Access to medicines versus access to treatment: the case of type 1 diabetes.

a International Insulin Foundation, London, England. b Judge Business School, University of Cambridge, Cambridge, England. Correspondence to Ariane McCabe (e-mail: [email protected]). doi:10.2471/BLT.07.048710 (Submitted: 10 November 2007 – Revised version received: 22 March 2008 – Accepted: 16 April 2008 ) Introduction In recent years considerable attention has been paid to the issue of access to medicines. The topic burst into the global public spotlight in 2000 when 39 pharmaceutical companies took the South African government to court over its introduction of allegedly unlawful legislation, which gave the minister of health the right to import generic versions of patented drugs and allowed generics to be manufactured locally through compulsory licenses. After this trial, the terms parallel importation, compulsory licensing, intellectual property, generic drugs and TRIPS (the World Trade Organization’s agreement on trade-related aspects of intellectual property rights) became part of the vocabulary of many nongovernmental organizations and policy-makers seeking to improve access to medicines in the world’s poorest countries. Since then public-health policy debates have largely focused on patents on medicines as the main barrier to patients’ access to treatment. Advocates of this view blame patents for the high prices of essential medicines, putting them out of reach of many people who need them. Much of this controversy has specifically addressed medicines for communicable diseases such as HIV/ AIDS, malaria and tuberculosis. Less attention has been paid to the availability of drugs for noncommunicable diseases, although this group of illnesses including cardiovascular disease, cancer, chronic lung diseases and diabetes represents the leading causes of death worldwide.1,2 This paper will argue that access to medicines is not simply a consequence of patents and that it is only one part of the dilemma of care for noncommunicable diseases faced by patients in resource-poor settings. Access to medicines for chronic conditions Few studies have examined the issue of access to essential medicines for chronic diseases. However, a recent publication by Mendis et al.3 explores the availability and affordability of medicines for chronic conditions in Bangladesh, Brazil, Malawi, Nepal, Pakistan and Sri Lanka.3 The study concludes that there is a need to improve the availability of medicine for chronic diseases, particularly in the public sector, and that medicines used in treatment regimens should be made more affordable. However, this paper only examines the issue of price as a barrier to access to medicines and does not consider either the additional costs of care or the other constraints to care faced by patients with chronic disease. The focus on access to medicines is limited. Instead, policy-makers should take a broader view that encompasses barriers to access to treatment. Work has been conducted by two of the authors in Mali, Mozambique and Zambia with the Rapid Assessment Protocol for Insulin Access (RAPIA), a multi-level assessment of the health system.4,5 This has shown that while the treatment of patients with diabetes is poor, this cannot be attributed entirely to barriers resulting from the price of medicines. A more complex picture exists of what these barriers comprise. In none of the three countries surveyed was there one single price for insulin. Instead, prices depend on location of purchase, the complexity of the supply chain and the method by which the medicine was purchased. There is, for example, the price at which the government or central medical stores (CMS) purchase insulin and which may include duties or taxes. In some countries, government health facilities purchase insulin from the CMS at a higher price than the CMS purchased it from pharmaceutical companies or international distributors. This is due to the additional costs incurred as a result of the maintenance of storage facilities and transport costs that are passed on to the health units. Insulin may then be sold to patients with or without government subsidy. In Mali, for example, patients pay a higher cost for insulin than the CMS and health facilities because costs sustained along the distribution chain are paid for by the patient. However, Mozambique and Zambia have mechanisms in place so that patients receive free or subsidized insulin from government health facilities, although the frequent experience of stock shortages in these units3,5 means that some people will need to procure their insulin in private pharmacies at prices 25–125% higher than from public facilities. In the absence of patents, except for the newer analogue insulins, generic insulin is available only in certain countries. India, for example, has a few manufacturers but, unlike antiretrovirals, this insulin seems to be mainly for local use. In most resource-poor countries the main source of insulin is from the two major insulin producers, Novo Nordisk and Eli Lilly. While equity pricing arrangements exist for the purchase of insulin by ministries of health, these do not apply to the private sector and, furthermore, are in place only in selected countries.