A lawsuit aiming to prevent the release of drug safety data threatens patients and public health across Europe, 31 patient and public health groups from across Europe warn in an open letter published today.
UPDATES January 2020:
If successful, the lawsuit would force the European Medicines Agency to curtail its release of Clinical Study Reports, documents that provide detailed information on clinical trials of new medicines.
Without access to Clinical Study Reports, scientists cannot fully understand the risks that patients taking these drugs are exposed to.
The ongoing court case pits PTC Therapeutics International, a drug manufacturer, against the European Medicines Agency. The pharmaceutical company’s argument that Clinical Study Reports should be considered commercially confidential was rejected by the General Court in February 2018.
That judgement is now under appeal at the European Court, which is expected to reach a decision in early 2020.
The European Ombudsman has consistently advocated for greater transparency.
In contrast, a legal opinion published by an Advocate General in September 2019 supported the company’s arguments, setting off alarm bells among patient groups and transparency advocates. The European Court will take this opinion into account, but is not bound to follow its reasoning.
Pharmaceutical companies submit Clinical Study Reports (CSRs) to regulators when they apply for a marketing license for a new medicine. CSRs are typically over 1,000 pages in length and provide a very detailed picture of the design, conduct, and outcomes of clinical trials, including data on the side effects experienced by individual patients.
Several studies show that barring independent scientists' and public health agencies' access to CSRs will prevent them from gaining a full picture of the benefits and harms of medicines.
Nonetheless, regulators for many years kept the CSRs in their vaults under lock and key.
In October 2016, the European Medicines Agency became the first regulator worldwide to routinely and proactively make CSRs available, drawing praise from numerous public health groups. The European Medicines Agency already redacts commercially confidential information contained in CSRs (usually a only few pages per document) before releasing them. A second regulator, Health Canada, has recently also begun releasing CSRs.
Patient and public health groups fear that if the European Court rules against the European Medicines Agency’s transparency policy in early 2020, this would jeopardise scientists’ and public health agencies’ access to these documents, and undo years of progress towards greater transparency in medicine in Europe and worldwide.
According to the open letter, continued access to CSRs is "is literally of vital interest for patients" and "fundamental to ensure patient safety".
Till Bruckner, founder of TranspariMED, said:
"Locking away medical evidence would endanger the lives of patients and add more fuel to the explosion in healthcare costs. If a pharmaceutical company refuses to disclose the full evidence on its products, why should taxpayers continue to pay for them?"
"In a modern democracy, the very idea of a public regulator withholding potentially life-saving evidence on the safety and quality of drugs is absurd. There is an overwhelming public interest in continuing to make Clinical Study Reports available to the scientific community and other stakeholders. Scientists and public health agencies must be able to access the complete evidence base on the benefits and harms of medicines that patients in Europe take."
(Comments by other stakeholders and observers can be found in a previous TranspariMED blog on this topic.)
The open letter has been signed by TranspariMED and 30 other groups, including the German and Austrian Health Technology Assessment agencies and the Transparency International Health Initiative.