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COVID-19 Vaccines and Therapeutics: Regulatory Integrity
News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020
The European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines.
In an open letter sent to European Ombudsman Emily O’Reilly in response to an enquiry on the role of EMA and its pandemic task force during the COVID-19 crisis, the Agency explains that it is applying the same independence measures to its experts dealing with COVID-19 treatments and vaccines as it does for those dealing with all medicines. This includes the experts involved in providing advice on these medicines’ development, as well as the experts evaluating them.
These tried and tested measures ensure that EMA’s recommendations are driven only by science and public-health needs, and not by any other interests.
The letter also sets out the Agency’s transparency plans for COVID-19 treatments and vaccines. EMA will publish the clinical data underpinning its recommendations for all COVID-19 medicines. This falls under the scope of EMA’s landmark policy on proactive publication of clinical data, which the Agency is reinstating – exclusively for COVID-19 medicines at this point – following its suspension in August 2018 to allow the Agency to focus resources on its relocation from the United Kingdom to the Netherlands.
Because EMA considers maximum transparency as a pre-condition for fostering trust and confidence in the EU regulatory system, it is also planning a range of additional measures to provide the public prompt insights into its development and safety-monitoring processes. This includes for example the publication of the product information with details of the conditions of use even before the formal marketing authorisation will be granted, the expedited publication of the full European Public Assessment Report (EPAR) and the publication of the risk management plans for authorised COVID-19 medicines in their entirety, rather than as a summary.
The scale of the COVID-19 public health crisis has led to unprecedented efforts by all those involved in the development of medicines to treat and prevent COVID-19, compressing a process that typically requires several years into one lasting only several months.
EMA and the national competent authorities have responded to these challenges by fully mobilising their resources to expedite their advice and evaluation processes, while maintaining their safety and efficacy standards and applying tested independence and transparency rules.