Pricing any pharmaceutical drug for sale to the general public is daunting. Per Forbes, setting a high ceiling price for a new drug could be problematic as physicians could shy away from prescribing the drug, because the cost could be too great for the benefit. Setting too low of a price could imply inferiority, that the drug is too "weak" for the market.
Research and development Much research, needed to create drugs is done by the
public sector. In addition, pharmaceutical companies also do much research prior to producing medications. The table shows research and development statistics for pharmaceutical companies as of 2013 per Astra Zeneca.
Severin Schwan, the CEO of the Swiss company Roche, reported in 2012 that Roche's research and development costs in 2014 amounted to $8.4 billion, a quarter of the entire
National Institutes of Health budget. Pharmaceutical companies spend a large amount on research and development before a drug is released to the market and costs can be further divided into three major fields: the discovery into the drug's specific medical field, clinical trials, and failed drugs.
Discovery The process of drug discovery can involve scientists determining the
antibodies, viruses, or bacteria that cause a specific disease or illness. The time frame can range from 3–20 years and costs can range between several million to tens of millions of dollars. Research teams attempt to break down disease components to find abnormal events/processes taking place in the body. • Phase 1 lasts several months and aims to assess the safety and dosage of the drug. The purpose is to determine how the drug affects the body. • Phase 2 lasts several months to two years and aims to assess the efficacy and side effect profile of the drug. A single phase 3 trial can cost upwards of $100 million. It accounts for about 90 percent of the cost to pharmaceutical companies to develop a medication.
Failed drugs The processes of "discovery" and clinical trials amounts to approximately 12 years from research lab to the patient, in which about 10% of all drugs that start pre-clinical trials ever make it to actual human testing.
Relationship and
Harvoni, both of which attempt to cure or treat major diseases (HIV/AIDS and
hepatitis C). Public outcry has worked in many cases to control and even decide the pricing for some drugs. For example, there was severe backlash over Daraprim, a drug that treats toxoplasmosis.
Turing Pharmaceuticals under the leadership of
Martin Shkreli raised the price of the drug 5,500% from $13.50 to $750 per pill.
Patents and monopoly rights One of the most important factors that determine the cost of a drug is the availability of competing drugs and treatments. Having two or more manufacturers producing drugs for the same disease tends to reduce costs. For example,
U.S. patent law grants a monopoly for 20 years after filing. After that period, the same product from different manufacturers - known as
generic drugs - can be sold, usually resulting in a substantial price reduction and possible shift in market share. Two patents that are commonly used are
process patents and drug
product patents. Process patents only provide developers intellectual claim to the methods in which the product was manufactured, so a competitor can make the same drug by a different method without violating the patent. In some cases, a new treatment is more effective than an older treatment, or a given drug may work better than competitors for only some patients. The availability of an imperfect substitution erodes prices to a lesser degree than would a perfect substitute. Some countries grant additional protections from competition for a limited period, such as
test data exclusivity or
supplementary protection certificates. Additional incentives are available in some jurisdictions for manufacturers of
orphan drugs for rare diseases, including extended monopoly protection, tax credits, waived fees, and relaxed approval processes due to the small number of affected patients.
Transparency The process of creating drugs to testing them to selling them is a long process. Aside from the costs for research and trials, many consumers are unaware of the process of the
drug supply chain. There are many middlemen and companies that buy and sell the drugs. This includes "drug manufacturers, drug wholesalers, pharmacies, and payers." Transparency between drug manufacturers and sellers increases accountability between producers and consumers and allows for patients to know more about what they are paying for. Prescription Drug Price Locators allow for patients to learn of more cost-effective sellers and find discounts that will benefit them. In an effort by the U.S. Department of Health and Human Services (
HHS) to regulate drug price transparency in television advertising in 2019, the HHS saw a resistance to change against legislation. Although what the HHS sought to change was a step in the right direction for drug price transparency, Federal Judge Amit P. Mehta ruled in favor of the pharmaceutical industry. The ruling was based on the inability to give the HHS such power to enact such legislations. Policymakers have a lot to take into account when regarding the issue of transparency, as there are many middlemen involved in the selling and buying of prescription drugs. ==Effects on consumers==