The European Medicines Agency’s path to greater access to pharmaceutical regulatory data: balancing intellectual property rights and the right to privacy

Abstract

The paper examines the relationship between intellectual property (IP) and human rights by focusing on the rights of the patient and of companies generating data for the purposes of submitting data on pharmaceutical products for the purposes of obtaining market authorization in the European Union (EU). From the perspective of companies submitting data, concerns have centred on whether the European Medicines Agency (EMA) policy on disclosure of clinical study reports infringes companies’ right to protection of personal data under the Charter of Fundamental Rights of the EU. Companies submitting such data argue that it constitutes commercial confidential information that should be protected. Conversely public health activists have argued that, despite advances in data transparency, withholding information on the grounds of commercial confidentiality is a major barrier to the access to clinical trial data. The paper concludes that it will still be several years before the most commercially sensitive documents are published under new guidelines. Until these documents are published, considerable uncertainties will remain as to the extent of redactions permitted. Such uncertainties run counter to the ultimate goal of achieving a patient-centred approach to regulatory affairs which underpins the new EU strategy for the pharmaceutical sector.

Keywords: Intellectual property, regulatory test data, clinical trial data, pharmaceutical products, confidentiality, human rights, Charter of Fundamental Rights of the European Union, European Medicines Agency