The European Commission will call for “cooperation between different stakeholders to bring about positive change” in the pharmaceutical sector, according to a leaked communication accompanying the revision of the EU’s drug framework.
After several delays, the Commission will unveil its initiative to revamp the EU’s general legislation on medicines for human use on Wednesday (26 April).
This reform is the last major health file to be unveiled by the EU executive before the current legislative term ends in the second half of 2024.
In a leaked document obtained by EURACTIV, the Commission lists five main drives of the reform: Ensuring ‘equitable access to safe, effective, and affordable medicines’; enhancing security of supply; offering ‘an attractive, innovation- and competitiveness friendly’ environment for the pharmaceutical sector; making medicines manufacturing ‘more environmentally sustainable’; and addressing antimicrobial resistance (AMR).
The leaked Commission draft communication still needs to be formally approved by the College of Commissioners on Wednesday but such documents are usually unlikely to be subject to change.
“Reforming the pharmaceutical legislation is an opportunity to create a patient-centred, forward-looking, and sustainable framework that brings benefits for patients, our society and healthcare systems in Europe while ensuring the EU industry remains globally competitive,” the document reads.
In a recent interview with EURACTIV, Health Commissioner Stella Kyriakides stressed that the most challenging thing about the reform was to find the right balance between affordability and access to medicines and preserving innovation supporting the pharmaceutical industry in Europe.
“You need to have both,” she said, adding that “striking this balance is not going to be easy”.
In the leaked document, the Commission acknowledged the role of industry as “fundamental, both for meeting patients’ needs and for driving innovation and competitiveness, in an area where the EU must maintain its global leadership and strengthen its resilience”.
The reform “will require cooperation between different stakeholders to bring about positive change,” the Commission continued.
A sweetener to industry
According to the document, the package will include a proposal for a new directive and a new regulation “to modernise, simplify, and replace” the existing 2001 and 2004 directives, which constitute the current EU pharmaceutical legislation, as well as the 2006 paediatric regulation and the 2000 regulation on medicines for rare diseases
“In addition, the Commission is proposing a Council Recommendation on AMR [antimicrobial resistance] to complement and strengthen the EU’s response,” the document reads
As widely anticipated, the Commission is expected to present a new incentive system for the production of novel antibiotics to tackle antimicrobial resistance – a silent killer that claims more than 35,000 lives per year in Europe.
These vouchers are listed among the ‘smart ways to enable the development of novel antimicrobials as a matter of urgency.’
Strongly requested by the pharmaceutical industry, the voucher could be a sweetener offered to drug manufacturers and developers, who are on a war footing regarding the expected modification of intellectual property (IP) rights.
The reform “proposes to test for 15 years a transferable data exclusivity voucher scheme for novel antimicrobials”.
According to the document, “the voucher will grant an additional year of regulatory data protection to the developer of the antimicrobial, which the developer can either use for one of its own products or sell to another marketing authorisation holder.”
“Financial pull incentives – in the form of procurement mechanisms – could be brought in,” the leaked communication also points out.
A ‘pull’ mechanism pays for results rather than for the effort of researchers, creating incentives for private sector engagement by creating viable market demand.
Shortages and environmental risk assessment
The document says that “shortages of medicines are also a growing concern, which can have serious consequences for patients”.
The recent winter brought particular problems for Europe, with a marked rise in respiratory infections and continued cases of COVID-19 causing a spike in demand for antibiotics and painkillers.
A particular headache was the short supply of amoxicillin, an antibiotic used to treat bacterial infections.
The new pharma rules will introduce “requirements for continuous monitoring of shortages” with an increased role for the industry in doing so.
“Obligations on marketing authorisation holders will be strengthened, including earlier and harmonised reporting of shortages of medicines and maintenance of shortage prevention plans,” the document reads.
The EU’s medicine agency (EMA) “will be empowered with a strengthened coordination role to monitor and manage critical shortages of medicines at EU level at all times”.
Another new feature is the strengthening of the so-called environmental risk assessment (ERA) of medicines “to ensure a better evaluation and limit the potential adverse impacts of medicines on the environment and public health”.
According to the draft document, the ERA will be reinforced “by introducing a refusal ground for the marketing authorisation where companies do not provide adequate evidence for evaluating the environmental risks or if the proposed risk mitigation measures are insufficient to address the identified risks.”
ERA will also be extended to all products already in the market and potentially harmful to the environment.
Luca Bertuzzi contributed to the reporting.
[Edited by Zoran Radosavljevic]
