Research & Development The Research & Development (R&D) process is the first value chain activity and involves multiple stages. It includes the early research phase, the preclinical testing phase, three phases of clinical trials and the patent application. Society as a whole is dependent on the pharmaceutical industry to create new medicines and monitor their effectiveness after they are released into the market. Due to the high level of risk and expenditure in R&D, R&D-based pharmaceutical companies typically take into account the potential to recoup costs and generate profits when making decisions about which medicines to develop. 16 Without the proper oversight from governments in the R&D process, the financial structures that surround the development of new medicines create a risk that a company will be incentivised to prioritise profit-making over the needs of public health. Concurrently, R&D-based pharmaceutical companies have strong control over the R&D process when there are inadequate policies regulating the R&D process, which can create conflicts of interest and corruption vulnerabilities. 17 This combination of perverse financial incentives and significant corruption risks can lead to regulatory capture and other harmful practices, such as medicines being put into the market that are unsafe, lack efficacy and provide little or no therapeutic benefit. For example, studies in Canada, France and the Netherlands have shown a general decrease in recent years in the number of new medicines offering therapeutic advantages to previously approved drugs. 18 Before a newly developed medicine can enter a market a pharmaceutical company must prove its efficacy and safety to regulatory agencies by carrying out randomised control trials (RCTs). As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. 19 20 When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. 21 This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients. 22 The pharmaceutical industry is the biggest funder of RCTs and often contracts them out to academia and contract research organisations (CROs). 23 Research has shown that clinical trials funded by industry are more likely to produce positive results than RCTs funded by other sponsors. 24 One study found that 94 per cent of industry funded RCT results dealing with
Rodwin, M., ‘Five uneasy pieces to pharmaceutical policy reform’. Journal of Law, Medicine & Ethics, 41, 3 (2013), p.582. 17 Lexchin, J., ‘Those who have the gold make the evidence: how the pharmaceutical industry biases the outcomes of clinical trials of medications’. Science and Engineering Ethics, 18, 2 (2012), p.247. 18 Light, D.W., et al., ‘Institutional corruption of pharmaceuticals and the myth of safe and effective drugs’. Journal of Law, Medicine & Ethics, 14, 3 (2013), p.592. 19 Lexchin, 2012, p.248. 20 Brown, A.B., ‘Understanding pharmaceutical research manipulation in the context of accounting manipulation’. Journal of Law, Medicine and Ethics, 41, 3 (2013), p.611. 21 Lexchin, 2012, p.247. 22 Lemmens, T., & Gibson, S., ‘Decreasing the data deficit: improving post-market surveillance in pharmaceutical regulation’. McGill Law Journal, 59, 4 (2014), p.952. 23 Rodwin, 2013, p.583. 24 Lundh, A., et al., ‘Industry sponsorship and research outcome’. Cochrane Database Systematic Reviews, 12, 12 (2012), p.2. 16
8