EMA Sets Up System for Reporting Shortages for COVID-19-Related Medicines
The European Medicines Agency (EMA) is setting up a single-point-of-contact system with pharmaceutical companies for reporting drug shortage or potential drug shortages related to the novel coronavirus (COVID-19) outbreak.
The EMA reports that some EU member states have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon (as reported on April 6, 2020). These include medicines used in intensive care units such as certain anesthetics, antibiotics, and muscle relaxants as well as medicines used off-label for COVID-19. EU authorities are therefore putting in place additional measures to mitigate the impact of the pandemic on the supply chain of medicines in a coordinated manner.
The EMA says that shortages or potential shortages are being affected by a variety of factors, such as lockdown in factories due to quarantine, logistical issues caused by border closures, export bans, lockdowns in third countries supplying medicines to the EU, increased demand due to the treatment of COVID-19 patients, stockpiling in certain hospitals, individual stockpiling by citizens and EU member states. To avoid shortages due to stockpiling, some EU member states have imposed restrictions on the number of packs that can be prescribed to patients or purchased by citizens.
To help mitigate supply disruptions, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for coordinated action on shortages within the EU in this pandemic, is currently setting up, with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between industry and the EU Executive Steering Group. With this system, each pharmaceutical company will report directly to the EMA, both for centrally authorized and nationally authorized medicines, anticipated shortages or current shortages of critical medicines used in the context of COVID-19. In parallel, pharmaceutical companies will continue to be required to report such shortages to the relevant national competent authorities.
The i-SPOC system, which is similar to the single point of contact (SPOC) network which was set up in 2019 between the EMA and the national competent authorities to share information on medicine shortages, is based on the appointment of an i-SPOC in each pharmaceutical company, who will feed information on current or anticipated shortages of COVID-19-related medicines to the EMA. The EMA says that this new mechanism will allow better oversight of ongoing supply issues irrespective of the licensing route and a quicker flow of information with the pharmaceutical industry with the objective of mitigating and, if possible, preventing shortages in the context of COVID-19 medicines.
In the context of the pandemic, EMA and the EU network are considering mitigation measures, such as regulatory actions to support increased manufacturing capacities by speeding up the approval of a new manufacturing line or site. The EMA says that discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of supply shortages.
In addition, the EU Executive Steering Group is considering areas where regulatory rules could be applied with greater flexibility during the pandemic to secure supply of critical medicines. The EMA says that further information will be given in a question-and-answer document, currently under development.
EMA forms separate COVID-19 task force
In a separate development, the EMA has finalized the composition and goals of a newly formed task force, the COVID-19 EMA Pandemic Task Force (COVID-ETF), to assist EU member states and the European Commission in dealing with the development, authorization and safety monitoring of therapeutics and vaccines intended for treatment or prevention of the novel coronavirus (COVID-19).
The main purpose of the COVID-ETF is to draw on the expertise of the European medicines regulatory network and ensure a fast and coordinated response to the COVID-19 pandemic. The task force is accountable to EMA’s Committee for Medicinal Products for Human Use (CHMP) for all its activities.
The COVID-ETF is chaired by the EMA and is composed of the Chair and Vice Chair of the CHMP, the Pharmacovigilance Risk Assessment Committee, the Pediatric Committee, and relevant working parties, as well as the Coordination Group for Mutual Recognition and Decentralized Procedures–Human, and the Clinical Trials Facilitation and Coordination Group. It will include CHMP rapporteurs and co-rapporteurs for all COVID-19 medicines and vaccines, as well as additional experts as needed, including those involved in the review of applications received at national level. Additional observers will be invited on a case-by-case basis.