Governments and industry ‘combining to stall drug development’
pharmafile | November 9, 2015 | News story | Research and Development, Sales and Marketing | BMJ, R&D, drug development
Both government and industry practices are responsible for the innovation deficit in the pharmaceutical sector, meaning that “the majority of new medicines entering the market offer few clinical advantages over existing alternatives.”
That is the conclusion of an analysis by academic researchers in health policy, published in the British Medical Journal (BMJ). Experts from Imperial College London and the London School of Economics looked at evidence from the medical literature, and pharma figures showing the industry’s growth, investment and R&D pipelines.
They found that the drug development process is being hindered by government practices, including a low bar for market entry of new products, dwindling government investment in research, and inconsistent international health technology assessment procedures. These factors are combining and ‘actively discouraging innovation’, the researchers argue.
“Regulatory demands run counter to facilitating the development of better medicines” the authors say. “As a result of inconsistent and unpredictable regulations, pharmaceutical companies need to tailor their drug applications on a market-by-market basis, often using expensive, local contractors, and are unable to find economies of scale for their global activities.”
Although record numbers of new drugs are hitting the market (41 approvals in the US and 40 in Europe in 2014; compared to a 50-year average of 20 approvals a year), “studies evaluating the clinical importance of new drugs consistently report a negative trend when it comes to drug performance.”
For example, data suggests that just 10% of the 122 new medicines that came onto the European market between 1999 and 2005 were superior to drugs already on offer. Despite this, the pharma market grew by a factor of 2.5 in real terms between 1990 and 2010.
This was largely driven by low evidence requirements from regulators, which are resulting in faster approvals – significant implications for drug safety. The researchers uncovered data that shows there has been an estimated 35% increase in safety warnings and market withdrawals since 1992, with over a quarter of drugs approved since 1992 receiving black box warnings or being withdrawn from the market.
This situation is ‘compounded’ by pharma industry practices that prioritises research in certain therapy areas, such as cancer, and “allocates a disproportionate share of R&D budgets to late-stage development candidates.” The industry’s increasingly risk-averse processes also favour mergers and acquisitions, to buffer companies from losses.
“This encourages research on me-too products, which provide more reliable returns on investment at the potential expense of breakthroughs in other areas and in breach of the implicit contract between firms and society…. There are more than five statins, over 15 beta blockers, and over 30 anti-diabetic drugs. [This] cannot always be justified, especially if they do not offer demonstrable quality of life, convenience, or therapeutic benefits to different patient sub-groups.”
The authors propose several solutions, to improve the drug development process and “to send the correct signals to drug companies”:
- Identifying priority therapeutic areas and making research in these areas more economically attractive. “This could be through public-private partnerships, advance market commitments, extended marketing exclusivity, or policies to share the risk of financing early stage research.”
- Governments could more closely monitor takeovers to encourage competition and deter industry-wide consolidation
- Pricing and reimbursement policies should reward clinically superior medicines and not ‘me-too drugs’
- Preferentially reimbursing drugs that offer clinically meaningful improvements over existing alternatives, so that governments ‘could encourage true breakthroughs’
The authors conclude: “Countries should send a coordinated signal to the industry independently of their differing approaches to regulation. Stricter evidence requirements at the time of market entry and requiring evidence of clinical effectiveness in robust trials would be important first steps.”
Lilian Anekwe
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