The global health care sector is innovative, impactful and, despite addressing fundamental problems in human health, can be inescapably faddish. Despite the industry’s pride in an empirical approach that yields robust and practicable data, the covers of Nature, Science and Cell can be as ephemeral as those of Vogue and Tatler. The latest in vogue topic – increased transparency in the pharmaceutical industry – is practical and emotive, and it is also gathering momentum. But unlike many of its front-page predecessors, is unlikely to recede.
Importance of Transparency
The primary drivers behind the demand for increased transparency are maximizing public trust in the pharmaceutical sector and increasing concerns for patient safety. At the same time, as biopharma companies struggle with falling productivity, patent cliffs, and increasing economic pressures, their concerns about what is considered proprietary are lessening, resulting in an increase in pre-competitive consortia and other forms of data and resource sharing. Further, confidence in publicly available data is a pre-requisite for open innovation and big-data initiatives including pre-competitive consortia for target screening, such as those led by the Structural Genomics Consortium. This is supported by moves in academia and industry to publish data relating to potential target sites and compound structures. Moreover, the freer flow of information is likely to increase the efficiency of the R&D ecosystem by promoting collaboration and reducing duplicate research activity.
Examples of Increased Transparency in the Life Sciences
A major perceived impetus behind calls for increased transparency in the life sciences is a number of high profile cases of alleged misconduct by pharmaceutical companies. For example, GlaxoSmithKline’s record $3 billion fine for allegedly misrepresenting products and withholding clinical trial data.GSK has responded to the calls for increased transparency by making all its historic clinical trial data publicly available, increasing the expectation that other major pharmaceutical companies will follow suit. Notably, pressure has increased on Roche to release clinical data relating to its controversial antiviral, Tamiflu. Patient advocacy groups, who demonstrated their growing influence in the health care sector by contributing to the revision of the FDA’s original decision not to approve the gene therapy Glybera, also support the drive towards transparency. Similarly, change is afoot in academia.
As public funding for science remains constrained, greater value is demanded per ‘research dollar;’ this includes initiatives to ensure that publications arising from publicly funded research are made available on an open access basis – a measure that is now stipulated by the Wellcome Trust in the UK. And some in the U.S. have called for similar restrictions around NIH funded work. Further, forthcoming changes in the U.S. Sunshine Act mandate increased transparency in relationships between clinicians and pharmaceutical companies – highlighting the importance of transparency throughout the translation path from life science research to commercially viable patient outcomes.
A Transparent Cell Therapy Industry 2027?
While greater transparency in the health care sector has the potential to accelerate life science translation and improve operational practices in big pharma, it is not without potential limitations. For example, greater transparency in R&D may in some respects run contrary to the industry trend to secure value through ‘trade secrets,’ particularly relating to biomanufacturing techniques, given the lack of established intellectual property strategies in the cell therapy industry. Additionally, the compliance burden generated by an increase in public dissemination is likely to add financial strain to small and medium-sized enterprises (SMEs). Finally, an ethical dichotomy could confront regulators with a responsibility to ensure transparency to the general public, whilst maintaining confidentiality for patients and trial sponsors.
The prospect of greater transparency is undoubtedly a double-edged sword, juxtaposing important commercial, ethical and practical issues. However, like it or not, transparency is here to stay. While greater transparency is not without its risks to all stakeholders, it need not represent an unassailable challenge; rather, one in which cell therapies can lead the way. The proficient management of these risks is achievable and will be essential to translate the great stem cell science of today into the great cell therapy businesses of tomorrow.
Note: In addition to any prior disclosures (see author bio, below), D.A.B. has been a paid consultant of Nature Publishing Group within the last seven years for which he received remuneration of less then $10,000.
David Brindley
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