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

Perspectives In recent years, pharmaceutical companies have introduced new expensive medicines, some of which target only small patient populations. For example, trastuzumab (Herceptin®), imatinib (Glivec®) and sofosbuvir (Sovaldi®) 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, the World Health Organization included several such expensive medicines in their model list of essential medicines, 1 despite current prices of 60 000–100 000 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 the 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 the International Covenant on Economic, Social and Cultural Rights, which declares " the States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. " By September 2016, over 160 countries have ratified or acceded to the Covenant. and Uruguay, patients have used Article 12 to litigate through domestic courts for the reimbursement of expensive medicines. 3 In the Netherlands, advocates of patients with Pompe's disease – a rare muscle disease – based part of their arguments on the fact that it was the patients' right to receive continued reimbursement of an expensive treatment with marginal health benefits. Decision-makers decided to continue reimbursement, despite the fact that many other patients in the 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 the right to health? Is the 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 the principle of the progressive realization of the right to health. 2 The United Nations Committee on Economic, Social and Cultural Rights describes progressive realization as States Parties' obligation to use the maximum of its available resources to move as expeditiously and effectively as possible towards achieving the highest attainable standard of health for everyone. 2,4 The approach does not necessarily create an immediate right for everyone to …