As the EU health ministers go on to gather in Brussels on April 23–24 in order to discuss access when it comes to critical medicines and go on to formally launch the Critical Medicines Alliance, the European Medicines Agency- EMA has gone ahead and taken a step further as well as published its own recommendations so as to address vulnerabilities within the production and also the delivery of medicines that happen to be on the EU’s critical list.
Following the COVID crisis, EMA had been given a reinforced role when it came to crisis preparedness as well as management of medicines in order to ensure that the medicines are available in the case of a public health emergency.
Medicines Shortages Steering Group – MSSG from EMA is foreseen to play a stronger role when it comes to providing advice in terms of revised pharmaceutical legislation, and the list of recommendations happens to be made in anticipation of such a new role.
The recommendations are going to be tailored to the specificities when it comes to each medicine on the list, and EMA will stop short in terms of making recommendations on industrial policy strategies such as financial incentives.
Nonetheless, there happen to be some concrete proposals specifically for companies, especially those with authorization so as to market a medicine in one or more EU countries, also called Market Authorization Holders – MAHs.
Companies
MAHs may as well receive recommendations in order to propose measures so as to increase production capacity and, at the same time, also meet requirements in the EU. There will also be further stress placed on MAHs when it comes to potential obligations in order to provide shortage prevention plans – SPP.
Stockpiles
The MSSG happens to call for effective tracking when it comes to stocks so as to mitigate shortages, and supply chains should indeed be tested for robustness so that they are not beholden to only one producer and there happen to be no geopolitical threats in their access.
States should make sure that a buffer stock happens to be available so as to protect themselves from fluctuations within the demand for medicines as well as active ingredients. While some states already do this, it does not happen to be the case across the board. At the end of the day, the EMA may turn to the European Commission so as to propose stockpiling at the EU level, however, this would be the last resort.
Procurement
One way to ensure the availability of medicines all across the EU, to countries large and otherwise, would be by way of joint procurement. This could go on to take numerous forms, like straight forward joint procurement when it comes to a specific medicine, contractual incentives, or even capacity reservation contracts.
Investment when it comes to API
One of the particularly challenging issues is the struggle to maintain production when it comes to Active Pharmaceutical Ingredients- API in Europe.
These ingredients happen to be often produced in a much more competitive way outside Europe, especially across China and India, which goes on to leave Europe vulnerable in times of actual need, as was seen throughout the COVID pandemic.
The EMA remarks that this matter rests squarely in the domain of the Critical Medicines Alliance. Novel tools or even new financing mechanisms could indeed be a possibility; however, the MSSG is not explicit in terms of what these might be. Alternatively, it may as well come from some member states going ahead and acting together or with the support of the EU.
Cooperation
EMA happens to believe that there could be far greater cross-border cooperation when it comes to regulatory authorities so as to expedite the authorization in terms of variations.
The MSSG happens to be focused on developing regulatory as well as policy recommendations which happen to focus on the short- to medium-term. It is complementary to the Critical Medicines Alliance and will therefore focus on long-term measures within the gamut of industrial policy in order to address susceptibilities in the supply chain when it comes to critical medicines.
