Ben Goldacre’s “Bad Pharma” propelled the issue of clinical trial transparency into public discourse when it was published in September 2012. The European Medicines Agency (EMA) responded quickly – discussing both the practical and policy issues surrounding clinical data transparency as early as November that same year. Since then, the EMA has continued to develop its open access policy though consultations with the public and various stakeholders, resulting in the agency’s policy of proactively releasing clinical study reports. the EMA released guidance around the publication of clinical data earlier this year (1).
It hasn’t been an easy ride for the agency, with some pharma companies fighting hard to prevent their data from being released – and the situation isn’t getting any easier; in late September, the President of the General Court of the European Union suspended the release of clinical trial data requested by third parties under the EU’s “Transparency Regulation” (no. 1049/2001). The Court’s first order blocked the release of a clinical study report for Translarna (PTC Therapeutics), a centrally authorized medicine for the treatment of Duchenne’s muscular dystrophy. The second order, issued at the same time, blocked the release of three toxicity studies for Bravecto (Intervet), a veterinary medicine. Both PCT Therapeutics and Intervet argue that release of the requested documents would infringe their right to protect commercially confidential information contained in their dossiers, whereas the EMA claims the court decisions are “at odds with the EMA’s efforts to allow access to documents on medicines” (2). The EMA will be appealing the decisions, adding that the court cases will be a “good opportunity” to test its new rules. The EMA’s position is that the clinical reports are “not confidential per se.” Stefano Marino, the EMA’s Head of Legal Department, argues that although the reports may contain some commercially confidential information – which should be redacted – a “blanket” protection for disclosure “seems neither consistent with the legislation nor advocated by our stakeholders, including an overwhelming majority of pharmaceutical companies.”
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References
- EMA, “External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use”, (2016). Available at: http://bit.ly/1RsfIeS. Last accessed October 13, 2016. EMA, “New judicial decisions at odds with EMA’s efforts to allow access to documents on medicines”, (2016). Available at: http://bit.ly/2dgXe6M. Last accessed October 13, 2016.
