EU Reveals Plan To Speed Development Of New COVID-19 Therapies
Project Includes A ‘Therapeutics Booster’ And R&D/Manufacturing Support
Executive Summary
Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.
The European Commission has produced a new strategy intended to boost the development of new therapeutic products for COVID-19, with the aim of approving “at least” three new products by October, and possibly two more by the end of the year.
Its proposals include new regulatory flexibilities, support for innovative R&D, an increase in manufacturing capacity, and clear rules on the procurement of resulting products.
The “EU Strategy on COVID-19 Therapeutics” is intended to help find potential new treatments for patients with COVID-19 as well as those suffering from “long COVID,” the often serious and long-lasting after-effects of COVID-19 infection. It will complement the existing EU strategy on coronavirus vaccines.
According to the commission, while vaccines have been shown to save lives, they will not eradicate the disease and there will still be a need for therapeutics for patients in hospital or at home.
But at present the availability of COVID-19 medicines is still limited, with only Gilead Sciences, Inc.'s Veklury (remdesivir) authorized at EU level, the commission says, and there is no common framework for developing and deploying targeted therapeutics in Europe.
Health commissioner Stella Kyriakides said there was a need for a “strong push on treatments to limit the need for hospitalization, speed up recovery times, and reduce mortality. Patients in Europe and across the world should have access to world-class COVID-19 medicines.”
By the end of the year the commission expects three to five new products to have been authorized, seven rolling reviews to have begun, and three new joint procurement contracts to be in place.
Flexible Regulatory Approaches
The priority for this year is to establish a portfolio of 10 potential therapeutics and identify “five of the most promising ones” by June. To this end, “flexible regulatory approaches” will be used to speed up assessments, the commission says.
These approaches include rolling reviews, making full use of conditional marketing authorizations, offering scientific support to speed up review procedures, and flexibility in relation to labeling and packaging requirements as well as manufacturing, import, distribution and pharmacovigilance activities.
EU-level emergency use authorization of medicines “would ensure an even faster access to medicinal products” – European Commission
Noting that EU member states can already use emergency use authorization for products before they are formally approved, the commission says it is currently considering a legislative proposal for an EU-level emergency use authorization of medicines “that would ensure an even faster access to medicinal products in the context of public health emergencies.” The idea of such a procedure for vaccines was mooted earlier this year. (Also see "Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval" - Pink Sheet, 3 Mar, 2021.)
Incidentally, on 7 May the European Medicines Agency announced that it had begun a rolling review of sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology for the treatment of COVID-19. The product is already being assessed by the EMA under a mechanism that offers harmonized advice to member states wishing to approve a product’s emergency use before marketing authorization. (Also see "EMA Reviews GSK/Vir’s COVID-19 Antibody To Support Early Use By Member States" - Pink Sheet, 16 Apr, 2021.)
EC’s Red Lines On Procurement Of Therapeutics
In relation to the purchase of therapeutics, the commission says there will be “an allocation mechanism for scarce products” and there will be “no parallel national procurement for the same products or services.”
This is a reference to the controversy that arose when some member states impatient with the EU’s unified approach to buying COVID-19 vaccines began negotiating their own procurement arrangements for vaccines in the EU’s advance purchase agreement (APA) portfolio.
The commission notes that it has already signed a joint procurement framework with Gilead for remdesivir, and that since October last year it has signed more than 70 contracts for 19 medicines to treat more severe COVID-19 cases.
It says it is “ready to conclude further joint procurement contracts to facilitate the equitable availability of, and access to, new COVID-19 therapeutics across the EU.” Currently, “discussions are ongoing on three new joint procurements for COVID-19 therapeutics awaiting marketing authorizations from the commission on the EMA’s recommendation.”
"The commission will consider streamlined solutions in this context to maximize the strategic role of joint procurement in achieving key preparedness goals" – European Commission
However, clearly mindful of the problems with vaccine purchasing, it says that while joint procurement agreements have proved successful in securing equitable access to medicines for all interested member states, “the instrument has also shown its limitations.”
The commission will therefore “consider streamlined solutions in this context to maximize the strategic role of joint procurement in achieving key preparedness goals – emphasizing fair access, choice, quality, sustainability and value for public spending, while enabling adaptation to national conditions.”
To achieve greater speed and flexibility in the current legal framework, participating member states and other joint procurement agreement signatories would need to adhere to shorter administrative deadlines, use a distribution key where the resources being procured prove to be scarce, place a certain percentage of orders in the first few months of the contract, and “refrain from engaging in parallel procurement processes for the same products or services.”
‘Innovation Booster’
As part of the strategy, a “therapeutics innovation booster” will be established by July to get a “clear overview” of projects under development and to support the most promising ones from preclinical research to marketing authorization.
Matchmaking events will be organized for supply chain actors to ensure that sufficient production capacity and speedy manufacturing are in place to deal with any surge in demand for therapeutics.
In addition, the commission plans to run a health data pilot to give EU regulators faster access to real world data and real world evidence. The pilot will be launched in the third quarter ahead of the commission's proposal for a European Health Data Space, which is intended to improve access to, and exchange of, health data for research, policy-making and regulatory purposes.
The pilot is expected to facilitate the EMA’s and national medicine agencies’ access to real world data “in order to check the safety and efficacy of therapeutics.”
Financial Support
Some financial support is being made available for the implementation of the strategy. €90m ($109m) will be invested in population studies and clinical trials to establish links between risk factors and health outcomes for use in health policy and clinical management.
€5m will be invested in generating high-quality safety data on potential therapeutics in clinical trials, and EU countries will be given financial support of €2m for “expedited and coordinated assessments to facilitate approval of clinical trials.”
Another €5m will go towards mapping the development stage, production capacity and supply chains of selected therapeutics, “including possible bottlenecks.” This should result in an interactive mapping platform available to all member states “by mid-2022 at the latest.”
'Ever-Ready' Manufacturing Capacity
A €40m “preparatory action” will be implemented to support “flexible manufacturing and access” under the EU Fab project, which is intended to ensure the EU has sufficient manufacturing capacity.
The commission says the Fab project will set up a network of “ever-warm” production capacities for vaccine and therapeutics manufacturing at EU level. Over time this project will become “an important asset” for the future European Health Emergency Preparedness and Response Authority (HERA), “for which a proposal is due later this year,” the commission notes.
HERA is intended to make sure the EU can anticipate and respond effectively to future serious cross-border health threats. Earlier this year the commission announced the “HERA Incubator,” which will streamline the approval of vaccines against variants of the virus and is the first stage of the HERA project. (Also see "EU Explains Plans To Speed Up Variant Vaccine Approvals" - Pink Sheet, 25 Mar, 2021.)