Athens supports regulatory obligation for pricing and reimbursement, to ensure medicines access

Talks around the 'incentives-cluster' within the ongoing negotiation to revise the EU's pharma legislation remain wide open, with member states favouring different options. Athens supports the so-called 'delinked option', as Aris Angelis, Secretary General for Strategic Planning of the Greek health ministry, explained to Euractiv.

During the Belgian presidency's last EPSCO meeting in June, the Greek health minister, Adonis Georgiadis, expressed Athens' support for maintaining the regulatory data protection period at eight years, with two additional years of market protection and a maximum total protection period of 11 years, as Euractiv reported.

On the incentives system, Greece favours establishing a freestanding obligation for companies to file for pricing and reimbursement (P&R) with any member state that requests their products to ensure access to innovative and affordable medicines across the EU.

"The Greek Government expresses strong support for the fourth option, also known as the 'delinked option', with certain reservations," Angelis told Euractiv.

He explained that this approach emphasises placing a separate stand-alone obligation on companies rather than relying on the market access incentives system. The Greek Government's reservations relate to the implementation of such an approach.

Ensuring access

According to Angelis, the 'delinked option' is regarded as a more effective solution, a more predictable and accountable framework, for ensuring equitable access to innovative medicines across all Member States, including smaller countries such as Greece.

"Primarily, it addresses the fundamental challenge of ensuring consistent availability of innovative treatments throughout the EU, independent of market dynamics", he claims, adding that unlike the three other options, "which rely on an incentive-based 'opt-in' system where Member States request products and companies submit P&R applications on 'reasonable terms', followed by several potential incremental conditions (relating to negotiation outcomes, company access plan application and final product release in the market), the fourth option introduces a clear regulatory obligation for companies to ensure product availability."

"By removing the reliance on market incentives, whose effect might vary and be insufficient, the fourth option ensures that access to innovative treatments is guaranteed through regulatory requirements," Angelis explains.

According to the Greek health ministry Secretary General, this shift also eliminates uncertainties related to whether companies will respond to incentives, thereby fostering a more uniform and reliable approach to medicine availability.

In addition, it promotes equitable access by ensuring that all Member States are covered.

"By potentially obligating companies to engage in P&R negotiations with any Member State that requests their products, such an approach addresses access disparities and ensures that innovative treatments are not restricted to specific regions or markets," said Angelis.

Athens also believes that the delinked option enhances predictability and accountability, as it establishes a firm regulatory requirement for companies.

"In other words, this requirement makes it easier to hold companies accountable for ensuring that their products are available across the EU," Angelis adds.

Measurable and objective criteria for UMN incentives

Unmet Medical Needs (UMN) incentives for normal and orphan medicines are another discussion point among member states. For the Greek government, these incentives are of particular importance, as they offer crucial guidance for fostering innovation both at the national and EU levels, according to Angelis.

"These incentives are pivotal in directing research and development efforts towards areas where there is a significant lack of effective treatments, thereby addressing pressing health challenges and improving patient outcomes", he tells Euractiv.

As Angelis explained, for UMN incentives to be effective, it is essential that the criteria used to identify products addressing these needs are objective and measurable, "In other words, [the criteria should be] operational."

"Objective criteria ensure that the identification process is transparent and consistent, reducing the risk of subjective biases and ensuring that incentives are directed towards areas where they can have the greatest impact," he adds.

An associate professor of Health Economics, Angelis explained that "Quantifiable metrics can include the prevalence of the condition, the severity of the unmet need in tandem with the availability of existing (clinically effective and cost-effective) treatments, and the potential improvement in patient outcomes that a new treatment might offer compared to existing therapies."

High Unmet Medical Need definition

Within this context, the Greek Government advocates for a rigorous definition of High Unmet Medical Needs that incorporates such clear, objective, and quantifiable criteria.

"This definition should be based on a comprehensive assessment of the medical condition in question, including its prevalence, the current treatment landscape, and the potential benefits of new therapeutic options," Angelis says, adding:

"It is important that this definition not only reflects the clinical significance of the unmet need but also ensures that the incentives are allocated effectively to address genuine gaps in treatment."

Comparative clinical trials, as a rule

The Greek health ministry also supports the idea that comparative head-to-head clinical trials should be a general common obligation.

"This approach allows the most robust evaluation of new treatments relative to existing options, ensuring that new treatments really provide actual benefits over current therapies," Angelis says.

However, it shouldn't be a rule 'set in stone'. "The Greek Government acknowledges that there may be specific conditions and circumstances that warrant exceptions to this general rule," he notes.

He stresses these exceptions should be well-defined and based on objective criteria, "such as the nature of the medical condition, the stage of development of the treatment, and the availability of data".

"Such flexibility ensures that the evaluation process remains fair and relevant, accommodating the unique challenges posed by different therapeutic areas," he adds.

A well-defined, objective, and quantifiable framework for UMN incentives, complemented by a clear definition of High UMN, will allow the EU to better direct resources "towards addressing significant health challenges and fostering innovation in areas where it is most needed", he remarked.

[By Vasiliki Angouridi, Edited by Brian Maguire | Euractiv's Advocacy Lab]