The Greek government is moving ahead with plans to establish a ‘Pharmaceutical Innovation Fund’. Although anticipated, the mechanism described in the proposed legislation has raised industry concerns, primarily due to the country’s stifling pharmaceutical market environment.
Greek health minister Adonis Georgiadis presented the draft law during Monday’s ministerial council, following its circulation to pharmaceutical companies.
While the fund’s stated objective is to ensure accelerated patient access to innovative therapies, companies warn that unresolved issues with its financing model and cost-sharing mechanisms could undermine participation.
“The primary aim of an innovation fund is to strengthen the country’s attractiveness for the early launch of advanced medicinal and priority therapies that, under the current framework, companies may be reluctant or may significantly delay to introduce in Greece,” Kyriakos Souliotis, professor of health policy and dean at the School of Social and Political Sciences at the University of Peloponnese, told Euractiv.
He explained that these are highly effective, often life-saving or life-transforming treatments for serious conditions, and the stakes are high. Ensuring patients are granted swift access to such therapies while safeguarding the financial sustainability of the health system is important.
“The rationale for such a mechanism is largely based on the industry’s concerns about Greece’s attractiveness as a launch market, and the wish of the system to offer access to such treatments but pay only what offers measurable value,” he added.
“The success of the fund will depend to a large extent on the framework set out in the legislation – and here, every detail matters,” Labrina Barmpetaki, head of the Pharma Innovation Forum (PIF), told Euractiv.
Fund’s outline unveiled
Also known as the ‘Transitional Reimbursement Fund’, the mechanism aims to ensure controlled, conditional access for patients to advanced therapy medicinal products (ATMPs) and medicines included in the European Medicines Agency’s PRIME priority scheme, bridging the gap until a final reimbursement decision is taken.
According to the current draft, Euractiv has learned that to qualify, medicines must have been submitted to horizon scanning, be supported by a physician’s request justifying clinical need, and be accompanied by a formal commitment from the marketing authorisation holder, the pharmaceutical company that is, to continue supplying the treatment free of charge if the product exits the Fund without securing reimbursement.
Companies must also agree with the Fund’s Committee on outcome indicators, data collection requirements, and the duration of participation in the Fund. Treating physicians will be required to submit outcome data at defined intervals; failure to do so will trigger the automatic termination of therapy and the rejection of reimbursement for the individual patient, with retroactive effect.
The fund is set to have a €50 million budget. Innovative medicines may remain in the fund for 24 to 30 months, depending on the therapy. If outcome data fail to demonstrate sufficient benefit, or if no agreement is reached on price, the product will not be added to the reimbursement list. In such cases, the manufacturer would be obliged to continue supplying the medicine at no cost if the treating physician deems continuation of treatment necessary.
As Professor Souliotis explained, because these therapies often have limited data sets – for example, due to small patient populations – conditional reimbursement allows treatments to be made available while real-world effectiveness is closely monitored.
“Using managed entry agreements, payment is linked to outcomes and real-world data feeds into price negotiations, leading to fairer decisions,” he added.
Souliotis, who consulted on the mechanism’s preliminary proposal, suggests that any unused funds should roll over to the next year to accommodate further increases in uptake of new therapies relative to the health care system’s capacity.
Amendments needed, industry warns
In a joint letter to the general secretary for strategic planning at the ministry of health, the Greek Pharmaceutical Federation (SFEE) and PIF argue that, for the mechanism to succeed, critical adjustments are needed.
According to the letter seen by Euractiv, industry representatives argue that the Innovation Fund should not be burdened by automatic rebates or clawbacks during the transitional period, warning that retrospective financial obligations would undermine predictability and discourage participation.
They also oppose provisions that would require companies to continue supplying medicines free of charge if a therapy exists, the fund without securing reimbursement, saying this would distort price negotiations, shift excessive risk onto manufacturers, and place inappropriate decision-making power in the hands of treating physicians.
Instead, they say that treatments provided after non-inclusion in the reimbursement list should fall under the existing rebate and clawback framework, rather than being supplied at no cost.
“We stressed in our joint letter that it is crucial to avoid provisions that act as disincentives to participation and could result in the creation of an Innovation Fund without innovative therapies,” Barmpetaki remarked, after pointing out that PIF has been supporting the creation of such a mechanism for some time.
For Mihalis Himonas, general manager of SFEE, the fund is a positive step towards improving access to innovative medicines in Greece, in line with practices already implemented across Europe.
Commenting to Euractiv, he cautioned, however, that “As the framework is being finalised, it is essential that the fund is supported by adequate and sustainable financing, as well as clear and predictable operational criteria for the pharma companies, ensuring transparency and long-term viability.”
Moving towards a February vote
“With the right structure in place, the Fund can contribute to reducing access inequalities, strengthening the sustainability of the healthcare system, and delivering meaningful benefits for patients and public health,” Himonas noted.
Barmpetaki shared the same belief, underlining the importance of replacing the current approach of putting successive barriers to access with a policy focused on attracting innovative treatments that can demonstrate their value for patients and the health system.
“We consider it essential to expedite the legislative drafting process and to intensify a constructive and productive dialogue with the Ministry of Health, leading to a clear and workable agreement between the state and the pharmaceutical industry on the Fund’s operating terms”, she remarked.
According to the Ministry of Health, the bill is expected to be put to a parliamentary vote in February, with ministry sources telling Euractiv that the text hasn’t been finalised and changes are expected.
[BM]