Vaccine development and production is economically complex and prone to market failure. Many of the diseases most demanding a vaccine, including HIV, malaria and tuberculosis, exist principally in poor countries. Pharmaceutical firms and biotechnology companies have little incentive to develop vaccines for these diseases because there is little revenue potential. Even in more affluent countries, financial returns are usually minimal and the financial and other risks are great.[1]
Most vaccine development to date has relied on "push" funding by government, universities and non-profit organizations.[2] Many vaccines have been highly cost effective and beneficial for public health.[3] The number of vaccines actually administered has risen dramatically in recent decades.[4] This increase, particularly in the number of different vaccines administered to children before entry into schools may be due to government mandates and support, rather than economic incentive.[5]
While vaccine research and development is done by many small companies,[6] large-scale vaccine manufacturing is done by an oligopoly of big manufacturers.[6] [7] A March 2020 New York Times article described the political effects of this market structure: "government and international health organizations know that any vaccine developed in a lab will ultimately be manufactured by large pharmaceutical firms. At this critical juncture with coronavirus, no health expert would publicly criticize drug companies, but privately they complain that pharma is a major speed bump in developing lifesaving vaccines."[8]
Concentration and monopolization of the manufacture of specific drugs has also led to supply shortages, and significant healthcare costs for employing people to track down hard-to-get drugs.[9]
This oligopoly power allows vaccine manufacturers to engage in price discrimination, and vaccine prices are often two orders of magnitude higher than the manufacturer's stated manufacturing costs, . Sales agreements often require that the buyer keeps the price secret and agrees to other non-competitive restrictions; the exact nature and extent of this problem is hard to characterize, due to agreements being secret.[10] Price secrecy also disadvantages vaccine purchasers in price negotiations. It also makes market analysis difficult and hinders efforts to improve affordability.
The first decade of the 2000s saw a large number of mergers and acquisitions, and, 80% of the global vaccine market was in the hands of five multinationals: GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, and Novartis.[11] Of these, Novartis does not focus on vaccine development.[12] Patents on key manufacturing processes help maintain this oligopoly.[13]
In the past, the market power of pharmaceutical companies has delayed responses to epidemics. Manufacturers have successfully negotiated favourable terms, including market guarantees and indemnification, from governments, as a condition of manufacturing vaccines. This has delayed responses to some epidemics by months, and prevented responses to other pandemics entirely.[8] Some intellectual property issues also hinder vaccine development for epidemic preparedness, as in the case of rVSV-ZEBOV.[14]
There is also no business incentive for pharmaceutical companies to test vaccines that are only of use to poor people.[15] Vaccines developed for rich countries may also have short expiry dates,and requirements that they be refrigerated until they are injected and given in multiple shots, all of which may be very difficult in remote areas. In some cases it has simply never been tested whether the vaccine will still be effective if the requirements are not followed (say, if it retains potency for several days unrefrigerated).[16]
In almost all cases, pharmaceuticals including vaccines are developed with public funding, but profits and control of price and availability are legally accorded to private companies.[17] The profits of large pharmaceutical companies are mostly used on dividends and share buybacks, which inflate executive pay, and on lobbying and advertising.[18] Innovation is generally bought along with the small companies that developed it, rather than produced in-house;[19] [20] [21] low percentage R&D spending is sometimes touted as an attraction to investors.[22] The financialization focus of the pharmaceutical industry, especially in the US, has been cited as an obstacle to innovation.[20]
There have been ethical issues raised with accepting donations of generally unaffordable vaccines.[23]
While the vaccine market makes up only 2-3% of the pharmaceutical market worldwide, it is growing at 10-15% per year, much faster than other pharmaceuticals .[11] Vaccine demand is increasing with new target population in emerging markets (partly due to international vaccine funders;[16] in 2012, UNICEF bought half of the world's vaccine doses[11]). Vaccines are becoming the financial driver of the pharmaceutical industry, and new business models may be emerging. Vaccines are newly being marketed like pharmaceuticals.[11]
Vaccines offer new opportunities for funding from public-private partnerships (such as CEPI[8] [24] and GAVI[25]), governments, and philanthropic donors and foundations (such as GAVI and CEPI's donors[8] [25]). Pharmaceutical companies have representation on the boards of public-private global health funding bodies including GAVI[26] and CEPI.[27] Private donors often find it easier to exert influence through public-private partnerships like GAVI than through the traditional public sector and multilateral government institutions like the WHO; PPPs also appeal to public donors.[25] Philanthropic funding means that vaccines are now rolled out to large developing markets less than 10 or 20 years after they are developed,[26] [28] during the patent validity term of the patent owner. Newer vaccines are much more expensive than older ones.[29] Lower-income countries are increasingly a profitable vaccine market.[16]
Baker (2016) observed that the vast majority of the cost of most diagnostic, preventive and treatment procedures are patent royalties: The unit costs are almost universally a tiny fraction of the price to the consumer. Moreover, in the US "the government spends more than $30 billion a year on biomedical research through theNational Institutes of Health". And researchers (individuals and organizations) routinely obtain patents on products whose development was paid for by taxpayers, per the Bayh–Dole Act of 1980. Baker claims that the US population would have better health care at lower cost if the results of that research were all placed in the public domain.[30]
Moreover, the cost of those diagnostic, preventive and treatment procedures would be lower the world over if the results of publicly-funded research were in the public domain. This would likely lead to better control of infectious diseases worldwide. That, in turn, would likely reduced the disease load in the US.[31]