations under human rights treaties in General Comment 3, as well as a well-founded set of principles adopted by a group of scholars and policy-makers in Limburg Principles. …