Europe’s biopharma sponsors, or at least some of them, are resisting transparency when it comes to the proactive publishing of study reports upon completion of the study. The European Medicines Agency (EMA) gradually improved its transparency policy. With Brexit and associated staff loss and planned move to Amsterdam, the EMA claimed that they faced workload issues and that transparency initiative would be impacted. Transparency proponents (academics, researchers, civil society organizations, and digital transparency media such as TrialSite News) grew concerned that the trend was going in the wrong direction. With an imminent challenge to transparency by the “General Advocate,” a new court hearing in 2020 has many concerned.
Why not transparency?
Biopharmaceutical firms are generally against transparency as they claim that the disclosure of study reports to the public compromises highly competitive confidential information. In fact, according to a court case in Europe on appeal —PTC Therapeutics International vs. EMA, although the General Court upheld the EMA interpretation that a general presumption of confidentiality does not protect the full disclosure of clinical study reports. That judgment is being appealed.
Transparency Proponents Concerned about Advocate General
The Advocate General of the Court of Justice of the European Union, Gerard Hogan, has come out and agreed that full study report disclosure compromises companies’ commercial interests. Clearly, industry interests’ lobbying has reached beyond his ear and into his soul.
The final Court ruling is expected by early 2020, and if they follow with this logic, then the EMA transparency policy will have been dealt a serious setback. According to the European Public Health Alliance (EPHA), the public right to access clinical trial data and information faces imminent risk.
A ‘Singular focus on Commercial and Business Considerations’
Since Mr. Hogan appears to be solely focused on the industry’s concerns, it has many alarmed in Europe. After all, many have struggled to get to the point where industry sponsors are required to publicly disclose study reports so that the public can have a better understanding of powerful and expensive drugs that are put on the markets in Europe. They fret that the recent moves appear to ignore the underlying motivations for a strengthened transparency policy in the first place
The patients and their safety are of paramount concern. Across the “Pond” in America, that was the very reason that the FDA was created by legislation way back in 1906. After all, in a market economy, where patients (and their physicians and medical professionals) are also consumers of health products, is it not imperative that such consumers have access to appropriate information so that they can make informed consumption decisions.
Move to Liberate Markets (including Healthcare Consumers in Europe)
True free-market capitalism requires such transparency. This is not what at least some drug makers desire—they want free markets when it benefits them, and regulated and protected markets when that is convenient.
The business desires access to those markets, to those consumers, and they can even secure a form of monopoly with the patent process. In many cases, drugs were financed to some extent, with public monies. Many public universities undertake early drug discovery and translational research to prepare the intellectual property for commercialization—there is a lifecycle to drug development that often includes public expenditure. Moreover, once a company files a patent, competitors (and generic producers) have access to that information.
The European rule-makers should not succumb to certain singular interests and remember markets are holistic and represent a wide range of interests and transparency surely is necessary for informed consumers to make optimal choices—and patient safety of paramount concern.