Cost of Biotech Drug Development and Affordability Issues in LMICs

Abstract

Pharmaceutical companies invest in the development and testing of their drugs including by funding clinical trials. Furthermore, pharmaceutical companies also spend a large amount of money on advertising. For instance, in 2016 US$6.7 billion was spent on direct-to-consumer pharmaceutical advertising alone in the USA [1]. Worldwide spending on medicines reached $1.2 trillion in 2018 and will exceed $1.5 trillion by 2023, according to “The Global Use of Medicine in 2019 and Outlook to 2023” [2,3]. Although, access to essential medicines is problematic for one third of all persons worldwide [4]. Limited access to essential medicines (EMs) for treating chronic diseases is a major challenge in lowand middle-income countries (LMICs) [4,5]. Average public sector availability of even low-cost generic medicines ranges from 30% to 55% across 36 LMICs [6]. Price of drugs, vaccines, and diagnostics is a major burden in 105 middle income countries round the globe, comprising of 70% of the world population, 75% of the poor [7]. While public hospitals offer free or subsidized treatment including essential medicines, the high patient caseloads, underfunding and inefficient medicine distribution systems are barriers to consistent service provision [8]. Moreover, 90% of the population in developing countries purchase medicines through out-of-pocket (OOP) payments [7]. Poor availability of medicines in the public sector has pushed up household OOP expenditure, making them the largest household expenditure item after food [9]. However, The WHO has set a minimum of 80% as target availability of medicines for both communicable and non-communicable diseases in all countries [10]. But Pharmaceutical companies have a substantial desire in developing drugs for chronic diseases and cancer treatments, not only because of high prevalence, but also because these drugs are often used in long term [11]. Pharmaceutical patents maintain drug prices well above the cost of production and can restrict access to needed medicines [12]. Biotech drugs have completely changed the management of several diseases, including cancer and autoimmune diseases such as, psoriasis, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease [13]. The high cost of biotech medications (target a gene or protein and typically are injected or infused, associated with treating a chronic condition) often requires significant OOP expenditures [14,15]. Some studies say that pharmaceutical companies price drugs monopolistically, protected by patent rights, while others believe that the high prices for orphan drugs simply allow drug R&D and production costs. However, the global orphan drug market is estimated to reach US $209 billion by 2022 accounting for 21.4% of total branded prescription drug sales [16]. According to the Tufts Center for Drug Development, it costs, on average, $100 million in 1975, around $900 million before 2004 and 1.3 billion after 2005 to develop a new drug and bring it to market [17,18]. While, Scavone et.al, 2019 reported that entire time that passes from the R&D phase until the drug’s marketing approval can last up to 15 years, and it is characterized by extremely high costs, usually exceeding $1.2 billion [19]. Gouglas et.al, 2018 *Corresponding author: Abdul Kader Mohiuddin, Department of Pharmacy, World University of Bangladesh, Bangladesh. Received Date: July 16, 2019 Published Date: July 29, 2019 ISSN: 2687-8100 DOI: 10.33552/ABEB.2019.02.000538