Market failure Role of the state for biopharmaceutical Market shaping in biopharmaceutical The problem with the biopharmaceutical innovation system (broad) > 4 key items > 1. Strategy 2. IP 3. Pricing 4. financialisation of biopharmaceutical firms Potential papers to read / understand context from?
Mazzucato, M and Li, H. L. (2020). A market-shaping approach for the biopharmaceutical industry: governing innovation towards the public interest. UCL Institute for Innovation and Public Purpose, Working Paper Series (IIPP WP 2020-21)
This role stems from prevailing economic theory, which does not consider the state a key driver of market creation (Arrow 1972; Mazzucato 2016). State intervention is thus justified only in areas characterised by market failures — such as coordination or information failures,(Stiglitz and Weiss 1981; Coase 1960) imperfect competition, under- provision of positive externalities, over-provision of negative externalities (Stern 2007) and under- provision of new knowledge arising from basic research — with actions restricted to levelling the playing field so that industry and competition can thrive; devising market mechanisms to internalise external benefits or costs; and funding basic public goods, such as science, infrastructure and education.

**^This view has significantly limited policymakers’ understanding and choice of tools for addressing problems with the biopharmaceutical innovation system (Mazzucato 2013; Mazzucato 2017).

(IF USED IN ARGUMENT, LINK TO MARKET FAILURE QUOTE FROM POLICY RESEARCH)** | Addressing these persistent problems in the biopharmaceutical innovation system requires a different framing of the role of the public sector from the one that governments have chosen: that of market fixer (Mazzucato 2020). | | a lack of directionality to meet key needs; inefficient collaboration; high prices that fail to reflect the public contribution; and an overly financialised business model.

First, many areas of medical need — especially in public health — are unmet and underfinanced. The system is skewed towards revenue-rich ailments (Barrenho, Miraldo and Smith 2019).

Diseases relevant to high-income countries are seven to eight times more likely to be investigated than those that mainly affect low- and middle-income countries (Røttingen et al. 2013).

Disease groups that present smaller financial returns are largely overlooked. | Firms also often pursue low-risk strategies that can more easily yield commercial success instead of developing innovations to address unmet needs.

Two major strategies to achieve this include ever-greening (extending the monopoly period on a drug by artificially extending the life of a patent or other exclusivity) and developing me-too drugs (drugs that are structurally related to a first-in-class compound and share the same therapeutic purposes, but with only minor differences in the pharmacological profile that provide, at best, incremental innovation) (Feldman 2017; Aronson and Green 2020).

(If used in argument, source data to demonstrate AMR resistance funding and use the same structure as in this paper) | Reinforcement of the intellectual property rights (IPR) system has increasingly come at the expense of effective collaboration.

The current innovation system, in which the product development and manufacturing processes are increasingly intertwined, is highly disintegrated, unsuitable for solving the complex problems that arise from the non-modular nature of biopharmaceutical innovation (Mazzucato and Roy 2019; Pisano 2006).

As the need for the transfer of knowledge and know-how becomes greater, the constraints of patents for incentivising and facilitating dynamic models of knowledge exchange and production become more evident. As the major incentive for innovation in our current system, the IPR system encourages a protectionist attitude around research, with each actor working in secrecy and isolation.

This creates further barriers to addressing the existing insufficiencies in effective and transparent data sharing in both public and private research institutions, (Miller et al. 2017; Miller et al. 2015; Chen et al. 2016) which can result in wasted financial resources and duplication of scientific efforts (Al- Shahi Salman et al. 2014; Dijkers 2019; Owens 2016).

This blocks the ability of new, basic science to be fully disseminated, diffused, and translated into future innovation (Mazzoleni and Nelson 1998; Orsi, Sevilla and Coriat 2006).

This makes the research process less efficient and exposes research and its outcomes to bias in favour of actors’ specific interests (be they financial or scientific). | High drug pricing forms a major barrier to access to medicines across the world. Even though most treatments are heavily paid for by the taxpayer, with public funds from organisations like the US National Institutes of Health (NIH), when breakthrough treatments do make it to market, they often have price tags that are beyond the reach of the taxpayers themselves.

The ability to charge high prices is based on the monopoly protection granted through patents on new drugs. Despite substantial public funding of R&D — globally, some estimate that the public pays for between one- to two-thirds of upfront drug R&D costs (Røttingen et al. 2013) — there are no guarantees that drugs developed from publicly funded research will be affordable and accessible.

this pricing continues to ignore the collective nature of value creation, and the lack of safeguards for drug pricing ex ante, as well as the imbalance in price setting and bargaining power between the public sector and the private sector, remains unchallenged (Mazzucato and Roy 2019). | Companies have become overly financialised, limiting reinvestment into production and innovation, and focusing on short-term return.

One of the most common symptoms of this problem is the extent to which share buybacks are used, in which companies purchase their own stocks to boost the value of the remaining ones to shareholders in equity markets (Lazonick et al. 2017; Collington 2020).

Big biopharmaceutical firms increasingly disinvest from riskier upstream research and instead focus more on acquiring products from biotech companies that are already in later clinical trial stages (Arora and Gambardella 1995) | (Barrenho, Miraldo and Smith 2019).

(Mazzucato and Roy 2019)

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